NovoMix 30 Penfill (NovoMix 30 Penfill) - litaelo tsa tšebeliso

Lebitso la machabeng - novomix 30 penfill

Sebopeho le mofuta oa tokollo.

Ho emisoa bakeng sa tsamaiso ea SC tšoeu, homogenible (ntle le maqhubu, ho ka hlaha mehlala sampole), ha e kopantsoe, e hlohloreha, e theha lekhopho le tšoeu ebile e le 'mala o makatsang kapa o batlang o se na mebala, ka ho tsoaka ka hloko ho kopantseng le ho emisa ho sa kopane. 1 ml e na le "" insulin "ea" insulin "ea methapo e 'meli - 100%," "insulin" "" "(" insulin "" "" "" "" "" "" insulin "" "" "" "" "" "70%"

Bahlomphehi: glycerol - 16 mg, phenol - 1.5 mg, metacresol - 1,72 mg, chloride ea zinc - 19.6 μg, sodium chloride - 0,877 mg, sodium hydrogen phosphate dihydrate - 1,25 mg, protamine sulfate

0,33 mg ea sodium hydroxide

2.2 mg, hydrochloric acid

1,7 mg, metsi d / i - ho fihlela 1 ml.

Ho emisoa d / p / ho kenngoa ha 100 PIECES / 1 ml: li-cartridge 3 ml 5 likhomphutha.

3 ml (300 PIECES) - li-cartridge (5) - maleiri (1) - lipakete tsa karete.

Ketso ea pharmacological.

NovoMix 30 Penfill ke ho emisoa ka mekhahlelo e 'meli e kenyang motsoako oa li-insulin analog: insuble insulin aspart (30% e sebetsang ka nakoana ea insulin analog) le likristale tsa "aspart protamine insulin" (70% e sebetsang ka insulin analog).

Sesebelisoa se sebetsang sa NovoMix 30 Penfill ke insulin aspart, e hlahisoang ke mokhoa o kopanyang oa biotechnology oa DNA o sebelisang mofuta oa Saccharomyces cerevisiae.

Insulin aspart ke insulin e fumanehang habonolo ea motho e thehiloeng ho indices ea molarity.

Kamora taolo e poteletseng ea NovoMix 30 Penfill, phello e ba teng ka nako ea metsotso e 10-20. Boholo
phello e bonoa ka bongata ho tloha ho lihora tse 1 ho isa ho tse 4 kamora ho kenngoa. Nako ea lithethefatsi e fihla lihora tse 24.

Ka teko ea kliniki ea likhoeli tse tharo e bapisang bakuli ba nang le lefu la tsoekere la mofuta oa 2 le ba fumanang NovoMix 30 Penfill le biphasic insulin ea motho makhetlo a mabeli habeli ka letsatsi pele ho lijo tsa hoseng le lijo tsa mantsiboea, NovoMix 30 Penfill e bontšitsoe hore e fokotse tsoekere ea mali ea postprandial ka matla haholo (kamora lijo tsa hoseng le tsa mantsiboea).

Tlhatlhobo ea Meta ho tsoa litekong tse robong tsa kliniki tse amang bakuli ba nang le lefu la tsoekere
Mefuta ea 1 le ea 2 e bonts'itse hore NovoMix 30 Penfill, ha e fanoa pele ho lijo tsa hoseng le lijo tsa mantsiboea, e fana ka taolo e ntle ea litekanyetso tsa tsoekere ea mali ea postprandnal (keketseho e atileng ea likhahla tsa tsoekere ea prandial kamora lijo tsa hoseng, lijo tsa motšeare le lijo tsa mantsiboea), ha li bapisoa le insulin 30 ea motho.

Le ha glucose e potlakileng e ne e phahame ho bakuli ba sebelisang NovoMix 30 Penfill, ka kakaretso, NovoMix 30 Penfill e na le phello e ts'oanang le ho phahama ha hemoglobin ea glycosylated (HbA_1c), joalo ka insulin ea motho ea biphasic 30.

Phuputsong e 'ngoe e amanang le bakuli ba 341 ba nang le lefu la tsoekere la mofuta oa 2, bakuli ba ne ba sa hlophisoe ka lihlopha tsa kalafo feela NovoMix 30 Penfill, NovoMix 30 Penfill ka kopanelo le metformin le metformin hammoho le sulfonylurea derivative.

HbA mahloriso_1c kamora libeke tse 16 tsa kalafo ha lia ka tsa fapana ho bakuli ba amohelang NovoMix 30 Penfill hammoho le metformin le ho bakuli ba fumanang metformin hammoho le sephetho se tsoang ho sulfonylurea. Thutong ena, bakuli ba 57% ba ne ba e-na le basal HbA_1c e ne e phahame ho feta 9%, kalafong ena ea bakuli ba nang le NovoMix 30 Penfill hammoho le metformin ho lebisitse ho fokotseheng ho hoholo hoa mahloriso
Hba_1cho feta ho bakuli ba fumanang metformin hammoho le sulfonylurea.

Phuputsong e 'ngoe, bakuli ba nang le mofuta oa lefu la tsoekere la mofuta oa 2 ba nang le taolo e fokolang ea glycemic ba neng ba sebelisa lithethefatsi tsa hypoglycemic tsa molomo ba ne ba khethiloe lihlopheng tse latelang: ho amohela NovoMix 30 habeli ka letsatsi (bakuli ba 117) le ho amohela insulin glargine hang ka letsatsi (bakuli ba 116). Kamora libeke tse 28 tsa ts'ebeliso ea lithethefatsi, ho fokotseha ho tloaelehileng ha mahloriso a HbA_1c sehlopheng sa NovoMix, Penfill e 30 e ne e le 2,8% (boleng ba mantlha ba mantlha e ne e le 9.7%). Ho 66% le 42% ea bakuli ba sebelisitseng NovoMix 30 Penfill qetellong ea thuto, boleng ba HbA_1c li ne li le ka tlase ho 1% le 6.5%, ka ho latellana. Moetso oa "glucose" o potlakileng o theohile ka 7 mmol / L (ho tloha ho 14,0 mmol / L qalong ea thuto ho fihlela ho 7.1 mmol / L).

Liphetho tsa tlhahlobo ea "meta-data" e fumanoeng nakong ea liteko tsa bongaka tse amang bakuli ba nang le lefu la tsoekere la mofuta oa 2 li bontšitse ho fokotseha hoa palo eohle ea liketsahalo tsa nocturnal hypoglycemia le hypoglycemia e matla ea NovoMix 30 penfill ha e bapisoa le insulin ea motho ea letsatsi la 30 ka nako e ts'oanang. Hypoglycemia ho bakuli ba fumanang NovoMix 30 Penfill e ne e phahame.

Bana le bacha. Ho ile ha etsoa tlhahlobo ea bongaka ea libeke tse 16 e neng e bapisa tsoekere ea mali ka mor'a lijo le NovoMix 30 (pele ho lijo), insulin / biphasic human insulin 30 (pele ho lijo) le isofan-insulin (e fanoe pele ho robala). Phuputso eo e ne e kenyelletsa bakuli ba 167 ba lilemo li 10 ho isa ho 18. Litekanyetso tsa HbA_1c ka bobeli lihlopha li ile tsa lula li le haufi le litekanyetso tsa pele thutong eohle. Hape, ha u sebelisa NovoMix 30 Penfill kapa biphasic insulin ea motho, ho ne ho se na phapang liphihlelong tsa hypoglycemia.

Phuputso e entsoeng ka mahlakore a mabeli e sa boneng mahlo e ile ea boela ea etsoa ho palo ea bakuli ba lilemo tse 6 ho isa ho 12 (bakuli ba 54 kaofela, libeke tse 12 bakeng sa mofuta o mong le o mong oa kalafo). Ts'ebetso ea hypoglycemia le keketseho ea tsoekere ka mor'a lijo lihlopheng tsa bakuli ba sebelisang NovoMix 30 Penfill li ne li le tlase haholo ha li bapisoa le litekanyetso tse teng sehlopheng sa bakuli ba sebelisang insulin ea motho ea bumpas 30. HbA boleng_1c qetellong ea thuto, sehlopheng sa li-insulin tsa motho ea biphasic 30 li ne li le tlase haholo ho feta sehlopheng sa bakuli ba sebelisang NovoMix 30 Penfill.

Bakuli ba baholo. Pharmacodynamics NovoMix 30 Penfill ho bakuli ba tsofetseng le ba senile ha e e-so ithutoe. Leha ho le joalo, liphuputsong tse sa sebetseng tse nang le tšibollo ea likarolo tse peli tse sa sebetseng tse entsoeng ho bakuli ba 19 ba nang le lefu la tsoekere la mofuta oa 2 lefu la lilemo tsa 65-83 (ho bolela lilemo tse 70), li-pharmacodynamics le pharmacokinetics tsa insulin aspart le insulin ea insulin ea batho. Phapang e amanang le pharmacodynamics (tekanyo e phahameng ea infusion ea tsoekere - GIR_max le sebaka se katlasehong ea tekanyo ea tlhahiso ea sona bakeng sa metsotso e 120 ka mor'a ts'ebetso ea litokisetso tsa insulin - AUC_{GIR, 0-120 metsotso}) lipakeng tsa insulin aspart le insulin ea motho ho bakuli ba tsofetseng li ne li tšoana le tsa baithaopi ba phetseng hantle le ho bakuli ba banyenyane ba nang le lefu la tsoekere.

Mofumahali

Ho insulin aspart, ho emisoa ha amino acid proline e maemong a B28 bakeng sa asiti ea aspartic ho fokotsa tloaelo ea limolek'hule tsa ho theha li-hemogle karolong e qhibilihang ea NovoMix 30 Penfill, e hlokometsoeng ka insulin ea insulin. Ntlheng ena, insulin aspart (30%) e kenngoa ho mafura a subcutaneous ka potlako ho feta insulin e qhibilihang e fumanehang ka insulin ea insulin. 70% e setseng e oela ka foromo ea kristale, protamine-insulin aspart, sekhahla sa ho amoheloa se tšoanang le sa "insulin" ea motho.

Khokahano e phahameng ea "insulin" serum ea mali kamora ho tsamaisoa ha NovoMix 30 Penfill e phahame ka makhetlo a 50 ho feta ea biphasic insulin ea motho ea 30, mme nako eo e e nkang ho e fihlela e khutšoanyane habeli ho feta ea biphasic insulin ea motho.

Ho baithaopi ba phetseng hantle, kamora ho tsamaisoa ha scvo ea NovoMix 30 ka tekanyo ea boima ba 'mele ea 0,20 U / kg, palo e phahameng ea insulin aspart ka serum ea mali e fihlile kamora metsotso e 60 mme e bile 140 ± 32 pmol / L. Nako ea T_1/2NovoMix 30, e bonts'a tekanyo ea ho amoheloa ha karoloana e amanang le protamine, e ne e le lihora tse 8-9. Mefuta ea insulin ea insulin e khutletse molemong oa lihora tse 15-18 kamora ho tsamaisoa ha lithethefatsi ka mokhoa o ikhethileng. Bakeng sa bakuli ba nang le lefu la tsoekere la mofuta oa 2 lefu le holimo, ho ile ha fihleloa boholo bo phahameng kamora metsotso e 95 kamora ts'ebetso mme ba lula kaholimo ho bonyane lihora tse 14.

Batho ba baholo le ba senile. Boithuto ba bongaka ba meriana ba NovoMix 30 ho bakuli ba tsofetseng le ba senile ha bo so etsoa. Leha ho le joalo, phapang e lekanang ho li-pharmacokinetics pakeng tsa insulin aspart le insulin ea insulin ea batho ba tsofetseng ho bakuli ba tsofetseng ba nang le lefu la tsoekere la 2 (lilemo tse 65-83, lilemo tse pakeng tsa lilemo tse 70) li ne li tšoana le tsa baithaopi ba phetseng hantle le ho bakuli ba banyenyane ba nang le lefu la tsoekere. Ho bakuli ba tsofetseng, ho ile ha bonoa ho fokotseha ha lebelo la ho amoheloa ha bana, e leng ho ileng ha lebisa ho theoha ha T_max (Metsotso e 82 (sebaka sa ho arola lipotso: metsotso e 60-120), ha karolelano ea boholo bo phahameng (C_max) e ne e ts'oana le e bonoang ho bakuli ba banyane ba nang le lefu la tsoekere la 2, le hanyane ho feta ho bakuli ba nang le lefu la tsoekere la mofuta oa 1.

Bakuli ba nang le mathata a ho renal le hepatic. Phuputso e entsoeng ka pharmacokinetics ea NovoMix 30 Penfill ho bakuli ba nang le bothata ba ho ruruha ba mokokotlo ba mokokotlo le mosebetsi oa hepatic ha ea ka ea etsoa. Leha ho le joalo, ka keketseho ea tekanyetso ea lithethefatsi ho bakuli ba nang le methapo e fapaneng ea aimper le a hepatic, ho ne ho se na liphetoho phetohong ea pharmacokinetics ea soluble insulin aspart.

Bana le bacha. Thepa ea pharmacokinetic ea NovoMix 30 Penfill ho bana le bacha ha e so ithutoe. Leha ho le joalo

Theknoloji ea pharmacokinetic le pharmacodynamic ea soluble aspart insulin e ithutile ho bana (ba lilemo li 6 ho isa ho 12) le bacha (ba lilemo li 13 ho isa ho 17) ba nang le lefu la tsoekere la mofuta oa 1.

Ho bakuli ba lihlopha tsohle tsa lilemo, insulin aspart e ne e khetholloa ka ho kenngoa ka potlako le litekanyetso tsa T_maxjoalo ka batho ba baholo. Leha ho le joalo, boleng ba C_max ka lihlopha tse peli li ne li fapane, e leng ho bonts'a bohlokoa ba khetho ea motho ka mong ea tekanyetso ea insulin.

Ts'ireletseho ea teropo e makatsang. Nakong ea lithuto tsa preclinical, ho ne ho se na kotsi ho batho, e thehiloeng ho data e amoheloang ka kakaretso.

lithuto tsa polokeho ea meriana, sebelisa tšebeliso ea kotsi, ts'ebeliso ea lefutso le kotsi ea ho beleha.

Litekong tsa in vitro, tse kenyeletsang ho tlama insulin le li-receptor tsa IGF-1 le phello ea khalo ea lisele, ho ile ha bontšoa hore thepa ea "insulin" ea insulin e tšoana le ea insulin ea motho. Boithuto bo boetse bo bontšitse hore ho ikarola ho tlamang hoa insulin aspart ho li-insulin receptors ho lekana le ho insulin ea motho.

Mofuta oa 1 oa lefu la tsoekere. Mofuta oa 2 oa lefu la tsoekere (molemong oa ho hanyetsoa ke li-hypoglycemic agents, ho hanyetsa lithethefatsi tsena nakong ea kalafo e kopaneng).

Mokhoa oa ho fokotsa litekanyetso le mokhoa oa ts'ebeliso ea leloala le lecha la 30.

NovoMix 30 Penfill e etselitsoe tsamaiso e tlase. U ke ke ua kenya NovoMix 30 Penfill kahare, kaha sena se ka lebisa ho hypoglycemia e matla. NovoMix 30 e boetse e lokela ho qojoa intramuscularly. NovoMix 30 Penfill bakeng sa infcutaneous insulin infusion (PPII) lipompong tsa insulin e ke ke ea sebelisoa. Tekanyo ea NovoMix 30 Penfill e khethoa ke ngaka ka bonngoe boemong bo bong le bo bong, ho latela litlhoko tsa mokuli. Ho fihlela boemo bo nepahetseng ba glycemia, ho kgothaletswa ho laola khatello ea tsoekere maling le ho fetola tekanyetso ea lithethefatsi.

Bakuli ba nang le lefu la tsoekere la mofuta oa 2, NovoMix 30 Penfill, ba ka fuoa meriana e le monotherapy hape ba kopantsoe le lithethefatsi tsa hypoglycemic maemong ao boemo ba glucose ba mali bo sa laoleheng hantle feela ka lithethefatsi tsa molomo tsa hypoglycemic.

Qalo ea phekolo. Bakeng sa bakuli ba nang le lefu la tsoekere la mofuta oa pele ba babeli ba fuoeng insulin, ba lokela ho sebelisa lethalamo la ho qala la NovoMix 30 Penfill ke likarolo tse 6 pele ho lijo tsa hoseng le likarolo tse 6 pele ho lijo tsa mantsiboea. Ho kenngoa ha likarolo tse 12 tsa NovoMix 30 Penfill hang ka letsatsi mantsiboea (pele ho lijo tsa mantsiboea) le hona hoa lumelloa.

Fetisetsa mokuli ho tsoa litokisetsong tse ling tsa insulin. Ha u fetisetsa mokuli ho tsoa ho insulin ea insulin ea motho ho NovoMix 30 Penfill e lokela ho qala ka ho ts'oana

tekanyetso le mokhoa oa tsamaiso. Ebe u lokisa tekanyetso ho latela litlhoko tsa mokuli ka mong (bona litlhahiso tse latelang bakeng sa karolo ea litekanyetso tsa moriana). Joalo ka mehla, ha u fetisetsa mokuli ho mofuta o mocha oa insulin, ho hlokahala hore a be le taolo e tiileng ea bongaka nakong ea phetisetso ea mokuli le libekeng tsa pele tsa ho sebelisa moriana o mocha.

Matlafatso ea kalafo. Ho matlafatsa kalafo ea "novoMix 30" ea penfill hoa khoneha ka ho fetola tekanyetso e le 'ngoe ea letsatsi le letsatsi ho ea habeli. Ho khothalletsoa hore kamora ho fihlela tekanyetso ea likarolo tse 30 tsa sesebelisoa sa lithethefatsi ts'ebeliso ea NovoMix 30 Penfill habeli ka letsatsi, e arola tekanyetso ka likarolo tse peli tse lekanang - hoseng le mantsiboea (pele ho lijo tsa hoseng le tsa mantsiboea). Phetoho ea ts'ebeliso ea NovoMix 30 Penfill makhetlo a mararo ka letsatsi e ka etsahala ka ho arola tekanyetso ea hoseng ka likarolo tse peli tse lekanang mme o hlahisa likarolo tsena tse peli hoseng le lijong tsa motšeare (makhetlo a mararo a letsatsi le letsatsi lethathamo).

Phetoho ea khokahano. Ho lokisa tekanyo ea NovoMix 30 Penfill, ho sebelisoa haholo ha tsoekere e potlakileng ea tsoekere e fumanoeng matsatsing a mararo a fetileng. Ho hlahloba ho lekana ha tekanyetso e fetileng, sebelisa boleng ba khatello ea tsoekere maling maling pele ho lijo tse latelang. Phetoho ea tekanyetso e ka etsoa hang ka beke ho fihlela boleng ba HbA bo fihletsoeng bo fihlelletsoa._1c. Se ke oa eketsa tekanyetso ea lithethefatsi haeba hypoglycemia e hlokometsoe nakong ena. Phetoho ea moriana e ka ba e hlokahalang ha ho ntlafatsa ts'ebetso ea mokuli, ho fetola lijo tsa hae tse tloaelehileng, kapa ho ba le boemo ba ho phutholoha. Ho lokisa tekanyo ea NovoMix 30 Penfill, ho khothalletsoa ho sebelisa litlhahiso tse latelang bakeng sa tekanyo ea tekanyetso:

Ts'oaetso ea glucose ea mali pele ho lijo	NovoMkks 30 tokiso khafetsa
10 mmol / l	> 180 mg / dl	+ 6 likarolo

Lihlopheng tse ikhethang tsa bakuli. Joalo ka mehla, ha u sebelisa litokisetso tsa "insulin", ho bakuli ba lihlopha tse ikhethileng, khatello ea tsoekere ea mali e lokela ho laoloa ka hloko le litekanyetso tsa "aspart" aspart ka boeona.

Batho ba baholo le ba senile. NovoMix 30 Penfill e ka sebelisoa ho bakuli ba tsofetseng, leha ho le joalo, boiphihlelo ka ts'ebeliso ea eona hammoho le lithethefatsi tsa molomo tsa hypoglycemic ho bakuli ba lilemo tse ka tlase ho 75 li lekanyelitsoe.

Bakuli ba nang le mathata a ho renal le hepatic. Bakeng sa bakuli ba nang le bothata ba ho renal kapa hepatic, tlhoko ea insulin e ka fokotsoa.

Bana le bacha. NovoMix 30 Penfill e ka sebelisoa ho phekola bana le bacha lilemong tse fetang tse 10 maemong ao ho sebelisoang insulin e tsoakiloeng pele. Lintlha tsa kliniki tse fokolang li fumaneha bakeng sa bana ba lilemo tse 6-9 (sheba karolo ea Pharmacodynamic Properties).

NovoMix 30 Penfill e lokela ho tsamaisoa ka mokhoa o sa reng letho ka thipa kapa ka mpeng ea mpa ea mpa. Haeba ho hlokahala, sethethefatsi se ka tšeloa mahetleng kapa marikeng.

Hoa hlokahala ho fetola sebaka sa ente kahare ho sebaka sa anatomical e le ho thibela nts'etsopele ea lipodystrophy.
Joalo ka litokisetso tse ling tsa insulin, nako ea ts'ebetso ea NovoMix 30 Penfill e latela tekanyo, sebaka sa tsamaiso, matla a phallo ea mali, mocheso le boemo ba boikoetliso ba 'mele.

Ha e bapisoa le biphasic insulin ea motho, NovoMix 30 Penfill e qala ho sebetsa kapele, kahoo e lokela ho tsamaisoa hang-hang pele ho lijo. Ha ho hlokahala, NovoMix 30 Penfill e ka tsamaisoa nakoana kamora lijo.

Litaelo bakeng sa bakuli mabapi le tšebeliso ea NovoMix 30 Penfill.

U ke ke ua sebelisa NovoMix 30 Penfill:

Haeba o na le allergic (hypersensitive) ho insulin aspart kapa eng kapa eng ea likarolo tse etsang NovoMix 30 Penfill.

Haeba u ikutloa hore hypoglycemia ea atamela (tsoekere e tlase ea mali).

Bakeng sa infcutaneous insulin infusion (PPII) lipompong tsa isisulin.

Haeba cartridge kapa lisebelisoa tsa ho kenyelletsa ka cartridge e kentsoeng li oele, kapa mokotla o senyehile kapa o sithabetse.

Haeba maemo a polokelo ea moriana a tlotsoe kapa a hoamisitsoe ke serame.

Haeba insulin ha e soeufetse ebile e koahetsoe ke maru ka mor'a ho kopanya.

Haeba likhahla tse tšoeu li lula li ntse li itokisitse kamora ho kopanya kapa haeba likarolo tse tšoeu li khomarela ka tlase kapa mabota a mokotla.

Pele o sebelisa NovoMix 30 Penfill:

Lekola lebokose ho etsa bonnete ba hore ho khethoa mofuta o nepahetseng oa insulin.

Kamehla sheba mokotla oa katse, ho kenyelletsa le piston ea rabara. Se ke oa sebelisa mokotla-kepe haeba o na le tšenyo e bonahalang, kapa haeba lekhalo le bonahala pakeng tsa piston le strip e tšoeu holima cartridge. Bakeng sa tataiso e eketsehileng, bona litaelo tsa ho sebelisa sistimi bakeng sa tsamaiso ea insulin.

Kamehla sebelisa nale e ncha bakeng sa sejo se seng le se seng ho thibela tšoaetso.

NovoMix 30 Penfill le li-needle li etselitsoe feela ts'ebeliso ea motho ka mong.

NovoMix 30 ke ea entcutaneous ente. Le ka mohla u se ke oa tsamaisa insulin ena ka methapo kapa kahare.

Nako le nako, chencha sebaka sa ente sebakeng sa anatomical. Sena se tla thusa ho fokotsa kotsi ea litiiso le liso sebakeng sa ente ea ente. Libaka tse ntle ka ho fetisisa tsa ente ke lebota la ka mpeng la mpa, li-buttocks, serope sa anterior kapa lehetla. Insulin e tla sebetsa ka potlako haeba e kenngoa leboteng la mpa ea ka ntle. Lekola khafetsa khatello ea hau ea tsoekere ea mali.

Tsamaiso ea ho kopanya insulin.

Pele u kenya mokotla mokatong oa ente ho tsamaisa insulin, e tšoare ka mocheso oa kamore ebe o kopanya joalokaha ho hlalositsoe ka tlase.

Ha u sebelisa NovoMix 30 Penfill ka lekhetlo la pele, phutha mokotla ka liatla tsa hau makhetlo a 10 - ho bohlokoa hore mokotla o maemong a otlolohileng. Ka nako eo phahamisa le ho theola cartridge makhetlo a 10 ho ea holimo le tlase e le hore bolo ea khalase e ka har'a mokotla e tlohe pheletsong e 'ngoe ea karache ho ea lehlakoreng le leng. Pheta mananeo ana ho fihlela
ho fihlela mokelikeli o fetoha o mosoeu ebile o koahetsoe ke maru. Mokhoa oa ho kopanya o tla ba bonolo haeba ka nako ena insulin e fihlile mocheso oa kamore. Kenya hang-hang.

Pele ho ente e 'ngoe le e' ngoe e latelang, tšela sesebelisoa sa ente ka mokotla ho sona ho fihlela mokelikeli o fetoha o mosoeu ebile o le maru, empa bonyane makhetlo a 10. Kenya hang-hang.

Lekola hore bonyane likarolo tse 12 tsa insulin li lula mokotleng ho etsa bonnete ba hore li tsoakoa hantle. Haeba ho setse likarolo tse ka tlase ho 12, sebelisa NovoMix 30 Penfill.

Mokhoa oa ho tsamaisa insulin.

Insulin e lokela ho kenngoa ka tlas'a letlalo. Sebelisa mokhoa oa ente o khothalletsoang ke ngaka kapa mooki, latela litaelo tsa tsamaiso ea insulin tse hlalositsoeng litaelong tsa sesebelisoa sa hau sa insulin.

Tšoara nale ka tlasa letlalo la hao bonyane metsotsoana e tšeletseng. E boloka e hatelloa ho fihlela nale e ntšoa tlasa letlalo. Sena se tla netefatsa hore tekanyetso e felletseng ea insulin ea bolokoa 'me e tla thibela mali ho kena ka sekekeng sa insulin kapa mokokotlong.

Kamora ente e 'ngoe le e' ngoe, etsa bonnete ba ho tlosa le ho lahla nale, le ka mohla u se ke oa boloka penvo ea NovoMix 30 ka nale e kentsoeng. Ho seng joalo, mokelikeli o ka tsoa mokotla, o ka hlahisang litekanyetso tse fosahetseng tsa insulin.

Se ke oa tlatsa mokotla ka insulin.

NovoMix 30 Penfill e etselitsoe hore e sebelisoe ka litsamaiso tsa ente ea insulin ea Novo Nordisk le NovoFine kapa NovoTvist.

Haeba NovoMix 30 Penfill le insulin e 'ngoe ka har'a karache ea Penfill e sebelisoa bakeng sa kalafo ka nako e le ngoe, ho bohlokoa ho sebelisa mekhoa e' meli e arohaneng bakeng sa ho tsamaisa insulin, e le 'ngoe bakeng sa mofuta o mong le o mong oa insulin.

Joalo ka tšireletso, lula o na le polokelo ea insulin ha o ka lahleha kapa oa senya Penvo ea hau ea NovoMix 30.

Litlhoko tsa ts'ebeliso Remix e ncha 30 penfilla.

NovoMix 30 Penfill le linale ke tsa ts'ebeliso ea hau feela. Se ke oa tlatsa mokotla oa Penfill. NovoMix 30 Penfill e ka se sebelisoe haeba kamora ho e kopanya e sa soeufale ebile e le maru. E lokela ho totobatsoa ho mokuli tlhokeho ea ho kopanya ho emisoa ha NovoMix 30 Penfill hang hang pele o sebelisoa. Se ke oa sebelisa NovoMix 30 Penfill haeba e le lehloa. Bakuli ba lokela ho lemosoa hore ba lahlele nale ka mor'a ente e 'ngoe le e' ngoe.

Litla-morao.

Boitšoaro bo bobe bo bonoang ho bakuli ba sebelisang NovoMix 30 ke haholo-holo ke phello ea litheko tsa insulin. Ketsahalo e mpe e atileng haholo ka insulin ke hypoglycemia. Khafetsa ea litla-morao tse amanang le ts'ebeliso ea NovoMix 30 e fapana ho latela palo ea bakuli, mofuta oa litla-morao tsa lithethefatsi, le taolo ea glycemic.

Boemong ba pele ba kalafo ea insulin, liphoso tsa refractive, edema le liphetoho li ka hlaha sebakeng sa ente
lithethefatsi (ho kenyelletsa bohloko, redness, urticaria, ho ruruha, hematoma, ho ruruha le ho hlohlona sebakeng sa ente). Hangata matšoao ana ke a nakoana. Phetoho e potlakileng taolong ea glycemic e ka lebisa boemong ba "neuropathy ea bohloko bo hlobaetsang," hangata bo ka khutlisoang. Ho matlafatsoa ha kalafo ea insulin ka ntlafatso e matla taolong ea metabolism ea carbohydrate ho ka lebisa ho mpefala ha nakoana maemong a lefu la tsoekere, ha ntlafatso ea nako e telele taolong ea glycemic e fokotsa kotsi ea tsoelo-pele ea lefu la tsoekere. Lethathamo la litla-morao li hlahisoa tafoleng.

Litlamorao tsohle tse hlahisitsoeng ka tlase, li ipapisitse le tlhahlobo ea tlhahlobo ea kliniki, e hlophisitsoe ho latela sekhahla sa nts'etsopele ho latela MedDRA le tsamaiso ea litho. Tekanyo ea litla-morao e hlalosoa e le: khafetsa (≥1 / 10), hangata (≥ 1/100 ho lithethefatsi, e fokotsa ho kenngoa ha lijo ka bongata.

Mafu a khahlang, haholo a tšoaetsanoang le feberu, hangata a eketsa tlhoko ea mmele ea insulin. Phetoho ea mori le eona e ka hlokahala haeba mokuli a e-na le mafu a a amanang le a liphio, sebete, ho senyeha hoa sesole sa adrenal, gland ea pituitary kapa tšoelesa ea qoqotho.

Ha u fetisetsa mokuli ho mefuta e meng ea insulin, matšoao a pele a li-hypoglycemia a ka fetoha kapa a ba tlase haholo ha a bapisoa le ba sebelisang mofuta oa insulin o fetileng.

Phetisetso ea mokuli ho tsoa litokisetsong tse ling tsa insulin. Ho fetisetsoa ha mokuli ho mofuta o mocha oa insulin kapa tokisetso ea insulin ea moetsi e mong ho tlameha ho etsoa ka tlasa tlhokomelo e thata ea bongaka. Haeba u fetola khatello ea maikutlo, mofuta, moetsi le mofuta (insulin ea motho, analog ea insulin ea motho) ea litokisetso tsa insulin le / kapa mokhoa oa tlhahiso, ho ka hlokahala phetoho ea tekanyetso. Bakuli ba tlohelang litokisetso tse ling tsa insulin ho ea kalafo ka NovoMix 30 Penfill ba ka hloka ho eketsa khafetsa ea liente kapa ho fetola lethal dose ha li bapisoa le litekanyetso tsa litokisetso tsa insulin tsa pele. Haeba ho hlokahala, tokiso ea litekanyetso, e ka etsoa ka ente ea pele ea moriana kapa nakong ea libeke tsa pele kapa likhoeli tsa kalafo.

Likarabelo tsa sebakeng sa ente. Joalo ka kalafo e meng ea insulin, methapo e ka hlaha setsing sa ente, se bonahatsoang ke bohloko, bokhubelu, hives, ho ruruha, hematomas, ho ruruha le ho hlohlona. Ho fetola sebaka sa ente khafetsa sebakeng se tšoanang sa anatomical ho ka fokotsa mats'oao kapa ho thibela nts'etsopele ea maikutlo ana. Reaction hangata e nyamela kamora matsatsi a seng makae ho isa ho libeke tse 'maloa. Maemong a sa tloaelehang, ho ka hlokahala ho hlakola NovoMix 30 Penfill ka lebaka la karabelo setsing sa ente.

Ts'ebeliso e tšoanang ea lithethefatsi tsa sehlopha sa thiazolidinedione le litokisetso tsa insulin.Litaba tsa ho ntlafala ha lefu la pelo le sa foleng li tlalehiloe kalafong ea bakuli ba nang le thiazolidinediones hammoho le litokisetso tsa insulin, haholoholo haeba bakuli ba joalo ba na le mabaka a tlisoang ke ho hola ho sa feleng ha pelo. Ntlha ena e lokela ho ananeloa ha ho fanoa ka phekolo ea ho kopanya le thiazolidinediones le litokisetso tsa insulin ho bakuli. Ka ho khethoa ha mofuta o joalo oa phekolo, ho bohlokoa ho etsa tlhahlobo ea bongaka ea bakuli ho bona matšoao le matšoao a ho se atlehe ha pelo, boima ba mmele le boteng ba edema. Haeba matšoao a ho hloleha ha pelo a mpefala ho bakuli, kalafo e nang le thiazolidinediones e tlameha ho khaotsa.

Tšusumetso ho bokhoni ba ho khanna makoloi le ho sebetsa ka mekhoa.Bokhoni ba bakuli ba ho tsepamisa mohopolo le sekhahla sa karabelo se ka senyeha nakong ea hypoglycemia, e ka bang kotsi maemong ao bokhoni bona bo hlokahalang haholo (mohlala, ha o khanna makoloi kapa o sebetsa ka mechine le metjeko).

Bakuli ba lokela ho eletsoa ho nka mehato ea ho thibela nts'etsopele ea hypoglycemia ha u ntse u khanna. Sena ke sa bohlokoa haholo ho bakuli ba se nang matšoao a tlisoang ke ho ba le hypoglycemia kapa ba nang le liketsahalo tsa khafetsa tsa hypoglycemia. Maemong ana, ho tšoaneleha ho tšoaneleha ha ho khanna le ho etsa mosebetsi o joalo.

Bongata.

Tekanyetso e itseng e hlokahalang bakeng sa overdose ea insulin ha e e-so theoe, empa hypoglycemia e ka hlaha butle butle haeba ho fanoa ka litekanyetso tse phahameng haholo tsa insulin mabapi le litlhoko tsa mokuli.

Mokuli a ka felisa hypoglycemia e bonolo ka ho nka lijo tse tsoekere kapa tsoekere tse nang le tsoekere. Ka hona, ho khothalletsoa hore bakuli ba nang le lefu la tsoekere ba lule ba nkile lihlahisoa tse nang le tsoekere.

Maemong a hypoglycemia e matla, ha mokuli a sa tsebe letho, 0.5 mg ho 1 mg ea glucagon e lokela ho tsamaisoa ka methapo kapa ka tšohanyetso (motho ea koetlisitsoeng a ka tsamaisa) kapa tharollo ea glucose e kenang (dextrose) (ke setsebi sa bongaka feela se ka laelang). Ho hlokahala hape ho fana ka dextrose ka methapo haeba mokuli a sa hlaphoheloe ho hlaphoheloa metsotso e 10-15 kamora ho tsamaisoa ha glucagon. Kamora ho hlaphoheloa kelellong, mokuli o eletsoa ho nka lijo tse nang le lik'habohaedreite ho thibela ho khutla ha hypoglycemia.

Ho sebelisana le lithethefatsi tse ling.

Hypoglycemic phello ea ka insulin eketsa molomo lithethefatsi hypoglycemic, Mao inhibitors, Ace inhibitors, k'habone anhydrase inhibitors, bao e seng khetha beta-blockers, bromocriptine, octreotide, sulphonamides, anabolic steroid, tetracyclines, clofibrate, ketoconazole, mebendazole, pyridoxine, theophylline, cyclophosphamide, fenfluramine, lithethefatsi Li +, ethanol le lithethefatsi tse nang le ethanol. Mekhoa ea ho thibela pelehi ea molomo, corticosteroids, lihormone tsa qoqotho, li-thiazide diuretics, heparin, tridclic antidepressants, sympathomimetics, danazole, clonidine, BMKK, diazoxide, morphine, phenytoin, nikotine e fokolisa phello ea hypoglycemic. Tlas'a tšusumetso ea reserpine le salicylates, ho fokolisa le ho eketsa ts'ebetso ea moriana ho ka khoneha.

Maemo a phomolo a tsoang litlolong tsa litlama.

Lipehelo le maemo a polokelo.

Boloka ka mocheso oa 2 ° C ho isa ho 8 ° C (sehatsetsing), empa eseng haufi le sehatsetsi. Se ke oa chesa. Bakeng sa mabokose a bulehileng: Se ke oa boloka ka sehatsetsing. Boloka ka mocheso o sa feteng 30 ° C. Sebelisa pele ho libeke tse 4.

Boloka mabokose ka lebokoseng la karete ho a sireletsa.

NovoMix 30 Penfill e lokela ho sireletsoa mochesong o matla le khanya. Qoba hole le bana.

Bophelo ba Shelf ke lilemo tse 2.

Ts'ebeliso ea lithethefatsi ea penfill ea Novomix 30 feela joalo ka ha u laetsoe ke ngaka, litaelo li fanoe bakeng sa ho buuoa!

Mokhoa oa kopo ea NovoMix 30 Penfill ka foromo ea ho emisoa

NovoMix® 30 Penfill® e etselitsoe tsamaiso e tlase. Se ke oa tsamaisa NovoMix® 30 Penfill® kahare, kaha sena se ka lebisa ho hypoglycemia e matla. Tsamaiso ea methapo ea methapo ea NovoMix® 30 Penfill® le eona e lokela ho qojoa. Se ke oa sebelisa NovoMix® 30 penfill® bakeng sa infcutaneous insulin infusion (PPII) lipompong tsa insulin.

Tekanyo ea NovoMix® 30 Penfill® e khethoa ke ngaka ka bonngoe boemong bo bong le bo bong, ho latela litlhoko tsa mokuli. Ho fihlela boemo bo nepahetseng ba glycemia, ho kgothaletswa ho laola khatello ea tsoekere maling le ho fetola tekanyetso ea lithethefatsi.

Bakuli ba nang le lefu la tsoekere la mofuta oa 2, NovoMix® 30 Penfill® ba ka fuoa meriana e le monotherapy hape ba kopantsoe le lithethefatsi tse tsoang ho hypoglycemic maemong ao boemo ba glucose ba mali bo sa laoleheng feela ke lithethefatsi tsa molomo tsa hypoglycemic.

Bakeng sa bakuli ba nang le lefu la tsoekere la mofuta oa pele ba babeli ba fuoeng insulin, ba lokela ho sebelisa lethalamo la ho qala la NovoMix® 30 Penfill® ke li-unit tse 6 pele ho lijo tsa hoseng le li 6 unit pele lijong. Ho kenngoa ha likarolo tsa 12 tsa NovoMix® 30 Penfill® hang ka letsatsi ka shoalane (pele ho lijo tsa mantsiboea) le hona hoa lumelloa.

Phetisetso ea mokuli ho tsoa litokisetsong tse ling tsa insulin

Ha u fetisetsa mokuli ho tsoa biphasic insulin ea motho ho NovoMix® 30, Penfill® e lokela ho qala ka lethal dose le mokhoa o tšoanang oa tsamaiso. Ebe u lokisa tekanyetso ho latela litlhoko tsa mokuli ka mong (bona litlhahiso tse latelang bakeng sa karolo ea litekanyetso tsa moriana). Joalo ka mehla ha u fetisetsa mokuli ho mofuta o mocha oa insulin, ho hlokahala tlhokomelo e matla ea bongaka nakong ea phetisetso ea mokuli le libekeng tsa pele tsa ho sebelisa moriana o mocha.

Ho matlafatsa NovoMix® 30 Phekolo ea Penfill® e ka etsahala ka ho fetola tekanyetso e le 'ngoe ea letsatsi le letsatsi ho ea habeli. Ho khothalletsoa hore kamora ho fihlela tekanyetso ea likarolo tse 30 tsa sesebelisoa sa lithethefatsi ts'ebeliso ea NovoMix® 30 Penfill® habeli ka letsatsi, e arola tekanyo ka likarolo tse peli tse lekanang - hoseng le mantsiboea (pele ho lijo tsa hoseng le tsa mantsiboea). Phetoho ea ts'ebeliso ea NovoMix® 30 Penfill® makhetlo a mararo ka letsatsi e khonahala ka ho arola tekanyetso ea hoseng ka likarolo tse peli tse lekanang le ho kenya likarolo tsena tse peli hoseng le lijong tsa mots'eare (makhetlo a mararo a letsatsi le letsatsi).

Ho lokisa tekanyetso ea NovoMix® 30 Penfill®, khatello ea mali e potlakileng ea tsoekere e fumanehang matsatsing a mararo a fetileng e sebelisoa.

Ho hlahloba ho lekana ha tekanyetso e fetileng, sebelisa boleng ba khatello ea tsoekere maling maling pele ho lijo tse latelang.

Phetoho ea tekanyetso e ka etsoa hang ka beke ho fihlela boleng ba HbA1c bo fihlelletsoe.

Se ke oa eketsa tekanyetso ea lithethefatsi haeba hypoglycemia e hlokometsoe nakong ena.

Phetoho ea moriana e ka ba e hlokahalang ha ho ntlafatsa ts'ebetso ea mokuli, ho fetola lijo tsa hae tse tloaelehileng, kapa ho ba le boemo ba ho phutholoha.

Ho lokisa tekanyetso ea NovoMix® 30 Penfill®, ho khothalletsoa ho sebelisa litlhahiso tse latelang tsa litlatsetso tsa tekanyetso:

Ts'oaetso ea glucose ea mali pele ho lijo

Lihlopheng tse ikhethang tsa bakuli

Joalo ka mehla, ha u sebelisa litokisetso tsa "insulin", ho bakuli ba lihlopha tse ikhethileng, khatello ea tsoekere ea mali e lokela ho laoloa ka hloko le litekanyetso tsa "aspart" aspart ka boeona.

Batho ba baholo le ba senile

NovoMix® 30 Penfill® e ka sebelisoa ho bakuli ba tsofetseng, leha ho le joalo, boiphihlelo ka ts'ebeliso ea eona hammoho le lithethefatsi tsa molomo tsa hypoglycemic ho bakuli ba lilemo tse ka tlase ho 75 li lekanyelitsoe.

Bakuli ba nang le mathata a ho renal le hepatic:

Bakeng sa bakuli ba nang le bothata ba ho renal kapa hepatic, tlhoko ea insulin e ka fokotsoa.

Bana le bacha:

NovoMix® 30 Penfill® e ka sebelisoa ho phekola bana le bacha lilemong tse fetang tse 10 maemong ao ho sebelisoang insulin e tsoakiloeng pele. Lintlha tsa kliniki tse fokolang li fumaneha bakeng sa bana ba lilemo tse 6-9 (sheba karolo ea Pharmacodynamic Properties).

NovoMix® 30 Penfill® e lokela ho tsamaisoa ka mokhoa o potang ka lethekeng kapa ka mpeng ea mpa ea mpa. Haeba ho hlokahala, sethethefatsi se ka tšeloa mahetleng kapa marikeng.

Hoa hlokahala ho fetola sebaka sa ente kahare ho sebaka sa anatomical e le ho thibela nts'etsopele ea lipodystrophy. Joalo ka litokisetso tse ling tsa insulin, nako ea ts'ebetso ea NovoMix® 30 Penfill® e itšetlehile ka tekanyo, sebaka sa tsamaiso, matla a phallo ea mali, mocheso le boemo ba tšebetso ea 'mele.

Ha e bapisoa le biphasic insulin ea motho, NovoMix® 30 Penfill® e sebetsa ka potlako ho feta, kahoo e lokela ho tsamaisoa hang-hang pele ho lijo. Haeba ho hlokahala, NovoMix® 30 Penfill® e ka tsamaisoa nakoana kamora lijo.

Mokhoa oa ho sebelisa: litekanyetso le kalafo

S / c seropeng kapa ka mpeng ea mpa ea mpa. Haeba ho hlokahala, sebakeng sa mahetla kapa marikhoe. Hoa hlokahala ho fetola sebaka sa ente kahare ho sebaka sa anatomical e le ho thibela nts'etsopele ea lipodystrophy. Moriana o fanoa hang-hang pele ho lijo, haeba ho hlokahala, hang ka mor'a lijo. Mocheso oa "insulin" o sebelisoang o lokela ho ba ka mocheso oa kamore.

Tekanyetso ea lithethefatsi e khethoa ke ngaka ka bonngoe boemong bo bong le bo bong, ho ipapisitse le khatello ea mali maling. Ka karolelano, tekanyetso ea letsatsi le letsatsi ea NovoMix 30 Penfill ke boima ba 'mele ba 0.5-1 U / kg. Ho bakuli ba hanyetsang insulin (ho kenyeletsoa le ka lebaka la botenya), tlhoko ea insulin ea letsatsi le letsatsi e kanna ea eketsoa, 'me ho bakuli ba nang le insulin ea secretion ea insulin, e kanna ea fokotsoa.

Insulin NovoMiks: tekanyetso ea lithethefatsi bakeng sa tsamaiso, litlhahlobo

Insulin NovoMiks ke setlhare se nang le li-hormone tsa 'mele tse fokotsang tsoekere. E tsamaisoa kalafo ea lefu la tsoekere mellitus, ka bobeli mefuta e itšetlehileng ka insulin le e seng insulin. Nakong ea melon, lefu lena le hasane likhutlong tsohle tsa polanete, ha 90% ea batho ba nang le lefu la tsoekere ba tšoeroe ke mofuta oa bobeli oa lefu lena, karolo e setseng ea 10% - ho tloha sebopeho sa pele.

Video (tlanya ho bapala).

Liente tsa insulin li bohlokoa, ka tsamaiso e sa lekanang, litlamorao tse ke keng tsa fetoloa mmeleng esita le lefu li etsahala. Ka hona, motho e mong le e mong ea nang le lefu la tsoekere la lefu la tsoekere, ba lelapa la hae le metsoalle ba tlameha ho "hlometse" ka tsebo ka lithethefatsi tsa hypoglycemic le insulin, hammoho le ts'ebeliso e nepahetseng ea eona.

Insulin e fumaneha naheng ea Denmark ka mokhoa oa ho emisoa, e ka bang katekong ea 3 ml (NovoMix 30 Penfill) kapa ka pene ea syringe ea 3 ml (NovoMix 30 FlexPen). Ho emisoa ho na le mebala e tšoeu, ka linako tse ling ho etsoa ha li-flakes ho khonahala. Ka ho thehoa ha serethe se tšoeu le mokelikeli o phatsimang ka holim'a lona, o hloka feela ho le sisinya, joalo ka ha ho boletsoe litaelo tse kentsoeng.

Lintho tse sebetsang tsa moriana ke li-insulin tse fumanehang habonolo (30%) le likristale, hammoho le insulin aspart protamine (70%). Ntle le likarolo tsena, lithethefatsi li na le glycerol, metacresol, sodium hydrogen phosphate dihydrate, chloride ea zinc le lintho tse ling.

Video (tlanya ho bapala).

Metsotso e 10-20 ka mor'a ho kenngoa ha moriana tlas'a letlalo, o qala phello ea eona ea hypoglycemic. Insulin aspart e hokahana le li-receptor tsa hormone, ka hona tsoekere e kenngoa ke lisele tsa pherekano le ho sitisa tlhahiso ea eona ho tsoa ho sebete. Kameho e kholo ka ho fetisisa ea tsamaiso ea insulin e bonoa ka mor'a lihora tse 1-4, 'me phello ea eona e nka lihora tse 24.

Lithuto tsa pharmacological ha li kopanya insulin le lithethefatsi tse fokotsang tsoekere tsa mofuta oa II lefu la tsoekere li bontšitse hore NovoMix 30 hammoho le metformin e na le phello e matla ho feta hypoglycemic ho feta kopanyo ea sulfonylurea le metformin.

Leha ho le joalo, bo-ramahlale ha baa ka ba leka litlamorao tsa lithethefatsi ho bana ba banyenyane, batho ba botsofaling le ba nang le mathata a methapo ea lesapo kapa ea liphio.

Ke ngaka feela e nang le tokelo ea ho fana ka tekanyetso e nepahetseng ea insulin, ho nahanela boemo ba glucose maling a mokuli. Re lokela ho hopola hore moriana o fanoa ka bobeli ka mofuta oa lefu lena le kalafo e sa sebetseng ea mofuta oa bobeli.

Ka lebaka la hore li-hormone tsa biphasic li sebetsa ka potlako haholo ho feta lihormone tsa motho, hangata li tsamaisoa pele li ja lijo, leha ho ka etsahala hore u li tsamaise haufinyane kamora hore li fuoe lijo.

Letšoao le tloaelehileng la tlhokeho ea lefu la tsoekere ho hormone, ho latela boima ba lona (ka li-kilogram), ke likarolo tsa 0.5-1 ka letsatsi. Litekanyetso tsa letsatsi le letsatsi tsa lithethefatsi li ka eketseha ha bakuli ba sa nahanele li-hormone (mohlala, ka botenya) kapa li fokotseha ha mokuli a e-na le mehloli e meng ea insulin. Ho molemo ho kenella kahara thipa, empa ho ka etsahala le kahara mpa ea mekotla kapa lehetla. Ha ho ratehe ho hlaba sebakeng se le seng, esita le sebakeng se le seng.

Insulin NovoMix 30 FlexPen le NovoMix 30 Penfill e ka sebelisoa e le sesebelisoa se ka sehloohong kapa se kopantsoe le lithethefatsi tse ling tsa hypoglycemic. Ha e kopantsoe le metformin, lethal dose la pele la hormone ke likarolo tse 0,2 tsa ketso ka kilogramu ka letsatsi. Ngaka e tla khona ho bala tekanyo ea lithethefatsi tsena tse peli ho latela matšoao a glucose maling le litšobotsi tsa mokuli. Re lokela ho hlokomela hore mathata a ho phekola a renal kapa a sebete a ka baka ho fokotseha hoa tlhoko ea lefu la tsoekere ho insulin.

NovoMix e tsamaisoa feela ka mokhoa o ikhethileng (haholoanyane ka algorithm ea ho tsamaisa insulin ka mokhoa o ikhethileng), ho thibetsoe ka thata ho etsa ente ka har'a mesifa kapa kahare. E le ho qoba sebopeho sa li-inferior, hangata ho hlokahala hore u fetole sebaka sa ente. Ho entoa ho ka etsoa libakeng tsohle tse bonts'itsoeng pele, empa phello ea lithethefatsi e etsahala pejana ha e hlahisoa sebakeng sa thekeng.

Setlhare se bolokiloe e le moea oa lilemo ho tloha ka letsatsi la ho lokolloa. Tharollo e ncha e sa sebelisoeng ka sehatsetsing kapa pene ea syringe e bolokiloe sehatsetsing ho tloha ho likhato tse peli ho isa ho tse 8, mme e sebelisoe ka mocheso oa kamore matsatsi a ka tlase ho 30.

Ho thibela khanya ea letsatsi ho kena, lesela le sirelletsang le tlameha ho apesoa pene.

NovoMix ha e na likhohlano ntle le ha fokotseha ka sekhahla sa tsoekere kapa ts'ebetso e eketsehileng ea ntho efe kapa efe e teng.

Re lokela ho hlokomela hore nakong ea pelehi ha ngoana, ha ho litla-morao tse ileng tsa fumanoa ho 'm'a ea lebelletsoeng le ngoana oa hae.

Ha ho anyesa, insulin e ka tsamaisoa, kaha ha e fetisetsoe ho lesea ka lebese. Empa leha ho le joalo, pele a sebelisa NovoMix 30, mosali o hloka ho buisana le ngaka e tla fana ka litlolo tse sireletsehileng.

Ha e le kotsi e ka bakoang ke moriana, e amana haholo le boholo ba litekanyetso. Ka hona, ho bohlokoa haholo ho fana ka moriana o laetsoeng, ho shebella litlhahiso tsohle tsa ngaka. Litlamorao tse ka ba teng:

Boemo ba hypoglycemia (ho feta mabapi le hore na hypoglycemia ke eng ho lefu la tsoekere), e tsamaeang le ho felloa ke kelello le ho ts'oaroa.
Ho potlaka letlalong, urticaria, ho hlohlona, ho fufuleloa, ho phahama ha anaphylactic, angioedema, ho eketseha ha pelo le ho fokotsa khatello ea mali.
Fetoha ka tokollo, ka linako tse ling - nts'etsopele ea retinopathy (ho se sebetse hantle ha likepe tsa retina).
Lipid dystrophy sebakeng sa ente, hammoho le bofubelu le ho ruruha sebakeng sa ente.

Maemong a ikhethileng, ka lebaka la ho se tsotelle ha mokuli, ho ka hlaha lithethefatsi tse ngata, matšoao a tsona a fapana, ho latela boteng ba boemo bona. Matšoao a hypoglycemia ke ho otsela, pherekano, ho nyekeloa, ho hlatsa, tachycardia.

Ka overdose e bonolo, mokuli o hloka ho ja sehlahisoa se nang le tsoekere e ngata. E ka ba li-cookies, lipompong, lero le monate, ho bohlokoa hore o be le ho hong lenaneng lena. Tekanyetso e feteletseng e hloka ts'ebetso ea "glucagon" hang-hang, haeba mmele oa mokuli o sa arabele ente ea glucagon, mofani o lokela ho tsamaisa tsoekere.

Kamora ho etsa hore boemo bo tloaelehe, mokuli o lokela ho sebelisa lik'habohaedreite habonolo ho thibela hypoglycemia e phetoang hangata.

Ha o fana ka ente ea insulin ea NovoMix 30, bohlokoa bo lokela ho fanoa ke hore lithethefatsi tse ling li na le phello ho phello ea eona ea hypoglycemic.

Joala haholo bo eketsa phello e fokotsang tsoekere ea insulin, 'me beta-adrenergic blockers li-mask tsa matšoao a boemo ba hypoglycemic.

Ho latela lithethefatsi tse sebelisoang hammoho le insulin, ts'ebetso ea eona e ka eketseha le ho fokotseha.

Ho fokotseha ha tlhoko ea li-hormone ho bonoa ha ho sebelisoa lithethefatsi tse latelang:

lithethefatsi tse kahare tsa hypoglycemic,
monoamine oxidase inhibitors (MAO),
angiotensin converting enzyme (ACE) inhibitors,
beta-adrenergic blockers
octreotide
li-anabolic steroids
salicylates,
sulfonamides,
lino tse tahang.

Lithethefatsi tse ling li fokotsa ts'ebetso ea insulin mme li eketsa tlhoko ea mokuli bakeng sa eona. Ts'ebetso e joalo e etsahala ha ho sebelisoa:

lihormone tsa qoqotho
glucocorticoids,
kutloelo-bohloko
danazole le thiazides,
lithibela-pelehi tse nkang kahare.

Lithethefatsi tse ling ha li lumellane le NovoMix insulin. Pele ho tsohle, ke lihlahisoa tse nang le li-thiols le sulfite. Mori o boetse o thibetsoe ho kenyelletsa tharollo ea infusion. Ho sebelisa insulin le li-agents tsena ho ka lebisa litlamorao tse mpe haholo.

Kaha sethethefatsi se hlahisoa kantle ho naha, theko ea sona e phahame haholo. E ka rekoa ka lengolo la ngaka litlakeng kapa ea odara inthanete webosaeteng ea morekisi. Litsenyehelo tsa moriana li itšetlehile ka hore na tharollo e ka har'a k'habote kapa pente ea syringe le hore na e paka eng. Theko e fapana bakeng sa NovoMix 30 Penfill (likhara tse 5 ka pakete) - ho tloha ho li-ruble tse 1670 ho isa ho 1800 tsa Russia, mme NovoMix 30 FlexPen (lipeni tse 5 tsa syringe ka pakete) e na le litšenyehelo ho tloha ho 1630 ho isa ho li-ruble tsa Serussia tse 2000.

Litlhahlobo tsa batho ba bangata ba nang le lefu la tsoekere ba kenang li-biphasic hormone li ntle. Ba bang ba re ba fetohetse NovoMix 30 kamora ho sebelisa li-insulin tse ling tsa maiketsetso. Mabapi le sena, hoa khoneha ho totobatsa melemo e joalo ea lithethefatsi joalo ka tšebeliso ea ts'ebeliso le ho fokotseha ha monyetla oa boemo ba hypoglycemic.

Ntle le moo, leha moriana o e-na le lethathamo le le leng la lintho tse ka 'nang tsa hlaha hampe, li etsahala ka seoelo. Ka hona, NovoMix e ka nkoa e le lithethefatsi tse atlehileng ka botlalo.

Ehlile ho bile le litlhahlobo tsa hore maemong a mang o ne a sa tšoanele. Empa moriana o mong le o mong o na le li-contraindication.

Maemong moo pheko e sa lokelang mokuli kapa e bakang litla-morao, ngaka e eang e ka fetola mofuta oa kalafo. Ho etsa sena, o fetola tekanyetso ea moriana kapa o bile o hlakola tšebeliso ea oona. Ka hona, ho na le tlhoko ea ho sebelisa moriana o nang le phello e tšoanang ea hypoglycemic.

Ho lokela ho hopoloa hore litokisetso tsa Penfill tsa NovoMix 30 le NovoMix 30 ha li na li ka bapisoa le karolo e sebetsang - insulin. Ngaka e ka u fa moriana o nang le litlamorao tse tšoanang.

Meriana ena e rekisoa ka taelo ea ngaka. Ka hona, haeba ho hlokahala, kalafo ea insulin, mokuli o lokela ho buisana le ngaka.

Lithethefatsi tse nang le litlamorao tse tšoanang ke tsena:

Humalog Remix 25 ke analogue ea maiketsetso ea qoqotho e hlahisoang ke 'mele oa motho. Karolo e ka sehloohong ke insulin lispro. Motsoako o boetse o na le phello e khuts'oane ka ho laola maemo a glucose le metabolism ea ona. Ke ho emisoa ka tšoeu, e ntšoang ka pene ea syringe e bitsoang Quick Pen. Litsenyehelo tse tloaelehileng tsa moriana (lipeni tse 5 tsa lisenthara tse 3 ml ka 'ngoe) ke li-ruble tse 1860.
Himulin M3 ke insulin e sebetsanang le maemo a mahareng e lokolloang ka ho emisoa. Naha ea tlhahiso ea moriana ona ke Fora. Ntho e sebetsang ea lithethefatsi ke insulin ea motho. Ka mokhoa o hlakileng e fokotsa khatello ea "glucose" maling ntle le ho baka ho qala ha hypoglycemia. Marakeng oa meriana oa Russia, ho ka rekoa mefuta e mengata ea litlhare, joalo ka Humulin M3, Humulin Regular, kapa Humulin NPH. Theko e tloaelehileng ea lithethefatsi (lisenthimithara tse 5 tsa 3 ml) e lekana le li-ruble tse 1200.

Motsoako oa sejoale-joale o tsoetse pele, hona joale liente tsa insulin li hloka ho etsoa makhetlo a 'maloa feela ka letsatsi. Lipene tsa samente tse bonolo li nolofalletsa mokhoa ona khafetsa. Mmaraka oa meriana o fana ka khetho e mengata ea li-insulin tse fapaneng tsa maiketsetso. E 'ngoe ea lithethefatsi tse tsebahalang ke NovoMix, e fokotsang maemo a tsoekere ho litekanyetso tse tloaelehileng ebile e sa lebise ho hypoglycemia. Tšebeliso e nepahetseng ea eona, hammoho le lijo le ho ikoetlisa li tla netefatsa bophelo bo bolelele le bo se nang bohloko ho batho ba lefu la tsoekere.

Ntho ea thuso ea pele
Lebenkele la inthanete
Mabapi le k'hamphani
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Motsamaisi oa lebitso:
+7 (495) 258-97-03
+7 (495) 258-97-06
Email: imeile e sirelelitsoe
Aterese: Russia, 123007, Moscow, ul. 5th Trunk, d.12.

Sebaka sa marang-rang sa semmuso sa Radar Sehlopha sa Likhamphani ®. Encyclopedia ea mantlha ea lithethefatsi le thepa ea bongaka ea semmuso ea Marang-rang ea Russia. Lenane la lithethefatsi Rlsnet.ru le fa basebelisi monyetla oa ho fumana litaelo, litheko le litlhaloso tsa lithethefatsi, tlatsetso ea lijo, lisebelisoa tsa bongaka, lisebelisoa tsa bongaka le lihlahisoa tse ling. Tataiso ea meriana e kenyelletsa tlhahisoleseling mabapi le sebopeho le mofuta oa tokollo, ts'ebetso ea pharmacological, matšoao a ts'ebeliso, contraindication, litla-morao, tšebelisano ea lithethefatsi, mokhoa oa ts'ebeliso ea lithethefatsi, lik'hamphani tsa meriana. Sesebelisoa sa lithethefatsi se na le litheko tsa meriana le lihlahisoa tsa meriana ho la Moscow le metseng e meng ea Russia.

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Ha u qotsa lisebelisoa tsa tlhahisoleseling tse phatlalalitsoeng maqepheng a sebaka sa marang-rang sa www.rlsnet.ru, ho hokela mohloli oa tlhahisoleseling.

Re har'a marang-rang a sechaba:

Litokelo tsohle li sirelelitsoe.

Ts'ebeliso ea thepa ea khoebo ha e lumelloe.

Tlhahisoleseling ena e etselitsoe litsebi tsa tlhokomelo ea bophelo bo botle.

INSULINUM ASPARTUM A10A D05

HO FIHLELA LEFOMO LA SEBELISO:

belaela. d / ka. 100 IU / ml cartridge 3 ml, sehlaha. ka kalakeng ea syringe, Che. 1, Che. 5

No. UA / 4862/01/01 ho tloha ka la 2/15 / 100 ho isa ho la 2/15 / 2015

hypoglycemia, hypersensitivity ho insulin aspart kapa motsoako ofe kapa ofe oa lithethefatsi.

karabelo e mpe e bonoang ho bakuli ba sebelisang NovoMix 30 FlexPen e amana haholo le boholo ba tekanyetso e sebelisitsoeng ea moriana mme ke pontšo ea ketso ea meriana le insulin. Litlamorao tse atileng haholo tsa kalafo ea insulin ke hypoglycemia. E ka etsahala haeba tekanyo e feta haholo tlhoko ea mokuli ea insulin. Hypoglycemia e matla e ka baka ho felloa ke letsoalo le / kapa ho tsitsinyeha, e lateloang ke ho senyeha hoa nakoana hoa ts'ebetso ea boko esita le lefu. Ho latela liphetho tsa lithuto tsa bongaka, le tlhaiso-leseling e tlalehiloeng kamora hore moriana o thelisoe 'marakeng, liketsahalo tsa hypoglycemia tse ngata li fapana ka lihlopha tse fapaneng tsa bakuli le ka litekanyetso tse fapaneng tsa litekanyetso, ketsahalo ea hypoglycemia e matla ho bakuli ba fumanang insulin aspart e tšoana le ho ba amohelang batho insulin
Se latelang ke khafetsa ea karabelo e mpe eo, ho ea ka lithuto tsa tleliniki e ka amanngoeng le ho hlahisoa ha moriana NovoMix 30 Flexpen.
Ho latela khafetsa ea liketsahalo, liphetoho tsena li arotsoe ka tsona ka linako tse ling (>1/1000, 1/10 000,

Litags: Novo Nordisk, NOVOMIX 30 FLEXPEN, NOVOMIX 30 FLEXPEN

Ketso ea pharmacological

Hypoglycemic agent, analogue ea insulin ea motho ea nako e mahareng.

E sebetsana le receptor e itseng kahara metso ea ka ntle ea lisele mme e etsa motsoako oa "insulin-receptor" o kenyelletsang ts'ebetso ea methapo, ho kenyeletsa synthetese ea li-enzymes tse 'maloa tsa bohlokoa (hexokinase, pyruvate kinase, glycogen synthetase). Ho fokotseha ha tekanyo ea tsoekere maling maling ke ka lebaka la keketseho ea lipalangoang tsa eona tse ka hare, ho eketsoa hoa bongata ke lisele, ho hlohlelletsa polelo ea lipogenesis, glycogenogeneis, le phokotso ea sekhahla sa tlhahiso ea tsoekere ke sebete.

E na le ts'ebetso e tšoanang le ea insulin ea motho ka tsela e lekanang. Ho ts'oaroa ha proline ea amino acid e maemong a B28 ka aspic acid ho fokotsa tloaelo ea limolek'hule tsa ho theha li-hexamers karolong e qhibilihang ea lithethefatsi, e bonoang ka insulin ea metsi a qhibilihang. Ntlheng ena, insulin aspart e nkuoa ho tsoa ho mafura a subcutaneous ka potlako ho feta insulin e qhibilihang e fumanehang ka insulin ea insulin. Protulin ea "insulin" e kenngoa nako e telele.

Kamora 's / c tsamaiso ea NovoMix 30 Penfill, phello e ba teng kamora metsotso e 10-20, phello e kholo - ka lihora tse 11. Nako ea ts'ebetso ea NovoMix 30 Penfill e fihla lihora tse 24 (ho latela tekanyo, sebaka sa tsamaiso, matla a phallo ea mali, mocheso oa' mele le boemo ba ts'ebetso ea 'mele. )

Tlhophiso ea Nosological (ICD-10)

Ho emisoa bakeng sa tsamaiso e potolohileng	1 ml
ntho e sebetsang:
"insulin" - "insulin" insulin ("%") le li-insulin tsa "insulin" ("70%)"	Li-PIECES tse 100 (3.5 mg)
Baeti: glycerol - 16 mg, phenol - 1.5 mg, metacresol - 1,72 mg, chloride ea zinc - 19.6 mg, sodium chloride - 0,877 mg, sodium hydrogen phosphate dihydrate - 1,25 mg, protamine sulfate - hoo e ka bang 0.33 mg sodium hydroxide - e ka bang 2,2 mg, hydrochloric acid - e ka bang 1,7 mg, metsi a ente - ho fihla ho 1 ml
Cartridge e le 'ngoe (3 ml) e na le likarolo tse 300

NOVOMIKS 30 Fofa - foromo ea ho lokolla, sebopeho le sephutheloana

Ho emisoa bakeng sa tsamaiso ea SC soeufetse, o hloekile (ntle le makhopho, makhapetla a ka hlaha sampole), ha e kopantsoe, ea thella, e etsa sethala se mosoeu ebile e le 'mala o motala kapa o batlang o se na' mala, ka mokhoa o hlokolosi o lokela ho theha ho emisoa ho hoholo.

PRING glycerol, phenol, metacresol, chloride ea zinc, sodium chloride, sodium hydrogen phosphate dihydrate, protamine sulfate, sodium hydroxide, hydrochloric acid, metsi d / i.

* Setsi sa 1 se tšoana le 35 μg (kapa 6 nmol) ea "anulin" ea "insulin".

3 ml (300 PIECES) - li-cartridge tsa khalase (1) - lipentšele tsa syringe tsa mefuta e mengata ea li-ente tse 'maloa (5) - liphutheloana tsa karete.

Analogue ea insulin ea motho ea nako e mahareng ka ho qaleha ho potlaka ha ketso.

NovoMix 30 Flexpen ke ho emisoa ka mekhahlelo e 'meli ho kenyelletsa "anulin insulin anart" (30% e nkang insulin analog) le likristale tsa "analog" ea "insulin" ("70%"-insulin analog).

Insulin aspart e fumanoang ke recotomantant biotechnology ea DNA e sebelisa mofuta oa Saccharomyces cerevisiae.

Insulin aspart ke insulin e fumanehang habonolo ea motho e thehiloeng ho indices ea molarity.

Ho fokotseha ha tekanyo ea tsoekere maling ho etsahala ka lebaka la keketseho ea lipalangoang tsa eona tse kahare kamora ho tlangoa ha insulin aspartors ea mesifa le mafura le thibelo ea tlhahiso ea tsoekere ke sebete.

Kamora ho ts'oaroa ha s / No taMix 30 ea lithethefatsi, phello e ba teng kamora metsotso e 10-20. Phello e phahameng e bonoa lihora tse 1-4 kamora ho ente.Nako ea lithethefatsi e fihla lihora tse 24.

Ka teko ea kliniki ea likhoeli tse tharo e bapisang bakuli ba nang le lefu la tsoekere la mofuta oa 2 le ba fumanang NovoMix 30 Flex Pen le biphasic insulin ea motho makhetlo a 2 2 / letsatsi pele ho lijo tsa hoseng le lijo tsa mantsiboea, NovoMix 30 FlexPen e bontšitsoe hore e fokotsa khatello ea "gluprose" ea postprandial glucose. (Kamora lijo tsa hoseng le tsa mantsiboea).

Tlhahlobo ea "meta" ea data e fumanoeng litekong tse 9 tsa kliniki tse amang bakuli ba nang le lefu la tsoekere la mofuta oa 2, e bonts'itse hore NovoMix 30 FlexPen, ha e fanoa pele ho lijo tsa hoseng le lijo tsa mantsiboea, e fana ka taolo e ntle ea khatello ea "glucose" ea postprandial ka bongata maling lijo tsa hoseng, lijo tsa motšeare le lijo tsa mantsiboea), ha li bapisoa le insulin ea batho ea bophasic 30. Le ha khatello ea tsoekere e potlakileng ho bakuli ba fumanang Novo Remix 30 FlexPen e ne e phahame, ka kakaretso NovoMix 30 FlexPen e fana ka tšoanang. ystvie ea mahloriso ea haemoglobin glycosylated (HbA_1C), joalo ka insulin ea motho ea biphasic 30.

Phuputsong e 'ngoe e amanang le bakuli ba nang le mofuta oa lefu la tsoekere la mofuta oa 2 mellitus (n = 341), bakuli ba ne ba hlophisitsoe ka mokhoa o hlophisitsoeng ho lihlopha tsa kalafo feela ka NovoMix 30 FlexPen, NovoMix 30 FlexPen hammoho le metformin le metformin e kopantsoeng le litlamorao tsa sulfonylurea. HbA mahloriso_1C kamora libeke tse 16 tsa kalafo ha lia ka tsa fapana ho bakuli ba amohelang NovoMix 30 Flexpen hammoho le metformin le ho bakuli ba fumanang metformin hammoho le sepheo se tsoang ho sulfonylurea. Thutong ena, bakuli ba 57% ba ne ba e-na le basal HbA_1C e ne e phahame ho feta 9%, ho lingaka tsena tsa kalafo tse nang le NovoMix 30 FlexPen hammoho le metformin ho lebisitse ho fokotseheng ho hoholo hoa mahloriso a HbA_1Cho feta ho bakuli ba fumanang metformin hammoho le sulfonylurea.

Phuputsong e 'ngoe, bakuli ba nang le mofuta oa lefu la tsoekere la mofuta oa 2 ba nang le taolo e fokolang ea glycemic ba nkileng litlhare tsa hypoglycemic tsa molomo ba ile ba ngolisoa ka kotlolloho lihlopheng tse latelang: NovoMix 30 FlexPen makhetlo a 2 / ka letsatsi (bakuli ba 117) le insulin glargine 1 nako / letsatsi (bakuli ba 116). Kamora libeke tse 28 tsa ts'ebeliso ea lithethefatsi, ho fokotseha ho tloaelehileng ho HbA_1C sehlopheng sa kopo ea NovoMix, 30 Flexpen e ne e le 2,8% (boleng ba mantlha ba mantlha e ne e le 9.7%). 66% le 42% ea bakuli ba sebelisang NovoMix 30 FlexPen ba ile ba tšoauoa ka litekanyetso tsa HbA qetellong ea thuto_1C ka tlase ho 7% le 6.5% ka ho latellana. Moetso oa "glucose" o potlakileng o theohile ka 7 mmol / L (ho tloha 14 mmol / L qalong ea thuto ho isa ho 7.1 mmol / L).

Liphetho tsa tlhahlobo ea "meta-data" e fumanoeng litekong tsa bongaka tse amang bakuli ba nang le lefu la tsoekere la mofuta oa 2 ho bontšitse ho fokotseha hoa palo eohle ea liketsahalo tsa nocturnal hypoglycemia le hypoglycemia e matla ea NovoMix 30 FlexPen ha e bapisoa le insulin ea motho ea letsatsi le letsatsi. hypoglycemia ho bakuli ba fumanang NovoMix 30 Flexpen e ne e phahame haholo.

Phuputso ea bongaka ea libeke tse 16 e ile ea etsoa ho bana le lilemong tsa bocha tse neng li bapisa tsoekere ea mali ka mor'a lijo le NovoMix 30 FlexPen (pele ho lijo), insulin / biphasic insulin ea motho (pele ho lijo) le insulin-isophan (e fanoe pele robala). Phuputso eo e ne e kenyelletsa bakuli ba 167 ba lilemo li 10 ho isa ho 18. Litekanyetso tsa HbA_1C ka bobeli lihlopha li ile tsa lula li le haufi le litekanyetso tsa pele thutong eohle. Hape, ha u sebelisa NovoMix 30 Flexpen kapa biphasic insulin ea motho, ho ne ho se na phapang liphihlelong tsa hypoglycemia. Phuputso e entsoeng ka mahlakore a mabeli e sa boneng mahlo e ile ea boela ea etsoa ho palo ea bakuli ba lilemo tse 6 ho isa ho 12 (bakuli ba 54 kaofela, libeke tse 12 bakeng sa mofuta o mong le o mong oa kalafo).Ts'ebetso ea hypoglycemia le keketseho ea tsoekere ka mor'a ho ja sehlopheng se tšoaroang ka NovoMix 30 FlexPen li ne li le tlase haholo ha li bapisoa le boleng ba sehlopha se sebelisang insulin ea motho ea bumpas 30. Litekanyetso tsa HbA_1C qetellong ea thuto, sehlopheng sa li-insulin tsa biphasic tsa motho tse 30 li ne li le tlase haholo ho feta sehlopheng se sebelisang NovoMix 30 Flexpen.

Pharmacodynamics ea NovoMix 30 FlexPen ho bakuli ba tsofetseng le ba senile ha e so ithutoe. Leha ho le joalo, liphuputsong tse sa sebetseng tse nang le tšibollo ea likarolo tse peli tse sa sebetseng tse entsoeng ho bakuli ba 19 ba nang le lefu la tsoekere la mofuta oa 2 lefu la lilemo tsa 65-83 (ho bolela lilemo tse 70), li-pharmacodynamics le pharmacokinetics tsa insulin aspart le insulin ea insulin ea batho. Phapang e amanang le pharmacodynamics (tekanyo e phahameng ea infusion ea tsoekere - GIR_max le sebaka se katlasehong ea tekanyo ea tlhahiso ea sona bakeng sa metsotso e 120 ka mor'a ts'ebetso ea litokisetso tsa insulin - AUC_{GIR, 0-120 metsotso}) lipakeng tsa insulin aspart le insulin ea motho ho bakuli ba tsofetseng li ne li tšoana le tsa baithaopi ba phetseng hantle le ho bakuli ba banyenyane ba nang le lefu la tsoekere.

Ho insulin aspart, ho emisoa ha proline amino acid e maemong a B28 bakeng sa asiti ea aspartic ho fokotsa tloaelo ea limolek'hule tsa ho theha li-hexamers karolong e qhibilihang ea NovoMix ® 30 FlexPen ®, e bonoang ka insulin ea metsi. Ntlheng ena, insulin aspart (30%) e kenngoa ho mafura a subcutaneous ka potlako ho feta insulin e qhibilihang e fumanehang ka insulin ea insulin. 70% e setseng e oela ka foromo ea kristale ea protamine-ipsulin aspart, sekhahla sa ho amoheloa se tšoanang le sa "insulin" ea motho.

Ha o sebelisa NovoMix ® 30 FlexPen ® C_max serum insulin e kaholimo ho 50% ho feta ha u sebelisa insulin ea motho ea bumpas 30, ha nako ea ho fihla C e fihla_max Makhetlo a 2 tlase ka karolelano. Ha s / c tsamaiso ea moriana e fihla ho baithaopi ba phetseng hantle ka tekanyo ea 0,2 U / kg boima ba 'mele C_max insulin aspart e ne e le 140 ± 32 pmol / L mme e fumanoe kamora metsotso e 60.

Ho bakuli ba nang le lefu la tsoekere la mofuta oa 2 lefu la tsoekere_max e fihletse metsotso e 95 ka mor'a taolo mme e lutse e le kaholimo ho lihora tse 14 bonyane

Ts'ebetso ea serum insulin e khutlela boemong ba eona ba pele kamora lihora tse 15-18 ka mor'a ho entoa ka sc.

T_1/2e bontšang sekhahla sa ho kenngoa ha karoloana e amanang le protamine ke lihora tse 8-9

Pharmacokinetics maemong a khethehileng a kliniki

Boithuto ba bongaka ba li-pharmacokinetics ba NovoMix ® 30 FlexPen ® ho bakuli ba tsofetseng ha boa etsoa. Leha ho le joalo, phapang e teng ka har'a pharmacokinetics lipakeng tsa insulin aspart le insulin ea insulin ea batho ba tsofetseng ho bakuli ba tsofetseng ba nang le mofuta oa 2 lefu la tsoekere (lilemo tse 65-83, lilemo tse pakeng tsa lilemo tse 70) li ne li tšoana le tsa baithaopi ba phetseng hantle le ho bakuli ba banyenyane ba nang le lefu la tsoekere la mellitus. Ho bakuli ba tsofetseng, ho ile ha bonoa ho fokotseha ha lebelo la ho amoheloa ha bana, e leng ho ileng ha lebisa ho theoha butle ha T_max (Linomoro tse mashome a mahlano a metso e meraro (bophara ba li-interquartile: 60-120 metsotso), ha karolelano C_max e ne e ts'oana le e bonoang ho bakuli ba banyane ba nang le lefu la tsoekere la 2, le hanyane ho feta ho bakuli ba nang le lefu la tsoekere la mofuta oa 1.

Phuputso e entsoeng ka pharmacokinetics ea NovoMix ® 30 FlexPen ® ho bakuli ba nang le bothata ba ho ruruha ba mokokotlo le mosebetsi oa hepatic ha ea ka ea etsoa. Leha ho le joalo, ka keketseho ea tekanyetso ea lithethefatsi ho bakuli ba nang le methapo e fapaneng ea aimper le a hepatic, ho ne ho se na phetoho ho pharmacokinetics ea soluble insulin aspart.

Thepa ea pharmacokinetic ea NovoMix ® 30 FlexPen ® ho bana le lilemong tsa bocha ha e so ithutoe. Leha ho le joalo, thepa ea pharmacokinetic le pharmacodynamic ea soluble insulin aspart e ithutile ho bana (ba lilemo li 6 ho isa ho 12) le bacha (ba lilemo li 13 ho isa ho 17) ba nang le lefu la tsoekere la mofuta oa 1.Ho bakuli ba lihlopha tsohle tsa lilemo, insulin aspart e ne e khetholloa ka ho kenngoa ka potlako le litekanyetso tsa T_maxjoalo ka batho ba baholo. Leha ho le joalo, boleng ba C_max ka lihlopha tse peli li ne li fapane, e leng ho bonts'a bohlokoa ba khetho ea motho ka mong ea tekanyetso ea insulin.

NovoMix30 FlexPen e etselitsoe tsamaiso ea sc. Setlhare se ke ke sa tsamaisoa iv. hona ho ka lebisa ho hypoglycemia e matla. Ho hlokahala hape ho qoba tsamaiso ea methapo ea NovoMix30 FlexPen. Se ke oa sebelisa NovoMix 30 FlexPen bakeng sa infcutaneous insulin infusion lipompong tsa insulin.

Tekanyo ea NovoMix 30 FlexPen e khethoa ke ngaka ka bonngoe le maemong ohle, ho latela litlhoko tsa mokuli. Ho fihlela litekanyetso tse ngata tsa glycemia, ho kgothaletswa ho lekola phallo ea tsoekere maling le ho fetola tekanyetso ea lithethefatsi.

Bakuli ba nang le mofuta oa lefu la tsoekere la mofuta oa 2 mellitus NovoMix 30 FlexPen ba ka fuoa meriana e le monotherapy hape ba kopantsoe le lithethefatsi tsa hypoglycemic le maemong ao ha boemo ba glucose ba mali bo sa laoloeng ka ho lekana ke lithethefatsi tsa hypoglycemic tsa molomo.

Bakeng sa mofuta oa bakuli ba 2 ba lefu la tsoekere ba fuoeng insulin pele, lethalori la ho qala la NovoMix 30 FlexPen le khothalletsoang ke li-unit tse 6 pele ho lijo tsa hoseng le 6 unit pele lijong. Kenyelletso ea likarolo tse 12 tsa NovoMix 30 Flexpen e boetse e lumelloa nako e 1 / letsatsi ka shoalane (pele ho lijo tsa mantsiboea).

Phetisetso ea mokuli ho tsoa litokisetsong tse ling tsa insulin

Ho ho fetisetsa mokuli ho tsoa biphasic insulin ea motho ho NovoMix 30 Flexpen lokela ho qala ka lethal dose le mofuta o tšoanang. Ebe u lokisa tekanyetso ho latela litlhoko tsa mokuli ka mong (bona tafole bakeng sa litlhahiso mabapi le karolo ea lithethefatsi). Joalo ka mehla ha u fetisetsa mokuli ho mofuta o mocha oa insulin, ho hlokahala hore a be le taolo e tiileng ea bongaka nakong ea phetisetso ea mokuli le libekeng tsa pele tsa ho sebelisa moriana o mocha.

Ho matlafatsa kalafo ea NovoMix 30 FlexPen hoa khoneha ka ho fetola tekanyetso ea letsatsi le letsatsi ho ea habeli. Ho khothalletsoa hore kamora ho fihlela tekanyetso ea likarolo tse 30 tsa sesebelisoa sa lithethefatsi ts'ebelisong ea NovoMix 30 Flexpen makhetlo a 2 / ka letsatsi, o arola tekanyetso ka likarolo tse 2 tse lekanang - hoseng le mantsiboea (pele ho lijo tsa hoseng le tsa mantsiboea).

Phetoho ea ts'ebeliso ea NovoMix 30 Flexpen makhetlo a 3 / ka letsatsi e ka khoneha ka ho arola tekanyetso ea hoseng ka likarolo tse 2 tse lekanang mme o tsamaise likarolo tsena tse peli hoseng le lijong tsa mots'eare (makhetlo a mararo a letsatsi le letsatsi).

Ho lokisa tekanyetso ea NovoMix 30 FlexPen, khatello ea lijo tse tlase ka ho fetisisa tsa tsoekere e fumanoeng matsatsing a 3 a fetileng e sebelisoa.

Ho hlahloba ho lekana ha tekanyetso e fetileng, sebelisa boleng ba khatello ea tsoekere maling maling pele ho lijo tse latelang.

Phetoho ea tekanyetso e ka etsoa hang ka beke ho fihlela boleng ba HbA bo fihletsoeng bo fihlelletsoa._1C.

Se ke oa eketsa tekanyetso ea lithethefatsi haeba hypoglycemia e hlokometsoe nakong ena.

Phetoho ea moriana e ka ba e hlokahalang ha ho ntlafatsa ts'ebetso ea mokuli, ho fetola lijo tsa hae tse tloaelehileng, kapa ho ba le boemo ba ho phutholoha.

Ho fetola tekanyetso ea NovoMix 30 FlexPen, ho kgothaletsoa ho sebelisa litlhahiso tsa tekanyetso ea lethalamo tse thathamisitsoeng tafoleng:

Ho emisoa ka tsela e ikhethileng, Novo Nordisk

NovoMix® 30 Penfill®

Ho emisoa bakeng sa tsamaiso ea subcutaneous ea 1 ml ntho e sebetsang: insulin aspart - soluble insulin aspart (30%) le likristale tsa insulin aspart protamine (70%) 100 IU (3.5 mg) excipients: glycerol - 16 mg, phenol - 1.5 mg , metacresol - 1,72 mg, zinc (ka sebopeho sa chloride ea zinc) - 19.6 μg, chloride ea sodium - 0,877 mg, sodium hydrogen phosphate dihydrate - 1,25 mg, protamine sulfate - hoo e ka bang 0.32 mg, sodium hydroxide - hoo e ka bang 2 , 2 mg, hydrochloric acid - e ka bang 1,7 mg, metsi a ente - ho fihla ho 1 ml 1 cartridge (3 ml) e na le 300 PIECES

NovoMix® 30 FlexPen ®

Ho emisoa bakeng sa tsamaiso ea subcutaneous ea 1 ml ntho e sebetsang: insulin aspart - soluble insulin aspart (30%) le likristale tsa insulin aspart protamine (70%) 100 IU (3.5 mg) excipients: glycerol - 16 mg, phenol - 1.5 mg , metacresol - 1,72 mg, zinc (ka sebopeho sa chloride ea zinc) - 19.6 μg, chloride ea sodium - 0,877 mg, sodium hydrogen phosphate dihydrate - 1,25 mg, protamine sulfate - hoo e ka bang 0.32 mg, sodium hydroxide - hoo e ka bang 2 , 2 mg, hydrochloric acid - e ka bang 1,7 mg,metsi bakeng sa ente - ho fihlela 1 ml 1 pentšele ea syringe e tlatsitsoeng pele (3 ml) e na le 300 PIECES

Homogenible e tšoeu e omileng ntle le sephooko. Ho ka hlaha lipalesa ka har'a sampole.

Ha e eme, ho emisoa hoa foforeha, ebe e ba 'mala o mosoeu ebile e le' mala o moputsoa kapa o batlang o se na 'mala.

Ha o kopanya pula pele ho latela mokhoa o hlalositsoeng litaelong tsa ts'ebeliso ea bongaka, ho ts'oaroa ho hoholo ho lokela ho ba teng.

Ho insulin aspart, ho emisoa ha amino acid proline e maemong a B28 bakeng sa asiti ea aspartic e fokotsa tloaelo ea limolek'hule tsa ho theha li-hexamers karolong e qhibilihang ea NovoMix® 30 Penfill® / FlexPen ®, e hlokometsoeng ka insulin ea metsi. Ntlheng ena, insulin aspart (30%) e kenngoa ho mafura a subcutaneous ka potlako ho feta insulin e qhibilihang e fumanehang ka insulin ea insulin. 70% e setseng e oela ka foromo ea kristale ea protamine-insulin aspart, e leng boemo ba ho ts'oaroa bo tšoanang le ba "insulin" ea motho.

Serum Cmax ea insulin ka mor'a ho tsamaisoa ha NovoMix® 30 Penfill® / FlexPen® e phahame ka makhetlo a 50 ho feta ea biphasic insulin 30, 'me Tmax e khutšoanyane habeli ho feta ea biphasic insulin ea motho ea 30.

Ho baithaopi ba phetseng hantle, kamora ho tsamaisoa ha scvo ea NovoMix® 30 ka tekanyo ea 0,2 U / kg ea boima ba 'mele Cmax ea insulin aspart ho serum e fihlelitsoe kamora metsotso e 60 mme e lekana le (140 ± 32) pmol / L. Nako ea T1 / 2 ea NovoMix® 30, e bonts'ang tekanyo ea ho amoheloa ha karoloana e tlameletsoeng protamine, e ne e le lihora tse 8-9. Boemo ba insulin ka serum ea mali bo khutletse mohatong oa pele oa lihora tse 15-18 kamora ho tsamaisoa ha moriana. Ho bakuli ba nang le mofuta oa lefu la tsoekere la mofuta oa 2, Cmax e ile ea fihleloa ka metsotso e 95 kamora tsamaiso mme ea lula kaholimo ho lihora tse 14 bonyane.

Batho ba baholo le ba senile. Boithuto ba bongaka ba meriana ba NovoMix® 30 ho bakuli ba tsofetseng le ba senile ha bo so etsoa. Leha ho le joalo, phapang e lekantsoeng ea pharmacokinetics lipakeng tsa insulin aspart le insulin ea insulin ea batho ba tsofetseng ho bakuli ba tsofetseng ba nang le mofuta oa 2 lefu la tsoekere (lilemo tse 65-83, ho bolela lilemo tse 70) li ne li tšoana le tsa baithaopi ba phetseng hantle le bakuli ba banyenyane ba nang le lefu la tsoekere. Ho bakuli ba tsofetseng, ho ile ha bonoa ho fokotseha ha lebelo la ho amoheloa ha bana, e leng ho ileng ha fokotseha ha T1 / 2 (makhetlo a 82 min ququartile range - 60-120 min), athe Cmax e tloaelehileng e ne e ts'oana le e bonoang ho bakuli ba banyenyane ba nang le mofuta oa lefu la tsoekere la mellitus, le hanyane ho feta ho Bakuli ba lefu la tsoekere la 1.

Bakuli ba nang le mathata a ho renal le hepatic. Ha ho na li-pharmacokinetics tsa NovoMix® 30 penfill® / FlexPen® li ithutile ho bakuli ba nang le bothata ba ho ruruha le ho ba le hepatic. Leha ho le joalo, ka keketseho ea tekanyetso ea lithethefatsi ho bakuli ba nang le methapo e fapaneng ea aimper le a hepatic, ho ne ho se na liphetoho phetohong ea pharmacokinetics ea soluble insulin aspart.

Bana le bacha. Thepa ea pharmacokinetic ea NovoMix® 30 Penfill® / FlexPen® ha e so ithutoe ho bana le lilemong tsa bocha. Leha ho le joalo, thepa ea pharmacokinetic le pharmacodynamic ea soluble insulin aspart e ile ea ithutoa ho bana (ba lilemo li 6 ho isa ho tse 12) le bacha (ba lilemo li 13 ho isa ho 17) ka mofuta oa lefu la tsoekere la lefu la 1. ho batho ba baholo. Leha ho le joalo, litekanyetso tsa Cmax lihlopheng tsena tsa lilemo tse peli li ne li fapane, e leng ho bonts'a bohlokoa ba khetho ea motho ka mong ea litekanyetso tsa "insulin".

NovoMix® 30 Penfill® / FlexPen ® ke ho emisoa ka mekhahlelo e 'meli ho kenyelletsang insulle ea insulin (30% e sebetsang ka nakoana ea insulin analog) le likristale tsa "anartulin" insulin anulin (70% e sebetsang ka insulin analog). Sesebelisoa se sebetsang NovoMix® 30 Penfill® / FlexPen® ke insulin aspart, e hlahisoang ke mokhoa oa ho ikatisa oa biotechnology oa DNA o sebelisang mofuta oa Saccharomyces cerevisiae.

Insulin aspart ke equipotential soluble insulin ea motho e thehiloeng ho molarity ea eona.

Ho fokotseha ha tsoekere ea mali ho etsahala ka lebaka la keketseho ea phallo ea eona ea bohlokoa ka mor'a ho tlangoa ha insulin receptors ea mesifa le mafura le thibelo e ts'oanang ea tlhahiso ea tsoekere ke sebete. Kamora taolo ea SC ea NovoMix® 30 Penfill® / FlexPen ®, phello e ba teng ka nako ea metsotso e 10-20. Phello e phahameng e bonoa ka bongata ho tloha ho lihora tse 1 ho isa ho tse 4 kamora ho kenngoa. Nako ea lithethefatsi e fihla lihora tse 24.

Thutong ea bongaka ea ho bapisoa ea likhoeli tse tharo e kenyeletsang bakuli ba nang le lefu la tsoekere la mofuta oa 2 le ileng la amohela NovoMix® 30 penfill® / FlexPen® le biphasic insulin ea motho ka makhetlo a 2, makhetlo a 2 ka letsatsi, pele ho lijo tsa hoseng le tsa lijo tsa mantsiboea, NovoMix® 30 Penfill e bontšitsoe ® / FlexPen ® e fokotsa maemo a tsoekere ea mali ea postprandial ho feta (kamora lijo tsa hoseng le tsa lijo tsa hoseng).

Tlhahlobo ea meta ea tlhaiso-leseling e fumanoeng lithutong tse 9 tsa kliniki tse amang bakuli ba nang le lefu la tsoekere la mofuta oa 2 li bonts'itse hore NovoMix® 30 Penfill® / FlexPen ® ha e fanoa pele ho lijo tsa hoseng le lijo tsa mantsiboea e fana ka taolo e ntle ea maemo a tsoekere ea mali ea postprandial litekanyetso tsa tsoekere ea prandial kamora lijo tsa hoseng, lijo tsa motšeare le lijo tsa mantsiboea) ha li bapisoa le insulin ea motho ea biphasic 30. Le ha litekanyetso tsa glucose tse potlakileng ho bakuli ba sebelisang NovoMix® 30 Penfill® / FlexPen® li ne li phahame, ka kakaretso NovoMix® 30 Penfill® / FlexPen® Ke phello e tšoanang ka ea mahloriso ya glycated haemoglobin (HbA1c), hammoho le biphasic batho ka insulin 30.

Phuputsong ea bongaka e kenyang bakuli ba 341 ba nang le lefu la tsoekere la mofuta oa 2, bakuli ba ne ba sa hlophisoe ka lihlopha tsa kalafo feela NovoMix® 30 Penfill® / FlexPen®, NovoMix® 30 Penfill® / FlexPen® hammoho le metformin le metformin hammoho le metropin. Khokahano ea HbA1c kamora libeke tse 16 tsa kalafo e ne e sa fapana ho bakuli ba amohelang NovoMix® 30 Penfill® / FlexPen® hammoho le metformin, le ho bakuli ba fumanang metformin hammoho le sulfonylurea. Phuputsong ena, ho 57% ea bakuli, khatello ea mantlha ea HbA1c e ne e phahame ho feta 9%; ho bakuli bana, kalafo ea NovoMix® 30 Penfill® / FlexPen ® hammoho le metformin e bakile ho fokotseha ho hoholo hoa mahloriso a HbA1c ho feta ho bakuli ba tšoaroang ke metformin hammoho le lits'oants'o tse tsoang ho eona. sulfonylureas.

Phuputsong e 'ngoe, bakuli ba nang le mofuta oa lefu la tsoekere la mofuta oa 2 ba nang le taolo e fokolang ea glycemic ba neng ba sebelisa lithethefatsi tsa hypoglycemic tsa molomo ba ile ba ngolisoa ka boomo lihlopheng tse latelang: ho amohela NovoMix® 30 habeli ka letsatsi (bakuli ba 117) le ho amohela insulin glargine 1 ka letsatsi (bakuli ba 116). Kamora libeke tse 28 tsa taolo ea lithethefatsi, ho fokotseha ho tloaelehileng ha mahloriso a HbA1c sehlopheng sa NovoMix® 30 Penfill® / FlexPen ® e ne e le 2,8% (boleng ba pele bo bolelang e ne e le 9.7%). Ho 66% le 42% ea bakuli ba sebelisang NovoMix® 30 Penfill® / FlexPen®, qetellong ea thuto, boleng ba HbA1c bo ne bo le ka tlase ho 7 le 6.5%, ka ho latellana. Moetso oa "glucose" o potlakileng o theohile ka 7 mmol / L (ho tloha 14 mmol / L qalong ea thuto ho isa ho 7.1 mmol / L).

Liphetho tsa tlhahlobo ea "meta-data" e fumanoeng litekong tsa bongaka tse amang bakuli ba nang le lefu la tsoekere la mofuta oa 2 li bontšitse ho fokotseha hoa palo eohle ea liketsahalo tsa nocturnal hypoglycemia le hypoglycemia e matla le NovoMix® 30 Penfill® / FlexPen® ha e bapisoa le biphasic insulin 30. Kotsi e akaretsang ea hypoglycemia ea motšehare ho bakuli ba fumanang NovoMix® 30 Penfill® / FlexPen® e ne e le phahame.

Bana le bacha. Teko ea bongaka ea libeke tse 16 e ile ea etsoa ho bapisa tsoekere ea mali kamora ho ja le NovoMix® 30 (pele ho lijo), insulin ea motho / biphasic insulin ea 30 (pele ho lijo) le isofan-insulin (e fanoe pele ho robala). Phuputso eo e ne e kenyelletsa bakuli ba 167 ho tloha ho lilemo tse 10 ho isa ho tse 18. Litekanyetso tse tloaelehileng tsa HbA1c lihlopheng ka bobeli li lula li le haufi le litekanyetso tsa mantlha nakong eohle ea thuto. Hape, ha u sebelisa NovoMix® 30 Penfill® / FlexPen ® kapa biphasic insulin ea motho, ho ne ho se na phapang lipakeng tsa hypoglycemia.

Phuputso e entsoeng ka mahlo a mabeli e sa boneng hape e ile ea etsoa ho palo ea bakuli ho tloha ho lilemo tse 6 ho isa ho tse 12 (bakuli ba 54 ka kakaretso, libeke tse 12 bakeng sa mofuta o mong le o mong oa kalafo). Keketseho ea hypoglycemia le keketseho ea tsoekere ka mor'a lijo lihlopheng tsa bakuli ba sebelisang NovoMix® 30 Penfill® / FlexPen® li ne li le tlase haholo ha li bapisoa le boleng sehlopheng sa bakuli ba sebelisang insulin ea motho ea bophasic 30. HbA1c boleng qetellong ea thuto sehlopheng sa biphasic insulin ea motho e 30 e ne e le tlase haholo ho feta sehlopheng sa bakuli ba sebelisang NovoMix® 30 Penfill® / FlexPen®.

Bakuli ba baholo. The pharmacodynamics of NovoMix® 30 Penfill® / FlexPen® ho bakuli ba tsofetseng le ba senile ha e e-so fumanoe lipatlisiso. Leha ho le joalo, liphuputsong tse sa sebetseng tse nang le tšibollo ea likarolo tse peli tse sa sebetseng tse entsoeng ho bakuli ba 19 ba nang le lefu la tsoekere la mofuta oa 2-83 ba lilemo li 65-83 (ho bolela lilemo tse 70), li-pharmacodynamics le pharmacokinetics tsa insulin aspart le insulin ea insulin ea batho. Phapang e lekanang litekanyetsong tsa paramente ea pharmacodynamic (tekanyo e phahameng ea ts'oaetso ea glucose - GIRmax le sebaka se katlasetsoeng tekanyo ea tlhahiso ea sona bakeng sa metsotso e 120 ka mor'a ts'ebetso ea litokisetso tsa insulin - AUCGIR, 0-120 min) lipakeng tsa insulin aspart le insulin ea motho ho bakuli ba tsofetseng li ne li tšoana le tsa bakuli ba phetseng hantle. baithaopi le ho bakuli ba banyenyane ba nang le lefu la tsoekere.

Tlhahiso-leseling ea polokeho

Boithuto ba preclinical ha bo a ka ba hlahisa kotsi efe kapa efe ho batho, bo ipapisitse le datha tse tsoang lipatlisisong tse amoheloang ka kakaretso tsa polokeho ea meriana, kotsi ea ts'ebeliso e pheta-phetoang, lefutso le kotsi ea ho ikatisa.

Itsenko-Cushing's syndrome: monographic. . - M: Bongaka, 1988 .-- 224 leq.
Dobrov, A. Lefu la tsoekere - eseng bothata / A. Dobrov. - M .: House House (Minsk), 2010 .-- 166 leq.
Efimov A.S. Lefu la tsoekere Moscow, ntlo ea phatlalatso "Medicine", 1989, 288 maq.
Melnichenko G. A., Peterkova V. A., Tyulpakov A. N., Maksimova N. V. Epreli syndromes in endocrinology, Ts'ebetso - M., 2013. - 172 leq.
Balabolkin M.I., Klebanova E.M., Kreminskaya V.M. Fundamental and thyroidology ea bongaka - Medical, M., 2013. - 816 leq.

E re ke itsebise. Lebitso la ka ke Elena. Ke qetile lilemo tse fetang 10 ke sebetsa ke le setsebi sa endocrinologist. Ke lumela hore hajoale ke setsebi lebaleng la ka mme ke batla ho thusa baeti bohle ba sebakeng sena ho rarolla mesebetsi e rarahaneng eseng joalo. Lisebelisoa tsohle tsa sebaka sena sa marang-rang li bokelloa ebe li sebetsoa ka hloko e le hore li fetise litaba tsohle tse hlokahalang ka hohle kamoo ho ka khonehang. Pele o sebelisa se hlalosoang webosaeteng, ho hlokahala tumellano ea ho buisana le litsebi kamehla.

Tlhaloso ea foromo ea litekanyetso

Homogenible e tšoeu e omileng ntle le sephooko. Ho ka hlaha lipalesa ka har'a sampole.

Ha e eme, ho emisoa hoa foforeha, ebe e ba 'mala o mosoeu ebile e le' mala o moputsoa kapa o batlang o se na 'mala.

Ha o kopanya precipitate ho latela mokhoa o hlalositsoeng ho Litaelo bakeng sa ts'ebeliso ea bongaka, ho emisoa ho sa lokelang ho lokela ho ba teng.

Mofumahali

NovoMix ® 30 Penfill ® ke ho emisoa ka mekhahlelo e 'meli e kenyelletsang insuble insulin aspart (30% e nkang insulin analog) le likristale tsa "analog" ea "insulin" ea "insulin" ". Ntho e sebetsang NovoMix ® 30 Penfill ® ke insulin aspart, e hlahisoang ke mokhoa oa ho kopanya biotechnology ea DNA u sebelisa khatello. Saccharomyces cerevisiae.

Insulin aspart ke equipotential soluble insulin ea motho e thehiloeng ho molarity ea eona.

Ho fokotseha ha tsoekere ea mali ho etsahala ka lebaka la keketseho ea phallo ea eona ea bohlokoa ka mor'a ho tlangoa ha insulin receptors ea mesifa le mafura le thibelo e ts'oanang ea tlhahiso ea tsoekere ke sebete. Kamora ho tsamaisoa ha tsela ea NovoMix ® 30 Penfill ®, phello e ba teng ka nako ea metsotso e 10 ho isa ho e leshome. Phello e phahameng e bonoa ka bongata ho tloha ho lihora tse 1 ho isa ho tse 4 kamora ho kenngoa. Nako ea lithethefatsi e fihla lihora tse 24.

Thutong ea bongaka ea ho bapisa ea likhoeli tse tharo e kenyelletsang bakuli ba nang le lefu la tsoekere la mofuta oa 2 le mofuta oa 2 ba amohetseng NovoMix ® 30 Penfill ® le insulin ea insulin ea motho makhetlo a 2 2 ka letsatsi pele ho lijo tsa hoseng le lijo tsa mantsiboea, ho ile ha bontšoa hore NovoMix ® 30 Penfill ® e fokotsa maemo a postprandial haholoanyane tsoekere ea mali (kamora lijo tsa hoseng le tsa lijo tsa hoseng).

Tlhahlobo ea "meta-data" ho tsoa litekong tse 9 tsa kliniki tse amang bakuli ba nang le lefu la tsoekere la mofuta oa 2 li bonts'itse hore NovoMix ® 30 Penfill®, e fanoang pele ho lijo tsa hoseng le lijo tsa mantsiboea, e fana ka taolo e ntle ea maemo a tsoekere ea mali ea postprandial kamora lijo tsa hoseng, lijo tsa mots'eare le lijo tsa mantsiboea), ha li bapisoa le insulin ea biphasic ea motho 30 Le ha litekanyetso tsa tsoekere tse potlakileng ho bakuli ba sebelisang NovoMix ® 30 Penfill ® li ne li phahame, ka kakaretso, NovoMix ® 30 Penfill ® e na le phello e ts'oanang ho glycosylated hemoglobin mahlaseli (HbA _1c ), joalo ka insulin ea motho ea biphasic 30.

Phuputsong e 'ngoe e amanang le bakuli ba 341 ba nang le lefu la tsoekere la mofuta oa 2, bakuli ba ne ba sa hlophisoe ka lihlopha tsa kalafo feela NovoMix ® 30 Penfill ®, NovoMix ® 30 Penfill ® e kopantsoe le metformin le metformin hammoho le metropin. HbA mahloriso _1c kamora libeke tse 16 tsa kalafo ha lia ka tsa fapana ho bakuli ba amohelang NovoMix ® 30 Penfill ® hammoho le metformin le ho bakuli ba fumanang metformin hammoho le derivative ea sulfonylurea. Thutong ena, bakuli ba 57% ba ne ba e-na le basal HbA _1c e ne e phahame ho feta 9%; ho bakuli bana, kalafo e nang le NovoMix ® 30 Penfill ® hammoho le metformin e lebisitse ho fokotseheng ho hoholo hoa mahloriso a HLA _1s ho feta ho bakuli ba fumanang metformin hammoho le sulfonylurea.

Phuputsong e 'ngoe, bakuli ba nang le mofuta oa lefu la tsoekere la mofuta oa 2 ba nang le taolo e fokolang ea glycemic ba neng ba sebelisa lithethefatsi tsa hypoglycemic tsa molomo ba ile ba ngolisoa ka boomo lihlopheng tse latelang: ho amohela NovoMix ® 30 habeli ka letsatsi (bakuli ba 117) le ho amohela insulin glargine e 1 ka letsatsi (bakuli ba 116). Kamora libeke tse 28 tsa ts'ebeliso ea lithethefatsi, ho fokotseha ho tloaelehileng ha mahloriso a HbA _1c sehlopheng sa NovoMix ® 30, Penfill ® e ne e le 2,8% (boleng ba mantlha ba mantlha e ne e le 9.7%). Ho 66% le 42% ea bakuli ba sebelisang NovoMix ® 30 Penfill ®, qetellong ea thuto, litekanyetso tsa HbA _1c li ne li le ka tlase ho 7 le 6.5%, ka ho latellana. Moetso oa "glucose" o potlakileng o theohile ka 7 mmol / L (ho tloha 14 mmol / L qalong ea thuto ho isa ho 7.1 mmol / L).

Liphetho tsa tlhahlobo ea "meta-data" e fumanoeng litekong tsa bongaka tse amang bakuli ba nang le lefu la tsoekere la mofuta oa 2 ho bontšitse ho fokotseha hoa palo eohle ea liketsahalo tsa nocturnal hypoglycemia le hypoglycemia e matla le NovoMix ® 30 Penfill ® ha e bapisoa le insulin ea insulin ea motho ka nako e ts'oanang. ho hlaha hoa hypoglycemia ea motšehare ho bakuli ba fumanang NovoMix ® 30 Penfill ® e ne e phahame.

Bana le bacha. Teko ea bongaka ea libeke tse 16 e ile ea etsoa ho bapisa tsoekere ea mali kamora ho ja le NovoMix® 30 (pele ho lijo), insulin ea motho / biphasic insulin ea 30 (pele ho lijo) le isofan-insulin (e fanoe pele ho robala).Phuputso eo e ne e kenyelletsa bakuli ba 167 ba lilemo li 10 ho isa ho 18. Litekanyetso tsa HLA _1s ka bobeli lihlopha li ile tsa lula li le haufi le litekanyetso tsa pele thutong eohle. Hape, ha u sebelisa NovoMix ® 30 Penfill ® kapa biphasic insulin ea motho, ho ne ho se na phapang lipakeng tsa hypoglycemia.

Phuputso e entsoeng ka mahlakore a mabeli e sa boneng mahlo e ile ea boela ea etsoa ho palo ea bakuli ba lilemo tse 6 ho isa ho 12 (bakuli ba 54 kaofela, libeke tse 12 bakeng sa mofuta o mong le o mong oa kalafo). Ts'ebetso ea hypoglycemia le keketseho ea tsoekere ka mor'a lijo lihlopheng tsa bakuli ba sebelisang NovoMix ® 30 Penfill ® li ne li le tlase haholo ha li bapisoa le boleng ba sehlopha sa bakuli ba sebelisang insulin ea motho ea bumpas 30. HbA _1c qetellong ea thuto, sehlopheng sa li-insulin tsa motho ea biphasic 30 li ne li le tlase haholo ho feta sehlopheng sa bakuli ba sebelisang NovoMix ® 30 Penfill ®.

Bakuli ba baholo. Pharmacodynamics NovoMix ® 30 Penfill ® ho bakuli ba tsofetseng ha e e-so fumanoe lipatlisiso. Leha ho le joalo, liphuputsong tse sa sebetseng tse nang le tšibollo ea likarolo tse peli tse sa sebetseng tse entsoeng ho bakuli ba 19 ba nang le lefu la tsoekere la mofuta oa 2 lefu la lilemo tsa 65-83 (ho bolela lilemo tse 70), pharmacodynamics le pharmacokinetics ea insulin aspart le insulin ea insulin ea batho. Phapang e amanang le pharmacodynamics (tekanyo e phahameng ea infusion ea tsoekere - GIR _max le sebaka se katlasehong ea tekanyo ea tlhahiso ea sona bakeng sa metsotso e 120 ka mor'a ts'ebetso ea litokisetso tsa insulin - AUC _{GIR, 0-120 metsotso} ) lipakeng tsa insulin aspart le insulin ea motho ho bakuli ba tsofetseng li ne li tšoana le tsa baithaopi ba phetseng hantle le ho bakuli ba banyenyane ba nang le lefu la tsoekere.

Ya data preclinical empa polokeho

Litekong in vitro Ho kenyelletsa ho tlama ho insulin le li-receptor tsa IGF-1 le phello ea kholumo ea lisele, ho ile ha bontšoa hore thepa ea "aspart insulin" e tšoana le ea insulin ea motho. Boithuto bo boetse bo bontšitse hore ho ikarola ho tlamang hoa insulin aspart ho li-insulin receptors ho lekana le ho insulin ea motho.

Mofumahali

Ho insulin aspart, ho emisoa ha amino acid proline e maemong a B28 bakeng sa asiti ea aspartic ho fokotsa tloaelo ea limolek'hule tsa ho theha li-hemogle karolong e qhibilihang ea NovoMix® 30 Penfill®, e bonoang ka insulin ea metsi. Ntlheng ena, insulin aspart (30%) e kenngoa ho mafura a subcutaneous ka potlako ho feta insulin e qhibilihang e fumanehang ka insulin ea insulin. 70% e setseng e baloa ka mofuta oa kristale oa protamine-insulin aspart, sekhahla sa ho amoheloa se tšoanang le sa "insulin" ea motho.

C _max serum insulin kamora ho tsamaisoa ha NovoMix ® 30 Penfill ® e phahame ka 50% ho feta ea "insulin" ea insulin ea motho. 30 a T _max Makhetlo a 2 a khuts'oane ha a bapisoa le biphasic insulin ea motho 30.

Ho baithaopi ba phetseng hantle kamora ho tsamaisoa ha lithethefatsi NovoMix ® 30 ka tekanyo ea 0,2 PIECES / kg C _max insulin aspart ka serum e fumanoe kamora metsotso e 60 mme e ne (140 140 32) pmol / L. Nako ea T _1/2 NovoMix ® 30, e bonts'ang sekhahla sa ho kenngoa ha karoloana e tlameletsoeng ka protamine, e ne e le lihora tse 8-9. Boemo ba insulin ka serum ea mali bo khutletse ts'ebetsong ea pele ea lihora tse 15-18 kamora ho tsamaisoa ha lithethefatsi ka mokhoa o ikhethileng. Ho bakuli ba nang le lefu la tsoekere la mofuta oa 2 lefu la tsoekere _max e fihlelitsoe metsotso e 95 ka mor'a taolo mme e lutse e le kaholimo ho bonyane lihora tse 14

Batho ba baholo le ba senile. Boithuto ba bongaka ba meriana ba NovoMix ® 30 ho bakuli ba tsofetseng le ba senile ha bo so etsoa. Leha ho le joalo, phapang e teng ka har'a pharmacokinetics lipakeng tsa insulin aspart le insulin ea insulin ea batho ba tsofetseng ho bakuli ba tsofetseng ba nang le mofuta oa 2 lefu la tsoekere (lilemo tse 65-83, lilemo tse pakeng tsa lilemo tse 70) li ne li tšoana le tsa baithaopi ba phetseng hantle le ho bakuli ba banyenyane ba nang le lefu la tsoekere la mellitus.Ho bakuli ba tsofetseng, ho ile ha bonoa ho fokotseha ha lebelo la ho amoheloa ha bana, e leng ho ileng ha lebisa ho theoha butle ha T _1/2 (Linomoro tse mashome a mahlano a metso e robeli (bophara ba maqhubu a marang-rang - 60-20 min), ha karolelano ea C _max e ne e ts'oana le e bonoang ho bakuli ba banyenyane ba nang le lefu la tsoekere la 2, le hanyane ho feta ho bakuli ba nang le lefu la tsoekere la mofuta oa 1.

Bakuli ba nang le mathata a ho renal le hepatic. Phuputso e entsoeng ka pharmacokinetics ea NovoMix ® 30 Penfill ® ho bakuli ba nang le bothata ba ho ruruha ba mokokotlo le ho ba le hepatic ha ea ka ea etsoa. Leha ho le joalo, ka keketseho ea tekanyetso ea lithethefatsi ho bakuli ba nang le methapo e fapaneng ea aimper le a hepatic, ho ne ho se na liphetoho phetohong ea pharmacokinetics ea soluble insulin aspart.

Bana le bacha. Thepa ea pharmacokinetic ea NovoMix ® 30 Penfill ® ho bana le lilemong tsa bocha ha e so ithutoe. Leha ho le joalo, thepa ea pharmacokinetic le pharmacodynamic ea soluble insulin aspart e ile ea ithutoa ho bana (ba lilemo li 6 ho isa ho 12) le bacha (ba lilemo li 13 ho isa ho 17) ka mofuta oa lefu la tsoekere la lefu la 1. _max joalo ka batho ba baholo. Leha ho le joalo, boleng ba C _max ka lihlopha tse peli li ne li fapane, e leng ho bonts'a bohlokoa ba khetho ea motho ka mong ea tekanyetso ea insulin.

Bokhachane le pelehi

Boiphihlelo ba tleleniki ka tšebeliso ea NovoMix ® 30 Penfill ® nakong ea kemolo e lekanyelitsoe.

Leha ho le joalo, datha e tsoang litekong tse peli tsa bongaka tse laoloang ka mokhoa o sa reroang (ka ho latellana tsa basali baimana ba 157 le ba 14 ba amohetseng insulin aspart ka mofuta oa mantlha oa bolus) ha ea ka ea senola litlamorao tsa insulin aspart ka boimana kapa nakong ea bophelo ba masea / masea a sa tsoa hlaha. Ntle le moo, teko ea bongaka e sa sebetseng e kenyelletsang basali ba 27 ba nang le lefu la tsoekere ba neng ba amohela insulin aspart le insulin ea insulin (insulin aspart e amohetse basali ba 14, insulin ea 13), lintlha tse tšoanang tsa polokeho bakeng sa mefuta ka bobeli ea insulin li bontšitsoe.

Nakong ea ho qala ho ka etsahala ha moimana le nakong eohle ea bophelo ba hae, ho hlokahala hore ho hlahlojoe ka hloko boemo ba bakuli ba nang le lefu la tsoekere le ho beha leihlo tsoekere maling. Tlhokahalo ea insulin, joalo ka molao, e fokotseha ho trimester ea pele mme butle-butle e eketseha ka li-trimesters tsa bobeli le tsa boraro tsa boimana. Nakoana kamora ho hlaha, tlhoko ea insulin kapele e khutlela boemong bo neng bo le pele ho ima.

Nakong ea ho anyesa, NovoMix ® 30 Penfill ® e ka sebelisoa ntle le lithibelo. Tsamaiso ea insulin ho 'm'a ea anyesang ha se tšokelo ho ngoana. Leha ho le joalo, ho ka hlokahala hore o fetole tekanyetso ea NovoMix ® 30 Penfill ®.

Litlamorao

Liphetoho tse mpe tse bonoang ho bakuli ba sebelisang lithethefatsi NovoMiks ® 30, li bakoa haholo ke phello ea litheko tsa insulin. Ketsahalo e mpe e atileng haholo ka insulin ke hypoglycemia. Khafetsa ea litlamorao tse amanang le ts'ebeliso ea NovoMix ® 30 e fapana ho latela palo ea bakuli, mofuta oa litla-morao tsa lithethefatsi, le taolo ea glycemic.

Boemong ba pele ba kalafo ea "insulin", liphoso tsa refractive, edema le liphetoho li ka hlaha sebakeng sa ente (ho kenyelletsa bohloko, bokhubelu, hives, ho ruruha, ho ruruha, ho ruruha le ho hlohlona sebakeng sa ente). Hangata matšoao ana ke a nakoana. Phetoho e potlakileng taolong ea glycemic e ka lebisa boemong ba bohloko ba methapo ea maikutlo, bo atisang ho fetoha. Ho matlafatsoa ha kalafo ea insulin ka ntlafatso e matla taolong ea metabolism ea carbohydrate ho ka lebisa ho mpefala ha nakoana maemong a lefu la tsoekere, ha ntlafatso ea nako e telele taolong ea glycemic e fokotsa kotsi ea tsoelo-pele ea lefu la tsoekere.

Lethathamo la liphetoho tse bohloko le hlahisoa ka har'a tafole.

Liphetoho tsohle tse mpe tse hlalositsoeng ka tlase, li thehiloe ho data ea teko ea bongaka, li hlophisitsoe ho latela khafetsa ea ntlafatso ho latela MedDRA le tsamaiso ea litho. Kotsi ea karabelo e mpe e hlalosoa e latelang: khafetsa (≥1 / 10), hangata (≥1 / 100, ® 30 Penfill ® ha ea lokela ho kopanngoa le lithethefatsi tse ling.

Tekanyetso le tsamaiso

NovoMix ® 30 Penfill ® e etselitsoe s / c kenyelletso. Se ke oa tsamaisa NovoMix ® 30 Penfill ® iv, joalo ka hona ho ka lebisa ho hypoglycemia e matla. Tsamaiso ea methapo ea NovoMix ® 30 Penfill ® le eona e lokela ho qojoa. U ke ke ua sebelisa NovoMix ® 30 penfill ® bakeng sa infcutaneous insulin infusion (PPII) lipompong tsa insulin.

Tekanyetso ea NovoMix ® 30 Penfill ® e khethoa ke ngaka ka bonngoe boemong bo bong le bo bong, ho latela litlhoko tsa mokuli. Ho fihlela boemo bo nepahetseng ba glycemia, ho kgothaletswa ho laola khatello ea tsoekere maling le ho fetola tekanyetso ea lithethefatsi.

NovoMix ® 30 Penfill ® e ka ngolloa ho bakuli ba nang le lefu la tsoekere la mofuta oa 2 lefu ka bobeli e le monotherapy hape e kopantsoe le lithethefatsi tsa hypoglycemic tsa molomo maemong a moo boemo ba tsoekere ea mali bo laoloang ka ho loketseng ke lithethefatsi tsa hypoglycemic tsa molomo.

Bakeng sa bakuli ba nang le lefu la tsoekere la mofuta oa pele ba babeli ba fuoeng insulin, ba lokela ho sebelisa lethalamo la ho qala la NovoMix ® 30 Penfill ® ke li-unit tse 6 pele ho lijo tsa hoseng le likarolo tse 6 pele ho lijo tsa mantsiboea. Ho kenngoa ha likarolo tsa 12 tsa NovoMix ® 30 Penfill ® hang ka letsatsi ka shoalane (pele ho lijo tsa mantsiboea) le eona e lumelloa.

Phetisetso ea mokuli ho tsoa litokisetsong tse ling tsa insulin

Ha o fetisetsa mokuli ho tsoa biphasic insulin ea motho ho NovoMix ® 30 Penfill ®, motho o lokela ho qala ka tekanyetso le mokhoa o le mong oa tsamaiso. Ebe u lokisa tekanyetso ho latela litlhoko tsa mokuli ka mong (bona litlhahiso tse latelang bakeng sa karolo ea litekanyetso tsa moriana). Joalo ka mehla, ha u fetisetsa mokuli ho mofuta o mocha oa insulin, ho hlokahala hore a be le taolo e tiileng ea bongaka nakong ea phetisetso ea mokuli le libekeng tsa pele tsa ho sebelisa moriana o mocha.

Ho matlafatsa kalafo ea NovoMix ® 30 Penfill ® hoa khoneha ka ho fetola tekanyetso e le 'ngoe ea letsatsi le letsatsi ho ea habeli. Ho khothalletsoa hore kamora ho fihlela tekanyetso ea likarolo tse 30 tsa sesebelisoa sa lithethefatsi ts'ebelisong ea NovoMix ® 30 Penfill ® makhetlo a 2 ka letsatsi, o arola tekanyetso ka likarolo tse peli tse lekanang - hoseng le mantsiboea (pele ho lijo tsa hoseng le tsa mantsiboea).

Phetoho ea ts'ebeliso ea NovoMix ® 30 Penfill ® makhetlo a 3 ka letsatsi e ka etsahala ka ho arola tekanyetso ea hoseng ka likarolo tse peli tse lekanang le ho hlahisa likarolo tsena tse peli hoseng le lijong tsa motšehare (makhetlo a mararo a letsatsi le letsatsi lethal dose).

Ho lokisa tekanyetso ea NovoMix ® 30 Penfill ®, khatello ea tsoekere ea mali e potlakileng ka ho fetisisa e fumanoeng matsatsing a mararo a fetileng e sebelisoa.

Ho hlahloba ho lekana ha tekanyetso e fetileng, sebelisa boleng ba khatello ea tsoekere maling maling pele ho lijo tse latelang.

Phetoho ea tekanyetso e ka etsoa hang ka beke ho fihlela boleng ba HbA bo fihletsoeng bo fihlelletsoa. _1c . Se ke oa eketsa tekanyetso ea lithethefatsi haeba hypoglycemia e hlokometsoe nakong ena.

Phetoho ea moriana e ka ba e hlokahalang ha ho ntlafatsa ts'ebetso ea mokuli, ho fetola lijo tsa hae tse tloaelehileng, kapa ho ba le boemo ba ho phutholoha.

Ho lokisa lethal dose ea NovoMix ® 30 Penfill ®, ka tlase ke likhothaletso bakeng sa karolo ea eona (bona tafole).

Ts'oaetso ea glucose ea mali pele ho lijo	Phetoho ea litekanyetso tsa NovoMix ® 30 Penfill ®, UNIT
10 mmol / L (> 180 mg / dL)	+6

Lihlopheng tse ikhethang tsa bakuli

Joalo ka mehla, ha u sebelisa litokisetso tsa "insulin", ho bakuli ba lihlopha tse ikhethileng, khatello ea tsoekere ea mali e lokela ho laoloa ka hloko le litekanyetso tsa "aspart" aspart ka boeona.

Batho ba baholo le ba senile. NovoMix ® 30 Penfill ® e ka sebelisoa ho bakuli ba tsofetseng, leha ho le joalo, boiphihlelo ka ts'ebeliso ea eona hammoho le lithethefatsi tsa molomo tsa hypoglycemic ho bakuli ba lilemo tse ka tlase ho 75 li lekanyelitsoe.

Bakuli ba nang le ts'oaetso ea bosiu bosiu le sebete. Bakeng sa bakuli ba nang le bothata ba ho renal kapa hepatic, tlhoko ea insulin e ka fokotsoa.

Bana le bacha. NovoMix ® 30 Penfill ® e ka sebelisoa ho phekola bana le bacha lilemong tse fetang tse 10 maemong ao ho sebelisoang insulin e tsoakiloeng pele. Lintlha tse fumanehang tsa kliniki li fumaneha ho bana ba lilemo li 6-9 (bona Pharmacodynamics).

NovoMix ® 30 Penfill ® e lokela ho tsamaisoa ka mokhoa o potelletseng ka thipa kapa ka mpeng ea mpa ea mpa. Haeba ho hlokahala, sethethefatsi se ka tšeloa mahetleng kapa marikeng.

Hoa hlokahala ho fetola sebaka sa ente kahare ho sebaka sa anatomical ho thibela nts'etsopele ea lipodystrophy.

Joalo ka litokisetso tse ling tsa insulin, nako ea ts'ebetso ea NovoMix ® 30 Penfill ® e itšetlehile ka tekanyo, sebaka sa tsamaiso, matla a phallo ea mali, mocheso le boemo ba ts'ebetso ea 'mele.

Ha ho bapisoa le insulin ea motho ea biphasic, NovoMix ® 30 Penfill ® e qala ho nka khato kapele, ka hona e lokela ho tsamaisoa hang-hang pele e nka mokopi. Haeba ho hlokahala, NovoMix ® 30 Penfill ® e ka tsamaisoa haufinyane kamora ho nka mokopi.

Bongata

Matšoao Leha ho le joalo, tekanyetso e itseng e hlokahalang bakeng sa overdose ea insulin ha e so theoe hypoglycemia e ka hlaha butle butle haeba litekanyetso li phahame haholo ha li bapisoa le litlhoko tsa mokuli.

Phekolo. Mokuli a ka felisa hypoglycemia e bonolo ka ho nka lijo tse tsoekere kapa tsoekere tse nang le tsoekere. Ka hona, ho khothalletsoa hore bakuli ba nang le lefu la tsoekere ba lule ba nkile lihlahisoa tse nang le tsoekere.

Boemong ba Hypoglycemia e matla, ha mokuli a sa tsebe letho, o lokela ho kena ho tloha ho 0.5 mg ho 1 mg ea glucagon ho / m kapa s / c (e ka tsamaisoa ke motho ea koetlisitsoeng), kapa ka / ka tharollo ea glucose (dextrose) (ke setsebi sa bongaka feela se ka kenang). Ho hlokahala hape ho tsamaisa dextrose iv haeba mokuli a sa hlaphoheloe kelellong metsotso e leshome le metso e mehlano ka mor'a ts'ebetso ea glucagon. Kamora ho hlaphoheloa kelellong, mokuli o eletsoa ho nka lijo tse nang le lik'habohaedreite ho thibela ho khutla ha hypoglycemia.

Litlhokahalo tsa polokeho

NovoMix ® 30 Penfill ® le linale ke tsa ts'ebeliso ea hau feela. Se ke oa tlatsa mokotla oa Penfill ®.

NovoMix ® 30 Penfill ® e ka se sebelisoe haeba kamora ho e kopanya e sa soeufale ebile e le maru.

E lokela ho totobatsoa ho mokuli tlhokeho ea ho kopanya ho emisoa ha NovoMix® 30 Penfill® hang pele o sebelisoa.

Se ke oa sebelisa NovoMix ® 30 Penfill ® haeba e leqhoa. Bakuli ba lokela ho lemosoa hore ba lahlele nale ka mor'a ente e 'ngoe le e' ngoe.

Litaelo tse khethehileng

Pele ho leeto le lelelele le amanang le phetoho ea libaka, mokuli o lokela ho buisana le ngaka ea hae, kaha ho fetola nako ho bolela hore mokuli o lokela ho ja le ho fana ka insulin ka nako e fapaneng.

Hyperglycemia Tekanyetso e sa lekaneng kapa ho khaotsa ho phekoloa, haholo-holo ka lefu la tsoekere la mofuta oa 1, ho ka lebisa nts'etsopele ea hyperglycemia le lefu la tsoekere la lefu la tsoekere. Matšoao a hyperglycemia hangata a hlaha butle butle ka mor'a lihora tse 'maloa kapa matsatsi. Matšoao a hyperglycemia ke maikutlo a ho nyoriloe, ho eketseha ha moroto o ntšoang, ho nyekeloa, ho hlatsa, ho otsela, ho ruruha le ho omella ha letlalo, molomo o omileng, ho felloa ke takatso ea lijo le ponahalo ea monko oa asiti moeeng o tsoang.Ntle le kalafo e nepahetseng, hyperglycemia ho bakuli ba lefu la tsoekere la mofuta oa 1 e ka lebisa ho lefu la tsoekere la ketoacidosis, boemo bo ka bolaeang.

Hypoglycemia Ho tlōla lijo kapa ho ikoetlisa ka thata ka tsela e sa reroang ho ka lebisa ho hypoglycemia. Hypoglycemia e ka boela ea hlaha haeba tekanyetso ea insulin e phahame haholo ha e bapisoa le litlhoko tsa mokuli (bona "Litlamorao", "Overdose").

Ha ho bapisoa le insulin ea motho ea biphasic, ho hlahisoa ha NovoMix ® 30 Penfill ® ho na le phello e boletsoeng ho feta ea hypoglycemic nakong ea lihora tse 6 ka mor'a taolo. Ntlheng ena, maemong a mang, ho ka hlokahala hore u fetole tekanyetso ea insulin le / kapa mofuta oa lijo. Kamora ho lefa tefo ea metabolism ea carbohydrate, ka mohlala, ka kalafo e matlafatsang ea insulin, bakuli ba ka ba le matšoao a tloaelehileng a lingaka tsa hypoglycemia, tseo bakuli ba lokelang ho tsebisoa ka tsona. Matšoao a tloaelehileng a temoso a ka nyamela ka nako e telele ea lefu la tsoekere. Taolo e matla ea glycemia ho bakuli e ka eketsa kotsi ea hypoglycemia, ka hona, keketseho ea tekanyetso ea NovoMix ® 30 Penfill ® e tlameha ho etsoa ka tlasa tlhokomelo e thata ea bongaka (bona "Tekanyetso le Tsamaiso").

Kaha NovoMix ® 30 Penfill ® e lokela ho sebelisoa mabapi le ho ja lijo ka kotloloho, motho o lokela ho nahanela tekanyo e phahameng ea ho qala ha litlamorao kalafong ea bakuli ba nang le mafu a kopaneng kapa ho sebelisa lithethefatsi tse fokotsang ho kenella ha lijo.

Ha u fetisetsa mokuli ho mefuta e meng ea insulin, matšoao a pele a li-hypoglycemia a ka fetoha kapa a ba tlase haholo ha a bapisoa le ba sebelisang mofuta oa insulin o fetileng.

Phetisetso ea mokuli ho tsoa litokisetsong tse ling tsa insulin. Ho fetisetsoa ha mokuli ho mofuta o mocha oa insulin kapa tokisetso ea insulin ea moetsi e mong ho tlameha ho etsoa ka tlasa tlhokomelo e thata ea bongaka. Haeba u fetola khatello ea maikutlo, mofuta, moetsi le mofuta (insulin ea motho, analog ea insulin ea motho) ea litokisetso tsa insulin le / kapa mokhoa oa tlhahiso, ho ka hlokahala phetoho ea tekanyetso. Bakuli ba tlohelang litokisetso tse ling tsa insulin ho ea kalafo ka NovoMix ® 30 Penfill ® e ka hloka ho eketsa khafetsa ea liente kapa ho fetola lethal dose ha e bapisoa le litekanyetso tsa litokisetso tsa insulin tsa pele. Haeba ho hlokahala, tokiso ea litekanyetso, e ka etsoa ka ente ea pele ea moriana kapa nakong ea libeke tsa pele kapa likhoeli tsa kalafo.

Likarabelo tsa sebakeng sa ente. Joalo ka kalafo e meng ea insulin, methapo e ka hlaha setsing sa ente, se bonahatsoang ke bohloko, bokhubelu, hives, ho ruruha, hematomas, ho ruruha le ho hlohlona. Ho fetola sebaka sa ente khafetsa sebakeng se tšoanang sa anatomical ho ka fokotsa mats'oao kapa ho thibela nts'etsopele ea maikutlo ana. Reaction hangata e nyamela kamora matsatsi a seng makae ho isa ho libeke tse 'maloa. Maemong a sa tloaelehang, NovoMix ® 30 Penfill ® e ka hloka ho hlakoloa ka lebaka la karabelo setsing sa ente.

Ts'ebeliso e tšoanang ea lithethefatsi tsa sehlopha sa thiazolidinedione le litokisetso tsa insulin. Litaba tsa ho ntlafala ha lefu la pelo le sa foleng li tlalehiloe kalafong ea bakuli ba nang le thiazolidinediones hammoho le litokisetso tsa insulin, haholoholo haeba bakuli ba joalo ba na le mabaka a tlisoang ke ho hola ho sa feleng ha pelo.Ntlha ena e lokela ho ananeloa ha ho fanoa ka phekolo ea ho kopanya le thiazolidinediones le litokisetso tsa insulin ho bakuli. Ka ho khethoa ha mofuta o joalo oa phekolo, ho bohlokoa ho etsa tlhahlobo ea bongaka ea bakuli ho bona matšoao le matšoao a ho se atlehe ha pelo, boima ba mmele le boteng ba edema. Haeba matšoao a ho hloleha ha pelo a mpefala ho bakuli, kalafo e nang le thiazolidinediones e tlameha ho khaotsa.

Tšusumetso ho bokhoni ba ho khanna makoloi le ho sebetsa ka mekhoa. Bokhoni ba bakuli ba ho tsepamisa mohopolo le sekhahla sa karabelo se ka senyeha nakong ea hypoglycemia, e ka bang kotsi maemong ao bokhoni bona bo hlokahalang haholo (mohlala, ha o khanna makoloi kapa o sebetsa ka mechine le metjeko).

Fomu ea tokollo

Ho emisoa bakeng sa tsamaiso e potolohileng, 100 PIECES / ml. Likarolong tsa khalase ea sehlopha sa hydrolytic 1, e tiisitsoeng ka li-discs tsa rabara ka lehlakoreng le leng le li-piston tsa rabara ka lehlakoreng le leng, 3 ml e 'ngoe le e' ngoe, bolo ea khalase e behiloe ka har'a cartridge ho tsamaisa ho kopanya ha ho emisoa, ka har'a pakete ea li-cartridge tsa 5, ka pakete ea karete ea 1.

Litla-morao tsa phello ea Novomix 30:

Litla-morao tse amanang le phello ea metabolism ea carbohydrate: hypoglycemia (ho fufuleloa ho eketsehileng, letlalo la mokhathala, ho tšoha kapa ho thothomela, ho tšoenyeha, mokhathala o sa tloaelehang kapa bofokoli, ho ferekana, ho lahleheloa ke khatello ea kelello, ho tsekela, tlala e matla, ho senyeha ha nakoana hoa pono, hlooho e bohloko) , ho nyekeloa pelo, tachycardia). Hypoglycemia e matla e ka lebisa ho lahleheloe ke letsoalo le / kapa ho sithabela, ho senyeha hoa nakoana kapa ho sa fetoheng hoa boko le lefu.

Litla-morao: Ho ka etsahala - urticaria, lekhopho la letlalo, seoelo - maikutlo a anaphylactic. Litla-morao tse akaretsang li ka kenyelletsa lekhopho la letlalo, letlalo le boreleli, ho fufuleloa ho eketsehileng, mathata a ka mpeng, angioedema, ho hema ka thata, tachycardia le ho fokotseha ha khatello ea mali.

Boitšoaro ba lehae: ho hlaseloa ke lefu la ho fokola (ho ruruha, ho ruruha, ho hlohlona ha letlalo sebakeng sa ente), hangata le ha nakoana le ho feta ha kalafo e ntse e tsoela pele, lipodystrophy ea khonahala.

Tse ling: qalong ea kalafo ha li na seoelo - edema, mohlomong phoso e khathollang

Sebelisa nakong ea bokhachane le pelehi.

Phihlelo ea Clinical le insulin aspart ka nako ea bokhachane e fokola haholo.

Ho lithuto tsa liteko tsa liphoofolo, ha ho liphapang tse fumanoeng pakeng tsa embryotoxicity le teratogenicity ea insulin aspart le insulin ea motho. Nakong ea ts'ebetso ea bokhachane e ka bang teng le nakong eohle ea bophelo ba hae, ho hlokahala hore ho hlahlojoe ka hloko boemo ba bakuli ba nang le lefu la tsoekere le ho hlokomela boemo ba tsoekere maling. Tlhokahalo ea insulin, joalo ka molao, e fokotseha ho trimester ea pele mme butle-butle e eketseha ka li-trimesters tsa bobeli le tsa boraro tsa boimana. Nakong ea ha lesea le hang kamora ho hlaha, litlhoko tsa insulin li ka theoha haholo. Nakoana kamora ho hlaha, tlhoko ea insulin kapele e khutlela boemong bo neng bo le pele ho ima.

Insulin asprat e ka sebelisoa nakong ea lactation (matsoele), le tokiso ea li-insulin e ka hlokahala.

Litaelo tse ikhethileng tsa ho sebelisa Novomix 30 penfill.

Tekanyetso e sa lekaneng ea insulin kapa ho khaotsa ho phekoloa, haholo-holo ka lefu la tsoekere la mofuta oa 1, ho ka lebisa nts'etsopele ea hyperglycemia kapa lefu la tsoekere la tsoekere. Matšoao a hyperglycemia hangata a hlaha butle butle ka mor'a lihora tse 'maloa kapa matsatsi. Matšoao a hyperglycemia ke ho nyekeloa ke pelo, ho hlatsa, ho otsela, ho omella le ho omella letlalong, molomo o omileng, tlhahiso ea mokokotlo, lenyora le ho felloa ke takatso ea lijo, le ponahalo ea monko oa acetone moeeng o tsoang. Ntle le kalafo e loketseng, hyperglycemia e ka lebisa lefung. Kamora ho lefa tefo ea metabolism ea carbohydrate, ka mohlala, ka kalafo e matla ea insulin, bakuli ba ka ba le matšoao a tloaelehileng a li-precursors tsa hypoglycemia.

Ho bakuli ba nang le lefu la tsoekere ba nang le taolo e nepahetseng ea metabolic, mathata a morao a lefu la tsoekere a fetoha hamorao 'me a tsoela pele butle butle. Mabapi le sena, ho khothalletsoa ho etsa mesebetsi e reretsoeng ho ntlafatsa taolo ea metabolic, ho kenyelletsa le ho lekola boemo ba tsoekere maling.

Litholoana tsa li-pharmacodynamic tsa li-analog tsa insulin tse liehang ho sebetsa ke hore tsoelo-pele ea hypoglycemia ha e sebelisoa e qala pejana ho feta ka ts'ebeliso ea insulin ea insulin.

E lokela ho nahana ka tekanyo e phahameng ea nts'etsopele ea phello ea hypoglycemic ho kalafo ea bakuli ba nang le mafu a kopaneng kapa ho sebelisa lithethefatsi tse fokotsang ho kenngoa ha lijo. Ka boteng ba maloetse a kopaneng, haholo a tšimoloho ea tšoaetso, tlhoko ea insulin, joalo ka molao, ea eketseha. Ho senyeha ha renal kapa hepatic ho ka lebisa ho fokotseha hoa litlhoko tsa insulin.

Ha u fetisetsa mokuli ho mefuta e meng ea insulin, matšoao a pele a li-hypoglycemia a ka fetoha kapa a ba tlase haholo ha a bapisoa le ba sebelisang mofuta oa insulin o fetileng.

Ho fetisetsoa ha mokuli ho mofuta o mocha oa insulin kapa tokisetso ea insulin ea moetsi e mong ho tlameha ho etsoa ka tlasa tlhokomelo e thata ea bongaka. Haeba u fetola khatello ea maikutlo, mofuta, moetsi le mofuta (insulin ea motho, insulin ea liphoofolo, analogue ea insulin ea motho) ea litokisetso tsa insulin le / kapa mokhoa oa tlhahiso, ho ka hlokahala phetoho ea tekanyetso.

Phetoho ea tekanyetso ea insulin e ka hlokahala ka phetoho ea lijo le ho ikoetlisa ho eketsehileng. Ho ikoetlisa hang ka mor'a ho ja ho ka eketsa kotsi ea hau ea hypoglycemia. Ho tlōla lijo kapa ho ikoetlisa ka tsela e sa reroang ho ka lebisa ho holiseng hypoglycemia.

Phetoho e kholo maemong a puseletso bakeng sa metabolism ea carbohydrate e ka lebisa ho boemo ba methapo ea bohloko ea methapo, eo hangata e fetohang.

Ntlafatso ea nako e telele taolong ea glycemic e fokotsa kotsi ea tsoelo-pele ea lefu la tsoekere. Leha ho le joalo, ho eketsoa ha kalafo ea insulin ka ntlafatso e matla taolong ea glycemic ho ka tsamaisana le ho senyeha ha nakoana ha lefu la tsoekere.

Ha e khothalletsoe hore e sebelisoe baneng ba ka tlase ho lilemo tse 6.

Tšusumetso ho bokhoni ba ho khanna makoloi le litsamaiso tsa taolo

Bokhoni ba bakuli ba ho tsepamisa mohopolo le sekhahla sa karabelo se ka senyeha nakong ea hypoglycemia le hyperglycemia, e ka bang kotsi maemong ao bokhoni bona bo hlokahalang haholo (mohlala, ha o khanna koloi kapa o sebetsa ka mechine le metjeko). Bakuli ba lokela ho eletsoa hore ba nke mehato ea ho thibela nts'etsopele ea hypoglycemia le hyperglycemia ha u khanna koloi 'me u sebetsa ka mekhoa. Sena ke sa bohlokoa haholo ho bakuli ba se nang matšoao a tlisoang ke ho ba le hypoglycemia kapa ba nang le liketsahalo tsa khafetsa tsa hypoglycemia. Maemong ana, monyetla oa mosebetsi o joalo o lokela ho nahanoa.

Ho kenella ha penfill ea Novomix 30 le lithethefatsi tse ling.

Hypoglycemic phello ea ka insulin ntlafatsa lithethefatsi molomo hypoglycemic, Mao inhibitors, inhibitors Ace, k'habone inhibitors anhydrase, khetha beta-blockers, bromocriptine, octreotide, sulfonamides, anabolic steroid, tetracyclines, clofibrate, ketoconazole, mebendazole, pyridoxine, theophylline, cyclophosphamide, fenfluramine, litokisetso lithium litokisetso tse nang le ethanol.

Lithibela-pelehi tsa molomo, GCS, lihormone tsa qoqotho, li-diaztics tsa thiazide, heparin, li-antidepressants tsa tranthicine, li-sympathomimetics, danazole, clonidine, calcium channel blockers, diazoxide, morphine, phenytoin, nikotine e fokolisa phello ea hypoglycemic ea insulin.

Tlas'a tšusumetso ea reserpine le salicylates, ho fokolisa le ho eketsa ts'ebetso ea moriana ho ka khoneha.

Meriana e nang le thiol kapa sulfite, ha e eketsoa ho insulin, e baka tšenyo.

Lipotso, likarabo, litlhahlobo mabapi le lithethefatsi NovoMix 30 Penfill

Tlhahisoleseling e fanoeng e reretsoe litsebi tsa bongaka le tsa meriana. Tlhahisoleseling e nepahetseng ka ho fetelletseng ka lithethefatsi e fumaneha litaelong tse tlamelletsoeng ke moqapi. Ha ho na tlhahisoleseling e thathamisitsoeng leqepheng lena kapa leha e le efe ea sebaka sa rona sa marang-rang e ka sebeletsang e le sebaka sa boipiletso ba motho ho setsebi.