Matšoao a ts'ebeliso le thepa ea insulin Detemir

Mahlale a morao-rao a kopaneng a DNA a ntlafalitse boemo ba ts'ebetso ea "insulin" e bonolo. Insemir insulin e hlahisoa ke li-biotechnology tse amanang le DNA hape li sebelisa mofuta Saccharomyces cerevisiae, ke analog ea insulin ea nako e telele ea ts'ebetso ea motho e nkileng nako e telele ka ts'ebetso e se nang morero. Boemo ba liketso bo fapana haholo ha bo bapisoa le isofan-insulin le insulin glargine. Ketso ea nako e telele e hlaha ka lebaka la mokhatlo oa "disemir" oa "insulin" sebakeng sa ente ea ente le ho hokahana ha limolek'hule ho albin ka komporong e nang le ketane ea mafura a acid. Ha e bapisoa le isofan-insulin, "insulin" ea "detemir" e fetisoa butle butle ka har'a li-tishu tsa sepheo sa "peripheral". Mekhoa ena e kopantsoeng ea ho lieha ea ho tsamaisa e fana ka monko o tsoaloang hape le boemo ba ts'oaetso ea insulin. Detemir insulin e tšoauoa ka matla a makenete a ho bonahatsoa ha liketsahalo ho bakuli ha a bapisoa le insulin NPH kapa insulin glargine. Boiketso bo bonts'itsoeng mabapi le ts'ebetso bo bakoa ke lintlha tse peli: insemir ea insulin e lula e le boemong bo qhibilihang maemong ohle ho tloha ka mokhoa oa eona oa litekanyetso ho ea ho mokokotlo oa "insulin" le phello e makatsang ea ho tlama ho serum albin.
Ka ho sebelisana le li-receptor tse khethehileng ho membrane ea cytoplasmic e ka ntle ea lisele, e theha motsoako oa "insulin-receptor" o kenyelletsang ts'ebetso ea methapo, ho kenyelletsa tlhahiso ea li-enzyme tse ngata tsa bohlokoa (hexokinase, pyruvate kinase, glycogen synthetase, jj.). Ho fokotseha ha tsoekere ea mali ho bakoa ke keketseho ea sephethe-phethe sa eona, ho eketseha ha lisele, khothatso ea lipogenesis, glycogenogeneis, ho fokotseha ha tlhahiso ea tsoekere ke sebete, jj. Lihora tse 4 ho isa ho tse 14 ka mor'a tsamaiso. Kamora ho tsamaisoa ha subcutaneous, karabelo ea pharmacodynamic e ne e lekana le tekanyetso e fanoeng (phello e phahameng, nako ea ts'ebetso, phello e akaretsang). Kamora ho ente ea SC, detemir e tlama ho albin ka ketane ea eona ea mafura. Kahoo, boemong ba ts'ebetso e tsitsitseng, mahloriso a insulin e sa koaheloang ka bongata a fokotseha haholo, e lebisang boemong bo tsitsitseng ba glycemia. Nako ea ts'ebetso ea detemir ka tekanyo ea 0,4 IU / kg ke lihora tse 20, ka hona, moriana o beoa habeli ka letsatsi ho bakuli ba bangata. Lithutong tsa nako e telele (likhoeli tse 6), tsoekere ea plasma e potlakileng ho bakuli ba nang le lefu la tsoekere I e ne e le betere ha e bapisoa le isofan-insulin, e boletsoeng motheong / kalafo ea bolus. Taolo ea glycemic (glycosylated hemoglobin - HbA1c) nakong ea kalafo ka sesole sa insulin e ne e ka bapisoa le ea kalafo le isofan-insulin, ka kotsi e tlase ea ho ba le hypoglycemia ea bosiu le ho se be teng ha keketseho ea boima ba 'mele nakong ea ts'ebeliso ea eona. Boemo ba taolo ea tsoekere ea bosiu bo boreleli ebile bo na le insulin e ngata ha e bapisoa le insulin, e bonahatsoang ke kotsi e tlase ea hypoglycemia bosiu.
Palo e phahameng ea "insulin" ea "insulin" ea seramu ea mali e fihlella lihora tse 6-8 kamora ho tsamaisoa. Ka regimen ea tsamaiso ea habeli ea letsatsi le letsatsi, litekanyetso tse tsitsitseng tsa moriana serum ea mali li fihlelleha kamora liente tse 2-3.
Ho inactivation ho tšoana le ho lokisoa ha insulin ea motho, li-metabolites tsohle tse entsoeng ha li sebetse. Lithuto tsa ho Kopanya Liprotheine in vitro le ho vivo bontša ho ba sieo ha litšebelisano tsa bohlokoahali tsa bongaka lipakeng tsa ho hlohlona ha insulin le mafura acid kapa lithethefatsi tse ling tse tlama ho liprotheine tsa mali.
Bophelo ba halofo ea bophelo ka mor'a ente ea sc bo khetholloa ke tekanyo ea ho amoheloa ho tsoa lithong tsa subcutaneous mme ke lihora tse 5-7, ho latela tekanyetso.
Ha s / ho kenyelletsa ea mahloriso ka serum ea mali li ne li lekana le lethal dose le fanoang (boholo ba mahloriso, tekanyo ea ho amoheloa).
Lihlopheng tse ikhethang tsa bakuli
Thepa ea Pharmacokinetic e ile ea ithutoa baneng (ba lilemo li 6 ho isa ho tse 12) le bacha (ba lilemo li 13 ho isa ho tse 17) mme ba bapisoa le batho ba baholo ba nang le mofuta oa lefu la tsoekere la lefu la tsoekere. Ho ne ho se na phapang ea thepa ea pharmacokinetic. Ho ne ho se na phapang e kholo litabeng tsa pharmacokinetics ea detemir insulin pakeng tsa bakuli ba tsofetseng le ba banyenyane, kapa lipakeng tsa bakuli ba nang le ts'ebetso ea mokokotlo oa mokokotlo le oa hepatic le bakuli ba phetseng hantle.

Ts'ebeliso ea "insulin" ea lithethefatsi

E etselitsoe tsamaiso e tsamaeang ka tlas'a lefatše. Tekanyetso e hlahisoa ka bonngoe boemong bo bong le bo bong. Detemir insulin e lokela ho fuoa makhetlo a 1 kapa a mabeli ka letsatsi ho ipapisitse le litlhoko tsa mokuli. Bakuli ba hlokang ho sebelisa habeli ka letsatsi bakeng sa taolo e nepahetseng ea tsoekere ea mali ba ka kena tekong ea mantsiboea ebang ke nakong ea lijo tsa mantsiboea, kapa pele ho robala, kapa lihora tse 12 kamora lethal la hoseng. Detemir insulin e kenngoa ka lethekeng ka seropeng, leboteng la ka mpeng la mpa kapa lehetleng. libaka tsa ente e lokela ho fetoloa leha e kenngoa sebakeng se le seng. Joalo ka li-insulin tse ling, ho bakuli ba tsofetseng le bakuli ba nang le bothata ba ho renal kapa hepatic, maemo a tsoekere ea mali a lokela ho bea leihlo haholoanyane le tekanyetso ea bohloeki ka bo eona. Phetoho ea dose e kanna ea hlokahala ha ho ntlafatsoa ts'ebetso ea mokuli, ho fetola lijo tsa hae tse tloaelehileng, kapa bokuli bo tšoanang.

Litla-morao tsa bakoang ke insulin ea lithethefatsi

Boitšoaro bo bobe bo bonoang ho bakuli ba sebelisang insulin bo amanang le insulin bo itšetleha haholo ka tekanyetso mme bo ntlafala ka lebaka la phello ea litheko tsa insulin. Hypoglycemia hangata ke litla-morao tse atileng haholo. Hypoglycemia ea hlaha haeba tekanyetso e phahameng haholo ea moriana e fanoa e amana le tlhoko ea mmele ea insulin.
Karabelo setsing sa ente e ka bonoa ka kalafo ho bakuli ba ka bang 2%. Karolo ea bakuli ba fumanang kalafo le ba lebelletsoeng ho nts'etsapele litlamorao e hakanyetsoa ho 12%. Boemo ba liketsahalo tse bohloko nakong ea liteko tsa kliniki bo hlahisoa ka tlase.
Mathata a amanang le metabolism le phepo e nepahetseng: khafetsa (1/100, ≤1 / 10).
Hypoglycemia: matšoao a hypoglycemia hangata a hlaha ka tšohanyetso. Tsena li kenyelletsa "mofufutso o batang", letlalong la letlalo, mokhathala o eketsehileng, ho tšoha kapa ho thothomela, ho tšoenyeha, mokhathala o sa tloaelehang kapa bofokoli, ho ferekana kelellong, ho fokotseha ho tsepamisa maikutlo, ho otsela, tlala e matla, pono e fifatsang, hlooho e bohloko, ho nyekeloa ke pelo, ho hlonama. Hypoglycemia e matla e ka lebisa ho lahleheloa ke kelello le / kapa ho tsitsipana, ho senyeha hoa nakoana kapa ho sa fetoheng hoa ts'ebetso ea boko, esita le lefu.
Mathata a akaretsang le lintho tse etsahalang setsing sa ente: khafetsa (1/100, ≤1 / 10).
Likarabelo tsa sebakeng sa ente: Litla-morao tsa hypersensitivity (redness, ho ruruha le ho hlohlona sebakeng sa ente) li ka hlaha nakong ea kalafo ea insulin. Liphetoho tsena hangata li ba tsa nako e khuts'oane mme li nyamela ka kalafo e tsoelang pele.
Rare (1/1000, ≤1 / 100).
Lipodystrophy: e ka hlaha sebakeng sa ente ka lebaka la ho se latele molao oa ho fetola sebaka sa ente sebakeng se le seng. Edema: e ka hlaha mohato oa pele oa kalafo ea insulin. Hangata matšoao ana ke a nakoana.
Mathata a tsamaiso ea 'mele ea ho itšireletsa mafung: ka seoelo (1/1000, ≤1 / 100).
Litla-morao: urticaria, lekhopho la letlalo le ka hlaha ka lebaka la hypersensitivity. Matšoao a hypersensitivity a ka kenyelletsa ho hlohlona, ​​ho fufuleloa, ho phahama ha ka mpeng, angioedema, ho hema ka thata, ho akheha, le phallo ea mali. Nts'etsopele ea maikutlo a hypersensitivity e ka beha bophelo kotsing.
Ho sitisoa ha pono: ka seoelo (1/1000, ≤1 / 100).
Mathata a hlalosang
: Ts'oaetso e khathollang e ka hlaha mohato oa pele oa kalafo ea insulin. Hangata matšoao ana ke a nakoana. Lefu la tsoekere la retinopathy. Ho ntlafala ha nako e telele taolong ea glycemic ho fokotsa kotsi ea tsoelo-pele ea lefu la tsoekere. Leha ho le joalo, keketseho ea kalafo ea insulin ka ntlafatso e matla taolong ea metabolism ea carbohydrate e ka lebisa keketseho ea nakoana matšoao a lefu la tsoekere.
Mathata a tsamaiso ea methapo: e sa fumaneheng haholo (1/10000, ≤1 / 1000).
Peripheral neuropathy
: Phetoho e potlakileng taolong ea glycemic e ka lebisa boemong ba bohloko ba methapo ea maikutlo, bo atisang ho feto-fetoha.

Litaelo tse khethehileng bakeng sa tšebeliso ea lithethefatsi tsa insulin

Detemir insulin e fana ka taolo e ntlafalitsoeng ea glycemic (e thehiloeng ho litekanyo tsa tsoekere ea plasma ea tsoekere) ha e bapisoa le isofan-insulin. Tekanyetso e sa lekaneng ea insulin kapa ho khaotsa ho phekoloa, haholo-holo ka mofuta oa lefu la tsoekere la mellitus, ho ka lebisa kholong ea hyperglycemia kapa lefu la tsoekere. E le molao, matšoao a pele a hyperglycemia a hlaha butle butle, ho feta lihora tse 'maloa kapa matsatsi. Matšoao ana a kenyelletsa lenyora, ho ntša metsi kapele, ho nyekeloa ke pelo, ho hlatsa, ho otsela, redness le ho omella ha letlalo, molomo o omileng, ho felloa ke takatso ea lijo, monko oa acetone moeeng o tsoang. Ka mofuta oa lefu la tsoekere la lefu la tsoekere, ntle le kalafo e nepahetseng, hyperglycemia e lebisa nts'etsopele ea lefu la tsoekere la lefu la tsoekere 'me le ka lebisa lefung. Hypoglycemia e ka hlaha haeba tekanyetso ea insulin e phahame haholo ha e bapisoa le tlhoko ea insulin ho mokuli ea itseng. Ho tlōla lijo kapa ho ikoetlisa ka matla ho ka lebisa ho hypoglycemia. 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. Mafu a khahlang, haholo a tšoaetsanoang le feberu, hangata a eketsa tlhoko ea mmele ea insulin.
Fetoha ho tsoa mefuteng e meng ea insulin
Ho fetisoa ha mokuli ho ea mofuta o mocha oa "insulin" kapa "insulin" ho tsoa ho moetsi e mong ho lokela ho etsahala tlasa taolo e thata ea bongaka. Haeba u fetola motsoako, moetsi, mofuta, mefuta (phoofolo, motho, mofuta oa insulin ea motho) le / kapa mokhoa oa tlhahiso ea eona (liphatsa tsa lefutso kapa insulin ea tlhaho ea liphoofolo), ho ka hlokahala phetoho ea tekanyetso. Bakuli ba fetohelang kalafo ea insulin ba ka batla ho fetola tekanyetso ha ba bapisoa le litekanyetso tsa insulin eo pele e neng e sebelisoa. Tlhokahalo ea tokiso ea litekanyetso li ka hlaha kamora ho hlahisoa ha tekanyetso ea pele kapa ka libeke kapa likhoeli tse 'maloa tse qalang. Detemir insulin ha ea lokela ho tsamaisoa iv, kaha sena se ka lebisa ho hypoglycemia e matla. Ho se sebetse hantle ka tsamaiso ea i / m ho potlakile ebile ho isa tekanyong e kholo ha ho bapisoa le tsamaiso ea subcutaneous. Haeba insulin ea insulin e tsoakoa le mefuta e meng ea insulin, boemo ba karolo e le 'ngoe kapa bobeli ba tsona bo tla fetoha. Ho kopanya insulin le insulin ka analogue e potlakileng ea insulin, joalo ka insulin, e lebisa ho boemo ba setšoantšo bo nang le phello e fokotsitsoeng le e liehang ho bapisoa le tsamaiso ea bona e arohaneng.
Ho fetisoa ho tsoa ho li-insulin tse mahareng le insulin ea nako e telele ho levemir insulin ho ka hloka tokiso ea tekanyo le nako. Joalo ka li-insulin tse ling, ho khothalletsoa ho lekola ka hloko maemo a tsoekere ea mali nakong ea phetolelo le libekeng tsa pele tsa tsamaiso e ncha ea insulin. Ho lokisa kalafo e kopantsoeng ea hypoglycemic (lethal dose le nako ea tsamaiso ea mefuta e fokolang ea insulin kapa lethal dose ea li-hypoglycemic agents) ho ka hlokahala.
Detemir insulin ha e reretsoe ho sebelisoa lipompong tsa insulin.
Sebelisa nakong ea bokhachane le pelehi. Ha hona joale ha ho na datha mabapi le ts'ebeliso ea bongaka ea insulin ka nako ea boimana le ho lactation. Boithuto ba tšebetso ea ho hlahisa liphoofolo liphoofolong ha boa ka ba senola liphapang lipakeng tsa insulin le insulin ea motho mabapi le embryotoxicity le teratogenicity. Ka kakaretso, ho hlokahala tlhokomelo e hlokolosi ea basali ba bakhachane ba nang le lefu la tsoekere nakong eohle ea bokhachane, le ha ba rera ho ima. Tlhokahalo ea insulin ka har'a trimester ea pele ea bokhachane hangata e fokotseha, ebe ho trimesters ea bobeli le ea boraro e eketseha. Nakoana kamora ho hlaha, tlhoko ea insulin kapele e khutlela boemong bo neng bo le pele ho ima. Bakeng sa basali ba anyang matsoele, ho ka hlokahala phetoho ea lethal dose ea inulin le lijo.
Tšusumetso ho bokhoni ba ho khanna koloi le ho sebetsa ka mekhoa. Bokhoni ba bakuli ba ho tsepamisa mohopolo le sekhahla sa karabelo se ka senyeha nakong ea hypoglycemia kapa 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 se bohlokoa haholo ho bakuli ba se nang kapa ba nang le matšoao a fokotsehileng a moriana oa ho ba le hypoglycemia kapa liketsahalo tsa khafetsa tsa hypoglycemia. Maemong ana, o lokela ho nahana ka monyetla oa ho khanna kapa ho etsa mosebetsi o tšoanang.

Litšebelisano tsa lithethefatsi insulin

Hona le lithethefatsi tse 'maloa tse amang tlhokahalo ea insulin.
Phello ea hypoglycemic ea insulin e ntlafatsoa ke: hypoglycemic lithethefatsi molomo, Mao inhibitors, inhibitors Ace, k'habone anhydrase inhibitors, bao e seng khetha β-blockers, bromocriptine, sulfonamides, anabolic steroid, tetracyclines, clofibrate, ketoconazole, mebendazole, pyridoxine, theophylline, cyclophosphamide, fenfluramine, lithium, lithethefatsi tse nang ethanol.
Phello ea hypoglycemic ea insulin ea fokolisa: lithibela-pelehi tsa molomo, li-corticosteroid, lihormone tsa qoqotho, li-diaztics tsa thiazide, heparin, li-antidepressants tsa trio, li-audiathomimetics, danazole, clonidine, li-blockchain tse liehang tsa calcium, diazoxide, morphine, phenytoin, nikotine. Tlas'a tšusumetso ea reserpine le salicylates, ho ka etsahala ho fokolisa kapa ho ntlafatsa ts'ebetso ea lithethefatsi Octreotide / lanreotide, e ka eketsang le ho fokotsa tlhoko ea 'mele ea insulin. Li-blockers tsa Β-adrenergic li ka pata matšoao a hypoglycemia le ho lieha ho hlaphoheloa ka mor'a hypoglycemia. Joala bo ka ntlafatsa le ho lelefatsa phello ea hypulin.
Ho se lumellane
Ka mohlala, lithethefatsi tse ling tse nang le thiol kapa sulfite ha motsoako o eketsoa ka tharollo ea "insulin" li ka baka tšenyo. Ka hona, u se ke ua eketsa mokelikeli oa "insulin" tharollong ea infusion.

Bongata ba lithethefatsi Insulin, litlhare le kalafo

Tekanyetso e khethehileng e lumellang ho bua ka overdose ea insulin ha e so theoe, empa hypoglycemia e ka hlaha butle butle haeba ho hlahisitsoe lethalinyana le phahameng haholo bakeng sa mokuli ea itseng. Matšoao hypoglycemia
Phekolo: mokuli a ka tlosa hypoglycemia e bonolo ka ho ja tsoekere, tsoekere kapa lijo tse nang le lik'habohaedreite tse ngata. Ka hona, ho khothalletsoa hore bakuli ba nang le lefu la tsoekere ba lule ba nkile tsoekere, liswiti, likuku kapa lero le monate la litholoana.Maemong a hypoglycemia e matla, ha mokuli a sa tsebe letho, 0.5-1 mg ea glucagon v / m kapa s / c, (e ka tsamaisoa ke motho ea koetlisitsoeng), kapa iv dextrose (tsoekere), e lokela ho tsamaisoa.
INSERT INTO `info` (` ID`, `Name`,` NameBase`, `TEXT`,` IsUsed`, `Tlhaloso`,` KeyWords`) LITLHAKU (li ka kenngoa feela ke setsebi sa bongaka). Tsamaiso e kenelletseng ea dextrose e boetse ea hlokahala haeba mokuli a sa hlaphoheloe metsotso e 10-15 kamora ho tsamaisoa ha glucagon. Kamora ho hlaphoheloa kelellong, mokuli o eletsoa hore a je lijo tse nang le lik'habohaedreite e le ho qoba ho phetoa hape ha hypoglycemia.

Lethathamo la litlama tsa litlama moo o ka rekang insulin teng:

Fomu ea tokollo, sebopeho le sephutheloana

Tharollo bakeng sa tsamaiso ea sc e pepeneneng, e se nang 'mala.

1 ml1 pene ea syringe
insulinLIHLOOHO TSE 100300 PIECES *

Baeti: glycerol, phenol, metacresol, zinc acetate, sodium chloride, sodium dihydrogen phosphate dihydrate, hydrochloric acid kapa sodium hydroxide, metsi d / i.

* Yuniti e le 'ngoe e na le 142 uling ea "insulin" e se nang letsoai e amanang le yuniti e le' ngoe. insulin ea motho (IU).

3 ml - li-cartridge tsa khalase (1) - lipentšele tsa senotlolo tse ngata tse ka nooang bakeng sa ente e phetoang (5) - lipakete tsa karete.

Ketso ea pharmacological

Hypoglycemic drug. Ke analogue e bonolo ea insulin ea batho ba nkileng nako e telele ha ba sebetsa ka sefahleho. E hlahisitsoe ke biotechnology ea DS e sebelisang mofuta o mong oa Saccharomyces cerevisiae.

Boemo ba ts'ebetso ea lithethefatsi Levemir ® FlexPen ® ha bo fapana haholo ha bo bapisoa le insulin-isophan le insulin glargine.

Ketso ea nako e telele ea lithethefatsi Levemir ® FlexPen ® e bakoa ke mokhatlo o phatlalalitsoeng oa "limolek'hule" tsa "insulin" sebakeng sa ente sejoang le ho ts'oaroa ha limolek'hule tsa lithethefatsi ho albumin ka kamano le ketane ea lehlakore. Ha ho bapisoa le insulin-isophan, detemir ea insulin e lieha ho fihla linthong tse ka sehlohlolong. Mekhoa ena e kopantsoeng ea ho lieha ea ho tsamaisa e fana ka mokhoa o mongata oa ho hlahisa le tlhahiso ea Levemir ® FlexPen ® ha e bapisoa le insulin-isophan.

E sebetsana le receptor e itseng ho membrane e ka ntle ea cytoplasmic 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 tsoekere maling ho bakoa ke keketseho ea lipalangoang tsa eona tse makatsang, ho monya ho eketsehileng ka lisele, ho hlohlona ha lipoxandis, glycogenogeneis, le ho fokotseha hoa tlhahiso ea tsoekere ke sebete.

Bakeng sa tekanyetso ea 0.2-0.4 U / kg 50%, phello e phahameng ea lithethefatsi e hlaha ka bongata ho tloha lihora tse 3-4 ho isa ho tse 14 kamora ho tsamaisoa. Nako ea ts'ebetso e fihlile ho lihora tse 24, ho latela tekanyetso, e etsang hore ho khonehe ho tsamaisa nako e le 1 / letsatsi kapa makhetlo a 2 / letsatsi.

Kamora ho tsamaisoa ha sc, karabelo ea pharmacodynamic e ne e lekana le lethal dose le fanoang (phello e phahameng, nako ea ts'ebetso, phello e akaretsang).

Boithuto ba nako e telele ho bakuli ba nang le lefu la tsoekere la mofuta oa 2 ba amohetseng kalafo ea insal ea insulin hammoho le lithethefatsi tsa molomo tsa hypoglycemic, ho bonahalitsoe taolo ea glycemic (ho latela glycosylated hemoglobin -1s) khahlano le semelo sa kalafo ka Levemir ® FlexPen ®, e ne e ka bapisoa le insulin-isophan le insulin glargine e nang le phaello e tlase ea boima.

Fetoha boima ba 'mele ka kalafo ea insulin

Nako ea ho ithutaInsulin detemir hangInsulin detemir habeliIsulin insulin Insulin glargine
Libeke tse 20+ 0,7 kg+ 1,6 kg
Libeke tse 26+ 1,2 kg+ 2.8 kg
Libeke tse 52+ 2.3 kg+ 3.7 kg+ 4 kg

Ka lithuto, ts'ebeliso ea kalafo ea ho kopanya le lithethefatsi tsa Levemir ® FlexPen ® le li-hypoglycemic tsa molomo ho 61-65% ea linyeoe li fokolitse kotsi ea ho ba le hypoglycemia e bobebe bosiu, ho fapana le insulin-isophan.

Lithutong tsa nako e telele (likhoeli tse ≥6), tsoekere ea plasma e potlakileng ho bakuli ba nang le lefu la 1 lefu la tsoekere e ne e le hantle ha e bapisoa le kalafo le Levemir ® FlexPen ® ha e bapisoa le insulin-isophan e laetsoeng kalafo ea mantlha / bolus, ho kenyelletsa le lithuto tse kenyeletsang bana le bacha ba lilemo tse 6 ho isa ho 17. Taolo ea glycemic (HbA1s) nakong ea phekolo le Levemir ® FlexPen ® e ne e bapisoa le eo ka kalafo ea insulin-isophan, e nang le kotsi e tlase ea hypoglycemia ea bosiu mme ha ho na keketseho ea boima ba 'mele ka Levemir ® FlexPen ®.

Boemo ba taolo ea glycemic ea bosiu bo bataletse ebile bo na le Levemir ® FlexPen ® ha bo bapisoa le insulin-isophan, e bonts'ang kotsi e tlase ea ho ba le hypoglycemia ea bosiu.

Ha o sebelisa Levemir ® FlexPen ®, tlhahiso ea antibody e ile ea bonoa. Leha ho le joalo, ntlha ena ha e ame taolo ea glycemic.

Mofumahali

Ka tsamaiso ea sc, litefiso tsa serum li ne li lekana le tekanyetso e fanoeng (Cmax, degree ea ho amoheloa).

Cmax fihlella lihora tse 6-8 kamora tsamaiso. Le tsamaiso ea C ka makhetlo a mabeli letsatsi le letsatsis e fumanoe kamora liente tse 2-3.

Phapang ea ho kenella ka hare ea motho a le mong e batla e le tlase bakeng sa Levemir ® FlexPen ® ha e bapisoa le litokisetso tse ling tsa insulin.

Bohareng Vd detemir insulin (hoo e ka bang 0,1 l / kg) e bontša hore karolo e phahameng ea "insulin" e potoloha maling.

Lithuto tse kopanyang liprotheine tsa in vitro le vivo li bonts'a ho se sebetse hoa tšebelisano-hloko ea bohlokoa lipakeng tsa insulin le li-acid tse ngata kapa lithethefatsi tse ling tse nang le protein.

Meetso ea biotransformation ea insulin e amanang le insulin e tšoana le ea litokisetso tsa insulin tsa motho, li-metabolites tsohle tse entsoeng ha li sebetse.

Seteishene T1/2 kamora ho ente ea sc, ho khethoa ka tekanyo ea ho amoheloa ho tsoa lithong tse ka tlasana mme ke lihora tse 5-7, ho latela tekanyo.

Pharmacokinetics maemong a khethehileng a kliniki

Ho ne ho se na phapang e kholo litabeng tsa bong pakeng tsa bongaka le meriana ea Levemir ® FlexPen ®.

Melemo ea pharmacokinetic ea lithethefatsi Levemir ® FlexPen ® e ile ea ithutoa ho bana (ba lilemo li 6-12) le bacha (lilemo tse 13 ho isa ho tse 17) mme ba bapisoa. Ho ne ho se na phapang ea thepa ea pharmacokinetic ha e bapisoa le bakuli ba baholo ba nang le lefu la tsoekere la mofuta oa 1.

Ho ne ho se na phapang e kholo litabeng tsa pharmacokinetics ea Levemir ® FlexPen ® lipakeng tsa bakuli ba tsofetseng le ba banyenyane, kapa lipakeng tsa bakuli ba nang le ts'ebetso ea mokokotlo oa mokokotlo le oa hepatic le bakuli ba phetseng hantle.

Lithuto tsa polokeho ea pele

Boithuto ba in vitro ka har'a sele ea motho, ho kenyelletsa le lithuto mabapi le ho tlama li-insulin receptors le IGF-1 (insulin-like factor factor), li bonts'itse hore insulin ea "insulin" e na le ts'ebelisano e tlase bakeng sa li-receptor ka bobeli mme e na le phello e nyane khong ea lisele ha e bapisoa le insulin ea motho.

Lintlha tsa preclinical tse thehiloeng lithutong tse tloaelehileng tsa polokeho ea meriana

Melemo ea litekanyetso

Levemir ® FlexPen ® e etselitsoe tsamaiso ea sc.

Tekanyetso le khafetsa tsa tsamaiso ea lithethefatsi Levemir ® FlexPen ® li ikemiselitsoe ka bomong maemong ka mong.

Phekolo ka Levemir ® FlexPen ® hammoho le lithethefatsi tsa molomo tsa hypoglycemic, ho khothalletsoa ho qala ka nako ea 1 / letsatsi ka tekanyetso ea li-PIECES tse 10 kapa 0,1-0.2 PIECES / kg. Tekanyetso ea Levemir ® FlexPen ® e lokela ho khethoa ka bonngoe ho latela boleng ba glucose ea plasma. Ho ipapisitsoe le liphetho tsa lithuto, tse latelang ke likhothaletso tsa ho fuoa litekanyetso ka tekanyetso:


Lijo tsa tsoekere ea plasma li lekantsoe ka boikemelo pele ho lijo tsa hosengPhetoho ea moriana oa lithethefatsi Levemir ® FlexPen ® (ED)
> 10 mmol / L (180 mg / dL)+8
9.1-10 mmol / L (163-180 mg / dl)+6
8.1-9 mmol / L (145-162 mg / dl)+4
7.1-8 mmol / L (127-144 mg / dl)+2
6.1-7 mmol / L (109-126 mg / dl)+2
Haeba boleng bo le bong ba lero la lero la mali:
3.1-4 mmol / L (56-72 mg / dl)-2

Haeba Levemir ® FlexPen ® e sebelisoa e le karolo ea regimen ea mantlha / bolus, e lokela ho beoa makhetlo a 1 kapa a mabeli ka letsatsi ho ipapisitse le litlhoko tsa mokuli. Bakuli ba hlokang ts'ebeliso ea lithethefatsi makhetlo a 2 / ka letsatsi bakeng sa taolo e nepahetseng ea glycemia ba ka kena tekong ea mantsiboea ka nako ea lijo tsa mantsiboea, kapa pele ho robala, kapa lihora tse 12 kamora hore ba noe hoseng. Levemir ® FlexPen ® e tsamaisoa ka serope, lebota la mpa la mpa kapa lehetleng. Libaka tsa ente e lokela ho fetoloa leha li hlahisoa sebakeng se le seng.

Ho ea bakulibotsofehammoho bakuli ba nang le bothata ba ho phekola masapo a mmele kapa a sebete maemo a tsoekere ea mali a lokela ho beoa leihlo haholoanyane le ho lokisoa ha litekanyetso.

Phetoho ea moriana e ka hlokahala le ha o ntlafatsa ts'ebetso ea 'mele ea mokuli, ho fetola lijo tse tloaelehileng, kapa bokuli bo tšoanang.

Ho phetisetso ho tsoa ho li-insulin tse mahareng le insulin ea nako e telele ho Levemir ® FlexPen ® insulin tekanyo le tokiso ea nako e kanna ea hlokahala. Ho hlahlojoa ka hloko maemo a tsoekere ea mali nakong ea phetisetso le libekeng tsa pele tsa moriana o mocha ho khothaletsoa. Ho ka hlokahala tokiso ea kalafo e kopanetsoeng ea hypoglycemic (tekanyetso le nako ea tsamaiso ea litokisetso tsa insulin tse khutšoane kapa lethal dose ea lithethefatsi tse tsoang ka molomo).

Lipehelo tsa ts'ebeliso ea lithethefatsi Levemir ® FlexPen ®

Levemir ® FlexPen ® pene ea syringe le dispenser. Tekanyetso ea insulin e laetsoeng ka bongata ho tloha ho 1 ho isa ho 60 yuniti e ka fetoloa ka li-unit tsa 1. NovoFine ® le NovoTvist ® li-needle tsa ho fihla ho 8mm li etselitsoe ho sebelisoa le Levemir ® FlexPen ®. Ho latela mehato ea ts'ireletso, o lokela ho lula o nkile sesebelisoa sa ho tsamaisa insulin maemong a tahlehelo kapa a senya FlexPen ®.

Pele o sebelisa Levemir ® FlexPen ®, etsa bonnete ba hore ho khethoa mofuta o nepahetseng oa insulin.

Ho itokisetsa ente: Tlosa cap, tlosa diseketso tsa rabara ka swab e enngoeng ea joala ea bongaka, tlosa sekontiri se sirelletsang ka nale e ka lahloang, ka hloko le ka botlalo sutuletsa nale ka lereng la Levemir ® FlexPen ® . Ho hlokahala hore nale e ncha e sebelisoe hangata ka ente e 'ngoe le e' ngoe. Se ke oa inama kapa ua senya linale. Ho qoba liente tsa kotsi, u se ke oa khutlisetsa mokokotlo ka hare ho nale.

Ho tlosa moea pele ho mokotla. Ts'ebeliso e tloaelehileng, pene ea syringe e ka bokella moea ka lesobeng le kahara metsi pele ho ente e ngoe le e ngoe. Ho qoba ho fumana bubble ea moea le ho hlahisa tekanyetso ea moriana, litaelo tse latelang li lokela ho ananeloa:

- daela likarolo tse 2 tsa moriana,

- beha Levemir ® FlexPen ® ka ho toba ka nale ka holimo mme ka makhetlo a 'maloa u tlanye polokelo ka mokotla oa hau e le hore lipompo tsa moea li tsebe ho ea holimo kaporong.

- ha o ntse o tšoere Levemir ® FlexPen ® o na le nale, o tobetse konopo ea ho qala tsela eohle, mokhethoa oa litekanyetso o tla khutlela zero.

- Lerotholi la insulin le lokela ho hlaha qetellong ea nale, haeba sena se sa etsahale, ebe o pheta mokhoa, empa eseng makhetlo a fetang 6. Haeba insulin ha e tsoe ka nale, sena se bontša hore pene ea syringe e na le phoso mme ha ea lokela ho sebelisoa hape.

Ho hlophisoa ha dose. Etsa bonnete ba hore sethala sa litekanyetso se behiloe ho "0". Fumana palo ea UNIT e hlokahalang bakeng sa ente. Tekanyetso e ka fetoloa ka ho potoloha sesebelisoa sa litekanyetso kae kapa kae. Ha o potoloha sekhechisi sa litekanyetso, tlhokomelo e lokela ho nkuoa hore e se ke ea tobetsa ka phoso konopo ea ho qala ho thibela ho lokolloa ha tekanyetso ea insulin. Ha ho khonehe ho theha tekanyetso e fetang palo ea UNITS e setseng mokotleng. Se ke oa sebelisa sekala sa masala ho lekanya litekanyetso tsa insulin.

Kenyelletso ea moriana. Kenya nale ena ka mokhoa o ikhethileng. Ho etsa ente, tobetsa konopo ea ho qala ho fihlela "0" e hlaha ka pel'a letšoao la litekanyetso. Ha o tsamaisa moriana, konopo ea ho qala feela e lokela ho hatelloa. Ha sethala sa litekanyetso se potoloha, tsamaiso ea lethal dose e ke ke ea etsahala. Kamora ho ente, nale e lokela ho siuoa tlasa letlalo bakeng sa metsotsoana e 6 (sena se tla netefatsa ho kenngoa ka tekanyetso e felletseng ea insulin). Ha o tlosa nale, boloka konopo ea ho qala e hatelloa ka botlalo, sena se tla netefatsa ho kenngoa ha tekanyetso e felletseng ea moriana.

Ho ntšoa ha nale. Koala nale ka khoele e kantle ebe o e manolla kalaneng. Lahla nale, o hlokomela mehato ea ts'ireletso. Kamora ho entoa ka leng, nale e lokela ho tlosoa. Ho seng joalo, mokelikeli o ka tsoa ka pente, e leng se ka hlahisang litekanyetso tse fosahetseng.

Basebeletsi ba tsa bongaka, beng ka bona le bahlokomeli ba bang ba lokela ho latela mehato e akaretsang ha ba tlosa le ho lahlela linale ho qoba kotsi ea lithupa tsa nale tse kotsi.

Levemir ® FlexPen ® e sebelisitsoeng e lokela ho lahloa ka nale e halikiloeng.

Boloka le tlhokomelo. Bokantle ba pene ea syringe bo ka hloekisoa ka swab ea k'hothone e tšeloang joala ba bongaka. Se ke oa kenya pente ea syringe ka joala, e hlatsoe kapa e tlatsoe oli ka eona. e ka senya sesebelisoa. Ho senyeha ha pente ea syringe le Levemir ® FlexPen ® dispenser ho lokela ho qojoa. Ho tlatsa pene ea syringe ha ho lumelloe.

Litla-morao

Boitšoaro bo bobe bo bonoang ho bakuli ba sebelisang Levemir ® FlexPen ® bo itšetlehile haholo ka litekanyetso le nts'etsopele ka lebaka la phello ea meriana le insulin. Litlamorao tse atileng haholo ke hypoglycemia, e bang teng ha tekanyo e phahameng haholo ea moriana e fanoa e amanang le tlhoko ea mmele ea insulin. Ho tsoa lithutong tsa bongaka hoa tsebahala hore hypoglycemia e matla, e hlalositsoeng e le tlhoko ea ho kenella ha motho oa boraro, e hlaha ho hoo e ka bang 6% ea bakuli ba fumanang Levemir ® FlexPen ®.

Boitšoaro sebakeng sa ente e ka bonoa khafetsa ka Levemir ® FlexPen ® ho feta ka ho hlahisa insulin ea motho. Lintho tsena li kenyelletsa bofubelu, ho ruruha, ho lapa, ho ruruha le ho hlohlona sebakeng sa ente. Lintho tse ngata tse etsahalang libakeng tsa ente ea bongoana li nyane ebile li haella ka nakoana, i.e. nyamela ka kalafo e tsoelang pele matsatsi a 'maloa ho isa libeke tse' maloa.

Karolo ea bakuli ba fumanang kalafo le Levemir ® FlexPen ®, ba lebelletsoeng ho nts'etsapele litlamorao, e hakanyetsoa e le 12%. Liketsahalo tsa litla-morao, tseo ho nahanoang hore li amana le Levemir ® FlexPen ® nakong ea liteko tsa kliniki, li hlahisoa ka tlase.

Lintho tse mpe tse amanang le phello ea metabolism ea carbohydrate: khafetsa (> 1/100, 1/100, 1/1000, 1/1000, 1/1000, 1/10 000, contraindication mabapi le ts'ebeliso ea lithethefatsi

- kutlwelobohloko ya motho ka mong dikarolong tsa moriana.

Ha ho kgothaletswe ho sebelisa lithethefatsi Levemir ® FlexPen ® ho bana ba ka tlase ho lilemo tse 6, hobane lithuto tsa tliliniki sehlopheng sena sa bakuli ha li e-so tšoaroe.

Ts'ebeliso ea moriana nakong ea kemaro le lactation

Boiphihlelo ba tleliniking ka ts'ebeliso ea insulin ea insulin nakong ea kemero le nakong ea ho anyesa e lekanyelitsoe.

Boithuto ba mosebetsi oa ho ba le liphoofolo liphoofolong ha boa ka ba senola phapang lipakeng tsa insulin ea insulin le insulin ea motho mabapi le embryotoxicity le teratogenicity.

Ka kakaretso, ho hlokahala tlhokomelo e hlokolosi ea basali ba bakhachane ba nang le lefu la tsoekere nakong eohle ea kemero, le ha ba rera ho ima. Tlhokahalo ea insulin ka har'a trimester ea pele ea bokhachane hangata e fokotseha, ebe ho trimesters ea bobeli le ea boraro e eketseha. Nakoana kamora ho hlaha, tlhoko ea insulin kapele e khutlela boemong bo neng bo le pele ho ima.

Ho basali ba anyang, ho ka hlokahala litekanyetso tsa insulin le phetoho ea lijo.

Ho sebelisana le lithethefatsi

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

Phello ea hypoglycemic ea insulin e fokotsoa ke lithibela-pelehi tsa molomo, li-corticosteroids, li-iodine tse nang le iodine, li-hematotin, li-thiazide diuretics, heparin, li-antidepressants tsa troteclic, li-medathomimetics, danazole, clonidine, li-blockcode tsa "calcium" tsa nakoana, diazoxide, morphine, morphine, morphine, morphine, morphine.

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

Octreotide, lanreotide ka bobeli li ka eketsa le ho fokotsa tlhoko ea mmele ea insulin.

Beta-blockers li ka pata matšoao a hypoglycemia le ho lieha ho hlaphoheloa kamora ho hlohlona ha hypoglycemia.

Ethanol e ka ntlafatsa le ho lelefatsa phello ea li-insulin.

Lithethefatsi tse ling, ka mohlala, tse nang le lihlopha tsa thiol kapa sulfite, ha li kenyelletsoa ho lithethefatsi Levemir ® FlexPen ®, li ka baka ts'abo ea insulin.

Levemir ® FlexPen ® ha ea lokela ho eketsoa ka tharollo ea infusion.

Lipehelo le maemo a polokelo

Lethathamo B. Setlhare se lokela ho bolokoa ka sehatsetsing ka mocheso oa 2 ° ho isa ho 8 ° C (sehatsetsing, empa hole le sehatsetsi), se ke oa hoama. Bophelo ba Shelf - likhoeli tse 30.

Ho sirelletsa ho tloha leseli, pente ea syringe e lokela ho bolokoa le cap ,.

Kamora tšebeliso ea pele, Levemir ® FlexPen ® ha ea lokela ho bolokoa ka sehatsetsing. E sebelisoa kapa e kenngoe ka pente ea syringe e nang le Levemir ® FlexPen ® e lokela ho bolokoa ka mocheso o sa feteng 30 ° C bakeng sa libeke tse 6.

Moriana o lokela ho bolokoa o le hole le bana.

Foromo ea litekanyetso

Tharollo bakeng sa tsamaiso e potolohileng ea 100 PIECES / ml

1 ml ea tharollo e na le

ntho e sebetsang - insulin detemir 100 IU (2400 nmol = 14.2000 mg),

Baeti: zinc, glycerol, phenol, metacresol, sodium hydrogen phosphate dihydrate, sodium chloride, 2 M hydrochloric acid kapa sodium hydroxide (tharollo ea 2 M) (ho fetola pH), metsi bakeng sa ente.

Cartridge e le 'ngoe e na le 3 ml ea tharollo, e lekanang le PIERES tse 300.

Karolo e le 'ngoe ea "insulin" ea hau e na le "insulin" ea "insulin" e se nang letsoai. Karolo e le 'ngoe ea insulin detemir (IU) e lumellana le yuniti e le' ngoe ea insulin ea motho.

Mokelikeli o pepenene, o se nang 'mala. Nakong ea polokelo, ho ka ba le menahano e metle haholo ea ho thetsa.

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