Octreotide Depot 20 m: litaelo tsa tšebeliso

Lebitso la machabeng:Octreotide-depo

Sebopeho le mofuta oa tokollo

Lyophilisate bakeng sa ho hlophisoa ha ho emisoa bakeng sa taolo ea methapo ea ketso ea nako e telele ea 'mala o mosoeu kapa o mosoeu ka lesela le bosehla bo bosehla, ka mokhoa oa phofo kapa boima ba porous bo hatisitsoeng letlapeng, solvent e sebelisitsoeng ke metsi a se nang' mala o sa bonahaleng, ho emisoa ho tšoeu kapa ho soeufala ka lero le bosesane bo loileng. selenogppy Botlolo e le 1 e na le 10 mg ea octreotide. Bahlomphehi: Copolymer ea DL-lactic le glycolic acid - 270 mg, D-mannitol - 85 mg, carboxymethyl cellulose sodium letsoai - 30 mg, polysorbate-80 - 2 mg.

Solvent: mannitol, ente 0,8% - 2 ml.

Bophahamo ba botlolo ea khalase e lefifi ke 10 ml. Sekiti se kenyelletsa "ampoule e le 'ngoe ea" solvent, syringe e ka lahloang, 2 d / le nale, le lisosa tse 2 tsa joala. E kentsoe ka lebokoseng la karete.

Lyophilisate bakeng sa ho hlophisoa ha ho emisoa bakeng sa taolo ea methapo ea ketso ea nako e telele ea 'mala o mosoeu kapa o mosoeu ka lesela le bosehla bo bosehla, ka mokhoa oa phofo kapa boima ba porous bo hatisitsoeng letlapeng, solvent e sebelisitsoeng ke metsi a se nang' mala o sa bonahaleng, ho emisoa ho tšoeu kapa ho soeufala ka lero le bosesane bo loileng. selenogppy Botlolo e le 1 e na le 20 mg ea octreotide. Bahlomphehi: Copolymer ea DL-lactic le glycolic acid - 560 mg, D-mannitol - 85 mg, carboxymethyl cellulose sodium letsoai - 30 mg, polysorbate-80 - 2 mg.

Solvent: mannitol, ente 0,8% - 2 ml.

Bophahamo ba botlolo ea khalase e lefifi ke 10 ml. Sekiti se kenyelletsa "ampoule e le 'ngoe ea" solvent, syringe e ka lahloang, 2 d / le nale, le lisosa tse 2 tsa joala. E kentsoe ka lebokoseng la karete.

Lyophilisate bakeng sa ho hlophisoa ha ho emisoa bakeng sa taolo ea methapo ea ketso ea nako e telele ea 'mala o mosoeu kapa o mosoeu ka lesela le bosehla bo bosehla, ka mokhoa oa phofo kapa boima ba porous bo hatisitsoeng letlapeng, solvent e sebelisitsoeng ke metsi a se nang' mala o sa bonahaleng, ho emisoa ho tšoeu kapa ho soeufala ka lero le bosesane bo loileng. selenogppy Botlolo e le 1 e na le 30 mg ea octreotide. Bahlomphehi: kopolymer ea DL-lactic le glycolic acid - 850 mg, D-mannitol - 85 mg, carboxymethyl cellulose sodium letsoai - 30 mg, polysorbate-80 - 2 mg.

Solvent: mannitol, ente 0,8% - 2 ml.

Bophahamo ba botlolo ea khalase e lefifi ke 10 ml. Sekiti se kenyelletsa "ampoule e le 'ngoe ea" solvent, syringe e ka lahloang, 2 d / le nale, le lisosa tse 2 tsa joala. E kentsoe ka lebokoseng la karete.

Sehlopha sa tliliniki le meriana

Sehlopha sa Pharmacotherapeutic

Somatostatin (analogue ea maiketsetso)

Ts'ebetso ea pharmacological ea lithethefatsi Octreotide Depot

Octreotide-depot ke mofuta o nkileng nako e telele oa octreotide bakeng sa tsamaiso ea methapo, ho etsa bonnete ba hore o boloka kalafo e tsitsitseng ea octreotide maling bakeng sa libeke tse 4. Octreotide ke kalafo ea pathogenetic bakeng sa lihlahala tse hlalosang li-receptor tsa somatostatin ka mafolofolo.

Octreotide ke octapeptide ea maiketsetso e nkiloeng ka tsela ea tlhaho ea hormone somatostatin mme e na le litlamorao tse tšoanang tsa meriana, empa ketso ea nako e telele haholo.

Lithethefatsi li hatella ka tšohanyetso secretion ea hormone ea kholo (GH), hammoho le li-peptide le serotonin tse hlahisoang tsamaisong ea gastroenteropancreatic endocrine.

Ho batho ba phetseng hantle, octreotide, joalo ka somatostatin, e hatella secretion ea GH e bakoang ke arginine, ts'ebetso ea 'mele le insulin hypoglycemia, secretion ea insulin, glucagon, gastrin le li-peptide tse ling tsa tsamaiso ea gastroenteropancreatic endocrine, e bakoang ke ho ja lijo, hammoho le secretion ea secretion, secreulin. e bakoang ke thyroliberin. Tšusumetso e hatellang ho secretion ea hormone ea kholo ho octreotide, ho fapana le somatostatin, e bontšoa ka mokhoa o moholo haholo ho feta secretion ea insulin.Tsamaiso ea octreotide ha e tsamaisane le ts'ebetso ea hypersecretion ea lihormone ke mochine o seng molaong oa karabelo.

Ho bakuli ba nang le acromegaly, tsamaiso ea Octreotide-depot e fana ka maemong a mangata ho fokotseha ho sa feleng ha khatello ea GR le ho tloaela ha khatello ea insulin e tšoanang le kholo ea 1 / somatomedin C (IGF-1).

Ho bakuli ba bangata ba nang le acromegaly, Octreotide Depot e fokotsa haholo matšoao a kang hlooho, ho ruruha ho feteletseng, paresthesia, mokhathala, ho opeloa ke masapo le manonyeletso. Ho ile ha tlalehoa hore kalafo e nang le octreotide ho bakuli ka bomong ba nang le pituitary adenomas secreting GH e bakile ho fokotseha ha boholo ba tumor.

Ka ho boloka li-tumellano tsa "endocrine" tsa "gastrointestinal" le "pancreas", li fana ka tlhokomeliso ea matšoao a mantlha a mafu ana.

Depo ea 30 octreotide depo ka mor'a libeke tse ling le tse ling tse 4 e liehisa kholo ea tumor ho bakuli ba nang le ho boloka le ho sa patise ntho e tloaelehileng (metastatic) neuroendocrine tumor ea letlalo, ileum, sefofu, kholoni, transverse colon le sehlomela se bopehileng ka seboko, kapa metastases ea tumello ea neuroendocrine. Moriba o eketsehile haholo nako ea tsoelo-pele mokhahlelong ona oa bakuli: nako ea khubung ea tsoelo-pele e ne e le likhoeli tse 14,3 ha ho bapisoa le likhoeli tse 6 sehlopheng sa placebo. Kamora ho qeta likhoeli tse 6 tsa kalafo, ho tsitsa ho ile ha bonoa ho bakuli ba 66% sehlopheng sa Octreotide-depot le 37% ea bakuli sehlopheng sa placebo. Setlhare sena se ne se sebetsa hantle ho eketseng nako ea ho hola, ka bobeli bakeng sa ho boloka le ho sa patise li-tumiso tsa neuroendocrine.

Ho hlahala ha "carcinoid tumors", tšebeliso ea octreotide e ka lebisa ho fokola ha matšoao a lefu lena, haholoholo, joalo ka "mahlaseli a chesang" le lets'ollo. Maemong a mangata, ntlafatso ea tleliniking e tsamaisana le ho fokotseha ha plasma serotonin mahloriso le ho pepisoa ha 5-hydroxyindoleacetic acid ka har'a moroto.

Ka lihlorong tse tšoauoang ke hyperproduction ea vasoactive intestinal peptide (VIPoma), ts'ebeliso ea octreotide ho bakuli ba bangata e lebisa ho fokotseha hoa lets'ollo le matla la sephiri, e leng tšobotsi ea boemo bona, boo, bo lebisang ntlafatsong ea bophelo ba mokuli. Ka nako e ts'oanang, ho na le phokotseho ea pherekano e tšoanang le ea tekano ea electrolyte, mohlala, hypokalemia, e u lumellang ho hlakola tsamaiso ea 'muso le ea botsoali ea fluid le li-electrolyte. Ho latela tomography e kopantsoeng, bakuli ba bang ba theola kapa ba emisa ho tsoela pele ha tumor, 'me ba fokotsa le boholo ba eona, haholoholo metastases ea sebete. Ntlafatso ea kliniki hangata e tsamaisana le ho fokotseha (ho fihlela litekanyetso tse tloaelehileng) pokellong ea vasoactive intestinal peptide (VIP) ho plasma.

Ka glucagonomas, ts'ebeliso ea octreotide maemong a mangata e lebisa ho fokotseha ho hlokomelehang ha makhopho a potang ka thata a fetohang, e leng tšobotsi ea boemo bona. Octreotide ha e na phello efe kapa efe ho teba ha lefu la tsoekere mellitus, eo hangata e bonoang ka glucagonomas, 'me hangata ha e fokotse tlhoko ea lithethefatsi tsa insulin kapa molomo. Ho bakuli ba nang le lets'ollo, octreotide e baka ho fokotseha ho lona, ​​e tsamaeang le keketseho ea boima ba 'mele. Ka tšebeliso ea octreotide, ho fokotseha ka sekhahla ha glucagon e plasma hangata ho hlokomeloa, leha ho le joalo, ka kalafo ea nako e telele, phello ena ha e phehelle. Ka nako e ts'oanang, ntlafatso ea matšoao e lula e tsitsitse nako e telele.

Ho gastrinomas / Zollinger-Ellison syndrome, octreotide, e sebelisoang e le monotherapy kapa hammoho le histamine H 2 receptor blockers le proton pump inhibitors, e ka fokotsa ho theoa ha hydrochloric acid ka mpeng mme ea lebisa ntlafatsong ea tleliniki.le mabapi le lets'ollo. Hape hoa khoneha ho fokotsa botebo le matšoao a mang, a amanang le peptides ea motsoako, ho kenyelletsa maqhubu. Maemong a mang, ho na le ho fokotseha ho hoholo ha khatello ea gastrin plasma.

Ho bakuli ba nang le insulinomas, octreotide e fokotsa khatello ea insulin e maling. Ho bakuli ba nang le li-tumor tse sebetsang, octreotide e ka netefatsa ho khutlisetsoa le ho lokisoa ha tloaelo ea tlhaho ka nako ea ts'ebetso. Bakeng sa bakuli ba nang le tumello ea mokokotlo le tse sa sebetseng hantle, taolo ea glycemic e ka ntlafala ntle le ho fokotseha ka nako e telele ka nako e telele molemong oa insulin.

Bakeng sa bakuli ba nang le hlahala tse sa tloaelehang, hyperproducing ukuaji wa ho nts'etsopele ea hormone e hlahisang factor (somatoliberinomas), octreotide e fokotsa botebo ba matšoao a acromegaly. Hona, ho bonahala, ho amana le khatello ea secretion ea kholo ea ho lokolla li-hormone le GH. Nakong e tlang, hoa khoneha ho fokotsa boholo ba gland ea pituitary, e ileng ea eketsoa pele ho kalafo.

Ho bakuli ba nang le kankere ea senya ea tšoelesa ea senya (HGRP), letamo la lisele tsa neuroendocrine le hlahisang tumellano ea li-receptor tsa somatostatin bakeng sa mefuta ea octreotide (mefuta ea SS2 le SS5) e khethollang kutloisiso ea tumor ho octreotide. Ts'ebeliso ea Octreotide-Depot ha e kopane le dexamethasone khahlano le nalane ea androgen blockade (lithethefatsi kapa li-surge castration) ho bakuli ba nang le HGRP e khutlisetsa kutloisiso ea phekolo ea li-hormone mme e lebisa ho fokotseha hoa prostate itseng antigen (PSA) ho bakuli ba fetang 50%.

Ho bakuli ba HGRG ba nang le metastases ea masapo, kalafo ena e tsamaea le phello e hlalositsoeng le ea nako e telele ea analgesic. Ho feta moo, ho bakuli bohle ba arabileng molemong oa phekolo e kopaneng le Octreotide Depot, boleng ba bophelo le ho pholoha bo sa phekoleheng bo ntlafalitsoe haholo.

Mofumahali

Lintlha tse fumanehang ka pharmacokinetics ea lithethefatsi Octreotide-depot ha li fanoe.

Acromegaly (ha ho sa na phello e lekaneng ho tsoa kalafong ea ho buoa, kalafo ea radiation le kalafo ka li-agonists tsa dopamine, ho bakuli ba sa sebetseng, hammoho le ho bakuli ba hanneng kalafo ea ho buoa), phomolo ea matšoao a hlahala a gastroentero-pancreatic endocrine system (carcinoid tumors ka ho ba le lefu la carcinoid, tumors, e tšoauoang ke hyperproduction ea peptide e holofatsang ea mala - VIP, glucagon, gastrinomas / Zollinger-Ellison syndrome, insulinomas, tumors e khethiloeng ke tlhahiso ea somatoliberin - somatoliberinomas, lets'ollo le hanoang ho bakuli ba AIDS. Thibelo ea mathata ka mor'a ho buuoa ka pancreatic, ho emisa ho tsoa mali le ho thibela ho pheta hape methapong ea varicose ea esophagus le cirrhosis (hammoho le endoscopic sclerotherapy).

Contraindication sethethefatsi

Hypersensitivity ho octreotide kapa likarolo tse ling tsa lithethefatsi.

E ka banglebela lithethefatsi li lokela ho fuoa mokhoa oa cholelithiasis, lefu la tsoekere, nakong ea kemolo le nakong ea kemolo.

Mokhoa oa litekanyetso le mokhoa oa ts'ebeliso Octreotide Depot

Lithethefatsi Octreotide-Depot e lokela ho fanoa feela ka ho kenella ka hare ho intramuscularly (IM), mokokotlong oa gluteus. Ka liente tse phetoang khafetsa, lehlakore le letšehali le le letona le lokela ho fetoloa. Ho emisoa ho lokela ho lokisoa kapele pele ho ente. Ka letsatsi la ente, vial e nang le lithethefatsi le ampoule e nang le solvent e ka bolokoa ka mocheso oa kamore.

Phekolo ea aceromegaly ho bakuli bao s / c tsamaiso ea octreotide e fanang ka taolo e lekaneng ea liponahatso tsa lefu lenaMotsoako oa ho qala oa Octreotide Depot ke 20 mg ka beke tse 'ne le tse ling tse 3. U ka qala kalafo ka Octreotide-Depot ka letsatsi kamora taolo ea ho qetela ea s / c ea octreotide.Nakong e tlang, lethal dose le lokisoa ka ho nahanela khatello ea maikutlo serum ea GR le IGF-1, hammoho le matšoao a kalafo. Haeba kamora kalafo ea likhoeli tse 3 ho ne ho sa khonehe ho fihlella phello e lekaneng ea kliniki le biochemical (haholoholo, haeba khatello ea GR e lula ka holimo ho 2,5 μg / L), lethal dose le ka eketsoa ho 30 mg e fanoang ka mor'a libeke tse ling le tse ling tse nne.

Maemong ao ha kamora ho qeta likhoeli tse 3 tsa kalafo le Octreotide-Depot ka tekanyetso ea 20 mg, ho fokotseha ho tsoelang pele.
serum GH mahloriso a ka tlase ho 1 μg / l, normalization ea mahloriso a IGF-1 le ho nyamela hoa matšoao a feto-fetohang a acromegaly, o ka fokotsa tekanyetso ea lithethefatsi Octreotide-depot ho 10 mg. Leha ho le joalo, ho bakuli bana ba fumanang tekanyetso e nyane ea Octreotide Depot, mohopolo oa serum oa GR le IGF-1, hammoho le matšoao a lefu lena, o lokela ho beoa leihlo ka hloko.

Bakuli ba fumanang lethal dose e tsitsitseng ea Octreotide-depot ba lokela ho hlahlojoa likhoeli tse ling le tse ling tse 6 bakeng sa ho tsepamisa maikutlo ho GH le IGF-1.

Bakuli bao kalafo ea bona ea ho buoa le ea radiation e sa sebetseng hantle kapa e sa sebetseng, hammoho le bakuli ba hlokang kalafo ea nako e khuts'oane lipakeng tsa lithuto tsa radiation ho fihlela nts'etsopele ea ts'ebetso ea eona e felletseng, ho kgothaletsoa ho etsa teko ea kalafo ka liente tsa sc octreotide e le ho lekola liteko tsa eona ts'ebetso le mamello e akaretsang, mme ke feela ka mor'a phetoho eo ho ts'ebeliso ea lithethefatsi Octreotide-depot ho latela morero o kaholimo.

Ho kalafo ea li-tumor tsa endocrine tsa mpa ea mpa le manyeme ho bakuli bao Tsamaiso ea octreotide e fanang ka taolo e lekaneng ea lipontšo tsa lefu lena, lethal dose la khothalletso la lithethefatsi Octreotide-Depot ke 20 mg ka beke tse 'ne. Ts'ebetso ea sc ea octreotide e lokela ho tsoelapele libeke tse ling tse 2 kamora ts'ebetso ea pele ea lithethefatsi Octreotide-Depot.

Ho bakuli ba neng ba sa amohela sperm octreotide, ho khothalletsoa hore kalafo e qale ka ho s.c. tsamaiso ea octreotide ka tekanyo ea 0,1 mg makhetlo a 3 / letsatsi bakeng sa nako e khuts'oane ea nako (hoo e ka bang libeke tse peli) ho hlahloba ts'ebetso ea eona le mamello e akaretsang. Ke feela kamora sena, lithethefatsi Octreotide-depot e laetsoe ho latela morero o kaholimo.

Maemong ha kalafo e nang le Octreotide-Depot bakeng sa likhoeli tse 3 e fana ka taolo e lekaneng ea lipontšo tsa kliniki le matšoao a biology a lefu lena, ho ka khonahala ho fokotsa tekanyetso ea Octreotide-Depot ho 10 mg,
beetsweng mong le e mong libeke tse 4. Maemong ao ka mor'a likhoeli tse 3 tsa kalafo le Octreotide-Depot, ntlafatso e lekanyelitsoeng e fumanoe, lethalolo le ka eketsoa ho 30 mg ka beke tse 'ne. Khahlano le nalane ea kalafo le Octreotide-Depot, ka matsatsi a mang ho ka etsahala ho eketsa lipontšo tsa bongaka ba li-tumellano tsa endocrine tsa mokokotlo oa mpa le manyeme. Maemong ana, tsamaiso e eketsehileng ea s / c ea octreotide ka tekanyetso e sebelisitsoeng pele ho qala kalafo le Octreotide Depot e khothalletsoa. Sena se ka etsahala haholo likhoeling tse peli tsa pele tsa kalafo, ho fihlela phekolo ea octreotide ho plasma e se e fihlelitsoe.

Ho etsa lekunutu le ho se patelle liphoso tse tloaelehileng (metastatic) tsa "lesapo" la letlalo, ileum, sefofu, colon e nyolohang, colon le transmit ea vermiform, kapa metastasis ea tumellano ea neuroendocrine ntle le lesion ea mantlha. Tekanyetso e khothalletsoang ea Octreotide Depot ke 30 mg ka mor'a libeke tse 'ne. Phekolo ea Octreotide-depot e lokela ho ntšetsoa pele ho fihlela matšoao a hlahala a hlahala.

Ho kalafo ya mofets'e oa kankere ea senya ea senya Motsoako oa ho qala oa Octreotide Depot ke 20 mg ka beke tse 'ne le tse ling tse 3. Nakong e tlang, tekanyetso e lokisoa ho nahanoa ka matla a khatello ea PSA e serum, hammoho le matšoao a kliniki. Haeba kamora kalafo ea likhoeli tse 3 ho ne ho sa khonehe ho atleha
phello e lekaneng ea kliniki le ea biochemical (PSA fokotsa), lethal dose le ka eketsoa ho 30 mg e fanoang libeke tse ling le tse ling tse 4.

Phekolo le Octreotide Depot e kopantsoe le dexamethasone, e laetsoeng ka molomo ho latela morero o latelang: 4 mg ka letsatsi bakeng sa khoeli e le ngoe, ebe 2 mg ka letsatsi bakeng sa libeke tse 2, ebe 1 mg ka letsatsi (lethal dose).

Kalafo ea Octreotide-depot le dexamethasone ea bakuli ba kileng ba sebelisa kalafo ea lithethefatsi tsa antiandrogen e kopantsoe le ts'ebeliso ea analogue ea gonadotropin-releading hormone (GnRH). Tabeng ena, ente ea analogue ea GnRH (fomu ea depo) e etsoa ka nako e le ngoe ka libeke tse 4.

Bakuli ba fumanang Octreotide Depot ba lokela ho etsa tlhahlobo ea khoeli le khoeli bakeng sa ho tsepamisa likelello tsa PSA.

Ho bakuli ba nang le bothata ba ho fokola ba le renal, hepatic le bakuli ba tsofetseng ha ho na tlhoko ea ho lokisa regimen ea litekanyetso tsa lithethefatsi Octreotide-depot.

Bakeng sa prophylaxis ea pancreatitis e hlobaetsang le ea morao haholo lithethefatsi Octreotide-Depot ka tekanyetso ea 10 kapa 20 mg e fanoa hang ha ho pejana ho matsatsi a 5 mme ha ho ka feta matsatsi a 10 pele ho ts'ebetso e buoang.

Melao ea ho lokisa ho emisoa le tsamaiso ea moriana

Setlhare sena se tšeloa ka oli feela. Ho emisoa bakeng sa ente ea methapo ea methapo ea methapo ho lokisoa ka tšilafalo e fanoang hang-hang pele ho tsamaiso. Moriana o lokela ho lokisoa le ho tsamaisoa feela ke basebeletsi ba tsa bongaka ba koetlisitsoeng ka ho khethehileng.

Pele ho ente, ampoule e nang le solvent le botlolo e nang le moriana e lokela ho tlosoa sehatsetsing ebe e tlisoa mocheso oa kamore (metsotso e 30-50 e ea hlokahala). Boloka botlolo ka sethethefatsi Octreotide-Depot e tiile. Tlanya vial habobebe, etsa bonnete ba hore lyophilisate eohle e ka tlase ea vial.

Bula sephutheloana sa syringe ebe o hokela nale ea 1,2 mm x 50 mm ho syringe ho bokella solvent. Bula ampoule ka solvent ebe o kenya syringe litaba tsohle tsa ampoule le solvent, beha syringe ho lethal dose ea 2.0 ml. Tlosa cap, ea polasetiki ho tloha vial e nang le lyophilisate. Tšoaea ntho e thibang rabara ea vial ka thipa ea joala. Kenya lenala ka har'a vial ea lyophilisate bohareng ba sethala sa rabara ebe o kenya solate ka hloko leboteng le ka hare la vial ntle le ho ama se kahare sa vial ka nale.

Tlosa syringe ho vial. Vial e lokela ho lula e sa sisinyehe ho fihlela solvent e tletse ka botlalo ka liforomo tsa lyophilisate le mofuta oa ho emisoa (hoo e ka bang metsotso e 3-5). Ka nako eo, ntle le hore o fetole botlolo, o lokela ho sheba hore na ho na le lyophilisate e omelletseng maboteng le boteng ba botlolo. Haeba mouoane o omileng oa lyophilisate o fumanoe, tloha vial ho fihlela o tletse ka botlalo.

Kamora hore u kholoe ka ho se be teng ha masala a omileng a li-lyophilisate, lintho tse kahare tsa vial li lokela ho tsoakoa ka hloko le metsamao e chitja bakeng sa metsotsoana e 30-60 ho fihlela ho emisoa ho sa feleng. Se ke oa hlakola kapa oa sisinyeha vial, hobane sena se ka baka tahlehelo ea li-flakes le ho emisoa ho sa lokelang.

Kenya kapele nale ka sekontiri se thibelang rabara ka vial. Ebe karolo ea nale e theotsoe 'me, ha e ts'ela botlolo ka sekhahla sa likhato tse 45, butle-butle e hule ho emisoa ka syringe ka botlalo. Se ke oa phahamisa botlolo ha u ntse u thaepa. Tekanyo e nyane ea lithethefatsi e ka sala marakong le tlase ho vial. Ts'ebeliso ea masala maboteng le tlase ea botlolo e ananeloa.

Hang ka mor'a ho bokella ho emisoa, nka nale ka 'mala oa pinki ka nale e nang le pane e tala (0.8 x 40 limilimithara), phetisa sekirine ka hloko' me u tlose moea siling.

Ho emisoa ha lithethefatsi Octreotide-Depot ho lokela ho tsamaisoa hang kamora ho itokisoa. Ho emisoa ha lithethefatsi Octreotide-Depot ha hoa lokela ho kopanngoa le lithethefatsi tse ling ka syringe e le 'ngoe.

- tšoaea sebaka sa ente ka swab ea joala. Kenya nale ka botebo ka har'a gluteus maximus, ebe o hula ka sekhahla selei ho etsa bonnete ba hore ha ho na tšenyo ea sekepe.Hlohlelletsa ho emisoa butle-butle ka khatello e sa feleng ho syringe plunger.

Haeba e kenella ka sejelong sa mali, sebaka sa ente le nale li lokela ho fetoloa. Ha o koala nale, e kenye le nale e ngoe e bophara ba eona.

Ka liente tse phetoang khafetsa, lehlakore le letšehali le le letona le lokela ho fetoloa.

Litlamorao

Boitšoaro ba lehae: ka tsamaiso ea i / m ea Octreotide-depot, bohloko bo khonahala, ha bo tlase hangata ho ruruha le ho soaha sebakeng sa ente (hangata e bonolo, e khuts'oane).

Ho tsoa pampiring ea ka mpeng: ho ipolaisa tlala, ho nyekeloa ke pelo, ho hlatsa, ho opeloa ke mpa ka mpeng, ho thunya, ho qaleha ha khase e ngata, litulo tse otlolohileng, lets'ollo, steatorrhea. Le ha phello ea mafura a nang le mafura a ka eketseha, ho fihlela joale ha ho na bopaki ba hore kalafo ea nako e telele ka octreotide e ka lebisa ho nts'etsopele ea khaello ea likarolo tse itseng tsa limatlafatsi ka lebaka la malabsorption (malabsorption). Maemong a sa tloaelehang, liketsahalo li ka tšoana le ho sitisoa hoa mpa ka mpeng: ho thunya ho tsoelang pele, bohloko bo boholo karolong ea epigastric, tsitsipano ea lebota la mpa. Tšebeliso ea nako e telele ea Octreotide Depot e ka lebisa ho thehoeng ha li-gallstones.

Ho tsoa ho makhopho: ho tlalehiloe maemo a sa tloaelehang a pancreatitis e matla e qalileng ka lihora tsa pele kapa matsatsi a ho sebelisa octreotide. Ka tšebeliso ea nako e telele, ho bile le maemo a pancreatitis a amanang le cholelithiasis.

Ho tsoa ho sebete: Ho na le litlaleho tse arohaneng tsa nts'etsopele ea ts'ebetso ea sebete e sa sebetseng (hepatitis e hlobaetsang ntle le cholestasis ka mokhoa o tloaelehileng oa transaminase kamora ho hlakoloa ha octreotide), nts'etsopele ea butle-butle ea hyperbilirubinemia, e tsamaeang le keketseho ea ALP, GGT le, ho isa tekanyong e nyane, lipatlisiso tse ling.

Ka lehlakoreng la metabolism: Kaha Octreotide Depot e na le tšusumetso e kholo sebopeho sa GH, glucagon le insulin, e ka ama metabolism ea glucose. Mamello ea tsoekere e fokotsehileng ka mor'a ho ja. Ka tšebeliso ea nako e telele ea Octreotide sc maemong a mang, hyperglycemia e phehellang e ka hlaha. Hypoglycemia le eona e ile ea bonoa.

Tse ling: maemong a sa tloaelehang, ho lahleheloa ke moriri ka nakoana kamora ho tsamaisoa ha octreotide, ho hlaha ha bradycardia, tachycardia, ho hema hanyane, ho soetseha ha letlalo, anaphylaxis ho tlalehiloe. Ho na le litlaleho tse arohaneng mabapi le nts'etsopele ea maikutlo a hypersensitivity reaction.

Bokhachane le pelehi

Ha ho na boiphihlelo le Octreotide Depot nakong ea kemolo le nakong ea ho anyesa.

Ka hona, nakong ea kemaro, moriana o lokela ho laeloa feela haeba phaello e ka ba teng ho mme e feta kotsi e ka bang teng ho lesea.

Ho anyesa sefuba ha se khothalletsoe ha u sebelisa lithethefatsi nakong ea ho nyekeloa.

Kopo ea ts'ebetso ea sebete e sa sebetseng Ho bakuli ba nang le ts'ebetso ea sebete e sa sebetseng ha ho na lebaka la ho lokisa lethathamo la litekanyetso tsa Octreotide-Depot. Kopo ea ts'ebetso ea liphio e sa sebetseng Ho bakuli ba nang le ts'ebetso ea renal e sa sebetseng ha ho na lebaka la ho lokisa regimen ea litekanyetso tsa Octreotide-depot.

Sebelisa ho bakuli ba tsofetseng

Ho bakuli ba tsofetseng, ha ho na tlhoko ea ho lokisa regimen ea litekanyetso tsa Octreotide Depot.

Litaelo tse khethehileng tsa ho amoheloa Octreotide Depot

Ka lihlahala tsa pituitary, ho hlokahala hore ho hlahlojoe bakuli ka hloko ka lebaka la keketseho e ka bang teng ka boholo ba li tumor ka nts'etsopele ea likarolo tse bonoang tsa pono. Maemong ana, o lokela ho nahana ka tlhoko ea mekhoa e meng ea kalafo. Ha phekolo ea li-tumor tsa gastroentero-pancreatic endocrine maemong a sa tloaelehang, ho ka khutla ka tšohanyetso matšoao. Bakeng sa bakuli ba nang le insulinomas nakong ea kalafo, ho ka bonoa keketseho ea ho teba le ho teba ha hypoglycemia. Botebo ba litla-morao tse tsoang mpeng ea mpa ea mpa bo fokotseha ka ho hlahisoa ha moriana lipakeng tsa lijo kapa ka nako ea ho robala.Ka kalafo ea nako e telele (acromegaly), pele le nakong ea kalafo (likhoeli tse ling le tse ling tse 6 ho ea ho tse 12) - ultrasound ea gallbladder.

Majoe a ka hara galase e kholo, leha ho le joalo, leha a fumanoa, a atisang ho tšoana. Boteng ba matšoao a kliniki, ho bontšoa kalafo e hlokofatsang kapa ea ho buuoa. Qoba liente tse ngata sebakeng se le seng nako le nako. Pele ho tsamaiso, futhumatsa tharollo ea mocheso oa kamore. Sebelisa nakong ea bokhachane le pelehi ka lipontšo tse phethahetseng. Ho feto-fetoha ha maemo mokhoeng oa tsoekere ea mali ho ka fokotsoa ke ho tsamaisoa khafetsa ha tekanyetso e tlase. Nakong ea kalafo, ho hlokahala hore ho sebelisoe kemiso ea "glucose" e hlophisehileng hantle haholo bathong ba nang le mali a tsoang methapong ea varicose ea esophagus e nang le lefu la sebete - menyetla ea ho ba le hyperglycemia.

Bongata

Hajoale, linyeoe tsa overdose ea Octreotide-Depot ha li tlalehiloe.

Tšebelisano le Meriana e meng

Octreotide e fokotsa ho monya ha cyclosporin ho tsoa mala, mme e liehise ho kenngoa ha cimetidine.

Ka tšebeliso e tšoanang ea octreotide le bromocriptine, bioavailability ea morao e eketseha.

Ho na le bopaki ba lingoliloeng tsa hore somatostatin analogues e ka fokotsa ho hlaka ha metabolic ea lintho tse hlahisitsoeng ke li-isoenzymes tsa cytochrome P450, tse ka hlahisoang ke khatello ea GR. Kaha ho ke ke ha khoneha ho khetholla litlamorao tse tšoanang tsa octreotide, lithethefatsi tse entsoeng ka metso ea eyeenzymes ea cytochrome P450 system mme li na le mofuta o moqotetsane oa kalafo (quinidine le terfenadine) li lokela ho laeloa ka hloko.

Lipehelo tsa Maemo a Phomolo ea meriana

Setlhare ke ngaka.

Lipehelo le maemo a polokelo

Setlhare se lokela ho bolokoa sebakeng se ommeng le se lefifi, moo bana ba sa bang mocheso oa 2 ° ho isa ho 8 ° C. Bophelo ba Shelf ke lilemo tse 3.

Ts'ebeliso ea lithethefatsi Oktreotid-depot feela joalo ka ha ho laetsoe ke ngaka, litaelo li fanoe bakeng sa ho buuoa!

Fomu ea tokollo

Motsoako o fumaneha ka tsela ea tharollo ea jekeng, o behiloeng ka ampong tse 1 ml kapa likhalase tse 5 ml.

Octreotide Depot le Octreotide Nako e telele li fumaneha ka mokhoa oa phofo ea lyophilized kapa e kopantsoeng le porous ka mokhoa oa pente e bonolo ea mebala ea litekanyetso tse fapaneng. Ho kenyelletsa moo, ho kopantsoe le khanya e sa bonahaleng e sa bonahaleng le ho emisoa hape, e leng ho emisoa ha moriti o bobebe.

Hape, phapang ena ea bongaka e ka fanoa ka mokhoa oa lyophilisate bakeng sa ho hlophisoa ha setlamo se reretsoeng tsamaiso ea methapo ka ketso ea nako e telele ea 0,01-0.03 g ea karolo e sebetsang mefuteng ea likhalase tse lefifi. Ntle le moo, ho kenyelitsoe sephutheloana se ka etsang 2 ml, solringe, li-needle tse sa sebetseng hantle le joala ba joala. Setha e le 'ngoe liente.

Pharmacodynamics le pharmacokinetics

Setlhare sena ke analogue ea maiketsetso. zangolotearho ba le litlamorao tse tšoanang tsa pharmacological, empa nako e telele.

Phekolo ea Octreotide e etsoa ha ho hlokahala ho hatella secretion ea hormone ea kholo, e eketsehang ea methapo kapa e bakoang ke arginine, insulin hypoglycemia kapa ho ikoetlisa. Phello e ba ho putlama secretion ea insulin, gastrin, glucagon le serotonin, e ka eketsoang hape kapa ea bakoa ke lijo. Phepelo ea secretion e hlokometsoe insulinle glucagone a susumetsangargininesecretion e fokotsehile thyrotropinbakoang ke thyroliberin.

Ho sebelisa lithethefatsi pele kapa nakong ea ts'ebetso ea pancreatic ho ka fokotsa kotsi ea mathata a hlahang ka mor'a ts'ebeliso ea ts'ebetso, mohlala:pancreatic fistula, sepsis, abscesses, a hlobaetsang le a pancreatitis a hlobaetsang le a morao.

Phekolo ea ho tsoa mali ho tsoa methapong ea varicose ka mpeng ea bakuli ba nang le lefu la cirrhosis la sebete hammoho le kalafo e itseng - sclerosing and hemostatic, e thusa ho emisa ho tsoa mali hantle le ho thibela mali a tsoang khafetsa.

Ka hare ho 'mele ho na le monko o potlakileng le o felletseng oa ntho e sebetsang. Maemong ana, khatello e phahameng ea Octreotide ka plasma ea mali e fihlella kamora metsotso e 30. Karolo eo e kopana le liprotheine tsa plasma ka 65%, empa ho hokahana ha eona le likarolo tse entsoeng ka mali ha ho na thuso. Ho tlosoa hoa moriana ho etsahala ka mekhahlelo e mengata ka popelong le ka thuso ea liphio.

Matšoao a ho sebelisoa

Lithethefatsi tse thehiloeng ho Octreotide li etselitsoe:

• acromegalyhaeba ho se sebetse hantle ho hlokometsoedopamine agonistsle haeba ho ka se khonehe ho etsa kalafo ea bongaka e sebelisang thipa kapa ea radiation,
• endocrine tumors gastroenteropancreatic system,
• glucagonomas, gastrinomas,
• insulomas, zangoloteolomas,
• hana lets'ollo ho bakuli ba nang le AIDS
• ho buuoa ka pancreatic, ho kenyelletsa le thibelo ea mathata,
• ho tsoa mali, thibelo ea ho oela hape maemong a varicose methapong ea esophagus ka cirrhosis ea sebete le tse ling.

Contraindication

Ntho e ka sehloohong e sitisang tšebeliso ea lithethefatsi ke hypersensitivity

Ho hlokahala tlhokomeliso ha u phekola bakuli. cholelithiasis,lefu la tsoekere,ho lebone le boimana.

Litlamorao

Ha u phekola le Octreotide, ho ferekana ha tšebetso ea tšilo ea lijo ho ka etsahala ka tsela e latelang: ho hlatsa, ho nyekeloa le pelo, anorexiabohloko botlaela, lets'ollo,letheorrhea, ho hema ka mpeng, ho ruruha lefu la pelo ntle le cholestasis, ts'ebetso e eketsehileng ea transpase tsa hepatic, hyperbilirubinemia, pancreatitis e hlobaetsang le ba bang.

E kanna ea ntlafalaalopecia le karabelo. Lipontšo tsa lehae ha li khethoe: ho hlonama, ho hlohlona, ​​ho chesa, bofubelu kapa ho ruruha. Tšebeliso ea nako e telele hangata e tsamaisana le ho thehoa ha li-gallstones, ho fokotsa mamello ea glucose le ho phehella hyperglycemia, hypoglycemia.

Octreotide, litaelo tsa tšebeliso (Mokhoa le litekanyetso)

Octreotide ea lithethefatsi e etselitsoe intravenous, intramuscular kapa tsamaiso e poteletseng. Litekanyetso li beoa ka bonngoe, ho latela mofuta oa lefu le litšobotsi tsa mokuli. Mohlala, acromegaly le tumor ea sistimi ea gastroenteropancreatic e hloka tsamaiso e potolohileng letsatsi le letsatsi ea makhetlo a 1-2 ho 50-100 mcg. Ho etsa ts'ebetso ea thibelo ea mathata ka lebaka la ts'ebetso ea manyeme ho kenyelletsa ts'ebetso ea subcutaneous ea lethal dose ea pele hora pele ho laparotomy, ebe e fanoa letsatsi le letsatsi makhetlo a 3 ho isa ho a 100 ka beke. Ha ho hlokahala ho emisa ho tsoa mali ho tsoa methapong ea varicose ea sefuba, ho kenngoa infravenous infusions ka 25 μg / h bakeng sa bonyane matsatsi a 5.

Litaelo tsa ho sebelisoa Octreotide Depot le Octreotide Long FS litlaleho tseo li etselitsoeng tsona ente ea methapo e tebileng ho mesifa ea gluteal. Ha tsamaiso ea subcutaneous ea Octreotide e lumella bakuli ho laola ka nepo ponahatso ea lefu lena, tekanyetso ea pele ea Depo le Long e fanoa ho 20 mg ka beke tse 'ne le tse ling bakeng sa likhoeli tse 3. Ebe moriana o ntlafatsoa ho latela matšoao a lefu lena le lipontšo tsa kliniki.

Haeba bakuli ba ne ba sa amohela Octreotide ka tsela e sa sebetseng, joale kalafo ka moemeli enoa le mokhoa o lokela ho qala libeke tse 2. Mokhoa ona o tla lekola ts'ebetso ea ona le ho mamella, ka mor'a moo o ka etsa kalafo ka Octreotide-Depot kapa nako e telele.

Bongata

Haeba ho na le overdose ea Octreotide kapa Octreotide-Long, ho ka etsahala: ho fokotseha ha nakoana hoa sekhahla sa pelo, bohloko ba ka mpeng tlhaho ho nyekeloaho fifatsa sefahleho, lets'ollo. Tabeng ena, kalafo ea matšoao e etsoa.

Litaba tsa overdose ea Octreotide-Depot ha e so ka e hlalosoa ho tsa tleliniking.

Tšebelisano

Ts'ebeliso e lekanang ea lithethefatsi le Cyclosporinee theola boemo ba eona serum, e liehisa ho monyacimetidine le likarolo tsa bohlokoa tse tsoang moetlong oa tšilo ea lijo. Haeba octreotide e laetsoe hammohoinsulinka molomo hypoglycemic lithethefatsi, beta blockers, BKK le diuretics, hoa hlokahala ho etsa liphetoho tsa litekanyetso tsa bona. Tšebeliso e kopanetsoeng le Bromocriptine e ka eketsa bioavailability ea eona.

Ho ile ha fumaneha hore sethethefatsi sena se fokotsa ho pepeseha ha metabolic ea lintho tse hlahisoang ke li-enzymes tsa cytochrome P450 tse hlahisoang ke khatello ea lihormone tsa kholo. Ka hona, ha u fana ka litlhare tse joalo, ho lokela ho sebelisoa temoso.

Li-analog tsa Octreotide

Ka pharmacology, li-analogues tse ngata tsa Octreotide lia fumanoa, ntho e ka sehloohong ho tsona ke Sandostatin.

Phello e tšoanang e na le:Somatostatin, Diferelin le Sermorelin.

Joalo ka ha u tseba, joala bo ka thibela synthesis lihormoneka hona, ts'ebeliso ea eona le mofuta ofe kapa ofe oa Octreotide e hanyetsitsoe.

Tlhahlobo mabapi le Octreotide

Re lokela ho tseba hore lipuisano tse fumanehang marang-rang mabapi le tšebeliso ea lithethefatsi le katleho ea tsona ha lia tloaeleha. Ka tloaelo, basebelisi ba botsa lipotso ho litsebi tseo ba li thahasellang hore na phekolo ea bokuli e sebetsa hakae.

Leha ho le joalo, ts'ebetsong ea bongaka, foromo ea Depot e sebelisoa haholo. Ka nako e ts'oanang, litlhahlobo ho Octreotide Depot bonts'a hore e sebelisetsoa pancreatitis, le mefuta e hlobaetsang le e sa foleng ea lefu lena. Ehlile, pheko ena e laetsoe ke setsebi feela mme ho lokela ho lebelloa hore kalafo e tla etsoa bonyane beke.

Foromo ea litekanyetso

Lyophilisate bakeng sa ho hlophisoa ha ho emisoa bakeng sa taolo ea methapo ea methapo ea ketso ea nako e telele ea 10,0 mg, 20,0 mg kapa 30.0 mg ka botlalo ka solvent ea 2 ml (Mannitol, tharollo ea ente 0.8% 2 ml)

Botlolo e le 'ngoe e na le

ntho e sebetsang - octreotide 10,0 mg, 20,0 mg, 30.0 mg,

Baeti: kopolymer ea DL-lactic le glycolic acid, D-Mannitol, carboxymethyl cellulose sodium letsoai, polysorbate-80.

Solvent: D-Mannitol, metsi a ente.

Liphofo tse phofo kapa li-porous, tse kopantsoeng letlapeng, lekhopho le lesoeu kapa le lesoeu le bosoeu bo bosehla.

Solvent: mokelikeli o sa hlakileng o hlakileng

Ho emisoa hape: Ka tlatsetso ea solvent le ho ruruha, ho emisoa ho hoholo ha mmala o mosoeu kapa o mosoeu ka liforomo tsa tinge tse boreleli. Ho emisoa bocha ha hoa lokela ho ba bonyane metsotso e 5. Ha e eme, ho emisoa hoa hlohlona, ​​empa ho tsosoa habonolo ka ho thothomela. Ho emisoa ho lokela ho fetela ka bolokolohi ka hara seratsoana ka nale ea 0840.

Melemo ea pharmacological

Mofumahali

Ka tsamaiso ea methapo, octreotide e kenella ka botlalo.

Phepelo ea mali maling e fihlella kamora metsotso e ka bang 30.

Ho tlama liprotheine ke hoo e ka bang 65%. Ho tlangoa ha octreotide ho lisele tsa mali ha ho na taba. Bophahamo ba karolelano ke 0.27 l / kg. Octreotide e tšeloa matla ka har'a sebete.

Tlhahiso e felletseng ke 160 ml / min. T1 / 2 ke metsotso e 100. Hoo e ka bang 32% ka sebopeho se sa fetoheng se epolloa ke liphio. Ho bakuli ba tsofetseng, clearance ea fokotseha, 'me T1 / 2 ea eketseha. Ha e sa sebetse hantle hantle haholo ke lefutso, e emisoa.

Farmacodynamics

Octreotide Depot ke octapeptide ea maiketsetso e nkiloeng ka tsela ea tlhaho ea hormone somatostatin mme e na le litlamorao tse tšoanang tsa meriana, empa ketso ea nako e telele. Lithethefatsi li hatella ka tšohanyetso secretion ea hormone ea kholo (GH), hammoho le li-peptide le serotonin tse hlahisoang tsamaisong ea gastro-entero-pancreatic endocrine.

Ho carcinoid tumors ts'ebeliso ea Octreotide e lebisa ho fokotseha ho hoholo ha matšoao a joalo ka maikutlo a ho sutumetsa le lets'ollo, leo maemong a mangata le tsamaeang le ho fokotseha ha khatello ea serotonin kahara plasma le excretion ea 5-hydroxyindoleacetic acid ka har'a moroto.

Ho maqeba a tšoauoang ke phepo e matla ea peptide ea mala (VIPs), ts'ebeliso ea Octreotide e lebisa ho fokotseha hoa lets'ollo le matla la sephiri. Ka nako e ts'oanang, ho fokotseha ha ho lekana hoa elektrone ea electrolyte ho etsahala. Ho bakuli ba bang, tsoelo-pele ea hlahala ea lieha kapa ea emisa esita le boholo ba eona bo fokotseha, haholoholo metastases ea sebete. Ntlafatso ea kliniki hangata e tsamaisana le ho fokotseha (ho fihlela litekanyetso tse tloaelehileng) pokellong ea vasoactive intestinal peptide (VIP) ho plasma.

Ho glucagonomas ts'ebeliso ea Octreotide-depo maemong a mangata e lebisa ho fokotseha ho hlokomelehang ha mokoetla a potolohileng a necrotizing. Octreotide-depot ha e na phello efe kapa efe ho teba ha lefu la tsoekere mellitus, eo hangata e bonoang ka glucagonomas, 'me hangata ha e fokotse tlhoko ea lithethefatsi tsa insulin kapa tsa molomo. Ho bakuli ba nang le lets'ollo, Octreotide e baka ho fokotseha ha eona, e tsamaeang le keketseho ea boima ba 'mele. Ka tšebeliso ea Octreotide, ho fokotseha ho potlakileng ha khatello ea tsoekere ka plasma hangata ho hlokomeleha, leha ho le joalo, ka kalafo ea nako e telele phello ena ha e bolokehe. Ka nako e ts'oanang, ntlafatso ea matšoao e lula e tsitsitse nako e telele.

Ho gastrinomas / Zollinger-Ellison syndrome Depo ea Octreotide, e sebelisoang e le monotherapy kapa e kopantsoe le H2-receptor blockers, e ka fokotsa tlhahiso ea acid ka mpeng mme ea lebisa ntlafatsong ea kliniki, ho kenyeletsoa le lets'ollo. Botebo ba matšoao a mang, ho kenyeletsa le ho sesa, le bona bo fokotsehile. Maemong a mang, ho na le ho fokotseha ho hoholo ha khatello ea gastrin plasma.

Ho bakuli ba nang le insulinomas Depo ea Octreotide e fokotsa boemo ba insulin e maling maling (phello ena e ka ba ea nakoana - hoo e ka bang lihora tse 2). Ho bakuli ba nang le li-tumor tse sebetsang, Octreotide Depot e ka netefatsa ho khutlisetsoa le ho lokisoa ha li-Normoglycemia nakong ea ts'ebetso. Bakeng sa bakuli ba nang le tumello ea mokokotlo le tse sa sebetseng hantle, taolo ea glycemic e ka ntlafala ntle le ho theoha ka nako e telele ka nako e telele maemong a insulin maling.

Ho letšollo le hanyetsang ho bakuli ba nang le lefu la thuto ea methapo ea mali (AIDS) ts'ebeliso ea Octreotide e lebisa ho tlatseng kapa setulo se tloaelehileng bathong ba nang le lets'ollo, ba sa laoloang ke kalafo e lekaneng ea antimicrobial le / kapa antidiarrheal.

Ho bakuli ba sebetsanang le pancreatic, tšebeliso ea Octreotide nakong le ka mor'a ho buuoa e fokotsa menyetla ea mathata a tloaelehileng a ts'ebetso (mohlala, pancreatic fistula, abscesses, sepsis, postoperative acute pancreatitis).

Ho Ho tsoa mali ho tsoa methapong ea varicose ea esophagus le mpeng ho bakuli ba lefu la cirrhosis ts'ebeliso ea Octreotide-Depot ha e kopantsoe le kalafo e khethehileng (mohlala, sclerotherapy) e lebisa ho emiseng ka mokhoa o atlehang ho tsoa mali le ho ts'oaroa hape ha mali, ho fokotseha ha palo ea tšelo ea mali le ntlafatso ea matsatsi a 5 a ho pholoha. Setlhare se fokotsa phallo ea mali a setho ka ho hatella lihormone tse holofatsang tse kang VIP le glucagon.

Tekanyetso le tsamaiso

Depo ea Octreotide e lokela ho tsamaisoa feela ka botebo intramuscularly (IM), ho gluteus maximus. Ka liente tse phetoang khafetsa, lehlakore le letšehali le le letona le lokela ho fetoloa. Ho emisoa ho lokela ho lokisoa kapele pele ho ente. Ka letsatsi la ente, vial e nang le lithethefatsi le ampoule e nang le solvent e ka bolokoa ka mocheso oa kamore.

Phekolo ea lihlahala tsa "endocrine" tsa "gastrointestinal" le manyeme

Bakeng sa bakuli bao Tsamaiso ea Octreotide e fanang ka taolo e lekaneng ea liponahatso tsa lefu lena, lethal dose la "Octreotide-Depot" ke 20 mg ka mor'a libeke tse 'ne. Tsamaiso ea sc ea Octreotide e lokela ho tsoelapele libeke tse ling tse 2 kamora taolo ea pele ea Octreotide Depot.

Ho bakuli ba e-so ka ba amohela Octreotide s / c, ho khothalletsoa ho qala kalafo ka s / c tsamaiso ea Octreotide ka tekanyo ea 0,1 mg makhetlo a 3 / letsatsi ka nako e khuts'oane ea nako (hoo e ka bang libeke tse 2) ho hlahloba ts'ebetso ea eona le mamello e akaretsang . Ke feela kamora sena, Octreotide Depot e laetsoe ho latela morero o kaholimo.

Maemong ha kalafo e nang le Octreotide-Depot bakeng sa likhoeli tse 3 e fana ka taolo e lekaneng ea lipontšo tsa kliniki le matšoao a biology a lefu lena, ho ka etsahala hore o fokotsa tekanyetso ea Octreotide-Depot ho isa ho 10 mg e boletsoeng ka mor'a libeke tse 'ne. Maemong moo kamora likhoeli tse 3 tsa kalafo le Octreotide-depot ntlafatso e itseng e fumanoe, lethal dose le ka eketsoa ho 30 mg ka beke tse 'ne. Khahlano le nalane ea kalafo e nang le Octreotide-depot, ka matsatsi a itseng, lipontšo tsa kliniki tse ikhethang tsa tumello ea mokokotlo oa mokokotlo le pancreas li ka ntlafatsoa. Maemong ana, tsamaiso e 'ngoe ea s / c ea Octreotide e khothaletsoa ho lethal dose le neng le sebelisoa pele ho qaleho ea kalafo le Octreotide-depot. Sena se ka etsahala haholo likhoeling tse peli tsa pele tsa kalafo ho fihlela phekolo ea octreotide ho plasma e fihlella.

Ha ho phekoloa kankere ea tšoelesa ea senya ea senya Motsoako oa ho qala oa Octreotide Depot ke 20 mg ka beke tse 'ne le tse ling tse 3. Nakong e tlang, tekanyetso e lokisoa ho nahanoa ka matla a khatello ea PSA e serum, hammoho le matšoao a kliniki. Haeba kamora kalafo ea likhoeli tse 3 ho ne ho sa khonehe ho fihlella phello e lekaneng ea kliniki le biochemical (ho fokotseha hoa PSA), lethal dose le ka eketsoa ho 30 mg e fanoang kamora libeke tse 4.

Phekolo ea Octreotide-depot e kopantsoe le ts'ebeliso ea dexamethasone, e behiloeng ka molomo ho latela morero o latelang: 4 mg ka letsatsi bakeng sa khoeli e le ngoe, ebe 2 mg ka letsatsi bakeng sa libeke tse 2, ebe 1 mg ka letsatsi (lethal dose).

Phekolo ka octreotide-depot le dexamethasone ho bakuli ba kileng ba sebelisa kalafo ea lithethefatsi tsa antiandrogen li kopantsoe le tšebeliso ea analogue ea gonadotropin-releading hormone (GnRH). Tabeng ena, ente ea GnRH analogue (foromo ea depo) e etsoa nako e le ngoe ka libeke tse 4.

Bakuli ba fumanang Octreotide Depot ba lokela ho etsa tlhahlobo ea khoeli le khoeli bakeng sa ho tsepamisa likelello tsa PSA.

Ho bakuli ba nang le bothata ba ho lemala ba nang le bothata ba ho lemala, hepatic le bakuli ba tsofetseng, ha ho na lebaka la ho lokisa mofuta oa mofuta oa Octreotide Depot.

Bakeng sa ho thibela pancreatitis e hlobaetsang le ea morao-rao

Lithethefatsi Octreotide-Depot ka tekanyetso ea 10 kapa 20 mg e tsamaisoa hang ha ho pejana ho matsatsi a 5 mme ha ho ka feta matsatsi a 10 pele ho ts'ebetso e buelletsoeng ea ho buoa.

Melao ea ho lokisa ho emisoa le tsamaiso ea moriana

Setlhare se fanoa feela ka mokokotlong.

Ho emisoa bakeng sa ente ea methapo ea methapo ea methapo ho lokisoa ka tšilafalo e fanoang hang-hang pele ho tsamaiso.

Moriana o lokela ho lokisoa le ho tsamaisoa feela ke basebetsi ba koetlisitsoeng ba bongaka.

Pele ho ente, ampoule e nang le solvent le botlolo e nang le moriana e lokela ho tlosoa sehatsetsing ebe e tlisoa mocheso oa kamore (metsotso e 30-50 e hlokahala).

Boloka botlolo ka Octreotide Depot e tiile. Tlanya vial habobebe, etsa bonnete ba hore lyophilisate eohle e ka tlase ea vial.

Bula sephutheloana ka syringe, hokela nale ea 1,2 mm x 50 mm ho syringe ho bokella solvent.

Bula ampoule ka solvent ebe o kenya syringe litaba tsohle tsa ampoule le solvent, beha syringe ho lethal dose ea 3,5 ml.

Tlosa cap, ea polasetiki ho tloha vial e nang le lyophilisate. Tšoaea ntho e thibang rabara ea vial ka thipa ea joala.Kenya lenala ka har'a vial ea lyophilisate bohareng ba sethala sa rabara ebe o kenya solate ka hloko leboteng le ka hare la vial ntle le ho ama se kahare sa vial ka nale. Tlosa syringe ho vial.

Vial e lokela ho lula e sa sisinyehe ho fihlela solvent e tletse ka botlalo ka lyophilisate le liforomo tsa ho emisa (hoo e ka bang metsotso e 3 ho isa ho e 5). Ka nako eo, ntle le hore o fetole botlolo, o lokela ho sheba hore na ho na le lyophilisate e omelletseng maboteng le boteng ba botlolo. Haeba li-solid tse omileng li fumanoa, siea vial ho fihlela e tletse ka botlalo.

Kamora ho etsa bonnete ba hore ha ho na masalla a omileng a li-lyophilisate, se kahare sa vial se lokela ho tsoakoa ka hloko motsamao o chitja bakeng sa metsotsoana e 30-60 ho fihlela ho emisoa ho sa feleng. Se ke oa hlakola kapa oa sisinyeha vial, hobane sena se ka baka tahlehelo ea li-flakes le ho emisoa ho sa lokelang.

Kenya kapele nale ka sekontiri se thibelang rabara ka vial. Ebe o theola sekhahla sa nale, 'me, ka ho lekanya vial ka sekala sa likhato tse 45, butle-butle hula ho emisa ka syringe ka botlalo. Se ke oa phahamisa botlolo ha u ntse u thaepa. Tekanyo e nyane ea lithethefatsi e ka sala marakong le tlase ho vial. Ts'ebeliso ea masala maboteng le tlase ea botlolo e ananeloa.

Hang hoba u bokelle sekontiri, khutlisetsa nale ka pine e pinki ka nale ka mofuta o motala (0,8 x 40 mm), ka hloko siling e fetele ka holimo mme o tlose moea ho tsoa syringe.

Ho emisoa ha Octreotide Depot ho lokela ho tsamaisoa hang kamora ho itokisa.

Ho emisoa ha Octreotide Depot ha hoa lokela ho kopanngoa le lithethefatsi tse ling ka seratsoaneng se le seng.

- tšoaea sebaka sa ente ka swab ea joala. Kenya nale ka botebo ka har'a gluteus maximus, ebe o hula ka sekhahla selei ho etsa bonnete ba hore ha ho na tšenyo ea sekepe. Hlohlelletsa ho emisoa butle-butle ka khatello e sa feleng ho syringe plunger.

Haeba e kenella ka sejelong sa mali, sebaka sa ente le nale li lokela ho fetoloa.

Ha u hlana le nale, e kenye nale ka nale e ngoe e bophara ba eona.

Ka liente tse phetoang khafetsa, lehlakore le letšehali le le letona le lokela ho fetoloa.

Litlamorao

Liphetoho tse mpe li hlahisoa ho latela makhetlo a etsahalang ka tatellano e latelang: khafetsa (≥1 / 10), hangata (≥1 / 100,  1/10), ka linako tse ling (≥1 / 1000, 1 / 100), ka seoelo (= ≥ 1/10000, 1 / 1000), ka seoelo haholo (1 / 10000), ho kenyelletsa melaetsa ka bomong.

- bohloko bo ka mpeng ba mpa, ho thunya, ho ruruha, lets'ollo

- Karabelo ea lehae haeba ho na le tsamaiso e poteletseng (bohloko, ho ruruha, bofubelu, ho teneha le ho chesa)

-Hypothyroidism, dysfunction ea thyroid

- ho tsekela, dyspnea, asthenia

- bradycardia, tachycardia, cholecystitis, ho kuta moriri

- makhopho a kulang ke ho hlohlona

ho nyekeloa ke pelo, ho hlatsa, ho etsoa ha gallstones (ka tšebeliso ea nako e telele ea Octreotide-Depot), cholecystitis, biliary sludge, steatorrhea (le ha ho lokolloa ha mafura ka mouoane ho ka eketseha, ha ho na sesupo sa hore kalafo ea nako e telele le Octreotide-depot e ka lebisa khaellong ea phepo e nepahetseng) ka lebaka la malabsorption (malabsorption), liketsahalo tse tšoanang le tšitiso ea ka mpeng: ho thunya ho tsoelang pele, bohloko bo boholo karolong ea epigastric, tsitsipano ea lebota la mpa, "ts'ireletso" ea mesifa.

acancia pancreatitis, anorexia, hangata litulo, hepatitis e hlobaetsang ntle le cholestasis, hyperbilirubinemia, eketseha alkaline phosphatase, gamma glutamylase, transaminases, thrombocytopenia, hyperkalemia

khatello ea mali ea methapo (ka tšebeliso e telele)

Botebo ba karabelo ea lehae bo ka fokotseha haeba o sebelisa tharollo ea mocheso oa kamore, kapa kenya tharollo e nyane ea tharollo e amehileng haholoanyane.

Litlaleho tsa morao-rao tsa litla-morao

anaphylaxis, allergic reaction, urticaria rash

a hlobaetsang le manyeme, a hlobaetsang le lefu la sethoathoa, hepatitis e hlobaetsang, cholestasis, spill of bile, cholestatic jaundice

Ho sebelisana le lithethefatsi

Octreotide e fokotsa ho monya ha cyclosporine, e fokotsa ho kenngoa ha cimetidine. Ho lokisa kalafo ea litekanyetso tsa li-diuretics tse sebelisoang ka nako e tšoanang, li-beta-blockers, "lietsahala" tsa "calcium" blockers, "insulin" le meriana ea "hypoglycemic" li hlokahala.

Ka tšebeliso e tšoanang ea octreotide le bromocriptine, bioavailability ea morao e eketseha.

Lithethefatsi tse entsoeng ka li-enzyme tsa sistimi ea cytochrome P450 le ho ba le lethathamo la lipilisi tse fokotsang tsa kalafo li lokela ho fanoa ka hloko.

Litaelo tse khethehileng

Ka tumello ea pituitary e kenyang GR, ho hlokahala hore ho hlahlojoe bakuli ba fumanang Octreotide Depot, hobane ho ka khoneha ho eketsa boholo ba marang-rang ka nts'etsopele ea mathata a tebileng a kang ho fokotsa tšimo ea pono. Maemong ana, tlhokeho ea mekhoa e meng ea kalafo e lokela ho nahanoa.

Ts'ebetso ea qoqotho e lokela ho beoa leihlo ho bakuli ba tšoaroang kalafo e telele le Octreotide Depot.

Litlaleho tse sa tloaelehang tsa bradycardia li tlalehiloe ka octreotide. Ntlheng ena, ho ka hlokahala hore o fetole lethal dose ea lithethefatsi tse kang beta-blockers, calcium block blockers kapa lithethefatsi tse sebelisoang ho laola chelete e lekanang le motlakase.

Ho 10-20% ea bakuli ba fumanang Octreotide Depot nako e telele, ponahalo ea majoe ka gallbladder e ka khona, ka hona, likhothaletso tse latelang li lokela ho tsotelloa.

Tataiso bakeng sa taolo ea bakuli nakong ea kalafo le Octreotide Depot mabapi le sebopeho sa majoe a gallbladder.

Pele ho khethoa ha Octreotide Depot, bakuli ba lokela ho hlahlojoa ka sehokelo sa gallbladder,

nakong ea kalafo le Octreotide-Depot, litlhahlobo tse pheta-phetoang tsa ultrasound ea gallbladder li lokela ho etsoa, ​​ka ho khetheha nakong ea likhoeli tse 6-12,

haeba majoe a fumanoa pele kalafo e qala, ho a hlokahala ho lekola melemo ea Octreotide-Depot kalafo ha e bapisoa le kotsi e ka bang teng e amanang le boteng ba li-gallstones. Ha ho na bopaki ba phello leha e le efe e mpe ea Octreotide Depot tseleng kapa tsoelo-pele ea bokuli bo seng bo ntse bo le teng.

Tsamaiso ea bakuli bao majoe a gallbladder a etsoang nakong ea kalafo le Octreotide Depot.

a) Majoe a asymptomatic gallbladder.

Ts'ebeliso ea Octreotide Depot e ka emisoa kapa ea tsoela pele - ho latela tlhahlobo ea tekanyo ea melemo / kotsi. Leha ho le joalo, ha ho na lebaka la ho etsa eng kapa eng ntle le ho tsoela pele ho shebella, ho e etsa khafetsa haeba ho hlokahala.

b) Majoe a Gallbladder a nang le matšoao a kliniki.

Ts'ebeliso ea Octreotide Depot e ka emisoa kapa ea tsoela pele - ho latela tlhahlobo ea tekanyo ea melemo / kotsi. Maemong ohle, mokuli o lokela ho phekoloa ka tsela e tšoanang le maemong a mang a lefu la gallstone le lipontšo tsa kliniki. Phekolo ea lithethefatsi e kenyelletsa tšebeliso ea motsoako oa litokisetso tsa bile acid (mohlala, chenodeoxycholic acid ka tekanyo ea 7.5 mg / kg ka letsatsi hammoho le ursodeoxycholic acid ka lethal dose le le leng) tlasa tataiso ea ultrasound ho fihlela majoe a fela ka botlalo.

Bakuli ba nang le insulinomas ba tšoaroang ka Octreotide-Depot ba ka ba le keketseho ea ho teba le ho ata ha hypoglycemia (sena se bakoa ke phello e boletsoeng ho feta ea secretion ea GH le glucagon ho feta secretion ea insulin, le nako e khuts'oane ea phello ea thibelo ea insulin. Bakuli ba joalo ba lokela ho beoa leihlo haufi-ufi qalong ea kalafo le Octreotide-depot, hammoho le phetoho e 'ngoe le e' ngoe ea litekanyetso tsa moriana. Ho fokotseha ho hoholo ha khatello ea "glucose" maling ho ka lekoa ho fokotsa taolo ea kamehla ea Octreotide Depot.

Nakong ea ho tsoa mali ho tsoa methapong ea varicose ea esophagus le mala ho bakuli ba nang le lefu la cirrhosis, menyetla ea ho ba le lefu la tsoekere e itšetlehileng ka lefu la tsoekere e ea eketseha, hammoho le liphetoho tsa litlhoko tsa insulin ho bakuli ba nang le lefu la tsoekere la mali li hlokahala.

Ho bakuli ba nang le lefu la tsoekere la mofuta oa I, Octreotide Depot e ka fokotsa tlhokahalo ea insulin. Ho bakuli ba se nang lefu la tsoekere le lefu la tsoekere la mofuta oa 2 lefu la tsoekere le bolokiloeng ka insulin, tsamaiso ea Octreotide Depot e ka lebisa keketseho ea "glucose" ea postprandial.

Ho bakuli ba bang, octreotide e ka fetola ho kenngoa ha mafura ka mpeng, ea fokotsa palo ea vithamine B12 maling mme ea baka phapang ho latela litekanyetso tsa tlhahlobo ea Schilling.

Bokhachane le pelehi

Ha ho na boiphihlelo ka tšebeliso ea lithethefatsi nakong ea kemolo, maemong a joalo lithethefatsi li laetsoe feela bakeng sa matšoao a felletseng. Nakong ea kalafo le Octreotide Depot, letsoele le lokela ho emisoa.

Ts'ebeliso ea bongaka

Ha ho na boiphihlelo le Octreotide Depot ho bana.

Lintlha tsa phello ea lithethefatsi ho bokhoni ba ho khanna koloi kapa mekhoa e ka bang kotsi

Litla-morao tse ling tsa Octreotide Depot li ka ama hampe matla a ho khanna makoloi le mekhoa e meng e hlokang ho tsepamisa maikutlo le ho potlaka ha maikutlo a psychomotor.

Lipehelo tsa Maemo a Phomolo ea meriana

Lebitso le naha ea moetsi

Deco Company LLC, Russia Federation

129344, Moscow, st. Yenisei, moaho oa 3, moaho oa 4

Lebitso le naha ea setifikeiti sa ngoliso

Farm Synthesis CJSC, Russian Federation

111024, Moscow, Kabelnaya 2-ya Street, ntlo ea 2, leq

Aterese ea mokhatlo e amohelang likopo ho tsoa ho bareki ka boleng ba lihlahisoa (thepa) Rephaboliking ea Kazakhstan

Raifarm LLP (Sesole)

RAPRIKI YA KAZAKHSTAN, Almaty, st. Timiryazev 42, bldg. 15/3 V.

Litšoantšo tsa 3D

Tlhaloso ea foromo ea litekanyetso

Liphofo tse phofo kapa tse halikiloeng, tse koahetsoeng ka lehare le letšo le lesoeu kapa le bosoeu le bosoeu bo bosehla.

Solvent: mokelikeli o sa bonahaleng oa mebala.

Ho emisoa hape: ho emisoa homogenible ho bosoeu kapa bosoeu ka tint e boreleli ea lerootho.

Matšoao Octreotide Depot

ha taolo e lekaneng ea lipontšo tsa lefu lena e etsoa ke sc tsamaiso ea octreotide,

ka ho se na phello e lekaneng ea kalafo ea kalafo le kalafo ea radiation,

Ho itokisetsa kalafo

bakeng sa kalafo pakeng tsa lithuto tsa radiation ho fihlela phello e sa feleng e hlaha,

ho bakuli ba sa sebetseng.

Therapy ea lihlahala tsa "endocrine" tsa "gastrointestinal" le "manyeme":

carcinoid tumors le phenomena ea carcinoid syndrome,

gastrinomas (Zollinger-Ellison syndrome),

glucagonomas (ho laola hypoglycemia nakong ea ts'ebetso, hammoho le kalafo ea tlhokomelo),

somatoliberinomas (tumors e tšoauoa ka ho hlahisa ka bongata tlhahiso ea lihimo tsa kholo ea kholo).

Phekolo ea mofets'e oa kankere ea senya ea senya: e le karolo ea kalafo e kopaneng mokokotlong oa ho buuoa kapa ho lahleloa bongaka.

Thibelo ea nts'etsopele ea pancreatitis e bohloko ea morao-rao: ka ts'ebetso e pharaletseng ea ka mpeng le ho kenella ka mpeng (ho kenyeletsa leka kankere ea mpeng, esophagus, colon, pancreas, tumor ea mantlha le ea bobeli).

Bokhachane le pelehi

Ha ho na boiphihlelo le Octreotide Depot nakong ea kemolo le nakong ea ho anyesa. Ka hona, nakong ea kemaro, moriana o fuoa feela haeba phaello e ka ba teng ho mme e feta kotsi e ka bang teng ho lesea. Ho anyesa sefuba ha se khothalletsoe ha u sebelisa lithethefatsi nakong ea ho nyekeloa.

Moetsi

Khamphani ke mong'a setifikeiti sa ngodiso: Farm-Sintez JSC.

Aterese ea molao: 111024, Russia, Moscow, ul. Cable ea 2, 2, leq. 46.

Aterese: 121357, Russia, Moscow, ul. Vereyskaya, 29, leq. 134, ofisi A403, A404.

Fono: (495) 796-94-33, fekse: (495) 796-94-34.

Mokhatlo o amohela likopo: Farm-Synthesis JSC.

Ketso ea pharmacological

Setlhare sa Octreotide-Depot ke foromo ea nako e telele ea octreotide bakeng sa tsamaiso ea methapo, ho etsa bonnete ba hore kalafo e tsitsitseng ea octreotide maling e na le libeke tse 4. Octreotide ke kalafo ea pathogenetic bakeng sa lihlahala tse hlalosang li-receptor tsa somatostatin ka mafolofolo. Octreotide ke octapeptide ea maiketsetso e nkiloeng ka tsela ea tlhaho ea hormone somatostatin mme e na le litlamorao tse tšoanang tsa meriana, empa ketso ea nako e telele haholo. Lithethefatsi li hatella ka tšohanyetso secretion ea hormone ea kholo (GH), hammoho le li-peptide le serotonin tse hlahisoang gastro - entero - pancreatic endocrine system.

Ho batho ba phetseng hantle, octreotide, joalo ka somatostatin, e hatella secretion ea GR e bakoang ke arginine, ts'ebetso ea 'mele le insulin hypoglycemia, secretion ea insulin, glucagon, gastrin le li-peptide tse ling tsa tsamaiso ea gastro-entero-pancreatic endocrine, e bakoang ke tšebeliso ea lijo, hammoho le ts'usumetso ea insulin. arginine, secretion ea thyrotropin e bakoang ke thyroliberin. Matla a hatellang ho secretion ea GR ho octreotide, ho fapana le somatostatin, a hlahisoa ka mokhoa o moholo haholo ho feta secretion ea insulin. Tsamaiso ea octreotide ha e tsamaisane le ts'ebetso ea hypersecretion ea lihormone ke mochine o seng molaong oa karabelo.

Ho bakuli ba nang le acromegaly, tsamaiso ea octreotide depot form e fana ka bongata ba maemo a fokotseha ho phehella ha mahloriso a GH le ho tloaeleha ha khatello ea insulin e kang kholo factor 1 / somatomedin C (IGF-1).

Ho bakuli ba bangata ba nang le acromegaly, sebopeho sa depo ea octreotide se fokotsa haholo matšoao a kang ho opeloa ke hlooho, ho ruruha, paresthesia, mokhathala, ho opeloa ke masapo le manonyeletso. Ho ile ha tlalehoa hore kalafo e nang le mofuta oa depo ea octreotide ho bakuli ka bomong ba nang le pituitary adenomas e boloka GH e bakile ho fokotseha ha boholo ba tumor.

Ka li-tumori tsa "endocrine tumors" tsa "secre" tsa gastrointestinal (GIT) le li-pancreas, tšebeliso ea kamehla ea matšoao a lefu lena.

Foromo ea depo ea octreotide ka tekanyetso ea 30 mg ka beke e 'ngoe le e' ngoe e liehisa kholo ea tumor ho bakuli ba nang le tumello ea tumello ea "leastendotine" e tloaelehileng ea metastatic
colon e nyolohang, kolone e arohaneng le sehlomathike sa vermiform, kapa metastases ea tumellano ea neuroendocrine ntle le ho tsepamisa maikutlo. Setlhare sena se ne se sebetsa hantle ho eketseng nako ea ho hola, ka bobeli bakeng sa ho boloka le ho sa patise li-tumiso tsa neuroendocrine.

Ho marang-rang a kankere ea mali, tšebeliso ea octreotide e ka lebisa ho fokotseha ha matšoao a lefu lena, haholoholo, joalo ka ho chesoa ke mocheso le lets'ollo. Maemong a mangata, ntlafatso ea bongaka e tsamaea le
ho fokotseha ha mahlaseli a serotonin ea plasma le excretion ea acid e 5-hydroxyindoleacetic ka har'a moroto.

Ka lihlorong tse tšoauoang ke hyperproduction ea vasoactive intestinal peptide (VIPoma), ts'ebeliso ea octreotide ho bakuli ba bangata e lebisa ho fokotseha hoa lets'ollo le matla la sephiri, e leng tšobotsi ea boemo bona, boo, bo lebisang ntlafatsong ea bophelo ba mokuli. Ka nako e ts'oanang, ho na le phokotseho ea pherekano e tšoanang le ea tekano ea electrolyte, mohlala, hypokalemia, e u lumellang ho hlakola tsamaiso ea 'muso le ea botsoali ea fluid le li-electrolyte. Ho latela tomography e kopantsoeng, bakuli ba bang ba theola kapa ba emisa ho tsoela pele ha tumor, 'me ba fokotsa le boholo ba eona, haholoholo metastases ea sebete. Ntlafatso ea kliniki hangata e tsamaisana le ho fokotseha (ho fihlela litekanyetso tse tloaelehileng) pokellong ea vasoactive intestinal peptide (VIP) ho plasma.

Ka glucagonomas, ts'ebeliso ea octreotide maemong a mangata e lebisa ho fokotseha ho hlokomelehang ha makhopho a potang ka thata a fetohang, e leng tšobotsi ea boemo bona. Octreotide ha e na phello e kholo ho teba ha lefu la tsoekere mellitus, hangata e bonoang ka glucagonomas, mme hangata ha e na
ho fokotsa tlhoko ea lithethefatsi tsa insulin kapa molomo. Ho bakuli ba nang le lets'ollo, octreotide e baka ho fokotseha ho lona, ​​e tsamaeang le keketseho ea boima ba 'mele. Ka tšebeliso ea octreotide, ho fokotseha ka sekhahla ha glucagon e plasma hangata ho hlokomeloa, leha ho le joalo, ka kalafo ea nako e telele, phello ena ha e phehelle. Ka nako e ts'oanang, ntlafatso ea matšoao e lula e tsitsitse nako e telele.

Ho gastrinomas / Zollinger-Ellison syndrome, octreotide, e sebelisoang e le monotherapy kapa ho kopantsoe le li-blockter tsa polasetiki tsa Ng-histamine le proton pump inhibitors, e ka fokotsa ho etsoa ha hydrochloric acid ka mpeng mme ea lebisa ntlafatsong ea tleliniki. le mabapi le lets'ollo. Hape hoa khoneha ho fokotsa botebo le matšoao a mang, a amanang le peptides ea motsoako, ho kenyelletsa maqhubu. Ho a mang
maemong, ho fokotsoa ho fokotseha ha bongata ba gastrin ho plasma. Ho bakuli ba nang le insulinomas, octreotide e fokotsa khatello ea insulin e maling. Ho bakuli ba nang le li-tumor tse sebetsang, octreotide e ka netefatsa ho khutlisetsoa le ho lokisoa ha tloaelo ea tlhaho ka nako ea ts'ebetso. Bakeng sa bakuli ba nang le tumello ea mokokotlo le tse sa sebetseng hantle, taolo ea glycemic e ka ntlafala ntle le ka nako e tšoanang
ho fokotseha ha nako e telele molemong oa insulin maling.

Bakeng sa bakuli ba nang le hlahala tse sa tloaelehang, hyperproducing ukuaji wa ho nts'etsopele ea hormone e hlahisang factor (somatoliberinomas), octreotide e fokotsa botebo ba matšoao a acromegaly. Hona, ho bonahala, ho amana le khatello ea secretion ea tlhahiso ea li-hormone tsa kholo le GH ka boeona. Nakong e tlang, hoa khoneha ho fokotsa boholo ba tšoelesa ea pituitary, e ileng ea eketsoa pele ho kalafo.

Ho bakuli ba nang le kankere ea senya ea tšoelesa ea senya (HGRP), letamo la lisele tsa neuroendocrine le hlahisang tumellano ea li-receptor tsa somatostatin bakeng sa mefuta ea octreotide (mefuta ea SS2 le SS5) e khethollang kutloisiso ea tumor ho octreotide. Ts'ebeliso ea lithethefatsi Octreotide-Depot ha e kopana le dexamethasone khahlano le nalane ea androgen blockade (lithethefatsi kapa thothokiso ea methapo) ho bakuli ba nang le HGRP e khutlisetsa kutloisiso ea phepo ea li-hormone mme e lebisa ho fokotseha hoa prostate e khethehileng ea antigen (PSA) ho feta 50% ea bakuli.

Ho bakuli ba HGRG ba nang le metastases ea masapo, kalafo ena e tsamaea le phello e hlalositsoeng le ea nako e telele ea analgesic. Ho feta moo, ho bakuli bohle ba arabileng molemong oa phekolo le motsoako oa lithethefatsi Octreotide-depot, boleng ba bophelo le bophelo bo sa phekoleheng ba mafube bo ntlafalitsoe haholo.

Matšoao Octreotide-Depot

Phekolo ea acromegaly:

• ha taolo e lekaneng ea lipontšo tsa lefu lena e etsoa ke sc tsamaiso ea octreotide,
• ka ho se na phello e lekaneng ea kalafo ea kalafo le kalafo ea radiation,
• Ho itokisetsa kalafo
• bakeng sa kalafo pakeng tsa lithuto tsa radiation ho fihlela phello e sa feleng e hlaha,
• ho bakuli ba sa sebetseng.

Phekolo ea lihlahala tsa "endocrine" tsa "gastrointestinal" le manyeme:

• carcinoid tumors le phenomena ea carcinoid syndrome,
• insulinomas
• VIPoma
• gastrinomas (Zollinger-Ellison syndrome),
• glucagonomas (ho laola hypoglycemia nakong ea ts'ebetso, hammoho le kalafo ea tlhokomelo),
• somatoliberinomas (tumors e tšoauoang ke hyperproduction ea kholo ea tlhaho ea tokollo ea hormone),
• kalafo ea bakuli ba nang le tumello ea sephiri le e sa patiloeng e tloaelehileng (metastatic) neuroendocrine ea letlalo, ileum, sefofu, kolone e nyolohang, colon le transmit, kapa metastases ea tumello ea neuroendocrine ntle le ho tsepamisa maikutlo.

Phekolo ea mofetše o thibelang li-cancer tsa tšoelesa ea senya:

• e le karolo ea kalafo e kopaneng mokokotlong oa ho buuoa kapa ho lahleloa bongaka.

Thibelo ea pancreatitis e bohloko ea morao-rao:

• ka ho buuoa ho hoholo ka mpeng le ho kenella ka har'a 'mele (ho kenyeletsa le mofets'e oa mala, esophagus, colon, manyeme, tšenyo ea hlahala lesapo la mpa le la sekhahla).

Melemo ea litekanyetso

Lithethefatsi Octreotide-Depot e lokela ho fanoa feela ka ho kenella ka hare ho intramuscularly (IM), mokokotlong oa gluteus. Ka liente tse phetoang khafetsa, lehlakore le letšehali le le letona le lokela ho fetoloa. Ho emisoa ho lokela ho lokisoa kapele pele ho ente. Ka letsatsi la ente, vial e nang le lithethefatsi le ampoule e nang le solvent e ka bolokoa ka mocheso oa kamore.

Phekolo ea aceromegaly ho bakuli bao s / c tsamaiso ea octreotide e fanang ka taolo e lekaneng ea lipontšo tsa lefu lena, lethal dose la khothaletso ea lithethefatsi Octreotide-Depot ke 20 mg ka nako ea libeke tse 4 bakeng sa likhoeli tse 3. U ka qala kalafo ka Octreotide-Depot ka letsatsi kamora taolo ea ho qetela ea s / c ea octreotide. Nakong e tlang, lethal dose le lokisoa ka ho nahanela khatello ea maikutlo serum ea GR le IGF-1, hammoho le matšoao a kalafo. Haeba kamora kalafo ea likhoeli tse 3 ho ne ho sa khonehe ho fihlella phello e lekaneng ea kliniki le biochemical (haholoholo, haeba khatello ea GR e lula ka holimo ho 2,5 μg / L), lethal dose le ka eketsoa ho 30 mg e fanoang ka mor'a libeke tse ling le tse ling tse nne.

Maemong ao ha kamora ho qeta likhoeli tse 3 tsa kalafo le Octreotide-Depot ka tekanyetso ea 20 mg, ho fokotseha ho tsoelang pele.
serum GH mahloriso a ka tlase ho 1 μg / l, normalization ea mahloriso a IGF-1 le ho nyamela hoa matšoao a feto-fetohang a acromegaly, o ka fokotsa tekanyetso ea lithethefatsi Octreotide-depot ho 10 mg. Leha ho le joalo, ho bakuli bana ba fumanang tekanyetso e nyane ea Octreotide Depot, mohopolo oa serum oa GR le IGF-1, hammoho le matšoao a lefu lena, o lokela ho beoa leihlo ka hloko.

Bakuli ba fumanang lethal dose e tsitsitseng ea Octreotide-depot ba lokela ho hlahlojoa likhoeli tse ling le tse ling tse 6 bakeng sa ho tsepamisa maikutlo ho GH le IGF-1.

Bakuli bao kalafo ea bona ea ho buoa le ea radiation e sa sebetseng hantle kapa e sa sebetseng, hammoho le bakuli ba hlokang kalafo ea nako e khuts'oane lipakeng tsa lithuto tsa radiation ho fihlela nts'etsopele ea ts'ebetso ea eona e felletseng, ho kgothaletsoa ho etsa teko ea kalafo ka liente tsa sc octreotide e le ho lekola liteko tsa eona ts'ebetso le mamello e akaretsang, mme ke feela ka mor'a phetoho eo ho ts'ebeliso ea lithethefatsi Octreotide-depot ho latela morero o kaholimo.

Phekolo ea lihlahala tsa "endocrine" tsa "gastrointestinal" le "pancreas" ho bakuli bao sc tsamaiso ea octreotide e fanang ka taolo e lekaneng ea lipontšo tsa lefu lena, lethal dose la "Octreotide-Depot" ke 20 mg ka mor'a libeke tse 'ne. Ts'ebetso ea sc ea octreotide e lokela ho tsoelapele libeke tse ling tse 2 kamora ts'ebetso ea pele ea lithethefatsi Octreotide-Depot.

Ho bakuli ba neng ba sa amohela sperm octreotide, ho khothalletsoa hore kalafo e qale ka ho s.c. tsamaiso ea octreotide ka tekanyo ea 0,1 mg makhetlo a 3 / letsatsi bakeng sa nako e khuts'oane ea nako (hoo e ka bang libeke tse peli) ho hlahloba ts'ebetso ea eona le mamello e akaretsang. Ke feela kamora sena, lithethefatsi Octreotide-depot e laetsoe ho latela morero o kaholimo.

Maemong ha kalafo e nang le Octreotide-Depot bakeng sa likhoeli tse 3 e fana ka taolo e lekaneng ea lipontšo tsa kliniki le matšoao a biology a lefu lena, ho ka khonahala ho fokotsa tekanyetso ea Octreotide-Depot ho 10 mg,
beetsweng mong le e mong libeke tse 4. Maemong ao ka mor'a likhoeli tse 3 tsa kalafo le Octreotide-Depot, ntlafatso e lekanyelitsoeng e fumanoe, lethalolo le ka eketsoa ho 30 mg ka beke tse 'ne. Khahlano le nalane ea kalafo le Octreotide-Depot, ka matsatsi a mang ho ka etsahala ho eketsa lipontšo tsa bongaka ba li-tumellano tsa endocrine tsa mokokotlo oa mpa le manyeme. Maemong ana, tsamaiso e eketsehileng ea s / c ea octreotide ka tekanyetso e sebelisitsoeng pele ho qala kalafo le Octreotide Depot e khothalletsoa. Sena se ka etsahala haholo likhoeling tse peli tsa pele tsa kalafo, ho fihlela phekolo ea octreotide ho plasma e se e fihlelitsoe.

Ho boloka le ho se patelle liphoso tse tloaelehileng (metastatic) neuroendocrine ea lesapo la letlalo, ileum, sefofu, colon e nyolohang, colon le transmit, kapa metastasis ea li-tumiso tsa neuroendocrine ntle le lesion ea mantlha: tekanyetso e khothalletsoang ea Octreotide Depot ke 30 mg ka beke tse 'ne. Phekolo ea Octreotide-depot e lokela ho ntšetsoa pele ho fihlela matšoao a hlahala a hlahala.

Ka kalafo ea mofets'e o thibelang li-cancer tsa tšoelesa ea senya, moriana oa pele o khothalletsoang oa Octreotide Depot ke 20 mg ka beke tse 'ne le tse ling bakeng sa likhoeli tse 3. Nakong e tlang, tekanyetso e lokisoa ho nahanoa ka matla a khatello ea PSA e serum, hammoho le matšoao a kliniki. Haeba kamora kalafo ea likhoeli tse 3 ho ne ho sa khonehe ho atleha
phello e lekaneng ea kliniki le ea biochemical (PSA fokotsa), lethal dose le ka eketsoa ho 30 mg e fanoang libeke tse ling le tse ling tse 4.

Phekolo le Octreotide Depot e kopantsoe le dexamethasone, e laetsoeng ka molomo ho latela morero o latelang: 4 mg ka letsatsi bakeng sa khoeli e le ngoe, ebe 2 mg ka letsatsi bakeng sa libeke tse 2, ebe 1 mg ka letsatsi (lethal dose).

Kalafo ea Octreotide-depot le dexamethasone ea bakuli ba kileng ba sebelisa kalafo ea lithethefatsi tsa antiandrogen e kopantsoe le ts'ebeliso ea analogue ea gonadotropin-releading hormone (GnRH). Tabeng ena, ente ea analogue ea GnRH (fomu ea depo) e etsoa ka nako e le ngoe ka libeke tse 4.

Bakuli ba fumanang Octreotide Depot ba lokela ho etsa tlhahlobo ea khoeli le khoeli bakeng sa ho tsepamisa likelello tsa PSA.

Bakeng sa bakuli ba nang le bothata ba ho lemala ho sa sebetseng hantle, sebete le ba holileng, ha ho na tlhoko ea ho lokisa mofuta oa kalafo ea lithethefatsi Octreotide-depot.

Bakeng sa thibelo ea pancreatitis e hlobaetsang le ea morao-rao, lithethefatsi Octreotide-Depot ka tekanyetso ea 10 kapa 20 mg e fanoa hang ha ho fetile matsatsi a 5 mme ha ho ka feta matsatsi a 10 pele ho ts'ebetso e buoang.

Melao ea ho lokisa ho emisoa le tsamaiso ea moriana

Setlhare sena se tšeloa ka oli feela. Ho emisoa bakeng sa ente ea methapo ea methapo ea methapo ho lokisoa ka tšilafalo e fanoang hang-hang pele ho tsamaiso. Moriana o lokela ho lokisoa le ho tsamaisoa feela ke basebeletsi ba tsa bongaka ba koetlisitsoeng ka ho khethehileng.

Pele ho ente, ampoule e nang le solvent le botlolo e nang le moriana e lokela ho tlosoa sehatsetsing ebe e tlisoa mocheso oa kamore (metsotso e 30-50 e ea hlokahala). Boloka botlolo ka sethethefatsi Octreotide-Depot e tiile. Tlanya vial habobebe, etsa bonnete ba hore lyophilisate eohle e ka tlase ea vial.

Bula sephutheloana sa syringe ebe o hokela nale ea 1,2 mm x 50 mm ho syringe ho bokella solvent. Bula ampoule ka solvent ebe o kenya syringe litaba tsohle tsa ampoule le solvent, beha syringe ho lethal dose ea 2.0 ml. Tlosa cap, ea polasetiki ho tloha vial e nang le lyophilisate. Tšoaea ntho e thibang rabara ea vial ka thipa ea joala. Kenya lenala ka har'a vial ea lyophilisate bohareng ba sethala sa rabara ebe o kenya solate ka hloko leboteng le ka hare la vial ntle le ho ama se kahare sa vial ka nale.

Tlosa syringe ho vial. Vial e lokela ho lula e sa sisinyehe ho fihlela solvent e tletse ka botlalo ka liforomo tsa lyophilisate le mofuta oa ho emisoa (hoo e ka bang metsotso e 3-5). Ka nako eo, ntle le hore o fetole botlolo, o lokela ho sheba hore na ho na le lyophilisate e omelletseng maboteng le boteng ba botlolo. Haeba mouoane o omileng oa lyophilisate o fumanoe, tloha vial ho fihlela o tletse ka botlalo.

Kamora hore u kholoe ka ho se be teng ha masala a omileng a li-lyophilisate, lintho tse kahare tsa vial li lokela ho tsoakoa ka hloko le metsamao e chitja bakeng sa metsotsoana e 30-60 ho fihlela ho emisoa ho sa feleng. Se ke oa hlakola kapa oa sisinyeha vial, hobane sena se ka baka tahlehelo ea li-flakes le ho emisoa ho sa lokelang.

Kenya kapele nale ka sekontiri se thibelang rabara ka vial. Ebe karolo ea nale e theotsoe 'me, ha e ts'ela botlolo ka sekhahla sa likhato tse 45, butle-butle e hule ho emisoa ka syringe ka botlalo. Se ke oa phahamisa botlolo ha u ntse u thaepa. Tekanyo e nyane ea lithethefatsi e ka sala marakong le tlase ho vial. Ts'ebeliso ea masala maboteng le tlase ea botlolo e ananeloa.

Hang ka mor'a ho bokella ho emisoa, nka nale ka 'mala oa pinki ka nale e nang le pane e tala (0.8 x 40 limilimithara), phetisa sekirine ka hloko' me u tlose moea siling.

Ho emisoa ha lithethefatsi Octreotide-Depot ho lokela ho tsamaisoa hang kamora ho itokisoa. Ho emisoa ha lithethefatsi Octreotide-Depot ha hoa lokela ho kopanngoa le lithethefatsi tse ling ka syringe e le 'ngoe.

- tšoaea sebaka sa ente ka swab ea joala. Kenya nale ka botebo ka har'a gluteus maximus, ebe o hula ka sekhahla selei ho etsa bonnete ba hore ha ho na tšenyo ea sekepe. Hlohlelletsa ho emisoa butle-butle ka khatello e sa feleng ho syringe plunger.

Haeba e kenella ka sejelong sa mali, sebaka sa ente le nale li lokela ho fetoloa. Ha o koala nale, e kenye le nale e ngoe e bophara ba eona.

Ka liente tse phetoang khafetsa, lehlakore le letšehali le le letona le lokela ho fetoloa.

Litla-morao

Boitšoaro ba lehae: ka taolo ea i / m ea Octreotide-depot, bohloko bo khonahala, hangata ha bo ruruhe le ho soaha sebakeng sa ente (hangata ho ba bonolo, ha nakoana).

Ho tsoa ho tšilo ea lijo: ho ipolaisa tlala, ho nyekeloa ke pelo, ho hlatsa, bohloko ba ka mpeng, ho thunya, ho etsoa ha khase e ngata, litulo tse hlephileng, lets'ollo, steatorrhea. Le ha phello ea mafura a nang le mafura a ka eketseha, ho fihlela joale ha ho na bopaki ba hore kalafo ea nako e telele ka octreotide e ka lebisa ho nts'etsopele ea khaello ea likarolo tse itseng tsa limatlafatsi ka lebaka la malabsorption (malabsorption).Maemong a sa tloaelehang, liketsahalo li ka tšoana le ho sitisoa hoa mpa ka mpeng: ho thunya ho tsoelang pele, bohloko bo boholo karolong ea epigastric, tsitsipano ea lebota la mpa. Tšebeliso ea nako e telele ea Octreotide Depot e ka lebisa ho thehoeng ha li-gallstones.

Ho tsoa ho manyeme: ho tlalehiloe linyeoe tse sa tloaelehang tsa pancreatitis e mpe ka mor'a lihora kapa matsatsi a ho sebelisa octreotide. Ka tšebeliso ea nako e telele, ho bile le maemo a pancreatitis a amanang le cholelithiasis.

Ka lehlakoreng la sebete: ho na le litlaleho tse arohaneng tsa nts'etsopele ea ts'ebetso ea sebete e sa sebetseng (hepatitis e hlobaetsang ntle le cholestasis ka mokhoa o tloaelehileng oa phepelo ka mor'a ho hlakoloa ha octreotide), nts'etsopele ea butle-butle ea hyperbilirubinemia, e tsamaeang le keketseho ea ALP, GGT le, ka tekanyo e nyane, transaminase tse ling.

Ho tloha lehlakoreng la metabolism: kaha Octreotide Depot e na le tšusumetso e kholo ho thehoeng ha GR, glucagon le insulin, e ka ama metabolism ea glucose. Mamello ea tsoekere e fokotsehileng ka mor'a ho ja. Ka tšebeliso ea nako e telele ea Octreotide sc maemong a mang, hyperglycemia e phehellang e ka hlaha. Hypoglycemia le eona e ile ea bonoa.

Tse ling: maemong a sa tloaelehang, ho lahleheloa ke moriri ka nakoana kamora ho tsamaisoa ha octreotide, ho hlaha ha bradycardia, tachycardia, ho hema ka thata, ho sohloka ha letlalo, anaphylaxis ho tlalehiloe. Ho na le litlaleho tse arohaneng mabapi le nts'etsopele ea maikutlo a hypersensitivity reaction.

Octreotide depo, litaelo tsa tšebeliso: mokhoa le litekanyetso

Octreotide Depot e etselitsoe tsamaiso ea methapo.

Ho emisoa ho lokisoa ke basebeletsi ba tsa bongaka ba koetlisitsoeng hang-hang pele ho ente. Bakeng sa dilution ea lyophilisate u sebelisa solvent e fanitsoeng.

Melao ea ho lokisa ho emisoa le tsamaiso ea Octreotide-depot:

1. Tlosa litokisetso sehatsetsing ebe o tlisa mocheso oa kamore (hangata ho nka metsotso e 30 ho isa ho e 50).
2. Ho ts'oara botlolo ka kotloloho, ho bonolo ho kokota ho eona e le hore lyophilisate eohle e itihele tlase.
3. Bula sephutheloana ka syringe ebe o hokela nale e nang le mofuta oa pinki pavilion 1.2x50 mm ka boholo ho eona.
4. Bula ampoule ka solvent, tlatsa tsohle tse ka hara syringe ebe u e beha ho lethal dose ea 2 ml.
5. Tlosa mokotla oa polasetiki ho vial ea lyophilized, disin ea khoele ka swab ea joala.
6. Kenya nale ea nale e kenang le solvent ka har'a vial ka bohareng ba sethala, 'me u tšollele tharollo ka kotloloho leboteng le kahare la vial ntle le ho ama litaba tsa nale.
7. Tlosa syringe 'me ue tlohele e sa phefumolohe ho fihlela lyophilisate e tletse ka ho lekaneng mme e theha ho emisoa (hoo e ka bang metsotso e 3-5). Ntle le hore o phetle botlolo, sheba hore na ho na le li-lyophilisate tse ka tlase le mabota. Haeba masala a phofo a ommeng a fumanoa, tlohela vial ka nakoana ho fihlela e felisoa ka botlalo.
8. Kamora ho etsa bonnete ba hore ha ho na li-lyophilisate tse sa rarolloang, kopanya ka hloko se kahare sa vial mochineng o chitja bakeng sa metsotsoana e 30-60, e le hore ho emisoa ho se ke ha ba letho. Se ke oa sisinyeha 'me u khutlisetsa botlolo, hona ho ka lebisa ho tahlehelo ea li-flakes, tse tla etsa hore lithethefatsi li se ke tsa sebetsa.
9. Ka potlako kenya syringe le nale ka hara vial ka sethala sa rabara. Fokotsa sekotoana sa nale tlase 'me ka angle ea 45 ° ea vial, bokella ho emisoa butle. Nako e nyane ea ho emisoa e ka lula fatše le mabota a vial. Masala ana a fanoa, ka hona ha ua lokela ho keka botlolo e shebile holimo ha u sebelisa moriana.
10. Phetoho ea nale e tšetsoeng ka nale e kenngoeng ka boka bo botala (0,8x40 limilimithara), phetisa sekirine ka hloko 'me u tlose moea ho sona.
11. - tšoaea sebaka sa ente ka swab ea joala.
12. Kenya nale e tebileng ka har'a mesifa ea gluteus maximus ebe o hulela piston hanyane ho etsa bonnete ba hore ha ho na ts'enyo sekepeng. Haeba e kenella ka sejelong sa mali, nale e lokela ho fetoloa hore e be bophara bo bong 'me setsi sa ente se lokela ho fetoloa.
13. Kenyelletsa ho emisoa ka ho phehella ts'oarello ea syringe.

Ho emisoa ho tsoang ho lyophilisate ha ho na sebopeho se tšoeu, se tšoeu kapa se soeufetse.

Ka liente tse phetoang khafetsa, mesifa ea gluteus ea letsoho le letšehali e lokela ho fetoloa.

Octreotide Depot ha ea lokela ho tsoakoa ka syringe e le ngoe le meriana e meng.

Setlhare se lula se bolokiloe sehatsetsing, empa ka letsatsi la ente, vial e nang le lyophilisate le ampoule e nang le solvent li lumelloa ho bolokoa ka mocheso oa kamore.

Pheko ea Acromegaly

Bakeng sa bakuli bao tšebeliso ea octreotide e nkang nakoana (bakeng sa ente ea subcutaneous) e fana ka taolo e lekaneng ea matšoao a lefu lena, ho ka etsahala ho qala tsamaiso ea Octreotide-depot ka letsatsi kamora taolo ea ho qetela ea s / c ea octreotide. Phekolo e qala ka tekanyetso ea 20 mg ka mor'a libeke tse 'ne, ho ena le litekanyetso u sebelisa likhoeli tse 3. Nakong e tlang, ngaka e fetola lethal dose ho latela lipontšo tsa bokuli le kalafo ea GR le IGF-1 serumeng ea mali.

Haeba nakong ea likhoeli tse 3 ho sa khonehe ho fihlela karabelo e lekaneng, ka bobeli bongaka le biochemical (haholoholo, haeba boemo ba GR bo sa theohe ka tlase ho 2,5 μg / l), lethal dose le eketseha ho 30 mg ka mor'a libeke tse 'ne.

Haeba kamora likhoeli tse 3 tsa tšebeliso ea kamehla ea lethal dose ea Octreotide-depot 20 mg ho na le phokotso e sa khaotseng ea khatello ea GR serum ea mali e ka tlase ho 1 μg / l, khatello ea IGF-1 e tloaelehileng le matšoao a khutlileng a acomegaly a nyamela, tekanyetso e le 'ngoe e ka fokotsoa ho 10 mg. Phekolo e lokela ho tsoela pele tlas’a tlhokomelo e haufi ea laboratori.

Bakuli ba fumanang litekanyetso tsa moriana tse tsitsitseng ba ka tseba likhakanyo tsa GR le IGF-1 hang ka likhoeli tse ling le tse ling.

Ha ho khethoa ha Octreotide-Depot ho hlokahala e le kalafo ea nako e khuts'oane lipakeng tsa lithuto tsa radiation, hammoho le ho bakuli ba nang le kalafo ea ts'ebetso ea radiation ba sa sebetseng kapa ba sa sebetse hantle, ho khothalletsoa ho etsa teko ea kalafo ka octreotide e sa sebetseng (bakeng sa tsamaiso ea sc) ho e lekola ketso le mamello ea motho ka mong, 'me ke feela ka mor'a moo sebelisa Octreotide Depot ho latela morero o hlalositsoeng ka holimo.

Ho sebelisana le lithethefatsi

Octreotide e fokotsa ho monya ha cyclosporin ho tsoa mala, mme e liehise ho kenngoa ha cimetidine.

Ka tšebeliso e tšoanang ea octreotide le bromocriptine, bioavailability ea morao e eketseha.

Ho na le bopaki ba lingoliloeng tsa hore somatostatin analogues e ka fokotsa ho hlaka ha metabolic ea lintho tse hlahisitsoeng ke li-isoenzymes tsa cytochrome P450, tse ka hlahisoang ke khatello ea GR. Kaha ho ke ke ha khoneha ho khetholla litlamorao tse tšoanang tsa octreotide, lithethefatsi tse entsoeng ka metso ea eyeenzymes ea cytochrome P450 system mme li na le mofuta o moqotetsane oa kalafo (quinidine le terfenadine) li lokela ho laeloa ka hloko.

Mofuta oa kalafo ea lihlahala tsa "endocrine" tsa "gastrointestinal" le "manyeme"

Bakeng sa bakuli bao tšebeliso ea octreotide e nkang nakoana e fana ka taolo e lekaneng ea matšoao a lefu lena, tekanyetso ea pele ea lithethefatsi ke 20 mg ka mor'a libeke tse 'ne. Maemong ana, kamora ho qala ts'ebetso ea Octreotide-depo, ts'ebeliso ea octreotide e hoelelitsoeng e ntse e tsoela pele libeke tse ling tse 2.

Bakeng sa bakuli ba neng ba sa amohela sperm octreotide, kalafo e khothalletsoa ho qala ka mofuta oa litekanyetso tsa moriana bakeng sa tsamaiso ea s / c ka tekanyo ea 0,1 mg makhetlo a 3 ka letsatsi bakeng sa libeke tse peli. Sena sea hlokahala e le ho lekola ts'ebetso ea sona le mamello ea motho ka mong. Ke ka hona feela moo Octreotide Depot e ka sebelisoang joalo ka ha ho hlalositsoe kaholimo.

Haeba kamora likhoeli tse 3 tsa kalafo ho ka ntlafatsoa karolo e itseng feela, Octreotide Depot 30 mg e fuoa libeke tse ling le tse ling tse 4. Maemong moo ho ka bang likhoeli tse 3 tsa kalafo ho ka khoneha ho fihlella taolo e lekaneng ea lipontšo tsa kliniki le matšoao a biological, lethal dose le ka fokotsoa ho 10 mg ka mor'a libeke tse 4.

Khahlano le nalane ea ts'ebeliso ea Octreotide-depot ka matsatsi a itseng (haholo likhoeling tse 2 tse qalang tsa kalafo, ho fihlela ho tsepamisa maikutlo a plasma a ntho e sebetsang), ponaletso ea bongaka ea li-tumellano tsa "endocrine tumor" ea "gastrointestinal" le "pancreas" li ka holisoa. Bakuli ba joalo ba khothalletsoa ho eketsa ts'ebetso ea sperm octreotide ka tekanyetso e boletsoeng pele ho qala ha Octreotide Depot.

Tabeng ea ho pata le ho se sebetse liphoso tse tloaelehileng tsa "neuroendocrine" ea kolon e fetohang, kolone, lefu, sefofu, li-jejunum le sehlomathiso, hammoho le metastases ea tumello ea neuroendocrine ntle le ho tsepamisa maikutlo, "Octreotide-depot" e beoa ka tekanyo ea 30 mg, beke tse ling le tse ling tse nne. Pheko e ntse e tsoela pele ho fihlela hlahala e ka laoloa (ho fihlela matšoao a tsoelo-pele ea eona a hlaha).

Pheko ea mofets'e oa mofets'e o thibelang li-hormone

Tekanyetso ea pele e khothalletsoang ea Octreotide Depot ke 20 mg ka beke tse 'ne le tse ling tse 3 bakeng sa likhoeli tse tharo. Nakong e tlang, ngaka e fetola lethal dose ho latela lipontšo tsa kliniki tsa lefu lena le khatello ea "antigen" ea senya e fumanehang ka serum ea mali.

Haeba ka nako ea likhoeli tse 3 tsa kalafo ho sa khonehe ho fihlela taolo e lekaneng ea matšoao a lefu lena le matšoao a biological (PSA e fokotsehileng), tekanyetso e eketsoa ho 30 mg ka mor'a libeke tse 4.

Octreotide-depot e sebelisoa hammoho le dexamethasone e sebelisitsoeng ka foromo ea methapo ea molomo ho latela moralo o latelang: 4 mg / letsatsi bakeng sa khoeli e le 'ngoe, ebe 2 mg / letsatsi bakeng sa libeke tse 2,' me ka mor'a moo 1 mg / letsatsi.

Ho bakuli ba kileng ba amohela kalafo ea antiandrogen ea lithethefatsi, ho kopantsoe ha Octreotide-Depot + Dexamethasone ho kopantsoe le ts'ebeliso ea analogue ea gonadotropin-ikopolla li-hormone tsa foromo ea depo, e kenang hang ka mor'a libeke tse 'ne.

Khoeli e 'ngoe le e' ngoe, nakong ea phekolo, ho tlameha ho tsepamisa mohopolo oa PSA.