Octreotide Depot 20 m: cov lus qhia rau kev siv

Thoob ntiaj teb lub npe:Lub kaum hli ntuj-depo

Kev Sib Sau thiab daim ntawv ntawm tso tawm

Lyophilisate rau kev npaj ncua kev kawm ntawv rau lub sijhawm ua haujlwm intramuscular ntawm kev ua lub sijhawm ntev ntawm cov xim dawb lossis dawb nrog lub xim daj me ntsis, hauv daim ntawv ntawm hmoov lossis ntxeem tau huab hwm coj mus rau ib ntsiav tshuaj, qhov hnyav thov yog cov xim tsis muaj pob tshab, cov kev npaj ncua yog dawb lossis dawb nrog tsaus muag daj, homogeneous. 1 lub raj mis muaj 10 mg ntawm octreotide. Tshwjxeeb: copolymer ntawm DL-lactic thiab glycolic acids - 270 mg, D-mannitol - 85 mg, carboxymethyl cellulose sodium ntsev - 30 mg, polysorbate-80 - 2 mg.

Cov hnyav mannitol, txhaj 0.8% - 2 ml.

Qhov ntim ntawm lub raj mis ntawm cov iav tsaus nti yog 10 ml. Cov khoom siv nrog 1 ampoule ntawm cov kuab tshuaj, ib rab koob tshuaj pov tseg, 2 d / thiab koob thiab 2 cawv cawv. Ntim rau hauv thawv ntawv thawv.

Lyophilisate rau kev npaj ncua kev kawm ntawv rau lub sijhawm ua haujlwm intramuscular ntawm kev ua lub sijhawm ntev ntawm cov xim dawb lossis dawb nrog lub xim daj me ntsis, hauv daim ntawv ntawm hmoov lossis ntxeem tau huab hwm coj mus rau hauv ib ntsiav tshuaj, qhov hnyav thov yog cov xim tsis muaj pob tshab, cov kev npaj ncua yog dawb los yog dawb nrog tsaus muag daj, homogeneous. 1 lub raj mis muaj 20 mg ntawm octreotide. Tshwjxeeb: copolymer ntawm DL-lactic thiab glycolic acids - 560 mg, D-mannitol - 85 mg, carboxymethyl cellulose sodium ntsev - 30 mg, polysorbate-80 - 2 mg.

Cov hnyav mannitol, txhaj 0.8% - 2 ml.

Qhov ntim ntawm lub raj mis ntawm cov iav tsaus nti yog 10 ml. Cov khoom siv nrog 1 ampoule ntawm cov kuab tshuaj, ib rab koob tshuaj pov tseg, 2 d / thiab koob thiab 2 cawv cawv. Ntim rau hauv thawv ntawv thawv.

Lyophilisate rau kev npaj ncua kev kawm ntawv rau lub sijhawm ua haujlwm intramuscular ntawm kev ua lub sijhawm ntev ntawm cov xim dawb lossis dawb nrog lub xim daj me ntsis, hauv daim ntawv ntawm hmoov lossis ntxeem tau huab hwm coj mus rau hauv ib ntsiav tshuaj, qhov hnyav thov yog cov xim tsis muaj pob tshab, cov kev npaj ncua yog dawb los yog dawb nrog tsaus muag daj, homogeneous. 1 lub raj mis muaj 30 mg ntawm octreotide. Tshwjxeeb: copolymer ntawm DL-lactic thiab glycolic acids - 850 mg, D-mannitol - 85 mg, carboxymethyl cellulose sodium ntsev - 30 mg, polysorbate-80 - 2 mg.

Cov hnyav mannitol, txhaj 0.8% - 2 ml.

Qhov ntim ntawm lub raj mis ntawm cov iav tsaus nti yog 10 ml. Cov khoom siv nrog 1 ampoule ntawm cov kuab tshuaj, ib rab koob tshuaj pov tseg, 2 d / thiab koob thiab 2 cawv cawv. Ntim rau hauv thawv ntawv thawv.

Cov chaw soj ntsuam thiab chaw muag tshuaj

Cov tshuaj pab pawg kho mob

Somatostatin (hluavtaws sib piv)

Pharmacological ua ntawm cov tshuaj Octreotide Depot

Octreotide-depot yog ib daim ntawv qhia tshuaj ntawm octreotide ua haujlwm ntev rau i / m tswj hwm, kom ntseeg tau tias kev saib xyuas kev noj qab haus huv ruaj khov ntawm octreotide hauv cov ntshav rau 4 lub lis piam. Octreotide yog kev kho mob pathogenetic rau cov qog uas nquag qhia somatostatin receptors.

Octreotide yog ib qho hluavtaws octapeptide uas yog qhov txuas ntawm lub ntuj hormone somatostatin thiab muaj cov teebmeem zoo li pharmacological, tab sis ntev dua ntawm kev ua.

Cov tshuaj suppresses pathologically nce zais cia ntawm kev loj hlob hormone (GH), nrog rau peptides thiab serotonin tsim nyob rau hauv gastroenteropancreatic endocrine system.

Hauv cov tib neeg muaj kev noj qab haus huv, octreotide, zoo li somatostatin, txwv tsis pub muaj kev zais GH tshwm sim los ntawm arginine, kev ua haujlwm ntawm lub cev thiab insulin hypoglycemia, muaj kev zais ntawm insulin, glucagon, gastrin thiab lwm yam peptides ntawm lub plab gastroenteropancreatic endocrine, los ntawm kev noj zaub mov, nrog rau kev zais pa, insulin. tshwm sim los ntawm thyroliberin. Qhov kev cuam tshuam ntawm kev zais ntawm kev loj hlob hormone hauv octreotide, hauv kev sib piv rau somatostatin, tau hais tawm rau ntau npaum li cas tshaj ntawm kev zais ntawm cov tshuaj insulin.Kev tswj hwm ntawm octreotide tsis yog nrog cov tshwm sim ntawm hypersecretion ntawm cov tshuaj hormones los ntawm lub tswv yim tsis zoo.

Hauv cov neeg mob uas muaj acromegaly, kev tswj hwm ntawm Octreotide-depot muab nyob rau hauv feem ntau ntawm cov teeb meem pheej tsis tshua muaj kev cia siab ntawm GR thiab qhov ib txwm ua haujlwm ntawm cov tshuaj insulin-zoo li kev loj hlob tau 1 / somatomedin C (IGF-1).

Hauv cov neeg mob feem ntau uas muaj acromegaly, Octreotide Depot txo qhov hnyav ntawm cov tsos mob xws li mob taub hau, tawm hws ntau dhau, mob caj dab, nkees, mob hauv pob txha thiab pob qij txha, mob hlab ntsha hlwb. Nws tau tshaj tawm tias kev kho mob nrog octreotide nyob rau hauv tus neeg mob tus neeg mob pituitary adenomas secreting GR ua rau txo qis qog.

Nrog kev zais cov kabmob endocrine ntawm txoj hnyuv thiab lub plab, kev siv Octreotide Depot muab tshuaj xyuas tas li ntawm cov tsos mob tseem ceeb ntawm cov kabmob no.

Ib qho 30 mg octreotide depot txhua 4 lub lis piam qeeb cov qog loj hlob nyob rau hauv cov neeg mob uas tsis zais thiab tsis zais qhov tshwm sim (metastatic) neuroendocrine qog ntawm cov tawv nqaij, ileum, dig muag, nce mus rau sab hauv plab hnyuv tee, transverse hnyuv taum thiab lub cev muaj cov kabmob loj, lossis metastases ntawm cov qog neuroendocrine. Cov tshuaj muaj zog nce lub sijhawm ntxiv rau qhov muaj mob hauv pawg no ntawm cov neeg mob: cov sij hawm nruab nrab mus rau qhov muaj yog 14.3 lub hlis piv rau 6 lub hlis hauv pawg placebo. Tom qab 6 lub hlis ntawm kev kho mob, kev noj qab haus huv tau pom nyob hauv 66% ntawm cov neeg mob hauv pab pawg Octreotide-depot thiab 37% ntawm cov neeg mob hauv cov placebo pawg. Cov tshuaj muaj txiaj ntsig zoo nyob rau hauv nce lub sijhawm mus rau kev muaj mob, ob qho tib si rau kev zais cia thiab tsis zais-neuroendocrine hlav.

Hauv cov qog carcinoid, kev siv octreotide tuaj yeem ua rau txo qis qhov mob hnyav ntawm cov tsos mob ntawm tus kabmob, feem ntau, xws li "kub cev" thiab raws plab. Feem ntau, kev txhim kho hauv tsev kho mob yog nrog poob qis hauv plasma serotonin concentration thiab tsis pom kev ntawm 5-hydroxyindoleacetic acid hauv cov zis.

Hauv cov qog ua cim los ntawm hyperproduction ntawm vasoactive plab hnyuv peptide (VIPoma), kev siv octreotide nyob rau hauv cov neeg mob feem ntau ua rau txo qis hauv cov neeg mob plab zom mov tsis txaus, uas yog cov yam ntxwv ntawm tus mob no, uas, nyeg, coj mus rau kev txhim kho hauv tus neeg mob lub neej zoo. Nyob rau tib lub sijhawm, muaj qhov txo qis uas cuam tshuam kev tsis txaus ntseeg nyob hauv lub ntsuas hluav taws xob, piv txwv li, hypokalemia, uas tso cai rau koj tshem tawm txoj kev nkag ua haujlwm thiab kev tswj hwm ntawm cov kua thiab electrolytes. Raws li xam tomography tom qab, hauv qee cov neeg mob muaj qeeb los yog nres qhov mob ntawm cov qog, thiab txawm tias nws txo qis nws qhov loj me, tshwj xeeb tshaj yog daim siab metastases. Cov kev txhim kho hauv tsev kho mob feem ntau yog nrog ib qho kev txo qis (nce mus rau qhov tseem ceeb) hauv kev saib xyuas ntawm vasoactive plab hnyuv peptide (VIP) hauv ntshav.

Nrog glucagonomas, kev siv octreotide feem ntau ua rau muaj kev ceeb toom txo qis ntawm pob qog ntshav necrotizing, uas yog cov yam ntxwv ntawm tus mob no. Octreotide tsis muaj qhov cuam tshuam loj rau qhov mob ntshav qab zib mellitus, feem ntau pom nrog glucagonomas, thiab feem ntau tsis txo qis qhov xav tau tshuaj insulin lossis tshuaj qhov ncauj hypoglycemic. Hauv cov neeg mob mob raws plab, octreotide ua rau nws txo qis, uas nrog los ntawm kev nce hauv lub cev. Nrog rau kev siv octreotide, kev txo qis sai sai hauv kev suav ntawm glucagon hauv cov ntshav feem ntau tau sau tseg, txawm li cas los xij, nrog kev kho mob ntev, cov nyhuv no tsis mob siab. Nyob rau tib lub sijhawm, txhim kho cov tsos mob tseem ruaj khov nyob rau ntev.

Hauv kev mob plab gastrinomas / Zollinger-Ellison syndrome, octreotide, siv los ua monotherapy lossis ua ke nrog histamine H 2 receptor blockers thiab proton twj tso kua mis inhibitors, tuaj yeem txo qhov tsim ntawm hydrochloric acid hauv plab thiab ua rau muaj kev txhim kho kho mob, suav nrogthiab hauv kev cuam tshuam rau raws plab. Nws tseem ua tau kom txo tau qhov mob hnyav thiab lwm cov tsos mob, tej zaum cuam tshuam nrog kev sib txuas ntawm peptides los ntawm cov qog, suav nrog dej ntas. Hauv qee kis, muaj kev txo qis hauv cov concentration ntawm gastrin hauv cov ntshav.

Hauv cov neeg mob insulinomas, octreotide txo qis kev tsim kho ntawm cov tshuaj insulin tiv thaiv kab mob hauv cov ntshav. Hauv cov neeg mob qog ua lub qog ua haujlwm, octreotide tuaj yeem ua kom muaj kev kho dua tshiab thiab kev kho mob ntawm normoglycemia hauv lub sijhawm preoperative. Hauv cov neeg mob uas tsis tuaj yeem mob qog thiab mob qog, glycemic tswj tau zoo tuaj yeem tsis muaj lub sijhawm ua ke txo qis hauv cov tshuaj insulin nyob rau hauv cov ntshav.

Hauv cov neeg mob uas muaj cov qog ua haujlwm tsis tshua muaj mob, hyperpro tsim kev loj hlob hormone tso qhov tshwm sim (somatoliberinomas), octreotide txo qhov mob hnyav ntawm acromegaly cov tsos mob. Qhov no, thaj, cuam tshuam nrog kev tsuj ntawm kev zais ntawm kev loj hlob hormone tso tawm yam thiab GH. Nyob rau hauv lub neej yav tom ntej, nws muaj peev xwm txo qhov me me ntawm lub caj pas pituitary, uas tau nce ua ntej kho.

Hauv cov neeg mob uas muaj kev tiv thaiv qog nqaij hlav prostate (HGRP), pas dej ntawm neuroendocrine hlwb qhia txog somatostatin receptors affinity rau octreotide (SS2 thiab SS5 yam) nce, uas txiav txim siab qhov rhiab ntawm qog mus octreotide. Kev siv Octreotide-Depot nyob rau hauv kev sib xyaw nrog dexamethasone tiv thaiv keeb kwm ntawm androgen blockade (tshuaj los yog phais mob) hauv cov neeg mob HGRP rov qab kho qhov mob rau kev kho hormone thiab ua rau muaj kev txo qis prostate tshwj xeeb antigen (PSA) hauv ntau dua 50% ntawm cov neeg mob.

Hauv cov neeg mob HGRG nrog cov pob txha metastases, qhov kev kho mob no nrog nws cov lus tshaj tawm thiab ua kom ntev ntev ua kom loog. Ntxiv mus, hauv txhua tus neeg mob uas tau teb ua ke nrog kev kho mob nrog Octreotide Depot, lub neej muaj txiaj ntsig zoo dua qub thiab tsis muaj sia nyob rov qab los ua kom zoo dua qub.

Cov Tshuaj Pharmacokinetics

Cov ntaub ntawv ntawm cov khw muag tshuaj ntawm cov tshuaj Octreotide-depot tsis muab.

Acromegaly (qhov tsis muaj txiaj ntsig los ntawm kev kho mob phais, kev kho hluav taws xob thiab kev kho mob nrog dopamine agonists, cov neeg mob tsis tuaj yeem, nrog rau cov neeg mob uas tsis kam kho mob phais), kev kho mob ntawm cov tsos mob qog ntawm gastroentero-pancreatic endocrine system (cov qog nqaij hlav uas muaj cov hlav carcinoid syndrome, qog, tsiag ntawv los ntawm hyperproduction ntawm vasoactive plab hnyuv peptide - VIPs, glucagon, gastrinomas / Zollinger-Ellison syndrome), insulinomas, qog cov cim los ntawm somatoliberin ntau lawm - somatoliberinomas, refractory raws plab hauv cov neeg mob AIDS. Kev tiv thaiv ntawm cov kev mob tshwm sim tom qab kev phais mob phais, txiav ntshav thiab tiv thaiv kom rov qab los ntawm cov leeg txoj hlab ntshav nrog txoj hlab ntsws (ua ke nrog endoscopic sclerotherapy).

Cov Yuav Tsum Muaj cov tshuaj

Hypersensitivity rau octreotide lossis lwm yam tshuaj ntawm cov tshuaj.

Nrog hais txogsaib xyuas cov tshuaj yuav tsum tau tsim tawm rau cholelithiasis, ntshav qab zib mellitus, thaum cev xeeb tub thiab thaum lactation.

Dosage regimen thiab cov qauv ntawm daim ntawv thov Octreotide Kev Lag Luam

Cov tshuaj Octreotide-Depot yuav tsum tau muab rau nkaus xwb intramuscularly (IM), hauv cov nqaij gluteus. Nrog kev hno tas, sab laug thiab sab xis yuav tsum sib hloov. Kev ncua yuav tsum tau npaj kom txhij ua ntej kev txhaj tshuaj. Txog hnub ntawm kev txhaj tshuaj, lub vial nrog siv tshuaj yaj yeeb thiab ampoule nrog cov kuab tshuaj tuaj yeem khaws cia rau hauv chav tsev kub.

Hauv kev kho mob ntawm acromegaly nyob rau hauv cov neeg mob rau tus neeg s / c tswj hwm ntawm octreotide muab kev tswj hwm kom tsim nyog ntawm cov tsos mob tshwm simQhov pom zoo kom pib noj ntawm Octreotide Depot yog 20 mg txhua 4 lub lis piam rau 3 hlis. Koj tuaj yeem pib kho nrog Octreotide-Depot hnub tom qab hnub kawg s / c tswj hwm ntawm octreotide.Nyob rau hauv lub neej yav tom ntej, cov koob tshuaj yog kho kom haum rau hauv kev suav tshuaj nyob rau hauv cov ntshav dej ntawm GR thiab IGF-1, nrog rau cov tsos mob hauv chaw kho mob. Yog tias tom qab 3 lub hlis ntawm kev kho mob nws tsis tuaj yeem ua tiav kev soj ntsuam thiab cov tshuaj biochemical siv tau (tshwj xeeb, yog tias qhov concentration ntawm GR tseem nyob siab dua 2.5 μg / L), qhov koob tshuaj yuav raug nce ntxiv rau 30 mg tswj hwm txhua 4 lub lis piam.

Hauv cov xwm txheej ntawd thaum tom qab 3 lub hlis ntawm kev kho mob nrog Octreotide-Depot ntawm koob tshuaj 20 mg, qhov txo qis
ntshiab GH concentration hauv qab 1 μg / l, ib txwm ua haujlwm ntawm lub siab ntawm IGF-1 thiab ploj ntawm qhov tshwm sim uas thim rov qab ntawm acromegaly, koj tuaj yeem txo qhov tshuaj ntawm cov tshuaj Octreotide-depot rau 10 mg. Txawm li cas los xij, hauv cov neeg mob no tau txais me me ntawm Octreotide Depot, qhov kev daws teeb meem ntawm GR thiab IGF-1, nrog rau cov tsos mob ntawm tus kab mob, yuav tsum tau ua tib zoo saib xyuas.

Cov neeg mob uas tau txais koob tshuaj zoo ntawm Octreotide-depot yuav tsum tau kuaj txhua 6 lub hlis rau cov tshuaj GH thiab IGF-1 ntau.

Cov neeg mob rau leej twg kev phais mob thiab kev kho hluav taws xob tsis ua hauj lwm zoo txaus lossis txawm tias tsis muaj txiaj ntsig, nrog rau cov neeg mob uas xav tau kev kho mob luv nruab nrab ntawm cov chav kawm ntawm kev kho mob hluav taws xob kom txog rau kev txhim kho nws cov txiaj ntsig tag nrho, nws raug nquahu kom ua qhov kev sim ntawm kev kho mob s / c txhaj tshuaj octreotide txhawm rau kom ntsuas nws kev ua tau zoo thiab kev nkag siab dav dav, thiab tsuas yog tom qab ntawd hloov mus rau kev siv tshuaj Octreotide-depot raws li cov txheej txheem saum toj no.

Ntawm kho kev mob ntawm cov qog endocrine ntawm txoj hnyuv thiab lub thiav hauv cov neeg mob rau leej twg s / c tswj hwm ntawm octreotide muab kev tswj hwm tus cwj pwm kom tsim nyog, qhov kev pom zoo thawj zaug ntawm cov tshuaj Octreotide-Depot yog 20 mg txhua 4 lub lis piam. Kev tswj hwm sc ntawm octreotide yuav tsum txuas txuas ntxiv rau 2 lub lis piam tom qab thawj zaug kev coj ntawm cov tshuaj Octreotide-Depot.

Hauv cov neeg mob uas tsis tau dhau los cov phev octreotide, nws raug nquahu tias yuav tsum tau kho nrog s.c. coj ntawm octreotide ntawm kev txhaj tshuaj ntawm 0.1 mg 3 zaug / hnub rau lub sijhawm luv (kwv yees li 2 lub lis piam) txhawm rau txhawm rau ntsuas nws qhov ua tau zoo thiab kev zam rau lub siab. Tsuas yog tom qab no, cov tshuaj Octreotide-depot yog tshuaj raws li cov qauv saum toj no.

Nyob rau hauv rooj plaub thaum kev kho mob nrog Octreotide-Depot rau 3 lub hlis muab kev tswj txaus ntawm kev kuaj mob thiab cov cim roj ntsha ntawm tus kab mob, nws muaj peev xwm txo qhov koob tshuaj Octreotide-Depot rau 10 mg,
taw txhua 4 lis piam. Hauv qhov xwm txheej uas tom qab 3 lub hlis ntawm kev kho mob nrog Octreotide-Depot, tsuas yog ua tiav kev txhim kho ib feem, qhov koob tshuaj tuaj yeem nce ntxiv rau 30 mg txhua 4 lub lis piam. Tawm tsam keeb kwm ntawm kev kho mob nrog Octreotide-Depot, nyob rau qee hnub nws muaj peev xwm nce cov kev soj ntsuam kev ua haujlwm tus yam ntxwv ntawm endocrine qog ntawm lub plab hnyuv plab thiab cov txiav. Hauv cov rooj plaub no, kev pom zoo ntxiv s / c tswj hwm ntawm octreotide hauv kev siv tshuaj ua ntej pib kho nrog Octreotide Depot raug pom zoo. Qhov no tuaj yeem tshwm sim hauv thawj 2 lub hlis ntawm kev kho mob, kom txog thaum kho tshuaj ntau ntawm octreotide hauv ntshav tau tiav.

Kev zais thiab tsis sib luag nrog cov mob (metastatic) neuroendocrine hlav ntawm daim tawv nqaij, tawv, dig muag, nce mus rau sab hauv, mob hnyuv tws thiab vermiform ntxiv, lossis metastasis ntawm neuroendocrine hlav tsis muaj qhov mob ua ntej: Qhov pom zoo koob tshuaj ntawm Octreotide Depot yog 30 mg txhua 4 lis piam. Txoj kev kho kom noj ntshav-Octototide yuav tsum ua txuas mus kom txog rau thaum cov cim mob qog.

Ntawm kho kev kho tus mob prostate-resistant prostate Qhov pom zoo kom pib noj ntawm Octreotide Depot yog 20 mg txhua 4 lub lis piam rau 3 hlis. Tom qab, cov koob tshuaj yog kho kom noj mus rau hauv tus account lub zog ntawm cov PSA concentration, nrog rau cov tsos mob hauv chaw kuaj mob. Yog tias tom qab 3 lub hlis ntawm kev kho mob nws ua tsis tiav
tsim nyog kho mob thiab tshuaj biochemical nyhuv (txo PSA), cov koob tshuaj yuav tau nce mus rau 30 mg tswj hwm txhua 4 lis piam.

Kev kho nrog Octreotide Depot yog muab xyaw nrog dexamethasone, uas yog tshuaj noj raws li cov txheej txheem hauv qab no: 4 mg ib hnub rau 1 hlis, tom qab ntawd 2 mg ib hnub rau 2 lub lis piam, tom qab ntawd 1 mg rau ib hnub (koob tshuaj txij nkawm).

Kev kho tus mob Octreotide-depot thiab dexamethasone ntawm cov neeg mob uas tau ua dhau los siv tshuaj kho mob antiandrogen yog ua ke nrog kev siv tshuaj tiv thaiv kab mob gonadotropin-tso cov tshuaj hormones (GnRH). Hauv qhov no, kev txhaj tshuaj ntawm GnRH analogue (daim ntawv fotot) yog nqa tawm 1 zaug hauv 4 lub lis piam.

Cov neeg mob uas tau txais Octreotide Depot yuav tsum kuaj txhua lub hli rau PSA ntau.

Ntawm cov neeg mob uas lub raum tsis zoo, cov kab mob siab, thiab cov neeg laus laus tsis tas yuav kho qhov tshuaj ntau npaum li cas ntawm cov tshuaj Octreotide-depot.

Rau prophylaxis ntawm kev mob caj dab tom qab zoo li tus mob pancreatitis cov tshuaj Octreotide-Depot nyob hauv ib koob tshuaj 10 lossis 20 mg yog muab ib zaug tsis dhau 5 hnub thiab tsis pub dhau 10 hnub ua ntej npaj siab yuav phais.

Cov kev cai npaj rau kev npaj ntawm kev ncua thiab kev tswj hwm ntawm cov tshuaj

Cov tshuaj siv tau tsuas yog hauv roj. Ib qho kev ncua rau kev txhaj tshuaj intramuscular yog npaj los siv cov tshuaj tov sai tam sim ua ntej tswjhwm. Cov tshuaj yuav tsum tau npaj thiab tswj hwm cov kws kho mob tshwj xeeb tau kawm xwb.

Ua ntej txhaj, ampoule nrog cov kuab tshuaj thiab lub raj mis nrog cov tshuaj yuav tsum tau muab tshem tawm hauv lub tub yees thiab nqa mus rau chav kub (30-50 feeb yog tsim nyog). Khaws lub raj mis nrog cov tshuaj Octreotide-Depot nruj me ntsis ncaj. Tapping lub vial maj mam, xyuas kom meej tias tag nrho cov lyophilisate yog nyob hauv qab ntawm lub vial.

Qhib cov pob ntim tshuaj thiab txuas 1.2 mm x 50 mm rab koob rau koob txhaj tshuaj kom sau cov kuab tshuaj. Qhib cov ampoule nrog cov kuab tshuaj thiab muab tso rau hauv cov phwj txhua cov ntsiab lus ntawm ampoule nrog cov kuab tshuaj, teeb koob txhaj tshuaj rau ib koob ntawm 2.0 ml. Tshem lub hau yas ntawm lub vial uas muaj cov tshuaj lyophilisate. Tshem tawm cov roj hmab nres ntawm lub thauv nrog cawv ib cawv cawv. Muab rab koob tso rau hauv lub lyophilisate vial los ntawm qhov chaw ntawm cov roj hmab nres thiab ua tib zoo muab cov kuab tshuaj mus rau sab hauv lub vial yam tsis kov cov ntsiab lus ntawm lub thauv nrog rab koob.

Tshem tawm cov khoom hauv qab txig. Lub vial yuav tsum nyob twj ywm tsis hloov mus txog thaum cov kuab tshuaj kom tag nrog cov tshuaj lyophilisate thiab cov ntawv ncua (rau li 3-5 feeb). Tom qab ntawd, tsis tas tig lub raj mis dua, koj yuav tsum kuaj seb puas muaj cov lyophilisate qhuav ntawm phab ntsa thiab hauv qab ntawm lub raj mis. Yog tias cov nplauv qhuav ntawm lub lyophilisate raug kuaj pom, tawm hauv lub vial kom txog thaum ua tiav.

Tom qab koj ntseeg tau tias qhov tsis muaj lyophilisate qhuav cov seem, cov ntsiab lus ntawm lub vial yuav tsum ua tib zoo sib xyaw rau hauv cov ntawv tsaig kom ntev li 30-60 vib nas this kom txog thaum muaj kev txwv tsis pub tsim homogeneous. Tsis txhob flip lossis co lub vial, vim tias qhov no yuav ua rau ploj ntawm flakes thiab raug tshem tawm tsis zoo.

Caw nrawm qhov koob los ntawm cov roj hmab nres rau hauv lub vial. Tom qab ntawd lub koob txhaj tshuaj tau raug txo qis thiab, los ntawm tilting lub vial ntawm ib kaum ntawm 45 degrees, maj mam kos cov kev ncua ntawv mus rau hauv cov koob txhaj tshuaj kom tiav. Tsis txhob ntxeev lub raj mis thaum ntaus ntawv. Ib qho me me ntawm cov tshuaj yuav nyob rau ntawm cov phab ntsa thiab hauv qab ntawm lub vial. Kev noj rau cov khoom seem ntawm phab ntsa thiab hauv qab ntawm lub raj mis yog coj mus rau hauv tus account.

Tam sim tom qab sau cov kev ncua, hloov rab koob nrog cov kab xaum liab nrog rab koob nrog lub kab ntsuab (0.8 x 40 mm), ua tib zoo muab lub taub hau thiab tshem cov pa ntawm lub koob txhaj tshuaj.

Ib qho kev ncua ntawm cov tshuaj Octreotide-Depot yuav tsum tau muab tswj tam sim ntawd tom qab npaj. Ib qho kev ncua ntawm cov tshuaj Octreotide-Depot yuav tsum tsis txhob muab nrog lwm cov tshuaj nyob hauv ib qho koob txhaj.

Siv cov cawv cawv tshuaj ntxuav mus rau qhov chaw txhaj tshuaj. Ntxig lub koob txhaj rau hauv cov gluteus maximus leeg, tom qab ntawd rub tawm cov koob txhaj plunger rov qab kom paub tseeb tias tsis muaj kev puas tsuaj rau lub nkoj.Qhia cov kev ncua ntxiv intramuscularly maj mam nrog lub siab tsis tu ncua ntawm cov koob txhaj tshuaj nqus dej.

Yog tias nws nkag rau hauv cov ntshav, qhov chaw txhaj tshuaj thiab rab koob yuav tsum hloov. Thaum txhaws lub koob, hloov nws nrog lwm rab koob ntawm tib lub taub.

Nrog kev hno tas, sab laug thiab sab xis yuav tsum sib hloov.

Sab sij huam

Cov tshuaj tiv thaiv hauv zos: nrog rau i / m tswj hwm ntawm Octreotide-depot, mob yog ua tau, tsis tshua hnov ​​mob thiab tawm pob rau ntawm thaj chaw txhaj tshuaj (feem ntau me me, luv luv nyob).

Los ntawm cov hnyuv: tsis nco qab, ntuav, ntuav, mob plab heev, tsam plab, ua kom pa roj ntau dhau, tso quav ua xua, raws plab, tso quav. Txawm hais tias kev tshem tawm cov rog nrog quav yuav nce ntxiv, kom txog hnub tim tsis muaj ib qho pov thawj pom tias kev kho mob ntev nrog octreotide tuaj yeem ua rau kev txhim kho ntawm lub cev tsis muaj qee yam ntawm cov khoom noj vim tias malabsorption (malabsorption). Qee qhov tsis tshua muaj tshwm sim, qhov tshwm sim uas zoo li lub plab hnyuv tsis tuaj yeem muaj tshwm sim: tsam plab, mob hnyav hauv thaj av epigastric, ua kom nruj ntawm lub plab phab ntsa. Lub caij nyoog siv Octreotide Depot tuaj yeem ua rau tsim cov mob gallstones.

Los ntawm cov txiav: Cov neeg uas tsis tshua pom muaj mob leeg hlwb uas tshwm sim nyob rau thawj teev lossis hnub uas tau siv cov tshuaj hu ua octreotide. Nrog rau kev siv ntev, muaj mob qog nqaij hlav nrog mob cholelithiasis.

Ntawm daim siab: Muaj cov ntawv tshaj tawm txawv txav ntawm kev txhim kho daim siab ua rau mob siab (mob siab tsis muaj cholestasis nrog kev hloov pauv tsis tu ncua tom qab tshem tawm octreotide), qhov kev txhim kho qeeb ntawm hyperbilirubinemia, nrog rau kev nce siab hauv ALP, GGT thiab, kom tsawg dua, lwm yam kev hloov pauv.

Los ntawm sab ntawm cov metabolism: Txij thaum Octreotide Depot muaj qhov txiaj ntsig dhau ntawm kev tsim GH, glucagon thiab insulin, nws tuaj yeem cuam tshuam cov metabolism hauv cov piam thaj. Muaj peev xwm txo qis qab zib ntxiv tom qab noj mov. Nrog kev siv lub sijhawm ntev ntawm Octreotide sc rau qee kis, mob siab ntsws hyperglycemia tuaj yeem tsim kho. Kuj tau pom hais tias Hypoglycemia.

Lwm yam: hauv qee qhov xwm txheej, kev ploj plaub hau ib ntus tom qab tswj hwm ntawm octreotide, qhov tshwm sim ntawm bradycardia, tachycardia, ua pa luv, ua pob ntawm daim tawv nqaij, anaphylaxis tau tshaj tawm. Muaj cov ntawv qhia txawv ntawm kev txhim kho cov tshuaj tiv thaiv hypersensitivity.

Cev xeeb tub thiab lactation

Tsis muaj kev paub dhau los ntawm Octreotide Depot thaum cev xeeb tub thiab thaum pub mis.

Yog li, thaum cev xeeb tub, cov tshuaj yuav tsum raug tsim tshwj yog tias muaj txiaj ntsig zoo rau leej niam ntau dua qhov muaj feem ua rau muaj menyuam hauv plab.

Kev pub mis niam tsis pom zoo thaum siv cov tshuaj thaum lactation.

Daim ntawv thov rau lub siab ua haujlwm tsis zoo Cov neeg mob uas lub siab tsis ua hauj lwm zoo tsis tas yuav tsum kho cov tshuaj noj kom zoo ntawm Octreotide-Depot.

Siv rau cov neeg mob laus

Hauv cov neeg mob laus, tsis tas yuav kho qhov tshuaj ntau npaum li cas ntawm Octreotide Depot.

Cov lus qhia tshwj xeeb rau kev txais neeg kawm Octreotide Kev Lag Luam

Nrog cov qog pituitary, kev ua tib zoo saib xyuas ntawm cov neeg mob yog qhov tsim nyog vim tias qhov tshwm sim tuaj yeem loj dua ntawm cov qog nrog kev txhim kho ntawm txoj kev nqaim ntawm qhov muag pom. Hauv cov rooj plaub no, qhov yuav tsum tau siv lwm txoj hauv kev kho yuav tsum raug txiav txim siab. Hauv kev kho tus mob gastroentero-pancreatic endocrine hlav hauv qee yam mob tsawg, cia li rov huam mob sai sai. Hauv cov neeg mob insulinomas thaum kho, qhov nce ntawm qhov mob hnyav thiab lub sij hawm ntawm hypoglycemia yuav raug sau tseg. Qhov hnyav ntawm cov kev mob tshwm sim los ntawm txoj hnyuv txo qis nrog kev qhia ntawm cov tshuaj nyob nruab nrab ntawm cov zaub mov noj lossis thaum mus pw.Nrog rau kev kho mob ntev (acromegaly), ua ntej thiab thaum kho (txhua txhua 6-12 lub hlis) - ultrasound ntawm lub kem plab.

Cov pob zeb nyob hauv lub qog, yog tias txawm li cas los xij lawv tshawb pom, feem ntau yog asymptomatic. Thaum muaj cov tsos mob hauv chaw kuaj mob, kev txuag kho lossis phais kho yog qhia. Zam ntau yam kev txhaj tshuaj ntawm tib qhov chaw nyob ntawm cov sijhawm luv. Ua ntej tswjhwm, muab kev daws rau hauv chav sov. Siv thaum cev xeeb tub thiab lactation nkaus xwb los ntawm kev qhia kiag li. Kev txau hauv cov ntshav qab zib yuav txo tau los ntawm kev tswj hwm ntau dua ntawm cov koob tshuaj qis dua. Thaum kho, kev saib xyuas cov ntshav qabzib hauv nruab siab yog qhov tsim nyog, tshwj xeeb tshaj yog nyob rau cov neeg mob los ntshav tawm ntawm txoj hlab ntshav ntawm txoj hlab pas nrog mob ntsws rau daim siab - kev pheej hmoo ntawm kev loj hlob hyperglycemia.

Noj ntau dhau

Tam sim no, cov teeb meem kev noj tshuaj ntau tshaj ntawm Octreotide-Depot tsis tau tshaj tawm.

Kev sib cuam tshuam nrog Lwm Yam Tshuaj

Octreotide txo qis cyclosporin nqus los ntawm cov hnyuv thiab ua rau qeeb ntawm kev nqus ntawm cimetidine.

Nrog rau kev siv txaws ib txhij octreotide thiab bromocriptine, lub bioavailability ntawm cov yav tas nce.

Muaj cov ntawv sau ua pov thawj tias somatostatin analogues tuaj yeem txo qhov kev zom zaub mov kom tsis txhob muaj cov tshuaj metabolized los ntawm isoenzymes ntawm cytochrome P450, uas tuaj yeem tshwm sim los ntawm kev siv GR. Txij li nws tsis tuaj yeem tshem tawm cov kev cuam tshuam zoo sib xws ntawm octreotide, cov tshuaj uas metabolized los ntawm isoenzymes ntawm cytochrome P450 system thiab muaj qhov nqaim kho ntau yam (quinidine thiab terfenadine) yuav tsum tau kho nrog kev ceev faj.

Cov Cai Siv Tshuaj So

Cov tshuaj yog ntawv yuav tshuaj.

Cov lus thiab cov xwm txheej ntawm kev cia

Cov tshuaj yuav tsum tau muab cia rau hauv qhov chaw qhuav, tsaus, ntawm qhov chaw ncav cuag ntawm cov menyuam yaus ntawm qhov kub ntawm 2 ° txog 8 ° C. Txee lub neej yog 3 xyoos.

Kev siv tshuaj yaj yeeb Oktreotid-depot tsuas yog raws li kws kho mob tau hais tseg, cov lus qhia tau muab rau siv!

Daim ntawv tso tawm

Cov tshuaj muaj nyob rau hauv daim ntawv ntawm kev daws rau kev txhaj tshuaj, tso rau hauv 1 ml ampoules lossis 5 ml vials.

Octreotide Kev Lag Luam thiab Octreotide Ntev muaj nyob rau hauv daim ntawv ntawm lyophilized hmoov los yog kev cog lus thiab loj thiab zawv zawg hauv daim ntawv ntawm lub teeb xim ntsiav tshuaj ntawm ntau yam tshuaj. Tsis tas li ntawd, qhov xim tsis muaj pob tshab xim ua kom pom kev zoo nkauj thiab rov ua dua kev ncua, uas yog homogeneous kev ncua ntawm lub teeb ntxoov ntxoo, tau txuas.

Tsis tas li, cov kev hloov pauv tshuaj muaj peev xwm muab tau nyob rau hauv daim ntawv ntawm lyophilisate rau kev npaj qhov kev ncua uas tau npaj rau kev tswj hwm intramuscular nrog kev ua lub sijhawm ntev ntawm 0.01-0.03 g ntawm cov kev ua kom nquag plias hauv tsaus iav vials. Ntxiv rau, lub pob ntawv muaj 2 ml ntawm ampoule nrog cov kuab tshuaj, pov tseg uas siv tshuaj, rab koob tshuaj tiv thaiv kab mob thiab lub khob dej cawv. Ib pawg yog rau ib qho kev txhaj tshuaj.

Pharmacodynamics thiab pharmacokinetics

Cov tshuaj no yog hluavtaws analogue. somatostatinmuaj cov teebmeem zoo li pharmacological, tab sis ntev lub sijhawm.

Kev kho tus mob Octreotide yog ua thaum nws tsim nyog los tswj kev zais cia ntawm kev loj hlob hormone, nce pathologically lossis tshwm sim los ntawm arginine, tshuaj insulin hypoglycemia lossis kev tawm dag zog. Qhov tshwm sim yog tuaj me me tso pa tawm ntawm insulin, gastrin, glucagon thiab tshuaj serotonin, uas tseem tuaj yeem raug nce pathologically lossis tshwm sim los ntawm cov zaub mov noj. Sau cia kev zais cia sau tseg tshuaj insulinthiab glucagonuas stimulatesargininetsawg tso pa tawm thyrotropintshwm sim los ntawm thyroliberin.

Siv cov tshuaj ua ntej lossis thaum txiav txim siab rau txiav phais tuaj yeem txo qhov tshwm sim ntawm cov xeeb ceem tom qab muaj teeb meem, piv txwv:pancreatic fistula, sepsis, mob qog ntshav, mob hnoos qeev tom qab zoo.

Kev kho mob los ntshav tawm ntawm txoj hlab ntshav sib txawv ntawm lub plab zom mov hauv cov neeg mob uas muaj mob rau daim siab ua ke nrog kev kho mob tshwj xeeb - sclerosing thiab hemostatic, pab kom tsis txhob los ntshav thiab tiv thaiv kom tsis txhob rov los ntshav.

Sab hauv lub cev muaj kev nrawm nrawm thiab ua kom tiav ntawm kev nquag. Hauv qhov no, qhov siab tshaj plaws ntawm Octreotide hauv cov ntshav plasma tau mus txog tom qab 30 feeb. Kev tivthaiv khi ua rau cov ntshav plasma ntau npaum li 65%, tabsis nws cov kev txuas nrog lub cev tsim ntawm cov ntshav tsis tseem ceeb. Kev tshem tawm ntawm cov tshuaj tshwm sim hauv ntau theem los ntawm txoj hnyuv thiab nrog kev pab ntawm lub raum.

Kev ntsuas rau siv

Cov tshuaj Octreotide-raws li raug xaj tau rau:

• acromegalyyog hais tias tsis muaj nuj nqis haisdopamine agonistsnrog rau yog tias nws tsis tuaj yeem ua rau kev phais mob lossis hluav taws xob kho,
• endocrine hlav lub plab zom mov plab kaw,
• glucagonomas, gastrinomas,
• insulomas, somatoliberinomas,
• refractory zawv plab hauv cov neeg mob AIDS
• txiav phais, nrog rau kev tiv thaiv ntawm cov teeb meem,
• los ntshav, kev tiv thaiv ntawm kev rov huam mob tuaj yeem mob hlab ntsha ua rau txoj hlab pas mob nrog rau cov hlab ntsws thiab lwm yam.

Cov Yuav Tsum Muaj

Lub ntsiab contraindication rau kev siv cov tshuaj no yog kev tiv thaiv tsis haum.

Kev ceev faj yuav tsum muaj thaum kho cov neeg mob. mob cholelithiasis,mob ntshav qab zib,ntawm kev pub mis thiab cev xeeb tub.

Sab sij huam

Thaum kho nrog Octreotide, kev tsis nyiam nyob hauv kev ua haujlwm ntawm lub plab zom mov tuaj yeem tshwm sim hauv daim ntawv: ntuav, xeev siab, kev tsis nco qabkev mob flatulence, raws plab,nrogtheorrhea, mob hnyuv txuas, mob siab rau tsis muaj cholestasis, nce kev ua haujlwm ntawm hepatic transaminases, hyperbilirubinemia, mob leeg mob hauv pob txha ua paug thiab lwm tus.

Tej zaum tseem yuav tsimalopecia thiab kev fab tshuaj tsis haumCov. Kev nthuav qhia hauv cheeb tsam tsis raug cais: mob, khaus, kub, liab lossis o tuajCov. Kev siv ntev ntev tau siv nrog ntau dua los ntawm kev tsim cov kab mob gallstones, txo cov ntshav qabzib tsawg, thiab ua lub cev ntev hyperglycemia, ntshav qab zib.

Octreotide, cov lus qhia rau kev siv (Txoj kev thiab qhov ntau npaum li cas)

Cov tshuaj Octreotide yog tsim rau leeg plab, intramuscular lossis subcutaneous cov thawj cojCov. Cov koob tshuaj yog teem ib lub zuj zus, noj mus rau hauv qhov xwm txheej ntawm tus kab mob thiab cov yam ntxwv ntawm tus neeg mob. Piv txwv, acromegaly thiab qog hlav ntawm lub plab zom mov system tau subcutaneous cov tswj hwm txhua hnub 1-2 zaug ntawm 50-100 mcg. Nqa cov kev tiv thaiv kev tiv thaiv kev mob uas tshwm sim los ntawm kev khiav haujlwm ntawm tus neeg mob taub hau txuam nrog subcutaneous thawj tswj ntawm thawj koob ib teev ua ntej laparotomy, tom qab ntawd nws raug tswj hwm txhua hnub 3 zaug 100 μg hauv ib lub lis piam. Thaum nws raug samfwm kom tsis txhob los ntshav los ntawm cov hlab ntsws ua haujlwm ntawm txoj hnyuv, qhov tso ntshav mus txuas ntxiv ntawm 25 μg / h yog siv rau tsawg kawg 5 hnub.

Cov lus qhia rau kev siv Octreotide Kev Lag Luam thiab Octreotide Ntev FS qhia tias lawv npaj siab rau sib sib zog nqus intramuscular txhaj rau hauv cov nqaij gluteal. Thaum cov tshuaj subcutaneous ntawm Octreotide tso cai rau cov neeg mob tswj kev txaus tus kabmob, thawj zaug ntawm Depo thiab Ntev yog ntawm 20 mg txhua 4 lub lis piam rau 3 lub hlis. Tom qab ntawd cov koob tshuaj tau hloov kho nyob ntawm cov cim ntsuas roj ntsha ntawm cov kab mob thiab cov tsos mob hauv tsev kho mob.

Yog tias yav dhau los cov neeg mob tsis tau txais Octreotide subcutaneously, ces txoj kev kho nrog tus neeg sawv cev no thiab cov qauv yuav tsum pib rau 2 lub lis piam. Txoj hauv kev no yuav ntsuas nws cov hauj lwm zoo thiab kev ua siab ntev, tom qab uas koj tuaj yeem ua cov kev kho mob nrog Octreotide-Depot lossis Ntev.

Noj ntau dhau

Yog tias dhau ntawm kev siv tshuaj ntau dhau ntawm Octreotide lossis Octreotide-Ntev, tej zaum yuav tshwm sim hauv qab no: luv-term txo nyob rau hauv lub plawv dhia, mob plab spastic xwm xeev siabyaug ntsej muag, zawv plabCov. Hauv qhov no, kev kho cov tsos mob raug ua.

Cov plaub ntawm kev noj tshuaj ntau tshaj ntawm Octreotide-Depot tsis tau piav qhia nyob hauv kev coj ua.

Kev sib txuam

Quag siv cov tshuaj nrog Cyclosporinelowers nws qib hauv cov ntshav dej, kev ua kom qis qiscimetidine thiab cov khoom siv muaj txiaj ntsig los ntawm lub plab zom mov. Yog tias octreotide tshuaj ua ke nrogtshuaj insulinlub qhov ncauj cov tshuaj hypoglycemic, beta blockers, BKK thiab tshuaj kho mob, nws yog qhov tsim nyog yuav tau hloov kho lawv cov koob tshuaj. Concomitant siv nrog Bromocriptine tej zaum yuav ua rau kom nws ntau qhov chaw ua haujlwm.

Nws tau pom tias cov tshuaj no txo ​​cov metabolism hauv kev tshem tawm ntawm cov tshuaj uas metabolized los ntawm cytochrome P450 enzymes tshwm sim los ntawm kev tsuj ntawm kev loj hlob hormone. Yog li, thaum sau ntawv rau cov tshuaj no, yuav tsum ua kom zoo.

Cov Lus Qhia Txog Octreotide

Hauv chaw muag tshuaj, muaj ntau yam duab ntawm Octreotide pom, lub ntsiab ntawm lawv yog Sandostatin.

Ib qho zoo sib xws yog muaj los ntawm:Somatostatin, Diferelin thiab Sermorelin.

Raws li koj paub, cawv tuaj yeem tiv thaiv hluavtaws cov tshuaj hormones, yog li ntawd, nws siv nrog txhua daim ntawv ntawm Octreotide yog contraindicated.

Kev tshuaj xyuas ntawm Octreotide

Nws yuav tsum raug sau tseg tias kev sib tham hauv online txog kev siv cov tshuaj no thiab nws cov txiaj ntsig tsis yog ib txwm muaj. Feem ntau, cov neeg siv nug cov lus nug rau cov kws tshwj xeeb uas lawv txaus siab txog qhov kev kho ntawm kev puas siab puas ntsws zoo dua.

Txawm li cas los xij, hauv kev sim siv, Depot daim ntawv yog feem ntau siv. Tib lub sijhawm, txheeb xyuas ntawm Octreotide Kev Lag Luam qhia tau tias nws yog siv rau pancreatitis, thiab raws li mob thiab mob ntev ntawm cov kev cuam tshuam no. Yog lawm, qhov cuab yeej no tsuas yog kho los ntawm tus kws kho mob tshwj xeeb thiab nws yuav tsum cia siab tias kev kho mob yuav ua rau tsawg kawg ib lub lim tiam.

Dosage daim ntawv

Lyophilisate rau kev npaj ncua ntawm kev ncua rau kev tswj hwm intramuscular ntawm kev ua haujlwm ntev ntawm 10.0 mg, 20.0 mg lossis 30.0 mg ua tiav nrog cov kuab tshuaj ntawm 2 ml (Mannitol, txhaj tshuaj 0.8% 2 ml)

Ib fwj muaj

cov tshuaj heev - octreotide 10.0 mg, 20.0 mg, 30.0 mg,

tus zam: copolymer ntawm DL-lactic thiab glycolic acids, D-Mannitol, carboxymethyl cellulose sodium ntsev, polysorbate-80.

Cov hnyav D-Mannitol, dej rau kev txhaj tshuaj.

Lyophilized hmoov lossis ntxeem tau, sib xyaw ua ke rau hauv cov ntsiav tshuaj, loj heev kom muaj xim dawb lossis dawb nrog lub ntsej muag daj ua daj.

Cov hnyav tsis muaj kob uas muaj kua ntshiab

Rov muab tshem tawm: Nrog rau qhov sib ntxiv ntawm cov kuab tshuaj thiab ntxhov siab, ib homogeneous kev ncua ntawm cov xim dawb lossis dawb nrog lub tsaus muag daj tinge cov ntaub ntawv. Lub txim ncua tsis pub hloov tawm yuav tsum tsis txhob ua rau ntev li 5 feeb. Thaum sawv ntsug, qhov kev ncua ntawv precipitates, tab sis yog yooj yim resuspended los ntawm kev co. Qhov kev ncua yuav tsum hla dhau mus rau txoj kev txhaj tshuaj mus txog qhov koob No. 0840.

Cov chaw muag tshuaj

Cov Tshuaj Pharmacokinetics

Nrog kev tswj hwm intramuscular, octreotide yog kiag li kev nqus.

Kev kho tshuaj nyob rau hauv cov ntshav tau mus txog tom qab kwv yees li 30 feeb.

Protein khi yog muaj li ntawm 65%. Qhov khi ntawm octreotide rau cov qe ntshav yog qhov tseem ceeb heev. Qhov ntim ntawm kev faib tawm yog 0.27 l / kg. Octreotide yog tshuaj tiv thaiv hauv lub siab.

Kev tshem tag nrho yog 160 ml / min. T1 / 2 yog 100 min. Txog 32% nyob rau hauv daim ntawv tsis hloov pauv yog mob tawm ntawm lub raum. Hauv cov neeg mob laus, kev ua kom tsawg zuj zus, thiab T1 / 2 nce. Hauv kev mob raum tsis ua haujlwm, kev tshem tawm yog ib nrab.

Farmacodynamics

Octreotide depot yog cov khoom siv hluavtaws octapeptide uas yog lub zog ntawm ntuj somatostatin thiab muaj cov teebmeem zoo li pharmacological, tab sis ntev dhau ntawm kev nqis tes ua. Cov tshuaj tawm tsam cov kab mob pathologically nce zais cia ntawm kev loj hlob hormone (GH), nrog rau peptides thiab serotonin ua rau hauv lub plab gastro-entero-pancreatic endocrine system.

Ntawm carcinoid qog kev siv ntawm Octreotide ua rau qhov txo qis ntawm qhov tshwm sim ntawm cov tsos mob xws li kev hnov ​​ntawm dej ntws thiab zawv plab, uas feem ntau tau nrog kev poob qis hauv kev ua haujlwm ntawm cov serotonin hauv plasma thiab kev tawm ntawm 5-hydroxyindoleacetic acid hauv cov zis.

Ntawm hlav hlav ua cim los ntawm hyperproduction ntawm vasoactive plab hnyuv peptide (VIPs), kev siv cov Octreotide ua rau muaj kev txo qis hauv cov neeg mob plab zom mov tsis muaj zog. Nyob rau tib lub sijhawm, txo qis ntawm qhov tsis txaus electrolyte tsis txaus tshwm sim. Hauv qee tus neeg mob, qhov kev nce qib ntawm cov qog qeeb los yog nres thiab txawm tias nws qhov loj me, tshwj xeeb tshaj yog daim siab metastases. Cov kev txhim kho hauv tsev kho mob feem ntau yog nrog ib qho kev txo qis (nce mus rau qhov tseem ceeb) hauv kev saib xyuas ntawm vasoactive plab hnyuv peptide (VIP) hauv ntshav.

Ntawm glucagonomas kev siv Octreotide-depot feem ntau ua rau muaj qhov txo qis ntawm kev tawm pob ntawm necrotizing tsiv pob. Octreotide-depot tsis muaj qhov cuam tshuam loj rau qhov mob ntshav qab zib mellitus, uas feem ntau tau pom nrog glucagonomas, thiab feem ntau tsis txo qis qhov xav tau tshuaj insulin lossis tshuaj hauv qhov ncauj hypoglycemic. Hauv cov neeg mob uas mob raws plab, Octreotide ua rau nws txo qis, uas nrog tus cev hnyav nce ntxiv. Nrog rau kev siv Octreotide, kev poob qis ntawm kev saib xyuas ntawm glucagon hauv cov ntshav feem ntau tau sau tseg, txawm li cas los xij, nrog kev kho mob ntev ntev cov nyhuv no tsis tau txais kev cawmdim. Nyob rau tib lub sijhawm, txhim kho cov tsos mob tseem ruaj khov nyob rau ntev.

Ntawm gastrinomas / Zollinger-Ellison syndrome Octreotide depot, siv los ua kev kho mob lossis ua ke nrog H2-receptor blockers, tuaj yeem txo cov kua qaub rau hauv lub plab thiab ua rau muaj kev txhim kho hauv tsev kho mob, suav nrog rau kev zawv plab. Qhov tsis txaus ntseeg ntawm lwm cov tsos mob, suav nrog kev tso dej tawm, kuj txo. Hauv qee kis, muaj kev txo qis hauv cov concentration ntawm gastrin hauv cov ntshav.

Hauv cov neeg mob nrog tshuaj insulinomas Octreotide depot txo cov qib ntawm cov tshuaj tiv thaiv insulin hauv cov ntshav (cov nyhuv no tuaj yeem ua rau luv luv - txog 2 teev). Hauv cov neeg mob qog ua lub qog ua haujlwm, Octreotide Depot tuaj yeem pab kho kom zoo dua qub thiab kho kom zoo ntawm normoglycemia nyob rau lub sijhawm puag ncig. Hauv cov neeg mob uas tsis tuaj yeem mob qog thiab mob qog, glycemic tswj tau zoo tuaj yeem tsis muaj lub sijhawm ua ke txo qis hauv cov ntshav insulin ntau ntau.

Ntawm zawv plab refractory nyob rau hauv cov neeg mob uas tau txhaj tshuaj tiv thaiv mob ntsws (AIDS) kev siv cov tshuaj Octreotide ua rau kev tso quav los ntawm qhov quav ib txwm muaj txog li 1/3 ntawm cov neeg mob uas mob raws plab, tsis tuaj yeem yog los ntawm kev siv tshuaj tua kab mob thiab / lossis tshuaj tua kab mob.

Hauv cov neeg mob phais pancreatic, kev siv Octreotide thaum lub sijhawm thiab tom qab kev phais mob txo qis kev pheej hmoo ntawm kev mob tshwm sim tom qab (piv txwv li, pancreatic fistula, mob qog, sepsis, postoperative acute pancreatitis).

Ntawm los ntshav los ntawm ntau txoj hlab ntsha ntawm txoj hlab pas thiab lub plab hauv cov neeg mob qog ntshav kev siv Octreotide-Depot ua ke nrog kev kho mob tshwj xeeb (piv txwv, sclerotherapy) ua rau kom muaj kev cuam tshuam ntau dua los ntshav thiab rov qab los ntshav thaum ntxov, txo qis cov ntshav ntawm cov ntshav thiab kev txhim kho hauv 5-hnub kev muaj sia nyob. Cov tshuaj txo cov ntshav hloov khoom hauv nruab nrog los ntawm kev tsim cov tshuaj vasoactive xws li VIP thiab glucagon.

Tsuas tshuaj thiab tswj hwm

Octreotide depot yuav tsum tau tswj hwm nkaus xwb tob intramuscularly (IM), hauv gluteus maximus. Nrog kev hno tas, sab laug thiab sab xis yuav tsum sib hloov. Kev ncua yuav tsum tau npaj kom txhij ua ntej kev txhaj tshuaj. Txog hnub ntawm kev txhaj tshuaj, lub vial nrog siv tshuaj yaj yeeb thiab ampoule nrog cov kuab tshuaj tuaj yeem khaws cia rau hauv chav tsev kub.

Hauv kev kho mob ntawm cov qog endocrine ntawm txoj hnyuv thiab txoj hlab ntsws

Hauv cov neeg mob rau leej twg s / c tswj hwm ntawm Octreotide qhia txog kev tswj hwm tus kab mob txaus, qhov kev xav kom pib ntawm Octreotide-Depot yog 20 mg txhua 4 lub lis piam. Kev tswj hwm sc ntawm Octreotide yuav tsum txuas ntxiv rau 2 lub lis piam tom qab thawj zaug tswj hwm ntawm Octreotide Depot.

Hauv cov neeg mob uas tsis tau txais yav dhau los Octreotide s / c, nws raug nquahu kom pib kho nrog s / c tswj hwm ntawm Octreotide ntawm koob tshuaj 0.1 mg 3 zaug / hnub rau lub sijhawm luv (kwv yees li 2 lub lis piam) txhawm rau txhawm rau ntsuas nws qhov ua tau zoo thiab kev zam Cov. Tsuas yog tom qab no, Octreotide Depot yog tshuaj raws li cov qauv saum toj no.

Nyob rau hauv rooj plaub thaum kev kho mob nrog Octreotide-Depot rau 3 lub hlis muab kev tswj txaus ntawm cov chaw kuaj mob thiab cov cim roj ntsha ntawm tus kab mob, nws muaj peev xwm txo qhov koob tshuaj Octreotide-Depot rau 10 mg tshuaj txhua 4 lub lis piam. Hauv qhov xwm txheej uas tom qab 3 lub hlis ntawm kev kho mob nrog Octreotide-depot tsuas yog ua tiav ib nrab txhim kho, qhov tshuaj yuav nce ntxiv rau 30 mg txhua 4 lub lis piam. Tawm tsam keeb kwm yav dhau los ntawm kev kho mob nrog Octreotide-depot, nyob rau qee hnub, qhov kev mob tshwm sim ntawm tus yam ntxwv ntawm cov qog endocrine ntawm lub plab hnyuv thiab lub caj pas tuaj yeem ua kom zoo dua. Hauv cov rooj plaub no, ntxiv s / c tswj hwm ntawm Octreotide raug pom zoo ntawm koob tshuaj uas tau siv ua ntej pib kho nrog Octreotide Depot. Qhov no tuaj yeem tshwm sim hauv thawj 2 lub hlis ntawm kev kho mob kom txog thaum kho tshuaj ntau ntawm octreotide hauv ntshav tau tiav.

Hauv kev kho mob los ntawm qog-resistant prostate cancer Qhov pom zoo kom pib noj ntawm Octreotide Depot yog 20 mg txhua 4 lub lis piam rau 3 hlis. Tom qab, cov koob tshuaj yog kho kom noj mus rau hauv tus account lub zog ntawm cov PSA concentration, nrog rau cov tsos mob hauv chaw kuaj mob. Yog tias tom qab 3 lub hlis ntawm kev kho mob nws tsis tuaj yeem ua tiav qhov kev soj ntsuam thiab cov tshuaj biochemical zoo (txo hauv PSA), qhov koob tshuaj yuav raug nce ntxiv rau 30 mg tswj hwm txhua 4 lub lis piam.

Kev kho tus mob Octreotide-depot yog ua ke nrog kev siv dexamethasone, uas tau hais tawm ntawm qhov ncauj raws li cov qauv hauv qab no: 4 mg ib hnub rau 1 hlis, tom qab ntawd 2 mg ib hnub rau 2 lub lis piam, tom qab ntawd 1 mg rau ib hnub (koob tshuaj txij nkawm).

Kev kho nrog octreotide-depot thiab dexamethasone hauv cov neeg mob uas tau ua dhau los siv tshuaj antiandrogen kho yog ua ke nrog kev siv tshuaj tiv thaiv kab mob gonadotropin-tso cov tshuaj hormones (GnRH). Hauv qhov no, kev txhaj tshuaj ntawm GnRH analogue (daim ntawv fotot) yog nqa tawm 1 zaug hauv 4 lub lis piam.

Cov neeg mob uas tau txais Octreotide Depot yuav tsum kuaj txhua lub hli rau PSA ntau.

Hauv cov neeg mob uas lub raum tsis zoo, mob hepatic, thiab cov neeg laus laus, tsis tas yuav kho qhov tshuaj ntau npaum li cas ntawm Octreotide Depot.

Rau kev tiv thaiv ntawm tus mob hnoos qeev tom qab zoo

Cov tshuaj Octreotide-Depot nyob rau hauv ib koob tshuaj 10 lossis 20 mg yog muab ib zaug tsis dhau 5 hnub thiab tsis pub dhau 10 hnub ua ntej qhov kev xav kho mob.

Cov kev cai npaj rau kev npaj ntawm kev ncua thiab kev tswj hwm ntawm cov tshuaj

Cov tshuaj yog muab tshuaj nkaus xwb intramuscularly.

Ib qho kev ncua rau kev txhaj tshuaj intramuscular yog npaj los siv cov tshuaj tov sai tam sim ua ntej tswjhwm.

Cov tshuaj yuav tsum tau npaj thiab muab tshuaj rau cov neeg ua haujlwm paub xwb.

Ua ntej txhaj, ampoule nrog cov kuab tshuaj thiab lub raj mis nrog cov tshuaj yuav tsum tau muab tshem tawm hauv lub tub yees thiab nqa mus rau chav kub (30-50 feeb yog tsim nyog).

Khaws lub raj mis nrog Octreotide Depot nruj me ntsis ncaj. Tapping lub vial maj mam, xyuas kom meej tias tag nrho cov lyophilisate yog nyob hauv qab ntawm lub vial.

Qhib lub ntim nrog cov phwj, muab txuas 1.2 hli x 50 hli koob rau lub koob txhaj kom sau cov kuab tshuaj.

Qhib cov ampoule nrog cov kuab tshuaj thiab muab tso rau hauv cov phwj txhua qhov ntawm cov ampoule nrog cov kuab tshuaj, teeb kua tshuaj rau ib koob tshuaj ntawm 3.5 ml.

Tshem lub hau yas ntawm lub vial uas muaj cov tshuaj lyophilisate. Tshem tawm cov roj hmab nres ntawm lub thauv nrog cawv ib cawv cawv.Muab rab koob tso rau hauv lub lyophilisate vial los ntawm qhov chaw ntawm cov roj hmab nres thiab ua tib zoo muab cov kuab tshuaj mus rau sab hauv lub vial yam tsis kov cov ntsiab lus ntawm lub thauv nrog rab koob. Tshem tawm cov khoom hauv qab txig.

Lub vial yuav tsum nyob twj ywm tsis hloov mus txog thaum cov tshuaj tov tag nrho nrog lub lyophilisate thiab cov ntawv ncua (ntev li 3 txog 5 feeb). Tom qab ntawd, tsis tas tig lub raj mis dua, koj yuav tsum kuaj seb puas muaj cov lyophilisate qhuav ntawm phab ntsa thiab hauv qab ntawm lub raj mis. Yog tias cov nplauv qhuav lyophilisate tau pom, tawm hauv lub vial kom txog thaum ua tiav.

Tom qab koj nco ntsoov tias tsis muaj cov lyophilisate qhuav seem, cov ntsiab lus ntawm lub vial yuav tsum ua tib zoo sib xyaw rau hauv cov lus sib dhos rau 30-60 vib nas this kom txog thaum muaj kev txwv tsis pub tsim homogeneous. Tsis txhob flip lossis co lub vial, vim tias qhov no yuav ua rau ploj ntawm flakes thiab raug tshem tawm tsis zoo.

Caw nrawm qhov koob los ntawm cov roj hmab nres rau hauv lub vial. Tom qab ntawv muab rab koob txo qis dua thiab, tilting lub raj mis ntawm kaum ntawm 45 degrees, maj mam kos cov kev ncua mus rau hauv cov koob txhaj tshuaj kom tiav. Tsis txhob ntxeev lub raj mis thaum ntaus ntawv. Ib qho me me ntawm cov tshuaj yuav nyob twj ywm rau ntawm cov phab ntsa thiab hauv qab ntawm lub vial. Kev noj rau cov khoom seem ntawm phab ntsa thiab hauv qab ntawm lub raj mis yog coj mus rau hauv tus account.

Tam sim tom qab sau cov kev ncua, hloov rab koob nrog cov kab xaum paj yeeb nrog rab koob nrog lub kab ntsuab (0.8 x 40 mm), ua tib zoo tig lub taub dej thiab tshem cov pa ntawm lub koob txhaj tshuaj.

Kev Xa Ntawv Rau Tus Txav Rau Kev Txhaum Plaub Yuav Tsum Ncaj Ncees yuav tsum muab rau siv tam sim ntawd tom qab npaj.

Kev Rau Txim Rau Cov Txo Rau Lub Plaub Hlis yuav tsum tsis txhob muab nrog lwm cov tshuaj nyob hauv tib lub koob txhaj.

Siv cov cawv cawv tshuaj ntxuav mus rau qhov chaw txhaj tshuaj. Ntxig lub koob txhaj rau hauv cov gluteus maximus leeg, tom qab ntawd rub tawm cov koob txhaj plunger rov qab kom paub tseeb tias tsis muaj kev puas tsuaj rau lub nkoj. Qhia cov kev ncua ntxiv intramuscularly maj mam nrog lub siab tsis tu ncua ntawm cov koob txhaj tshuaj nqus dej.

Yog tias nws nkag rau hauv cov ntshav, qhov chaw txhaj tshuaj thiab rab koob yuav tsum hloov.

Thaum ntsaws cov rab koob, hloov nws nrog lwm rab koob ntawm tib lub taub.

Nrog kev hno tas, sab laug thiab sab xis yuav tsum sib hloov.

Sab sij huam

Cov kev phiv tshuaj yog nthuav tawm raws li qhov muaj tshwm sim hauv cov txheej txheem hauv qab: ntau zaus (≥1 / 10), feem ntau (≥1 / 100,  1/10), qee zaum (≥1 / 1000, /1 / 100), tsis tshua muaj (= ≥ 1/10000, 1 / 1000), tsis tshua muaj neeg siv (1 / 10000), suav nrog cov lus hauv ib leeg.

- mob plab zom plab, tsam plab, cem quav, raws plab

- cov kev hloov hauv zos nyob rau hauv kev tswjfwm subcutaneous (mob, o, liab, liab vog thiab kub)

-hypothyroidism, lub qog ua haujlwm tsis zoo

- kiv taub hau, dyspnea, asthenia

- bradycardia, tachycardia, cholecystitis, plaub hau poob

- Ua xua pob khaus, khaus

xeev siab, ntuav, gallstones tsim (nrog rau kev siv ntev ntev ntawm Octreotide-Depot), cholecystitis, biliary sludge, steatorrhea (txawm hais tias tso tawm cov rog nrog quav yuav nce ntxiv, tsis muaj qhov qhia tau tias kev kho mob ntev nrog Octreotide-depot yuav ua rau kev noj zaub mov tsis muaj qab hau. vim malabsorption (malabsorption)), qhov tshwm sim zoo li mob plab hnyuv txhaws: tsam plab, mob hnyav hauv thaj av epigastric, qhov nro ntawm lub plab phab ntsa, leeg "tiv thaiv".

mob pancreatitis, mob tsis nco qab, tso quav ntau zaus, mob hepatitis tsis muaj cholestasis, hyperbilirubinemia, muaj ntau zog phosphatase, gamma glutamyl transferase, transaminases, thrombocytopenia, hyperkalemia

arterial hypertension (nrog rau kev siv ntev)

Qhov mob hnyav ntawm kev tsis haum rau hauv zos tuaj yeem raug txo yog tias koj siv txoj kev daws teeb meem ntawm chav tsev, lossis nkag mus rau cov ntim me dua ntawm cov tshuaj muaj zog ntau dua.

Cov kev tshaj tawm tom qab muag txog kev phiv

anaphylaxis, kev tsis haum tshuaj, kev tso tawm khaus

pancreatitis, mob siab, mob siab, cholestatic kab mob siab, cholestasis, txau ntawm cov kua tsib, cholestatic daj ntseg

Cov tshuaj sib cuam tshuam

Octreotide txo qis kev nqus ntawm cyclosporine, ua rau txo qis kev nqus ntawm cimetidine. Kev kho ntawm cov tshuaj ntau dua ntawm kev siv tshuaj diuretics, beta-blockers, "qeeb" calcium channel blockers, insulin, thiab qhov ncauj tshuaj hypoglycemic yog qhov tsim nyog.

Nrog rau kev siv txaws ib txhij octreotide thiab bromocriptine, lub bioavailability ntawm cov yav tas nce.

Tshuaj siv tshuaj tiv thaiv kab mob los ntawm cov enzymes ntawm cytochrome P450 system thiab muaj qhov nqaim kho ntau qhov yuav tsum tau txiav txim nrog kev ceev faj.

Cov lus qhia tshwj xeeb

Nrog cov qog pituitary tso zis GR, ceev faj kev saib xyuas ntawm cov neeg mob uas tau txais Octreotide Depot yog qhov tsim nyog, vim nws muaj peev xwm nce qhov loj ntawm qog nrog kev txhim kho ntawm cov kev mob hnyav xws li nqaim ntawm thaj chaw pom. Hauv cov rooj plaub no, xav tau lwm txoj hauv kev kho yuav tsum raug txiav txim siab.

Lub qog ua haujlwm yuav tsum tau saib xyuas hauv cov neeg mob niaj hnub kho mob nrog Octreotide Depot.

Cov ntawv ceeb toom tsis tshua muaj ntawm bradycardia tau tshaj tawm nrog octreotide. Hauv qhov no, nws yuav tsim nyog los kho lub koob tshuaj rau cov tshuaj xws li beta-blockers, calcium channel blockers lossis tshuaj siv los tswj cov dej-electrolyte tshuav nyiaj li cas.

Hauv 10-20% ntawm cov neeg mob tau txais Octreotide Depot ntev, qhov tshwm sim ntawm cov pob zeb hauv lub zais plab yog qhov ua tau, yog li ntawd, cov lus pom zoo hauv qab no yuav tsum raug coj los txiav txim.

Cov lus qhia rau kev tswj hwm cov neeg mob thaum kho nrog Octreotide Depot txog kev tsim cov pob zeb ua paug.

Ua ntej lub sijhawm teem tseg rau Octreotide Depot, cov neeg mob yuav tsum tau kuaj thawj zaug kuaj ultrasound ntawm lub qog,

thaum kho nrog Octreotide-Depot, kev kuaj ntshav dua ntxiv ntawm lub qob yuav tsum ua, nyiam dua thaum ncua sijhawm 6-12 lub hlis,

yog tias cov pob zeb tau pom ua ntej kev kho mob, nws yog ib qho tsim nyog los soj ntsuam cov txiaj ntsig muaj txiaj ntsig ntawm Octreotide-Depot kev kho mob piv rau cov kev pheej hmoo muaj feem cuam tshuam nrog muaj cov kab mob gallstones. Tsis muaj pov thawj txog qhov tshwm sim tsis zoo ntawm Octreotide Depot ntawm chav kawm los yog kev kwv yees ntawm tus kab mob gallstone uas twb muaj lawm.

Kev tswj hwm ntawm cov neeg mob nyob rau hauv tus neeg mob gallbladder pob zeb yog tsim thaum kho nrog Octreotide Depot.

a) Asymptomatic gallbladder pob zeb.

Kev siv Octreotide Depot tuaj yeem txuas mus ntxiv los yog txuas ntxiv - ua raws li kev ntsuas ntawm qhov txiaj ntsig / qhov ntsuas phom sij. Nyob rau hauv txhua rooj plaub, tsis tas yuav ua dab tsi ntxiv dua li txuas ntxiv qhov kev soj ntsuam, ua nws ntau dua yog tias tsim nyog.

b) Gallbladder pob zeb nrog cov tsos mob tshawb nrhiav.

Kev siv Octreotide Depot tuaj yeem txuas mus ntxiv los yog txuas ntxiv - ua raws li kev ntsuas ntawm qhov txiaj ntsig / qhov ntsuas phom sij. Nyob rau hauv txhua rooj plaub, tus neeg mob yuav tsum tau txais kev kho kom zoo ib yam li lwm qhov mob ntawm gallstone tus mob nrog kev kuaj mob. Kev noj tshuaj suav nrog kev siv sib xyaw ntawm bile acid npaj (piv txwv, chenodeoxycholic acid ntawm ib koob ntawm 7,5 mg / kg ib hnub hauv kev sib xyaw nrog ursodeoxycholic acid hauv tib lub tshuaj) nyob rau hauv kev taw qhia ultrasound kom txog thaum lub pob zeb ploj tag.

Cov neeg mob nrog insulinomas kho nrog Octreotide-Depot yuav muaj kev nce siab ntau thiab qhov ntev ntawm qhov mob ntshav qab zib tsawg (qhov no yog vim muaj qhov cuam tshuam ntau ntawm cov tshuaj tiv thaiv GH thiab glucagon dua li ntawm kev tso tshuaj ntawm insulin, nrog rau lub sijhawm luv luv ntawm cov tshuaj tiv thaiv ntawm insulin secretion). Cov neeg mob zoo li no yuav tsum tau saib zoo thaum pib kho nrog Octreotide-depot, nrog rau txhua qhov hloov pauv ntawm cov tshuaj. Kev hloov pauv tsis txaus nyob hauv cov concentration ntawm cov piam thaj hauv cov ntshav tuaj yeem sim txo los ntawm kev tswj hwm ntau ntawm Octreotide Depot.

Thaum los ntshav los ntawm cov leeg ntshav hlab ntsha mus rau txoj hlab pas thiab lub plab hauv cov neeg mob uas muaj kab mob siab, txoj kev pheej hmoo ntawm kev tsim cov tshuaj tiv thaiv ntshav qab zib mellitus yog nce ntxiv, nrog rau cov kev hloov pauv hauv insulin uas yuav tsum tau nyob hauv cov neeg mob ntshav qab zib mellitus yog ua tau, yog li ntawd, hauv cov xwm txheej no, kev tswj xyuas ntshav qabzib siab tseem ceeb.

Hauv cov neeg mob uas muaj ntshav qab zib hom 1, Octreotide Depot tuaj yeem txo qhov xav tau ntawm insulin. Hauv cov neeg mob uas tsis muaj ntshav qab zib mellitus thiab nrog hom 2 mob ntshav qab zib mellitus nrog cov tshuaj tiv thaiv insulin ib feem, kev tswj hwm ntawm Octreotide Depot tuaj yeem ua rau cov ntshav qabzib nce ntxiv.

Hauv qee tus neeg mob, octreotide tuaj yeem hloov kho kev nqus ntawm cov rog hauv cov hnyuv, txo qis qib vitamin B12 hauv cov ntshav thiab ua rau muaj qhov txawv txav ntawm cov cai ntawm cov txiaj ntsig ntawm qhov kev xeem Schilling.

Cev xeeb tub thiab lactation

Tsis muaj kev paub dhau los ntawm kev siv cov tshuaj thaum cev xeeb tub, nyob rau hauv cov mob zoo li no cov tshuaj yog tawm tsuas yog raws li kev qhia tseeb. Thaum kho nrog Octreotide Depot, yuav tsum tsum tsis txhob pub niam mis ntxiv.

Kev siv kho cov menyuam yaus

Tsis muaj kev paub dhau los ntawm Octreotide Depot hauv cov menyuam yaus.

Cov yam ntxwv ntawm cov nyhuv ntawm cov tshuaj ntawm lub peev xwm tsav lub tsheb lossis cov phom sij phom sij

Qee qhov kev mob tshwm sim ntawm Octreotide Depot tuaj yeem cuam tshuam tsis zoo rau kev muaj peev xwm tsav tsheb thiab lwm cov txheej txheem uas yuav tsum muaj kev nce siab ntxiv thiab ceev ntawm cov kev tiv thaiv psychomotor.

Cov Cai Siv Tshuaj So

Lub npe thiab lub teb chaws ntawm cov chaw tsim khoom

Hniav tuam txhab LLC, Lavxias teb sab Federation

129344, Moscow, st. Yenisei, lub tsev 3, lub tsev 4

Lub npe thiab lub teb chaws ntawm daim ntawv pov thawj rau npe tuav

Ua liaj ua teb hluavtaws CJSC, Lavxias Federation

111024, Moscow, Kabelnaya 2-ya txoj kev, tsev 2, p. 9

Lub chaw nyob ntawm cov koomhaum uas lees txais thov nyiaj los ntawm cov neeg siv khoom ntawm cov khoom lag luam zoo (cov khoom lag luam) hauv koom pheej ntawm Kazakhstan

Raifarm LLP (Raifarm)

TXOJ CAI NTAWM KAZAKHSTAN, Almaty, st. Timiryazev 42, bldg. 15/3 V.

3D duab

Kev piav qhia ntawm daim ntawv tshuaj

Lyophilized hmoov lossis ntxeem tau, sib xyaw ua ke rau hauv cov ntsiav tshuaj loj ntawm cov xim dawb lossis dawb nrog lub ntsej muag muag daj.

Cov hnyav kua xim tsis muaj pob tshab.

Rov muab tshem tawm: kev sim ib homogeneous ntawm xim dawb lossis dawb nrog lub ntsej muag daj uas tsaus muag.

Cov Kev Qhia Txog Octreotide Kev Lag Luam

thaum tswj hwm qhov txaus ntshai ntawm cov tsos mob tshwm sim los ntawm sc tswj hwm octreotide,

thaum tsis muaj qhov ua tau zoo ntawm kev phais mob kev kho mob thiab kev ntsuas hluav taws xob,

los npaj rau kev phais mob,

rau kev kho mob ntawm cov chav kawm ntawm kev kho mob hluav taws xob kom txog thaum cov nyhuv ntev mus,

inoperable cov neeg mob.

Kev kho cov qog endocrine ntawm lub plab zom mov thiab txiav:

carcinoid qog nrog cov tshwm sim ntawm carcinoid syndrome,

gastrinomas (Zollinger-Ellison syndrome),

glucagonomas (los tswj cov ntshav qog ntshav hauv lub sijhawm preoperative, ntxiv rau kev kho kev kho mob),

somatoliberinomas (qog cov hlav los ntawm kev ua haujlwm ntau dhau ntawm kev loj hlob hormone tso tawm yam).

Kev kho mob qog nqaij hlav cancer-resistant prostate: raws li ib feem ntawm kev sib txuas ua ke ntawm tus keeb kwm yav dhau los ntawm kev phais mob lossis kev mob kho mob.

Kev tiv thaiv ntawm kev txhim kho ntawm kev mob caj dab tom qab: nrog kev ua haujlwm ntau nyob rau ntawm lub plab thiab kab mob thoracoabdominal (suav nroghais txog mob qog noj ntawm lub plab, txoj hlab nqos mov, mob hnyuv, ua kab mob ua paug, thawj qog thiab pob qog nqaij hlav ntawm lub siab).

Cev xeeb tub thiab lactation

Tsis muaj kev paub dhau los ntawm Octreotide Depot thaum cev xeeb tub thiab thaum pub mis. Yog li no, thaum cev xeeb tub, cov tshuaj yog tawm tsuas yog muaj txiaj ntsig zoo rau leej niam outweighs qhov kev pheej hmoo rau tus menyuam hauv plab. Kev pub mis niam tsis pom zoo thaum siv cov tshuaj thaum lactation.

Chaw tsim tshuaj paus

Lub tuam txhab yog tus tswv ntawm daim ntawv pov thawj rau npe: Farm-Sintez JSC.

Chaw nyob raug cai: 111024, Russia, Moscow, ul. Thib Ob Kab, 2, p. 46.

Chaw nyob: 121357, Russia, Moscow, ul. Vereyskaya, 29, p. 134, chaw haujlwm A403, A404.

Xovtooj: (495) 796-94-33, fax: (495) 796-94-34.

Lub koom haum lees txais cov lus thov nyiaj: Farm-Synthesis JSC.

Pharmacological kev txiav txim

Cov tshuaj Octreotide-Depot yog daim ntawv qhia ua haujlwm ntev ntev rau octreotide ntau rau kev tswj hwm intramuscular, kom ntseeg tau tias kev saib xyuas kev noj qab haus huv ruaj khov ntawm octreotide hauv cov ntshav rau 4 lub lis piam. Octreotide yog kev kho mob pathogenetic rau cov qog uas nquag qhia somatostatin receptors. Octreotide yog ib qho hluavtaws octapeptide uas yog qhov txuas ntawm lub ntuj hormone somatostatin thiab muaj cov teebmeem zoo li pharmacological, tab sis ntev dua ntawm kev ua. Cov tshuaj suppresses pathologically nce zais cia ntawm kev loj hlob hormone (GH), nrog rau peptides thiab serotonin tsim tawm hauv lub plab - entero - pancreatic endocrine system.

Hauv cov tib neeg muaj kev noj qab haus huv, octreotide, zoo li somatostatin, txwv tsis pub muaj kev zais ntawm GR los ntawm arginine, kev ua haujlwm ntawm lub cev thiab insulin hypoglycemia, muaj kev zais ntawm insulin, glucagon, gastrin thiab lwm yam peptides ntawm lub plab gastro-entero-pancreatic endocrine system, los ntawm kev noj zaub mov, nrog rau kev ua kom muaj zog ntawm insulin. arginine, thyrotropin zais ntshis tshwm sim los ntawm thyroliberin. Qhov kev cuam tshuam ntawm kev txiav txim siab ntawm GR tawm ntawm kev sib xyaw octreotide, hauv kev sib piv rau somatostatin, tau hais tawm rau ntau yam tsis txaus siab dua ntawm kev zais tawm ntawm insulin. Kev tswj hwm ntawm octreotide tsis yog nrog cov tshwm sim ntawm hypersecretion ntawm cov tshuaj hormones los ntawm lub tswv yim tsis zoo.

Hauv cov neeg mob uas muaj acromegaly, kev tswj hwm ntawm octreotide depot daim ntawv muab nyob rau hauv feem ntau ntawm cov neeg mob pheej poob qis hauv kev cia siab ntawm GH thiab ib txwm ua haujlwm ntawm cov concentration ntawm insulin-zoo li kev loj hlob tau 1 / somatomedin C (IGF-1).

Hauv cov neeg mob feem ntau uas muaj acromegaly, daim ntawv depot ntawm octreotide cuam tshuam txo qhov hnyav ntawm cov tsos mob xws li mob taub hau, tawm hws, mob caj dab, nkees, mob rau pob txha thiab pob qij txha, mob hlab ntsha hlwb ib leeg. Nws tau tshaj tawm tias kev kho mob nrog rau ntawm cov qog octreotide rau cov neeg mob uas ua rau muaj kev tso pa tawm rau GH ua rau muaj cov qog loj tuaj.

Nrog secretory endocrine cov qog ntawm lub plab hnyuv plab hnyuv (GIT) thiab kab mob duav, siv daim ntawv octreotide depot muab tshuaj xyuas tas li ntawm cov tsos mob tseem ceeb ntawm cov kab mob no.

Ib daim ntawv xoos ntawm octreotide ntawm koob tshuaj 30 mg txhua 4 lub lis piam ua rau cov qog ua kom loj hlob hauv cov neeg mob uas tsis zais thiab tsis zais qhov sib luag (metastatic) neuroendocrine hlav ntawm cov tawv nqaij, iliac, dig muag,
ascending nyuv, transverse hnyuv thiab vermiform cov hnyuv tws, lossis metastases ntawm neuroendocrine hlav tsis muaj lub hom phiaj tseem ceeb. Cov tshuaj muaj txiaj ntsig zoo nyob rau hauv nce lub sijhawm mus rau kev muaj mob, ob qho tib si rau kev zais cia thiab tsis zais-neuroendocrine hlav.

Hauv cov qog carcinoid, kev siv octreotide tuaj yeem ua rau txo qis ntawm qhov mob hnyav ntawm cov tsos mob ntawm tus kabmob, feem ntau xws li kub cev thiab raws plab. Feem ntau, kev txhim kho mob hauv tsev kho mob tau nrog
ib qho kev txo qis hauv plasma serotonin concentration thiab tsis pom kev ntawm 5-hydroxyindoleacetic acid hauv cov zis.

Hauv cov qog ua cim los ntawm hyperproduction ntawm vasoactive plab hnyuv peptide (VIPoma), kev siv octreotide nyob rau hauv cov neeg mob feem ntau ua rau txo qis hauv cov neeg mob plab zom mov tsis txaus, uas yog cov yam ntxwv ntawm tus mob no, uas, nyeg, coj mus rau kev txhim kho hauv tus neeg mob lub neej zoo. Nyob rau tib lub sijhawm, muaj qhov txo qis uas cuam tshuam kev tsis txaus ntseeg nyob hauv lub ntsuas hluav taws xob, piv txwv li, hypokalemia, uas tso cai rau koj tshem tawm txoj kev nkag ua haujlwm thiab kev tswj hwm ntawm cov kua thiab electrolytes. Raws li xam tomography tom qab, hauv qee cov neeg mob muaj qeeb los yog nres qhov mob ntawm cov qog, thiab txawm tias nws txo qis nws qhov loj me, tshwj xeeb tshaj yog daim siab metastases. Cov kev txhim kho hauv tsev kho mob feem ntau yog nrog ib qho kev txo qis (nce mus rau qhov tseem ceeb) hauv kev saib xyuas ntawm vasoactive plab hnyuv peptide (VIP) hauv ntshav.

Nrog glucagonomas, kev siv octreotide feem ntau ua rau muaj kev ceeb toom txo qis ntawm pob qog ntshav necrotizing, uas yog cov yam ntxwv ntawm tus mob no. Octreotide tsis muaj qhov cuam tshuam loj rau qhov mob ntshav qab zib mellitus, feem ntau pom nrog glucagonomas, thiab feem ntau tsis muaj
kom txo qis qhov xav tau rau cov tshuaj insulin lossis qhov ncauj tshuaj hypoglycemic. Hauv cov neeg mob mob raws plab, octreotide ua rau nws txo qis, uas nrog los ntawm kev nce hauv lub cev. Nrog rau kev siv octreotide, kev txo qis sai sai hauv kev suav ntawm glucagon hauv cov ntshav feem ntau tau sau tseg, txawm li cas los xij, nrog kev kho mob ntev, cov nyhuv no tsis mob siab. Nyob rau tib lub sijhawm, txhim kho cov tsos mob tseem ruaj khov nyob rau ntev.

Hauv kev mob plab gastrinomas / Zollinger-Ellison syndrome, octreotide, siv los ua monotherapy lossis ua ke nrog Ng-histamine receptor blockers thiab proton twj tso kua mis inhibitors, tuaj yeem txo qhov tsim ntawm hydrochloric acid hauv plab thiab ua rau muaj kev txhim kho kho mob, suav nrog thiab hauv kev cuam tshuam rau raws plab. Nws tseem ua tau kom txo tau qhov mob hnyav thiab lwm cov tsos mob, tej zaum cuam tshuam nrog kev sib txuas ntawm peptides los ntawm cov qog, suav nrog dej ntas. Hauv qee qhov
hauv cov neeg mob, insulinomas, octreotide txo qis qhov kev xav ntawm cov tshuaj tiv thaiv kab mob insulin hauv cov ntshav. Hauv cov neeg mob qog ua lub qog ua haujlwm, octreotide tuaj yeem ua kom muaj kev kho dua tshiab thiab kev kho mob ntawm normoglycemia hauv lub sijhawm preoperative. Hauv cov neeg mob uas tsis tuaj yeem mob qog thiab malignant hlav, glycemic tswj tau zoo tuaj yeem tsis tas mus ua ke
lub caij nyoog ntev hauv qhov kev txo qis ntawm cov tshuaj insulin hauv cov ntshav.

Hauv cov neeg mob uas muaj cov qog ua haujlwm tsis tshua muaj mob, hyperpro tsim kev loj hlob hormone tso qhov tshwm sim (somatoliberinomas), octreotide txo qhov mob hnyav ntawm acromegaly cov tsos mob. Qhov no, thaj, cuam tshuam nrog kev tsuj tawm ntawm kev zais ntawm kev tso tawm ntawm kev loj hlob hormone thiab GH nws tus kheej. Nyob rau hauv lub neej yav tom ntej, nws muaj peev xwm kom txo qhov loj ntawm lub caj pas pituitary, uas tau nce ua ntej kev kho.

Hauv cov neeg mob uas muaj kev tiv thaiv qog nqaij hlav prostate (HGRP), pas dej ntawm neuroendocrine hlwb qhia txog somatostatin receptors affinity rau octreotide (SS2 thiab SS5 yam) nce, uas txiav txim siab qhov rhiab ntawm cov qog mus rau octreotide. Kev siv cov tshuaj Octreotide-Depot nyob rau hauv kev sib xyaw nrog dexamethasone tiv thaiv keeb kwm ntawm androgen blockade (tshuaj los yog phais mob lub cev) hauv cov neeg mob HGRP rov qab kho qhov mob rau kev kho hormone thiab ua rau muaj qhov txo qis prostate tshwj xeeb antigen (PSA) hauv ntau dua 50% ntawm cov neeg mob.

Hauv cov neeg mob HGRG nrog cov pob txha metastases, qhov kev kho mob no nrog nws cov lus tshaj tawm thiab ua kom ntev ntev ua kom loog. Ntxiv mus, hauv txhua tus neeg mob uas tau teb ua ke nrog kev kho mob nrog rau kev siv tshuaj Octreotide-depot, lub neej muaj txiaj ntsig zoo thiab cov kab mob tsis muaj txiaj ntsig tseem muaj txiaj ntsig zoo.

Cov Kev Qhia Tawm Octreotide-Chaw Muag Khoom

Hauv kev kho mob ntawm acromegaly:

• thaum tswj hwm qhov txaus ntshai ntawm cov tsos mob tshwm sim los ntawm sc tswj hwm octreotide,
• thaum tsis muaj qhov ua tau zoo ntawm kev phais mob kev kho mob thiab kev ntsuas hluav taws xob,
• los npaj rau kev phais mob,
• rau kev kho mob ntawm cov chav kawm ntawm kev kho mob hluav taws xob kom txog thaum cov nyhuv ntev mus,
• inoperable cov neeg mob.

Hauv kev kho cov qog endocrine ntawm txoj hnyuv thiab lub caj pas:

• carcinoid qog nrog cov tshwm sim ntawm carcinoid syndrome,
• tshuaj insulinomas
• VIPoma
• gastrinomas (Zollinger-Ellison syndrome),
• glucagonomas (los tswj cov ntshav qog ntshav hauv lub sijhawm preoperative, ntxiv rau kev kho kev kho mob),
• somatoliberinomas (qog cov hlav los ntawm kev ua haujlwm ntau dhau ntawm kev loj hlob hormone tso tawm yam),
• kev kho mob ntawm cov neeg mob ua kom tsis zais thiab tsis zais lwm tus (metastatic) neuroendocrine hlav ntawm daim tawv nqaij, tawv nqaij, dig muag, nce pob qij txha, mob hnyuv thiab mob hnyuv tws, lossis metastases ntawm neuroendocrine qog yam tsis muaj lub hom phiaj tseem ceeb.

Hauv kev kho mob los ntawm qog-resistant prostate cancer:

• raws li ib feem ntawm kev sib txuas ua ke ntawm tus keeb kwm yav dhau los ntawm kev phais mob lossis kev mob kho mob.

Hauv kev tiv thaiv ntawm tus mob hnoos qeev tom qab zoo:

• nrog cov kev phais mob plab thiab thoracoabdominal ntxiv (suav nrog rau mob qog nqaij hlav hauv lub plab, txoj hlab nqos mov, mob hnyuv taum, mob plab, thawj thiab lwm yam mob qog ua rau lub siab).

Kev noj tshuaj ntxiv

Cov tshuaj Octreotide-Depot yuav tsum tau muab rau nkaus xwb intramuscularly (IM), hauv cov nqaij gluteus. Nrog kev hno tas, sab laug thiab sab xis yuav tsum sib hloov. Kev ncua yuav tsum tau npaj kom txhij ua ntej kev txhaj tshuaj. Txog hnub ntawm kev txhaj tshuaj, lub vial nrog siv tshuaj yaj yeeb thiab ampoule nrog cov kuab tshuaj tuaj yeem khaws cia rau hauv chav tsev kub.

Hauv kev kho mob ntawm acromegaly nyob rau hauv cov neeg mob rau leej twg s / c tswj hwm ntawm octreotide muab kev tswj hwm kom tsim nyog ntawm cov tsos mob, tus thawj pom zoo ntawm cov tshuaj Octreotide-Depot yog 20 mg txhua 4 lub lis piam rau 3 lub hlis. Koj tuaj yeem pib kho nrog Octreotide-Depot hnub tom qab hnub kawg s / c tswj hwm ntawm octreotide. Nyob rau hauv lub neej yav tom ntej, cov koob tshuaj yog kho kom haum rau hauv kev suav tshuaj nyob rau hauv cov ntshav dej ntawm GR thiab IGF-1, nrog rau cov tsos mob hauv chaw kho mob. Yog tias tom qab 3 lub hlis ntawm kev kho mob nws tsis tuaj yeem ua tiav kev soj ntsuam thiab cov tshuaj biochemical siv tau (tshwj xeeb, yog tias qhov concentration ntawm GR tseem nyob siab dua 2.5 μg / L), qhov koob tshuaj yuav raug nce ntxiv rau 30 mg tswj hwm txhua 4 lub lis piam.

Hauv cov xwm txheej ntawd thaum tom qab 3 lub hlis ntawm kev kho mob nrog Octreotide-Depot ntawm koob tshuaj 20 mg, qhov txo qis
ntshiab GH concentration hauv qab 1 μg / l, ib txwm ua haujlwm ntawm lub siab ntawm IGF-1 thiab ploj ntawm qhov tshwm sim uas thim rov qab ntawm acromegaly, koj tuaj yeem txo qhov tshuaj ntawm cov tshuaj Octreotide-depot rau 10 mg. Txawm li cas los xij, hauv cov neeg mob no tau txais me me ntawm Octreotide Depot, qhov kev daws teeb meem ntawm GR thiab IGF-1, nrog rau cov tsos mob ntawm tus kab mob, yuav tsum tau ua tib zoo saib xyuas.

Cov neeg mob uas tau txais koob tshuaj zoo ntawm Octreotide-depot yuav tsum tau kuaj txhua 6 lub hlis rau cov tshuaj GH thiab IGF-1 ntau.

Cov neeg mob rau leej twg kev phais mob thiab kev kho hluav taws xob tsis ua hauj lwm zoo txaus lossis txawm tias tsis muaj txiaj ntsig, nrog rau cov neeg mob uas xav tau kev kho mob luv nruab nrab ntawm cov chav kawm ntawm kev kho mob hluav taws xob kom txog rau kev txhim kho nws cov txiaj ntsig tag nrho, nws raug nquahu kom ua qhov kev sim ntawm kev kho mob s / c txhaj tshuaj octreotide txhawm rau kom ntsuas nws kev ua tau zoo thiab kev nkag siab dav dav, thiab tsuas yog tom qab ntawd hloov mus rau kev siv tshuaj Octreotide-depot raws li cov txheej txheem saum toj no.

Hauv kev kho mob ntawm cov qog endocrine ntawm lub plab hnyuv thiab lub caj pas ntawm tus neeg mob rau leej twg sc kev tswj hwm ntawm octreotide muab kev tswj kom tsim nyog ntawm cov tsos mob tshwm sim, kev xav kom pib noj ntawm Octreotide-Depot yog 20 mg txhua 4 lub lis piam. Kev tswj hwm sc ntawm octreotide yuav tsum txuas txuas ntxiv rau 2 lub lis piam tom qab thawj zaug kev coj ntawm cov tshuaj Octreotide-Depot.

Hauv cov neeg mob uas tsis tau dhau los cov phev octreotide, nws raug nquahu tias yuav tsum tau kho nrog s.c. coj ntawm octreotide ntawm kev txhaj tshuaj ntawm 0.1 mg 3 zaug / hnub rau lub sijhawm luv (kwv yees li 2 lub lis piam) txhawm rau txhawm rau ntsuas nws qhov ua tau zoo thiab kev zam rau lub siab. Tsuas yog tom qab no, cov tshuaj Octreotide-depot yog tshuaj raws li cov qauv saum toj no.

Nyob rau hauv rooj plaub thaum kev kho mob nrog Octreotide-Depot rau 3 lub hlis muab kev tswj txaus ntawm kev kuaj mob thiab cov cim roj ntsha ntawm tus kab mob, nws muaj peev xwm txo qhov koob tshuaj Octreotide-Depot rau 10 mg,
taw txhua 4 lis piam. Hauv qhov xwm txheej uas tom qab 3 lub hlis ntawm kev kho mob nrog Octreotide-Depot, tsuas yog ua tiav kev txhim kho ib feem, qhov koob tshuaj tuaj yeem nce ntxiv rau 30 mg txhua 4 lub lis piam. Tawm tsam keeb kwm ntawm kev kho mob nrog Octreotide-Depot, nyob rau qee hnub nws muaj peev xwm nce cov kev soj ntsuam kev ua haujlwm tus yam ntxwv ntawm endocrine qog ntawm lub plab hnyuv plab thiab cov txiav. Hauv cov rooj plaub no, kev pom zoo ntxiv s / c tswj hwm ntawm octreotide hauv kev siv tshuaj ua ntej pib kho nrog Octreotide Depot raug pom zoo. Qhov no tuaj yeem tshwm sim hauv thawj 2 lub hlis ntawm kev kho mob, kom txog thaum kho tshuaj ntau ntawm octreotide hauv ntshav tau tiav.

Kev zais thiab tsis ua kom tsis sib luag (metastatic) neuroendocrine cov qog ntawm daim tawv nqaij, ileum, dig muag, nce toj siab, mob plab hnyuv tws thiab hnyuv tws, lossis metastasis ntawm neuroendocrine hlav tsis muaj qhov mob ua ntej: qhov koob tshuaj pom zoo ntawm Octreotide Depot yog 30 mg txhua 4 lub lis piam. Txoj kev kho kom noj ntshav-Octototide yuav tsum ua txuas mus kom txog rau thaum cov cim mob qog.

Hauv kev kho cov tshuaj tiv thaiv kab mob qog nqaij hlav prostate, cov tshuaj pom zoo thaum pib ntawm Octreotide Depot yog 20 mg txhua 4 lub lis piam rau 3 hlis. Tom qab, cov koob tshuaj yog kho kom noj mus rau hauv tus account lub zog ntawm cov PSA concentration, nrog rau cov tsos mob hauv chaw kuaj mob. Yog tias tom qab 3 lub hlis ntawm kev kho mob nws ua tsis tiav
tsim nyog kho mob thiab tshuaj biochemical nyhuv (txo PSA), cov koob tshuaj yuav tau nce mus rau 30 mg tswj hwm txhua 4 lis piam.

Kev kho nrog Octreotide Depot yog muab xyaw nrog dexamethasone, uas yog tshuaj noj raws li cov txheej txheem hauv qab no: 4 mg ib hnub rau 1 hlis, tom qab ntawd 2 mg ib hnub rau 2 lub lis piam, tom qab ntawd 1 mg rau ib hnub (koob tshuaj txij nkawm).

Kev kho tus mob Octreotide-depot thiab dexamethasone ntawm cov neeg mob uas tau ua dhau los siv tshuaj kho mob antiandrogen yog ua ke nrog kev siv tshuaj tiv thaiv kab mob gonadotropin-tso cov tshuaj hormones (GnRH). Hauv qhov no, kev txhaj tshuaj ntawm GnRH analogue (daim ntawv fotot) yog nqa tawm 1 zaug hauv 4 lub lis piam.

Cov neeg mob uas tau txais Octreotide Depot yuav tsum kuaj txhua lub hli rau PSA ntau.

Hauv cov neeg mob uas tsis muaj mob raum, mob siab thiab cov neeg laus laus, tsis tas yuav kho qhov tshuaj ntau npaum li cas ntawm cov tshuaj Octreotide-depot.

Txog rau kev tiv thaiv tus mob tom qab kawg ntawm cov leeg hlaus, cov tshuaj Octreotide-Depot nyob rau hauv ib koob tshuaj 10 lossis 20 mg yog muab ib zaug tsis pub dhau 5 hnub thiab tsis pub dhau 10 hnub ua ntej npaj siab phais.

Cov kev cai npaj rau kev npaj ntawm kev ncua thiab kev tswj hwm ntawm cov tshuaj

Cov tshuaj siv tau tsuas yog hauv roj. Ib qho kev ncua rau kev txhaj tshuaj intramuscular yog npaj los siv cov tshuaj tov sai tam sim ua ntej tswjhwm. Cov tshuaj yuav tsum tau npaj thiab tswj hwm cov kws kho mob tshwj xeeb tau kawm xwb.

Ua ntej txhaj, ampoule nrog cov kuab tshuaj thiab lub raj mis nrog cov tshuaj yuav tsum tau muab tshem tawm hauv lub tub yees thiab nqa mus rau chav kub (30-50 feeb yog tsim nyog). Khaws lub raj mis nrog cov tshuaj Octreotide-Depot nruj me ntsis ncaj. Tapping lub vial maj mam, xyuas kom meej tias tag nrho cov lyophilisate yog nyob hauv qab ntawm lub vial.

Qhib cov pob ntim tshuaj thiab txuas 1.2 mm x 50 mm rab koob rau koob txhaj tshuaj kom sau cov kuab tshuaj. Qhib cov ampoule nrog cov kuab tshuaj thiab muab tso rau hauv cov phwj txhua cov ntsiab lus ntawm ampoule nrog cov kuab tshuaj, teeb koob txhaj tshuaj rau ib koob ntawm 2.0 ml. Tshem lub hau yas ntawm lub vial uas muaj cov tshuaj lyophilisate. Tshem tawm cov roj hmab nres ntawm lub thauv nrog cawv ib cawv cawv. Muab rab koob tso rau hauv lub lyophilisate vial los ntawm qhov chaw ntawm cov roj hmab nres thiab ua tib zoo muab cov kuab tshuaj mus rau sab hauv lub vial yam tsis kov cov ntsiab lus ntawm lub thauv nrog rab koob.

Tshem tawm cov khoom hauv qab txig. Lub vial yuav tsum nyob twj ywm tsis hloov mus txog thaum cov kuab tshuaj kom tag nrog cov tshuaj lyophilisate thiab cov ntawv ncua (rau li 3-5 feeb). Tom qab ntawd, tsis tas tig lub raj mis dua, koj yuav tsum kuaj seb puas muaj cov lyophilisate qhuav ntawm phab ntsa thiab hauv qab ntawm lub raj mis. Yog tias cov nplauv qhuav ntawm lub lyophilisate raug kuaj pom, tawm hauv lub vial kom txog thaum ua tiav.

Tom qab koj ntseeg tau tias qhov tsis muaj lyophilisate qhuav cov seem, cov ntsiab lus ntawm lub vial yuav tsum ua tib zoo sib xyaw rau hauv cov ntawv tsaig kom ntev li 30-60 vib nas this kom txog thaum muaj kev txwv tsis pub tsim homogeneous. Tsis txhob flip lossis co lub vial, vim tias qhov no yuav ua rau ploj ntawm flakes thiab raug tshem tawm tsis zoo.

Caw nrawm qhov koob los ntawm cov roj hmab nres rau hauv lub vial. Tom qab ntawd lub koob txhaj tshuaj tau raug txo qis thiab, los ntawm tilting lub vial ntawm ib kaum ntawm 45 degrees, maj mam kos cov kev ncua ntawv mus rau hauv cov koob txhaj tshuaj kom tiav. Tsis txhob ntxeev lub raj mis thaum ntaus ntawv. Ib qho me me ntawm cov tshuaj yuav nyob rau ntawm cov phab ntsa thiab hauv qab ntawm lub vial. Kev noj rau cov khoom seem ntawm phab ntsa thiab hauv qab ntawm lub raj mis yog coj mus rau hauv tus account.

Tam sim tom qab sau cov kev ncua, hloov rab koob nrog cov kab xaum liab nrog rab koob nrog lub kab ntsuab (0.8 x 40 mm), ua tib zoo muab lub taub hau thiab tshem cov pa ntawm lub koob txhaj tshuaj.

Ib qho kev ncua ntawm cov tshuaj Octreotide-Depot yuav tsum tau muab tswj tam sim ntawd tom qab npaj. Ib qho kev ncua ntawm cov tshuaj Octreotide-Depot yuav tsum tsis txhob muab nrog lwm cov tshuaj nyob hauv ib qho koob txhaj.

Siv cov cawv cawv tshuaj ntxuav mus rau qhov chaw txhaj tshuaj. Ntxig lub koob txhaj rau hauv cov gluteus maximus leeg, tom qab ntawd rub tawm cov koob txhaj plunger rov qab kom paub tseeb tias tsis muaj kev puas tsuaj rau lub nkoj. Qhia cov kev ncua ntxiv intramuscularly maj mam nrog lub siab tsis tu ncua ntawm cov koob txhaj tshuaj nqus dej.

Yog tias nws nkag rau hauv cov ntshav, qhov chaw txhaj tshuaj thiab rab koob yuav tsum hloov. Thaum txhaws lub koob, hloov nws nrog lwm rab koob ntawm tib lub taub.

Nrog kev hno tas, sab laug thiab sab xis yuav tsum sib hloov.

Sab sij huam

Cov tshuaj tiv thaiv hauv zos: nrog rau i / m tswj hwm ntawm Octreotide-depot, mob yog ua tau, tsawg dua ntaws thiab tawm pob rau ntawm qhov chaw txhaj tshuaj (feem ntau me, luv luv nyob).

Los ntawm cov hnyuv: ua kom mob plab, xeev siab, ntuav, mob plab heev, tsam plab, tsim cov roj ntau dhau, tso quav ua xua, raws plab, steatorrhea. Txawm hais tias kev tshem tawm cov rog nrog quav yuav nce ntxiv, kom txog hnub tim tsis muaj ib qho pov thawj pom tias kev kho mob ntev nrog octreotide tuaj yeem ua rau kev txhim kho ntawm lub cev tsis muaj qee yam ntawm cov khoom noj vim tias malabsorption (malabsorption).Qee qhov tsis tshua muaj tshwm sim, qhov tshwm sim uas zoo li lub plab hnyuv tsis tuaj yeem muaj tshwm sim: tsam plab, mob hnyav hauv thaj av epigastric, ua kom nruj ntawm lub plab phab ntsa. Lub caij nyoog siv Octreotide Depot tuaj yeem ua rau tsim cov mob gallstones.

Los ntawm cov txiav ua kab mob ntsws: tsis tshua muaj tus neeg muaj mob voos qoos uas tsim los hauv thawj teev lossis hnub tom qab uas tau siv octreotide. Nrog rau kev siv ntev, muaj mob qog nqaij hlav nrog mob cholelithiasis.

Ntawm ib sab ntawm daim siab: muaj cov ntawv ceeb toom cais ntawm kev txhim kho ntawm lub siab ua haujlwm tsis txaus (mob siab tsis muaj kab mob siab cholestasis nrog kev hloov kho tsis tu ncua tom qab tshem tawm octreotide), qhov kev txhim kho qeeb ntawm hyperbilirubinemia, nrog rau kev nce hauv ALP, GGT thiab, kom tsawg dua, lwm yam kev hloov pauv.

Los ntawm ib sab ntawm cov metabolism: txij li Octreotide Depot muaj qhov txiaj ntsig dhau ntawm kev tsim GR, glucagon thiab insulin, nws tuaj yeem cuam tshuam cov metabolism hauv cov piam thaj. Muaj peev xwm txo qis qab zib ntxiv tom qab noj mov. Nrog kev siv lub sijhawm ntev ntawm Octreotide sc rau qee kis, mob siab ntsws hyperglycemia tuaj yeem tsim kho. Kuj tau pom hais tias Hypoglycemia.

Lwm yam: hauv qee qhov tsis tshua muaj tshwm sim, kev txiav plaub hau ib ntus tom qab tswj hwm ntawm octreotide, qhov tshwm sim ntawm bradycardia, tachycardia, ua tsis taus pa, tawv nqaij ua pob khaus, anaphylaxis tau tshaj tawm. Muaj cov ntawv qhia txawv ntawm kev txhim kho cov tshuaj tiv thaiv hypersensitivity.

Octreotide depot, cov lus qhia rau siv: txoj kev thiab qhov ntau npaum li cas

Octreotide Depot yog npaj rau kev tswj hwm intramuscular.

Kev raug ncua yog npaj los ntawm cov neeg kho mob kawm ua ntej txhaj tshuaj. Rau kev zom taus ntawm cov lyophilisate siv cov tshuaj hnyav.

Cov kev cai npaj rau kev npaj ncua kev kawm thiab kev coj ua ntawm Octreotide-depot:

1. Tshem tawm qhov kev npaj los ntawm tub yees thiab nqa mus rau chav sov (qhov no feem ntau yuav siv sijhawm 30 mus rau 50 feeb).
2. Tuav lub raj mis ncaj ncaj, nws yog ib qho yooj yim khob nws thiaj li tias tag nrho cov lyophilisate tog mus rau hauv qab.
3. Qhib lub ntim nrog cov phwj thiab muab ib rab koob nrog cov paj yeeb dawb 1.2x50 hli hauv qhov loj rau nws.
4. Qhib cov ampoule nrog cov kuab tshuaj, sau tag nrho cov ncauj lus rau hauv cov phwj tshuaj thiab muab nws tso rau ib koob tshuaj 2 ml.
5. Tshem lub hau yas ntawm lub lyophilisate vial, ntxuav lub cork nrog lub khob cawv cawv.
6. Tso cov koob txhaj tshuaj nrog cov kuab tshuaj mus rau hauv lub vias mus rau hauv nruab nrab ntawm cov nres nres thiab ua tib zoo nchuav qhov kev daws teeb meem raws lub puab sab hauv ntawm lub thauv uas tsis chwv lub ntsiab lus ntawm rab koob.
7. Tshem tawm cov koob txhaj tshuaj thiab tawm ntawm lub vial tsis muaj zog kom txog thaum lub lyophilisate tag nrho nrog cov kuab tshuaj thiab ua rau ncua kev kawm (kwv yees li 3-5 feeb). Tsis tas tig lub raj mis dhau, xyuas seb puas muaj lyophilisate qhuav rau hauv qab thiab phab ntsa. Yog tias pom cov hmoov av qhuav seem, tawm hauv lub thauv ntev ntev kom txog thaum yaj tag.
8. Tom qab ua kom paub tseeb tias tsis muaj cov tshuaj lom uas tsis muaj kev pab cuam, ua tib zoo sib xyaw cov ntsiab lus ntawm lub vial rau hauv kev ncig rau 30-60 vib nas this, kom qhov kev ncua ntawv yog homogeneous. Tsis txhob co thiab tig lub hwj, qhov no tuaj yeem ua rau poob ntawm cov plaub ya ri, uas yuav ua rau cov tshuaj tsis tuaj yeem.
9. Muab cov koob txhaj sai sai nrog rab koob tso rau hauv lub vial los ntawm kev siv roj hmab nres. Txo qhov qis ntawm rab koob qis dua thiab ntawm 45 ° kaum ntawm lub vial, maj mam sau cov kev ncua. Txuag me me ntawm kev ncua ntawv yuav nyob twj ywm rau hauv qab thiab phab ntsa ntawm lub vial. Qhov seem no tau muab, yog li koj yuav tsum tsis txhob tig lub raj mis sab hauv thaum noj cov tshuaj.
10. Hloov cov txheej txheem tso nrog cov koob ntxig ntxig nrog lub txig ntsuab (0.8x40 mm), maj mam tig lub koob txhaj tshuaj thiab tshem cov cua ntawm nws.
11. Siv tshuaj tua kab mob nrog lub khob cawv cawv.
12. Ntxig lub koob txhaj rau hauv cov nqaij gluteal thiab rub lub piston rov qab me ntsis kom paub tseeb tias tsis muaj kev puas tsuaj hauv lub nkoj. Yog tias nws nkag mus rau hauv cov hlab ntshav, lub koob yuav tsum hloov pauv mus rau lwm qhov ntawm tib lub taub thiab qhov chaw txhaj tshuaj yuav tsum tau hloov.
13. Qhia cov kev ncua ntxiv los ntawm kev nias lub plunger lub koob txhaj tshuaj tas li.

Qhov tshem tawm npaj los ntawm lyophilisate yog homogeneous, dawb lossis daj-dawb.

Nrog kev rov qab ua ntxiv, txoj cai glutus nqaij txoj cai thiab sab laug yuav tsum tau sib hloov.

Octreotide Depot yuav tsum tsis txhob sib xyaw nrog cov koob txhaj tshuaj nrog lwm cov tshuaj.

Cov tshuaj yeej ib txwm khaws cia rau hauv tub yees, tab sis nyob rau hnub ntawm kev txhaj tshuaj, lub vial nrog lyophilisate thiab ampoule nrog cov kuab tshuaj yog tau tso cai cia hauv chav sov.

Acromegaly txoj kev kho

Rau cov neeg mob uas tau siv luv octreotide (rau kev txhaj tshuaj subcutaneous) muab kev tswj hwm tus cwj pwm ntawm tus kab mob txaus, nws muaj peev xwm pib tswj hwm kev kho mob Octreotide-depot hnub tom qab kawg s / c tswj hwm ntawm octreotide. Lawv pib kho nrog ib koob tshuaj 20 mg txhua 4 lis piam, ntawm qhov tshuaj no yuav siv rau 3 lub hlis. Yav tom ntej, kws kho mob kho cov koob tshuaj nyob ntawm saib mob kis thiab tus mob GR thiab IGF-1 hauv cov ntshav cov ntshav.

Yog tias tsis pub dhau 3 lub hlis nws tsis tuaj yeem ua tiav cov lus teb tsim nyog, ob qhov chaw kuaj mob thiab tshuaj lom neeg (tshwj xeeb, yog tias qib GR tsis poob qis dua 2.5 μg / l), qhov koob tshuaj tau nce mus rau 30 mg txhua 4 lub lis piam.

Yog tias tom qab 3 lub hlis ntawm kev siv tshuaj tas zog ntawm Octreotide-depot 20 mg muaj qhov txo qis hauv qhov kev tso tseg ntawm GR hauv cov ntshav cov ntshav hauv qab 1 μg / l, qhov concentration ntawm IGF-1 yog li qub thiab thim rov qab cov tsos mob ntawm acromegaly ploj, ib koob tshuaj yuav raug txo mus rau 10 mg. Txoj kev kho yuav tsum ua txuas mus kom ze hauv chav saib xyuas.

Cov neeg mob uas tau txais cov tshuaj khov kho nyob rau lub cev tuaj yeem txiav txim siab qhov concentration ntawm GR thiab IGF-1 ib zaug txhua rau lub hlis.

Thaum lub sijhawm teem rau Octreotide-Depot yuav tsum muaj kev kho mob luv ntawm nruab nrab ntawm kev kawm ntawm kev kho hluav taws xob, zoo li nyob rau cov neeg mob uas kev phais mob thiab hluav taws xob tau ua tsis tau zoo lossis tsis muaj txiaj ntsig, nws raug nquahu kom ua qhov kev sim ntawm kev kho mob nrog luv-octreotide (rau kev tswj hwm sc) kom ntsuas nws kev txiav txim thiab ib leeg ua siab ntev, thiab tsuas yog tom qab ntawv thov Octreotide Depot raws li cov txheej txheem piav qhia saum toj no.

Yeeb tshuaj sib cuam tshuam

Octreotide txo qis cyclosporin nqus los ntawm cov hnyuv thiab ua rau qeeb ntawm kev nqus ntawm cimetidine.

Nrog rau kev siv txaws ib txhij octreotide thiab bromocriptine, lub bioavailability ntawm cov yav tas nce.

Muaj cov ntawv sau ua pov thawj tias somatostatin analogues tuaj yeem txo qhov kev zom zaub mov kom tsis txhob muaj cov tshuaj metabolized los ntawm isoenzymes ntawm cytochrome P450, uas tuaj yeem tshwm sim los ntawm kev siv GR. Txij li nws tsis tuaj yeem tshem tawm cov kev cuam tshuam zoo sib xws ntawm octreotide, cov tshuaj uas metabolized los ntawm isoenzymes ntawm cytochrome P450 system thiab muaj qhov nqaim kho ntau yam (quinidine thiab terfenadine) yuav tsum tau kho nrog kev ceev faj.

Kev kho cov qog endocrine ntawm lub plab hnyuv thiab lub cev ua xoos

Rau cov neeg mob nyob rau hauv uas siv luv luv ua yeeb yaj kiab octreotide muab kev tswj kom zoo ntawm cov tsos mob ntawm tus kab mob, thawj zaug koob tshuaj yog 20 mg txhua 4 lub lis piam. Ntxiv mus, tom qab pib ua haujlwm tswj hwm ntawm Octreotide-depot, kev siv lub suab quaj qw yog txuas ntxiv rau lwm 2 lub lis piam.

Rau cov neeg mob uas tsis tau dhau los cov phev octreotide, kev kho mob raug pom zoo kom pib ntawm daim ntawv ntau npaum li cas ntawm cov tshuaj rau s / c tswj hwm ntawm ib koob ntawm 0.1 mg 3 zaug hauv ib hnub rau txog 2 lub lis piam. Qhov no yog qhov tsim nyog txhawm rau ntsuas nws cov txiaj ntsig thiab kev ua siab ntev rau ib leeg. Tsuas yog tom qab ntawd tuaj yeem Octreotide Depot siv tau raws li tau piav los saum no.

Yog tias tom qab 3 lub hlis dhau los ntawm kev kho tsuas yog ib feem txhim kho tau tiav, Octreotide Depot 30 mg txhua 4 lub lis piam tau muab tshuaj. Hauv qhov xwm txheej uas tsis pub dhau 3 lub hlis ntawm txoj kev kho mob nws muaj peev xwm ua tiav kom muaj kev tswj hwm txaus los ntawm cov chaw kuaj mob thiab cov cim roj ntsha, cov koob tshuaj tuaj yeem txo mus rau 10 mg txhua 4 lub lis piam.

Tawm tsam cov keeb kwm yav dhau los ntawm kev siv Octreotide-depot nyob rau qee hnub (feem ntau hauv thawj 2 lub hlis ntawm kev kho mob, kom txog thaum kho ntshav ntau ntawm cov tshuaj muaj peev xwm ua tiav), cov kab mob kev soj ntsuam cov yam ntxwv ntawm cov qog endocrine ntawm lub plab hnyuv thiab lub caj pas tuaj yeem ua kom nrov dua. Cov neeg mob zoo li no tau hais qhia ntxiv kom cia lub suab qw octreotide ntawm ib koob tshuaj uas tau sau tseg ua ntej pib lub Octreotide Depot.

Nyob rau hauv cov ntaub ntawv ntawm kev zais thiab tsis zais cov neuroendocrine hlav ntawm transverse hnyuv, nce pob hauv plab hnyuv, ileum, dig muag, jejunum thiab hnyuv tws, nrog rau metastases ntawm neuroendocrine hlav tsis muaj lub hom phiaj tseem ceeb, Octreotide-depot yog tshuaj hauv ib koob ntawm 30 mg txhua 4 lub lis piam. Txoj kev kho yog txuas ntxiv mus kom txog thaum cov qog tuaj yeem tswj tau (kom txog thaum cov cim ntawm nws qhov kev tshwm sim).

Kev kho mob ntawm qog-resistant prostate cancer

Qhov pom zoo thawj zaug pom zoo ntawm Octreotide Depot yog 20 mg txhua 4 lub lis piam rau 3 hlis. Yav tom ntej, kws kho mob kho cov koob tshuaj nyob ntawm saib lub chaw txhaj tshuaj ntawm tus kab mob thiab cov concentration ntawm cov prostatic antigen hauv cov ntshav cov ntshav.

Yog tias nyob hauv 3 lub hlis ntawm kev kho nws tsis tuaj yeem ua tiav kev tswj hwm ntawm cov tsos mob soj ntsuam ntawm tus kab mob thiab cov cim roj ntsha (txo PSA), qhov koob tshuaj tau nce ntxiv rau 30 mg txhua 4 lub lis piam.

Octreotide-depot yog siv ua ke nrog dexamethasone siv nyob rau hauv cov tshuaj noj ntawm qhov ncauj raws li cov txheej txheem hauv qab no: 4 mg / hnub rau 1 hlis, tom qab ntawd 2 mg / hnub rau 2 lub lis piam, thiab tom qab ntawd 1 mg / hnub.

Hauv cov neeg mob uas yav tas los tau txais kev kho tshuaj antiandrogen, kev sib xyaw ntawm Octreotide-Depot + Dexamethasone yog ua ke nrog kev siv cov analogue ntawm gonadotropin-tso cov tshuaj hormone ntawm cov ntawv rho, uas tau txhaj ib zaug txhua 4 asthiv.

Txhua lub hlis thaum kho, nws yog qhov tsim nyog los txiav txim siab qhov concentration ntawm PSA.