Daim ntawv txiav txim - kev daws teeb meem rau kev tswj hwm subcutaneous: tsis muaj xim lossis yuav luag tsis muaj xim (3 ml txhua * hauv cov ntawv ntim iav, uas tau muab ntim rau hauv cov hnab yas xau pov tseg rau ntau qhov kev txhaj tshuaj, hauv ib pob duab los ntawm 1, 2 lossis 3 koob txhaj tshuaj).

* Hauv 1 rab koob xaum (3 ml) muaj 10 koob tshuaj 1.8 mg, 15 koob ntawm 1.2 mg lossis 30 koob ntawm 0.6 mg.

Cov tshuaj tseem ceeb: liraglutide, hauv 1 ml - 6 mg.

Ntu cov khoom siv: hydrochloric acid / sodium hydroxide q.s., sodium hydrogen phosphate dihydrate, phenol, propylene glycol, dej rau kev txhaj tshuaj.

Cov Tshuaj Hauv Tshuaj

Liraglutide yog ib qho khoom noj tsis haum ntawm tib neeg GLP-1 (glucagon-zoo li peptide-1). Ua los ntawm cov txheej txheem biotechnology ntawm kev tso tawm DNA (deoxyribonucleic acid) siv Saccharomyces cerevisiae lim, uas muaj 97% homology nrog tib neeg GLP-1, khi thiab ua kom GLP-1 receptors hauv tib neeg.

GLP-1 receptor yog lub hom phiaj rau haiv neeg GLP-1, uas yog endogenous hormone ntawm incretin uas ua rau cov ntshav qabzib-insulin muaj zais cia rau hauv pancreatic cells-hlwb. Piv nrog cov haiv neeg GLP-1, cov pharmacodynamic thiab pharmacokinetic profiles ntawm liraglutide tso cai nws yuav tsum tau noj ib hnub ib zaug.

Nrog kev txhaj tshuaj subcutaneous, qhov ntev ua haujlwm ntawm qhov quav yeeb tshuaj yog raws peb txoj kev ua haujlwm:

kev sib koom tes tus kheej, uas muab ncua ntev liraglutide,
khi rau albumin,
qib siab ntawm enzymatic ruaj khov tiv thaiv DPP-4 (dipeptidyl peptidase-4) thiab NEP (enzyme nruab nrab endopeptidase), uas ua kom T ntev_1/2 (ib nrab-lub neej) ntawm ib yam khoom los ntawm ntshav ntshav.

Cov txiaj ntsig ntawm liraglutide yog ua raws li kev sib cuam tshuam nrog cov kis tshwj xeeb GLP-1, raws li cov txiaj ntsig ntawm theem uas cAMP (cyclic adenosine monophosphate) nce. Raws li kev txiav txim ntawm cov tshuaj, glucose-dependent stimulation ntawm insulin secretion yog pom, thiab kev ua haujlwm ntawm pancreatic cells-cells txhim kho. Nyob rau tib lub sijhawm, piam thaj-kev tsuj ntshav ntawm kev cuam tshuam ntau dhau kev tso ua ke ntawm glucagon tshwm sim. Yog li, nrog kev nce ntxiv hauv cov concentration ntawm cov ntshav qabzib, glucagon secretion yog suppressed thiab insulin secretion yog tsa.

Ntawm qhov tod tes, hauv cov neeg mob hypoglycemia, liraglutide txo qis cov tshuaj insulin tsis muaj cov tshuaj tiv thaiv glucagon tso pa tawm. Tus txheej txheem rau kev txo qis glycemia tseem suav nrog kev qeeb me ntsis hauv kev ua kom lub plab zom mov. Siv cov txheej txheem uas ua rau txo qis kev tshaib plab thiab txo qis hauv kev siv lub zog, liraglutide ua rau txo qis nqaij adipose thiab poob phaus.

GLP-1 yog lub zog tswj kev ua kom qab los noj mov thiab cov khoom noj uas muaj calorie, lub receptors ntawm no peptide nyob rau ntau thaj chaw ntawm lub paj hlwb uas koom nrog cov kev cai ntawm lub qab los noj mov.

Thaum ua cov kev tshawb fawb tsiaj, nws tau pom tias los ntawm kev ua kom tshwj xeeb ntawm GLP-1 receptors, liraglutide ua rau cov cim kev ua kom meej dua thiab ua kom lub cev ua kom tsis muaj zog, thiaj li ua rau poob phaus.

Tsis tas li, raws li cov kev tshawb fawb tsiaj, liraglutide qeeb kev loj hlob ntawm cov ntshav qab zib. Cov tshuaj yog qhov ua tau zoo nyob rau hauv kev tshwj xeeb ntawm kev tua kab mob hlwb (pancreatic cell-cell proliferation) thiab tiv thaiv kev tuag ntawm β-hlwb (apoptosis), uas yog ntxias los ntawm cytokines thiab cov roj dawb. Yog li, liraglutide nce insulin biosynthesis thiab nce β-cell ntau. Tom qab normalizing cov piam thaj hauv siab, liraglutide nres nce qhov ntau ntawm pancreatic β-cells.

Cov neeg muaj yeej muaj lub sijhawm ntev 24-teev thiab hloov kho glycemic, uas yog ua tiav los ntawm kev txo qis ntawm kev saib xyuas ntawm cov roj ntsha sai thiab tom qab noj mov nrog hom 2 ntshav qab zib.

Cov Tshuaj Pharmacokinetics

Tom qab ua haujlwm subcutaneous, liraglutide nqus tau qeeb, T_max (lub sijhawm kom mus txog qhov siab tshaj plaws) hauv cov ntshav yog 8-12 teev. C_max (qhov siab tshaj plaws) hauv cov ntshav tom qab kev tswj hwm ib koob ntawm 0.6 mg yog 9.4 nmol / L. Thaum siv cov koob tshuaj ntawm 1.8 mg nruab nrab C_ss (ua kom siab sib npaug) hauv ntshav mus txog li 34 nmol / L. Cov kis ntawm cov tshuaj tau txhim kho hauv qhov sib piv nrog cov koob tshuaj. Kev nkag siab ntawm tus kheej coefficient ntawm kev sib txawv rau AUC (thaj chaw hauv qab qhov ntsuas-lub sijhawm nkhaus) tom qab tswj hwm ntawm liraglutide hauv ib qho tshuaj yog 11%. Kev tsis raug cai ntawm bioavailability yog li 55%.

Xauj V_d (ntim ntawm kev faib khoom) ntawm liraglutide hauv cov ntaub so ntswg nrog subcutaneous txoj kev tswj hwm yog 11-17 u, tus nqi nruab nrab ntawm V_d tom qab kev tswj hwm zoo - 0.07 l / kg. Cov ntsiab lus tseem ceeb ntawm liraglutide nrog cov plasma protein yog sau tseg (> 98%).

Kev siv cov metabolism hauv liraglutide tshwm sim zoo li cov protein loj, tsis tau koom ua ib txoj hauv kev rau kev nthuav tawm ntawm qee yam khoom hauv nruab nrog cev. Rau 24 teev tom qab kev tswj hwm ntawm tib qho tshuaj, cov tshuaj tsis hloov pauv tseem ua lub ntsiab lus tseem ceeb ntawm cov ntshav muaj ntshav. Ob lub cev tshuaj tau kuaj pom hauv cov ntshav (≤ 9 thiab ≤ 5% ntawm tag nrho cov koob tshuaj).

Tsis hloov pauv liraglutide tom qab muab tshuaj 3 H-liraglutide tso zis lossis tso quav tsis tau txiav txim. Tsuas yog ib feem me me ntawm cov metabolites cuam tshuam nrog cov tshuaj tau tawm ntawm lub raum los yog los ntawm cov hnyuv (6 thiab 5%, feem). Tom qab subcutaneous thawj coj ntawm ib koob tshuaj liraglutide, qhov nruab nrab ntawm kev txiav tawm hauv lub cev yog kwv yees li 1.2 l / h nrog kev tshem tawm T_1/2 txog 13 teev.

Kev ntsuas rau siv

Raws li cov lus qhia, Viktoza siv rau kev mob ntshav qab zib hom 2 nrog rau kev noj haus thiab kev tawm dag zog kom ua tiav glycemic tswj.

Txoj hauv kev ntawm txoj kev siv tshuaj:

tshuaj mob hlwb
kev sib txuas ua ke nrog ib lossis ntau qhov ncauj hypoglycemic tus neeg sawv cev (thiazolidinediones, sulfonylureas, metformin) hauv cov neeg mob uas tsis ua tiav cov glycemic tswj tau zoo nyob rau yav dhau los kho,
kev sib xyaw nrog kev kho mob nrog basal insulin hauv cov neeg mob uas ua tsis tiav ua tiav kev tswj glycemic siv Victoza ua ke nrog metformin.

Cov Yuav Tsum Tau Ua

mob ketoacidosis,
ntshav qab zib hom 1
ntau yam kab mob neocyloos neoplasia 2,
lub siab ua tsis taus haujlwm,
mob raum tsis zoo,
ntshav qab zib gastroparesis,
mob hnyuv kab mob,
mob plawv tsis ua haujlwm ntawm chav III - IV ua haujlwm raws li kev faib tawm los ntawm New York Cardiology Association (NYHA),
keeb kwm ntawm kev mob kheesxaws medullary, nrog rau kev txheeb ze,
hnub nyoog txog 18 xyoo
cev xeeb tub thiab lactation
kev sib xyaw ua si rau ib qho twg ntawm Victoza.

cov mob qog
mob plawv tsis ua hauj lwm ntawm I - II ua haujlwm chav kawm raws li NYHA kev faib tawm,
hnub nyoog tshaj 75 xyoo.

Cov lus qhia rau kev siv Victoza: txoj kev thiab qhov ntau npaum li cas

Victoza yuav tsum tau muab tshuaj subcutaneously rau hauv lub plab, xub pwg lossis ncej puab ib hnub ib zaug, tsis hais noj mov dab tsi. Qhov chaw thiab lub sijhawm ntawm kev txhaj tshuaj tuaj yeem hloov tau yam tsis muaj kev hloov kho koob tshuaj, txawm li cas los xij, nws yog qhov tsim nyog los tswj cov tshuaj nyob rau tib lub sijhawm ntawm hnub, uas yooj yim rau tus neeg mob.

Txhawm rau txhawm rau txhim kho lub plab zom mov, kev kho mob yog pom zoo nrog koob tshuaj txhua hnub ntawm 0.6 mg. Tom qab ib lub lim tiam tsawg kawg, cov koob tshuaj tau nce siab txog 1.2 mg. Yog tias tsim nyog, txhawm rau kom ua tiav cov kev tswj hwm zoo glycemic, suav nrog qhov kev kuaj mob ntawm Victoza, qhov kev nce ntxiv rau 1.8 mg yog ua tau yam tsawg ib lub lim tiam tom qab. Kev siv cov koob tshuaj ntau dua yog tsis pom zoo.

Cov tshuaj muaj peev xwm ua tau ntxiv rau qhov kev kho mob txuas ntxiv nrog metformin los yog kev sib koom tes kho nrog metformin ua ke nrog thiazolidinedione. Cov koob tshuaj ntawm cov xim kawg tsis tas yuav ua kom haum.

Cov neeg mob tuaj yeem ntxiv rau sulfonylurea derivative kev kho mob lossis kev sib txuas ua ke metformin ua ke nrog sulfonylurea derivatives. Hauv qhov no, kom txo qis kev pheej hmoo ntawm kev tsim cov ntshav tsis txaus siab, qhov koob tshuaj sulfonylurea derivatives yuav tsum raug txo kom tsawg.

Victoza tseem tuaj yeem ntxiv rau cov tshuaj insulin basal, tab sis kom txo qis kev pheej hmoo ntawm hypoglycemia, nws yog qhov tsim nyog los txo cov koob tshuaj insulin.

Thaum twg tsis txhaj koob tshuaj:

yog tias tsis pub dhau 12 teev dhau los, koj yuav tsum nkag mus rau qhov tsis nco qab sai li sai tau,
yog tias ntau dua 12 teev tau dhau mus lawm, koob tshuaj yuav tsum muab ntxiv rau hnub tom qab ntawm lub sijhawm teem, i.e., nws tsis tas yuav them nyiaj rau qhov koob tshuaj uas ploj lawm los ntawm kev qhia ntxiv lossis ntxiv rau ob zaug.

Cov lus qhia rau kev siv Victoza (Txujci thiab ntau npaum li cas)

S / c tau txhaj rau lub plab / ncej puab ib hnub ib zaug, tsis hais txog ntawm cov khoom noj.

Nws yog qhov zoo dua rau nkag mus rau tib lub sijhawm ntawm ib hnub. Qhov chaw txhaj tshuaj yuav txawv. Cov tshuaj tsis tuaj yeem nkag rau hauv / thiab thiab m.

Lawv pib kho nrog 0.6 mg ib hnub twg. Tom qab ib lub lim tiam, cov koob tshuaj tau nce siab txog 1.2 mg. Yog tias tsim nyog, rau qhov kev tswj hwm zoo glycemic, nce ntxiv rau 1.8 mg tom qab ib lim tiam. Qhov koob tshuaj saum toj no 1.8 mg yog qhov ua tsis tau.
Nws yog feem ntau thov rau kev kho ntxiv. Metforminlossis Metformin+ Thiazolidinedionehauv koob tshuaj yav dhau los. Thaum ua ke nrog sulfonylurea derivatives, qhov koob tshuaj ntawm tom kawg yuav tsum raug txo kom tsawg, txij li tsis xav tau ntshav qog.

Nrog kev qhia ntawm kev noj tshuaj ntau dua 40 zaug ntawm thaj tsam nruab nrab, xeev siab thiab ntuav tshwm sim. Kev kho mob raws qab.

Thaum noj nrog Paracetamol cov koob tshuaj ntawm qhov kawg tsis tas yuav ua kom haum.

Tsis ua rau muaj kev hloov pauv tseem ceeb hauv cov tshuaj pharmacokinetics Atorvastatin.

Koob tshuaj kho Griseofulvin nrog kev siv nrawm ntawm Victoza tsis yog yuav tsum tau ua.

Kuj tsis muaj kev kho Dozlizinoprilthiab Digoxin.

Cov nyhuv cuam tshuam Ethinyl estradiolthiab Levonorgestrel thaum noj nrog Viktoza tsis hloov pauv.

Yeeb tshuaj cuam tshuam nrog Cov tshuaj insulinthiab Warfarin tsis kawm ntawv.

Tso tawm los ntawm kev kho mob.

Muab cia rau hauv tub yees li 2–8 ° C; khaws cia rau hauv chav tsev tsis kub tshaj 30 ° C yog qhov zoo.

Cov lus qhia: Liraglutide, Baeta(zoo ib yam li ntawm kev ntsuas ntawm kev ua, tab sis cov khoom ua si sib txawv).

Kev tshuaj xyuas ntawm cov kws kho mob txog Viktoz nqis los rau qhov tseeb tias qhov tshuaj yuav tsum tau siv raws li kev taw qhia thiab tsuas yog qhia los ntawm tus kws kho mob. Cov kev tshawb fawb pom tau tias cov tshuaj rau kev kho mob ntshav qab zib hom 2, Baeta thiab Victoza, tau txais txiaj ntsig zoo los ntawm kev tswj cov rog dhau. Cov ntsiab lus no yog qhov tseem ceeb vim tias txoj haujlwm tseem ceeb hauv kev kho mob rau cov neeg mob nrog kev kuaj mob no yog poob phaus.

Cov tshuaj yog npaj rau TSHUAJ mob ntshav qab zibthiab kev tiv thaiv ntawm nws cov teeb meem, cov kab mob zoo cuam tshuam rau cov hlab plawv cov ntshav. Nws tsis tsuas yog qis dua theem ntawm cov piam thaj, tab sis kuj rov qab tsim cov khoom nruab nrog cev ntawm insulin hauv cov neeg mob ntshav qab zib. Hauv kev sim tsiaj, nws tau ua pov thawj tias nyob hauv nws cov cawv cov qauv ntawm beta hlwb thiab lawv txoj haujlwm yog rov ua haujlwm. Kev siv cov tshuaj tso cai rau kev nkag mus rau kev kho kom zoo Mob ntshav qab zib Hom 2.

Viktoza rau kev poob phaus hauv qee cov neeg mob ntshav qab zib tau siv ua kev kho mob ntshav qab zib. Txhua tus neeg mob tau sau tseg tias tsis qab los noj mov ntau. Qhov ntsuas cov ntshav qab zib nyob hauv nruab hnub tsis pub dhau qhov txwv, qib tau rov qab zoo li qub nyob rau ib hlis triglycerides.

Cov tshuaj tau sau tawm ntawm koob tshuaj 0.6 mg ib hnub ib zaug rau ib lim tiam, tom qab ntawd cov koob tshuaj tau nce siab txog 1.2 mg. Lub sijhawm tiv thaiv yog 1 xyoos. Cov txiaj ntsig tau zoo tshaj plaws tau pom nrog kev sib xyaw ua ke nrog Metformin. Hauv thawj lub hlis ntawm kev kho mob, qee cov neeg mob poob 8 kg. Cov kws kho mob ceeb toom rau kev tswj hwm tus kheej ntawm cov tshuaj no rau cov neeg uas xav kom poob phaus. Kev siv nws nqa tau kev pheej hmoo lub qog mob cancer thiab muaj tshwm sim pancreatitis.

Kev txheeb xyuas ntawm cov kab ntawv yog feem ntau tsis zoo. Feem ntau cov neeg poob ceeb thawj ceeb toom poob phaus ntawm 1 kg hauv ib hlis, ntawm qhov zoo tshaj 10 kg rau rau lub hlis. Cov lus nug tau hais txog sib tham: puas muaj ib qho kev cuam tshuam hauv kev cuam tshuam hauv cov metabolism hauv kev xav tau ntawm 1 kg hauv ib hlis? Txawm tias muaj tseeb hais tias kev noj haus thiab kev tawm dag zog yog tseem yuav tsum tau ua.

"Kev cuam tshuam cov metabolism ... tsis muaj."

“Kuv lees tias kev kho tshuaj yog qhov tsim nyog rau qib 3-4 ntawm kev rog dhau, thaum cov metabolism tawm mus yuam kev, tab sis ntawm no? Kuv tsis to taub ... "

“Hauv tebchaws Ixayees, yam tshuaj no tsuas yog kho rau cov neeg mob ntshav qab zib nrog rau qib uas tsis muaj piam thaj. Koj tsuas tsis tau txais daim ntawv qhia xwb. "

“Tsis muaj ib yam dab tsi zoo hauv cov tshuaj no. Txog 3 hlis + 5 kg. Tab sis kuv tsis siv nws kom yuag poob, Kuv yog tus mob ntshav qab zib. "

Koj tuaj yeem yuav hauv Victoza hauv Moscow hauv ntau cov chaw muag tshuaj. Tus nqi ntawm cov tshuaj txhaj hauv ib 3 ml koob txhaj tshuaj xev No. 2 hauv ntau lub tsev muag tshuaj xws li 7187 rubles. mus txog 11258 rub.

Kev daws rau sc administration tsis muaj kob lossis yuav luag tsis muaj xim, pob tshab.

Cov zam: sodium hydrogen phosphate dihydrate - 1.42 mg, propylene glycol - 14 mg, phenol - 5.5 mg, hydrochloric acid / sodium hydroxide - q.s., dej rau kev txhaj tshuaj - txog 1 ml.

3 ml - iav cartridges (1) - koob txhaj tshuaj (1) - pob khoom los ntawm cardboard.
3 ml - iav daim cartridges (1) - iav syringe (2) - pob khoom los ntawm cardboard.
3 ml - iav daim cartridges (1) - iav syringe (3) - pob khoom los ntawm cardboard.

Kev siv tshuaj hypoglycemic. Liraglutide yog ib qho khoom sib piv ntawm tib neeg glucagon-zoo li peptide-1 (GLP-1), ua los ntawm recombinant DNA biotechnology siv Saccharomyces cerevisiae lim, uas muaj 97% homology nrog tib neeg GLP-1, uas khi thiab ua kom GLP-1 receptors hauv tib neeg. GLP-1 receptor ua haujlwm raws li lub hom phiaj rau haiv neeg GLP-1, endogenous hormone incretin, uas cov tshuaj tiv thaiv tsis muaj ntshav qabzib-insulin secretion hauv pancreatic beta hlwb. Tsis zoo li haiv neeg GLP-1, cov pharmacokinetic thiab pharmacodynamic profiles ntawm liraglutide tso cai rau nws muab rau cov neeg mob ib hnub 1 zaug / hnub.

Cov ntawv ua haujlwm ntev ntawm cov tshuaj tiv thaiv liraglutide raws li kev txhaj tshuaj subcutaneous yog muab los ntawm peb cov txheej txheem: kev koom nrog tus kheej, uas ua rau cov tshuaj ncua qeeb, khi rau albumin thiab qib siab ntawm enzymatic kev ruaj khov nrog kev hwm rau dipeptidyl peptidase-4 (DPP-4) thiab qhov nruab nrab endopeptidase enzyme (NEP) , vim tias qhov uas ntev ib nrab-lub neej ntawm cov tshuaj los ntawm cov ntshav tau xyuas kom meej. Qhov kev ua ntawm liraglutide yog vim muaj kev sib cuam tshuam nrog cov kis tshwj xeeb GLP-1, vim qhov kev ua haujlwm ntawm theem ntawm cyclic cAMP adenosine monophosphate nce. Hauv qab ntawm liraglutide, qabzib-dependent stimulation ntawm insulin secretion tshwm sim. Nyob rau tib lub sijhawm, liraglutide suppresses ntau dhau ntawm cov piam thaj tsis pub dhau glucagon. Yog li, nrog nce cov ntshav qabzib concentration, insulin secretion yog tsa thiab glucagon secretion yog suppressed. Ntawm qhov tod tes, thaum lub sijhawm hypoglycemia, liraglutide tsawg dua cov insulin secretion, tab sis tsis inhibit glucagon tso pa tawm. Tus txheej txheem rau kev ua qis glycemia kuj suav nrog qeeb me ntsis hauv kev ua kom lub plab zom mov. Liraglutide txo lub cev qhov hnyav thiab ua rau lub cev rog siv cov txheej txheem uas txo kev tshaib plab thiab txo qis kev siv zog.

Liraglutide muaj cov kev pab cuam ntev li 24 teev thiab txhim kho glycemic tswj los ntawm kev txo qis qhov kev mob siab ntawm cov ntshav ceev ceev thiab tom qab noj hauv cov neeg mob uas muaj ntshav qab zib hom 2.

Nrog kev nce ntxiv hauv cov ntshav qabzib concentration, liraglutide ntau ntxiv insulin secretion. Thaum siv stepwise qab zib infusion, insulin secretion tom qab tswj hwm ntawm ib koob ntawm liraglutide rau cov neeg mob uas muaj hom 2 mob ntshav qab zib mellitus nce mus rau ib qib piv rau cov uas hauv kev noj qab haus huv.

Liraglutide ua ib feem ntawm kev sib xyaw ua ke nrog metformin, glimepiride lossis kev sib xyaw ntawm metformin nrog rosiglitazone rau 26 lub lis piam los ua rau muaj kev txheeb cais (p 98%).

Hauv 24 teev tom qab kev tswj hwm kom noj qab haus huv cov neeg ua haujlwm pab dawb ntawm ib qho koob tshuaj 3 H-liraglutide sau npe nrog lub xov tooj cua isotope, lub ntsiab plasma tseem tsis hloov pauv liraglutide. Tau kuaj pom ob lub plasma ntshav dawb (≤ 9% thiab ≤ 5% ntawm tag nrho cov ntshav ntshav ntshav). Liraglutide yog metabolized endogenously zoo li cov protein loj.

Tom qab tau noj 3 H-liraglutide siv, tshuaj liraglutide tsis hloov pauv tsis pom nyob rau hauv cov zis lossis quav. Tsuas yog ib feem me me ntawm kev tswj hwm radioactivity hauv daim ntawv ntawm metabolites cuam tshuam nrog liraglutide (6% thiab 5%, feem) tau raug cais tawm los ntawm lub raum lossis dhau los ntawm cov hnyuv. Cov tshuaj kua hluav taws xob raug tawm ntawm lub raum los yog los ntawm txoj hnyuv, feem ntau yog nyob rau thawj 6-8 hnub tom qab cov tshuaj, thiab yog peb yam tshuaj lom. Qhov nruab nrab ntawm kev tshem tawm hauv lub cev tom qab sc tswj hwm ntawm liraglutide hauv ib koob tshuaj yog kwv yees li 1.2 l / h nrog kev tshem tawm ib nrab-lub neej ntawm kwv yees li 13 teev.

Cov ntaub ntawv los ntawm cov kev tshawb fawb pharmacokinetic nyob rau hauv pab pawg zoo noj qab haus huv thiab tsom xam cov ntaub ntawv pharmacokinetic tau nyob hauv cov neeg mob (hnub nyoog 18 txog 80 xyoo) qhia tias hnub nyoog tsis muaj kev cuam tshuam loj hauv lub pharmacokinetic khoom ntawm liraglutide.

Ib tug pej xeem-based pharmacokinetic tsom xam ntawm cov ntaub ntawv tau los ntawm kev kawm txog kev cuam tshuam ntawm liraglutide hauv cov neeg mob ntawm cov neeg tawv dawb, dub, Neeg Esxias thiab Latin Asmeskas cov haiv neeg tau qhia tias haiv neeg tsis muaj kev cuam tshuam loj hauv lub pharmacokinetic ntawm liraglutide.

Cov kis ntawm liraglutide nyob rau hauv cov neeg mob uas tsis tshua mob mus rau qhov hnyav tsis ua haujlwm tau raug txo qis li 13-23% piv nrog rau cov pab pawg ntawm cov ntsiab lus noj qab haus huv. Hauv cov neeg mob uas muaj kev tiv thaiv kabmob hepatic tsis txaus (raws li kev faib tawm rau menyuam yaus-Pugh, qhov mob tau loj dua> 9 cov ntsiab lus), kev kis ntawm liraglutide yog qis dua (44%).

Lub Npe Lag Luam: Lub Neej za

INN: Liraglutide

Kev piav qhia
Tsis muaj kob los sis yuav luag tsis muaj kob xim pob tshab daws.

ATX code - A10BX07.

Cov Tshuaj Hauv Tshuaj
Liraglutide muaj cov kev pab cuam ntev li 24 teev thiab txhim kho glycemic tswj los ntawm kev txo qis qhov kev mob siab ntawm cov ntshav ceev ceev thiab tom qab noj mov hauv cov neeg mob uas muaj ntshav qab zib hom 2.
Cov kua nplaum-cov kua nyeem cov kua dej muaj cov kua qab
Nrog kev nce ntxiv hauv cov ntshav qabzib concentration, liraglutide ntau ntxiv insulin secretion. Thaum siv stepwise qab zib infusion, insulin secretion tom qab tswj hwm ntawm ib koob ntawm liraglutide rau cov neeg mob uas muaj hom 2 mob ntshav qab zib mellitus nce rau hauv qib piv rau cov uas hauv kev noj qab haus huv (Daim 1).

Victoza: cov lus qhia rau kev siv thiab tshuaj xyuas

Lub npe Latin: Victoza

ATX Code: A10BX07

Tus nquag ua hauj lwm: liraglutide (Liraglutide)

Cov tsim tawm: Novo Nordisk, A / C (Novo Nordisk, A / S) (Denmark)

Hloov kho cov lus piav qhia thiab yees duab: 08/15/2018

Cov nqi hauv khw muag tshuaj: los ntawm 10 500 rubles.

Tus neeg mob yog tus agonist ntawm glucagon-zoo li polypeptide (GLP) receptors, ib tus neeg sawv cev hypoglycemic.

* Hauv 1 rab koob xaum (3 ml) muaj 10 koob tshuaj 1.8 mg, 15 koob ntawm 1.2 mg lossis 30 koob ntawm 0.6 mg.

Cov tshuaj tseem ceeb: liraglutide, hauv 1 ml - 6 mg.

Ntu cov khoom siv: hydrochloric acid / sodium hydroxide q.s., sodium hydrogen phosphate dihydrate, phenol, propylene glycol, dej rau kev txhaj tshuaj.

Nrog kev txhaj tshuaj subcutaneous, qhov ntev ua haujlwm ntawm qhov quav yeeb tshuaj yog raws peb txoj kev ua haujlwm:

kev sib koom tes tus kheej, uas muab ncua ntev liraglutide,
khi rau albumin,
qib siab ntawm enzymatic ruaj khov tiv thaiv DPP-4 (dipeptidyl peptidase-4) thiab NEP (enzyme nruab nrab endopeptidase), uas ua kom T ntev_1/2 (ib nrab-lub neej) ntawm ib yam khoom los ntawm ntshav ntshav.

Raws li cov lus qhia, Viktoza siv rau kev mob ntshav qab zib hom 2 nrog rau kev noj haus thiab kev tawm dag zog kom ua tiav glycemic tswj.

Txoj hauv kev ntawm txoj kev siv tshuaj:

tshuaj mob hlwb
kev sib txuas ua ke nrog ib lossis ntau qhov ncauj hypoglycemic tus neeg sawv cev (thiazolidinediones, sulfonylureas, metformin) hauv cov neeg mob uas tsis ua tiav cov glycemic tswj tau zoo nyob rau yav dhau los kho,
kev sib xyaw nrog kev kho mob nrog basal insulin hauv cov neeg mob uas ua tsis tiav ua tiav kev tswj glycemic siv Victoza ua ke nrog metformin.

mob ketoacidosis,
ntshav qab zib hom 1
ntau yam kab mob neocyloos neoplasia 2,
lub siab ua tsis taus haujlwm,
mob raum tsis zoo,
ntshav qab zib gastroparesis,
mob hnyuv kab mob,
mob plawv tsis ua haujlwm ntawm chav III - IV ua haujlwm raws li kev faib tawm los ntawm New York Cardiology Association (NYHA),
keeb kwm ntawm kev mob kheesxaws medullary, nrog rau kev txheeb ze,
hnub nyoog txog 18 xyoo
cev xeeb tub thiab lactation
kev sib xyaw ua si rau ib qho twg ntawm Victoza.

cov mob qog
mob plawv tsis ua hauj lwm ntawm I - II ua haujlwm chav kawm raws li NYHA kev faib tawm,
hnub nyoog tshaj 75 xyoo.

Kev taw qhia ntawm kev siv tshuaj

Txhua rab koob xwj yog tsim rau ib leeg siv.

Cov tshuaj yuav tsum tau muab tshuaj siv cov koob siv li 8 hli ntev thiab txog 32G tuab (tsis suav nrog, yog li ntawd yuav nyias siv). Cov koob txhaj tshuaj siv ua ke yog nrog cov koob txhaj tshuaj pov tseg NovoTvist thiab NovoFayn.

Kev tsim txom Victoza yuav tsum tsis txhob siv yog tias cov tshuaj zoo li txawv dua li kua ntshiab, yuav luag tsis muaj kob lossis tsis muaj kob.

Koj tsis tuaj yeem nkag mus rau cov tshuaj yog tias nws tau hla tawm.

Tsis txhob tso xaum xaum nrog cov koob txuas. Tom qab txhua txoj kev txhaj tshuaj, nws yuav tsum tau muab pov tseg. Qhov kev ntsuas no tiv thaiv cov tshuaj ua kom quav, paug thiab kis ntawm cov tshuaj, thiab tseem tuaj yeem lav qhov raug.

Victoza: lus piav qhia, cov lus qhia rau kev siv, duab

Cov tshuaj Victoza tau qhia rau siv nyob rau hauv cov neeg mob uas muaj hom 2 mob ntshav qab zib mellitus raws li cov tshuaj tiv thaiv. Nws yog siv ua ke nrog kev noj haus thiab ua kom lub cev ua kom lub cev ntshav qab zib ntau ntau.

Cov kua roj ntsha uas yog ib feem ntawm cov tshuaj no ua rau lub cev hnyav thiab lub cev rog. Nws ua rau ntawm qhov chaw ntawm lub hauv nruab nrab hauv lub paj hlwb uas yog lub luag haujlwm rau qhov kev xav ntawm kev tshaib plab. Tus neeg mob pabcuam pab tus neeg mob lub siab kom ntev ntev los ntawm kev txo lub zog siv.

Cov tshuaj no tuaj yeem siv los ua cov tshuaj ywj siab, los yog ua ke nrog lwm cov tshuaj. Yog tias kev kho mob nrog cov tshuaj muaj metformin, sulfonylureas lossis thiazolidinediones, nrog rau cov tshuaj insulin tsis muaj qhov xav tias yuav tshwm sim, ces Victoza kuj yuav raug tshuaj rau cov tshuaj uas twb tau siv lawm.

Daim ntawv yuav tshuaj thiab siv cov tshuaj los ntawm cov poj niam cev xeeb tub lossis lactating

Cov tshuaj muaj liraglutide tsis pom zoo rau siv thaum cev xeeb tub thiab thaum npaj rau nws. Lub sijhawm no, cov piam thaj ib txwm yuav tsum tau tswj nrog cov tshuaj muaj cov tshuaj insulin. Yog hais tias tus neeg mob siv Victoza, tom qab ntawd cev xeeb tub nws txoj kev txais yuav tsum nres tam sim ntawd.

Cov nyhuv ntawm cov tshuaj rau cov zoo ntawm cov kua mis tseem tsis tau paub. Thaum lub sijhawm pub mis, noj Viktoza tsis pom zoo.

Sab sij huam

Thaum kuaj Victoza, feem ntau cov neeg mob yws ntawm cov teeb meem ntawm txoj hnyuv txhaws. Lawv pom tias ntuav, raws plab, quav tawv, mob plab. Cov tshwm sim no tau pom nyob hauv cov neeg mob thaum pib txoj kev tswj hwm thaum pib ntawm chav kawm ntawm kev tswj hwm tshuaj. Nyob rau hauv lub neej yav tom ntej, ntau zaus ntawm cov kev mob tshwm sim tau txo qis heev, thiab cov xwm txheej ntawm cov neeg mob tau ruaj khov.

Cov kev mob tshwm sim los ntawm cov kab mob ua pa tuaj pom tshwm ntau zaus, li ntawm 10% ntawm cov neeg mob. Lawv mob cov kab mob ua pa. Thaum noj cov tshuaj no, qee tus neeg mob yws yws yws tias mob taub hau tas li.

Nrog cov kev kho nyuaj nrog ntau cov tshuaj, hypoclycemia tuaj yeem tsim kho. Yeej, qhov tshwm sim no yog yam ntxwv nrog kev kho mob nrog rau Viktoza thiab cov tshuaj nrog sulfonylurea derivatives.

Txhua qhov mob tshwm sim uas tshwm sim thaum noj cov tshuaj no tau hais lub ntsiab lus hauv lub rooj 1.

Tag nrho cov kev mob tshwm sim hauv cov lus qhia tau raug txheeb xyuas thaum lub sij hawm ntev kev tshawb fawb ntawm cov theem thib peb ntawm cov tshuaj Victoza, thiab raws li cov lus tshaj tawm hauv kev lag luam. Cov kev mob tshwm sim hauv kev tshawb nrhiav mus ntev tau pom hauv ntau dua 5% ntawm cov neeg mob noj Victoza, piv nrog cov neeg mob uas tau kho nrog lwm cov tshuaj.

Tsis tas li ntawd nyob rau hauv cov lus no tau teev cov kev mob tshwm sim hauv ntau dua 1% ntawm cov neeg mob thiab qhov ntau zaus ntawm lawv txoj kev txhim kho yog 2 zaug ntawm kev nthuav dav thaum noj lwm yam tshuaj. Tag nrho cov kev mob tshwm sim hauv cov lus qhia tau muab faib ua pawg raws qhov kabmob thiab ntau zaus tshwm sim.

Kev ntshav siab

Qhov no tshwm sim nyob rau hauv cov neeg mob noj Victoza tau mob sib khuav. Hauv kev muaj mob ntshav qab zib mellitus kho tsuas yog nrog cov tshuaj no, qhov tshwm sim ntawm kev mob ntshav qab zib tsawg tsis tau sau tseg.

Ib qho kev mob tshwm sim, qhia los ntawm qhov kev mob siab tshaj plaws ntawm lub qog ntshav qab zib, tau pom thaum lub sijhawm kho mob nrog Viktoza nrog kev npaj muaj sulfonylurea derivatives.

Cov kev kho nyuaj ua ke nrog liraglutide nrog cov tshuaj uas tsis muaj sulfonylurea tsis muab cov kev phiv rau hauv daim ntawv ntawm hypoglycemia.

Lub plab zom mov

Qhov tshwm sim tsis zoo ntawm lub plab zom mov feem ntau tau hais tawm los ntawm ntuav, xeev ntuav thiab zawv plab. Lawv tau pom lub teeb thiab muaj cov yam ntxwv ntawm thawj theem ntawm kev kho. Tom qab muaj qhov txo qis ntawm qhov tshwm sim ntawm cov kev mob tshwm sim no. Cov tshuaj ntawm kev tshem tawm yeeb tshuaj vim qhov tshwm sim tsis zoo los ntawm txoj hnyuv plab tsis tau sau tseg.

Hauv kev tshawb nrhiav ntev ntev ntawm cov neeg mob noj Victoza ntxiv nrog cov tshuaj metformin, tsuas yog 20% yws ntawm ib qho xeev siab thaum kho, kwv yees li 12% raws plab.

Kev kho mob zoo nrog cov tshuaj muaj liraglutide thiab sulfonylurea derivatives ua rau cov kev mob tshwm sim hauv qab no: 9% ntawm cov neeg mob yws ntawm xeev siab thaum noj tshuaj, thiab kwv yees li 8% yws tias raws plab.

Thaum muab piv rau qhov tshwm sim tsis zoo thaum siv tshuaj Viktoza thiab lwm yam tshuaj zoo sib xws hauv cov chaw muag tshuaj, qhov tshwm sim ntawm kev mob tshwm sim hauv 8% ntawm cov neeg mob noj Victoza thiab 3.5 - noj lwm yam tshuaj.

Qhov feem pua ntawm cov nyom tshwm sim hauv cov neeg laus me ntsis siab dua. Cov kab mob tsis haum, xws li lub raum tsis ua haujlwm, cuam tshuam qhov tshwm sim ntawm kev phiv tshuaj.

Kev mob caj dab

Hauv kev xyaum kho mob, muaj ntau kis ntawm qhov tshwm sim tsis zoo ntawm cov tshuaj xws li kev txhim kho thiab exacerbation ntawm pancreatic pancreatitis tau tshaj tawm. Txawm li cas los xij, tus naj npawb ntawm cov neeg mob nyob rau hauv uas tus kab mob no tau tshawb pom los ntawm kev noj Victoza tsawg dua 0.2%.

Vim tias muaj qhov feem pua tsawg ntawm cov kev mob tshwm sim no thiab qhov tseeb hais tias pancreatitis yog ib qho kev mob tshwm sim ntawm cov ntshav qab zib, nws tsis muaj peev xwm lees paub meej lossis tsis kam lees qhov tseeb.

Lub qog ua haujlwm

Raws li kev soj ntsuam cov nyhuv ntawm cov tshuaj rau cov neeg mob, qhov xwm txheej tag nrho ntawm kev phiv tshuaj los ntawm cov thyroid caj pas tau tsim. Kev soj ntsuam tau ua tiav thaum pib ntawm qhov pib ntawm kev kho thiab nrog rau siv ntev liraglutide, placebo thiab lwm yam tshuaj.

Qhov feem pua ntawm qhov tshwm sim yog li nram qab no:

liraglutide - 33.5,
placebo - 30,
lwm yam tshuaj - 21.7

Qhov ntev ntawm cov nqi no yog tus lej ntawm cov kev mob tshwm sim los ntawm 1000 tus neeg mob-xyoo siv nyiaj nyiaj. Thaum noj tshuaj, muaj kev pheej hmoo ntawm kev loj hlob tshwm sim los ntawm cov thyroid caj pas.

Ntawm cov kev mob tshwm sim feem ntau, cov kws kho mob nco ntsoov nce ntxiv ntawm cov ntshav calcitonin, cov leeg ntshav thiab ntau yam mob ntawm cov thyroid caj pas.

Thaum noj Victoza, cov neeg mob pom tias tshwm sim ntawm kev fab tshuaj tsis haum. Ntawm lawv, cov tawv nqaij khaus, urticaria, ntau hom pob khaus yuav txawv. Ntawm cov mob hnyav, muaj ntau kis ntawm anaphylactic hnov nrog cov tsos mob hauv qab no:

txo hauv cov ntshav siab,
o tuaj
txog siav
lub plawv dhia rau lub siab.

Tshuaj ntau dhau

Raws li kev qhia ntawm kev kawm txog cov tshuaj, muaj ib kis ntawm kev noj tshuaj ntau dhau. Nws cov koob tau tshaj 40 zaug qhov kev pom zoo. Cov nyhuv ntawm overdose yog heev xeev siab thiab ntuav. Xws li qhov tshwm sim xws li hypoglycemia tsis tau sau tseg.

Tom qab txoj kev kho tsim nyog, kev ua tiav ntawm tus neeg mob thiab qhov ua tiav ntawm qhov tshwm sim los ntawm kev noj ntau dhau ntawm cov tshuaj tau sau tseg. Yog tias muaj kev noj ntau dhau, nws yuav tsum ua raws li kws kho mob pom zoo thiab ua raws li kev kho mob uas tsim nyog.

Kev sib cuam tshuam ntawm Victoza nrog Lwm Cov Tshuaj

Thaum ntsuas qhov ua tau zoo ntawm liraglutide rau kev kho mob ntshav qab zib mellitus, nws qis qis ntawm kev cuam tshuam nrog lwm yam tshuaj uas ua rau cov tshuaj tau sau tseg. Nws tseem raug sau tseg tias liraglutide muaj qee yam ntxim rau kev nqus ntawm lwm yam tshuaj vim muaj teeb meem hauv kev tshem tawm lub plab.

Kev siv cov pa tshuaj paracetamol thiab Victoza ib txhij tsis tas yuav tsum kho qhov tshuaj ntawm txhua qhov tshuaj. Tib yam siv rau cov tshuaj hauv qab no: atorvastatin, griseofulvin, lisinopril, qhov ncauj tawm tsam. Thaum muaj kev sib koom tes nrog kev siv yeeb tshuaj ntawm cov hom no, qhov kev poob qis hauv lawv qhov kev ua tau zoo kuj tsis tau pom.

Rau cov txiaj ntsig zoo dua ntawm kev kho mob, hauv qee kis, kev tswj hwm ib txhij ntawm insulin thiab Viktoza kuj yuav raug tshuaj. Kev sib cuam tshuam ntawm ob hom tshuaj no tsis tau kawm yav tas los.

Txij li cov kev tshawb fawb txog kev sib raug zoo ntawm Viktoza nrog rau lwm cov tshuaj tsis tau ua, cov kws kho mob tsis pom zoo kom siv ntau cov tshuaj rau tib lub sijhawm.

Kev siv ntawm cov tshuaj thiab ntau npaum li cas

Cov tshuaj no raug txhaj tshuaj subcutaneously rau hauv tus ncej puab, sab caj npab sab sauv, lossis plab. Rau kev kho mob, txhaj tshuaj 1 zaug nyob rau ib hnub yog txaus lub sijhawm twg los tau, tsis hais noj zaub mov. Lub sijhawm txhaj thiab qhov chaw nws txhaj tshuaj tuaj yeem hloov los ntawm tus neeg mob ntawm nws tus kheej. Hauv qhov no, nws yog ib qho tseem ceeb kom ua tau raws li cov teev tseg ntawm cov tshuaj.

Txawm hais tias qhov tseeb tias lub sijhawm tsis txhaj tshuaj tsis tseem ceeb, nws tseem pom zoo kom tswj hwm cov tshuaj nyob rau tib lub sijhawm, uas yooj yim rau tus neeg mob.

Tseem Ceeb! Victoza tsis tau txais koob tshuaj intramuscularly lossis intravenously.

Cov kws kho mob pom zoo kom pib kho nrog 0.6 mg liraglutide ib hnub. Maj mam, cov koob tshuaj ntawm cov tshuaj yuav tsum tau nce. Tom qab ib lub lim tiam ntawm kev kho mob, nws cov koob tshuaj yuav tsum tau nce ntxiv 2 zaug. Yog tias yuav tsum tau ua, tus neeg mob tuaj yeem nce lub koob tshuaj ntxiv rau 1.8 mg nyob rau lub lim tiam tom ntej kom tau txais txiaj ntsig zoo tshaj plaws. Ib qho kev nce ntxiv ntawm koob tshuaj yog tsis pom zoo.

Cov neeg raug tsim txom tuaj yeem raug siv los ntxiv rau cov tshuaj uas muaj metformin lossis hauv kev kho mob nyuaj nrog metformin thiab thiazolidinedione. Hauv qhov no, qhov kev siv ntawm cov tshuaj no tuaj yeem tso rau hauv tib theem yam tsis muaj kev kho kom haum.

Siv Viktoza ua ib qho kev sib ntxiv rau cov tshuaj muaj sulfonylurea derivatives los yog kev kho mob nyuaj nrog cov tshuaj, nws yog ib qho tsim nyog yuav txo qis ntawm sulfonylurea, vim tias kev siv tshuaj nyob rau hauv cov koob tshuaj yav dhau los tuaj yeem ua rau mob ntshav qab zib tsawg.

Txhawm rau txhawm rau hloov kho qhov tshuaj txhua hnub ntawm Viktoza, nws tsis tas yuav tsum tau ua qhov kev ntsuas kom txiav txim siab txog qib qab zib. Txawm li cas los xij, kom tsis txhob muaj ntshav qab zib hauv cov theem pib ntawm kev kho mob nyuaj nrog kev npaj muaj sulfonylurea, nws yog qhov yuav tsum tau soj ntsuam kom tsis tu ncua cov ntshav ntawm cov ntshav hauv cov ntshav.

Kev siv cov tshuaj hauv cov pab pawg tshwj xeeb ntawm cov neeg mob

Cov tshuaj no tuaj yeem siv tsis hais tus neeg mob lub hnub nyoog. Cov neeg mob muaj hnub nyoog laus dua 70 xyoo tsis tas yuav hloov tshwj xeeb rau txhua hnub ntawm cov tshuaj. Clinically, qhov tshwm sim ntawm cov tshuaj rau cov neeg mob hnub nyoog qis dua 18 xyoo tsis tau tsim. Txawm li cas los xij, txhawm rau tiv thaiv qhov tshwm sim ntawm kev phiv thiab mob tshwm sim, cov tshuaj tsis pom zoo rau cov neeg mob hnub nyoog qis dua 18 xyoo.

Kev txheeb xyuas ntawm kev tshawb fawb qhia tau tib yam nkaus ntawm tib neeg lub cev, tsis hais poj niam txiv neej thiab haiv neeg. Qhov no txhais tau hais tias qhov kev kho mob ntawm cov tshuaj tiv thaiv mob siab yog ywj pheej ntawm tus neeg mob poj niam txiv neej thiab haiv neeg.

Tsis tas li ntawd, tsis muaj kev cuam tshuam los ntawm kev tshawb fawb cov nyhuv ntawm liraglutide lub cev qhov hnyav pom. Cov kev tshawb fawb pom tau tias lub cev qhov ua rau lub cev tsis muaj kev cuam tshuam rau qhov tseem ceeb ntawm cov tshuaj.

Nrog rau cov kab mob ntawm cov khoom nruab nrog sab hauv thiab txo qis hauv lawv cov haujlwm, piv txwv li, lub siab lossis lub raum tsis ua haujlwm, ib qho kev txo qis hauv kev ua haujlwm ntawm cov tshuaj nquag ntawm cov tshuaj tau pom. Rau cov neeg mob uas muaj cov kab mob zoo li no, kev kho tshuaj tsis tas yuav tsum tau txhaj.

Hauv cov neeg mob uas tsis tshua muaj hepatic me me, qhov ua tau ntawm liraglutide tsawg dua li thaj tsam 13-23%. Hauv daim siab ua haujlwm tsis zoo, qhov ua haujlwm tau yuav luag yog ib nrab. Kev sib piv tau ua rau cov neeg mob lub siab ua haujlwm.

Hauv raum tsis ua haujlwm, nyob ntawm qhov mob hnyav ntawm cov kabmob, qhov ua haujlwm ntawm Viktoza txo qis los ntawm 14-33%. Yog tias muaj mob hauv lub raum ua tsis zoo, piv txwv li, yog tias qhov mob raum tsis ua haujlwm, qhov tshuaj tsis pom zoo.

Cov ntaub ntawv los ntawm cov lus qhia ua pov thawj rau cov tshuaj.