Galvus® Vildagliptin

Type 2 shuga mellitus ndi kagayidwe kachakudya komwe kamayamba chifukwa chophwanya mgwirizano wa insulin ndi maselo.

Anthu omwe ali ndi mtundu uwu wa malaise sangakhalebe ndi shuga wokwanira kudzera mu zakudya komanso njira zina zapadera. Madokotala amamulembera Vildagliptin, amene amachepetsa shuga m'magazi ovomerezeka.

Zambiri, kapangidwe ndi mawonekedwe ake amasulidwe

Vildagliptin ndi nthumwi ya gulu latsopano la mankhwalawa omwe amagwiritsidwa ntchito mosamala pochiza matenda amtundu wa 2 shuga. Imalimbikitsa ma pancreatic islets ndipo imalepheretsa ntchito ya dipeptidyl peptidase-4. Ili ndi vuto la hypoglycemic.

Mankhwalawa amatha kuthandizidwa ngati chithandizo chofunikira, komanso kuphatikiza ndi mankhwala ena. Zimaphatikizidwa ndi zotumphukira za sulfonylurea, ndi thiazolidinedione, ndi metformin ndi insulin.

Vildagliptin ndi dzina lapadziko lonse lapansi pazomwe zimagwira. Pamsika wamankhwala pali mankhwala awiri okhala ndi izi, mayina awo ogulitsa ndi Vildagliptin ndi Galvus. Yoyamba imangokhala ndi Vildagliptin, yachiwiri - kuphatikiza kwa Vildagliptin ndi Metformin.

Kutulutsa mawonekedwe: mapiritsi okhala ndi mlingo wa 50 mg, atanyamula - 28 zidutswa.

Pharmacodynamics ndi pharmacokinetics

Vildagliptin ndi chinthu chomwe chimalepheretsa dipeptidyl peptidase ndi kuwonjezeka momveka bwino mu GLP ndi HIP. Mahomoni amatulutsidwa m'matumbo mkati mwa maola 24 ndikuwonjezereka poyankha chakudya. Thupi limalimbikitsa kuzindikira kwa maselo a betta a shuga. Izi zimapangitsa kuti magwiritsidwe ntchito a glucose amadalira secretion wa insulin.

Ndi kuwonjezeka kwa GLP, pali kuwonjezeka kwa kulingalira kwa maselo a alpha kuti akhale shuga, omwe amatsimikizira kuti matenda a shuga amatengera shuga. Pali kuchepa kwa kuchuluka kwa lipids m'magazi pochiritsira. Ndi kuchepa kwa glucagon, kuchepa kwa insulin kukaniza kumachitika.

Zomwe zimagwira zimagwira mwachangu, zimachulukitsa kuchuluka kwa mahomoni m'magazi pambuyo pa maola 2. Kumanga mapuloteni ochepa kumadziwika - osaposa 10%. Vildagliptin imagawidwa chimodzimodzi pakati pa maselo ofiira am'magazi ndi plasma. Kuchuluka kwake kumachitika pambuyo pa maola 6. Mankhwalawa amatengeka bwino pamimba yopanda kanthu, komanso chakudya, mayankho amadzachepa pang'ono - - 19%.

Sichichita ndipo sichichedwetsa isoenzymes, si gawo lapansi. Imapezeka m'madzi a m'magazi pambuyo pa maola 2. Hafu ya moyo kuchokera ku thupi ndi maola atatu, ngakhale mutamwa. Biotransfform ndiye njira yayikulu yodziwitsira kunja. 15% ya mankhwalawa amachotsera ndowe, 85% - ndi impso (zosasinthika 22.9%). Kuphatikizika kwakukulu kwa zinthu kumatheka pokhapokha mphindi 120.

Zizindikiro ndi contraindication

Chizindikiro chachikulu cha kusankhidwa ndi matenda a shuga a 2. Vildagliptin imafotokozedwa ngati chithandizo chachikulu, mankhwala ophatikizira awiri (ndi gawo lina la mankhwala), komanso mankhwala othandizira atatu (pogwiritsa ntchito mankhwala awiri).

Poyamba, chithandizo chimachitika limodzi ndi masewera olimbitsa thupi komanso zakudya zosankhidwa mwapadera. Ngati monotherapy singagwire ntchito, zovuta zimagwiritsidwa ntchito limodzi ndi mitundu yotsatirayi ya mankhwala otsatirawa: zotumphukira za Sulfonylurea, Thiazolidinedione, Metformin, insulin.

Zina mwazoyipa:

• tsankho
• kuwonongeka kwaimpso,
• mimba
• kuchepa kwa lactase
• chiwindi ntchito,
• Anthu ochepera 18
• kulephera kwa mtima
• kuyamwa
• galactose tsankho.

Malangizo ogwiritsira ntchito

Mapiritsi amatengedwa pakamwa popanda kutanthauza chakudya. Mlingo wothandizila umatsimikiziridwa ndi dokotala, poganizira momwe wodwalayo alili ndi kulolerana ndi mankhwalawo.

Mlingo woyenera ndi 50-100 mg. Woopsa 2 mtundu wa shuga, mankhwalawa mankhwala 100 mg tsiku. Kuphatikiza ndimankhwala ena (munthawi ya chithandizo cha magawo awiri), kudya tsiku lililonse ndi 50 mg (piritsi 1). Ndi osakwanira kwambiri panthawi yovuta mankhwala, mlingo umawonjezeka mpaka 100 mg.

Palibe chidziwitso chokwanira chogwiritsira ntchito mankhwalawa panthawi yapakati komanso mkaka wa m`mawere. Chifukwa chake, gawo ili ndilosafunika kumwa mankhwala omwe aperekedwa. Chisamaliro chapadera chikuyenera kuthandizidwa kwa odwala omwe ali ndi matenda a chiwindi / impso.

Anthu osakwana zaka 18 sayenera kugwiritsa ntchito mankhwalawa. Sibwino kuyendetsa galimoto mutamwa mankhwalawo.

Pogwiritsa ntchito vildagliptin, kuwonjezeka kwa ziwindi za chiwindi kungawonedwe. Panthawi yayitali chithandizo, tikulimbikitsidwa kuwunika mozama momwe zinthu zikuyendera ndikusintha kwamankhwala.

Ndi kuwonjezeka kwa aminotransferases, ndikofunikira kuyesanso magazi. Ngati Zizindikiro ziwonjezereka nthawi zopitilira 3, mankhwalawo amayimitsidwa.

Zotsatira zoyipa ndi bongo

Mwa zina zomwe zingachitike ndi zovuta:

• asthenia
• kunjenjemera, chizungulire, kufooka, mutu,
• kusanza, kusanza, kuwonetsa Reflux esophagitis, flatulence,
• zotumphukira edema,
• kapamba
• kunenepa
• chiwindi
• Khungu loyera, urticaria,
• Matenda enanso ambiri.

Mankhwalawa amaloledwa ndi odwala, mlingo wovomerezeka watsiku ndi tsiku umafika mpaka 200 mg patsiku. Mukamagwiritsa ntchito zoposa 400 ml, izi zitha kuchitika: kutentha, kutupa, kuchuluka kwa malekezero, nseru, kukomoka. Ngati zizindikiro zikuchitika, ndikofunikira kutsuka m'mimba ndikupempha thandizo kuchipatala.

Ndikothekanso kuwonjezera mapuloteni a C-reactive, myoglobin, creatine phosphokinase. Angioedema nthawi zambiri imawonedwa ikaphatikizidwa ndi ACE inhibitors. Ndi kusiya kwa mankhwalawa, mavuto amatha.

Kuyanjana Ndi Mankhwala Ndi Analogi

Kuthekera kwa mgwirizano wa vildagliptin ndi mankhwala ena ndizochepa. Panalibe zotsatira zamankhwala omwe amagwiritsidwa ntchito kawirikawiri pochiza matenda a shuga a mtundu wa 2 (Metformin, Pioglitazone ndi ena) ndi mankhwala ocheperako (Amlodipine, Simvastatin).

Mankhwala amatha kukhala ndi dzina lamalonda kapena dzina lomweli ndi chinthu chogwira ntchito. M'mafakitare mungapeze Vildagliptin, Galvus. Pokhudzana ndi contraindication, dokotala amatipatsa mankhwala ofananawa omwe amawonetsa njira yofanana yothandizirana.

Zofanizira zamankhwala ndizophatikiza:

• Onglisa (saxagliptin yogwira pophika),
• Januvia (chinthu - sitagliptin),
• Trazenta (chigawo chimodzi - linagliptin).

Mtengo wa Vildagliptin umachokera ku ma ruble 760 mpaka 880, kutengera malire a mankhwalawo.

Mankhwalawa azikhala pa kutentha osachepera madigiri 25 m'malo owuma.

Maganizo a akatswiri ndi odwala

Malingaliro a akatswiri ndi kuwunika kwa odwala pamankhwala ake ndiabwino.

Poyerekeza ndi momwe amamwa mankhwalawa odwala omwe ali ndi matenda a shuga a 2, zotsatirazi zimadziwika:

• kutsika kwamphamvu kwa shuga,
• kukonza chizindikiro chovomerezeka,
• kugwiritsa ntchito mosavuta
• Kulemera kwa thupi panthawi ya monotherapy kumakhalabe chimodzimodzi,
• mankhwala limodzi ndi antihypertensive kwenikweni,
• Zotsatira zoyipa zimachitika kawirikawiri,
• kusowa kwa zochitika za hypoglycemic pakumwa mankhwala,
• lipid kagayidwe kachakudya,
• chitetezo chabwino
• kusintha kagayidwe kazakudya,
• yabwino kwa odwala ambiri omwe ali ndi matenda a shuga a mtundu wachiwiri.

Vildagliptin pakuchitika kafukufukuyu yatsimikizira kuti ntchitoyi ndi yofunika komanso yolekerera zabwino. Malinga ndi chithunzi cha chipatala ndi zizindikiro zowunikira, palibe milandu ya hypoglycemia yomwe idawonedwa panthawi ya mankhwala.

Vildagliptin imadziwika kuti ndi mankhwala othandizira a hypoglycemic, omwe amaperekedwa kwa mtundu wachiwiri wa odwala matenda ashuga. Imaphatikizidwa mu Medicines Register (RLS). Amawerengedwa ngati monotherapy komanso kuphatikiza ndi othandizira ena. Kutengera ndi matendawa, momwe mankhwalawo amathandizira, mankhwalawa amatha kuthandizidwa ndi Metmorphine, zotumphukira za sulfonylurea, insulin. Dokotala wothandizirayo akupereka mankhwala molondola ndi kuwunika wodwalayo. Nthawi zambiri, odwala matenda ashuga a 2 amakhala ndi matenda amodzimodzi. Izi zimasokoneza kwambiri kusankha kwa mankhwala ochepetsa mphamvu ya shuga. Zikatero, insulin ndiyo njira yachilengedwe kwambiri yotsitsira shuga. Kudya kwake mopitirira muyeso kumatha kuyambitsa hypoglycemia, kuwonda. Pambuyo pa phunziroli, zidapezeka kuti kugwiritsa ntchito Vildagliptin limodzi ndi insulin kumatha kupeza zotsatira zabwino. Chiwopsezo chotenga matenda a mtima, hypoglycemia imachepetsedwa, lipid ndi carbohydrate metabolism imapangidwa bwino popanda kulemera.

Frolova N. M., endocrinologist, dokotala wamtundu wapamwamba kwambiri

Ndakhala ndikutenga Vildagliptin kwazaka zopitilira, dokotala adandiuza kuti ndiziphatikize ndi Metformin. Ndinkada nkhawa kwambiri kuti nthawi yayitali kwambiri ndikalandira chithandizo chamankhwala. Koma adachira ndimakolo asanu okha mpaka 85 yanga. Mwa zovuta zina, ndimakonda kudzimbidwa komanso kusanza. Mwambiri, chithandizo chamankhwala chimapereka zomwe zimafunikira ndipo zimadutsa popanda zotsatira zoyipa.

Olga, wazaka 44, Saratov

Zinthu zamavidiyo kuchokera kwa Dr. Malysheva okhudza zinthu zomwe zingagwiritsidwe ntchito ngati kuwonjezera mankhwala osokoneza bongo:

Vildagliptin ndi mankhwala othandiza omwe amachepetsa shuga komanso kusintha ntchito ya pancreatic. Ithandizanso odwala omwe sangathe kuphatikiza shuga pochita masewera olimbitsa thupi ndi zakudya zapadera.

Mlingo

Piritsi limodzi lili

ntchito yogwira - vildagliptin 50 mg,

zokopa: microcrystalline cellulose, anhydrous lactose, sodium starch glycolate mtundu A, magnesium stearate.

Mapiritsiwo ndi oyera kuti ayambitse chikaso pamtundu, wozungulira mozungulira, wokhala ndiwosalala komanso wojambula, wolemba "NVR" mbali imodzi ndi "FB" mbali inayo.

Mankhwala

Pharmacokinetics

Pambuyo pakulowetsa pamimba yopanda kanthu, nthawi yoti mukwaniritse Cmax ya vildagliptin m'madzi am'magazi ndi ma 1.75. Mukamamwa ndi chakudya, kuchuluka kwa mankhwalawa kumacheperachepera: pali kutsika kwa Cmax ndi 19% ndikuwonjezeka kwa Tmax mpaka maola 2,5. kuchuluka kwa mayamwidwe ndi AUC.

Kumangiriza kwa vildagliptin kuma protein a plasma ndikotsika (9.3%). Mankhwalawa amagawidwa chimodzimodzi pakati pa plasma ndi maselo ofiira amwazi. Kugawa kwa Vildagliptin kumachitika mopitilira muyeso, Vss mogwirizana pakatha jakisoni wa iv ndi malita 71.

Biotransfform ndiye njira yayikulu yodziwitsira ya vildagliptin. Mu thupi la munthu, 69% ya mlingo wa mankhwalawo amasandulika. Metabolite yayikulu - lay151 (57% ya mlingo) imagwira ntchito pamankhwala ndipo ndi mankhwala a hydrolysis a cyanocomponent. Pafupifupi 4% ya mankhwalawa amapezeka amide hydrolysis.

M'maphunziro oyesera, zotsatira zabwino za DPP-4 pa hydrolysis yamankhwala zimadziwika. Vildagliptin sichimaphatikizidwa ndi gawo la cytochrome P450 isoenzymes. Kafukufuku wa in vitro awonetsa kuti vildagliptin sikuletsa kapena kulimbikitsa cytochrome P450 isoenzymes.

Pambuyo pakukulitsa vildagliptin olembedwa ndi 14C, pafupifupi 85% ya mankhwalawa amuchotsa mkodzo, 15% ndi ndowe. 23% ya mankhwala omwe amamwa pakamwa amawachotsa impso. Mukaperekedwa m'maphunziro oyenera, kuchuluka kwa plasma ndi chiwonetsero cha vildagliptin ndi 41 l / h ndi 13 l / h, motsatana. Pafupifupi theka moyo wa mankhwala pambuyo mtsempha wa magazi makonzedwe pafupifupi maola 2. Hafu ya moyo pambuyo mkamwa makonzedwe ali pafupifupi 3 maola ndipo sizimatengera mlingo.

Vildagliptin imatengedwa mwachangu ndipo kuphatikiza kwake konse kwamlomo ndi 85%. Mu achire mlingo, kuchuluka kwa plasma ndende ya vildagliptin ndi malo pansi pa plasma ndende nthawi (AUC) pamapindikira ndi pafupifupi kuchuluka kwa mlingo womwe waperekedwa.

Magulu apadera a odwala

Panalibe kusiyana pama paracokinetic magawo a Galvus® pakati pa odwala amphongo ndi amuna azaka zosiyana komanso okhala ndi ma body body index osiyanasiyana (BMI). Kuthekera kwa Galvus® poletsa ntchito ya dipeptidyl peptidase-4 (DPP-4) sikunali kotengera pa jenda.

Kudalira kwa magawo a pharmacokinetic a mankhwala a Galvus® pa index yam'mimba sanapeze. Kuthekera kwa mankhwala a Galvus® kupondaponda ntchito ya DPP-4 sikunali kudalira BMI ya wodwalayo.

Kuwonongeka kwa chiwindi

Zotsatira zakuchepa kwa chiwindi pa pharmacokinetics ya Galvus® adaphunzira kwa odwala omwe ali ndi vuto lochepa kwambiri, lochita komanso lofooka la chiwindi malinga ndi Child-Pugh (kuchokera pamitu 6 yofatsa mpaka 12 mfundo zowopsa) poyerekeza ndi odwala omwe ali ndi chiwindi chosungidwa. Pambuyo pa limodzi mlingo wa Galvus® (100 mg) mwa odwala omwe ali ndi vuto lochepa kwambiri kwa chiwindi, kuchepa kwa chiwonetsero cha mankhwala kunawonedwa (ndi 20% ndi 8%, motero), pomwe odwala omwe ali ndi vuto la chiwopsezo cha hepatic chizindikiritsochi chinawonjezeka. ndi 22%. Popeza kusintha kwakukulu (kuchuluka kapena kuchepa) paziwonetsero zakukonzekera kwa Galvus® kunali pafupifupi 30%, izi sizikuwoneka kuti ndizofunika kwambiri pakubwera kwathu. Panalibe kulumikizana pakati pa kuperewera kwa chiwindi ndi kukula kwa kusintha kwa mawonekedwe a Galvus®.

Sitikulimbikitsidwa kupereka mankhwala a Galvus® kwa odwala omwe ali ndi vuto la chiwindi, kuphatikiza milandu yomwe ALT kapena AST imakhala yoposa> 3 times kuposa malire apamwamba asanayambe mankhwala.

Matenda aimpso

Odwala omwe ali ndi vuto lochepa kwambiri, loyezera, komanso aimpso, AUC mtengo wa vildagliptin ukuwonjezeka pafupifupi 1.4, 1.7, ndi 2 nthawi, motero, poyerekeza ndi odwala omwe ali ndi vuto laimpso. Mtengo wa AUC wa metabolite lay151 ukuwonjezeka nthawi 1.6, 3.2 ndi 7.3, chifukwa metabolite BQS867 mtengo wake unakwera pafupifupi pafupifupi 1.5, 3 ndi 71.4, 2.7 ndi 7.3 mwa odwala omwe ali ndiofatsa zolimbitsa thupi komanso zolimbitsa thupi zimapangitsa, poyerekeza ndi odzipereka athanzi. Odwala omwe ali ndi vuto la impso, kuonekera kwa vildagliptin kuli kofanana ndi kuwonekera kwa odwala omwe ali ndi vuto laimpso. Kuzungulira kwa15151 kwa odwala omwe ali ndi vuto la impso kumapeto kwa nthawi yayitali pafupifupi 2-3 kuposa odwala omwe ali ndi vuto laimpso. Odwala omwe ali ndi vuto la impso, mungafunike kusintha kwa mankhwalawa (onani gawo "Mlingo ndi Administration").

Kutupa kwa vildagliptin ndi hemodialysis kumakhala kochepa (3% mkati mwa maola 3-4 a hemodialysis omwe anachita maola 4 pambuyo pa kumwa.

Pharmacokinetics mu Okalamba

M'maphunziro okalamba (zaka ≥70) omwe alibe matenda ena, panali kuwonjezeka kwa chiwonetsero chonse cha Galvus® (mutatenga 100 mg kamodzi patsiku) ndi 32% ndikuwonjezeka kwa ndende ya plasma ndi 18% poyerekeza ndi maphunziro abwinobwino aang'ono zaka (zaka 18 mpaka 40). Zosintha izi zilibe tanthauzo lakuchipatala. Kuthekera kwa mankhwala a Galvus® kupondereza zochitika za DPP-4 sizinadalire zaka za wodwalayo m'magulu azaka zophunziridwa.

Pharmacokinetics mwa ana

Palibe deta pa pharmacokinetics yamankhwala mu ana.

Palibe umboni wokhudzana ndi mtundu pakati pa pharmacokinetics of Galvus®.

Mankhwala

Vildagliptin ndi membala wa gulu laomwe limapangitsa kuti insulini iphatikizidwe ndi maselo a pancreatic islet ndi choletsa kusankha kwa dipeptidyl peptidase-4 (DPP-4), yopangidwa kuti izithandizira pakulamulira kwa glycemic.Zotsatira za kulepheretsa kwa DPP-4, kuchuluka kwa mahomoni amkati amtundu wa GLP-1 (glucagon-ngati peptide-1) ndi HIP (glucose-insulinotropic polypeptide) ukuwonjezeka pamimba yopanda kanthu ndikatha kudya.

Kulandila vildagliptin kumayambitsa kuponderezedwa kwachangu ndi kokwanira kwa ntchito ya DPP-4. Odwala omwe ali ndi matenda a shuga a 2, vildagliptin amalepheretsa ntchito ya enzyme DPP-4 kwa maola 24.

Poonjezera kuchuluka kwa mahomoni amtunduwu, vildagliptin imawonjezera chidwi cha maselo a beta ku glucose, zomwe zimapangitsa kuti shuga itulutsidwe ndi shuga. Vildagliptin muyezo wa tsiku lililonse wa 50-100 mg bwino, amakhala ndi ma cell a beta-cell kwa odwala omwe ali ndi matenda a shuga a 2. Kukula kwa magwiridwe antchito a maselo a beta kumatengera kuwonongeka koyamba; mwa anthu omwe alibe matenda a shuga (kuchuluka kwa shuga), vildagliptin simalimbikitsa kutulutsa kwa insulin komanso sikuchepetsa shuga.

Mwakulitsa msanga wa endo native GLP - 1, vildagliptin imawonjezera mphamvu ya maselo a alpha ku glucose, kukonza shuga yokwanira shuga. Chifukwa chake, kuponderezana kwa kusungika kwa glucagon kosakwanira chifukwa cha kudya kumapangitsa kuchepa kwa insulin.

Kuchulukitsidwa kwabwino kwa kuchuluka kwa insulin / glucagon chifukwa cha kuchuluka kwa mahomoni a insretin pa hyperglycemia kumayambitsa kuchepa kwa kupanga kwa chiwindi m'magazi opanda kanthu ndipo atatha kudya, potero amachepetsa glycemia.

Kuchedwa kwa m'mimba, komwe ndi chimodzi mwazodziwika za kuwonjezeka kwa GLP-1, sikunawonedwe panthawi ya chithandizo cha vildagliptin. Kuphatikiza apo, kugwiritsa ntchito vildagliptin, kuchepa kwa milomo ya chakudya pambuyo pakudya kunawonedwa, kosakhudzana ndi mphamvu ya insretin ya vildagliptin pakukonzanso ntchito ya islet.

Zizindikiro zogwiritsidwa ntchito

Type 2 matenda a shuga:

komanso monotherapy kuphatikiza zakudya ndi masewera olimbitsa thupi, komanso odwala omwe ali ndi contraindication pochiza ndi metformin kapena tsankho lake,

Monga mbali ya mankhwala othandizira awiri:

Metformin odwala omwe ali ndi vuto losakwanira glycemic, ngakhale mlingo waukulu wololedwa ndi metformin monotherapy,

ndi sulfonylurea odwala omwe ali ndi vuto lochepa la glycemic, ngakhale mlingo waukulu wololedwa ndi metformin monotherapy ndi odwala omwe ali ndi contraindication kuti metformin mankhwala kapena tsankho lake,

ndi thiazolidinedione mu odwala omwe ali ndi vuto losakwanira glycemic komanso odwala omwe ali oyenera mankhwala a thiazolidinedione,

ngati gawo limodzi la zinthu zitatu zomwe zimagwiritsidwa ntchito popanga mankhwala a sulfonylurea ndi metformin, pamene zakudya, masewera olimbitsa thupi, komanso ziwalo ziwiri sizipangitsa kuti glycemic ikwaniritse.

kuphatikiza ndi insulini (wokhala ndi kapena wopanda metformin), pamene zakudya, kuchita masewera olimbitsa thupi, komanso mlingo wokhazikika wa insulin sizingayambitse kuyang'anira kwa glycemic kokwanira.

Mlingo ndi makonzedwe

Galvus® imatengedwa pakamwa mosasamala kanthu za kudya.

Mlingo wovomerezeka wa mankhwalawa nthawi ya monotherapy kapena ngati gawo limodzi la mankhwala ophatikizika ndi metformin, thiazolidinedione kapena gawo limodzi la zinthu zitatu zomwe zimagwiritsidwa ntchito popanga mankhwala ndi sulfonylurea ndi metformin kapena kuphatikiza ndi insulin, 100 mg patsiku, 50 mg m'mawa ndi 50 mg madzulo.

Monga gawo limodzi la magawo awiri ophatikizira mankhwala ndi sulfonylurea, muyezo wa Galvus® ndi 50 mg kamodzi patsiku m'mawa. Mu gululi la odwala, mlingo wa 100 mg patsiku sunagwire ntchito kuposa mlingo wa 50 mg patsiku.

Mukamagwiritsa ntchito limodzi ndi sulfonylurea, lingalirani kuchepetsa mlingo wa sulfonylurea kuti muchepetse chiopsezo cha hypoglycemia.

Osagwiritsa ntchito Mlingo wowonjezera wa 100 mg.

Ngati wodwala sanamwe mankhwalawa panthawi, Galvus® iyenera kumwedwa wodwala akangokumbukira izi. Osagwiritsa ntchito ufa wapawiri tsiku lomwelo.

Chitetezo ndikuyenda bwino kwa vildagliptin monga gawo limodzi la zinthu zitatu zophatikiza ndi metformin ndi thiazolidinedione sizinakhazikitsidwe.

Zambiri pazokhudza magulu apadera a odwala

Okalamba okalamba (≥ wazaka 65)

Popereka mankhwala kwa odwala okalamba, kusintha kwa mankhwala sikofunikira.

Odwala ndi mkhutu aimpso ntchito

Kusintha kwa Mlingo sikofunikira popereka mankhwala kwa odwala omwe ali ndi gawo loyambirira la kulephera kwa impso (ndi creatinine chilolezo cha 50 ml / min). Odwala omwe ali ndi kuchepa kwapakati kapena kwambiri aimpso kapena omwe ali ndi vuto la impso yotsiriza, mlingo woyenera wa Galvus® ndi 50 mg kamodzi patsiku.

Odwala omwe ali ndi vuto la chiwindi

Galvus® sayenera kulembedwa kwa odwala omwe ali ndi vuto la chiwindi, kuphatikiza odwala omwe akuchipatala, omwe akuwonjezeka ndi ntchito ya alanine aminotransferase (ALT) kapena aspartate aminotransferase (AST)> nthawi 3 kuyerekeza ndi malire apamwamba abwinobwino (VGN).

Ana ndi achinyamata ochepera zaka 18

Sikulimbikitsidwa kupereka mankhwala kwa ana ndi achinyamata ochepera zaka 18. Zambiri pakugwiritsa ntchito bwino mankhwalawa Galvus® mwa ana ndi achinyamata osakwana zaka 18 sizipezeka.

Zotsatira zoyipa

Mukamagwiritsa ntchito Galvus® ngati monotherapy kapena kuphatikiza mankhwala ena, machitidwe ambiri oyipa anali odekha, osakhalitsa, ndipo sanafunikire kusiya kwa mankhwalawa. Palibe kulumikizana komwe kunapezeka pakati pa zochitika zazovuta komanso zaka, jenda, fuko, nthawi yogwiritsira ntchito, kapena mtundu wa dosing.

Zotsatira zotsatirazi zimasankhidwa ndi pafupipafupi, zomwe zimadziwika koyamba.

Mukamagwiritsa ntchito mankhwalawaGalvus®monga monotherapy

Mukamagwiritsa ntchito Galvus® pa mlingo wa 50 mg 1 nthawi / tsiku kapena 2 kawiri / tsiku, pafupipafupi kuleka kwa mankhwalawa chifukwa cha kusintha kwakachitika (0,2% kapena 0,1%, motsatana) sikunali kwakukulu kuposa komwe kuli mu gulu la placebo (0.6%) kapena mankhwala oyerekeza ( 0,5%).

Poyerekeza ndi mbiri ya monotherapy ndi Galvus® pa mlingo wa 50 mg 1 nthawi / tsiku kapena 2 kawiri / tsiku, zochitika za hypoglycemia popanda kuwonjezera kuwonongeka kwa vutoli zinali 0.5% (2 anthu kuchokera 409) kapena 0,3% (4 kuchokera 1,082), omwe amafanana ndi mankhwalawa kuyerekezera ndi placebo (0.2%). Pogwiritsa ntchito mankhwalawa Galvus® mu mawonekedwe a monotherapy, palibe kuwonjezeka kwa kulemera kwamthupi la wodwala.

Kuyang'anira ma enzyme a chiwindi

Pakhala pali kawirikawiri malipoti a zizindikiro za kukanika kwa hepatic (kuphatikizapo hepatitis), yomwe, monga lamulo, anali asymptomatic ndipo sanakhale ndi zotsatila zamankhwala. Monga zotsatira za kafukufuku zawonetsa, ntchito ya chiwindi imabwereranso mwakale atasiya kulandira chithandizo. Musanayambe chithandizo ndi Galvus®, ndikofunikira kuyang'ana ntchito ya chiwindi kuti mudziwe zoyambirira. Mukamalandira mankhwala ndi Galvus®, chiwindi chimayang'aniridwa miyezi itatu iliyonse pachaka choyamba ndikuwunikidwa nthawi ndi nthawi. Wodwala akakhala ndi zochita zambiri za aminotransferases, zotsatira zake ziyenera kutsimikiziridwa ndi kafukufuku wachiwiri, kenako azindikire magawo a ziwindi za chiwindi ntchito kufikira atasintha. Ngati ntchito ya AST kapena ALT ndiyokwana katatu kapena kupitirira kuposa malire apamwamba, tikulimbikitsidwa kuletsa mankhwalawo.

Ndikupanga kwa jaundice kapena zizindikiro zina zamagulu operewera a chiwindi pogwiritsa ntchito Galvus®, mankhwalawa ayenera kuyimitsidwa nthawi yomweyo. Pambuyo pakuwonetsa zizindikiro za ntchito ya chiwindi, chithandizo cha mankhwala sichitha kuyambiranso.

Kafukufuku wazachipatala wa vildagliptin mwa odwala omwe ali ndi kalasi yogwira I-III malinga ndi gulu la New York Heart Association (NYHA) adawonetsa kuti chithandizo cha vildagliptin sichimagwira ntchito yamanzere yamitsempha kapena kuwonongeka kwa mtima komwe kumachitika poyerekeza ndi placebo. Zochitika zamankhwala mu NYHA yogwira ntchito gulu la III odwala omwe akutenga vildagliptin ndi ochepa ndipo palibe zotsatira zomaliza.

Palibe zokuchitikirani ndi kugwiritsa ntchito vildagliptin pamavuto azachipatala kwa odwala omwe ali ndi kalasi ya IV malinga ndi NYHA ndipo, chifukwa chake, kugwiritsa ntchito odwala sikulimbikitsidwa.

Panthawi yophunzira zaukali wazokhudza miyendo ya anyani, zotupa za pakhungu, kuphatikizapo matuza ndi zilonda, zinajambulidwa. Ngakhale kuti palibe kuwonjezeka kwa zotupa pakhungu pazoyeserera zachipatala, palibe chidziwitso chochepa pochiza odwala omwe ali ndi matenda a khungu omwe ali ndi matenda a shuga. Kuphatikiza apo, malipoti okhudzana ndi zotupa zamakhungu amphongo ndi okokomeza adalandiridwa panthawi yotsatsa. Chifukwa chake, popereka mankhwala, tikulimbikitsidwa kuti odwala omwe ali ndi matenda ashuga azitha kuwunika omwe ali ndi vuto la khungu monga matuza kapena zilonda zam'mimba.

Kugwiritsa ntchito vildagliptin kumalumikizidwa ndi chiopsezo chokhala ndi pancreatitis pachimake.

Odwala ayenera kudziwitsidwa za mawonekedwe a pancreatitis yachilendo.

Ngati pali kukayikira kwa kapamba, kugwiritsa ntchito mankhwalawa kuyenera kusiyidwa, ngati kapamba amatsimikizira, ndiye kuti chithandizo cha Galvus® sichiyenera kuyambiranso. Muyenera kusamala mukamagwiritsa ntchito mankhwalawa odwala omwe ali ndi mbiri yovuta ya kapamba.

Monga mukudziwa, sulfonylurea imayambitsa hypoglycemia. Odwala omwe atenga vildagliptin osakanikirana ndi sulfonylurea ali pachiwopsezo cha kukhala ndi hypoglycemia. Kuchepetsa kwa sulfonylurea kungafunikire kuti muchepetse chiopsezo cha hypoglycemia.

Mapiritsiwo ali ndi lactose. Odwala omwe ali ndi cholowa chokhala ndi chiberekero cha fructose, kuperewera kwa lappase, glucose malabsorption - galactose sayenera kugwiritsa ntchito Galvus®.

Mimba komanso nthawi yoyamwitsa

Palibe deta yokwanira yogwiritsira ntchito Galvus® mwa amayi apakati. Kafukufuku wazinyama awonetsa kawopsedwe kazibongo pogwiritsa ntchito mankhwala okwanira. Chiwopsezo chomwe chilipo kwa anthu sichikudziwika. Chifukwa cha kusowa kwa chidziwitso pakuwonekera kwa anthu, mankhwalawa sayenera kugwiritsidwa ntchito panthawi yomwe ali ndi pakati.

Sizikudziwika ngati vildagliptin adachotsedwa mkaka wa m'mawere. Kafukufuku wazinyama awonetsa kutulutsidwa kwa vildagliptin kukhala mkaka. Galvus® siyenera kugwiritsidwa ntchito poyamwitsa.

Kafukufuku wazotsatira za Galvus® pa chonde sanachitepo kanthu.

Mawonekedwe a mphamvu ya mankhwala pa kuyendetsa magalimoto kapena machitidwe ena owopsa

Kafukufuku wokhudzana ndi mphamvu ya Galvus® pakutha kuyendetsa magalimoto kapena njila zina sizinachitike. Ndi chitukuko cha chizungulire pakumwa mankhwala, odwala sayenera kuyendetsa magalimoto kapena kugwira ntchito ndi njira.

Bongo

Zizindikiro mukamagwiritsa ntchito mankhwala a 400 mg / tsiku, kupweteka kwamisempha kumatha kuchitika, kawirikawiri, mapapo ndi kuchepa kwapakati paresthesia, kutentha thupi, edema komanso kuwonjezeka kwapang'onopang'ono kwa ndende ya lipase (2 times kuposa VGN). Ndi kuwonjezeka kwa mlingo wa Galvus® mpaka 600 mg / tsiku, kukulitsa kwa edema ya malekezero okhala ndi paresthesias ndi kuwonjezereka kwa kuchuluka kwa CPK, ALT, protein-m-protein komanso myoglobin ndizotheka. Zizindikiro zonse za mankhwala osokoneza bongo komanso kusintha kwa magawo a ma laboratite amatha pambuyo pakutha kwa mankhwalawa.

Chithandizo: kuchotsa mankhwala m'thupi ndi hemodialysis ndizokayikitsa. Komabe, hydrolytic metabolite yayikulu ya vildagliptin (lay151) imatha kuchotsedwa m'thupi ndi hemodialysis.

Wogwirizira Sitifiketi Yoyang'anira

Novartis Pharma AG, Basel, Switzerland

Adilesi ya bungwe lomwe lachititsa madera a Republic of Kazakhstan

zonena kuchokera kwa ogula pamkhalidwe wamalonda

Nthambi ya Novartis Pharma Services AG ku Kazakhstan

050051 Almaty, St. Lugansk, 96

tel.: (727) 258-24-47

fakisi: (727) 244-26-51

2014-PSB / GLC-0683-s tarehe 07/30/2014 ndi EU SmPC