Galvus Met® (Galvus Met)

Kufotokozera za mtundu wa kipimo

Mapiritsi, 50 mg + 500 mg: chowulungika, chophatikizidwa m'mphepete, chophimbidwa ndi utoto wamtundu wa chikasu chowala pang'ono pang'ono. Chizindikiro cha NVR chiri mbali imodzi ndipo LLO ili mbali inayo.

Mapiritsi, 50 mg + 850 mg: chowulungika, chophatikizidwa m'mphepete, yokutidwa ndi utoto wamtundu wachikasu wokhala ndi timalo tofowoka. Kumbali ina ndikulemba "NVR", inayo - "SEH".

Mapiritsi, 50 mg + 1000 mg: chowulungika, chophatikizidwa m'mphepete, chophimbidwa ndi kanema wamtundu wa chikasu chakuda chofiirira. Pali "NVR" wolemba mbali imodzi ndi "FLO" mbali inayo.

Mankhwala

Kapangidwe ka Gal Gal Met kamakhala ndi othandizira awiri a hypoglycemic omwe ali ndi njira zosiyanasiyana zochitira: vildagliptin, omwe ali mgulu la dipeptidyl peptidase-4 inhibitors (DPP-4), ndi metformin (mu mawonekedwe a hydrochloride), woimira gulu la Biguanide. Kuphatikizidwa kwa zinthuzi kumakupatsani mwayi wolamulira kuchuluka kwa shuga m'magazi a 2 omwe ali ndi matenda a shuga a 24.

Vildagliptin, nthumwi ya kalasi ya othandizira kulumikizana ndi zida zapachiberekero, mosamala amaletsa enzyme DPP-4, yomwe imawononga mtundu 1 wa glucagon ngati peptide (GLP-1) ndi glucose-insulinotropic polypeptide (HIP).

Metformin imachepetsa kupanga shuga ndi chiwindi, imachepetsa kuyamwa kwa glucose m'matumbo ndikuchepetsa kukana kwa insulin polimbikitsa kutulutsa ndi kugwiritsa ntchito shuga mwa zotumphukira zake.

Metformin imathandizira kuphatikizika kwa glycogen synthetase pochita glycogen synthetase ndipo imakulitsa mayendedwe a glucose ndi mapuloteni ena amtundu wa glucose transporter (GLUT-1 ndi GLUT-4).

Kulepheretsa mwachangu komanso kwathunthu kwa ntchito ya DPP-4 pambuyo pa vildagliptin kumayambitsa kuwonjezeka kwa zonse zoyambira komanso zotsitsimutsa chakudya za GLP-1 ndi HIP kuchokera m'matumbo kupita kutsekemera kwatsiku lonse.

Kuchulukitsa kuchuluka kwa GLP-1 ndi HIP, vildagliptin kumapangitsa kuwonjezeka kwa chidwi cha pancreatic β-cell ku glucose, zomwe zimabweretsa kusintha kwa secretion wa glucose-based insulin. Kuchulukitsa kwa magwiridwe antchito a β-cell kumadalira kuchuluka kwa kuwonongeka kwawo koyamba, choncho mwa anthu opanda shuga - omwe amakhala ndi shuga m'magazi am'magazi), vildagliptin simalimbikitsa kutulutsa kwa insulin komanso sikuchepetsa kuchuluka kwa shuga.

Mwakulitsa kuchuluka kwa mawonekedwe amkati mwa GLP-1, vildagliptin kumawonjezera chidwi cha maselo a α-glucose, zomwe zimapangitsa kuti pakhale kusintha kwamalamulo a shuga a glucagon. Kutsika kwa kuchuluka kwa glucagon okwanira mutatha kudya, kumapangitsa kuchepa kwa insulin.

Kuwonjezeka kwa kuchuluka kwa insulin / glucagon motsutsana ndi maziko a hyperglycemia, chifukwa cha kuchuluka kwa kuchuluka kwa GLP-1 ndi HIP, kumayambitsa kuchepa kwa kupanga kwa shuga ndi chiwindi nthawi ya chakudya komanso pambuyo pake, zomwe zimayambitsa kuchepa kwa kuchuluka kwa shuga m'magazi am'magazi.

Kuphatikiza apo, motsutsana ndi kagwiritsidwe ntchito ka vildagliptin, kuchepa kwa kuchuluka kwa lipids m'madzi am'magazi pambuyo podyedwa, komabe, izi sizikugwirizana ndi zomwe zimachitika pa GLP-1 kapena HIP komanso kusintha kwa magwiridwe antchito a cell pancreatic islet.

Amadziwika kuti kuwonjezeka kwa ndende ya GLP-1 kungapangitse kuti m'mimba muchepetse pang'ono, komabe, motsutsana ndi kugwiritsidwa ntchito kwa vildagliptin, zotsatira zofananira sizimawonedwa.

Pogwiritsa ntchito vildagliptin mu 5759 odwala omwe ali ndi mtundu wa 2 shuga mellitus wa masabata 52 monga monotherapy kapena osakanikirana ndi metformin, zotumphukira za sulfonylurea, thiazolidinedione, kapena insulin, kuchepa kwakukulu kwakanthawi kwakanthawi kwa kuchuluka kwa glycated hemoglobin (НbА)_1s) komanso kusala magazi.

Metformin imathandizira kulolerana kwa glucose mwa odwala omwe ali ndi matenda a shuga 2 mwakuchepetsa kuchuluka kwa glucose nthawi yoyamba komanso isanachitike.

Mosiyana ndi mankhwala a sulfonylurea, metformin sayambitsa hypoglycemia kwa odwala omwe ali ndi matenda a shuga 2 kapena anthu athanzi (kupatula milandu yapadera). Mankhwalawa ndi mankhwalawa sikuti kumayambitsa kukula kwa hyperinsulinemia. Pogwiritsa ntchito metformin, insulin katulutsidwe sikasintha, pomwe insulin imayang'ana m'matumbo opanda kanthu ndipo masana imatha kuchepa.

Pogwiritsa ntchito metformin, njira yothandiza pa kagayidwe ka lipoproteins imadziwika: kuchepa kwa kuchuluka kwa cholesterol, LDL cholesterol ndi triglycerides, yosagwirizana ndi mphamvu ya mankhwalawa pakupezeka kwa shuga m'magazi a m'magazi.

Mukamagwiritsa ntchito mankhwala osakanikirana ndi vildagliptin ndi metformin mu Mlingo wa tsiku lililonse wa 1,500-,000,000 mg wa metformin ndi 50 mg wa vildagliptin 2 pa tsiku 1 chaka, kuchepa kwakukulu kwa kuchuluka kwa shuga m'magazi kunawonedwa (kutsimikiziridwa ndi kuchepa kwa mlozo wa HbA_1s) ndikuwonjezereka kwa chiwerengero cha odwala omwe ali ndi kuchepa kwa kuchuluka kwa HbA_1s zinali pafupifupi 0.6-0.7% (poyerekeza ndi gulu la odwala lomwe limangolandira metformin yokha).

Odwala omwe amalandila vildagliptin ndi metformin, kusintha kwakukulu pa kulemera kwamunthu poyerekeza ndi koyambirira sikunawonedwe. Masabata 24 atayamba chithandizo, m'magulu a odwala omwe amalandila vildagliptin osakanikirana ndi metformin, panali kuchepa kwa magazi ndi abambo mwa odwala omwe ali ndi matenda oopsa.

Pogwiritsa ntchito vildagliptin ndi metformin ngati mankhwala oyamba kwa odwala omwe ali ndi matenda a shuga 2, kutsika kwa HbA komwe kumadalira mlingo kumawonedwa kwa milungu 24_1s poyerekeza ndi monotherapy ndi mankhwalawa. Milandu ya hypoglycemia inali yochepa kwambiri m'magulu onse awiri ochiritsira.

Mukamagwiritsa ntchito vildagliptin (50 mg 2 kawiri pa tsiku) ndi / popanda metformin osakanikirana ndi insulin (pafupifupi mlingo - 41 PIECES) mwa odwala omwe amapezeka mu kafukufuku wazachipatala, chizindikiro cha HbA_1s ochulukitsa kuchuluka kwambiri - ndi 0.72% (chizindikiro choyambirira - pafupifupi 8.8%). Zomwe zimachitika mu hypoglycemia pagulu lochiritsidwalo zinali zofanana ndi zochitika za hypoglycemia pagulu la placebo.

Mukamagwiritsa ntchito vildagliptin (50 mg 2 kawiri pa tsiku) pamodzi ndi metformin (≥1500 mg) osakanikirana ndi glimepiride (≥4 mg / tsiku) mwa odwala omwe ali ndi kafukufuku wamankhwala, chiwonetsero cha HbA_1s kuchuluka kwakukulu kunatsika - ndi 0.76% (kuchokera pamlingo wapakati - 8.8%).

Pharmacokinetics

Zogulitsa. Akamamwa pamimba yopanda kanthu, vildagliptin imatengedwa mwachangu, T_max - Maola 1.75 atatha kukhazikitsa. Ndi zakudya zomwezi munthawi yomweyo, kuchuluka kwa mayeso a vildagliptin kumachepa pang'ono: pali kuchepa kwa C_max 19% ndi kuchuluka kwa T_max mpaka maola 2,5. Komabe, kudya sikumakhudza kuchuluka kwa mayamwa ndi AUC.

Vildagliptin imatengedwa mwachangu, ndipo tanthauzo lake lonse la bioavailability pambuyo pakamwa ndi 85%. C_max ndi AUC mu achire mlingo zosiyanasiyana kuchuluka pafupifupi malinga ndi mlingo.

Kugawa. Mlingo womangiriza wa vildagliptin ku mapuloteni a plasma ndi wotsika (9.3%). Mankhwalawa amagawidwa chimodzimodzi pakati pa plasma ndi maselo ofiira amwazi. Kugawa kwa Vildagliptin kumachitika mopitilira muyeso, V_ss Pambuyo pa utsogoleli wa iv ndi malita 71.

Kupenda. 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 mwanjira ina ndipo ndi chipangizo cha hydrolysis cha cyanocomponent. Pafupifupi 4% ya mankhwala omwe amapezeka amide hydrolysis.

M'maphunziro oyesera, zotsatira zabwino za DPP-4 pa hydrolysis yamankhwala zimadziwika. Vildagliptin sichimaphatikizidwa ndi gawo la cytochrome P450 isoenzymes. Malinga ndi kafukufuku mu vitro , vildagliptin si gawo lapansi la P450 isoenzymes, sichikuletsa ndipo sichilowetsa cytochrome P450 isoenzymes.

Kuswana. Pambuyo pakulowetsa mankhwalawa, pafupifupi 85% ya mankhwalawa imachotsedwa impso ndi 15% kudzera m'matumbo, impso ya vildagliptin yosasinthika ndi 23%. Ndi / pakubweretsa pafupifupi T_1/2 ukufika 2 maola, chilolezo chonse cha plasma ndi chilolezo cha vildagliptin ndi 41 ndi 13 l / h, motsatana. T_1/2 pambuyo kumeza pafupifupi 3 maola, ngakhale mlingo.

Magulu apadera a odwala

Gender, index misa, ndi mafuko sizikhudzanso pharmacokinetics ya vildagliptin.

Kuwonongeka kwa chiwindi. Odwala omwe ali ndi vuto la chiwindi ntchito yofatsa kwambiri (6-10 mfundo malinga ndi gulu la ana-Pugh), mutagwiritsidwa ntchito kamodzi, pali kuchepa kwa bioavailability wa vildagliptin ndi 8 ndi 20%, motero. Odwala omwe ali ndi vuto lowopsa la chiwindi (mfundo 12 malinga ndi gulu la Mwana-Pugh), bioavailability wa vildagliptin imachulukitsidwa ndi 22%. Kusintha kwakukulu mu bioavailability kwa vildagliptin, kuwonjezeka kapena kuchepa kwapakati mpaka 30%, sikofunika kuchipatala. Malumikizidwe apakati pa kuvuta kwa chiwindi ndi kuwonongeka kwa mankhwalawa sikunawonekere.

Matenda aimpso. Odwala omwe ali ndi vuto laimpso, ofatsa, olimbitsa, kapena oopsa a AUC, vildagliptin kuchuluka kwa 1,4, 1,7, ndi kawiri poyerekeza ndi chizindikiro cha odzipereka athanzi, motero. The AUC ya metabolite lay151 inakwera nthawi za 1.6, 3.2 ndi 7.3, ndipo metabolite BQS867 inachulukitsa 1.4, 2.7 ndi 7.3 kwa odwala omwe ali ndi vuto la Impso ofatsa, odziletsa komanso oopsa. Zambiri zochepa mu odwala omwe ali ndi vuto la impso. (CKD) zimawonetsa kuti zizindikiro zomwe zili mgululi ndizofanana ndi za odwala omwe ali ndi vuto la impso. Kuphatikizika kwa Lay151 metabolite kwa odwala omwe ali ndi gawo lotsiriza la CKD kumawonjezeka ndi nthawi 2-3 poyerekeza ndi kuchuluka kwa odwala omwe ali ndi vuto laimpso. Kuchotsa vildagliptin pa hemodialysis kumakhala kochepa (3% panthawi yopitilira maola opitilira 4 maola 4 pambuyo pa limodzi mlingo.

Odwala ≥65 wazaka zakubadwa. Kuchuluka kwachilengedwe kwa bioavailability wa 32% (kuchuluka C_max 18%) mwa odwala opitilira 70 siwofunika kwambiri ndipo samakhudza kuletsa kwa DPP-4.

Odwala ≤18 wazaka. Zomwe zimachitika mu pharmacokinetic za vildagliptin mwa ana ndi achinyamata ochepera zaka 18 sizinakhazikitsidwe.

Zogulitsa. Mtheradi wa bioavailability wa metformin atamwa kwambiri 500 mg pamimba yopanda 50-60%. T_max mu plasma - 1.81-2.69 mawola. Ndi kuwonjezeka kwa mlingo wa mankhwalawa kuchokera 500 mpaka 1500 mg kapena Mlingo kuchokera 850 mpaka 2250 mg mkati, kuwonjezeka kwapang'onopang'ono kwa magawo a pharmacokinetic kunadziwika (kuposa zomwe zingayembekezeredwe pa ubale wololera). Izi zimachitika osati chifukwa chosintha kuchotsedwa kwa mankhwalawo ngati kutsika kwake kumayamwa. Poyerekeza zakumbuyo yazakudya, kuchuluka ndi mayamwidwe a metformin kumachepera pang'ono. Chifukwa chake, ndi muyezo umodzi wa mankhwalawa pa 850 mg, kuchepa kwa C kunawonedwa ndi chakudya_max ndi AUC pafupifupi 40 ndi 25% komanso kuwonjezeka kwa T_max kwa mphindi 35 Kufunika kwamankhwala pazinthu izi sikunakhazikike.

Kugawa. Ndili ndi 850 mg imodzi, pamwamwa V_d metformin ndi (654 ± 358) l. Mankhwalawa sakumanga ma protein a plasma, pomwe ena amachokera ku sulfonylurea. Metformin imalowa m'magazi ofiira (mwina kulimbitsa njirayi kwakanthawi). Mukamagwiritsa ntchito metformin molingana ndi regimen yodziwika (muyezo wapadera komanso pafupipafupi pofotokozera) C_ss mankhwalawa m'madzi a m'magazi amafikira mkati mwa maola 24-48 ndipo, monga lamulo, sizidutsa 1 μg / ml. M'mayesero azachipatala a C_max metformin ya plasma sinapitirire 5 mcg / ml (ngakhale mutamwa mankhwala ambiri).

Kupenda. Pogwiritsa ntchito metformin imodzi yokha kwa odzipereka athanzi, imathiridwa impso osasinthika. Pankhaniyi, mankhwalawa samapangidwira m'chiwindi (palibe metabolites omwe apezeka mwa anthu) ndipo samatulutsidwa mu ndulu.

Kuswana. Popeza chiwonetsero cha impso cha metformin ndichokwera pafupifupi 3.5 kuchulukirapo kuposa kulengedwa kwa creatinine, njira yayikulu yothetsera mankhwalawa ndi secretion ya tubular. Mukamwetsa, pafupifupi 90% ya mlingo woyamwa umapukusidwa ndi impso nthawi yoyamba ya maola 24, ndi T_1/2 kuchokera m'madzi a m'magazi ndi pafupifupi maola 6.2. T_1/2 metformin yamagazi yonse ndi pafupifupi maora 17.6, zomwe zikuwonetsa kuchuluka kwa mankhwala ambiri m'maselo ofiira a magazi.

Magulu apadera a odwala

Paulo Sichikhudzanso ma pharmacokinetics a metformin.

Kuwonongeka kwa chiwindi. Odwala omwe ali ndi vuto la kuchepa kwa hepatic, kuphunzira za mankhwala a pharmacokinetic a metformin sikunachitike.

Matenda aimpso. Odwala ndi mkhutu aimpso ntchito (monga anayeza kwa creatinine chilolezo) T_1/2 metformin kuchokera ku plasma ndikuwonjezera magazi athunthu, ndipo mawonekedwe ake aimpso amachepetsa motengera kuchepa kwa chilolezo cha creatinine.

Odwala ≥65 wazaka zakubadwa. Malinga ndi kafukufuku wochepa wa pharmacokinetic, mwa anthu athanzi ≥65 wazaka, panali kuchepa kwa chiwonetsero chonse cha plasma ndi kuchuluka kwa T_1/2 ndi C_max poyerekeza ndi izi mwa achinyamata. Ma pharmacokinetics a metformin mwa anthu opitilira zaka 65 mwina amatengera kusintha kwa impso, chifukwa chake, odwala omwe ali ndi zaka zosaposa 80, Galvus Met ndizotheka ndi chilolezo chapadera cha creatinine.

Odwala ≤18 wazaka. Mankhwala a metformin a ana ndi achinyamata ochepera zaka 18 sanakhazikitsidwe.

Odwala amitundu yosiyanasiyana. Palibe umboni wazomwe zimachitika chifukwa cha kuleza mtima kwa mafuko a metformin. Mu maphunziro azachipatala olamulidwa a metformin mwa odwala omwe ali ndi mtundu wachiwiri wa shuga wokhudzana ndi mitundu yosiyanasiyana, zotsatira za hypoglycemic zamankhwala zimawonekera chimodzimodzi.

Kafukufuku akuwonetsa bioequivalence malinga ndi AUC ndi C_max Galvus Met m'milingo itatu yosiyanasiyana (50 mg + 500 mg, 50 mg + 850 mg ndi 50 mg + 1000 mg) ndi vildagliptin ndi metformin, omwe atengedwa Mlingo woyenera m'mapiritsi osiyana.

Kudya sizikhudzanso kuchuluka kwa mayamwidwe a vildagliptin mu kapangidwe ka mankhwala a Galvus Met. Makhalidwe a C_max ndi AUC wa metformin popanga mankhwala a Galvus Met pomwe akudya ndi chakudya chomwe chimachepa ndi 26 ndi 7%, motero. Kuphatikiza apo, motsutsana ndi maziko azakudya, kuyamwa kwa metformin kunayamba kuchepa, zomwe zinayambitsa kuwonjezeka kwa T_max (2 mpaka 4 maola). Kusintha kofananako C_max ndipo AUC yokhala ndi chakudya idadziwikanso pankhani yogwiritsira ntchito metformin payokha, komabe, mwanjira yomalizayi, kusintha sikunali kofunikira. Zotsatira za chakudya pa pharmacokinetics za vildagliptin ndi metformin popanga mankhwala a Galvus Met sizinasiyane ndi zomwe pomwa mankhwalawa onse.

Zowonetsera Galvus Met ®

Type 2 shuga mellitus (kuphatikiza mankhwala azakudya ndi masewera olimbitsa thupi):

osakwanira monotherapy ndi vildagliptin kapena metformin,

Odwala omwe amalandila kale mankhwala ophatikizira ndi vildagliptin ndi metformin ngati mankhwala osokoneza bongo,

kuphatikiza ndi sulfonylurea zotumphukira (katatu kuphatikiza chithandizo) mwa odwala omwe kale amathandizidwa ndi zotumphukira za sulfonylurea ndi metformin popanda chiwongolero chokwanira cha glycemic,

katatu kuphatikiza mankhwala ndi insulin odwala kale amalandira insulin mankhwala okhazikika mlingo ndi metformin popanda kukwaniritsa yoyenera glycemic control,

Monga chithandizo choyambirira cha odwala omwe ali ndi mtundu wa matenda a 2 a shuga ndi osakwanira pakulimbitsa thupi, kuchita masewera olimbitsa thupi komanso kufunika koyendetsa glycemic control.

Contraindication

Hypersensitivity to vildagliptin kapena metformin kapena chilichonse cha mankhwala,

Kulephera kwa impso kapena kuwonongeka kwa impso (ndi serum creatinine ndende ya ≥1.5 mg% (> 135 μmol / L) - kwa amuna ndi ≥1.4 mg% (> 110 μmol / L) - kwa azimayi),

zovuta pachimake ndi chiwopsezo cha aimpso kukanika: kuchepa magazi (ndi kutsegula m'mimba, kusanza), kutentha thupi, matenda opatsirana, mikhalidwe ya hypoxia (mantha, sepsis, matenda a impso, matenda a bronchopulmonary),

kukomoka mtima komanso kupsinjika kwa mtima, kuchepa kwamitsempha yamagazi, kuchepa kwamtima ndi mtima (mantha), kulephera kupuma,

chiwindi ntchito,

pachimake kapena matenda metabolic acidosis (kuphatikiza matenda ashuga a ketoacidosis osakanikirana kapena opanda chikomokere), matenda ashuga a ketoacidosis (ayenera kuwongoleredwa ndi insulin mankhwala), lactic acidosis (kuphatikizapo mbiri),

Pamaso pa opaleshoni, radioisotope, maphunziro a x-ray ndikumayambitsa othandizira - mankhwalawa sanalembedwe kwa maola 48 ndipo atatha maola 48 atachitika,

mtundu 1 shuga

uchidakwa wambiri, chakumwa chakumwa choledzeretsa,

kutsatira zakudya zochepa zama calori (zosakwana 1000 kcal / tsiku),

ana ochepera zaka 18 (mphamvu ndi chitetezo sizinakhazikitsidwe).

Popeza odwala omwe ali ndi vuto la chiwindi nthawi zina amakhala ndi lactic acidosis, yomwe mwina ndi imodzi mwazotsatira za metformin, Galvus Met sayenera kugwiritsidwa ntchito muodwala omwe ali ndi matenda a chiwindi kapena magawo amisala okhudza ziwindi.

Ndi chisamaliro: odwala omwe ali ndi zaka zopitilira 60 pochita masewera olimbitsa thupi chifukwa cha chiwopsezo cha lactic acidosis.

Mimba komanso kuyamwa

Pakafukufuku wazinyama zomwe zimagwiritsidwa ntchito ndi vildagliptin mu Mlingo wowirikiza 200 kuposa momwe analimbikitsira, mankhwalawa sanayambitse kuphwanya koyambirira kwa mluza ndipo sanatulutse mphamvu ya teratogenic. Pogwiritsa ntchito vildagliptin kuphatikiza ndi metformin paziwerengero 1: 10, mphamvu ya teratogenic sinapezekenso.

Popeza palibe chidziwitso chokwanira pakugwiritsa ntchito mankhwalawa Galvus Met mwa amayi apakati, kugwiritsa ntchito mankhwalawa panthawi yapakati kumatsutsana.

Metformin imadutsa mkaka wa m'mawere. Sizikudziwika ngati vildagliptin adachotsedwa mkaka wa m'mawere. Kugwiritsa ntchito mankhwala Galvus Met panthawi yoyamwitsa kumayesedwa.

Zotsatira zoyipa

Zomwe zili pansipa zikugwirizana ndi kugwiritsa ntchito vildagliptin ndi metformin mu monotherapy komanso kuphatikiza.

Chifukwa cha mankhwala a vildagliptin, kuwonongeka kwa chiwindi (kuphatikizapo hepatitis) sikunachitike kwenikweni. Nthawi zambiri, izi zakuphwanya ndi kupatuka kwa chiwindi ntchito zinayambira pazonse zimathetsedwa paokha popanda zovuta atasiya kumwa mankhwala. Mukamagwiritsa ntchito vildagliptin pa mlingo wa 50 mg 1 kapena 2 pa tsiku, pafupipafupi kuchuluka kwa michere ya chiwindi (ALT kapena ACT 3 nthawi yayitali kuposa VGN) inali 0,2 kapena 0,3%, motero (poyerekeza ndi 0,2% pagulu lolamulira) . Kuwonjezeka kwa ntchito ya ma enzymes a chiwindi nthawi zambiri anali asymptomatic, sanapite patsogolo, ndipo sanali limodzi ndi cholestasis kapena jaundice.

Njira zotsatirazi zinagwiritsidwa ntchito poyesa zochitika zazovuta (AE): Nthawi zambiri (≥1 / 10), nthawi zambiri (≥1 / 100, GIT), mulingo wa AE poyerekeza ndi mankhwala ophatikizira ndi vildagliptin ndi metformin anali 12.9%. anawona mu 18.1% ya odwala.

M'magulu a odwala omwe amalandila metformin osakanikirana ndi vildagliptin, matenda am'mimba adadziwika ndi pafupipafupi a 10-15%, ndipo pagulu la odwala omwe amalandila metformin osakanikirana ndi placebo, pafupipafupi ndi 18%.

Kuyesedwa kwakanthawi kachipatala kofikira zaka 2 sikunawonetse kupatuka kowonjezereka mu mbiri yachitetezo kapena zoopsa zomwe sizinachitike pogwiritsira ntchito vildagliptin monga monotherapy.

Kafukufuku wokhudzana ndi kuphatikiza kwa vildagliptin ndi metformin monga njira yoyambira yodwala matenda ashuga a 2 sikunawonetse zovuta zilizonse komanso zambiri zowonjezera chitetezo.

Kugwiritsa ntchito vildagliptin nthawi imodzi ndi insulin

M'mayeso azachipatala olamulidwa ndikugwiritsa ntchito vildagliptin pa 50 mg 2 kawiri pa tsiku osakanikirana ndi insulin pophatikizana ndi metformin kapena popanda iyo, pafupipafupi kuleka kwa chithandizo chamankhwala chifukwa cha kusinthika kwa mayankho olakwika anali 0.3% pagulu la vildagliptin, pomwe anali pagulu la placebo Panalibe kuchotsera mankhwala.

Zomwe zimachitika mu hypoglycemia zinali zofananira m'magulu onsewa (14% mu gulu la vildagliptin ndi 16.4% pagulu la placebo). Mu gulu la vildagliptin, milandu yayikulu ya hypoglycemia idadziwika mu odwala 2, mu gulu la placebo - mu 6.

Panthawi yomwe maphunziro anali atamalizidwa, mankhwalawo sanakhudze kulemera kwa thupi (kulemera kwa thupi kunawonjezeka ndi 0,6 kg poyerekeza ndi koyambirira m'gulu la vildagliptin, ndipo palibe kusintha komwe kudadziwika mu gulu la placebo).

Ma AE mu odwala omwe amalandira vildagliptin 50 mg 2 kawiri pa tsiku limodzi ndi insulin (yokhala ndi metformin kapena yopanda mawonekedwe) amaperekedwa pansipa.

Kuchokera ku dongosolo lamanjenje: Nthawi zambiri mutu.

Kuchokera m'mimba: Nthawi zambiri - nseru, gastroesophageal Reflux, infrequently - kutsegula m'mimba, kusangalala.

Kuchokera kumbali ya kagayidwe ndi zakudya: nthawi zambiri - hypoglycemia.

Zovuta ndi zovuta zina pamalo opangira jakisoni: nthawi zambiri - kuzizira.

Mukamagwiritsa ntchito vildagliptin limodzi ndi kukonzekera kwa sulfonylurea

Milandu yakulekera kwa mankhwala omwe amaphatikizidwa ndi chitukuko cha AE mu gulu lophatikiza mankhwala ndi vildagliptin, metformin ndi glimepiride sizinadziwike. Pophatikiza mankhwala a placebo, metformin ndi glimepiride, zochitika za AE zinali 0.6%.

Hypoglycemia nthawi zambiri imawonedwa m'magulu onse awiri (5.1% mu gulu lophatikiza mankhwala omwe ali ndi vildagliptin, metformin ndi glimepiride ndi 1.9% pagulu la mankhwala ophatikiza ndi placebo, metformin ndi glimepiride). Mu gulu la vildagliptin, gawo limodzi la hypoglycemia lalikulu lidadziwika.

Panthawi yomwe kafukufukuyu adamalizidwa, palibe zotsatira zazikulu zakukula kwa thupi zomwe zidapezeka (+0.6 makilogalamu mu gulu la vildagliptin ndi makilogalamu −0.1 mu gulu la placebo).

Ma AE mu odwala omwe amalandira vildagliptin 50 mg kawiri pa tsiku osakanikirana ndi metformin ndi sulfonylureas amaperekedwa pansipa.

Kuchokera ku dongosolo lamanjenje: Nthawi zambiri - chizungulire, kugwedezeka.

Zovuta ndi zovuta zina pamalo opangira jakisoni: Nthawi zambiri kutopa.

Kuchokera kumbali ya kagayidwe ndi zakudya: nthawi zambiri - hypoglycemia.

Pa khungu ndi subcutaneous minofu: Nthawi zambiri - hyperhidrosis.

Mukamagwiritsa ntchito vildagliptin monga monotherapy

Kuchokera ku dongosolo lamanjenje: Nthawi zambiri - chizungulire, pafupipafupi - kupweteka kwa mutu.

Kuchokera m'mimba: pafupipafupi - kudzimbidwa.

Pa khungu ndi subcutaneous minofu: pafupipafupi - zotupa pakhungu.

Kuchokera kumbali ya minofu ndi mafupa ophatikizika: nthawi zambiri - arthralgia.

Zovuta ndi zovuta zina pamalo opangira jakisoni: pafupipafupi - zotumphukira edema.

Mukamagwiritsa ntchito mankhwala osakanikirana ndi vildagliptin ndi metformin, kuwonjezereka kwakukulu pama pafupipafupi a AEs omwe atchulidwa pamwambapa sikunawonedwe.

Kumbuyo kwa monotherapy ndi vildagliptin kapena metformin, zochitika za hypoglycemia zinali 0.4% (mowerengeka).

Monotherapy yokhala ndi vildagliptin ndi chithandizo chophatikizidwa cha vildagliptin + metformin sizinakhudze thupi la wodwalayo.

Kuyesedwa kwakanthawi kachipatala kofikira zaka 2 sikunawonetse kupatuka kowonjezereka mu mbiri yachitetezo kapena zoopsa zomwe sizinachitike pogwiritsira ntchito vildagliptin monga monotherapy.

Zotsatira zoyipa zotsatirazi zidazindikirika panthawi yotsatsa malonda (popeza zidziwitsozo zimanenedwa podzifunira kuchokera kwa anthu opanda muyeso, sizingatheke kudziwa motsimikizika kukula kwa ma AEs, chifukwa chake amalembedwera ngati pafupipafupi sichikudziwika): hepatitis (kusinthika kwina pakachotsedwa chithandizo), urticaria, kapamba, zilonda zamkati ndi zotupa.

Mukamagwiritsa ntchito metformin mu monotherapy

Kuchokera kumbali ya kagayidwe ndi zakudya: pafupipafupi - kusowa kwa chakudya, kawirikawiri - lactic acidosis.

Kuchokera m'mimba: Nthawi zambiri - flatulence, nseru, kusanza, kutsegula m'mimba, kupweteka kwam'mimba, nthawi zambiri - dysgeusia.

Pa mbali ya chiwindi ndi biliary thirakiti: osowa - hepatitis.

Pa khungu ndi subcutaneous minofu: kawirikawiri - zimachitika pakhungu (makamaka erythema, pruritus, urticaria).

Zambiri zasayansi: kawirikawiri - kuchepetsedwa mayamwidwe a vitamini B₁₂, kusintha kwa mafuta a chiwindi.

Kuchepetsa Vitamini B Mafuta₁₂ ndi kuchepa kwa kuchuluka kwake mu seramu yamagazi ndikugwiritsa ntchito metformin kunawonedwa kawirikawiri kwambiri kwa odwala omwe amalandira mankhwalawa kwa nthawi yayitali, ndipo, monga lamulo, sanayimire kufunikira kwakudwala. Kuganizira kuyenera kuperekedwa pakuchepetsa kuyamwa kwa vitamini B₁₂ Odwala ndi megaloblastic anemia.

Milandu ina ya hepatitis, yomwe imawonedwa pogwiritsa ntchito metformin, idathetsedwa atatha.

Kuchita

Pogwiritsa ntchito nthawi yomweyo vildagliptin (100 mg 1 nthawi patsiku) ndi metformin (1000 mg 1 nthawi patsiku), PCF yofunika kwambiri sanawoneke pakati pawo. Ngakhale pakumayesedwa kuchipatala, kapena panthawi yogwiritsa ntchito kwambiri Galvus Met mwa odwala omwe nthawi yomweyo amalandila mankhwala ndi zinthu zina, kulumikizana mosayembekezereka sikunapezeke.

Vildagliptin ali ndi mwayi wotsika wolumikizana ndi mankhwala. Popeza vildagliptin si gawo la ma enzymes a cytochrome P450, komanso sikulepheretsa kapena kuyambitsa ma isoenzymes awa, kuyanjana kwake ndi mankhwala omwe ali am'munsi, ma inhibitors, kapena P450 inducers sangayike. Pogwiritsa ntchito nthawi yomweyo vildagliptin sizikhudza kuchuluka kwa kagayidwe ka mankhwala omwe ali magawo a michere: CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 ndi CYP3A4 / 5.

Kuyanjana kwakukulu kwa vildagliptin ndi mankhwala omwe amagwiritsidwa ntchito kwambiri pochiza matenda a shuga 2 mellitus (glibenclamide, pioglitazone, metformin) kapena kukhala ndi masanjidwe ochepa othandizira (amlodipine, digoxin, ramipril, simvastatin, valsartan, warfarin) sanakhazikitsidwe.

Furosemide amawonjezera C_max ndi AUC wa metformin, koma sizikhudza chiwonetsero chake cha impso. Metformin otsitsa C_max ndi AUC ya furosemide komanso sizikhudza kuonekera kwake kwa impso.

Nifedipine kuchuluka mayamwidwe, C_max ndi AUC wa metformin, kuwonjezera, imawonjezera kuchulukitsidwa kwake ndi impso. Metformin kwenikweni sikukhudza magawo a pharmacokinetic a nifedipine.

Glibenclamide sizikhudza magawo a pharmacokinetic / pharmacodynamic a metformin. Metformin nthawi zambiri imatsitsa C_max ndi AUC ya glibenclamide, komabe, kukula kwa zotsatirazi kumasiyana kwambiri. Pachifukwachi, kufunikira kwakukhudzaku kumachitika pakadali pano.

Zachilengedwemwachitsanzo, amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamteren, trimethoprim, vancomycin ndi ena, omwe amathandizidwa ndi impso pogwiritsa ntchito katulutsidwe ka tubular, atha kugawana ndi metformin chifukwa cha mpikisano wodziwika bwino wa mayendedwe a tuber. Chifukwa chake, cimetidine imawonjezera kuchuluka kwa metformin m'madzi a m'magazi ndi AUC ndi 60 ndi 40%, motero. Metformin sichikhudza magawo a pharmacokinetic a cimetidine. Chenjezo liyenera kuchitika mukamagwiritsa ntchito Galvus Met limodzi ndi mankhwala omwe amakhudza ntchito ya impso kapena kugawa kwa metformin m'thupi.

Mankhwala ena. Mankhwala ena amatha kuyambitsa hyperglycemia ndikuchepetsa mphamvu ya othandizira a hypoglycemic. Mankhwalawa amaphatikiza thiazides ndi ma okitirositi ena, GCS, phenothiazines, kukonzekera kwa mahomoni a chithokomiro, estrogens, kulera kwapakamwa, phenytoin, nikotini acid, sympathomimetics, calcium antagonists ndi isoniazid. Pogwiritsa ntchito nthawi yomweyo mankhwala ngati amenewo kapena, m'malo mwake, ngati akuchoka, tikulimbikitsidwa kuyang'anira bwino ntchito ya metformin (zotsatira zake za hypoglycemic) ndipo ngati kuli kotheka, sinthani mlingo wa mankhwalawo. Kugwiritsa ntchito mosavomerezeka sikulimbikitsidwa danazole kuti mupewe zochitika za hyperglycemic za omaliza. Ngati mankhwala a danazol akufunika ndipo atayimitsa makonzedwe omaliza, kusintha kwa metformin kumafunika motsogozedwa ndi shuga ya magazi.

Chlorpromazine akamagwiritsa ntchito Mlingo waukulu (100 mg patsiku), umawonjezera glycemia, kuchepetsa kutulutsa kwa insulin. Mankhwalawa antipsychotic ndipo atayimitsa chomaliza, kusintha kwa mankhwala a Galvus Met kumafunika motsogozedwa ndi ndende ya magazi.

Iodini wokhala ndi radiopaque wothandizira: kafukufuku wama radiology ogwiritsa ntchito ayodini wokhala ndi ma radiopaque othandizira amatha kuyambitsa lactic acidosis kwa odwala omwe ali ndi matenda osokoneza bongo omwe amalephera kugwira ntchito mwamphamvu.

Cholowa β₂Muthana: kuchuluka glycemia chifukwa kukondoweza kwa of₂-makampani. Pankhaniyi, kuyang'anira glycemic ndikofunikira. Ngati ndi kotheka, insulin ikulimbikitsidwa.

Ndi munthawi yomweyo kugwiritsa ntchito metformin ndi sulfonylurea zotumphukira, insulin, acarbose, salicylates, kuchuluka kwa hypoglycemic kwenikweni ndikotheka.

Popeza kugwiritsa ntchito metformin kwa odwala omwe amamwa mowa kwambiri kumawonjezera chiopsezo cha lactic acidosis (makamaka panthawi yanjala, kutopa, kapena kulephera kwa chiwindi), mu chithandizo ndi Galvus Met, muyenera kupewa kumwa mowa ndi mankhwala okhala ndi ethyl mowa.

Mlingo ndi makonzedwe

Mlingo wa mankhwala a Galvus Met uyenera kusankhidwa payekha, kutengera kuthandizira komanso kulekerera kwa mankhwalawa. Mukamagwiritsa ntchito Galvus Met, musapitirire mlingo wovomerezeka wa tsiku ndi tsiku wa vildagliptin (100 mg).

Mlingo woyambirira wa Galvus Met uyenera kusankhidwa, poganizira nthawi yayitali ya matenda ashuga komanso kuchuluka kwa glycemia, mkhalidwe wodwalayo ndi mtundu wa chithandizo cha vildagliptin ndi / kapena metformin yomwe imagwiritsidwa kale ntchito kwa wodwala. Kuti muchepetse kuwonongeka kwa zoyipa m'magawo am'mimba, mawonekedwe a metformin, Galvus Met imatengedwa ndi chakudya.

Mlingo woyambirira wa mankhwalawa Galvus Met osagwira ntchito ya monotherapy ndi vildagliptin

Kuchiza kungayambike piritsi limodzi. (50 mg + 500 mg) kawiri pa tsiku, mutawunika momwe mankhwalawo amathandizira, mlingo umatha kuwonjezeka pang'onopang'ono.

Mlingo woyamba wa mankhwala Galvus Met ndi kulephera kwa monotherapy ndi metformin

Kutengera ndi mtundu wa metformin womwe watengedwa kale, chithandizo ndi Galvus Met chitha kuyamba ndi piritsi limodzi. (50 mg + 500 mg, 50 mg + 850 mg kapena 50 mg + 1000 mg) 2 pa tsiku.

Mlingo woyambirira wa Galvus Met mu odwala omwe adalandira kale mankhwala osakanikirana ndi vildagliptin ndi metformin mwa mapiritsi osiyana

Kutengera Mlingo wa vildagliptin kapena metformin womwe watengedwa kale, chithandizo ndi Galvus Met chiyenera kuyamba ndi piritsi lomwe lili pafupi kwambiri ndi kuchuluka kwa mankhwalawa (50 mg + 500 mg, 50 mg + 850 mg kapena 50 mg + 1000 mg), ndikusintha mlingo kuti ukhale kutengera luso.

Koyamba mlingo wa Galvus Met monga mankhwala oyambira kwa odwala omwe ali ndi matenda a shuga 2 osakwanira mthupi la zakudya komanso kuchita masewera olimbitsa thupi

Monga mankhwala oyambira, Galvus Met iyenera kutumikiridwa muyezo koyamba wa 50 mg + 500 mg kamodzi patsiku, ndipo mutasanthula njira yothandizira, pang'onopang'ono muwonjezere mlingo mpaka 50 mg + 1000 mg 2 pa tsiku.

Kuphatikiza mankhwala ndi Galvus Met ndi sulfonylurea zotumphukira kapena insulin

Mlingo wa Galvus Met amawerengedwa pamaziko a mlingo wa vildagliptin 50 mg × 2 kawiri pa tsiku (100 mg patsiku) ndi metformin pa mlingo wofanana ndi womwe kale umagwiritsidwa ntchito ngati mankhwala amodzi.

Magulu apadera a odwala

Matenda aimpso. Odwala omwe ali ndi vuto la impso, kusinthaku kwa mankhwalawa ndi Cl creatinine (owerengedwa ndi njira ya Cockcroft-Gault) pamtunda kuchokera pa 60 mpaka 90 ml / min kungafunike. Kugwiritsira ntchito kwa mankhwala a Galvus Met odwala ndi Cl creatinine VGN 2 nthawi). Ndi kuwonjezeka kwa mlingo wa vildagliptin mpaka 600 mg / tsiku, kukulitsa kwa edema yamapeto ndikotheka, limodzi ndi paresthesias ndikuwonjezereka kwa kuchuluka kwa CPK, mapuloteni a C-reactive ndi myoglobin, ndi ntchito ya AST. Zizindikiro zonse za mankhwala osokoneza bongo komanso kusintha kwa magawo a ma laboratite amatha pambuyo pakutha kwa mankhwalawa.

Chithandizo: Kuchotsa kwa mankhwala kuchokera mthupi kudzera mu dialysis ndikosatheka. Komabe, hydrolytic metabolite yayikulu ya vildagliptin (lay151) imatha kuchotsedwa m'thupi ndi hemodialysis.

Zizindikiro milandu yambiri ya metformin, kuphatikizapo Zotsatira za kumeza kwa mankhwalawa kuchuluka kwa g 50. Ndi mankhwala osokoneza bongo a metformin, hypoglycemia imawonedwa pafupifupi 10% ya milandu (komabe, ubale wake ndi mankhwalawo sunakhazikitsidwe). Mu 32% ya milandu, lactic acidosis idadziwika. Zizindikiro zoyambirira za lactic acidosis ndi mseru, kusanza, kutsegula m'mimba, kuchepa kwa thupi, kupweteka kwam'mimba, kupweteka kwa minofu, ndipo pakhoza kuchuluka kupuma, chizungulire, chikumbumtima chodwala komanso kukula kwa chikomokere.

Chithandizo: Zizindikiro, kutengera momwe wodwalayo alili komanso kuwonetsa kwake kwamankhwala. Amachotsedwa m'magazi pogwiritsa ntchito hemodialysis (chilolezo mpaka 170 ml / min) popanda chitukuko cha hemodynamic. Chifukwa chake, hemodialysis ingagwiritsidwe ntchito pochotsa metformin m'magazi ngati mankhwala atagwiritsidwa ntchito mopitirira.

Malangizo apadera

Odwala omwe amalandira insulin, Galvus Met sangathe kulowa m'malo mwa insulin.

Kuwonongeka kwa chiwindi. Popeza poika vildagliptin, kuwonjezereka kwa ntchito za aminotransferases (nthawi zambiri popanda mawonetseredwe a chipatala) kumadziwika nthawi zambiri kuposa gulu lolamulidwa, tikulimbikitsidwa kudziwa magawo a michere ya chiwindi musanayambe kugwiritsa ntchito mankhwala a Galvus Met, komanso pafupipafupi pakumwa. Ngati kuwonjezeka kwa ntchito ya aminotransferase kwapezeka, kafukufuku wobwereza ayenera kuchitika kuti atsimikizire zotsatira zake, kenako azindikire magawo amomwe amathandizidwe a chiwindi ntchito mpaka atasintha. Ngati kuchuluka kwa ntchito ya AST kapena ALT ndi 3 kapena kuposa pamenepo kuposa VGN kutsimikiziridwa ndikufufuza mobwerezabwereza, ndikulimbikitsidwa kuletsa mankhwalawo.

Lactic acidosis. Lactic acidosis ndizosowa kwambiri koma zovuta za metabolic zomwe zimachitika ndi kudzikundikira kwa metformin mthupi. Lactate acidosis yogwiritsira ntchito metformin imawonedwa makamaka mwa odwala omwe ali ndi matenda osokoneza bongo omwe ali ndi vuto lalikulu la aimpso. Chiwopsezo chokhala ndi lactic acidosis imawonjezera odwala omwe ali ndi vuto losakhazikika la matenda a shuga, okhala ndi vuto la ketoacidosis, kugona kwa nthawi yayitali, kumwa mowa kwambiri, kuwonongeka kwa chiwindi ndi matenda omwe amayambitsa hypoxia.

Ndi chitukuko cha lactic acidosis, kupuma movutikira, kupweteka kwam'mimba komanso hypothermia, ndikutsatira chikomokere, zimadziwika. Zizindikiro zotsatirazi za Laborator zimakhala ndi phindu lazidziwitso: kuchepa kwa magazi pH, kuchuluka kwa lactate mu seramu pamwamba pa 5 nmol / L, komanso kuchuluka kwa anionic interension ndi kuwonjezeka kwa chiŵerengero cha lactate / pyruvate. Ngati lactic acidosis ikukayikira, mankhwalawo ayenera kusiyidwa ndipo wodwalayo amapita kuchipatala nthawi yomweyo.

Kuyang'anira ntchito ya impso. Popeza metformin imapukusidwa kwambiri ndi impso, chiopsezo cha kudzikundikira kwake ndi kukula kwa lactic acidosis kumawonjezeka molingana ndi kuopsa kwa kusokonezeka kwa impso. Mukamagwiritsa ntchito mankhwalawa, Galvus Met amayenera kuwunikira ntchito ya impso, makamaka pazomwe zimathandizira kuphwanya kwake, monga gawo loyambirira la mankhwala omwe ali ndi antihypertensive mankhwala, othandizira a hypoglycemic kapena NSAIDs. Ntchito yamkati iyenera kuyesedwa musanayambe chithandizo ndi Galvus Met, ndipo osachepera 1 pachaka kwa odwala omwe ali ndi vuto laimpso komanso osachepera 2-4 pachaka odwala omwe ali ndi chilolezo cha creatinine pamlingo wocheperako, komanso okalamba odwala. Odwala omwe ali pachiwopsezo chokhala ndi vuto la impso, kuwunika kuyenera kuchitidwa kawiri kawiri pachaka. Ngati zizindikiro za kuwonongeka kwa impso zikuwoneka, Galvus Met iyenera kuyimitsidwa.

Kugwiritsa ntchito ayodini wokhala ndi ma radiopaque othandizira kudzera mu intravascular management. Mukamayambitsa maphunziro a x-ray omwe amafunikira ma intaneti a iodine okhala ndi ma radiopaque othandizira, Galvus Met iyenera kuyimitsidwa kwakanthawi (maola 48 asanafike, komanso mkati mwa maola 48 mutatha kuphunzira), chifukwa kuwongolera kwa ma ayodini okhala ndi ma radiopaque kungayambitse kuwonongeka kwambiri mu ntchito ya impso ndikuwonjezera chiopsezo cha lactic acidosis. Kuyambiranso kumwa Gal Gal Met pokhapokha mutayambiranso ntchito ya impso.

Hypoxia. Mu pachimake mtima kulephera (mantha), pachimake mtima kulephera, pachimake m`mnyewa wamtima infarction ndi zinthu zina yodziwika ndi hypoxia, kukula kwa lactic acidosis ndi prerenal pachimake aimpso kulephera. Zitachitika izi pamwambapa, mankhwalawo ayenera kusiyidwa pomwepo.

Zithandizo za opaleshoni. Panthawi yopangira opaleshoni (kupatula ntchito zing'onozing'ono zomwe sizikugwirizana ndi kuchepetsa kudya ndi madzi akumwa), mankhwala a Galvus Met ayenera kusiyidwa. Kuyambiranso kwa mankhwalawa ndikotheka pambuyo pobwezeretsanso zakudya zam'kamwa mwa odwala omwe ali ndi vuto lalikulu laimpso.

Kumwa mowa. Zapezeka kuti mowa umakulitsa mphamvu ya metformin pa lactate metabolism. Odwala ayenera kuchenjezedwa za kusaberekeka kwa uchidakwa pakugwiritsa ntchito mankhwalawa Galvus Met.

Kuzindikira kwa odwala omwe ali ndi matenda a shuga 2 omwe alabadira kale chithandizo. Ngati kupatuka kwachipatalaku malinga ndi chizolowezi chapezeka kapena matenda azachipatala akuwoneka kuti mkhalidwe wowonjezereka umakulirakulira (makamaka ndi zosamveka bwino komanso zowoneka zolakwika) mwa odwala omwe ali ndi yankho lokwanira kumankhwala, kuwunika kwa labotale kuyenera kuchitidwa nthawi yomweyo kuti adziwe ketoacidosis ndi / kapena lactic acidosis. Ngati acidosis yapezeka, muyenera kusiya kugwiritsa ntchito mankhwalawo ndikuchita zofunika kukonza momwe wodwalayo alili.

Hypoglycemia. Mwachizolowezi, mwa odwala omwe amalandila Galvus Met okha, hypoglycemia siziwonetsedwa, koma imatha kuchitika motsutsana ndi maziko azakudya zochepa zopatsa mphamvu (pomwe zolimbitsa thupi sizingalipidwe ndi zomwe zili ndi chakudya cha calorie) kapena motsutsana ndi zakumwa zoledzera. Kukula kwa hypoglycemia kumakhala makamaka kwa okalamba, ofooka kapena otopa, komanso motsutsana ndi maziko a hypopituitarism, adrenal insuffidence kapena kuledzera. Kwa odwala okalamba komanso omwe amalandira β-blockers, kuzindikira kwa hypoglycemia kumatha kukhala kovuta.

Kuchepa mphamvu kwa othandizira a hypoglycemic. Pansi pa kupsinjika (kuphatikizapo kutentha thupi, kuvulala, matenda, opaleshoni), kukulira odwala omwe amalandila othandizira a hypoglycemic malinga ndi chiwembu chokhazikitsidwa, kuchepa kwakukulu kwa mphamvu yotsiriza kwa nthawi yayitali ndikotheka. Pankhaniyi, zingakhale zofunikira kusiya kwakanthawi mankhwala a Galvus Met ndi insulin. Kuyambiranso kwa chithandizo ndi Galvus Met ndikotheka kumapeto kwa nthawi yovuta kwambiri.

Chonde. Pakafukufuku wazoyesedwa mu zinyama, kugwiritsa ntchito vildagliptin mu Mlingo kuwirikiza 200 kuposa momwe kunavomerezeka sizinayambitse vuto la kubereka.

Palibe zotsatira zoyipa chonde amuna ndi akazi pogwiritsa ntchito metformin mu Mlingo wa 600 mg / kg / tsiku, lomwe limakhala lokwera katatu kuposa njira yolimbikitsira anthu (atasinthidwa kukhala m'dera lamunthu). Kafukufuku wokhudza momwe chonde chaanthu sichinachitike.

Kukopa pa kuyendetsa magalimoto ndi kugwira ntchito ndi njira. Zotsatira za Galvus Met pakutha kuyendetsa magalimoto ndi machitidwe ake sizinaphunzire. Ndi chitukuko cha chizungulire kumbuyo komwe ntchito mankhwalawo, munthu ayenera kupewa kuyendetsa magalimoto ndi zida zake.

Wopanga

1. Novartis Pharma Stein AG, Switzerland.

2. Novartis Pharma Production GmbH. Oflingerstrasse 44, 79664, Ver, Germany.

Mwini wa satifiketi yolembetsa: Novartis Pharma AG. Lichtstrasse 35, 4056, Basel, Switzerland.

Zowonjezera pazamankhwala zimatha kupezeka pa adilesi: 125315, Moscow, Leningradsky pr-t, 72, bldg. 3.

Tele. ((495) 967-12-70, fakisi: (495) 967-12-68.