Hoʻokaʻaʻike Gvus Met® (Galvus Met)

ʻO ka wehewehe ʻana i ke ʻano dosis

Nā Pihi, 50 mg + 500 mg: oval, me nā kihi beveled, ua uhi ʻia me ka membrane o ke kiʻi ʻoniʻoni me ke aniani maʻemaʻe. Ma ka ʻaoʻao ʻo NVR ma kēlā ʻaoʻao a aia ʻo LLO ma ka ʻaoʻao.

Nā Pihi, 50 mg + 850 mg: oval, me nā kihi beveled, uhi ʻia me ke membrane kiʻi o ke melemele me kahi māpoki hina hina. Ma kekahi ʻaoʻao ka hōʻailona ʻo "NVR", ma kahi - "SEH".

Nā Pihi, 50 mg + 1000 mg: oval, me nā kihi beveled, uhi ʻia me nā membrane o ke kiʻi ʻoniʻoni me kahi kala hina. Aia kekahi "NVR" māka ma kekahi ʻaoʻao a me "FLO" ma ka ʻaoʻao.

Lapaʻau lāʻau

ʻO ka pūnaehana o ka lāʻau Galvus Met ka mea komo pū me 2 mau hypoglycemic a me nā ʻano hana like ʻole: vildagliptin, no ka papa o ka dipeptidyl peptidase-4 inhibitors (DPP-4), a me metformin (i ke ʻano o ka hydrochloride), he mākaukau o ka papa biguanide. ʻO ka hoʻohui ʻana o kēia mau mea e hiki ai iā ʻoe ke hoʻomalu hou aku i ka kaila o ke koko i ka poʻe maʻi me nā maʻi type 2 no 24 mau hola.

ʻO Vildagliptin, he māka o ka papa o ka mea hoʻolaha o ka insular pancreatic apparatus, sellyly pale i ka enzyme DPP-4, ka mea e hoʻopau i ka type 1 glucagon like-peptide (GLP-1) a me ka glucose-dependantine insulin -ropyp polypeptide (HIP).

Hoʻemi ka Metformin i ka hana o ka glucose i ka peka, e hōʻemi ana i ka lilo ʻana o ka glucose i loko o ka pūpoki a me ka hoʻohaʻahaʻa ʻana i ka kūleʻa o ka insulin ma o ka hoʻomaikaʻi ʻana i ka hoʻoulu ʻana a me ka hoʻohana ʻana i nā kūmole i nā kikoʻī periferi.

Hoʻonui ka Metformin i ka syntact glycogen intracellular ma ka hana ʻana i ka synthetase glycogen a hoʻonui i ka halihali glucose i kekahi mau protein transporter glucose membrane (GLUT-1 a me GLUT-4).

ʻO ka wikiwiki a hoʻopau paʻa o ka hana DPP-4 ma hope o ka vildagliptin e hoʻonui ai i ka basal a me nā mea hoʻowalewale ʻana i ka ʻai o GLP-1 a me HIP mai ka ʻōpū i loko o ka ʻōnaehana ʻōnaehana i ka ao.

ʻO ka hoʻonui ʻana i ka kao o ka GLP-1 a me HIP, ʻo vildagliptin e hoʻonui i ka naʻau o ka pancreatic β-cells i ka glucose, e alakaʻi ai i kahi hoʻomaikaʻi ʻana i ka huna o ka glucose i hilinaʻi ʻia. Hōʻike ka nui o ka holomua o ka hana o ka β-cell i ka pae o ko lākou hōʻeha mua ʻana, no laila i loko o nā poʻe me ka maʻi mellitus ʻole (me ka neʻe ʻana o ka glucose i ka plasma koko), ʻaʻole ʻo ka vildagliptin e hoʻoulu i ka neʻe ʻana o ka insulin a ʻaʻole e hōʻemi i ka hoʻoliʻiliʻi glucose.

I ka hoʻonui ʻana i ka kao o ka endogenous GLP-1, hoʻonui ka vildagliptin i ka hoʻololi ʻana o nā seleka o ka glucose i ka glucose, e alakaʻi ai i kahi holomua o ka hoʻoponopono o ka glucose i kālai ʻia ʻana o ka paleona. ʻO ka emi ʻana o ka hoʻohaʻahaʻa ʻia o ka glucagon ma hope o ka papa ʻaina, ma ka huli ʻana, e hoʻoneʻe i ka pale ʻana i ka insulin.

Ke hoʻonui nei i ka pae o ka insulin / glucagon e kū'ē ana i ke kua o ka hyperglycemia, ma muli o ka hoʻonui ʻana o ka neʻe o ka GLP-1 a me HIP, e hoʻolilo i ka emi ʻana o ka hana o ka glucose i ka ate ma ka wā a ma hope o ka ʻaina, ka mea e alakaʻi ai i ka emi o ke kaʻe o ka glucose i loko o ke koko koko.

Eia kekahi, e kū'ē i ka hope o ka hoʻohana ʻana o vildagliptin, kahi i hoʻohaʻahaʻa i ka hoʻoweliweli o lipids i ka plasma koko ma hope o ka māka ʻana o ka pāʻina, akā naʻe, ʻaʻole pili kēia hopena i kona hopena i ka GLP-1 a i ka HIP a me kahi hoʻomaikaʻi ʻana i ka hana o nā kuleana pālima pancreatic.

Ua ʻike ʻia ka piʻi ʻana o ka neʻe o ka GLP-1 hiki ke alakaʻi i ka hoʻoihue ʻana o ka ʻōpū, akā naʻe, i ke ʻano o ka hoʻohana ʻana o vildagliptin, ʻaʻole i mālama ʻia kahi hopena like.

Ke hoʻohana nei i vildagliptin i 5759 nā mea maʻi me ka diabetes mellitus type 2 no 52 mau wikiʻa e like me ka monotherapy a i hui pū ʻia me metformin, sulfonylurea derivatives, thiazolidinedione, a i ʻole insulin, he nui ka manawa nui o ka hōʻemi o ka neʻe o ka hemoglobin glycated (НbА)_1s) a me ka hookeai koko i ke koko.

Hoʻoulu ka Metformin i ka hoʻohaʻahaʻa glucose i nā maʻi me ka maʻi diabetes type 2 ma ka hoʻohaʻahaʻa ʻana i nā kukuna glucose glucose ma mua a ma hope o ka ʻai.

ʻAʻole i like me derivatives sulfonylurea, ʻaʻole ka metformin i ka hypoglycemia i ka poʻe maʻi me ka diabetes mellitus type 2 a i nā mea olakino paha (koe i nā maʻi kūikawā). ʻAʻole ke alakaʻi i ka lāʻau lapaʻau me ka hoʻomohala ʻana o ka hyperinsulinemia. Me ka hoʻohana ʻana o ka metformin, ʻaʻole i loli ka neʻe ʻana o ka insulin, ʻoiai ʻo ke komo ʻana o ka insulin i ka plasma ma loko o kahi ʻōpū ʻole a i ka lā e emi ana ka lā.

Ke hoʻohana nei i ka metformin, he hopena maikaʻi i ka metabolism o nā lipoproteins i hōʻike ʻia: kahi emi o ka neʻe o ka kolamu nui, LDL cholesterol a me ka triglycerides, ʻaʻole i pili pū me ka hopena o ka lāʻau lapaʻau ma ka hoʻoliʻi o ka glucose i ka plasma koko.

Ke hoʻohana nei i ka hopena hui me ka vildagliptin a me ka metformin i nā lā i kēlā me kēia lā 1,500-3,000 mg o ka metformin a me 50 mg o vildagliptin mau manawa 2 i hoʻokahi lā no ka makahiki 1, he ʻano nui ka nui o ka hoʻoliʻelima i ka hoʻoliʻi ʻana o ka hoʻokahe koko i mālama ʻia (i hoʻoholo ʻia e ka hoʻēmi ʻana o ka HbA index_1s) a me ka hoʻonuiʻana o ka hapa i nā mea maʻi e loaʻa ana i ka hōʻemi o ka neʻe ʻana o HbA_1s mau kālā ma ka liʻiliʻi he 0.6-0.7% (hoʻohālikelike ʻia me ka pūʻulu o nā maʻi i hoʻomau i loaʻa i ka metformin wale nō).

I ka poʻe maʻi e loaʻa ana i ka hui pū ʻana me vildagliptin a me ka metformin, he loli nui i ka nui o ke koʻikoʻi o ke kino i hoʻohālikelike ʻia me nā kūlana mua. 24 mau pule ma hope o ka hoʻomaka ʻana o ka mālama ʻana, i loko o nā hui o nā poʻe maʻi e loaʻa ana i ka vildagliptin i hui pū me ka metformin, i ka emi iki o ke koko a me ka makuakāne i nā mea maʻi me ka hypertension arterial.

Ke hoʻohana nei i ka hui ʻana o ka vildagliptin a me ka metformin ma ke ʻano he mālama mua no ka poʻe maʻi me ka maʻi diabetes mellitus type 2, ua nānā ʻia kahi nui o ka maʻi i ka HbA no 24 mau pule_1s ke hoʻohālikelike nei me ka monotherapy me kēia mau lāʻau. ʻO nā hihia o ka hypoglycemia ka liʻiliʻi ma ka hui mālama ʻelua.

Ke hoʻohana nei i vildagliptin (50 mg 2 mau manawa i ka lā) me ka / ʻaʻohe metformin e hui pū me ka insulin (awelika haʻahaʻa - 41 PIECES) i nā mea maʻi ma kahi mau noiʻi maʻi, ʻo ka māka HbA_1s ka hoʻohaʻahaʻa ʻana ma nā uila - e 0.72% (hōʻailona mua - he awelika o 8,8%). ʻO ka ulu ʻana o ka hypoglycemia i ka hui mālama ʻia i hoʻohālikelike ʻia me ka hoʻoulu ʻana o ka hypoglycemia i ka hui plasebo.

Ke hoʻohana nei i vildagliptin (50 mg 2 mau manawa i ka lā) e hui pū me ka metformin (≥1500 mg) hui pū me ka glimepiride (≥4 mg / lā) i nā mea maʻi i ka noiʻi lāʻau lapaʻau, ʻo ka māka HbA_1s ka hoʻohaʻahaʻa ʻana i ka helu - ma ka 0.76% (mai ka pae awelika - 8.8%).

Lapaʻau lāʻau

Kapehu. A lawe ma kahi ʻūhā piha, vildagliptin koke koke ʻia, T_max - 1.75 mau hola ma hope o ka hoʻokele ʻana. Me ka loaʻa o ka meaʻai i ka manawa like, e emi iki ka huina o ke kō o vildagliptin: e emi ana ka nui o C_max 19% a hoʻonui i T_max a hiki i nā hola 2.5. Akā naʻe, ʻaʻole pili ka ʻai i ke kiʻekiʻe o ka hoʻomoʻi ʻana a me ka AUC.

Hoʻopili koke ʻia ʻo Vildagliptin, a me kāna bioavailability kūʻokoʻa ma hope o ke alakaʻi waha ʻana he 85%. C_max a me AUC o ka nui o ka maʻi therapeutic e hoʻonui i ke kokoke i ke kaawale o ka nui.

Kahele. ʻO ka palena o ka pilina o vildagliptin i nā protein plasma he haʻahaʻa (9.3%). Kālaha ʻia ka lāʻau lapaʻau ma waena o ka plasma a me nā wahi hoʻoliʻiliʻi koko. Hoʻopili ʻia ka hoʻoili ʻana ʻo Vildagliptin, V_{ai ʻo ss} ma hope o ka lawelawe ʻana iv he 71 lita.

Hāpai. ʻO Biotransformation ke ala nui o ka excretion o vildagliptin. I ke kino o ke kanaka, ua hoʻohuli ʻia ka 70% o ka nui o ka lāʻau. ʻO ka metabolite nui, LAY151 (57% o ka momona), pharmacologically inactive a he huahana o ka hydrolysis o cyanocomponent. Ma kahi o 4% o ka loaʻaʻana o ka lāpō e lawe i ka hydrolysis amide.

Ma nā hoʻokolohua hoʻokolohua, ʻike ʻia kahi hopena maikaʻi o DPP-4 ma ka hydrolysis o ka lāʻau. ʻAʻole emailili ʻia ʻo Vildagliptin me ka komo ʻana o nā isoenzymes cytochrome P450. Wahi a noiʻi i loko o vitro , ʻO vildagliptin ʻaʻole ia he kāʻei o ka isoenzymes P450, ʻaʻole ia e pale a ʻaʻole hoʻokomo i ka cytochrome P450 isoenzymes.

Leʻaleʻa. Ma hope o ka helu ʻana i ka lāʻau, ua pili ka 85% o ka nui ma ka ʻōpū a me 15% ma o ka ʻōpū, ʻo ka renal excretion o vildagliptin i loli ʻole he 23%. Me kahi / i ka hoʻomaka ʻana o ka waena o T_1/2 a hiki i 2 mau hola, ʻo ka huina piha piha plasma a me nā hoʻomaʻemaʻe o ka vildagliptin he 41 a me 13 l / h. T_1/2 ma hope o ka helu ʻana ma kahi o 3 mau hola, inā paha i kauā.

Nā hui ahonui kūikawā

Hoʻopilikia, ʻo ka hoʻomaʻamaʻa ʻana o ke ʻano hui kino, a me ka moʻomeheu i ka hopena o ka pharmacokinetics o vildagliptin.

Hōʻeha ka naʻau ʻili. I nā mea maʻi me ka hana aho o ka puʻuwai a me ka palupalu i ke ʻano hōʻeha (6-10 mau wahi e like me ka helu ʻana o nā keiki-Pugh), ma hope o ka hoʻohana ʻana i ka lāʻau, aia ka emi ʻana o ka bioavailability o vildagliptin e 8 a 20%. I ka poʻe maʻi me ka maʻi pēpē koʻikoʻi (12 mau makai e like me ka helu ʻana o nā keiki-Pugh), hoʻonui ʻia ka bioavailability o vildagliptin e 22%. ʻO ka loli loa ma ka bioavailability o vildagliptin, he piʻi a hōʻemi paha i ka awelika a hiki i 30%, ʻaʻole ia he maʻi koʻikoʻi. ʻAʻole i ʻike ʻia kahi hopena ma waena o ka paʻakikī o ka hana o ka puho o ka lau a me ka bioavailability o ka lāʻau.

Hola paʻa kino hana. I nā mea maʻi me ka hana renal impaired, hōʻoluʻolu, maʻalahi, a i ʻole ka nui AUC, ua hoʻonui ʻia ka vildagliptin 1,4, 1.7, a me 2 mau manawa i hoʻohālikelike ʻia i kēia mākaukau i nā limahana olakino, kēlā me kēia. ʻO ka AUC o ka metabolite LAY151 i hoʻonui i ka 1,6, 3.2 a me 7.3 mau manawa, a me ka metabolite BQS867 i hoʻonui i ka 1,4, 2.7 a me 7.3 mau manawa i nā maʻi me nā hana renal impaired o ke kala, maʻalahi a paʻakikī. Pau nā ʻikepili i nā mea maʻi me nā maʻi mākaʻomaʻo hope loa (CKD) e hōʻike ai i nā hōʻailona ma kēia pūʻulu e like pū me nā mea i nā mea maʻi me nā maʻi koʻikoʻi. ʻO ka hoʻonaninani o ka metabolite LAY151 i nā mea maʻi me ka hopena o ka hope CKD i hoʻonui ʻia e nā manawa 2-3 e hoʻohālikelike ʻia i ka neʻe ʻana o nā mea maʻi me nā maʻi hōʻeha. ʻO ka wehe ʻana o vildagliptin i ka wā hemodialysis ua palena (3% i loko o ke kaʻina hana e ʻoi aku ma mua o 3-4 mau hola 4 mau hola ma hope o hoʻokahi pākahi.

ʻO nā maʻi ≥65 mau makahiki heʻumi. ʻO ka hoʻonui kiʻekiʻe loa ma ka bioavailability o ka lāʻau i ka 32% (hoʻonui C_max 18%) i nā mea maʻi ma mua o 70 he koʻikoʻi koʻikoʻi a ʻaʻole i pili i ka pāpā ʻana o DPP-4.

ʻO nā makahiki ≤18 makahiki. ʻAʻole i hoʻokū ʻia nā hiʻohiʻona ʻo ka pharmacokinetic o vildagliptin i loko o nā keiki a me nā ʻōpio ma lalo o 18 makahiki o kona mau makahiki.

Kapehu. ʻO ka bioavailability kūʻokoʻa o ka metformin i ka nānā ʻana i ka paona o 500 mg ma kahi ʻōpū ʻole he 50-60%. T_max i nā kaila plasma - 1.81–2.69 mau hola ma hope o ka hoʻokele ʻana. Me ka piʻi nui o ka lāʻau lapaʻau mai 500 a 1500 mg a i nā inaninau mai 850 a 2250 mg i loko, he piʻi lohi ka nui o nā lāʻau pharmacokinetic (ma mua o ka mea e manaʻo ʻia no kahi pilina linear). ʻAʻole ʻia kēia hopena e ka nui o ka hoʻololi ʻana o ka hōʻemi ʻana i ka lā lapaʻau e like me ke neʻe ʻana o kona komo ʻana. E kū'ē i ka papa o ke komo ʻana i ka meaʻai, ka palena a me ka helu o ka hoʻopiʻi ʻana o ka metformin i emi iki hoʻi. No laila, me hoʻokahi mau kaha o ka lāʻau i ka maʻa o kahi o 850 mg, ua emi ka nui o C me ka meaʻai_max a me AUC e pili ana i ka 40 a me 25% a me ka hoʻonui i T_max no 35 mau minuke ʻAʻole paʻa i ka maʻi koʻikoʻi o kēia mau ʻike.

Kahele. Me kahi pākaukau waha he 850 mg, ʻike V_{e d} metformin is (654 ± 358) l. ʻAʻole pono ka lāʻau lapaʻau e nakinaki i nā protein plasma, aʻo ka pilina o ka sulfonylurea e hoʻopaʻa ʻia iā lākou ma mua o ka 90%. Hoʻomoʻa ka Metformin i nā ʻāpana koko ʻokoʻa (ʻoi paha ka ikaika o kēia kaʻina ma mua o ka manawa). Ke hoʻohana ʻia i ka metformin e like me ke ʻano maʻamau (maʻamau ka palena a me ka neʻe o ka hoʻokele) C_{ai ʻo ss} hōʻea ka lāʻau lapaʻau i loko o ke koko koko i loko o nā hola 24-48 a, ma ke ʻano he kānāwai, ʻaʻole iʻoi aku i ka 1 μg / ml. I ka hoʻokolohua ʻana i nā hoʻokolohua kikowaena C_max ʻAʻole iʻoi aku ka metformin plasma ma mua o 5 mcg / ml (inā i lawe ʻia i ka nui kiʻekiʻe).

Hāpai. Me ka hoʻokele hoʻokahi o ka metformin i nā limahana olakino, ke excreted nei ia e nā kuli i loli ʻole. I kēia hihia, ʻaʻole i hoʻohālikelike ʻia ka lāʻau i loko o ke ake (ʻaʻole i ʻike ʻia nā metabolites i nā kānaka) a ʻaʻole i hoʻopā ʻia i ka bile.

Leʻaleʻa. No ka mea ʻo ka wehe ʻana o ka renal i ka metformin ma kahi o 3.5 mau manawa i ʻoi aku ma mua o ka hoʻopiha ʻana o creatinine, ʻo ke ala nui loa e hoʻopau ai i ka lāʻau lapaʻau ʻoi. I ka wā e ʻike ʻia ana, ma kahi o 90% o ka nui i ka pau ʻia i hoʻopio ʻia e nā keiki ma ka 24 mau hola mua, me T_1/2 mai ka pili koko mai e pili ana i 6.2 mau hola_1/2 metformin holoʻokoʻa holoʻokoʻa ma kahi o 17.6 mau hola, e hōʻike ana i ka hōʻemi o kahi mahele nui o ka lāʻau ma nā ʻāpana koko ʻulaʻula.

Nā hui ahonui kūikawā

Paul ʻAʻole ia e pili i ka pharmacokinetics o metformin.

Hōʻeha ka naʻau ʻili. I ka poʻe maʻi me ka maʻi hepatic, ʻaʻole i hoʻopaʻa ʻia kahi noiʻi o nā ʻano lāʻau pharmacokinetic o ka metformin.

Hola paʻa kino hana. I ka poʻe maʻi me ka hana renal impaired (e like me ke ʻano ʻana ma ka creinine clearance) T_1/2 nā metformin mai ka plasma a me ke koko holoʻokoʻa nui, a me ka hoʻokaʻawale ʻana o kona renal i ka hapa me ka hoʻemi ʻana o ka hoʻomaʻamaʻa creatinine.

ʻO nā maʻi ≥65 mau makahiki heʻumi. Wahi a nā haʻawina pharmacokinetic palena, i nā poʻe olakino ≥65 mau makahiki he makahiki, he nui ka emi ʻana o ka piha o ka Plaince plasma a me ka nui o ka T_1/2 a C_max ua hoʻohālikelike ʻia me kēia mau kuhikuhi i ka poʻe ʻōpio. ʻO kēia mau pharmacokinetics o metformin i loko o nā mea i ʻoi aku ma lalo o 65 mau makahiki he mau pilina paha e pili ana i nā loli i ka hana renal, a no laila ma nā mea maʻi i ʻoi aku ma mua o 80 mau makahiki, hiki ke koho wale iā Galvus Met me kahi clearance creatinine maʻamau.

ʻO nā makahiki ≤18 makahiki. ʻAʻole paʻa i nā hiʻohiʻona pharmacokinetic o metformin i loko o nā keiki a me nā'ōpio ma lalo o 18 makahiki o kona mau makahiki.

ʻO nā poʻe maʻi o nā ʻano ʻōiwi ʻē aʻe. ʻAʻohe mea hōʻike i ka hopena o ka hopena o ka hoʻomanawanui ma ka hiʻohiʻona pharmacokinetic o ka metformin. I nā haʻawina hoʻokolohua paʻa i ka metformin i nā maʻi me ka maʻi diabetes mellitus type 2 o nā ʻano ʻē aʻe, ua hōʻike ʻia ka hopena hypoglycemic o ka lāʻau lapaʻau i ka like like.

Hōʻike nā haʻawina i ke bioequivalence ma nā ʻano o AUC a me C_max ʻO Galvus Met i 3 mau pānaʻi like ʻole (50 mg + 500 mg, 50 mg + 850 mg a 50 mg + 1000 mg) a vildagliptin a me metformin, i lawe ʻia i nā ʻaina kūpono i nā papa ʻē aʻe.

ʻAʻole ʻai i ka ʻai i ka pae a me ka helu o ka ʻike ʻole ʻana o vildagliptin i ka mea hoʻohui o ka lāʻau Galvus Met. ʻĀina C_max a me AUC o nā metformin i ka hoʻohui o ka lāʻau Galvus Met i ka wā e lawe ana me ka meaʻai i hōʻemi ʻia e 26 a 7%. Eia kekahi, e kū i ke anuanu o ka inu ʻana i ka meaʻai, ua lohi ka make ʻana o ka metformin, ka mea i piʻi ai ka nui o T_max (2 i 4 mau hola). Nā loli like C_max a ua hōʻike ʻia ʻo AUC me ka ʻaina meaʻai i ka hihia o ka hoʻohana ʻana i ka metformin hoʻokaʻawale, eia naʻe, ma ka hihia hope loa, ʻaʻole i nui nā hoʻololi. ʻAʻole i like ka hopena o ka meaʻai ma ka pharmacokinetics o vildagliptin a me ka metformin i ka hoʻohui ʻana o ka lāʻau lapaʻau ʻo Galvus Met.

Nā hōʻailona ʻĀina Galvus Met ®

ʻO ka maʻi diabetes mellitus type 2 (i hui pū me ka papa lāʻau a me ka papa hana):

me ka lawa ʻole o ka monotherapy me vildagliptin a i metformin paha,

i ka poʻe maʻi ma mua e loaʻa ana i ka hui pū ʻana me vildagliptin a me ka metformin i ke ʻano o ka lāʻau hoʻokahi,

i ka hui ʻana me derivatives sulfonylurea (triple therapy therapy) i nā mea maʻi i mālama mua ʻia me nā derivatives sulfonylurea a me ka metformin me ka loaʻa ʻole o ka mau glycemic control,

i ka hui pū ʻana o ka triple me ka insulin i nā poʻe maʻi i loaʻa mua i ka inika insulin i kahi paʻa paʻa a me ka metformin me ka loaʻa ʻole o ka mana glycemic kūpono,

e like me ka hoʻomakaʻana o ka maʻi i nā mea maʻi me ka maʻi diabetes mellitus type 2 me ka lawa ʻole o ka hoʻokō ʻana i ka mālama ʻana i ka meaʻai, hoʻomaʻamaʻa a me ka pono e hoʻomaikaʻi i ka mana glycemic.

Nā Hoʻohui

hypersensitivity i vildagliptin a i metformin a i ʻole nā ​​meaʻokoʻa o ka lāʻau lapaʻau,

hana ʻole ʻole a i ʻole ke kauā ʻana o ka hana (me ka serum creatinine concentrations o ≥1.5 mg% (> 135 μmol / L) - no nā kāne a me ka 41.4 mg% (> 110 μmol / L) - no nā wahine).

nā hana ʻoi me ka pilikia o ka hoʻomohala ʻana i ka hana renal: dehydration (me ka maʻi ʻaʻa, ka luaʻi), ke ʻano, ka maʻi huelo, nā maʻi maʻi hypoxia (haʻalulu, sepsis, ʻehaʻeha, maʻi maʻi bronchopulmonary).

ka huakaʻi a me ke kuʻi hema ʻana o ka puʻuwai, ka myocardial infarction, ka maʻi cardiovascular failed (shock), ka huhū o ka hanu,

lawelawe aho ʻaia,

aʻeha a me ke ʻano kumuola acidabous (me ka hoʻomehana ketoacidosis i hui pū ʻia a i ʻole coma), ketoacidosis maʻi maʻi (pono e hoʻoponopono ʻia e ka insulin insulin), lactic acidosis (me ka mōʻaukala).

ma mua o ka hana ʻana, ka radioisotope, nā haʻawina x-ray me ka hoʻopuka ʻana i nā mea hoʻohālikelike - ʻaʻole i kuhikuhi ʻia ka lāʻau lapaʻau no 48 mau hola a i loko o nā hola 48 ma hope o ka lawe ʻana iā lākou.

maʻi diabetes type 1

humuhinu maoli, huakino makehewa

ka mālama ʻana i kahi meaʻai haʻahaʻa-emi (emi iho ma mua o 1000 kcal / lā),

nā keiki ma lalo o ke 18 mau makahiki o ka maikaʻi (a ʻaʻole i hoʻonohonoho ʻia ka maikaʻi a me ka palekana).

No ka mea, ua loaʻa nā maʻi me ka puʻuwai pale i ka hopena i kekahi mau manawa a ka lactic acidosis, ʻo ia paha kekahi o nā hopena ʻaoʻao o ka metformin, ʻaʻole pono ʻo Galvus Met i ka poʻe maʻi me nā maʻi o ka mahele a i ʻole nā ​​mea hoʻohālikelike biochemical pōpilikia o ka hana ate.

Me ka mālama: nā mea maʻi i ʻoi aku ma mua o 60 mau makahiki i ka wā e hana ai i ka hana kino olakino ma muli o ka hoʻonui nui o ka lactic acidosis.

ʻŌpū a me ka lactation

Ma nā hoʻokolohua hoʻokolohua ma nā holoholona me ka hoʻohana ʻana i vildagliptin i nā wai he 200 mau manawa i ʻoi aku i ko ke kau ʻana, ʻaʻole i hoʻokō ʻia ka lāʻau lapaʻau i ka hoʻomohala mua ʻana o ka embryo a ʻaʻole i kau i ka hopena teratogenic. Ke hoʻohana nei i vildagliptin i hui pū me ka metformin ma kahi hapa o 1:10, ʻaʻole i ʻike ʻia kahi hopena teratogenic.

No ka mea ʻaʻohe ʻike pono o ka hoʻohana ʻana i ka lāʻau Galvus Met i loko o nā wahine hāpai, ua contraindicated ka hoʻohana ʻana o ka lāʻau lapaʻau i ka wā hapai.

E hele a Metformin i ka waiū umauma. ʻAʻole i ʻike ʻia a hoʻopili ʻia ʻo vildagliptin i loko o ka waiū umauma. Ua hoʻohana ʻia ka hoʻohana ʻana i ka lāʻau Galvus Met i ka wā o ka hoʻoulu ʻana.

Nā hopena hopena

Pili ka ʻikepili ma lalo nei i ka hoʻohana ʻana o vildagliptin a me ka metformin i monotherapy a me ka hoʻohui.

Ma muli o ke ʻano o ka vildagliptin therapy, he hana hemahema (me ka hepatitis) i ʻike pinepine ʻole ʻia. I ka nui o nā hihia, ua hoʻoholo nā hana ʻino a me nā kuʻuna o ka hana o ka ate mai ka pākaukau ma o lākou pono ʻole me ka hoʻopiʻi ʻole ʻia ma hope o ka hoʻokuʻu ʻana i ka lāʻau lapaʻau. Ke kau nei i ka vildagliptin ma kahi o 50 mg 1 a i 2 mau manawa paha i ka lā, ʻo ka nui o ka hoʻonui ʻana i nā hana o nā kōme ate (ALT a i ʻole Hana 3 mau manawa e ʻoi aku ma mua o VGN) he 0.2 a i 0.3%, ia manawa (like me 0.2% i ka hui mana) . ^ E Ha yM. ʻO ka hoʻonui ʻana o nā hana o nā huina o nā ate ma ka hapanui o ka asymptomatic, ʻaʻole i holomua, ʻaʻole i hui pū ʻia e ka cholestasis a i ʻole jaundice.

Ua hoʻohana ʻia nā ʻōlelo i hala nei e loiloi i ka ulu ʻana o nā hanana ʻino (AE): pinepine pinepine (≥1 / 10), pinepine (≥1 / 100, GIT), ka helu o ka AE me ka hui pū ʻana me vildagliptin a me metformin he 12.9%. nānā i ka 18.1% o nā maʻi.

I nā hui o nā mea maʻi e loaʻa ana i ka metformin i hui pū me vildagliptin, ua loaʻa ka pilikia gastrointestinal me ka pinepine o 10-15%, a ma ka hui o nā mea maʻi e loaʻa ana i ka metformin i hui pū me ka pletebo, me ka piʻi o 18%.

ʻAʻole i hōʻike ʻia nā hoʻokolohua olakino lōʻihi a hiki i 2 mau makahiki i kekahi mau aʻe hou aʻe i ka profile palekana a i ʻole e kali ʻole ka manaʻo ʻole ke hoʻohana ʻana i vildagliptin e like me ka monotherapy.

ʻO kahi hōʻike o ka hoʻohana ʻana i kahi hui o vildagliptin a me ka metformin e hoʻomaka ana no ka hoʻomaka ʻana no ka maʻi diabetes mellitus type 2 ʻaʻole i hōʻike i kekahi mau pilikia a me nā ʻike palekana hou.

ʻO ka hoʻohana ʻana o vildagliptin i ka manawa like me ka insulin

I ka hoʻokolohua ʻana i nā hoʻokolohua paʻa i mālama ʻia me ka hoʻohana ʻana i vildagliptin ma kahi o 50 mg 2 mau manawa i ka lā me ka hui pū me ka insulin i hui pū me ka metformin a i ʻole, ka hopena o ka wehe ʻana o ka maʻi ma muli o ka hoʻomohala ʻana i nā hopena ʻino loa 0.3% i ka hui vildagliptin, ʻoiai i ka hui pletebo. ʻaʻole hoʻi i hoʻokuʻu ʻia ka lāʻau lapaʻau.

Ua hoʻohālikelike ʻia ka ulu ʻana o hypoglycemia i nā hui ʻelua (14% ma ka hui vildagliptin a me 16,4% i ka hui plasebo). I ka hui vildagliptin, ua ʻike ʻia nā hihia o ka hypoglycemia koʻikoʻi i nā mea maʻi 2, i ka hui plasebo - ma 6.

I ka manawa i pau ai ka noiʻi ʻana, ʻaʻole i pili ka lāʻau lapaʻau i ka nui o ke kino kino (hoʻonui ʻia ke kaumaha o ke kino e 0.6 kg i hoʻohālikelike ʻia i ka mea i ka mea i loko o ka hui vildagliptin, ʻaʻohe ʻano loli i ʻike ʻia i ka hui plasebo.

Ua hōʻike ʻia ma lalo nei nā mea maʻi i ka maʻi e loaʻa ana vildagliptin 50 mg 2 mau manawa i kahi lā me ka insulin (me a ʻole a i ʻole metformin).

Mai ka ʻōnaehana hoʻonāukiuki: pinepine ke kaumaha.

Mai ka palaki kuʻekuʻe: pinepine - hāhi, gastroesophageal reflux, pinepine - i ke ʻano - ka maʻi ʻōpū, lemulewa.

Mai ka ʻaoʻao o ka metabolism a me kaʻaiʻai: pinepine - hypoglycemia.

ʻO nā maʻi maʻamau a me nā pilikia i ka pūnaewele hōʻola: pinepine - ʻohiʻohi.

Ke hoʻohana nei i vildagliptin i hui pū me ka hoʻomākaukau o sulfonylurea

ʻO nā hihia o ka hopena o ka lāʻau e pili ana i ka hoʻomohala ʻana o ka AE i ka hui hui hui me vildagliptin, metformin a me glimepiride ʻaʻole i ʻike ʻia. I ka hui pūʻana o ka placebo, metformin a me glimepiride, ʻo ka ulu ʻana o AE he 0.6%.

Homo pinepine ʻia ka hypoglycemia ma nā hui ʻelua (5.1% i ka hui hui hui pū me vildagliptin, metformin a glimepiride a me 1.9% i ka hui hui hui pū me pletebo, metformin a me glimepiride). I ka hui vildagliptin, ua hōʻike ʻia kahi hanana o ka hypoglycemia koʻikoʻi.

I ka manawa i pau ai ka noiʻi ʻana, ʻaʻohe hopena koʻikoʻi o ka paona kino i ʻike ʻia (+0.6 kg i ka hui vildagliptin a me −0.1 kg i ka hui placebo).

Loaʻa ʻo ʻEle i loko o nā mea maʻi e loaʻa vildagliptin 50 mg 2 mau manawa i ka lā me ka hui pū me ka metformin a me ka sulfonylureas e hōʻike ʻia ma lalo nei.

Mai ka ʻōnaehana hoʻonāukiuki: pinepine - dizziness, tremor.

ʻO nā maʻi maʻamau a me nā pilikia i ka pūnaewele hōʻola: nā luhi pinepine.

Mai ka ʻaoʻao o ka metabolism a me kaʻaiʻai: pinepine - hypoglycemia.

Ma ka ʻāpana o ka ʻili a me ka kiko. pinepine - hyperhidrosis.

Ke hoʻohana ʻia vildagliptin e like me ka monotherapy

Mai ka ʻōnaehana hoʻonāukiuki: pinepine - dizziness, infrequently - male ʻole.

Mai ka palaki kuʻekuʻe: pinepine - constipation.

Ma ka ʻāpana o ka ʻili a me ka kiko. ʻohi - kūweʻe ʻili.

Mai ka ʻaoʻao o ka musculoskeletal a me ka hoʻopili hui: pinepine - arthralgia.

ʻO nā maʻi maʻamau a me nā pilikia i ka pūnaewele hōʻola: pinepine - peripheral edema.

Ke hoʻohana ʻia nei i ka lāʻau hui pū me vildagliptin a me ka metformin, he ulu nui ka nui o ka nui o ka piʻi ʻana o nā mea ma luna o ka mea i luna ʻia me ka vildagliptin.

Ma ke ʻano o ka monotherapy me vildagliptin a i metformin paha, ʻo ka ulu ʻana o ka hypoglycemia he 0.4% (pinepine).

ʻO Monotherapy me vildagliptin a me ka hui pū ʻana o vildagliptin + metformin ʻaʻole i hoʻopilikia i ke kaumaha o ke kanaka maʻi.

ʻAʻole i hōʻike ʻia nā hoʻokolohua olakino lōʻihi a hiki i 2 mau makahiki i kekahi mau aʻe hou aʻe i ka profile palekana a i ʻole e kali ʻole ka manaʻo ʻole ke hoʻohana ʻana i vildagliptin e like me ka monotherapy.

ʻO ka pahuhopu ka hopena i ʻike ʻia ma ka wā kūʻai mai (ʻoiai ua hōʻike ʻia ka ʻike i ka ʻimi ʻana mai ka lehulehu o ka nui o ka lehulehu, ʻaʻole hiki ke koho pono e hoʻoholo i ka ulu ʻana o kēia mau AE, a no laila ua helu ʻia lākou me ka ʻike ʻole ʻana o ka maʻamau): hepatitis (huli i ka wā i pau ʻia ke mālama ʻana), urticaria, pancreatitis, bullous a exfoliative ʻehaʻeha.

Ke hoʻohana ʻia o ka metformin ma monotherapy

Mai ka ʻaoʻao o ka metabolism a me kaʻaiʻai: pinepine pinepine - lilo i ka makemake, nui loa - lactic acidosis.

Mai ka palaki kuʻekuʻe: pinepine pinepine - flatulence, hoʻokeloke, hoʻopuka, maʻi ʻana, ʻeha o ka ʻōpū, pinepine - dysgeusia.

Ma ka ʻāpana o ka ate a me ka pēpē biliary: ākea loa - hepatitis.

Ma ka ʻāpana o ka ʻili a me ka kiko. ākea loa - kūlike ka ʻili (ma ke ʻano he erythema, pruritus, urticaria).

Nā ʻikepili a me ka ʻikepili kōkua: ākea loa - hoʻemi ʻia ka ʻike o ka vitamin B₁₂, loli i ka hana kūlike o ka hana.

Hoʻemi i ka Vitamin B Absorption₁₂ a me ka emi ʻana o kona kao i loko o ka serum o ke koko me ka hoʻohana ʻana i ka metformin i nānā pinepine ʻia i ka poʻe maʻi e loaʻa ana i ka lāʻau lapaʻau no ka manawa lōʻihi, a, me ke ʻano la, ʻaʻole i hōʻike i ka manaʻo kauka. Pono e hāʻawi ʻia ka noʻonoʻo ʻana e hoʻemi i ka komo ʻana o ka mauʻu B₁₂ i nā maʻi me nā anemia megaloblastic.

ʻO kekahi mau hihia o ka hepatitis, i ʻike ʻia me ka hoʻohana ʻana i ka metformin, i hoʻoholo ʻia ma hope o kona hoʻohemo ʻana.

Hoʻohui

Me ka hoʻohana like ʻana o vildagliptin (100 mg 1 manawa i kēlā me kēia lā) a me ka metformin (1000 mg 1 manawa i kēlā me kēia lā), ʻaʻole i mālama ʻia ka PCF koʻikoʻi ma waena o lākou. ʻAʻole hoʻi i ka wā o ka hoʻāʻo ʻana i ka lāʻau lapaʻau, ʻaʻole hoʻi i ka wā nui o ka hoʻohana ʻana o Galvus Met i nā maʻi i loaʻa i ka manawa i loaʻa i nā lāʻau lapaʻau a me nā mea ʻē aʻe, ʻaʻole i ʻike ʻia nā mea kū like ʻole.

He haʻahaʻa haʻahaʻa ʻo Vildagliptin no ka hoʻopili ʻana i nā lāʻau. Ma muli o vildagliptin ʻaʻole kahi kahi o nā enzyme cytochrome P450, ʻaʻole ia e hoʻopū a hoʻowalewale i kēia mau huaenzyme, ʻo kona pilina me nā lāʻau lapaʻau e kālai ʻia, a me nā mea i hoʻomalulu ʻia paha ka P450. Me ka hoʻohana like ʻana o vildagliptin ʻaʻole i pili i ka helu metabola o nā lāʻau lapaʻau he poʻe hoʻohālikelike o nā enzyme: CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 a me CYP3A4 / 5.

ʻO kahi hui olakino koʻikoʻi o vildagliptin me nā lāʻau lapaʻau e hoʻohana pinepine ʻia i ka mālama ʻana o ka maʻi mellitus type 2 (glibenclamide, pioglitazone, metformin) a i kahi me kahi pōkole pili pōkole (amlodipine, digoxin, ramipril, simvastatin, valsartan, warfarin) ʻaʻole i hoʻokumu.

Puʻu hoʻonui i C_max a me AUC o ka metformin, ʻaʻole pili i ka hoʻomaʻemaʻe loa. ʻO nā haʻahaʻa haʻahaʻa Metformin C_max a me AUC o ka furosemide a ʻaʻole hoʻi e pili i ka hoʻomaʻemaʻe ʻana i ka hana.

Nifedipine hoʻonui i ke komo ʻana, C_max a me AUC o ka metformin, ma ka mea, e hoʻonui i ka excretion e nā keiki. ʻAʻole hoʻomaʻamaʻa ʻo Metformin i nā hanana pharmacokinetic o ka nifedipine.

ʻO Glibenclamide ʻaʻole e pili i ka parakihi pharmacokinetic / pharmacodynamic o ka metformin. ʻOi aku ka haʻahaʻa Metformin ma C_max a me AUC o ka glibenclamide, ʻoiai ke kiʻekiʻe o ka hopena. No kēia kumu, ʻaʻole maopopo ke ʻano o ka maʻi koʻikoʻi o kēiaʻoihana.

Nā hui loinano ka laʻana, amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamteren, trimethoprim, vancomycin a me nā mea ʻē aʻe, e hoʻopili ʻia e nā ʻuhane e ka neʻe tubular, hiki i ka mea pili pū kekahi me metformin ma muli o ka hoʻokūkū no nā pūnaehana transportule renima. No laila, hoʻonui ka cimetidine i ke kaʻe o ka metformin i ka plasma koko a me kona AUC ma o 60 a 40%. ʻAʻole pili ʻo Metformin i nā ʻāpana pharmacokinetic o ka cimetidine. Pono e mālama pono i ka wā e hoʻohana ana iā Galvus Met me nā lāʻau lapaʻau e pili pū ana i ka hana kidney a i ʻole ka lawe ʻana i ka metformin i loko o ke kino.

ʻO nā ʻano lāʻau ʻē aʻe. Hiki i kekahi mau lāʻau ke hōʻeha i ka hyperglycemia a hōʻemi i ka hopena o nā mea hoʻonā hypoglycemic. ʻO kēlā mau lāʻau lapaʻau e pili ana i ka thiazides a me nā diuretics ʻē aʻe, GCS, phenothiazines, ka hoʻomākaukau ʻana i ka hormone thyroid, estrogens, contraceptives waha, phenytoin, waikama nikotinic, sympathomimetics, calcium antagonist a me isoniazid. Me ka hoʻohana like ʻana o ia lāʻau lapaʻau, a i ʻole, i ka hihia o kā lākou haʻalele ʻana, ke kuhikuhi ʻia e nānā pono i ka hopena o ka metformin (ʻo kona hopena hypoglycemic hopena) a, inā pono, hoʻoponopono i ka hopena o ka lāʻau. ʻAʻole kōkua ʻia ka hoʻohana ʻana danazole i mea e pale ai i ka hana hyperglycemic o ka hopena. Inā pono i ka mālama ʻana me ka danazol a ma hope o ka hoʻokuʻu ʻana i ka hoʻokele ʻana o ka hopena, pono ʻia ka hoʻoponopono ʻana o ka metformin i lalo o ka kaohi o ke kaila glucose o ke koko.

Chlorpromazine i ka wā i hoʻohana ʻia i nā inikua nui (100 mg i kēlā me kēia lā), e hoʻonui ana i ka glycemia, hoʻoemi i ka hoʻokuʻu ʻana i nā insulin. I ka mālamaʻana i nā antipsychotics a ma hope o ka hoʻokuʻu ʻana i ka hopena, pono ka hoʻoponopono ʻana o ka lāʻau i ka lāʻau Galvus Met ma lalo o ke koʻi o ke kaila o ka glucose koko.

ʻO nā mea hoʻopihapiha Iodine: ka noi a radiological e hoʻohana ana i nā ʻenehana me ka iubine iodine e hoʻomōhala i ka hoʻomohala ʻana o ka acidosis lactic i nā mea maʻi me ka maʻi mellitus me ka hana ʻole o ka hana.

Injectable β₂kau aloha hoʻonui i ka glycemia ma muli o ka hoʻouluʻana o β₂-ookehnlna. I kēia hihia, pono ka mana glycemic. Inā pono, ʻōlelo ʻia ka insulin.

Me ka hana like o ka metformin me nā derivatives sulfonylurea, insulin, acarbose, salicylates, hiki ke hoʻonui ʻia ka hopena hypoglycemic.

ʻO ka hoʻohana ʻana o ka metformin i nā mea maʻi me ka hoʻōho a me ka inu ʻawaʻawa e hoʻonui aku i ka hopena o ka lactic acidosis (ʻoi aku hoʻi i ka wā e pōloli ana, ʻeha ʻoe, a i ʻole hōʻino ʻia o ka pūpū), i ka mālama ʻana me Galvus Met, pono ʻoe e pale i ka inu ʻona a me nā lāʻau ʻona e pili ana i ka wai lālani.

ʻLoe a me ke kākele

ʻO ka nui o ka pauku lāʻau no ka lāʻau Galvus Met e pono ke koho pono ʻia, e pili ana i ka kūpono a me ke kūpaʻa o ka maʻi. Ke hoʻohana nei iā Galvus Met, ʻaʻole iʻoi aku ma kahi o ka nui o ka lā i ʻōlelo ʻia no ka vildagliptin (100 mg).

Pono e koho ʻia i ka lāʻau i ʻōlelo ʻia ʻia ʻo Galvus Met e noʻonoʻo ana i ka lōʻihi o ka papa o ka maʻi diabetes a me ka pae o ka glycemia, ke ʻano o ka mea maʻi a me ka hoʻoponopono ʻia ʻana o ka vildagliptin a me / a me ke metformin i hoʻohana mua i ka mea maʻi. No ka hoʻēmiʻana i ka paʻakikī o nā hopena ʻaoʻao mai ka digestive tract, ʻano ʻano o ka metformin, lawe ʻia ʻo Galvus Met me ka meaʻai.

ʻO ka hopena kumu o ka lāʻau Galvus Met me ka loaʻa ʻole o ka monotherapy me vildagliptin

Hiki ke hoʻomaka ʻia ka hoʻomaʻamaʻa ʻia me 1 papa. (50 mg + 500 mg) 2 mau manawa i ka lā, ma hope o ka loiloi ʻana i ka hopena therapeutic, hiki ke hoʻonui mālie ʻia ka lāʻau.

ʻO ka ʻōlelo kumu mua o ka lāʻau Galvus Met me ka loaʻa ʻole o ka monotherapy me ka metformin

Wahi a ka pona e pili ana i ka metformin ua lawe ʻia, hiki ke hoʻomaka ʻia ke mālama ʻana me Galvus Met me ka papa 1 papa. (50 mg + 500 mg, 50 mg + 850 mg a 50 mg + 1000 mg) 2 mau lā i ka lā.

ʻO ka hoʻohālikelike mua o Galvus Met i loko o nā poʻe maʻi i loaʻa i ka lāʻau hui hoʻohui me vildagliptin a me ka metformin i ke ʻano o nā papa i hoʻokaʻawale.

ʻO ka hiʻona ʻana o ka vildagliptin a i ʻole ka metformin i lawe ʻia, mālama ʻia me ka ʻo Galvus Met e hoʻomaka me kahi papa e like kokoke loa i ke ʻano o ka hoʻōla ʻana (50 mg + 500 mg, 50 mg + 850 mg a 50 mg + 1000 mg), a e hoʻoponopono i ka ʻoli ma ke helu ʻia i ka maikaʻi.

Initial dosis o Galvus Met me kahi hoʻomaka hoʻomaka i nā poʻe maʻi me ka type 2 diabetes mellitus me ka lawa ʻole o ka hoʻomaʻamaʻa ʻana o ka mālama ʻana i ka papa meaʻai a i ka hana

Ma kahi hoʻomaka ʻana, pono e kuhikuhi ʻia ʻo Galvus Met ma kahi inika mua o 50 mg + 500 mg hoʻokahi i ka lā, a ma hope o ka loiloi ʻana i ka hopena therapeutic, e piʻi mālie ka nui o ka make i 50 mg + 1000 mg 2 mau lā i ka lā.

Hoʻohui hui me Galvus Met a me nā derivatives o sulfonylurea a i ʻole insulin

Kuhi ʻia ka helu o Galvus Met ma ke kumu o ka maʻi vildagliptin 50 mg × 2 mau manawa i kahi lā (100 mg i kēlā me kēia lā) a me ka metformin i loko o kahi pane e like me ia ma mua o ka lāʻau hoʻokahi.

Nā hui ahonui kūikawā

Hola paʻa kino hana. I nā mea maʻi me ka hana renal impaired, hoʻoponopono ʻia ka lāʻau me ka Cl creatinine (i helu ʻia e ka ʻoihana Cockcroft-Gault) ma waena o 60 i ka 90 ml / min pono e koi ʻia. ʻO ka hoʻohanaʻana i ka lāʻau Galvus Met i loko o nā mea maʻi me Cl creatinine VGN 2 mau manawa). Me ka hoʻonui nui o ka vildagliptin i ka 600 mg / lā, hiki i ka hiki ʻana ke hoʻomohala o ka edema o ka hopena, i hele pū ʻia e paresthesias a me ka hoʻonui ʻana i ka ʻike o CPK, ka protein C-reactive a me myoglobin, a me ka hana AST. ʻO nā ʻōuli āpau o kahi overdose a me nā loli i nā ʻāpana laboratorium e pau ma hope o ka hoʻokuʻu ʻana o ka lāʻau.

Lāʻau: ka haʻalele ʻana o ka lāʻau mai ke kino ma o ka dialysis ʻaʻole hiki ʻole. Eia naʻe, hiki ke hoʻoneʻe iki i ka hydrolytic metabolite nui o vildagliptin (LAY151) mai ke kino e ka hemodialysis.

Nā Hoʻomaka i kekahi mau hihia o ka overdose o metformin, me nā ʻo ka hopena o ka mālama ʻana i ka lāʻau i ka nui o nā keu he 50 g. Me kahi overdose o ka metformin, hypoglycemia i nānā ma kahi o 10% o nā hihia (akā naʻe, ʻaʻole i hoʻokumu ʻia kona pilina me ka lāʻau). Ma nā 32% o nā hihia, ʻike ʻia ka lactic acidosis. ʻO nā hōʻailona mua o ka lactic acidosis ka maʻa, hoʻopuka, ka hele ʻana, ka hoʻemi ʻana o ke ʻano kino kino, ʻeha o ka ʻōpū, ka ʻeha o ka naʻau, a me ka nui o ka hanu, ka maʻi ʻōpū, nā mea ʻike ʻole a me ka hoʻomohala ʻana i ka piko.

Lāʻau: maʻi, maʻi, ma ke ʻano o ka mea maʻi a me nā hōʻike olakino. Hoʻokuʻu ʻia mai ke koko me ka hoʻohana ʻana i ka hemodialysis (me ka clearance a hiki i 170 ml / min) me ka hoʻomohala ʻana i ka maʻi hemodynamic. No laila, hiki ke hoʻohana ʻia nā hemodialysis e wehe i ka metformin mai ke koko inā he overdose o ka lāʻau.

Nā ʻōlelo kikoʻī

I nā poʻe maʻi e loaʻa ana i ka insulin, ʻaʻole hiki iā Galvus Met ke hoʻohuli i ka therapy insulin.

Hōʻeha ka hana ʻoluʻolu. Mai ka wā e kau ai i ka vildagliptin, he piʻi nui ka hana o aminotransferases (maʻa mau me ka hōʻike ʻole ʻana i nā mea lapaʻau) ʻike pinepine ʻia i ka hui o ka kaohi o ka hui, e manaʻo ʻia ana e hoʻoholo i nā ʻano biochemical hana o ka ate ma mua o ka hoʻohana ʻana i ka lāʻau Galvus Met, a me ka manawa no ka wā mālama. Inā ʻike ʻia ka hoʻonui ʻia o ka hana o ka aminotransferases, pono e hana ʻia ka hoʻokau hou ʻana e hiki ai ke hōʻoia i ka hopena, a laila hoʻoholo pinepine i nā ʻōhua biochemical o ka ate hana a hiki i ka wā maʻamau. Inā heʻoi aku ka nui o ka hana a AST a i ʻole ALT e piʻi a ʻoi aku paha iʻoi aku ma mua o VGN i hoʻopaʻa ʻia e ka noiʻi hou ʻana, pono ia e kāpae i ka lāʻau lapaʻau.

Lactic acidosis. Lactic acidosis ka hopena paʻakikī a maikaʻi loa akā ʻo ka hoʻopiʻi kūlohelohe e kū mai ana me ka hōʻemi o ka metformin i loko o ke kino. Lactate acidosis me ka hoʻohana ʻana o ka metformin i nānā nui ʻia i nā mea maʻi me ka maʻi mellitus me ka maʻi nui o ka hana ʻana. Hoʻokomo ka pilikia o ka hoʻomohala i ka acidosis lactic i nā mea maʻi me ka maʻi mellitus no ka maʻi mellitus me ka ketoacidosis, ka pōloli lōʻihi, ka hoʻoluhi waikahe lōʻihi, hana i ka naʻau a me nā maʻi e loaʻa ai ka hypoxia.

Me ka hoʻomohala ʻana o ka acidosis lactic, ʻo ka pōkole o ka hanu, ka ʻeha o ka ʻōpū a me ka hypothermia, i ukali ʻia e coma. ʻO kēia mau ʻōkuhi hana i loaʻa i ka waiwai diagnostic: kahi hōʻemi i ke koko pH, kahi kaila o ka lactate i ka serum ma luna o 5 nmol / L, a me kahi hoʻonui anionic wā nui a me ka hoʻonui nui aʻe o ka ratio o ka lactate / pyruvate. Inā kānalua ka lactic acidosis, pono e hoʻoneʻe i ka lāʻau a hoʻomaha koke ka maʻi maʻi i ka maʻi.

Ka nānā ʻana i ka hana kidney. No ka mea, ua hoʻoneʻe nui ʻia ka metformin e nā keiki, ʻo ka ʻeha o kona hōʻiliʻili ʻana a me ka hoʻomohala ʻana o ka acidosis lactic e piʻi like me ka hōʻeha o ka renal dysfunction. Ke hoʻohana nei i ka lāʻau lapaʻau, pono ʻo Galvus Met e loiloi pinepine i ka hana renal, ʻo ia hoʻi i nā kūlana e kōkua ai i ka hoʻopiʻi ʻana, e like me ka hana mua o ka mālama ʻana i nā lāʻau antihypertensive, hypoglycemic a i ʻole nā ​​NSAIDs. Pono e loiloi ʻia ka hana ʻo Renal ma mua o ka hoʻomaka ʻana o ka mālama ʻana me Galvus Met, a laila ma kahi o ka manawa 1 i kēlā me kēia makahiki i ka poʻe maʻi me ka hana hāmeʻa maʻamau a ma ka liʻiliʻi loa he 2-4 manawa i kēlā me kēia makahiki i ka poʻe maʻi me ka cleinine clearance ma lalo o ka pae haʻahaʻa, a ma ka ʻelemakule hoʻi. nā maʻi maʻi. I nā mea maʻi me ka hopena kiʻekiʻe o ka hoʻomohala ʻana i ka hana renal, pono ka hana ʻana i nānā pinepine ʻia 2-4 mau manawa i ka makahiki. Inā hele ʻole nā ​​hōʻailona o ka hana a ke kīpoki, pono e hōʻoki ʻia ʻo Galvus Met.

ʻO ka hoʻohana nui ʻana i nā mika radiopaque i loko no ka hoʻokō intravascular. Ke hoʻokō nei i nā haʻawina x-ray e koi ana i ka hoʻomoe ʻana o nā iea radiopaque iodine, pono ʻo Galvus Met e hōʻea iki i kahi manawa (48 mau hola ma mua, a i loko hoʻi o 48 mau hola ma hope o ka hoʻopaʻa ʻana), ʻoiai ka hana hoʻokō ʻana o nā ʻāpana e pili ana i ka radiodaque e pili ana i ka hana hōʻeha ma ka hana ʻana o ka pūpū a hoʻonui. ka hopena o ka acidact lactic. E hana hou i ka lawe ʻana i ka lāʻau lapaʻau Galvus Met ma hope wale nō o ka loiloi ʻana o ka hana moka.

Hypoxia Ma ka hana ole cardiovascular kaulike (pīhoihoi), ʻoi aku ka hopena o ka puʻuwai, paʻa o ka myocardial infarction a me nā kūlana ʻē aʻe e hōʻike ʻia ana e ka hypoxia, ka hiki ʻana o ka lactic acidosis a me ka hoʻomaikaʻi ʻana i ka hana a ke kauā mua o mua. Inā hele mai nā kūlana i luna, e hoʻokuʻu koke ʻia ka lāʻau.

Hoʻopuka ʻana i nā mea hanu. I ka wā o ka hōʻemi ʻana o nā mea maʻi (me ka ʻokoʻa ʻole o nā hana liʻiliʻi i pili ʻole i ka hoʻopiʻi ʻana i ka meaʻai a me ka inu o ka wai), pono e hoʻokuʻu ʻia ka lāʻau lapaʻau ʻo Galvus Met. Hiki ke hana hou ka lāʻau lapaʻau ma hope o ka hoʻihoʻi ʻana o ka ʻai o ka waha i nā mea maʻi me nā mea hoʻokaʻawale ʻē aʻe i ka hana o ka lua.

Inu waiʻona. Loaʻa ʻia ua hoʻonui ʻia ka waiʻona i ka hopena o ka metformin ma ka metabolism lactate. Pono e hōʻike ʻia ka poʻe maʻi e pili ana i ka hiki ʻole o ka hōʻemi kino ʻana i ka wā o ka hoʻohana ʻana i ka lāʻau Galvus Met.

ʻO ka hoʻonāʻana i nā maʻi me nā maʻi type 2 like ʻole i pane aku ma mua o ka lāʻau. Inā ʻike ʻia ke kūlohelohe o ke kikowaena mai ke ʻano a ʻike ʻia nā hōʻailona kulana e nui aʻe ai ke ʻano o ke ʻano nui (ʻoiai me nā hōʻailona kūlohelohe a me nā maʻi luhi) i nā mea maʻi me nā pane kūpono i mua o ka papa lāʻau, nā hana diagnostics hana pono e hana koke i ka huli ʻana i ka ketoacidosis a me / a i ʻole ka lactic acidosis. Inā ʻike ka acidosis, pono ʻoe e kāpae i ka hoʻohana ʻana i ka lāʻau lapaʻau a lawe i nā ala kūpono e hoʻoponopono aku i ke ʻano o ka mea maʻi.

Hypoglycemia. ʻO ka maʻamau, ma nā maʻi e loaʻa wale nō iā Galvus Met, ʻaʻole ʻike ʻia ka hypoglycemia, akā hiki ke kūpaʻa ʻia i ke ʻano o ke kīʻaha o ka mākeke (inā ʻaʻole i uku ʻia ka hana kino olakino e ka mākaukau o ka mea ʻai) a i ʻole ke kūpaʻa ʻana o ka inu wai. ʻO ka ulu ʻana o ka hypoglycemia ka mea maʻamau i ka poʻeʻelemakule, debilitated a hoʻohaʻahaʻa paha i nā maʻi, a me ke ʻano e pili ana i ka mua o ka hypopituitarism, ka hana adrenal a i ʻole nā ​​wai inu ʻona. I ka poʻe maʻi nā maʻi a me nā mea e loaʻa ana i ka β-blockers, hiki ke loaʻa ka paʻakikī o ka hypoglycemia.

Hoʻemi ka hopena o nā mea hoʻonā hypoglycemic. Ma lalo o ke kaumaha (me ka nūnū, nā maʻi trauma, ka maʻi, ka hōʻoki ʻana), ka hoʻomohala ʻana i nā mea maʻi e loaʻa ana i nā ʻaina hypoglycemic e like me ke kumu maʻamau, hiki ke hōʻemi ʻia ka hopena o ka mea i hala no kekahi manawa. I kēia hihia, pono ia e hoʻokaʻawale i ke ʻano lāʻau lapaʻau Galvus Met a me ka maʻi maʻi o ka insulin. Hiki ke hana hou i ka ho'ōla ʻana me Galvus Met ma hope o ka hopena o ke ʻano o ka maʻi nui.

Pūnaewele. Ma nā hoʻokolohua hoʻokolohua ma nā holoholona, ​​ʻo ka hoʻohana ʻana o vildagliptin i nā kekelē he 200 mau manawa i ʻoi aku i ko ke kaukau ʻana, ʻaʻole i hoʻolilo i ka maʻi hānai.

ʻAʻohe hopena maikaʻi i ka hānai i nā kāne a me nā wahine me ka hoʻohana ʻana i ka metformin i nā dosis o 600 mg / kg / lā, kahi mea e kokoke ana i ka 3 mau manawa iʻoi aku ma mua o ke ʻano i ʻōlelo ʻia i nā kānaka (i ka manawa i hoʻohuli ʻia i ke ʻano o ka ʻōpū o ke kino). ʻAʻole i mālama ʻia kahi hōʻike o ka hopena i ka ulu ʻana o ke kanaka.

Hoʻokomo i ka hiki ke alakaʻi i nā kaʻa a hana me nā mīkini. ʻO ka hopena o Galvus Met ma ka hiki ke lawe i nā kaʻa a me nā mīkini i aʻo ʻole ʻia. Me ka hoʻolālā ʻana o ka dizziness i ka hope o ka hoʻohana ʻana i ka lāʻau lapaʻau, pono ka mea e pale i ka lawe ʻana i nā kaʻa a me nā māka.

Mea hana

1. Novartis Pharma Stein AG, Kelemania.

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

Ka mea nona ka palapala hoʻopaʻa inoa: Novartis Pharma AG. Lichtstrasse 35, 4056, Basel, Switzerland.

Hiki ke loaʻa ka ʻike hou e pili ana i ka lāʻau lapaʻau ma ka helu: 125315, Moscow, Leningradsky pr-t, 72, bldg. 3.

Tel .: (495) 967-12-70, fax: (495) 967-12-68.