Galvus Met® (Galvus Met)

Nkọwa nke ụdị usoro onunu ogwu

Mbadamba ụrọ, 50 mg + 500 mg: oval, na beveled n'ọnụ, kpuchie ya na fim akpụkpọ ahụ nke ìhè edo edo na a obere pinkish tint. Akara nke NVR dị n'otu akụkụ ma LLO nọ n'akụkụ nke ọzọ.

Mbadamba ụrọ, 50 mg + 850 mg: oval, na beveled n'ọnụ, kpuchie ya na fim akpụkpọ ahụ nke odo na-adịghị ike grayish tint. N'otu akụkụ bụ akara "NVR", n'akụkụ nke ọzọ - “SEH”.

Mbadamba ụrọ, 50 mg + 1000 mg: oval, na beveled n'ọnụ, kpuchie ya na ihe nkiri akpụkpọ ahụ nke ọchịchịrị odo na agba aja aja tint. Enwere akara "NVR" n'otu akụkụ yana "FLO" n'akụkụ nke ọzọ.

Mlọ ọgwụ

Nhazi nke ọgwụ Galvus Met gụnyere ndị nnọchianya hypoglycemic 2 nwere usoro dị iche iche: vildagliptin, nke klas nke dipeptidyl peptidase-4 inhibitors (DPP-4), na metformin (n'ụdị hydrochloride), onye nnọchite anya klas biguanide. Njikọ nke ihe ndị a na-enye gị ohere ijikwa oke ike glucose ọbara n'ime ndị ọrịa nwere ụdị shuga 2 ruo awa 24.

Vildagliptin, onye nnọchi anya klas nke ndị na-akpali akpali nke ngwa ọrụ puru, na-egbochi enzyme DPP-4, nke na-ebibi ụdị 1 glucagon-like peptide (GLP-1) na glucose-polyulinptulin insulinotropic polypeptide (HIP).

Metformin na-ebelata mmepụta nke glucose site na imeju, na -ebelata nnabata nke glucose na eriri afọ ma na-ebelata insulin iguzogide site na ịkwalite mbido na ojiji nke glucose site na nsụ anụ ahụ.

Metformin na-akpali njikọ intancellular glycogen site na ime ihe na glycogen synthetase ma na-akwalite ụgbọ njem glucose site na protein protein ụfọdụ na-ebugharị glucose membrane (GLUT-1 na GLUT-4).

Ihe mgbochi zuru oke na ọrụ DPP-4 mgbe vildagliptin gasịrị na-eme ka mmụba na mkpokọta GLP-1 na HIP na-emetụta eriri afọ n'ime eriri ọbara kwa ụbọchị.

Bawanye uru nke GLP-1 na HIP, vildagliptin na-eme ka mmụba nke mkpụrụ ndụ panc-pancreatic cells-glucose na glucose, nke na-eduga n’ọganihu n’ime insulin na-egbochi glucose. Ogo nke mmezi nke ọrụ β-mkpụrụ ndụ dabere na ogo mbibi mbụ ha, yabụ na ndị mmadụ n’enweghi ọrịa shuga (ya na glucose n'ọbara plasma), vildagliptin anaghị akwalite izochi insulin ma ghara iwetulata glucose.

Site na ịbawanye uru nke GLP-1 nke endogenous, vildagliptin na-eme ka ọgbụgba α-sel na-abawanye uru glucose, na-eduga n'ịbawanye mma na nchịkwa glucose nke glucagon. Mbelata mgbanye glucagon dị elu mgbe nri gasịrị, n'aka nke ya, na-ebute mbelata nguzogide insulin.

Mmụba na oke nke insulin / glucagon megide mmalite nke hyperglycemia, n'ihi mmụba nke ịta ahụhụ nke GLP-1 na HIP, na-eme ka mbelata mmepụta glucose site na imeju ma n'oge nri, na-eduga n'ịbelata mkpokọta nke glucose na plasma ọbara.

Na mgbakwunye, megide nzụlite ojiji nke vildagliptin, mbelata mkpokọta lipids na plasma ọbara mgbe nri ama gasịrị, mmetụta a esonyereghị ya na nsonaazụ GLP-1 ma ọ bụ HIP na mmụba na ọrụ nke mkpụrụ ndụ akwara pancreatic.

A maara na mmụba nke ịta ahụhụ nke GLP-1 nwere ike iduga nwayọ mkpochapụ afọ, agbanyeghị na ojiji nke vildagliptin, a naghị ahụ mmetụta yiri nke ahụ.

Mgbe ị na-eji vildagliptin na 5759 ndị nwere ụdị shuga mellitus nke 2 maka izu 52 dị ka monotherapy ma ọ bụ na njikọta metformin, ọgwụ sulfonylurea, thiazolidinedione, ma ọ bụ insulin, ọnụ ọgụgụ dị ukwuu na-agbadata ọbara na-agba ume (НbА)._1s) na ibu ọnụ glukos ọbara.

Metformin na - eme ka nnabata glucose dị n'etiti ndị ọrịa nwere ụdị ọrịa shuga nke abụọ site na iwetulata glucose plasma ma ma tupu nri.

N'adịghị ka usoro sulfonylurea, metformin anaghị akpata hypoglycemia na ndị ọrịa nwere ụdị ọrịa shuga 2 nke ọrịa mamịrị ma ọ bụ na ndị nwere ahụike (ma e wezụga n'ọnọdụ ndị pụrụ iche). Usoro ọgwụgwọ nke iji ọgwụ ahụ emeghị ka mmepe nke hyperinsulinemia. N'iji metformin mee ihe, insulin insulin anaghị agbanwe agbanwe, ebe insulin na-etinye ihe na plasma na afọ na-enweghị isi na ụbọchị nwere ike ibelata.

Mgbe ị na-eji metformin, a na-ahụ mmetụta bara uru na metabolism nke lipoproteins: mbelata nke mkpokọta cholesterol, LDL cholesterol na triglycerides, ejikọghị ya na nsonaazụ ọgwụ ahụ na ntinye uche nke glucose na plasma ọbara.

Mgbe ị na-eji ọgwụgwọ njikọta na vildagliptin na metformin na usoro kwa ụbọchị nke 1,500-3,000 mg nke metformin na 50 mg nke vildagliptin ugboro 2 kwa ụbọchị maka afọ 1, a hụrụ ọnụ ọgụgụ na-adịgide adịgide na mgbake glucose ọbara (kpebisiri ike site na mbelata na HbA index._1s) na mmụba na oke nke ndị ọrịa nwere mbelata ihe gbasara HbA_1s dịkarịa ala 0.6-0.7% (ma e jiri ya tụnyere ndị ọrịa na-anata naanị metformin).

N'ime ndị ọrịa na-anata ngwakọta nke vildagliptin na metformin, mgbanwe ego na-emetụta ọnụ ọgụgụ ahụ dị ukwuu ma e jiri ya tụnyere ọnọdụ izizi. Izu iri abụọ na anọ a malitere ịgwọ ọrịa, n'ime ìgwè ndị ọrịa na-anata vildagliptin yana mgbakwunye metformin, ọbara ọgbụgba na nna nọ na ndị ọrịa nwere ọbara mgbali elu.

Mgbe ị na-eji nchikota vildagliptin na metformin dị ka ọgwụgwọ mbụ maka ndị ọrịa nwere ụdị ọrịa mellitus 2 dị, ana-ahụbelata mbelata HbA ruo izu iri abụọ na anọ._1s e jiri ya tụnyere monotherapy yana ọgwụ ndị a. Ọrịa hypoglycemia dị ntakịrị na otu ọgwụgwọ abụọ.

Mgbe ị na-eji vildagliptin (50 mg 2 ugboro n'ụbọchị) yana / na-enweghị metformin na insulin (nkezi nkezi - 41 PIECES) na ndị ọrịa n'ọmụmụ nyocha, na-egosi HbA._1s Statistically gbadapụrụ agbada - site na 0.72% (ihe ngosi izizi - nkezi nke 8.8%). Ọnọdụ nke hypoglycemia n'etiti ìgwè ndị e si n'ọbara yie nke ọrịa hypoglycemia n'òtù placebo.

Mgbe ị na-eji vildagliptin (50 mg 2 ugboro n'ụbọchị) yana metformin (≥1500 mg) na mgbakwunye na glimepiride (≥4 mg / ụbọchị) n'ime ndị ọrịa n'ọmụmụ ihe nyocha, ihe ngosi HbA._1s Statistically belatara belata - site na 0.76% (site na nkezi - 8.8%).

Mlọ ọgwụ

Egwu. Mgbe ewere ya na afọ efu, a na-etinye vildagliptin ngwa ngwa, T_max - 1.75 awa mgbe nchịkwa gasịrị. Site na nri n'otu oge nri, ọnụego nnabata vildagliptin na-ebelata ntakịrị: enwere mbelata na C_max 19% na mmụba na T_max ruru awa 2.5. Ka osila dị, iri nri anaghị emetụta ogo mmịpụta yana AUC.

A na-etinye Vildagliptin ngwa ngwa, yana bioavailability ya zuru oke mgbe nchịkwa ọnụ bụ 85%. C_max na AUC na usoro ọgwụgwọ ọgwụgwọ na-abawanye ihe dịka nha.

Nkesa. Ogo ịmachi vildagliptin na protein plasma dị ala (9.3%). A na-ekesa ọgwụ ahụ n’usoro n’etiti plasma na mkpụrụ ndụ ọbara uhie. Ihe nkesa Vildagliptin na - aputa ihe dika ele anya, V_ss mgbe nchịkwa iv bụ lita 71.

Metabolism. Biotransformation bu uzo mbu nke vildagliptin. N'ime ahụ mmadụ, 69% nke ọgwụ ọgwụ agbanwere. Isi metabolite, LAY151 (57% nke dose), anaghị arụ ọrụ ọgwụ ma bụrụ ngwaahịa nke hydrolysis nke cyanocomponent. Ihe dị ka 4% nke ọgwụ a na-enweta amide hydrolysis.

Na nyocha nnwale, enwere mmetụta dị mma nke DPP-4 na hydrolysis nke ọgwụ ahụ. Achọpụtaghị Vildagliptin na ntinye nke cytochrome P450 isoenzymes. Dabere na nyocha in vitro , vildagliptin abụghị mkpụrụ nke P450 isoenzymes, anaghị egbochi ma ọ bụ ghara iburu cytochrome P450 isoenzymes.

Ojiji. Mgbe ịgesụ ọgwụ ahụ, ihe dị ka 85% nke ọgwụ ahụ ka akụrụ na -apụta na 15% site na eriri afọ, excaltion nke akwara vildagliptin bụ 23%. Na a / na ntinye nke nkezi T_1/2 erute elekere abụọ, mkpochapu plasma na mkpochapu vildagliptin bụ 41 na 13 l / h, karị. Ndi_1/2 mgbe ingestion gachara dịka elekere 3, agbanyeghị usoro ọ bụla.

Ndị otu ọrịa pụrụ iche

Mmekọ nwoke na nwoke, ntụpọ nke aru, na agbụrụ anaghị emetụta ọgwụ ọgwụ nke vildagliptin.

Ọrụ imeju na-arụ ọrụ. N'ime ndị ọrịa nwere ọrụ imeju na-arụ ọrụ nke ịdị nfe ruo obere (6-10 isi dịka nhazi nke ụmụaka-Pugh), mgbe otu ọgwụ ahụ gasịrị, mbelata bioavailability nke vildagliptin site na 8 na 20%, n'otu n'otu. N'ime ndị ọrịa nwere nnukwu ọrịa imeju (isi iri abụọ na abụọ dabere na nhazi nke ụmụaka-Pugh), bioavailability nke vildagliptin na-abawanye site na 22%. Mgbanwe kachasị na bioavailability nke vildagliptin, mmụba ma ọ bụ ibelata na nkezi ruo 30%, abụghị ihe dị mkpa na ụlọ ọgwụ. Amaghị mmekọrịta dị n'etiti arụmọrụ na-akpata ọrụ yana ọgwụ bioavailability ya.

Alrụ ọrụ na-arụ ọrụ na ụlọ. N'ime ndị ọrịa nwere ọrụ ezumike mkpirikpi, obere, agafeghị oke, ma ọ bụ nke AUC siri ike, vildagliptin mụbara 1.4, 1.7, na ugboro abụọ ma e jiri ya gosipụta nke a na ndị ọrụ afọ ofufo nwere ahụike. The AUC nke metabolite LAY151 mụbara ugboro 1.6, 3.2 na 7.3, na metabolite BQS867 mụbara oge 1.4, 2.7 na 7.3 na ndị ọrịa nwere ọrụ mgbazi ezughị ezu, na-agafeghị oke ma sie ike, n'otu n'otu. Achịcha amachiri na ndị ọrịa nwere ọrịa akụrụ na-agwụ agwụ (CKD) na-egosi na ndị na - egosi ihe ndị otu a yiri nke ndị ọrịa nwere nsogbu gbasara akụrụ. Ntinye uche nke LAY151 metabolite na ndị ọrịa nwere ngwụcha ngwụcha nke CKD mụbara site na ugboro abụọ abụọ (3) ma e jiri ya tụnyere ịta ndị ọrịa nwere nnukwu akụrụ. Drawepụ vildagliptin n'oge ịba ọcha n'anya bụ nke a kpaara ókè (3% n'oge usoro na-adịgide karịa 3-4 awa 4 awa mgbe otu ọgwụ gasịrị).

Ndị ọrịa years65 afọ. Mmụba kachasị na bioavailability nke ọgwụ site na 32% (mụbaa C_max 18%) n'ime ndị ọrịa karịrị afọ 70 abụghị ọgwụ dị mkpa ma ọ naghị emetụta mmachi nke DPP-4.

Ndị ọrịa ≤18 afọ. Emebeghị ka njikwa ọgwụ nke vildagliptin dị na ụmụaka na ụmụaka nọ n'afọ iri na asatọ.

Egwu. Ezigbo bioavailability nke metformin mgbe etinye ya na ọgwụ nke 500 mg na afọ efu bụ 50-60%. Ndi_max na plasma - 1.81-2.69 awa mgbe nchịkwa gasịrị. Site na mmụba nke dose nke ọgwụ ahụ site na 500 ruo 1500 mg ma ọ bụ na usoro onunu ogwu site na 850 ruo 2250 mg n'ime, a hụrụ ntakịrị mmụba na ọgwụ pharmokokinetic (karịa ka a ga-atụ anya maka mmekọrịta kwụ ọtọ). Emepụtara mmetụta a ọ bụghị nke ukwuu site na mgbanwe na mkpocha ọgwụ ahụ dịka nkwụsịtụ na ntinye ya. N’ihe banyere nri oriri, ogo na ogo oriri nke metformin belatara ntakịrị. Yabụ, na iji otu ọgwụ na ọgwụ were nha 850 mg, nri ka na-ahụbelata na C_max na AUC ihe dị ka 40 na 25% na mmụba na T_max minit 35 Egosiputaghi uru ogwu a di ako.

Nkesa. Site na otu mkpụrụ ọgwụ ọnụ nke 850 mg, pụtara V_d metformin bụ (654 ± 358) l. Ọgwụ ọgwụ ahụ ejikọghị protein ndị dị na plasma, ebe ihe dị iche iche na-ejikọ ha karịa 90%. Metformin na-abanye n’ime mkpụrụ ndụ ọbara uhie (ikekwe usoro a siri ike n’ihu n’oge). Mgbe ị na-eji metformin dị ka usoro ọkọlọtọ (ọnụọgụ nchịkwa na oge nchịkwa) C_ss ọgwụ a na plasma ọbara ruru n'ime awa iri abụọ na anọ na iri anọ na anọ ọ ga-erukwa, dị ka iwu, ọ gafere 1 /g / ml. N'ime ule ụlọ ọgwụ na-achịkwa nke C_max plasma metformin agafeghị 5 mcg / ml (ọbụlagodi mgbe ewere ya na oke ọnya).

Metabolism. Site na otu nchịkwa intravenia nke metformin nye ndị ọrụ afọ ofufo nwere ahụ ike, ọ bụ ya ka akụrụ na-agbanweghi. N'okwu a, ọgwụ anaghị metabolized n'ime imeju (achọpụtaghị metabolites n'ime mmadụ) ma ọpụpụ na bile.

Ojiji. Ebe ọ bụ na mwepụ nke metformin gbasara metformin dị ihe dị ka okpukpu 3.5 karịa karịa nhichapụ nke creatinine, ụzọ kachasị mkpa iji kpochapụ ọgwụ bụ tubular secretion. Mgbe etinyere ya n’ime, ihe dịka 90% nke ihe a na-etinye na ya bụ akụrụ gafere n’ime awa iri abụọ na anọ izizi, yana T_1/2 Site na plasma ọbara dị ihe dị ka awa 6.2 T_1/2 Metformin ọbara niile dị ihe gbasara awa 17.6, nke na-egosi oke oke ọgwụ a n’erụ ọbara ọbara.

Ndị otu ọrịa pụrụ iche

Paul Ọ naghị emetụta ọgwụ pharmokokinetics nke metformin.

Ọrụ imeju na-arụ ọrụ. N'ime ndị ọrịa nwere oke ịba ọcha n'anya, a naghị eduzi ọmụmụ nke ọgwụ pharmacokinetic nke metformin.

Alrụ ọrụ na-arụ ọrụ na ụlọ. N’ime ndị ọrịa nwere nsogbu gbasara akụrụngwa (ka enyere ha aka ịrụ ya) T_1/2 metformin sitere na plasma na ọbara dum na-abawanye, nhichapu akwara ya na-agbadata ya na ngbanwe nke nwechapụ creatinine.

Ndị ọrịa years65 afọ. Dabere na ọmụmụ ọgwụ pharmacokinet ole na ole, na ndị agadi ≥65 afọ, enwere mbelata mkpochapụ plasma nke metformin na mmụba na T_1/2 na C_max e jiri ya gosipụta ndị a na-eto eto. Ndị a pharmacokinetics nke metformin na ndị mmadụ karịa afọ 65 nwere ike buru ụzọ metụtara mgbanwe na ọrụ mkpo ya, yabụ, na ndị ọrịa gbagoro afọ 80, Galvus Met ga-ekwe omume naanị nwechapụ ikike creatinine nkịtị.

Ndị ọrịa ≤18 afọ. Emebeghi ihe omuma nke ogwu nke metformin n’ime umuaka na umuaka ndi n’abughi 18 n’etu.

Ndị ọrịa nke agbụrụ dị iche iche. Enweghị ihe akaebe nke mmetụta agbụrụ nwere ndidi na njikwa ọgwụ nke metformin. Na nyocha ogwu nke metformin na ndị ọrịa nwere ụdị ọrịa shuga 2 nke agbụrụ dị iche, gosipụtara mmetụta hypoglycemic nke otu ọgwụ ahụ.

Mmụta emere gosiri bioequivalence na usoro nke AUC na C_max Galvus Met na usoro 3 dị iche iche (50 mg + 500 mg, 50 mg + 850 mg na 50 mg + 1000 mg) na vildagliptin na metformin, weere na usoro kwesịrị ekwesị na mbadamba iche iche.

Nri adighi emetuta ogo na ogo nnabata vildagliptin na mejuputa ogwu Galvus Met. Nha C_max na AUC nke metformin na nchịkọta nke ọgwụ Galvus Met mgbe ị na-eri nri belatara site na 26 na 7%, otu isi. Na mgbakwunye, megide nzụlite nri, nnabata nke metformin belatara, nke butere mmụba na T_max (Awa 2 ruo 4). Mgbanwe yiri nke C_max Achoputara na AUC tinyere nri iji mara ihe banyere iji metformin iche, otu obula odi na ikpeazu, mgbanwe ndi a adabeghị. Mmetụta nke nri na pharmacokinetics nke vildagliptin na metformin na nchịkọta nke ọgwụ Galvus Met adịghị iche na nke ahụ mgbe ị na-ewere ọgwụ abụọ iche.

Na-egosi Galvus Met ®

Elldị shuga shuga 2 (ya na ọgwụgwọ nri na mmega ahụ):

na ezughi oke nke monotherapy na vildagliptin ma ọ bụ metformin,

n'ime ndị ọrịa na-anata ọgwụgwọ nchikota na vildagliptin na metformin n'ụdị otu ọgwụ,

yana ọgwụ sulfonylurea (usoro nchikota ọgwụ atọ) na ndị ọrịa eburu ụzọ wee nweta usoro ọgwụgwọ sulfonylurea na metformin n’emeghị akara glycemic zuru oke,

na nkwonkwo okpukpu atọ na insulin na ndị ọrịa na-anata ọgwụgwọ insulin na ọgwụ kwụsiri ike na metformin n'emeghị nchịkwa glycemic zuru oke,

dị ka usoro ọgwụgwọ mbụ na ndị ọrịa nwere ụdị ọrịa shuga 2 na-enweghị ike nke usoro ọgwụgwọ nri, mmega ahụ yana mkpa iji melite njikwa glycemic.

Ihe ngbanwe

hypersensitivity na vildagliptin ma ọ bụ metformin ma ọ bụ ihe ọ bụla ọzọ nke ọgwụ ahụ,

ọdịda akụrụngwa ma ọ bụ ịrụ ọrụ ezigharị (ya na ụmụ nwoke na ≥1.5 mg% (> 135 μmol / L) - maka ụmụ nwanyị), ≥1.4 mg% (> 110 μmol / L).

Ọnọdụ nnukwu nsogbu nke ị nwere ịmalite ịrịa ọrịa akụrụ: akpịrị ịkpọ nkụ (na ọnya afọ, ọgbụgbọ), ahụ ọkụ, ọrịa na-efe efe, ọnọdụ hypoxia (ujo, sepsis, ọrịa akụrụ, ọrịa bronchopulmonary).

nnukwu obi na nkụda mmụọ, nnukwu ọrịa myocardial infarction, nnukwu ọrịa obi (oke ụjọ), ọdịda iku ume,

ọrụ imeju na-arụ ọrụ,

acidosis akwara ma ọ bụ nke na-adịghị ala ala (gụnyere ketoacidosis nke ọrịa mamịrị na mgbakwunye na ma ọ bụ na-enweghị coma), ketoacidosis ọrịa mamịrị (ekwesịrị idozi site na ọgwụgwọ insulin), lactic acidosis (gụnyere akụkọ ihe mere eme),

tupu ogwugwo, radioisotope, nyocha x-ray na ntinye nke ndị na - emegide ọdịiche - anaghị enye ọgwụ a awa 48 na n'ime awa 48 ka emechara ha.

ụdị shuga 1

egbu egbu egbu, ị alcoholụ mmanya na-egbu egbu,

rube isi na obere kalori (ihe na-erughị 1000 kcal / ụbọchị),

ụmụaka na-erubeghị afọ 18 (arụpụtaghị nrụpụta na nchekwa).

Ebe ọ bụ na ndị ọrịa nwere ọrụ imeju nwere nsogbu ụfọdụ nwere lactic acidosis, nke a nwere ike ịbụ otu n'ime mmetụta metformin, Galvus Met ekwesịghị iji ndị ọrịa nwere ọrịa imeju ma ọ bụ usoro mmịpụta biochemical nke ọrụ imeju.

Iji nlezianya: ndị ọrịa karịa afọ 60 mgbe ha na-arụ ọrụ anụ ahụ dị egwu n'ihi oke ihe ize ndụ nke lactic acidosis.

Ime na lactation

Na nyocha nnwale na ụmụ anụmanụ site na iji vildagliptin na doses 200 karịa karịa ka a tụrụ aro ya, ọgwụ ahụ emeghị ka mmebi nke mmalite nke ẹmbrayo ma ọ nweghị ọrụ teratogenic. Mgbe ị na-eji vildagliptin na metformin mee ihe na 1:10, a chọpụtaghị mmetụta teratogenic.

Ebe ọ bụ na enweghi data zuru oke banyere iji ọgwụ Galvus Met n'ime ụmụ nwanyị dị ime, a na-egbochi ọgwụ ọ duringụ duringụ n'oge afọ ime.

Metformin na-abanye n’ime mmiri ara. Amabeghị ma vildagliptin dị na mmiri ara. Iji ọgwụ a Galvus Metụ eme ihe n’oge a na-enye nwa ara.

Nsonaazụ

Ihe omuma di n'okpuru metụtara ojiji nke vildagliptin na metformin na monotherapy yana ijikọ.

N'ihi usoro ọgwụgwọ vildagliptin, ọrụ imeju na-arụ ọrụ (gụnyere ịba ọcha n'anya) adịghị ahụkebe. N'ọtụtụ oge, mmebi na ọghọm ndị a na-egosipụta arụmọrụ nke ebumpụta ụwa site n'echiche ka edoziri onwe ha n'enweghị nsogbu ọ bụla mgbe ịkwụsị ịgwọ ọgwụ. Mgbe ị na-etinye vildagliptin na dose nke 50 mg 1 ma ọ bụ ugboro abụọ kwa ụbọchị, ugboro ole nke mmụba na ọrụ nke enzymes imeju (ALT ma ọ bụ ACT ugboro 3 karịa VGN) bụ 0.2 ma ọ bụ 0.3%, n'otu n'otu (jiri ya tụnyere 0.2% n'ime ndị na-ahụ maka nchịkwa) . Mmụba na ọrụ nke enzymes imeju n'ọtụtụ ọnọdụ bụ asymptomatic, enweghị ọganihu, na cholestasis ma ọ bụ jaundice esoghị.

Ejiri ihe ndị a na-esote iji chọpụta ọnọdụ nke ihe ọghọm (AE): oge ​​mgbe (≥1 / 10), ọtụtụ mgbe (≥1 / 100, GIT), ọnụego AE ma e jiri ya tụnyere ọgwụgwọ njikọta na vildagliptin na metformin bụ 12.9%. chọpụtara na 18.1% nke ndị ọrịa.

N'ime ìgwè ndị ọrịa na-anata metformin yana vildagliptin, ọnụọgụ afọ dị n'etiti 10-15%, na ndị ọrịa na-anata metformin wee nwee njikọta yana ọnụọgụ 18%.

Ogologo oge nyocha ulo ogwu nke rue afọ 2 ekpughere ụzọ ndị ọzọ dị na profaịlụ nchekwa ma ọ bụ ihe egwu na-atụghị anya ya mgbe ị na-eji vildagliptin dị ka monotherapy.

Ọmụmụ ihe banyere ojiji nke njikọta nke vildagliptin na metformin dị ka mmalite ọgwụgwọ maka ụdị ọrịa shuga 2 bụ nke ekpughere ihe egwu ọ bụla na data nchekwa ọzọ.

Ojiji nke vildagliptin na insulin

N'ime ule ụlọ ọgwụ a na-achịkwa na iji vildagliptin na ọgwụ nke 50 mg 2 ugboro kwa ụbọchị yana insulin na njikọ ya na metformin ma ọ bụ na-enweghị ya, ugboro ole ịkwụsị ọrụ ahụ n'ihi mmepe nke mmeghachi omume ọjọọ bụ 0.3% na vildagliptin otu, ebe nọ na placebo otu enweghị onye wepụrụ ọgwụ.

Ọnọdụ nke hypoglycemia bụ nke yiri na otu abụọ (14% nọ na vildagliptin otu na 16.4% na placebo otu). N'ime otu vildagliptin, ekwuputara na ọrịa hypoglycemia siri ike na ndị ọrịa 2, na otu placebo - na 6.

N'oge emechara ọmụmụ ihe ahụ, ọgwụ ahụ enweghị mmetụta ọ bụla na nkezi ahụ dị oke elu (oke ahụ nwuru site na 0.6 n'arọ ma e jiri ya tụnyere nke mbụ na vildagliptin otu, ọ nweghị mgbanwe ọ bụla chọpụtara na placebo otu).

AEs na ndị ọrịa na-anata vildagliptin 50 mg ugboro abụọ kwa ụbọchị yana insulin (yana ma ọ bụ na-enweghị metformin).

Si ụjọ usoro: oge isi ọwụwa.

Site na eriri afọ: ọtụtụ mgbe - ọgbụgbọ, gastroesophageal reflux, ugboro ugboro - afọ ọsịsa, flatulence.

Site n'akụkụ nke metabolism na nri oriri: ọtụtụ mgbe - hypoglycemia.

Ọrịa na nkwarụ izugbe na saịtị ịgba ahụ: ọtụtụ mgbe - akpata oyi.

Mgbe ị na-eji vildagliptin na nchịkọta sulfonylurea

Edebeghi nkwupụta nke ịkwụsị ọgwụ ọjọọ na mmepe nke AE n'ime ọgwụ ọgwụgwọ njikọta na vildagliptin, metformin na glimepiride. Na njikọta ọgwụ nke placebo, metformin na glimepiride, ihe omume nke AE bụ 0.6%.

A na-ahụkarị hypoglycemia na otu abụọ ahụ (5.1% n'ime ọgwụ ọgwụgwọ njikọta na vildagliptin, metformin na glimepiride na 1.9% na ìgwè ọgwụgwọ na paịbo, metformin na glimepiride). N'ime otu vildagliptin, a chọpụtara otu ọrịa hypoglycemia siri ike.

N'oge emechara ihe omumu a, enweghi ihe di egwu banyere aru ahu (+0.6 n'arọ na vildagliptin otu na −0.1 kg na placebo otu).

AEs na ndị ọrịa na-anata vildagliptin 50 mg 2 ugboro kwa ụbọchị yana mgbakwunye metformin na sulfonylureas ka e gosipụtara n'okpuru.

Si ụjọ usoro: mgbe mgbe - anya isi, jijiji.

Ọrịa na nkwarụ izugbe na saịtị ịgba ahụ: ike ọgwụgwụ.

Site n'akụkụ nke metabolism na nri oriri: ọtụtụ mgbe - hypoglycemia.

Na akpụkpọ anụ ahụ ọtụtụ mgbe - hyperhidrosis.

Mgbe ị na-eji vildagliptin dị ka monotherapy

Si ụjọ usoro: ọtụtụ mgbe - anya isi, ugboro ugboro - isi ọwụwa.

Site na eriri afọ: ugboro ugboro - afọ ntachi.

Na akpụkpọ anụ ahụ ugboro ugboro - ọnya akpụkpọ.

Site n'akụkụ akwara na uru ahụ: ọtụtụ mgbe - arthralgia.

Ọrịa na nkwarụ izugbe na saịtị ịgba ahụ: ugboro ugboro - akụkụ ụkwara ume ọkụ.

Mgbe ị na-eji usoro njikọta ọgwụ na vildagliptin na metformin, mmụba dị ukwuu na-emetụta ụlọ ọrụ ugboro ugboro nke AE ndị dị n'elu nke edere na vildagliptin.

Na ndabere nke monotherapy na vildagliptin ma ọ bụ metformin, nnabata nke hypoglycemia bụ 0.4% (ugboro ugboro).

Monotherapy na vildagliptin na njikọta nke vildagliptin + metformin anaghị emetụta oke ahụ onye ọrịa.

Ogologo oge nyocha ulo ogwu nke rue afọ 2 ekpughere ụzọ ndị ọzọ dị na profaịlụ nchekwa ma ọ bụ ihe egwu na-atụghị anya ya mgbe ị na-eji vildagliptin dị ka monotherapy.

Achọpụtara mmeghachi omume ọjọọ ndị a na oge azụmaahịa (ebe a kọọrọ data ahụ site na afọ ofufo site na ọnụ ọgụgụ ebighi-ebi, ọ gaghị ekwe omume ịpụta ntụkwasị obi ugboro ole mmepe nke AE ndị a, yabụ na ha na-ekewa ya ka a na-amabeghị ugboro ugboro): ịba ọcha n'anya (tụgharịrị mgbe a kwụsịrị ọgwụgwọ), urticaria, pancreatitis, akpukpo aru na exfoliative anụ ahụ ọnya.

Mgbe ị na-eji metformin na monotherapy

Site n'akụkụ nke metabolism na nri oriri: Ọtụtụ mgbe - ọnwụ anaghị eri nri, ọ na - adịkarịkarị - lactic acidosis.

Site na eriri afọ: oge mgbe - flatulence, ọgbụgbọ, vomiting, afọ ọsịsa, mgbu nke afọ, oge - dysgeusia.

N'akuku nke imeju na akwara biliary: o siri ike - ịba ọcha n'anya.

Na akpụkpọ anụ ahụ enwerekarị anụ ahụ - mmeghachi omume anụ ahụ (ọkachasị erythema, pruritus, urticaria).

Laabu na akụrụngwa data: O siri ike - ibelata vitamin nke B₁₂, mgbanwe ntụgharị ọrụ arụmọrụ.

Mbelata Vitamin B belatara₁₂ na mbelata nke ịta ya na ọbara n'ọbara site n'iji metformin hụrụ nke a anaghị ahụkebe na ndị ọrịa na-anata ọgwụ ahụ ogologo oge, na, dịka iwu, nke ahụ anaghị anọchi anya uru ọghọm dị na ya. Ekwesịrị ichebara echiche iji belata nnabata nke vitamin B₁₂ n'ime ndị ọrịa nwere ọrịa megaloblastic.

E doziri ụfọdụ ikpe ịba ọcha n'anya, nke e ji ojiji metformin mee, mgbe ọ kwụsịrị.

Mmekorita

Site n'iji vildagliptin (100 mg 1 oge kwa ụbọchị) na metformin (1000 mg 1 oge kwa ụbọchị), a hụghị PCF dị ukwuu n'etiti ha. Ma ọ bụghị n'oge ule ụlọ ọgwụ, ma ọ bụ n'oge ọgwụgwọ sara mbara nke Galvus Met n'ime ndị ọrịa na-anata ọgwụ na ọgwụ ndị ọzọ n'otu oge, mmekọrịta ndị a na-atụghị anya ha achọpụtaghị.

Vildagliptin nwere ikike dị ala maka ịmekọrịta ọgwụ. Ebe ọ bụ na vildagliptin abụghị mkpụrụ nke enzymes cytochrome P450, ọ naghị egbochi ma ọ bụ na-egbochi iche iche ndị a, mmekọrịta ya na ọgwụ ndị na-agbanwe agbanwe, ndị na-egbochi ya, ma ọ bụ P450 inducers enweghị atụ. Iji vildagliptin na-eme n'otu oge anaghị emetụta metabolic ọnụego ọgwụ ndị na-anọchi enzymes: CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1 na CYP3A4 / 5.

Mmekọrịta mmekọrịta dị ukwuu nke vildagliptin na ọgwụ ndị a na-ejikarị na ọgwụgwọ nke ụdị shuga mellitus 2 (glibenclamide, pioglitazone, metformin) ma ọ bụ nwee usoro ọgwụgwọ dị warara (amlodipine, digoxin, ramipril, simvastatin, valsartan, warfarin).

Furosemide na-abawanye C_max na AUC nke metformin, mana ọ naghị emetụta nhichapụ nhichapu ya. Metformin lowers C_max na AUC nke furosemide ma ọ dịghị emetụta nhichapu mkpo ya.

Nifedipine na-abawanye mmịpụta, C_max na AUC nke metformin, na mgbakwunye, ọ na-eme ka ahụmkpọ ahụ dịkwuo ya. Metformin fọrọ nke nta ka ọ ghara imetụta ọgwụ pharmokokinetic nke nifedipine.

Glibenclamide emetụtaghị ọgwụ ọgwụ / ọgwụ ọgwụ nke metformin. Metformin na-agbadata C_max na AUC nke glibenclamide, agbanyeghị, ịdị ukwuu nke mmetụta ahụ dịgasị iche iche. Maka nke a, ebumnuche banyere mmekọrịta a bụ ihe edoghị edo anya.

Osisi cicationDịka ọmụmaatụ, amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamteren, trimethoprim, vancomycin na ndị ọzọ, akụrụ site na tubular zoro ezo, nwere ike ịkpụgharị metformin n'ihi asọmpi maka usoro ibufe tubule nkịtị na-ebugharị. Yabụ, cimetidine na-eme ka ịba ụba nke metformin dị na plasma ọbara na ya nke AUC site na 60 na 40%, n'otu n'otu. Metformin emetụtaghị ọgwụ pharmacokinetic nke cimetidine. Ekwesịrị ịkpachara anya mgbe ị na-eji Galvus Met yana ọgwụ ọgwụ ndị metụtara ọrụ akụrụ ma ọ bụ nkesa metformin n'ahụ.

Ọgwụ ndị ọzọ. Drugsfọdụ ọgwụ nwere ike ibute hyperglycemia ma belata ịdị mma nke ndị na - ahụ ike hypoglycemic. Ọgwụ ndị dị otú ahụ gụnyere thiazides na ọgwụ ndị ọzọ, GCS, phenothiazines, ọgwụ homonụ, estrogens, ọgwụ mgbochi, phenytoin, acid nicotinic, sympathomimetics, ndị na-emegide calcium na isoniazid. N'iji oge nke ọgwụ dị otu oge ma ọ bụ, na nke ozo, n'ihe banyere ịwepu ha, a na-atụ aro iji nlezianya nyochaa ịdị irè nke metformin (mmetụta ya na hypoglycemic) ma, ọ bụrụ na ọ dị mkpa, dozie ọgwụ ahụ. Agaghị atụ aro iji ihe mkpuchi oriri danazole iji zere ọrụ hyperglycemic nke ndị ikpeazụ. Ọ bụrụ na ọgwụgwọ na danazol dị mkpa ma kwụsịkwa ịchịkwa nke ngwụcha nke ikpeazụ, a chọrọ idozi dose nke metformin n'okpuru njikwa glucose ọbara.

Chlorpromazine mgbe eji ya na nnukwu doses (100 mg kwa ụbọchị), ọ na-abawanye glycemia, na-ebelata ntọhapụ nke insulin. Na ọgwụgwọ nke ọgwụ ịsa ahụ na mgbe ịkwụsịchara nke ikpeazụ, a chọrọ idozi dose nke ọgwụ Galvus Met n'okpuru nchịkwa nke ịkpụcha ọbara glucose.

Iodine nwere ihe na - enye rediopaque: omumu ihe omumu nehoria nke neeji ayodiin nwere iodine nwere ike ime ka mmepe nke lactic acidosis n’aria ndi n’arusi oria mellitus n’iru oruru ya n’ile.

A gaghị agbari₂nnabata nke okwu: mụbaa glycemia n'ihi mkpali nke β₂-adrenoreceptors. N'okwu a, njikwa glycemic dị mkpa. Ọ bụrụ na ọ dị mkpa, a na-atụ aro insulin.

Site na ojiji nke metformin n’otu oge na usoro nke sulfonylurea, insulin, acarbose, salicylates, mmụba na mmetụta hypoglycemic ga-ekwe omume.

Ebe ọ bụ na ojiji nke metformin na ndị ọrịa ị alcoholụbiga mmanya oke na-abawanye ihe ize ndụ nke lactic acidosis (karịsịa n'oge agụụ, ike ọgwụgwụ, ma ọ bụ imeju afọ), na ọgwụgwọ ya na Galvus Met, ị kwesịrị izere ị drinkingụ mmanya na ọgwụ ọjọọ nwere ethyl mmanya.

Usoro onunu ogwu na nhazi

Ekwesịrị ịhọrọ usoro ọgwụgwọ ọgwụ Galvus Met n’otu n’otu, dabere na ịdị irè na nnabata ọgwụgwọ. Mgbe ị na-eji Galvus Met, agabigala ọgwụ a na-atụ aro ka ọ bụrụ vildagliptin kwa ụbọchị (100 mg).

Ekwesịrị ịhọrọ usoro ọgwụgwọ mbụ nke Galvus Met na-eburu n'uche oge oge ọ ga-arịa ọrịa shuga na ọkwa nke glycemia, ọnọdụ onye ọrịa na usoro ọgwụgwọ nke vildagliptin na / ma ọ bụ metformin ejirila onye ọrịa ahụ. Iji belata ịdị njọ nke nsonaazụ site na mgbaze nri, njiri mara metformin, a na-ewere Galvus Met na nri.

Ngwọta mbụ nke ọgwụ Galvus Met na enweghị ike nke monotherapy na vildagliptin

Enwere ike ịmalite mbadamba ọgwụgwọ 1. (50 mg + 500 mg) ugboro 2 kwa ụbọchị, mgbe ị tụlechara ọgwụgwọ ọgwụgwọ, enwere ike ịbawanye dose ahụ.

Thezọ izizi ọgwụ Galvus Met na ọdịda nke monotherapy na metformin

Dabere na dose nke emeburu metformin, enwere ike ịmalite ọgwụgwọ na Galvus Met na mbadamba 1. (50 mg + 500 mg, 50 mg + 850 mg ma ọ bụ 50 mg + 1000 mg) 2 ugboro n'ụbọchị.

Ngwọta mbụ nke ọgwụ Galvus Met na ndị ọrịa na-anata ọgwụgwọ nkwonkwo na vildagliptin na metformin n'ụdị mbadamba dị iche.

Dabere na onodu ogwu nke vildagliptin ma ọ bụ metformin ewerelarị, ọgwụgwọ ya na Galvus Met kwesịrị ịmalite site na mbadamba ọgwụ dị ka o kwere mee ka usoro ọgwụgwọ a dị (50 mg + 500 mg, 50 mg + 850 mg ma ọ bụ 50 mg + 1000 mg), ma dozie dose ahụ dabere na ịdịmma ya.

Oge izizi nke Galvus Met dị ka ọgwụ ịmalite na ndị ọrịa nwere ụdị ọrịa shuga 2 nke ọrịa ezughị oke na usoro ọgwụgwọ nri na mmega ahụ.

Dịka usoro ọgwụgwọ amalite, ekwesịrị inye Galvus Met n ’ụzọ mbụ nke 50 mg + 500 mg otu ugboro n’ụbọchị, na mgbe ọ tụlechara usoro ọgwụgwọ, jiri nwayọ bulie dose ahụ gaa na 50 mg + 1000 mg 2 ugboro kwa ụbọchị.

Ngwakọta ngwakọta na Galvus Met na usoro mmanụ sulfonylurea ma ọ bụ insulin

A na-agbakọ ọ̀gwọ Galvus Met na ndabere nke vildagliptin 50 mg × 2 ugboro n'ụbọchị (100 mg kwa ụbọchị) yana metformin na dose hà ka nke a wereburu dịka otu ọgwụ.

Ndị otu ọrịa pụrụ iche

Alrụ ọrụ na-arụ ọrụ na ụlọ. N'ime ndị ọrịa nwere ọrụ ezumike mkpirisi, enwere ike idozigharị ya na Cl creatinine (nke ọnụ ọgụgụ Cockcroft-Gault gbakọọ) na 60 si 90 ml / min nwere ike ịchọ. Ojiji nke Galvus Met na ndị ọrịa nwere Cl creatinine VGN ugboro abụọ). Site na mmụba na dose nke vildagliptin ruo 600 mg / ụbọchị, mmepe nke edema nke nsọtụ ga-ekwe omume, yana paresthesias na mmụba nke mkpokọta nke CPK, C-reactive protein na myoglobin, na ọrụ AST. Ihe mgbaàmà nke ị ofụbiga mmanya ókè na mgbanwe na usoro nyocha ụlọ nyocha na-apụ n'anya mgbe ịkwụsị ọgwụ ahụ.

Ọgwụgwọ: iwepụ ọgwụ ahụ site na ahụ site na ịba ọcha n'anya bụ eleghi anya. Ma, enwere ike wepu metabolism nke mbu nke vildagliptin (LAY151) site na ahu site na hemodialysis.

Ọrịa ọtụtụ ikpe nke overdose nke metformin, gụnyere n'ihi nsonye ọgwụ ahụ na ọnụọgụ karịrị 50 g. Site na oke oke nke metformin, a hụrụ hypoglycemia n'ihe dị ka 10% nke ikpe (agbanyeghị, mmekọrịta ya na ọgwụ ahụ emebeghị ka o sie ike). Na 32% nke ikpe, a chọpụtara lactic acidosis. Ihe mgbaàmà mbido nke lactic acidosis bụ ọgbụgbọ, ọgbụgbọ, afọ ọsịsa, mbelata ahu, olu afọ, olu mgbu, enwere ike ịba ụba ume, akpịrị, imetụghị anya na mmepe nke coma.

Ọgwụgwọ: symptomatic, dabere n'ọnọdụ ọnọdụ onye ọrịa na ngosipụta nke ụlọ ọgwụ. A na - ewepu ya na ọbara site na iji hemodialysis (wepu ihe ruru 170 ml / min) na - enweghị mmepe nke ọgba aghara hemodynamic. Ya mere, enwere ike iji hemodialysis wepu metformin na ọbara ma a ofụọ ọgwụ mgbochi oke.

Ntụziaka pụrụ iche

N'ime ndị ọrịa na-anata insulin, Galvus Met enweghị ike dochie ọgwụ insulin.

Ọrụ imeju na-arụ ọrụ. Ebe ọ bụ na mgbe ị na-etinye vildagliptin, mmụba na ọrụ nke aminotransferases (na-enweghị ngosipụta nke ụlọ ọgwụ) ka a na-ahụkarị oge ụfọdụ karịa na ndị na-ahụ maka njikwa, a na-atụ aro ikpebi usoro biochemical nke ọrụ imeju tupu ị theụ ọgwụ Galvus Met, yana yana mgbe niile n'oge ọgwụgwọ. Ọ bụrụ na achọpụtara mmụba nke aminotransferases, ekwesịrị ịmụpụta ihe ugboro ugboro iji gosipụta nsonaazụ ahụ, wee chọpụta oge niile usoro biochemical na-arụ ọrụ nke imeju ruo mgbe ha ga-ahazi. Ọ bụrụ na ngafe nke ọrụ AST ma ọ bụ ALT dị elu karịa 3G karịa VGN site na nyocha ugboro ugboro, a na-atụ aro ka ịkagbu ọgwụ ahụ.

Lactic acidosis. Lactic acidosis bụ ihe dịkarịsịrị ala ma ọ na-akpata metabolic na-eme ya na nchịkọta nke metformin n'ahụ. Achọpụtara acidosis maka ojiji nke metformin tumadi na ndị ọrịa nwere ọrịa mellitus nwere nnukwu akụrụ. Ihe ize ndụ nke ịmalite ọrịa lactic acidosis na-abawanye na ndị ọrịa nwere ọrịa ọrịa ọrịa mellitus na-adịghị edozi, na ketoacidosis, agụụ ogologo oge, ị alcoholụbiga mmanya ókè, ọrụ imeju na-adịghị mma na ọrịa ndị na-akpata hypoxia.

Site na mmepe nke lactic acidosis, a na-ahụkarị mkpụmkpụ nke iku ume, olu afọ na hypothermia, nke na-esote Coma. Ndị na-egosi nyocha ụlọ nyocha ndị a nwere uru nchọpụta: mbelata ọbara pH, mkpokọta lactate na serum karịa 5 nmol / L, yana mmụba nke anionic na mmụba na nha lactate / pyruvate. Ọ bụrụ na echere na lactic acidosis, ekwesịrị ịkwụsị ọgwụ ahụ ma mee ka onye ọrịa ahụ gaa ụlọ ọgwụ ozugbo.

Nyochaa ọrụ akụrụ. Ebe ọ bụ na akụrụ na-ewepụta ihe dị ukwuu na akụrụ, ihe ọghọm nke mkpo ya na mmepe nke lactic acidosis na-abawanye na oke nha nrụrụ akụrụ. Mgbe ị na-eji ọgwụ ahụ eme ihe, Galvus Met kwesịrị ịtụle ọrụ renal mgbe niile, karịsịa n'ọnọdụ ndị na-esonye na mmebi ya, dịka usoro ọgwụgwọ mbụ na ọgwụ antihypertensive, ndị ọrụ hypoglycemic ma ọ bụ NSAIDs. Ekwesịrị ịtụle ọrụ ntaramahụhụ tupu ịmalite ọgwụgwọ na Galvus Met, mgbe ahụ ọ dịkarịa ala 1 oge kwa afọ na ndị ọrịa nwere ọrụ ezumike nkịtị ma ọ dịkarịa ala ugboro 2-4 kwa afọ na ndị ọrịa nwere mkpochapụ creatinine na ọkwa nkịtị, yana ndị agadi. ndị ọrịa. N'ime ndị ọrịa nọ n'ihe egwu dị elu nke ịmalite nrụrụ akụrụ, nlebara anya kwesịrị ka eme ọtụtụ ugboro ugboro ugboro 2-4 kwa afọ. Ọ bụrụ n ’ihe ịrịba ama nke ọrụ akwara arụrụala, Galvus Met kwesịrị ịkwụsị.

Ojiji nke iodine nwere radiopaque wakiil maka nchịkwa intravascular. Mgbe ị na-eduzi ọmụmụ ihe nyocha nke chọrọ nlekọta intravaskụla nke ndị na-enwe rediopaque iodine, Galvus Met kwesịrị ịkwụsịtụ nwa oge (awa 48 tupu, yana kwa n’ime awa 48 ka ọmụmụ ihe ahụ gachara), ebe ọ bụ na intravaskụl nke ndị na-enwe redio iodine nwere ikuku nwere ike ibute oke ọrụ na akụrụ na ịba ụba ọrụ. ihe egwu nke lactic acidosis. Resmalite ịmalite ị Galụ ọgwụ Galvus Met na-esochi naanị nyochachara nyocha gbasara ọrụ gbasara aha.

Hypoxia. Na ọrịa obi akwara na-akpata oke ụjọ (ujo), nkụda mmụọ nke obi, nnukwu myocardial infarction na ọnọdụ ndị ọzọ nke hypoxia mara, mmepe nke lactic acidosis na ọdịda akwara siri ike nke akwara ga-ekwe omume. Ọ bụrụ na ọnọdụ ndị dị n'elu ahụ bilitere, ekwesịrị ịkwụsị ọgwụ ahụ ozugbo.

Ihe ogwugwo. N'oge emegharị ahụ (ewezuga obere ọrụ ndị na-esiteghị na ịmachi nri na mmiri ị )ụ mmiri), ekwesịrị ịkwụsị ọgwụ ahụ Galvus Met. Ibidoghachi ọgwụ a ga - ekwe omume mgbe mweghachi nke ọgwụ a na-egbu egbu na ndị ọrịa nwere nnukwu ọrụ ezumike.

Alcoholụ mmanya na-egbu egbu. Achọpụtala na mmanya na-eme ka mmetụta nke metformin nwee metabolism lactate. E kwesịrị ịdọ ndị ọrịa ọdụ gbasara ịadụbiga mmanya oke n’oge ị duringụ ọgwụ Galvus Met.

N’echebe ndị ọrịa nwere ụdị ọrịa shuga 2 bụ ndị gwọburu ọgwụgwọ. Ọ bụrụ na achọpụtara ihe nyocha nke ụlọ nyocha ka ọ dị ugbua ma ọ bụ ihe mgbaàmà nke ọrịa na-egosi na ọnọdụ izugbe na-akawanye njọ (ọkachasị na-apụtaghị ìhè na mgbaàmà nke ọrịa) na ndị ọrịa nwere nzaghachi izizi zuru oke na ọgwụgwọ, a ga-eme nchọpụta ụlọ nyocha ozugbo ịchọpụta ketoacidosis na / ma ọ bụ lactic acidosis. Ọ bụrụ na achọpụtara acidosis, ị kwesịrị ị kwụsị ị usingụ ọgwụ ahụ ozugbo wee mee ihe ndị dị mkpa iji dozie ọnọdụ onye ọrịa ahụ.

Hypoglycemia. Dị ka ọ na-adị, na ndị ọrịa na-anata naanị Galvus Met, a naghị ahụ hypoglycemia, mana ọ nwere ike ime megide usoro nri nwere kalori (mgbe mmega ahụ siri ike anaghị akwụghachi ụgwọ site na nri kalori nke nri ahụ) ma ọ bụ megide nzụlite nke ị consumptionụ mmanya. Mmepe nke hypoglycemia bụ ihe dịkarịsịrị ike na ndị agadi, ndị ọrịa nwere nkụda mmụọ ma ọ bụ nke dara ada, yana megide usoro hypopituitarism, enweghị ume adrenal ma ọ bụ ị alcoholụbiga mmanya ókè. N'ime ndị ọrịa agadi na ndị na-anata ckers-blockers, nchọpụta nke hypoglycemia nwere ike isi ike.

Mbelata ịdị irè nke ndị na - ahụ maka hypoglycemic. N'okpuru nrụgide (gụnyere ahụ ọkụ, trauma, ọrịa, ịwa ahụ), na-etolite n'ime ndị ọrịa na-anata ndị ọrịa hypoglycemic dịka ụkpụrụ ọkọlọtọ dị, mbelata nke ọma na nke ikpeazụ maka oge ụfọdụ ga-ekwe omume. N'okwu a, ọ nwere ike ịdị mkpa ịkwụsị nwa oge ọgwụ Galvus Met na ọgwụ insulin. Oge ịmaliteghachi ọgwụgwọ ya na Galvus Met ga-ekwe omume mgbe ngwụcha nke nnukwu ọrịa ahụ gasịrị.

Ọmụmụ. N'ime nyocha nnwale na anụmanụ, iji vildagliptin na doses 200 ugboro elu karịa nke a tụrụ aro emeghị ka nsogbu ọmụmụ.

Enweghi mmetụta na-adịghị mma na ọmụmụ nke ụmụ nwoke na ụmụ nwanyị na iji ojiji nke metformin na usoro nke 600 mg / kg / ụbọchị, nke bụ ihe dị ka ugboro atọ karịa ka akwadoro maka ụmụ mmadụ (mgbe a gbanwere na mpaghara ahụ. Emebeghị nnyocha banyere uto ọmụmụ ụmụ mmadụ.

Mmetụta ikike ịkwọ ụgbọ ala ma jiri usoro rụọ ọrụ. Amụbeghị mmetụta Galvus Met n'ikike iji kwadoo ụgbọ na usoro. Site na mmepe nke ọgbụgba megide mmalite nke iji ọgwụ ahụ, mmadụ kwesịrị ịhapụ ịkwọ ụgbọala na usoro.

Emeputa

1. Novartis Pharma Stein AG, Switzerland.

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

Onye nwere asambodo ndenye aha: Novartis Pharma AG. Lichtstrasse 35, 4056, Basel, Switzerland.

Enwere ike inweta ozi ndị ọzọ gbasara ọgwụ ahụ na: 125315, Moscow, Leningradsky pr-t, 72, bldg. 3.

Tẹ.: (495) 967-12-70, faksị: (495) 967-12-68.