Kombigliz ogologo (Kombiglyze ogologo)

Aha mba:Kombiglyze ogologo

Ngwakọta na ụdị ntọhapụ

Mkpopụta Ihe Nkiri Edeputara Gburugburu. Otu mbadamba 1 nwere 1000 mg nke metformin, 2,5 mg nke saxagliptin.

N'ime blis 28 28 ma ọ bụ mbadamba 56. Ihe ngwugwu na igbe kaadi.

Mbadamba ihe eji agba agba nke agbaziri fim, 1000 mg + 5 mg. Na ngwugwu nke mbadamba 28 ma ọ bụ 56.

Mbadamba ihe eji agba agba nke agbaziri fim, 500 mg + 5 mg. Na ngwugwu nke mbadamba 28 ma ọ bụ 56.

Linlọ ọgwụ na ọgwụ ọgwụ

Ogwu hypoglycemic ọgwụ

Ndị na-ere ọgwụ

Ngwakọta hypoglycemic ejikọtara ọnụ maka nchịkwa ọnụ (dipeptidyl peptidase-4-inhibitor + biguanide)

Omume ọgwụ

Combogliz Prolong na-ejikọ ọgwụ hypoglycemic abụọ na usoro mmeju iji meziwanye njikwa glycemic na ndị ọrịa nwere ụdị ọrịa shuga 2 (DM2): saxagliptin, dipeptyl peptidase 4 inhibitor (DPP-4), na metformin, onye nnọchite klas biguanide.

Na nzaghachi banyere nri oriri site na obere eriri afọ, a na-ahapụ homonụ nke nwere ọbara n'ọbara, dị ka gluptagon-peptide-1 (GLP-1) na glucose na-adabere insulinotropic polypeptide (HIP). Homonụ ndị a na - akwalite mwepụta nke insulin n'ahụ mkpụrụ ndụ beta nke pancreatic, dabere na ntinye glucose n'ọbara, mana enzyme DPP-4 na - arụ ọrụ n'ime ọtụtụ nkeji. GLP-1 na-ebelata nzuzo nke glucagon na sel Alp pancreatic, na-ebelata mmepụta glucose imeju. N'ime ndị ọrịa nwere ọrịa shuga 2, a na-ebelata mkpụkọ nke GLP-1, mana azịza insulin na GLP-1 ka dị. Saxagliptin, ịbụ onye na-egbochi DPP-4, na-ebelata mmelata nke homonụ ndị dị na ya, si otú a na-abawanye itinye uche ha na oke ọbara ma na-eduga n'ịbelata glucose na-ebu ọnụ mgbe ha risịrị nri.

Metformin bụ ọgwụ hypoglycemic nke na-eme ka nnabata glucose dị n'etiti ndị ọrịa nwere ọrịa shuga 2, belata basal na nchịkọta glucose postprandial. Metformin na-ebelata mmepụta nke glucose site na imeju, na-ebelata nnabata nke glucose na eriri afọ ma na-abawanye njikwa insulin, na-abawanye mpaghara na ojiji nke glucose. N'adịghị ka nkwadebe nke sulfonylurea, metformin adịghị akpata hypoglycemia na ndị ọrịa nwere ọrịa shuga 2 ma ọ bụ ndị nwere ahụike (ma e wezụga n'ọnọdụ ndị pụrụ iche, lee akụkụ “ịkpachara anya” na “Ntuziaka Pụrụ Iche”), na hyperinsulinemia. N'oge usoro ọgwụgwọ metformin, mmiri ọgwụ insulin na-agbanwe agbanwe, ọ bụ ezie na insulin na-ebu ọnụ ma na-aza nri ị na-eri n'ụbọchị nwere ike ibelata.

Mlọ ọgwụ

Aclọ ọgwụ ọgwụ nke saxagliptin na metabolite ya na-arụ ọrụ, 5-hydroxy-saxagliptin, bụ otu ndị ọrụ afọ ofufo ahụike na ndị ọrịa nwere ụdị ọrịa shuga 2. Ofkpụrụ nke C max na mpaghara dị n'okpuru usoro AUC nke saxagliptin na metabolite na-arụ ọrụ na plasma mụbara n'ọtụtụ na nha nke sitere na 2.5 mg ruo 400 mg. Mgbe otu nchịkwa ọnụ nke saxagliptin dị na 5 mg site na ndị ọrụ afọ ofufo nwere ahụ ike, nkezi ụkpụrụ AUC nke saxagliptin na metabolite ya bụ 78 ng * h / ml na 214 ng * h / ml, ụkpụrụ C max na plasma bụ 24 ng / ml na 47 ng / ml kwekọrọ. Mgbanwe nke ogo nke AUC na C max nke saxagliptin na metabolite na-arụ ọrụ ya erughị 25%.

Iji ọgwụ a ugboro ugboro otu ugboro n'ụbọchị ọ bụla usoro, ọ nweghị ihe ngosipụta nke ukwu nke saxagliptin ma ọ bụ metabolite na-arụ ọrụ. Enweghị ndabere nke sacagliptin na metabolite ya na-arụ ọrụ na dose na oge mgbe etinyere ya maka ụbọchị 14 otu ugboro kwa ụbọchị na usoro onunu si 2.5 mg ruo 400 mg nke saxagliptin.

Na max, metformin gbanwetụrụ usoro a na-enweta na nkezi nke awa asaa. Nnweta nke metformin sitere na mbadamba ihe eji emezi emezi na-abawanye 50% mgbe nri. Na nrụpụta, AUC na Cmax nke metformin gbanwetụrụ ntọhapụ mụbara etu esi etu esi were dozie ya site na 500 ruo 2000 mg. Mgbe nchịkwa ugboro ugboro, ntọgharị nke metformin gbanwetụrụ agbakọghị na plasma. Ọ bụ akụrụ na - agbanwegharị Metformin na - agbanwegharị na akụrụ ya.

Mgbe nchịkwa ọnụ gasịrị, ọ dịkarịa ala 75% nke dose nke saxagliptin na-abanye. Iri nri emetụtaghi ọgwụ pharmokokinetics nke saxagliptin na ndị ọrụ afọ ofufo ahụ siri ike. Nri nwere oke abughi emetu C max nke saxagliptin, ebe AUC gbagoro 27% ma e jiri ya na-ebu ọnụ. Oge ị ga-eru C max (T max) maka saxagliptin mụbara site na ihe dị ka awa 0,5 mgbe ị na-a theụ ọgwụ ahụ nri ma e jiri ya na-ebu ọnụ. Agbanyeghị, mgbanwe ndị a adịchaghị mkpa n'ịgwọ ọrịa.

Mgbe otu ndọrọndọrọ ọnụ nke metformin gbanwetụrụ ntọhapụ, a na-enweta C max na nkezi mgbe awa asaa gachara, na agbarị awa anọ ruo awa asatọ. AUC na Cmax nke metformin gbanwere wepụtara esighi ike na usoro onunu ogwu a na-enweta site na 500 ruo 2000 mg. Ntinye uche ọgwụ kachasị na plasma ọbara bụ 0.6, 1.1, 1.4 na 1.8 μg / ml mgbe ị na-ewere ọgwụ 500, 1000, 1500 na 2000 mg otu ugboro kwa ụbọchị. Ọ bụ ezie na ogo nke nnabata (nke AUC tụrụ) nke metformin sitere na mbadamba metformin nke gbanwetụrụ na-abawanye ihe dị ka 50% mgbe eji nri, nri oriri emetụtaghị C max na T max nke metformin. Ihe oriri dị obere ma nwee nnukwu abụba nwere otu mmetụta na pharmacokinetics nke gbanwetụrụ metformin tọhapụ.

Njikọ nke saxagliptin na metabolite ya na protein protein n'ọbara abụghị ihe dị mkpa; yabụ, enwere ike iche na nkesa nke saxagliptin na mgbanwe na protein protein nke ọbara ọbara hụrụ na hepatic ma ọ bụ akụrụ agaghị enwe nnukwu mgbanwe.

Emebeghi ihe omumu banyere nkesa nkesa nke metformin gbanwetụrụ, agbanyeghị, olu pụtara nkesa nke metformin mgbe otu mkpụrụedemede nke metformin na-ebuputa mbadamba mkpụrụ ọgwụ ozugbo 850 mg nke ọkara 654 ± 358 L. Metformin nwere obere ihe jikọrọ protein ndị dị na plasma.

Saxagliptin bụ metabolized tumadi na ntinye nke isoenzymes nke cytochrome P450 ZA4 / 5 (CYP3A4 / 5) na nguzobe nke metabolite dị ike, mmetụta inhibitory nke nke megide DPP-4 bụ ugboro abụọ adịghị ike karịa nke saxagliptin.

Ọmụmụ ihe nyochara otu ọgwụ mgbochi intravenous ọgwụ ahụ nyere ndị ọrụ afọ ofufo nwere ahụike na-egosi na akụrụngwa metformin bụ nke akụrụ agbanweghi, metabolized n'ime imeju (a naghị achọpụta metabolites n'ime mmadụ), ọ naghị ewepụta ya na eriri afọ.

Saxagliptin kpụrụ akụrụ na site na eriri afọ. Mgbe otu ọgwụ were 50 mg nke akara 14 C-saxagliptin, akụrụ 24% nke ọgwụ ahụ ka aminagliptin na-agbanweghi agbanwe agbanwe yana 36% bụ metabolite nke saxagliptin. Ngụkọta akwara ozi hụrụ na mmamịrị ruru 75% nke ọgwụ a .ụrụ.

Nkezi mkpocha ezigharịrị nke saxagliptin dị ihe dị ka 230 ml / min, uru gbachapụrụ agbacha gbacha gbacha gbata ruru 120 ml / min. Maka isi metabolite, mkpochapu akụrụ bụ ihe pụtara na uru nke ikpocha ụwa. Ihe dị ka pacenti 22% nke ikuku redio a hụrụ na feces.

Mkpochapu ntaramahụhụ dị ihe dị ka okpukpu 3.5 karịa karịa mwepụ nke creatinine (CC), nke na-egosi na tubular secretion bụ ụzọ kachasị ewepu mmiri nke metformin.Mgbe ịwachara, ihe dịka 90% nke ọgwụ ahụ a gụrụ na-ewepụ akụrụ n’ime awa 24 mbụ, yana ọkara ndụ site na plasma nke dị ihe dị ka awa 6.2. N'ime ọbara, ọkara ndụ bụ ihe dịka awa 17.6, yabụ, ụbara ọbara ọbara nwere ike ịbụ akụkụ nke ekesa.

Pharmacokinetics n'ọnọdụ ndị pụrụ iche

A naghị atụ aro iji Combogliz Prolong na ndị ọrịa nwere ọdịda akụrụngwa (lee mpaghara "Contraindications").

N'ime ndị ọrịa nwere ajọ akụrụ dị obere, ogo nke AUC nke saxagliptin na metabolite na-arụ ọrụ ya bụ 20% na 70% (karị) karịa ụkpụrụ AUC na ndị ọrịa nwere ọrụ mkpo nkịtị. Ebe ọ bụ na anaghị ele ịrị elu dị ka uru ahụike anya dị ka ọgwụ, ọ naghị atụ aro imeghari ọnụọgụ nke saxagliptin na ndị ọrịa nwere ajọ akụrụ.

N'ime ndị ọrịa nwere ọrụ mgbazinye nsogbu (dịka nsonaazụ nke QC si dị), ọkara ndụ metformin sitere na plasma na ọbara na-abawanye na mkpụkọ akwara na-agbadata n'ike n'ike na QC.

N'ime ndị ọrịa nwere ọria nkwarụ dị nro, na-agafe agafe, ọ nweghị mgbanwe dị egwu na ọgwụ ọgwụ nke saxagliptin, ya mere, a chọghị ịgbanwe mgbanwe maka ndị ọrịa dị otú ahụ.

Enweghị ọmụmụ ọgwụ ọgwụ gbasara metformin na ndị ọrịa nwere nkwarụ hepatic.

Ndozigharị onodu saxagliptin dabere na okike ndi ọrịa adighi achoghi ya.

N'ime ihe omumu ihe omumu nke ndi oria nke nwere oria nke abuo, ihe hypoglycemic met metinin n’etiti nwoke na nwanyi.

N'ime ndị ọrịa afọ 65-80, ọ nweghị ọdịiche dị iche iche dị na ọgwụ ọgwụ nke saxagliptin ma e jiri ya tụnyere ndị ọrịa dị obere (afọ 18-40), ya mere, achọrọ nhazigharị ọgwụgwọ na ndị ọrịa agadi. Agbanyeghị, ekwesịrị iburu n'uche na n'ụdị ndị ọrịa a, mbelata ọrụ ezumike nwere ike yikarịrị (lee akụkụ "Usoro Ọgwụ na Nchịkwa" na "Ntuziaka Pụrụ Iche").

Enweghi oke data sitere na ihe omumu ihe omumu nke pharmacokinetics nke metformin n’ime ndi okenye n’enyemaka na-egosi na ngwucha plasma nke metformin na-ebelata, T 1/2 na-abawanye, na C max na-abawanye ma e jiri ya tụnyere ụkpụrụ nke parameters ndị a na-eto eto ndị ọrụ afọ ofufo siri ike. Dabere na data ndị a, mgbanwe nke ọgwụ pharmacokinetics nke metformin na afọ na-abawanye bụ kachasị site na mgbanwe nke ọrụ akụrụ. Ekwesighi inye ndị ọrịa gafere afọ 80 ozi Combogliz Prolong, ewezuga mgbe arụpụtara QC dị mma.

Emebeghị nnyocha nke pharmacokinetics nke saxagliptin na ụmụaka.

Emebeghị nnyocha banyere ọgwụ ọgwụ nke metformin gbanwee na ụmụaka.

Ọsọ na agbụrụ

A naghị atụ aro ka ịhazie dose nke saxagliptin dabere n'ọsọ onye ọrịa.

Enwebeghị nnyocha banyere ọgwụ ọgwụ nke metformin dabere na agbụrụ ndị ọrịa.

Elldị nke abụọ nke ọrịa shuga mellitus tinyere nri na mmega iji melite njikwa glycemic.

Ihe mgbochi iji ọgwụ Combogliz Prolong

Itibawanyewanye na onye ọ bụla na ọgwụ ahụ, mmeghachi omume dị njọ (anaphylaxis ma ọ bụ angioedema) na ndị na - egbochi DPP-4, ụdị 1 ọrịa mellitus (adịghị eji mụọ), jiri insulin (emeghị ya ịmụ), enweghị nsogbu afọ galactose, enweghị ụkọ lactase na glucose-galactose malabsorption, ịtụrụ ime, lactation, n’agbata afọ iri na asatọ (nchekwa na nrụpụta adịghị amụ), akụrụ gbasara akwara (serum creatinine ≥1.5 mg / dl for men, ≥1.4 mg / dl for women cystin ma ọ bụ mbelata creatinine nwechara), gụnyere ndị kpatara nnukwu ọrịa obi na-akpata (ujo), nnukwu myocardial infarction na ọrịa septicemia, ọrịa dị oke egwu nke enwere ihe ọghọm nke ọrụ akwara na-adịghị ala ala: akpịrị ịkpọ nkụ (ya na ọgbụgbọ na ọgbụgbọ, afọ ọsịsa),ahụ ọkụ, ọrịa na-efe efe siri ike, ọnọdụ nke hypoxia (ujo, sepsis, ọrịa akụrụ, ọrịa bronchopulmonary), ma ọ bụ metabolic acidosis, gụnyere ọrịa mamịrị ketoacidosis, ma ọ bụ na-enweghị coma, nnukwu ngosipụta dị ukwuu nke ọrịa na-adịghị ala ala nke nwere ike ibute mmepe nke hypoxia anụ ahụ (ọdịda okuku ume, obi obi ọgụ, nnukwu myocardial infarction), nnukwu ịwa ahụ na trauma (mgbe egosipụtara insulin ọgwụgwọ), ọrụ imeju na-arụ ọrụ. a alcoụrụma na-egbu egbu na ethanol na-egbu egbu, lactic acidosis (gụnyere akụkọ ihe mere eme), oge dịkarịa ala 48 awa tupu na n'ime awa 48 mgbe ịghasịrị redioisotope ma ọ bụ ọmụmụ redio na ntinye nke ndị na-enwe ọdịiche nwere iodine, na-agbaso nri nwere obere kalori (5% nke ndị ọrịa, ndị natara metformin mgbazi gbanwere ma zụlite ọtụtụ oge karịa ndị nọ n'ọnọdụ placebo bụ afọ ọsịsa na ọgbụgbọ / ọgbụgbọ.

A na-akọpụta mmetụta ndị a na-esote n'oge a na-ejikwa saxagliptin na post-azụ ahịa: nnukwu ọrịa pancreatitis na mmeghachi omume hypersensitivity, gụnyere anaphylaxis, angioedema, ihe ọkụ na urticaria. Ọ gaghị ekwe omume ịtụkwasị obi ugboro ole mmepe ndị a dị, ebe ọ bụ na ọnụọgụgụ ndị a na - amabeghị ozi, lee akụkụ “Contraindications” na "Ntụziaka pụrụ iche maka iwere Combogliz Prolong»).

Ọnụ ọgụgụ zuru oke nke lymphocytes

Saxagliptin

Mgbe ị na-eji saxagliptin, a na-achọpụta mbelata nke na-agbadata ọnụego nke lymphocytes zuru oke. Mgbe ị na-enyocha data jikọtara ọnụ nke izu iri abụọ na anọ, izu ọmụmụ na-achịkwa, a na-ahụkarị mbelata ihe dị ka mkpụrụ ndụ 100 na 120 / nke ọnụ ọgụgụ zuru oke nke lymphocytes site na mkpụrụ ndụ mbụ nke mkpụrụ ndụ 2200 / μl na iji saxagliptin na dose 5 mg na 10 mg, n'otu n'otu, tụnyere ya na pilasi. A hụrụ mmetụta yiri nke ahụ mgbe ị na-ewere saxagliptin na dose nke 5 mg na njikọta mbụ na metformin ma e jiri ya tụnyere metformin monotherapy. Enweghị ọdịiche dị n'etiti 2.5 mg saxagliptin na placebo. Ọgụ ndị ọrịa nọ na ọnụọgụ nke lymphocytes bụ cells 750 sel / μl bụ 0,5%, 1.5%, 1.4%, na 0.4% n'ime otu ndị na-agwọ ọgwụ saxagliptin na dose nke 2.5 mg, na dose nke 5 mg , na onodi ogwu nke 10 mg na placebo, n’otu n’otu. N'ọtụtụ n'ime ndị ọrịa na iji ugboro ugboro nke saxagliptin, enweghị nlọghachi ọ bụla, ọ bụ ezie na ụfọdụ ndị ọrịa ọnụ ọgụgụ nke lymphocytes belatara ọzọ na ịmaliteghachi usoro ọgwụgwọ na saxagliptin, nke dugara na mkpocha nke saxagliptin. Nsonye nke ọnụọgụ nke lymphocytes esoghị ihe ngosi ọgwụgwọ.

Ihe kpatara mbelata ọnụ ọgụgụ nke lymphocytes n'oge usoro ọgwụgwọ saxagliptin ma e jiri ya tụnyere placebo amabeghị. N'ọnọdụ nke ọrịa na-adịghị ahụkebe ma ọ bụ ogologo oge, ọ dị mkpa iji tụta ọnụọgụ nke lymphocytes. Mmetụta nke saxagliptin na ọnụọgụ nke lymphocytes n'ime ndị ọrịa nwere nsogbu na ọnụọgụ nke lymphocytes (dịka ọmụmaatụ, nje immunodeficiency virus mmadụ).

Saxagliptin

Saxagliptin enweghị mmetụta dị omimi ma ọ bụ usoro ịtụle na platelet na mpịakọta abụọ kpara ìsì, na-achịkwa nchekwa na nchekwa.

Ntinye vitamin B₁₂

Na nyocha ọgwụ gbasara metformin na-adigide n'ime izu iri abụọ na itolu, ihe dị ka 7% ndị ọrịa nwere mbelata okpo ọbara tupu oge vitamin B nkịtị.₁₂ ka ụkpụrụ ebighi ebi na-enweghị ngosipụta ọgwụgwọ. Agbanyeghị, ụdị mbelata dị otu a anaghị esonyere mmepe anaemia ma na –eweghachi ngwa ngwa mgbe ịkwụsị ọrụ metformin ma ọ bụ nweta vitamin B ọzọ.₁₂.

Ime na lactation

N'ihi eziokwu ahụ bụ na a gụbeghị ọgwụ Combogliz Prolong n'oge afọ ime, ekwenyeghị ọgwụ ahụ n'oge ime.

Amaghị ma saxagliptin ma ọ bụ metformin banye na mmiri ara.Ebe ọ bụ na enwere ike ịbanye na ọgwụ Combogliz Prolong n'ime mmiri ara, anaghị egbochi iji ọgwụ eme ihe n'oge a na-enye ya ara.

A na - egbochi ọgwụ iji ọgwụ ezumike arụ ọrụ (serum creatinine ≥1.5 mg / dl maka nwoke, ≥1.4 mg / dl maka nwanyị ma ọ bụ belata mebipụtara creatinine).

Ojiji nke ogwu n’ime umuaka

A na - egbochi ọgwụ iji ọgwụ ndị a na - erubeghị afọ 18 (amụbeghị nchekwa na ịdị irè).

Jiri ndị ọrịa agadi

Ebe ọ bụ na akụrụ na-emecha nke ziri ezi saxagliptin na metformin, na ndị agadi ndị agadi nwere ike belata ọrụ ọrụ akụrụ, a ga-eji Combogliz Prolong jiri nlezianya mee ihe na ndị agadi.

Ntụziaka pụrụ iche maka iwere Combogliz Prolong

Lactic acidosis bụ ihe na-adịghị ahụkebe, nnukwu nsogbu metabolic nke nwere ike ịmalite n'ihi mmụpụta nke metformin n'oge ọgwụgwọ ya na Combogliz Prolong. Site na mmepe nke lactic acidosis n'ihi iji metformin, ntinye ya na plasma ọbara karịrị 5 μg / ml.

N'ime ndị ọrịa nwere ọrịa shuga, lactic acidosis na-etolitekarị nnukwu akwara oke, gụnyere n'ihi ọrịa akụrụ nke afọ na ezughị oke akụrụ na-ezughị ezu, ọkachasị mgbe ị na-ewere ọtụtụ ọgwụ. N'ime ndị ọrịa nwere nkụchi obi, ọkachasị na ndị ọrịa nwere angina na-ejighi ike ma ọ bụ nnukwu nkụda obi na ihe nwere hypoperfusion na hypoxemia, enwere ohere dị ukwuu nke lactic acidosis. Ihe ọghọm nke ibute lactic acidosis na-abawanye na ogo nke ogo gbasara akụrụ na afọ onye ọrịa. Ekwesịrị ileba anya na ọrụ gbasara akụrụngwa na ndị ọrịa na - eburu metformin ma ekwesịrị ịnye ọgwụ opekempe opekata mpe. N'ime ndị ọrịa agadi, ọ dị mkpa ileba anya na ọrụ gbasara akụrụngwa. Ekwesighi inye ndị ọrịa afọ 80 na okenye karịa Metformin ọgwụ (ma ọ bụrụ na ọrụ ezumike n’ọrụ adịghị mma (dịka data QC) si dị, dị ka ndị ọrịa a na-adịkarị mfe maka mmepe nke lactic acidosis. Na mgbakwunye, ọgwụgwọ metformin kwesịrị ịkwụsị ozugbo ma ọ bụrụ na ọnọdụ nke hypoxemia, akpịrị ịkpọ nkụ, ma ọ bụ sepsis tolitere. Ebe ọ bụ na imeju imeju nwere ike belata ikike ịrọ oria lactate, ekwesighi inye ndị ọrịa ọgwụ akara ma ọ bụ ụlọ nyocha nke ọrịa imeju.

Mmalite nke lactic acidosis bụ nke a na-ahụkarị na ọ na-esite na mgbaàmà ndị na-enweghị isi dịka malaise, myalgia, ọdịda iku ume, oke ụra, mgbu na ahụ erighị ala. Hypothermia, hypotension, na bradyarrhythmia na-eguzogide ọgwụ nwere ike ịme. Onye ọrịa ahụ kwesịrị ịgwa dọkịta ahụ ihe niile banyere mgbaàmà ndị a ozugbo. Ọ bụrụ na achọpụtara ụdị ọrịa ahụ, ekwesịrị ịkwụsị ọgwụ metformin, ileba anya n'ọtụtụ elektrolytes, ahụ ketone, glucose ọbara, ọ bụrụ na egosipụtara, pH ọbara, ntinye lactate na itinye metformin na ọbara. Ihe mgbaàmà gastric na-etolite na ngwụsị nke usoro ọgwụgwọ metformin nwere ike ịbụ site na lactic acidosis ma ọ bụ ọrịa ọzọ.

Ibu ọnụ plasma plasma lactate na-adị elu karịa elu nkịtị karịa ma ọ dị n'okpuru 5 mmol / L na ndị ọrịa na-ewere metformin nwere ike igosipụta mmepe nke lactic acidosis, ọ nwekwara ike ịbụ n'ihi ihe ndị ọzọ, dị ka ọrịa mellitus na-enweghị mkpokọta, oke ibu, oke anụ ahụ ibu.

Ekwesịrị inyocha ọnụnọ nke lactic acidosis na ndị ọrịa niile nwere ọrịa mellitus na metabolic acidosis na-enweghị ihe ịrịba ama nke ketoacidosis (ketonuria na ketonemia). Lactic acidosis chọrọ ọgwụgwọ n'ụlọ ọnọdụ ụlọ ọgwụ. Ọ bụrụ na achọtara lactic acidosis na onye ọrịa na-ewere metformin, ị kwesịrị ịhapụ ị takingụ ọgwụ ahụ ozugbo wee malite usoro nkwado dum.Ọ na-atụ aro ka ịmalite usoro akwara ozigbo iji mezie acidosis na metformin suprem cumulated.

Dị ka ị maara, mmanya na-eme ka mmetụta nke metformin nwee metabolism nke lactate, nke na-abawanye ohere nke lactic acidosis. Belata ị alcoholụ mmanya mgbe ị na-a Comụ Combogliz Prolong.

A naghị akwado Combogliz Prolong maka ndị ọrịa nwere akara aka na ụlọ nyocha nke ọrịa imeju n'ihi ihe ize ndụ nke lactic acidosis.

Nyocha ọrụ akụrụ

Tupu ịmalite ọgwụgwọ na Combogliz Prolong na opekata mpe kwa afọ, ọ dị mkpa iji nyochaa ọrụ akụrụ. N'ime ndị ọrịa a na-enyo enyo na ọ nwere ọrụ akụrụ, a ga-enyocha ọrụ akụrụ ugboro ugboro yana ọgwụgwọ Combogliz Prolong ga-akwụsị ma ọ bụrụ na akara nke ọdịda akwara apụta.

Shouldkwesịrị ịkwụsịtụ iji ọgwụ ahụ Combogliz Prolong tupu usoro ọgwụgwọ ọ bụla (belụsọ maka obere usoro nke ejikọtaghị ya na ịmachi oke ị andụ mmiri na mmiri ọ ,ụ )ụ), amalitekwala ịmalite iji ya ruo mgbe onye ọrịa ahụ nwere ike ị takeụ ọgwụ n'ime ya wee gosipụta ọrụ akụrụ nkịtị. .

Agbanwe onodu adidi nke ndi oria nwere oria nke abuo bu ndi oria abuo

N'ime onye ọrịa nwere T2DM, onye chịburu ya nke ọma n’oge ọgwụgwọ ya na Combogliz Prolong, onye nwekwaara ihe n ’ụlọ nyocha ma ọ bụ nwee ọrịa (ọkachasị n’ihe banyere nchọpụta amamịghe), a ga-enyocha ihe ịrịba ama nke ketoacidosis ma ọ bụ lactic acidosis ozugbo. Nyocha ahụ kwesịrị ịgụnye mkpebi siri ike nke electrolytes n'ọbara ọbara, ketones, glucose ọbara na, ọ bụrụ na egosipụtara, pH ọbara, nchịkọta nke lactate, pyruvate na metformin. Ọ bụrụ n'ụdị acidosis etolite, a ga-akwụsị Combogliz Prolong ozugbo wee dezie ọgwụ hypoglycemic ọzọ.

Ojiji nke ọgwụ nwere ike ibute hypoglycemia

Ọgwụ ndị na-eme ka mmiri ọgwụ insulin na-akpali, dị ka sulfonylureas, nwere ike ịkpata hypoglycemia. Ya mere, iji belata ihe ize ndụ nke hypoglycemia mgbe ejikọtara ya na saxagliptin, ọ nwere ike ịdị mkpa iji belata ọgwụ nke na-eme ka mmiri ọgwụ insulin dịkwuo elu.

Hypoglycemia anaghị etolite n'ime ndị ọrịa na-a onlyụ nanị metformin n'ụzọ ọ na-adị, ma ọ nwere ike ịmalite site na oriri na-ezighi ezi nke carbohydrate, mgbe arụ ọrụ anụ ahụ anaghị arụ ọrụ site na oriri carbohydrate, ma ọ bụ site na iji ọgwụ hypoglycemic ndị ọzọ (dị ka sulfonylureas na ọgwụ insulin) ma ọ bụ mmanya. Okenye, ndi ọrịa na ndi nri na adighi nri ma obu ndi n’enweghi nsogbu ma obu oke mmanya ma obu egbu egbu bu ndi amachara acho hypoglycemic. N'ime ndị okenye na ndị ọrịa na-a betaụ ọgwụ mgbochi-egbochi, nchọpụta nke hypoglycemia nwere ike isi ike.

Usoro ọgwụgwọ na-emetụta ọrụ akụrụngwa ma ọ bụ nkesa metformin

A na-eji ọgwụ ndị na-akpata nkwekọ (dị ka ọgwụ cationic, nke zoro ezo site na nzuzo nke akụrụ), nke nwere ike imetụta ọrụ akụrụ, na-eduga mgbanwe mgbanwe dị ukwuu ma ọ bụ kpaghasasị nkesa nke metformin (lee akụkụ "Mmekọrịta na ọgwụ ndị ọzọ"), ka eji jiri ịkpachapụ anya.

Ihe omumu ihe omumu nke ihe omimi banyere ochicho ihe nke ndi mmadu

Mgbe ị na-eduzi ọmụmụ ihe gbasara akwara ozi na nchịkwa intravascular nke iodine nwere ihe dị iche iche, a na-achọpụta oke arụmọrụ akụrụ, nke nwere ike isonye na mmepe nke lactic acidosis na ndị ọrịa na-anata metformin. Ndị ọrịa a haziri maka ọmụmụ ihe dị otú a ga-akagbu ọgwụgwọ Combogliz Prolong n'ime awa 48 tupu ha emee usoro a, zere ị theụ ọgwụ ahụ n'ime awa 48 ka usoro ahụ gasịrị, ma maliteghachi ọgwụgwọ naanị mgbe ekwenyechara ọrụ akụrụ.

Ọkpụkpụ cardiovaskụla (ujo) nke mmalite ọ bụla, nkụchi obi na-egbu mgbu, nnukwu ọrịa myocardial infarction na ọnọdụ ndị ọzọ agbakwunyere hypoxia na lactic acidosis nwere ike ibute ọrịa azotemia prerenal. Site na mmepe nke ihe ijuanya dị otú a, ọ dị mkpa ịkagbu ọgwụgwọ ozugbo na Combogliz Prolong.

Ọbara glucose n'ọbara

Ahụ ọkụ, trauma, ofufe ọrịa, ịwa ahụ nwere ike ibute ịta ahụhụ nke glucose n'ọbara, nke jisiri ike ijikwa site n'enyemaka nke ọgwụ Combogliz Prolong. N'ọnọdụ ndị a, enwere ike ịhapụ ọgwụ oge ụfọdụ na ịnyefe onye ọrịa ahụ ọgwụ insulin. Mgbe kwụsịrị ịdị n'otu nke glucose n'ọbara ma melite ọnọdụ onye ọrịa n'ozuzu ya, enwere ike ịmaliteghachi ọgwụgwọ na Combogliz Prolong.

N'oge a na-eji saxagliptin na-azụ ahịa, a chọpụtara mmeghachi omume dị njọ hyperensitivity, gụnyere anaphylaxis na angioedema. Site na mmepe nke mmeghachi omume dị njọ, a ga-akwụsị ị shouldụ ọgwụ ahụ, a ga-enyocha ihe ndị ọzọ ga - eme ka mmepe nke ihe a ga - enyocha ya, na usoro ọgwụgwọ ọzọ maka ọrịa mellitus nke ọrịa shuga (lee "Contraindications" na ")"Nsonaazụ»).

N'ụghachite azụmaahịa nke saxagliptin, a natala ozi mkpesa gbasara ikpe gbasara ọrịa akwara. Ekwesịrị ịgwa ndị ọrịa na-ewere Combogliz Prolong banyere njirimara njirimara nke nnukwu pancreatitis: ogologo oge, nnukwu ihe mgbu n'ime afọ. Ọ bụrụ na ị na-enyo enyo mmepe nke pancreatitis, ị kwesịrị ịkwụsị ị Comụ ọgwụ Combogliz Prolong (lee akụkụ "Na-akpachara anya" na "Nsonaazụ»).

Mmetụta ikike ịkwọ ụgbọ ala na usoro nchịkwa

Emebeghị nnyocha banyere mmetụta saxagliptin na ike ịkwọ ụgbọala na usoro nchịkwa.

Buru n’uche na saxagliptin nwere ike ibute isi ọwụwa.

Dodoụbiga ya ókè

Site na iji ọgwụ a ogologo oge na usoro onunu ogwu ruo ugboro iri asatọ karịa ka a tụrụ aro ya, akọwaghị ihe mgbaàmà nke ịxụ mmanya.

N'ọnọdụ ị anụbiga mmanya ókè, ekwesịrị iji usoro ọgwụgwọ Symptomatic mee ihe. Saxagliptin na metabolite ya bụ isi sitere na hemodialysis wepụta ya (etu esi eme ya: 23% nke dose ahụ n'ime awa anọ).

Enweela ọtụtụ ikpe nke oke overformin nke metformin, gụnyere iwere ihe karịrị 50 g. Hypoglycemia bilitere na ihe dịka 10% nke ikpe, mana enweghị ntọala mmekọrịta ya na metformin. Na 32% nke oke oke nke metformin, ndị ọrịa nwere lactic acidosis. A na-ewepụta Metformin n'oge akụrụngwa, ebe mkpochasị ahụ ruru 170 ml / min.

Mmekọrịta na ọgwụ ndị ọzọ

Drugsfọdụ ọgwụ na-abawanye hyperglycemia (thiazide na ọgwụ ndị ọzọ, glucocorticosteroids, phenothiazines, nkwadebe nke iodine-nwere homonụ thyroid, estrogens, ọgwụ mgbochi, phenytoin, nicotinic acid, sympathomimetik, ngwa ngwa ndị na-egbochi calcium channel and isoniazid). Mgbe ị na-edepụta ma ọ bụ kagbuo ọgwụ ndị dị otú ahụ na onye ọrịa na-ewere Combogliz Prolong, jiri nlezianya nyochaa oke glucose na ọbara. Ogo nke ijikota metformin na protein plasma ọbara dị obere, yabụ enweghị atụ na ọ ga-emekọrịta ọgwụ nke agbadobere na protein ndị na-enye plasma, dịka salicylates, sulfonamides, chloramphenicol na probenecid (nke dị iche na usoro sulfonylurea, nke a na-ejikọ ọnụ ya na protein ndi).

Induction nke isoenzymes CYP3A4 / 5

Rifampicin na-ebelata mkpughe nke saxagliptin n'ebughị agbanwe AUC nke metabolite na-arụ ọrụ, 5-hydroxy-saxagliptin. Rifampicin anaghị emetụta mgbochi nke DPP-4 na plasma ọbara n'oge nkeji 24 nke ọgwụgwọ.

CYP3A4 / 5 Isoenzyme Ndị Inhibitors

Diltiazem kwalitere mmetụta nke saxagliptin mgbe ejikọtara ọnụ.Mmụba na ịta nke saxagliptin na plasma ọbara na-atụ anya site na iji amprenavir, aprepitant, erythromycin, fluconazole, fosamprenavir, grape mkpụrụ osisi na verapamil, agbanyeghị, a gaghị atụ aro ọgwụ ziriagli. Ketoconazole na-eme ka mmụba nke saxagliptin dị na plasma dị elu. A na-atụ anya mmụba dị ukwuu na mkpocha nke saxagliptin na plasma ọbara mgbe ejiri ike ndị ọzọ na-egbochi nzoenzymes CYP3A4 / 5 (dịka ọmụmaatụ, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir). Mgbe ejikọtara ya na ihe mgbochi siri ike nke CYP3A4 / 5 isoenzymes, a ga-ebelata ọgwụ nke saxagliptin na 2.5 mg.

Ọgwụ cationic (dịka ọmụmaatụ, amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterone, trimethoprim ma ọ bụ vancomycin), nke akụrụ na-agbanye site na nzacha ọnụ, nwere ike ịgagharị na metformin, na-asọrịta mpi maka sistemụ njem ụgbọelu. Na nyocha nke mmekorita ọgwụ nke metformin na cimetidine nwere otu nlekọta na ọgwụ ugboro ugboro, a chọpụtara mmekọrịta nke metformin na cimetidine maka nchịkwa ọnụ na ndị ọrụ afọ ofufo nwere ahụ ike, na mmụba 60% na mkpokọta kachasị nke metformin na plasma na ọbara dum na mmụba 40% na AUC nke metformin na plasma na dum ọbara. N'oge ọmụmụ otu ọgwụ ọgwụ ọjọọ, ọ nweghị mgbanwe na ọkara ndụ. Metformin emetụtaghị ọgwụ ọgwụ nke cimetidine. Ọ na-atụ aro iji nlezianya nyochaa ndị ọrịa na, ọ bụrụ na ọ dị mkpa, dozie dose ahụ na ndị ọrịa na-a cụ ọgwụ cationic nke ewepụrụ site na sistemụ akwara proalimal renal tubule.

Na omumu ihe banyere nmekorita ya na otu uzo ogwu a na ndi oria di oria abuo, ijikota metformin na glibenclamide emetutaghi pharmacokinetics ma obu pharmacodynamics.

Na nyocha nke mmekorita ọgwụ nke metformin na furosemide nwere otu ọgwụ ọgwụ, nke emere na ndị ọrụ afọ ofufo nwere ahụ ike, ekpughere nkwukọrịta ọgwụ ha. Furosemide na-abawanye C_max metformin na plasma na ọbara site na 22% na AUC n'ọbara site na 15% na-enweghị mgbanwe dị ukwuu na mkpochapu akwara nke metformin. Mgbe ejiri ya metformin C_max na AUC nke furosemide na-ebelata 31% na 12%, n'otu aka ahụ, ọkara ndụ na-ebelata 32% na-enweghị mgbanwe pụtara ìhè na mkpochapu mkpọsa nke furosemide. Enweghị data na mmekọrịta nke metformin na furosemide yana ijikọ ogologo oge.

Na nyocha nke mmekorita ọgwụ nke metformin na nifedipine na otu ọgwụ, nke a na-eme na ndị ọrụ afọ ofufo nwere ahụike, nifedipine na-abawanye C_max metformin na plasma site na 20% na AUC site na 9%, ma na-abawanye mkpụmkpụ nke akụrụ. Ndi_max na T_1/2 agbanweghị. Nifedipine na-abawanye nnabata nke metformin. Metformin nwere ihe fọrọ nke nta ka ọ bụrụ na ọ nweghị ọgwụ na ọgwụ ọgwụ nifedipine.

Saxagliptin na Metformin

Combinedjikọ ọnụ nke otu onunu ogwu nke saxagliptin (100 mg) na metformin (1000 mg) emetụtaghị ọgwụ pharmacokinetics nke saxagliptin ma ọ bụ metformin na ndị ọrụ afọ ofufo ahụike.

Enweghị ọmụmụ ọgwụ pụrụ iche nke mmekọrịta ọgwụ na Combogliz Prolong emebeghị, ọ bụ ezie na e jirila ihe ndị dị na ya meghee ọmụmụ: saxagliptin na metformin.

Mmetụta nke ọgwụ ndị ọzọ na saxagliptin

Glibenclamide: Ihe ijikọtara ọnụ nke saxagliptin (10 mg) na glibenclamide (5 mg), mkpụrụ nke na-anọpụ iche CYP2C9, mụbara C_max saxagliptin na 8%, agbanyeghị, saucagliptin AUC anaghị agbanwe agbanwe.

Pioglitazone: Njikọtara ugboro ugboro maka saxagliptin otu ugboro n'ụbọchị (10 mg) na pioglitazone (45 mg), mkpụrụ nke isoenzyme CYP2C8 (siri ike) na CYP3A4 (adịghị ike), anaghị emetụta ọgwụ pharmokokinetics nke saxagliptin.

Digoxin: Njikọtara ugboro ugboro maka saxagliptin otu ugboro n'ụbọchị (10 mg) na digoxin (0.25 mg), mkpụrụ nke P-glycoprotein, anaghị emetụta ọgwụ pharmokokinetics nke saxagliptin.

Simvastatin: Ihe jikọtara ugboro ugboro iji saxagliptin otu ugboro n'ụbọchị (10 mg) na simvastatin (40 mg), mkpụrụ nke CYP3A4 / 5 isoenzymes, mụbara C_max saxagliptin dị 21%, mana saxagliptin AUC anaghị agbanwe agbanwe.

Diltiazem: Ihe ijikọtara ọnụ nke saxagliptin (10 mg) na diltiazem (360 mg ogologo usoro onodu ogwu na nguzozi), ihe na-egbochi CYP3A4 / 5 isoenzymes, na-abawanye C_max saxagliptin site na 63%, yana AUC - oge 2.1. Nke a na mgbako dị kwekọrọ na C_max na AUC nke metabolite nọ n'ọrụ site na 44% na 36%, n'otu n'otu.

Ketoconazole: Ihe jikọtara ọnụ nke otu ọgwụ nke saxagliptin (100 mg) na ketoconazole (200 mg kwa elekere 12 na nha anya), na-abawanye_max na AUC nke saxagliptin 2.4 na 3.7 ugboro, n'otu n'otu. Nke a na mgbako dị kwekọrọ na C_max na AUC nke metabolite nọ n'ọrụ site na 96% na 90%, n'otu n'otu.

Rifampicin: Ihe jikọtara ọnụ nke otu ọgwụ ziri ezi nke saxagliptin (5 mg) na rifampicin (600 mg otu ugboro kwa ụbọchị na lowers)._max na AUC nke saxagliptin site na 53% na 76%, otu, na mmụba kwekọrọ na C_max(39%), mana enweghị mgbanwe dị ukwuu na AUC nke metabolite na-arụ ọrụ.

Omeprazole: Jikọtara otutu ojiji nke saxagliptin na dose nke 10 mg otu ugboro n'ụbọchị na omeprazole na dose nke 40 mg, mkpụrụ nke isoenzyme CYP2C19 (siri ike) na isoenzyme CYP3A4 (adịghị ike), onye na-egbochi CenP2C19 isoenzyme CYP2C19 na inducer MRP-3, noglọọdụ adịghị.

Aluminom hydroxide + magnesium hydroxide + simethicone: Ihe jikọtara ọnụ nke otu onodu ziri ezi nke saxagliptin (10 mg) na nkwusioru nke nwere hydro hydro hydroide (2400 mg), magnesium hydroxide (2400 mg) na simethicone (240 mg) lowers C._max saxagliptin na 26%, agbanyeghị saxagliptin AUC anaghị agbanwe.

Umuaka: Singlenara otu onodu ogwu zirigliptin (10 mg) awa 3 mgbe otu ọgwụ famotidine (40 mg), onye na - egbochi hOCT-1, hOCT-2, na hOCT-3, na - abawanye C_max saxagliptin site na 14%, agbanyeghị, saucagliptin AUC anaghị agbanwe agbanwe.

Usoro ahịa ọgwụ ahịa

Ogwu gi bu ogwu.

Usoro na ọnọdụ nchekwa

Mgbe okpomọkụ adịghị karịa 30 Celsius. Ekwela ka ụmụaka ghara iru ya. Ndụ shelf bụ afọ 3.

N'iji ọgwụ Combogliz ogologo oge naanị dị ka dọkịta si kwuo, a na-enye ntụziaka ahụ maka akwụkwọ!

Leasedị mwepụta, ihe mejupụtara na nkwakọ

A na enweta ya na uzo ato nke ihe ndi mejuputara (mg):

metformin - 1000, saxagliptin - 2.5,
metformin - 1000, saxagliptin - 5.0,
metformin - 500, saxagliptin - 5.0.

Ihe mgbakwunye gụnyere:

stereta magnesium,
carmonlose sodium
hypromellose.

E nwere mbadamba 7 na chara acha, na ngwungwu kaadiboodu nke nwere ikike mbu ụzọ enwere ike ịnweta blisters 4 ma ọ bụ 8.

Omume ọgwụ

Mbadamba ụrọ tinyere ihe ejiri ya mee, weputara ndọghachi na ọdịnaya ihe eji arụ ọrụ abụọ na-emeju ibe ha.

Metformin bụ biguanide. Ọ na - egbochi gluconeogenesis, na - egbochi ọzịza nke abụba ma mee ka uche nke ndị nnabata banye na insulin. A na - emekwa ka itinye glucose sel arụ ọrụ. Akụkụ ahụ anaghị emetụta ọdịnaya nke insulin n’ime ọbara n’onwe ya, anaghị akpata hypoglycemia. Ọ na-akpali njikọ nke glycogen. Mmụba glucose na-aba ụba n’ihi ikpughe sel. Ọzọkwa, ihe ahụ nwere ike belata ọnụego nnabata shuga na eriri afọ, n'ihi nke enwere ike ịbelata oke. Nwere ike melite ụfọdụ Njirimara nke ọbara.

Saxagliptin na - eme ka ntọhapụ nke homonụ akọwapụtara - incretins. Ha na - akwalite mwepụta nke insulin na mkpụrụ ndụ beta nke pancreas ma belata mmepụta glucagon n'ime ya. Ike nke saxagliptin bụ iji belata ọkwa gluu na afọ na nri.Na mgbakwunye, ntọhapụ nke afọ na-egbochi, nke mere na a na-enweta nsonaazụ ogologo oge. Ọ na - enye aka na oke ibu na ndị ọrịa mamịrị.

N'ihi nnweghari gbanwetụrụ, belata ihe ndị dị n’akụkụ akwara na-ebelata.

Ihe ngbanwe

Hypersensitivity na mmiri,
A akụkọ ihe mere eme nke anaphylactic ujo,
Ọrịa shuga 1dị 1
Lactose anabataghị,
Ọgwụ insulin
Ime nyocha jiri ihe ayodiin ayodiin (ihe ruru awa iri asatọ na asatọ tupu ma abali).
Ọrịa akụrụngwa na arụ ọrụ,
Ọrịa, ọrịa na-efe efe,
Ọrịa mamịrị ketoacidosis
A akụkọ ihe mere eme nke coma
Ihe ọghọm nke hypoxia anụ ahụ,
Akụkọ ihe mere eme nke lactic acidosis,
Nri kalori
Ime na lactation
N’agbata afọ 18
Alcoholism

Ntụziaka maka ojiji (usoro na usoro onunu ogwu)

Ahoputara ya n’otu n’otu n’ime ihe akaebe.

Were oge 1 n’otu oge n’otu oge. Ekwesighi igwu shei ahụ, ebe nke a na-emetụta ọnụego ntọhapụ. Na-a plentyụ mmiri buru ibu.

Usoro ọgwụgwọ malitere mbadamba 500 + 2.5 mg, mgbe ahụ enwere ike ịbawanye 1000 + 5 mg. Oke - 2000 + 5 mg. Jiri nwayọ bulie ogwu ahụ iji belata nsonaazụ achọghị.

Ọ bụrụ na tupu nke a, a na-agwọ onye ọrịa ahụ na ndị nwere ihe ndị a, mana iche, a na-ahọpụta usoro ahụ dabere na nke gara aga. Emebeghị ka elele nsonaazụ ahụ dị na ntughari sitere na ọgwụ hypoglycemic ndị ọzọ na ọgwụ a.

Nsonaazụ

Isi ọwụwa, isi ọwụwa,
Ọrịa ọnya mkpụrụ ndụ
Ihe mgbu
Ọrịa Sinusitis
Ogbugbu na vomiting
Ọrịa afọ ọsịsa
Uwe
Hypoglycemia (site na saxagliptin),
Urticaria,
Thrombocytopenia
Mmeghachi omume nfụkasị ahụ
Nasopharyngitis,
Ọrịa mamịrị
Ọrịa mgbu
Ọrịa ire ụtọ
Ire.

A ga-ewepụ ha ma ọ bụ site n'ịgbanwe usoro ahụ, ma ọ bụ ịkwụsị ịkwụsị ọgwụ.

Dodoụbiga ya ókè

Ọ bụrụ na ụkpụrụ gafere, lactic acidosis nwere ike ime. Nke a bụ nnukwu ihe nsonaazụ - ya bụ ọnwụ. Ọ bụrụ na enwere obi abụọ ọ bụla banyere mmepe ya, e kwesịrị ilebara onye ọrịa n'ụlọ ọgwụ. Thelọ ọgwụ ahụ nyere iwu maka ọgwụgwọ ịba ahụ na usoro ọgwụgwọ Symptomatic.

myalgia
okuku ume iku ume
ịmụba iro ụra
mgbu afọ
isi acetone si n'ọnụ ya.

Mgbe ị na-a drugsụ ọgwụ ndị ọzọ, karịsịa dabere na sulfonylurea, ihe ize ndụ nke hypoglycemia na-abawanye. Ihe omuma ya: adighi ike, pallor nke akpukpo aru, nsogbu nke aru (rue ihe), agu, iwe na ndi ozo. Mpempe dị mfe na-ewepụ oriri dị ụtọ. Na-agbanwe agbanwe ma dị njọ - ntụtụ nke glucagon ma ọ bụ ihe ndozi dextrose. Ọ dị mkpa iweta mmadụ ịmara, wee gakwuru dọkịta maka mgbanwe ịsụ ọgwụ.

Mkparịta ụka ọgwụ ọjọọ

Enweekwu ihe maka arụmọrụ akụrụngwa:

aluminium hydroxide,
pioglitazone
magnesium hydroxide,
rifampicin
GKS,
nicotinic acid
simethicone
estrogens
thiazide diuretics,
homonụ thyroid
isoniazid
umuaka,
ihe ndapụta
nnabata ọmiko
na - egbochi ọnụnọ calcium ngwa ngwa.

Belata arụmọrụ bekee:

diltiazem
fluconazole
amprenavir
verapamil
erythromycin
ketoconazole,
aprepitant
glibenclamide,
eji eme ugba mmuo
ihe ọ juiceụpeụ mkpụrụ osisi grape
famotidine
dịpụrụ adịpụ CYP3A4 / 5,
furosemide
nkwadebe cationic
nifedipine
ethanol.

Dọkịta na-aga ahụ kwesịrị ịma banyere ọgwụgwọ ya na ọgwụ ndị a mgbe ọ na-ede ọgwụ.

Ntụziaka pụrụ iche

Ebe ọ bụ na akịrị ahụ na-amịpụta ọgwụ nke akụrụ, a na-atụ aro ka ị na-eme nyocha mgbe niile ma nyochaa ọnọdụ ha iji gbochie nsogbu. Nke a bụ eziokwu karịsịa nye ndị agadi.

N'ime ndị ọrịa mgbe afọ 60 gasịrị, lactic acidosis na-apụta ọtụtụ mgbe. Achọrọ nlekọta site n'aka onye ọkachamara.

Ohere nke ịmalite ọrịa pancreatitis na-abawanye. Ihe mgbaàmà bụ isi, mgbu dị n’afọ.

Onye ọrịa ahụ kwesịrị ịmata mgbaàmà nke mmetụta ndị ọ na-enwe ma nwee ike ịnye enyemaka mbụ.

Ọ bụrụ na ọ dị mkpa, a na-ebufe usoro ịwa ahụ mmadụ na insulin.

Emebeghị nnyocha emere na nsonaazụ ikike nke ịnya ụgbọ. Agbanyeghị, na ijikọtara ọgwụgwọ, ekwesiri icheta ihe ize ndụ nke hypoglycemia. Saxagliptin nwekwara ike ibute isi ọwụwa na migraine. Mkpebi banyere ịnwe ike ịnya ụgbọ ala ma ọ bụ iji ihe eji arụ ọrụ arụ ọrụ bụ ọkachamara.

Tụnyere ihe analogues

Ọgwụ a nwere ọtụtụ ụtụ maka ihe mepụtara na akụrụngwa. Ọ ga-aba uru ịmara onwe gị na ha.

"Yanumet." Ọnụahịa - site na 2830 rubles maka mbadamba 56. Ngwakọta ahụ gụnyere metformin na sitagliptin. Na-emepụta ụlọ ọrụ Merck Sharp na Dome, USA. Enwere ike iji ya mee ihe na njikọta insulin, agbanyeghị, ọtụtụ mmetụta na contraindications. Edebela umu aka na ndi di ime. Ọtụtụ na-ede na ọgwụ ngwa ngwa belata ibu.

Galvus Met. Akwụ ụgwọ - 1500 rubles na n'elu. Nwere metformin na vildagliptin. Onye na - emepụta ihe - "Novartis", Switzerland. Ọ dị ọnụ ala karịa, ọ bụ ezie na ihe ndị dị na ya adịchaghị iche na “Comboglize”. Ndepụta nke contraindications yiri.

"Sobo Xr." Ọ nwere ihe mebere. Ndi ụlọ ọrụ AstraZeneca, Great Britain na-enye iwu. Erere ga-eri 1650 rubles n'otu mkpọ. Agbakwunyere ihe mmebe kachasị na Njirimara. Niile mmetụta na contraindications bụ otu.

Glibomet. Medicine nke ụlọ ọrụ "Berlin Chemie", Germany. Ọnụahịa - 350 rubles kwa ngwugwu. Ihe eji eme ihe - glibenclamide na metformin. Odighi nma maka onye obula. Ọtụtụ mmachi iji.

Bagomet. Mbadamba ụrọ nwere Metformin na glibenclamide. Ọnụahịa - site na 160 rubles. Ha nwere ogologo ọrụ, nke ụlọ ọrụ Chemistry Montpellier, Argentina mepụtara. Ihe kacha gbakwunye bụ ọnụ ala dị ala na njiri akụ ndị yiri ya. Contraindications yikwara.

Mkpebi ịgbanwe ọgwụ ọzọ bụ nke dọkịta. Amachibidoro ị medicationụ onwe gị ọgwụ!

Otutu enwere echiche oma banyere ogwu. Nanị ihe na-adịghị mma bụ ọnụ ahịa dị elu. Na nyocha a ka ekwuputara na ndi mere tupu metformin a ma atụnyere steeti gara aga nwere mmetụta dị ntakịrị. A na-ahụta ịta ahụ na-adịgide adịgide, mana naanị na nri.

Victor: “Ejiri m mbadamba metformin ruo ọtụtụ afọ. Ha kwụsịrị inye mmetụta ha chọrọ, dọkịta ahụ nyere iwu nchịkọta a “Combogliz Prolong”. Ihe m masịrị: ngwa ngwa na-enye nsonaazụ, naanị oneụọ otu mbadamba ụbọchị. Na-edobe ogo na shuga dị ala. Ihe m na-enweghị mmasị: enwere nsonaazụ, ọkachasị ma ọ bụrụ na ị mebie nri. Ọ na-enye aka nke ukwuu, n'agbanyeghị na ọ na-efu nnukwu ego. ”

Alexandra: “Abụ m onye ọrịa shuga nwere ọtụtụ ahụmahụ. N’oge na-adịbeghị anya, m na-eji naanị ọgwụ ọrịre. Ugbu a, m na-anabata Combogliz Prolong. Ọgwụ dị mma, enweghị m mmetụta ọ bụla. Ọ dị mma na oriri nnabata, ọnụahịa / ogo ruru m dabara kpamkpam. "

Mmechi

Ọgwụ a na-adị oke mma. Site na njirimara nke ntọhapụ, ọ na - enyere aka izere mmepe nke nsogbu na eriri afọ. Nyocha sitere n'aka ndị ọrụ ọgwụ ọjọọ na ndị ọkachamara na-akacha mma. Nanị ihe na-adịghị mma bụ ọnụ ahịa dị elu na mkpa iji nye iwu n'ụlọ ahịa ọgwụ. Ma ọ bụghị ya, ọ bụ ezigbo ọgwụ maka ọrịa shuga.

Ofzọ nke ngwa

Maka ndị okenye: Ana m eji ọnụ otu oge / ụbọchị n'oge nri abalị. Ekwesịrị ịhọrọ dose ahụ n'otu n'otu.
Dị ka ọ na -eme, na usoro ọgwụgwọ ngwakọta nwere saxagliptin na metformin, dose nke saxagliptin bụ 5 mg 1 oge / ụbọchị. Zọ akwadoro usoro ọgwụgwọ metformin gbanwere na-abụ 500 mg 1 oge / ụbọchị, enwere ike ịbawanye ya na 2000 mg 1 oge / ụbọchị.
A na-amụba dose nke metformin iji belata ihe ize ndụ nke mmetụta ndị sitere na eriri afọ.
Obere kachasị kwa ụbọchị: saxagliptin 5 mg na mepụtara metformin 2000 mg gbanwee.

- elldị ọrịa shuga abụọ nke mellitus jikọtara ya na nri na mmega ahụ iji melite njikwa glycemic.

Usoro onunu ogwu:

Otu mbadamba ihe eji etinye fim eji wepụta ya

1000 mg + 2.5 mg nwere.

Bekee arụ ọrụ: metformin hydrochloride 1000 mg + saxagliptin 2.5 mg

Isi nke mbadamba: metformin hydrochloride agwakọta na 0,5% magnesium stearate 1005.0 mg (1000.0 mg metformin hydrochloride + 5.0 mg magnesium stearate), sodium carmellose 50.0 mg, hypromellose 2208 393.0 mg, magnesium stearate 2.0 mg

akwa oyi akwa nke shei mkpuchi (nchebe): Opadry II ọcha (% m / m) 130.5 mg polyvinyl mmanya obere hydrolyzed 40,00%, titanium dioxide 25,00%, macrogol 3350 20.20%, talc 14.80%, 1 M ngwọta nke hydrochloric acid ka pH 2 , 0 ± 0.3 *,

akwa nke abụọ nke shei mkpuchi (arụ ọrụ): saxagliptin 2.5 mg, Opadray II white 20.0 mg, 1 M ngwọta nke hydrochloric acid to pH 2.0 ± 0.3 *,

ihe nkiri ịkpụ (akwa nke atọ nke mkpuchi (agba)): Opadry II odo (% m / m) 48.0 mg polyvinyl mmanya obere hydrolyzed 40,00%, titanium dioxide 24.25%, macrogol 3350 20,20%, talc 14.80%, aja aja oxide odo 0.75% , 1 M ngwọta nke hydrochloric acid ka pH 2.0 ± 0.3 *,

ink maka ide ihe: ink Opacode acha anụnụ anụnụ ** (% m / m) 0.03 mg indigo carmine aluminom varnish 16.00%, shellac

45% (20% agbasawara) na ethanol 55.40%, butanol 15.00%, propylene glycol 10.50%, isopropanol 3.00%, 28% ngwọta nke ammonium hydroxide 0.10%.

Otu mbadamba 500-mg + 5 mg ihe nkiri nwere.

Bekee arụ ọrụ: metformin hydrochloride 500 mg + saxagliptin 5 mg

Isi nke mbadamba: metformin hydrochloride na ngwakọta na 0,5% magnesium stearate 502.5 mg (500.0 mg metformin hydrochloride + 2.5 mg magnesium stearate), sodium carmellose 50.0 mg, hypromellose 2208 358.0 mg, hypromellose 2910 10.0 mg, microcrystalline cellulose 102.0 mg, magnesium stearate 1.0 mg,

akwa oyi akwa nke shei mkpuchi (nchebe): Opadry II ọcha (% m / m) 99.0 mg polyvinyl mmanya obere hydrolyzed 40,00%, titanium dioxide 25,00%, macrogol 3350 20.20%, talc 14.80%, 1 M ngwọta nke hydrochloric acid ka pH 2 , 0 ± 0.3 *, bi nke oyi akwa nke mkpuchi (arụ ọrụ): saxagliptin 5.0 mg, Opadry II white 20.0 mg, 1 M ngwọta nke hydrochloric acid to pH 2.0 ± 0.3 *,

ihe nkiri ịkpụ (akwa nke atọ nke mkpuchi (agba)): Opadry II tawny (% m / m) 33.0 mg polyvinyl mmanya obere hydrolyzed 40,00%, macrogol 3350 20,20%, titanium dioxide 19.58%, talc 14.80%, acha odo odo oxide odo 5, 00% na dye iron oxide red 0.42%, 1 M ngwọta nke hydrochloric acid ka pH 2.0 ± 0.3 *,

ink maka ide ihe: ink Opacode acha anụnụ anụnụ ** (% m / m) 0.03 mg indigo carmine aluminom varnish 16.00%, shellac

45% (20% agbasawara) na ethanol 55.40%, butanol 15.00%, propylene glycol 10.50%, isopropanol 3.00%, 28% ngwọta nke ammonium hydroxide 0.10%.

Otu mbadamba prọfesọ 1000 + 5 mg nwere:

Bekee arụ ọrụ: hydrochloride 1000 mg + saxagliptin 5 mg Isi nke mbadamba: metformin hydrochloride agwakọta na 0,5% magnesium stearate 1005.0 mg (1000.0 mg metformin hydrochloride + 5.0 mg magnesium stearate), sodium carmellose 50.0 mg, hypromellose 2208 393.0 mg, magnesium stearate 2.0 mg

akwa nke abụọ nke shei mkpuchi (arụ ọrụ): saxagliptin 5.0 mg, Opadry II white 20.0 mg, 1 M hydrochloric acid solution to pH 2.0 ± 0.3 *,

ihe nkiri ịkpụ (akwa nke atọ nke mkpuchi (agba)): Opadry II pink (% m / m) 48.0 mg polyvinyl mmanya obere hydrolyzed 40,00%, titanium dioxide 24.25%, macrogol 3350 20,20%, talc 14.80%, mmiri igwe na-acha ọbara ọbara 0.75% , 1 M ngwọta nke hydrochloric acid ka pH 2.0 ± 0.3 *,

ink maka ide ihe: ink Opacode acha anụnụ anụnụ ** (% m / m) 0.03 mg indigo carmine aluminom varnish 16.00%, shellac

45% (20% agbasawara) na ethanol 55.40%, butanol 15.00%, propylene glycol 10.50%, isopropanol 3.00%, 28% ngwọta nke ammonium hydroxide 0.10%.

* Ọ bụrụ na ọ dị mkpa, enwere ike iji 1 M sodium hydroxide mee ihe iji dozie pH.
** Ọ bụrụ na ọ dị mkpa, a na-agbakwunye mmanya isopropanol na ink mgbe ha na-edenye akara. Ọnọdụ nke eterem aluminom varnish na shellac ka dị na mbadamba nkume ndị ahụ mgbe edepụtara ya. A na-ewepụ solvent ndị dị na ink ink n'oge mmepụta n'oge ihicha.

Mbadamba 1000 mg + 2.5 mg:

Mbadamba ụrọ biconvex nke chachiri acha, nke a kpụrụ akpụ site na paịlị na-acha odo odo ka ọ na-acha odo odo na agba, yana okwu "2.5 / 1000" n'otu akụkụ yana "4222" n'akụkụ nke ọzọ, na-acha anụnụ anụnụ.

Mpempe 500 mg + 5 mg:
Mbadamba ụrọ biconvex nke chachiri acha, nke a kpụrụ site na aja aja na aja aja na aja aja, yana okwu "5/500" n'otu akụkụ yana "4221" n'akụkụ nke ọzọ, na-acha anụnụ anụnụ.

Mbadamba 1000 mg + 5 mg:
Mbadamba biconvex nke Capsule gbara okpu, kpuchie ya na mpempe akwụkwọ pink, na okwu "5/1000" n'otu akụkụ yana "4223" n'akụkụ nke ọzọ, na-acha anụnụ anụnụ.

NKWUKWU PHARMACOLOGIC

Mlọ ọgwụ

Usoro nke ime ihe
Combogliz Prolong® na-ejikọta ọgwụ hypoglycemic abụọ na usoro mmeju iji meziwanye njikwa glycemic na ndị ọrịa nwere ụdị ọrịa shuga 2 (T2DM): saxagliptin, dipeptidyl peptidase 4 inhibitor (DPP-4), na metformin, onye nnọchite anya klas biguanide.

Saxagliptin
Na nzaghachi banyere nri oriri site na obere eriri afọ, a na-ahapụ homonụ nke nwere ọbara n'ọbara, dị ka gluptagon-peptide-1 (GLP-1) na glucose na-adabere insulinotropic polypeptide (HIP). Homonụ ndị a na - akwalite mwepụta nke insulin n'ahụ mkpụrụ ndụ beta nke pancreatic, dabere na ntinye glucose n'ọbara, mana enzyme DPP-4 na - arụ ọrụ n'ime ọtụtụ nkeji. GLP-1 na-ebelata nzuzo nke glucagon na sel Alp pancreatic, na-ebelata mmepụta glucose imeju. N'ime ndị ọrịa nwere ọrịa shuga 2, a na-ebelata mkpụkọ nke GLP-1, mana azịza insulin na GLP-1 ka dị. Saxagliptin, ịbụ onye na-egbochi DPP-4, na-ebelata mmelata nke homonụ ndị dị na ya, si otú a na-abawanye itinye uche ha na oke ọbara ma na-eduga n'ịbelata glucose na-ebu ọnụ mgbe ha risịrị nri.

Metformin
Metformin bụ ọgwụ hypoglycemic nke na-eme ka nnabata glucose dị n'etiti ndị ọrịa nwere ọrịa shuga 2, belata basal na nchịkọta glucose postprandial. Metformin na-ebelata mmepụta nke glucose site na imeju, na-ebelata nnabata nke glucose na eriri afọ ma na-abawanye njikwa insulin, na-abawanye mpaghara na ojiji nke glucose. N'adịghị ka nkwadebe nke sulfonylurea, metformin adịghị akpata hypoglycemia na ndị ọrịa nwere ọrịa shuga 2 ma ọ bụ ndị nwere ahụike (ma e wezụga n'ọnọdụ ndị pụrụ iche, lee akụkụ “ịkpachara anya” na “Ntuziaka Pụrụ Iche”), na hyperinsulinemia. N'oge usoro ọgwụgwọ metformin, mmiri ọgwụ insulin na-agbanwe agbanwe, ọ bụ ezie na insulin na-ebu ọnụ ma na-aza nri ị na-eri n'ụbọchị nwere ike ibelata.

Arụmọrụ arụmọrụ yana nchekwa

Saxagliptin N'ime ụzọ abụọ kpuru ìsì, ọnwụnwa, nke a na-achịkwa nke a na-ahụ maka ọgwụ, ndị ọrịa karịrị 17,000 natara T2DM.

Nsonaazụ obi
Ọmụmụ SAVOR (Nyocha nke Nsonaazụ Cardiovascular na Ọrịa Ọrịa Ọrịa Saxagliptin) nyochara nsonaazụ obi na 16492 nwere ndị ọrịa T2DM (12959 nwere ọrịa obi na ọrịa obi (CVD), 3533 ndị nwere ọtụtụ ihe ihe egwu dị na obi ike. nsogbu nke vaskụla) na ụkpụrụ nke 6.5% ≤ HbA1c 14 C-saxagliptin 24% nke dose ahụ ka akụrụ na-agbanwe agbanwe dịka saxagliptin na-agbanweghị na 36% dị ka isi metabolite nke saxagliptin. Ngụkọta akwara ozi hụrụ na mmamịrị ruru 75% nke ọgwụ a .ụrụ. Nkezi mkpocha ezigharịrị nke saxagliptin dị ihe dị ka 230 ml / min, uru gbachapụrụ agbacha gbacha gbacha gbata ruru 120 ml / min. Maka isi metabolite, mkpochapu akụrụ bụ ihe pụtara na uru nke ikpocha ụwa. Ihe dị ka pacenti 22% nke ikuku redio a hụrụ na feces.

Metformin
Mkpochapu ntaramahụhụ dị ihe dị ka okpukpu 3.5 karịa karịa mwepụ nke creatinine (CC), nke na-egosi na tubular secretion bụ ụzọ kachasị ewepu mmiri nke metformin.Mgbe ịwachara, ihe dịka 90% nke ọgwụ ahụ a gụrụ na-ewepụ akụrụ n’ime awa 24 mbụ, yana ọkara ndụ site na plasma nke dị ihe dị ka awa 6.2. N'ime ọbara, ọkara ndụ bụ ihe dịka awa 17.6, yabụ, ụbara ọbara ọbara nwere ike ịbụ akụkụ nke ekesa.

Pharmacokinetics n'ọnọdụ ndị pụrụ iche

Odida ntaramahụhụ
A naghị atụ aro iji Combogliz Prolong® na ndị ọrịa nwere ọdịda akwara (lee akụkụ "Contraindications").

Saxagliptin
N'ime ndị ọrịa nwere ajọ akụrụ dị obere, ogo nke AUC nke saxagliptin na metabolite na-arụ ọrụ ya bụ 20% na 70% (karị) karịa ụkpụrụ AUC na ndị ọrịa nwere ọrụ mkpo nkịtị. Ebe ọ bụ na anaghị ele ịrị elu dị ka uru ahụike anya dị ka ọgwụ, ọ naghị atụ aro imeghari ọnụọgụ nke saxagliptin na ndị ọrịa nwere ajọ akụrụ.

Metformin
N'ime ndị ọrịa nwere ọrụ mgbazinye nsogbu (dịka nsonaazụ nke QC si dị), ọkara ndụ metformin sitere na plasma na ọbara na-abawanye na mkpụkọ akwara na-agbadata n'ike n'ike na QC.

Saxagliptin
N'ime ndị ọrịa nwere ọria nkwarụ dị nro, na-agafe agafe, ọ nweghị mgbanwe dị egwu na ọgwụ ọgwụ nke saxagliptin, ya mere, a chọghị ịgbanwe mgbanwe maka ndị ọrịa dị otú ahụ.

Metformin
Enwebeghị ọmụmụ ọgwụ ọgwụ nke metformin na ndị ọrịa nwere nkwarụ hepatic.

Saxagliptin
Ndozigharị onodu saxagliptin dabere na okike ndi ọrịa adighi achoghi ya.

Metformin
N'ime ihe omumu ihe omumu nke ndi oria nke nwere oria nke abuo, ihe hypoglycemic met metinin n’etiti nwoke na nwanyi.

Saxagliptin
N'ime ndị ọrịa afọ 65-80, ọ nweghị ọdịiche dị iche iche dị na ọgwụ ọgwụ nke saxagliptin ma e jiri ya tụnyere ndị ọrịa dị obere (afọ 18-40), ya mere, achọrọ nhazigharị ọgwụgwọ na ndị ọrịa agadi. Agbanyeghị, ekwesịrị iburu n'uche na n'ụdị ndị ọrịa a, mbelata ọrụ ezumike nwere ike yikarịrị (lee akụkụ "Usoro Ọgwụ na Nchịkwa" na "Ntuziaka Pụrụ Iche").

Metformin
Enweghi oke data sitere na ihe omumu ihe omumu nke pharmacokinetics nke metformin n’ime ndi okenye n’enyemaka na-egosi na mkpochapu plasma nke metformin na-ebelata, oghachaghi ndu-ya na abawanye, na Cmax na-abawanye dika atumatu nke paramita ndia n’onodu ndi n’adighi ezi. Dabere na data ndị a, mgbanwe nke ọgwụ pharmacokinetics nke metformin na afọ na-abawanye bụ kachasị site na mgbanwe nke ọrụ akụrụ. Ekwesighi ịnye Combogliz Prolong® nke ndị ọrịa gbagoro afọ 80, belụsọ na nsonaazụ QC gosikwara ọrụ nkịtị na-akwụkarị ụgwọ.

Saxagliptin
Emebeghị nnyocha nke pharmacokinetics nke saxagliptin na ụmụaka.

Metformin
Emebeghị nnyocha banyere ọgwụ ọgwụ nke metformin gbanwee na ụmụaka.

Ọsọ na agbụrụ

Saxagliptin A naghị atụ aro ka ịhazie dose nke saxagliptin dabere n'ọsọ onye ọrịa.

Metformin
Enwebeghị nnyocha banyere ọgwụ ọgwụ nke metformin dabere na agbụrụ ndị ọrịa.

Elldị nke abụọ nke ọrịa shuga mellitus tinyere nri na mmega iji melite njikwa glycemic.

NSOGBU NIILE

Mmụba uche n'otu n'otu na akụrụngwa nke ọgwụ,
Mmeghachi omume hypersensitivity siri ike (anaphylaxis ma ọ bụ angioedema) nye ndị na-egbochi DPP-4,
1dị shuga 1 ọrịa mellitus (nke a na-amụghị)
Jiri insulin (anaghị agụ ya)
Enweghị galactose ekweghị ibe nọrọ, ụkọ lactase na glucose-galactose malabsorption,
Ime ime, lactation,
Afọ ruru afọ iri na asatọ (nchekwa na arụmọrụ amụghị),
Renrụ ọrụ akụrụngwa arụrụala (serum creatinine ≥1.5 mg / dL maka ụmụ nwoke, ≥1.4 mg / dL maka ụmụ nwanyị ma ọ bụ belata ikike nke creatinine), gụnyere ndị kpatara ọrịa obi na-akpata oke ume (ujo), nnukwu myocardial infarction na septicemia,
Ọrịa ọjọọ nke enwere nsogbu ịbawanye gbasara akụrụ: akpịrị ịkpọ nkụ (ya na ọgbụgbọ, ọgbụgbọ), ọkụ, ọrịa na-efe efe, ọnọdụ hypoxia (ujo, sepsis, ọrịa akụrụ, ọrịa bronchopulmonary).
Acidosis akwara ma ọ bụ nke na-adịghị ala ala, gụnyere ketoacidosis mamịrị, nwere ma ọ bụ na-enweghị coma
Egosiputara nke oma site na oria ojoo na nke na adighi ala ala nke nwere ike ibute mmepe nke hypoxia ahu (okuku ume, odida obi, oria myocardial acaration).
Nnukwu ịwa ahụ na mmerụ ahụ (mgbe egosipụtara ọgwụ insulin)
Ọrụ imeju na-arụ ọrụ,
Aronicụrụma na-egbu egbu na ethanol na-egbu egbu,
Lactic acidosis (gụnyere akụkọ ihe mere eme),
Oge dịkarịa ala, awa iri asatọ na asatọ tupu ma ọ bụ n'ime awa iri asatọ na asatọ ka emechara nyocha redio ma ọ bụ x-ray na ntinye nke ndị na-ewe ayodiin nwere,
Followinggbaso Nri Ahụ Kalotọ (Ndị Ọrịa Agadi
Ebe enwere saxagliptin na metformin nwere akụrụ na-apụ apụ, na ndị agadi ndị agadi nwere ike na-agbadata ọrụ gbasara akụrụ, a ga-eji Combogliz Prolong® jiri nlezianya mee ihe na ndị agadi.

Saxagliptin
Enweghị ọdịiche dị iche iche na nchekwa ma ọ bụ ịdị irè nke ọgwụ ahụ na ndị ọrịa> afọ 65,> afọ 75, na ndị ọrịa na-eto eto.
Metformin
Ihe omumu ihe omumu nke metformin agunyeghi onu ogugu zuru oke nke ndi oria iji choputa ndiiche na nzaghachi ọgwụgwọ dika ndi oria na-eto eto, n’agbanyeghi na ahu ogwu ahughi gosiputa nzaghachi di iche na ndi agadi na ndi oria. Dịka ị maara, akụrụ na-apịpụta akụrụ dị iche iche, yabụ enwere ihe ọghọm nke ịmalite ihe ọghọm dị njọ na ndị ọrịa nwere ọdịda akụrụ. Ekwesịrị ịnye Combogliz Prolong® naanị maka ndị ọrịa nwere ọrụ ezumike nkịtị. Ekwesịrị ịnye ndị ọrịa ọrịa agadi na usoro ọgwụgwọ mmezi nke metformin, na-eburu n'uche mbelata ọrụ ọrụ gbasara aha. Ọ kwesịrị ịdị nhazigharị dose ọ bụla mgbe nyochachara nke ọma gbasara ọrụ gbasara akụrụ.

A mụbeghị nchekwa na ịdị mma nke ọgwụ ahụ na ndị ọrịa na-erubeghị afọ 18.

NWAANYI EGO

Mmeghachi omume na-adịghị mma na ọmụmụ nchịkwa glycemic mgbe ejiri yasaxagliptin na monotherapy yana agbakwunye na ọgwụ ndị ọzọ

Saxagliptin
Tebụl 1 chịkọtara ihe omume ọjọọ a hụrụ n'oge ule ụlọ ọgwụ (agbanyeghị ma onye nyocha enyochapụta ihe kpatara ya) na ≥5% nke ndị ọrịa na-anata saxagliptin 5 mg, yana ọnụego dị elu karịa otu placebo, dịka nyocha jikọtara nke ọmụmụ 24 izu. .

Isiokwu 1. Ihe omume dị njọ

Saxagliptin5mgN = 882

EbeN = 799

Ọkpụkpụ akụkụ akụkụ okuku ume na-efe efe

Ọrịa ọnya na-efe efe

Ọmụmụ ihe nchịkwa 5 na-achịkwa gụnyere na nyocha a bụ ọmụmụ monotherapy abụọ na otu ọmụmụ ọgwụgwọ njikọta na mgbakwunye nke saxagliptin na metformin, thiazolidinedione ma ọ bụ glibenclamide. N'ime ndị ọrịa na-ewere saxagliptin na ọnụọgụ abụọ nke 2.5 mg, isi ọwụwa (6.5%) bụ naanị ihe omume ọjọọ nke egosipụtara na oge nke> 5%, ma topụta ọtụtụ mgbe karịa na placebo otu.

Site na otu nyocha a jikọtara ọnụ, ihe omume ọjọọ hụrụ na> 2% nke ndị ọrịa na-ewere saxagliptin na ọnụọgụ nke 2.5 mg ma ọ bụ saxagliptin na dose nke 5 mg ma na-etolite> 1% karịa karịa na placebo otu gụnyere sinusitis (2, 9% na 2.6% e jiri ya tụnyere 1.6%, n'otu aka ahụ, mgbu afọ (2.4% na 1.7% ma e jiri ya tụnyere 0,5%), eriri afọ (1.9% na 2.3 % atụnyere 0.9%) na vomiting (2.2% na 2.3% e jiri ya tụnyere 1.3%).

Ọkpụkpụ mmebi ahụ bụ 1.0 na 0.6 n'ime afọ 100 ọ bụla, n'otu oge, mgbe ị na-ewere saxagliptin (nchịkọta nchịkọta nke 2.5 mg, 5 mg na 10 mg) na placebo. Ugboro nke okpukpo na ndị ọrịa na-ewere saxagliptin amụbaghị ka oge na-aga. E guzobebeghị mmekọrịta dị n'etiti ọrịa, na nchọpụta ọmụmụ egosipụtaghị mmetụta na-adịghị mma nke saxagliptin na anụ ahụ.

N'ime mmemme ụlọọgwụ, a chọpụtara mmepe nke thrombocytopenia nke kwekọrọ na nchoputa nke idiopathic thrombocytopenic purpura. Amaghị njikọ dị n'etiti mmepe nke ihe ịtụnanya a na nchịkwa nke saxagliptin.

Ihe omume ojoo jikọtara ya na nhazi nke saxagliptin na metformin na ọgwụgwọ nke ndị ọrịa nwere ụdị shuga 2 bụ ndị na-anatabeghị ọgwụgwọ na ọmụmụ njikwa glycemic.Saxagliptin
Tebụl 2 chịkọtara ihe omume ọjọọ a hụrụ (n'agbanyeghị agbanyeghị mmekọrịta dị na onye nyocha) na ≥ 5% nke ndị ọrịa na-esonye n'ọmụmụ ihe izu 24 ọzọ yana njikwa ike nke ijikọtara ọnụ nke saxagliptin na metformin na ndị ọrịa na-enwetabeghị ọgwụgwọ.

Isiokwu 2. Ihe omume dị njọ

Otutu(%)nke ndị ọrịa

Saxagliptin5mg+metformin*N = 320

Metformin* N = 328

* O buliri ọgwụ mbu nke metformin 500 mg / ụbọchị ka ọ bụrụ ntụtụ ọgwụ nke 2000 mg / ụbọchị.

N'ime ndị ọrịa na-anata saxagliptin na mgbakwunye na usoro ọgwụgwọ metformin ma ọ bụ dịka ọgwụgwọ nkwonkwo izizi, afọ ọsịsa bụ naanị nsogbu na-emetụta ọria na etolite na ≥ 5% nke ndị ọrịa na otu ọ bụla. Ọnọdụ nke afọ ọsịsa bụ 9.9%, 5.8% na 11.2% na saxagliptin otu 2.5 mg, saxagliptin 5 mg na placebo, otu, na ọmụmụ nke mgbakwunye nke saxagliptin na metformin, ihe kpatara ọnya afọ bụ 6.9% na 7.3% n'ime ọgwụ ọgwụgwọ agwakọta na saxagliptin 5 mg na metformin na ìgwè metformin monotherapy na ọmụmụ nke usoro ọgwụgwọ izizi na metformin.

Hypoglycemia

Saxagliptin
A na - anakọta ozi banyere hypoglycemia dị ka ihe ojoo na - eme n'ihi akụkọ banyere hypoglycemia; ọ nweghị ọtụtụ ihe omimi nke glucose chọrọ. Ihe kpatara hypoglycemia site na iji saxagliptin 2.5 mg, saxagliptin 5 mg na placebo (ihe niile dị ka monotherapy) bụ 4%, 5.6% and 4.1%, karị, and 7.8%, 5.8% and 5 %, otu, na mgbakwunye nke metformin. Ọrịa hypoglycemia bụ 3.4% na ndị ọrịa na-akpabeghị ọgwụgwọ nke buru saxagliptin na dose nke 5 mg yana metformin, na 4% na ndị ọrịa na metformin monotherapy.

Mmeghachi omume hypersensitivity

Saxagliptin
Na nyocha nke ọmụmụ ise dara ogbenye, a hụrụ ihe ọjọọ ndị metụtara hypersensitivity (dịka urticaria na akụkụ ihu) na 1.5%, 1.5% na 0.4% nke ndị ọrịa na-anata saxagliptin na dose nke 2.5 mg, saxagliptin na dose 5 mg na placebo, otu. Dabere na ndị na-eme nchọpụta, ọ dịghị otu n'ime ihe ịtụnanya ndị a na ndị ọrịa na-anata saxagliptin chọrọ ụlọ ọgwụ ma ghara itinye ndụ ndị ọrịa n'ihe egwu. N'ime nyocha data a na-adịghị mma, a napụrụ otu onye ọrịa na-anabata saxagliptin n'ọmụmụ n'ihi mmepe nke urticaria juputara na ọdịdị ihu.

Ndị na-egosi ọrụ arụ ọrụ

Saxagliptin
N'ime ndị ọrịa natara saxagliptin dịka monotherapy ma ọ bụ na njikọta na metformin, enweghị mgbanwe mgbanwe dị ukwuu na ọrụ physiological gosipụtara.

Monotherapy

Metformin
Na ihe omumu a na-achịkwa nsị, ihe ndị kacha njọ mere na-egosi na> 5% nke ndị ọrịa na-anata metformin mgbanwetụ agbanweela ma na-etolite ugboro ugboro karịa ndị nọ na placebo bụ afọ ọsịsa na ọgbụgbọ / ọgbụgbọ.

Mmeghachi omume Saxagliptin dị na Ọmụmụ SAVOR

N'ime ọmụmụ SAVOR, ndị ọrịa 8240 natara saxagliptin na dose nke 2.5 mg ma ọ bụ 5 mg otu ugboro kwa ụbọchị, na ndị ọrịa 8173 natara placebo.Ogologo oge ọgwụgwọ saxagliptin, n'agbanyeghị nkwụsị ọ bụla na ọgwụgwọ, bụ afọ 1.8. N'ime ndị ọrịa 3698 (45%), oge ọgwụgwọ saxagliptin bụ afọ 2-3. Ọnọdụ ọjọọ nke ihe omumu a na otu ndị ọrịa na-ewere saxagliptin (72.5%) bụ ihe atụ nke ajọ ihe mere na placebo otu (72.2%).

Ugboro nke ịkwụsị ịgwọ ọrịa n'ihi ihe omume dị njọ bụ ihe yiri ya na ndị ọrịa na-ewere saxagliptin (4.9%) na placebo (5%). Ọmụmụ ihe SAVOR tụlere nsonazụ saxagliptin na nsogbu nke nsogbu akwara. Achọpụtaghị saxagliptin na ọgwụgwọ ka ọ nwekwuo ihe egwu nsogbu nsogbu obi (dịka ọnụọgụ obi, infarction nonyoalal ischemic) na ndị ọrịa nwere T2DM ma e jiri ya tụnyere placebo (RR 1.00, 95% CI 0, 89, 1.12, P nke zuru oke nke lymphocytes

Saxagliptin
Mgbe ị na-eji saxagliptin, a na-achọpụta mbelata nke na-agbadata ọnụego nke lymphocytes zuru oke. Mgbe ị na-enyocha data jikọtara ọnụ nke izu iri abụọ na anọ, izu ọmụmụ na-achịkwa ọgwụ, mbelata nke ihe dị ka mkpụrụ ndụ 100 na 120 / nke ọnụ ọgụgụ zuru oke nke lymphocytes site na mkpụrụ ndụ mbụ nke mkpụrụ ndụ 2200 / μl ka aminagliptin dị na 5 mg na 10 mg, n'otu n'otu, jiri ya tụnyere placebo. . A hụrụ mmetụta yiri nke ahụ mgbe ị na-ewere saxagliptin na dose nke 5 mg na njikọta mbụ na metformin ma e jiri ya tụnyere metformin monotherapy. Enweghị ọdịiche dị n'etiti 2.5 mg saxagliptin na placebo. Ọgụ ndị ọrịa nọ na ọnụọgụ nke lymphocytes bụ cells 750 sel / μl bụ 0,5%, 1.5%, 1.4%, na 0.4% n'ime otu ndị na-agwọ ọgwụ saxagliptin na dose nke 2.5 mg, na dose nke 5 mg , na onodi ogwu nke 10 mg na placebo, n’otu n’otu. N'ọtụtụ n'ime ndị ọrịa na iji ugboro ugboro nke saxagliptin, enweghị nlọghachi ọ bụla, ọ bụ ezie na ụfọdụ ndị ọrịa ọnụ ọgụgụ lymphocytes belatara ọzọ na ịmaliteghachi usoro ọgwụgwọ na saxagliptin, nke dugara na mkpocha nke saxagliptin. Nsonye nke ọnụọgụ nke lymphocytes esoghị ihe ngosi ọgwụgwọ.

N'ime ọmụmụ SAVOR, a hụrụ mbelata ọnụ ọgụgụ nke lymphocytes n'olu saxagliptin na 0,5% nke ndị ọrịa, na otu placebo - na 0.4% nke ndị ọrịa.

Saxagliptin
Saxagliptin enweghị mmetụta dị omimi ma ọ bụ usoro ịtụle na platelet na mpịakọta abụọ kpara ìsì, na-achịkwa nchekwa na nchekwa.

Ntinye vitamin B12

Na nyocha ọgwụ gbasara metformin dị izu iri abụọ na iteghete, ihe dịka 7% ndị ọrịa gosipụtara mbelata ọghọm nke mbụ karịa mkpokọta vitamin B12 nkịtị ka enweghị ngosipụta ọgwụgwọ. Agbanyeghị, ụdị mbelata na-esikarị ike yana anaemia na agbake ngwa ngwa mgbe ịkwụsịsịrị metformin ma ọ bụ nweta vitamin B12 ọzọ.

OGBONA

Site na iji ọgwụ a ogologo oge na usoro onunu ogwu ruo ugboro iri asatọ karịa ka a tụrụ aro ya, akọwaghị ihe mgbaàmà nke ịxụ mmanya.

Metformin
Enweela ọtụtụ ikpe nke oke overformin nke metformin, gụnyere iwere ihe karịrị 50 g. Hypoglycemia bilitere na ihe dịka 10% nke ikpe, mana enweghị ntọala mmekọrịta ya na metformin. Na 32% nke oke oke nke metformin, ndị ọrịa nwere lactic acidosis. A na-ewepụta Metformin n'oge akụrụngwa, ebe mkpochasị ahụ ruru 170 ml / min.

NWAANYI NA EGO NA OBURU NA UMO EGO NA IME N’AKA

Saxagliptin metabolism bụ ihe cytochrome P450 3A4 / 5 isoenzyme sistemụ na-emegharị ya. Nnyocha ọmụmụ in vitro egosila na saxagliptin na metabolite ya bụ isi anaghị egbochi CYP1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 na 3A4 isoenzymes ma ghara ịbanye CYP1A2, 2B6, 2C9, na 3A4 isoenzymes. Ya mere, mmetụta saxagliptin na mkpochapụ metabolic nke ọgwụ na metabolism nke isoenzymes ndị a na-etinye na ya adịghị atụ anya mgbe ejikọtara ha ọnụ. Saxagliptin abụghị ihe mgbochi dị mkpa ma ọ bụ wepụta P-gp.

Metformin
Drugsfọdụ ọgwụ na-abawanye hyperglycemia (thiazide na ọgwụ ndị ọzọ, glucocorticosteroids, phenothiazines, nkwadebe nke iodine-nwere homonụ thyroid, estrogens, ọgwụ mgbochi, phenytoin, nicotinic acid, sympathomimetik, ngwa ngwa ndị na-egbochi calcium channel and isoniazid). Mgbe ị na-edepụta ma ọ bụ kagbuo ọgwụ ndị dị otú a na onye ọrịa na-ewere Combogliz Prolong®, a ga-eji nlezianya nyochaa nchịkọta glucose ọbara. Ogo nke ijikota metformin na protein plasma ọbara dị obere, yabụ enweghị atụ na ọ ga-emekọrịta ọgwụ nke agbadobere na protein ndị na-enye plasma, dịka salicylates, sulfonamides, chloramphenicol na probenecid (nke dị iche na usoro sulfonylurea, nke a na-ejikọ ọnụ ya na protein ndi).

Induction nke isoenzymes CYP3A4 / 5

Saxagliptin
Rifampicin na-ebelata mkpughe nke saxagliptin n'ebughị agbanwe AUC nke metabolite na-arụ ọrụ, 5-hydroxy-saxagliptin. Rifampicin anaghị emetụta mgbochi nke DPP-4 na plasma ọbara n'oge nkeji 24 nke ọgwụgwọ.

CYP3A4 / 5 Isoenzyme Ndị Inhibitors

Saxagliptin
Diltiazem kwalitere mmetụta nke saxagliptin mgbe ejikọtara ọnụ. Mmụba na ịta nke saxagliptin na plasma ọbara na-atụ anya site na iji amprenavir, aprepitant, erythromycin, fluconazole, fosamprenavir, grape mkpụrụ osisi na verapamil, agbanyeghị, a gaghị atụ aro ọgwụ ziriagli.

Ketoconazole na-eme ka mmụba nke saxagliptin dị na plasma dị elu. A na-atụ anya mmụba dị ukwuu na mkpokọ nke saxagliptin na plasma ọbara mgbe a na-eji ndị mgbochi ndị ọzọ ike CYP3A4 / 5 iche (dịka ọmụmaatụ, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir). Mgbe ejikọtara ya na ihe mgbochi siri ike nke CYP3A4 / 5 isoenzymes, a ga-ebelata ọgwụ nke saxagliptin na 2.5 mg.

Metformin
Ọgwụ cationic (dịka ọmụmaatụ, amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamteren, trimethoprim ma ọ bụ vancomycin), nke akụrụ na-agbanye site na nzacha zuru ụwa ọnụ, nwere ike iji usoro mmekọrịta mezigharị metformin, na-asọ mpi maka sistemụ ebugharị ebugharị ebugharị niile. Na omumu ihe banyere nmekorita ogwu nke metformin na cimetidine nwere otu ugboro ma obukwa ochichi ogwu, a choputara metformin na cimetidine mgbe ejiri okwu nlebara anya mee ya na ndi n’enyemaka, na-abawanye 60% na ntinye uche nke metformin na plasma na obara zuru oke na 40% na AUC nke metformin na plasma na dum ọbara. N'oge ọmụmụ otu ọgwụ ọgwụ ọjọọ, ọ nweghị mgbanwe na ọkara ndụ. Metformin emetụtaghị ọgwụ ọgwụ nke cimetidine. Ọ na-atụ aro iji nlezianya nyochaa ndị ọrịa na, ọ bụrụ na ọ dị mkpa, dozie dose ahụ na ndị ọrịa na-a cụ ọgwụ cationic nke ewepụrụ site na sistemụ akwara proalimal renal tubule.

Metformin
Na omumu ihe banyere nmekorita ya na otu uzo ogwu a na ndi oria di oria abuo, ijikota metformin na glibenclamide emetutaghi pharmacokinetics ma obu pharmacodynamics.

Metformin
Na nyocha nke mmekorita ọgwụ nke metformin na furosemide nwere otu ọgwụ ọgwụ, nke emere na ndị ọrụ afọ ofufo nwere ahụ ike, ekpughere nkwukọrịta ọgwụ ha. Furosemide na-abawanye Cmax nke metformin na plasma na ọbara site na 22% na AUC n'ọbara site na 15% na-enweghị mgbanwe dị ukwuu na mkpochapu akwara nke metformin. Mgbe ejikọtara ya na metformin, Cmax na AUC nke furosemide belatara site na 31% na 12%, otu ọ bụla, ọkara ndụ ga-eji 32% belata na enweghị mgbanwe pụtara ìhè na mkpochapu aha nke furosemide. Enweghị data na mmekọrịta nke metformin na furosemide yana ijikọ ogologo oge.

Metformin
Na nyocha nke mmekorita ọgwụ nke metformin na nifedipine na otu ọgwụ, nke a rụrụ site na ntinye ndị ọrụ afọ ofufo nwere ahụ ike, nifedipine na-abawanye Cmax nke plasma metformin site na 20% na AUC site na 9%, ma na-abawanye mkpụmkpụ site na akụrụ. Tmax na iwepu ọkara ndụ agbanweghị. Nifedipine na-abawanye nnabata nke metformin. Metformin nwere ihe fọrọ nke nta ka ọ bụrụ na ọ nweghị ọgwụ na ọgwụ ọgwụ nifedipine.

Saxagliptin na Metformin
Combinedjikọ ọnụ nke otu onunu ogwu nke saxagliptin (100 mg) na metformin (1000 mg) emetụtaghị ọgwụ pharmacokinetics nke saxagliptin ma ọ bụ metformin na ndị ọrụ afọ ofufo ahụike. Enweghị ọmụmụ ọgwụ pụrụ iche nke mmekọrịta ọgwụ na Combogliz Prolong® emebeghị, ọ bụ ezie na etinyere ụdị ọmụmụ ahụ ya na otu nke ya: saxagliptin na metformin.

Mmetụta nke ọgwụ ndị ọzọ na saxagliptin

Glibenclamide: Otu ejikọtara ọnụ nke saxagliptin (10 mg) na glibenclamide (5 mg), mkpụrụ nke CYP2C9 isoenzyme, mụbara Cmax nke saxagliptin site na 8%, mana AUC nke saxagliptin agbanweghị.
Pioglitazone: Njikọtara ugboro ugboro maka saxagliptin otu ugboro n'ụbọchị (10 mg) na pioglitazone (45 mg), mkpụrụ nke isoenzyme CYP2C8 (siri ike) na CYP3A4 (adịghị ike), anaghị emetụta ọgwụ pharmokokinetics nke saxagliptin.
Digoxin: Njikọtara ugboro ugboro maka saxagliptin otu ugboro n'ụbọchị (10 mg) na digoxin (0.25 mg), mkpụrụ nke P-glycoprotein, anaghị emetụta ọgwụ pharmokokinetics nke saxagliptin.
Simvastatin: Ihe jikọtara ugboro ugboro iji saxagliptin otu ugboro n'ụbọchị (10 mg) na simvastatin (40 mg), mkpụrụ nke CYP3A4 / 5 isoenzymes, mụbara stax nke saxagliptin na 21%, mana AUC nke saxagliptin agbanweghị.
Diltiazem: Ihe ijikọtara ọnụ nke saxagliptin (10 mg) na diltiazem (360 mg ogologo oge onodu ogwu na nguzozi), inhibzigharị nke CYP3A4 / 5, na-abawanye stax nke saxagliptin site na 63%, na AUC site na oge 2.1. Nke a na-esobelata mgbakwunye na Stax na AUC nke metabolite na-arụ ọrụ site na 44% na 36%, otu.
Ketoconazole: Ihe jikọtara ọnụ nke otu mkpụrụ ego nke saxagliptin (100 mg) na ketoconazole (200 mg kwa elekere 12 ọ bụla na mgbakwunye) na-abawanye Stax na AUC nke saxagliptin 2.4 na 3.7 ugboro. Nke a na-esobelata mgbakwunye na Stax na AUC nke metabolite nọ n'ọrụ site na 96% na 90%, n'otu n'otu.
Rifampicin: Ihe jikọtara ọnụ na iji mkpụrụ ndụ nke saxagliptin (5 mg) na rifampicin (600 mg otu ugboro kwa ụbọchị na ibelata) belata Stax na AUC nke saxagliptin site na 53% na 76%, n'otu n'otu, na mmụba kwekọrọ na Stax (39%), mana enweghị nnukwu mgbanwe na AUC metabolite nọ n'ọrụ.
Omeprazole: Jikọtara otutu ojiji nke saxagliptin na dose nke 10 mg otu ugboro n'ụbọchị na omeprazole na dose nke 40 mg, mkpụrụ nke isoenzyme CYP2C19 (siri ike) yana isoenzyme CYP3A4 (adịghị ike), onye na-egbochi CenP2C19 isoenzyme CYP2C19 na inducer MRP-3, peeji adịghị emetụta ọgwụ ahụ.

Aluminom hydroxide + magnesium hydroxide + simethicone:
Combinedjikọtara ọnụ iji mkpụrụ ego nke saxagliptin (10 mg) yana nkwusioru nwere hydro hydro hydroide (2400 mg), magnesium hydroxide (2400 mg) na simethicone (240 mg) belata Stax nke saxagliptin na 26%, agbanyeghị, saxagliptin AUC anaghị agbanwe.

Umuaka: Singlenweta otu usoro onodu saxagliptin (10 mg) 3 awa mgbe otu famotidine (40 mg), onye na-egbochi hOCT-1, hOCT-2, na hOCT-3, na-abawanye Cmax nke saxagliptin site na 14%, agbanyeghị, saxagliptin AUC anaghị agbanwe.

Mwepụta wepụtara ya na ihe mejupụtara

Mpempe usoro onunu ogwu - mbadamba ihe eji edeputara, ihe nkiri eji eme ya (n’ime igbe kaadi 4 blister nke mbadamba 7 na ntuziaka maka ijikọ Prolong, na mgbakwunye maka mbadamba 1000 + 2.5 mg - 8 blisters nke mbadamba 7):

usoro onunu ogwu 1000 mg + 2.5 mg: ihe eji akpu okpu, biconvex, ihe nlere onyonyo site na odo na odo, nke edere ya na acha anụnụ anụnụ n’otu akụkụ ka edere “2.5 / 1000”, n’akụkụ nke ọzọ - “4222”,
usoro onunu ogwu 500 mg + 5 mg: capsule-mepụtara, biconvex, uwe mkpuchi si na aja aja rue aja aja, edeputara na ink nke di n’otu akuku “5/500”, n’akuku ozo - “4221”,
onunu ogwu 1000 mg + 5 mg: capsule-udi, biconvex, pink film coat, ink na-acha anụnụ anụnụ n’otu akụkụ ka edepụtara “5/1000”, n’akụkụ nke ọzọ - "4223".

Ihe dị n'ime 1 mbadamba:

metformin hydrochloride - 1000 mg + saxagliptin - 2.5 mg,
metformin hydrochloride - 500 mg + saxagliptin - 5 mg,
metformin hydrochloride - 1000 mg + saxagliptin - 5 mg.

Ihe mejuputara na otu mbadamba ya, weputara ihe eji agba agba, ihe nkiri (1000 mg + 2.5 mg / 500 mg + 5 mg / 1000 mg + 5 mg):

okpokoro mbadamba: metformin hydrochloride na ngwakọta na 0,5% magnesium stearate - 1005 / 502.5 / 1005 mg, sodium carmellose - 50/50/50 mg, hypromellose 2208 - 393/358/393 mg, hypromellose 2910 - 0/10 / 0 mg, magnesium stearate - 2/1/2 mg, microcrystalline cellulose - 0/102/0 mg,
oyi akwa nke mbu (nchebe): Opadry II ọcha (% m / m) - 130.5 / 99 / 130.5 mg (mmiri polyvinyl nke mmiri dị obere - 40%, titanium dioxide - 25%, macrogol 3350 - 20.2% , talc - 14.8%), 1M hydrochloric acid solution - ruo pH 2 ± 0.3,
akwa nke abụọ nke shei mkpuchi (arụ ọrụ): saxagliptin - 2.5 / 5/5 mg, Opadry II white - 20/20 mg, 1M ngwọta nke hydrochloric acid - ruo pH 2 ± 0.3,
ink maka ederede: Opacode ink acha anụnụ anụnụ (% m / m) - 0.03 / 0.03 / 0.03 mg (indigo carmine aluminom varnish - 16%, shellac

45% na ethanol - 55.4%, butanol - 15%, propylene glycol - 10.5%, isopropanol - 3%, 28% ngwọta nke ammonium hydroxide - 0.1%).

Nke ato (agba) akwa nke shei mkpuchi:

1000 + 2,5 mg: Opadry II odo (% m / m) - 48 mg (mmiri polyvinyl akụkụ ụfọdụ - 40%, titanium dioxide - 24.25%, macrogol 3350 - 20.2%, talc - 14.8% , iron dye iron - 0.75%), 1M nke hydrochloric acid - rue pH 2 ± 0.3,
1000 + 5 mg: Opadry II tan (% m / m) - 33 mg (mmiri polyvinyl akụkụ mmiri - 40%, macrogol 3350 - 20.2%, titanium dioxide - 19.58%, talc - 14.8% , iron dye iron oxide - 5%, iron dye iron oxide - 0.42%), 1M nke hydrochloric acid - rue pH 2 ± 0.3,
500 + 5 mg: Opadry II pink (% m / m) - 48 mg (mmiri polyvinyl akụkụ mmiri - 40%, titanium dioxide - 24.25%, macrogol 3350 - 20.2%, talc - 14.8%, ọbara ọbara dye iron oxide - 0.75%), 1M nke hydrochloric acid na pH nke 2 ± 0.3.

AKWECKWỌ NDEC NA-EGO

Lactic acidosis

Lactic acidosis bụ ihe na-adịghị ahụkebe, nnukwu nsogbu metabolic nke nwere ike ịmalite n'ihi mmụpụta nke metformin n'oge ọgwụgwọ ya na Combogliz Prolong®. Site na mmepe nke lactic acidosis n'ihi iji metformin, ntinye ya na plasma ọbara karịrị 5 μg / ml.

Ekwesịrị ileba anya na ọrụ gbasara akụrụngwa na ndị ọrịa na - eburu metformin ma ekwesịrị ịnye ọgwụ opekempe opekata mpe. N'ime ndị ọrịa agadi, ọ dị mkpa ileba anya na ọrụ gbasara akụrụngwa. Ekwesighi inye ndị ọrịa afọ 80 na okenye karịa Metformin ọgwụ (ma ọ bụrụ na ọrụ ezinaụlọ adịghị mma (dịka data QC) si dị, dị ka ndị ọrịa a na-adịkarị mfe ịmalite mmepe lactic acidosis.Na mgbakwunye, ọgwụgwọ metformin kwesịrị ịkwụsị ozugbo ma ọ bụrụ na ọnọdụ nke hypoxemia, akpịrị ịkpọ nkụ, ma ọ bụ sepsis tolitere. Ebe ọ bụ na imeju imeju nwere ike belata ikike ịrọ oria lactate, ekwesighi inye ndị ọrịa ọgwụ akara ma ọ bụ ụlọ nyocha nke ọrịa imeju.

Ekwesịrị inyocha ọnụnọ nke lactic acidosis na ndị ọrịa niile nwere ọrịa mellitus na metabolic acidosis na-enweghị ihe ịrịba ama nke ketoacidosis (ketonuria na ketonemia).

Lactic acidosis chọrọ ọgwụgwọ n'ụlọ ọnọdụ ụlọ ọgwụ. Ọ bụrụ na achọtara lactic acidosis na onye ọrịa na-ewere metformin, ị kwesịrị ịhapụ ị takingụ ọgwụ ahụ ozugbo wee malite usoro nkwado dum. Ọ na-atụ aro ka ịmalite usoro akwara ozigbo iji mezie acidosis na metformin suprem cumulated.

Dị ka ị maara, mmanya na-eme ka mmetụta nke metformin nwee metabolism nke lactate, nke na-abawanye ohere nke lactic acidosis. Kwụsị ị ofụ mmanya mgbe ị na-a Comụ Combogliz Prolong®.

Imeju imeju

Ojiji nke Combogliz Prolong® bụ contraindicated na ndị ọrịa nwere akara ogwu na ụlọ nyocha nke ọrịa imeju n'ihi ihe egwu nke lactic acidosis.

Nyocha ọrụ akụrụ

Tupu ịmalite ọgwụgwọ na Combogliz Prolong® yana opekata mpe kwa afọ, ọ dị mkpa iji nyochaa ọrụ akụrụ. N'ime ndị ọrịa a na-eche na ọ nwere ọrụ ezumike, ọrụ mkpado kwesịrị ka elelee ya ọtụtụ oge, a ga-akwụsịkwa ịgwọ Combogliz Prolong if ma ọ bụrụ na akara nke ọdịda akwara apụta.

Usoro ịwa ahụ

Shouldkwesịrị ịkwụsị ịboụ Combogliz Prolong® tupu usoro ọgwụgwọ ọ bụla (belụsọ maka obere usoro emetụtaghị ịmachi nri na ị fluidụ mmiri), amalitekwala iji ya ruo mgbe onye ọrịa ahụ nwere ike ị theụ ọgwụ n'ime ya wee rụpụta ọrụ kwesịrị ekwesị. akụrụ.

Agbanwe onodu adidi nke ndi oria nwere oria nke abuo bu ndi oria abuo

N'ime onye ọrịa nwere T2DM, onye chịburu ya nke ọma n’oge ọgwụgwọ ya na Combogliz Prolong® ma nweekwa ihe dị iche iche na paradaịs ma ọ bụ nwee ọrịa (ọkachasị n’ihe banyere nchọpụta amamịghe), a ga-enyocha ihe ịrịba ama nke ketoacidosis ma ọ bụ lactic acidosis ozugbo. Nyocha ahụ kwesịrị ịgụnye mkpebi siri ike nke electrolytes n'ọbara ọbara, ketones, glucose ọbara na, ọ bụrụ na egosipụtara, pH ọbara, nchịkọta nke lactate, pyruvate na metformin. Ọ bụrụ n'ụdị nke acidosis etolite, ekwesịrị ịkwụsị nkwadebe Combogliz Prolong® ozugbo a ga-edekwa ọgwụ hypoglycemic ọzọ.

Ojiji nke ọgwụ nwere ike ibute hypoglycemia

Saxagliptin
Ngwakọta nke sulfonylureas na insulin nwere ike ibute hypoglycemia.Ya mere, iji belata ihe ize ndụ nke hypoglycemia na iji otu oge na saxagliptin, ịbelata dose nke sulfonylurea ma ọ bụ ọgwụ insulin nwere ike ịchọ.
Metformin
Hypoglycemia anaghị etolite n'ime ndị ọrịa na-a onlyụ nanị metformin n'ụzọ ọ na-adị, ma ọ nwere ike ịmalite site na oriri na-ezighi ezi nke carbohydrate, mgbe arụ ọrụ anụ ahụ anaghị arụ ọrụ site na oriri carbohydrate, ma ọ bụ site na iji ọgwụ hypoglycemic ndị ọzọ (dị ka sulfonylureas na ọgwụ insulin) ma ọ bụ mmanya. Okenye, ndi ọrịa na ndi nri na adighi nri ma obu ndi n’enweghi nsogbu ma obu oke mmanya ma obu egbu egbu bu ndi amachara acho hypoglycemic. N'ime ndị okenye na ndị ọrịa na-a betaụ ọgwụ mgbochi-egbochi, nchọpụta nke hypoglycemia nwere ike isi ike.

Usoro ọgwụgwọ na-emetụta ọrụ akụrụngwa ma ọ bụ nkesa metformin

A na-adụ ọdụ ịkpachara anya iji ọgwụ na-egbu egbu (dị ka ọgwụ cationic nke mmiri zoro ezo na -akpọ, na-emetụta ọrụ akụrụ, na-eduga mgbanwe dị ukwuu ma ọ bụ kpaghasị nkesa metformin (lee akụkụ “Mmekọrịta na ọgwụ ndị ọzọ”).

Ihe omumu ihe omumu nke ihe omimi banyere ochicho ihe nke ndi mmadu

Mgbe ị na-eduzi ọmụmụ ihe gbasara akwara ozi na nchịkwa intravascular nke iodine nwere ihe dị iche iche, a na-achọpụta oke arụmọrụ akụrụ, nke nwere ike isonye na mmepe nke lactic acidosis na ndị ọrịa na-anata metformin. Ndị ọrịa a haziri maka ọmụmụ ihe dị otú a kwesịrị ịkagbu ọgwụgwọ Combogliz Prolong® n'ime awa 48 tupu ha emee usoro a, zere ị theụ ọgwụ ahụ n'ime awa 48 ka usoro ahụ gasịrị, ma maliteghachi ọgwụgwọ naanị mgbe ekwenyechara ọrụ akụrụ.

Ọnọdụ hypoxic

Gbanwee na mgbanye glucose ọbara

Ahụ ọkụ, trauma, ọrịa, ịwa ahụ nwere ike iduga mgbanwe nke mkpokọta glucose na ọbara, nke a chịrị na mbụ ijikwa ọgwụ ọjọọ Combogliz Prolong®. N'ọnọdụ ndị a, enwere ike ịhapụ ọgwụ oge ụfọdụ na ịnyefe onye ọrịa ahụ ọgwụ insulin. Mgbe kwụsịrị ịdị n'otu nke glucose n'ọbara ma melite ọnọdụ onye ọrịa n'ozuzu ya, enwere ike ịmaliteghachi ọgwụgwọ Combogliz Prolong®.

Mmeghachi omume hypersensitivity

A kọọrọ mmeghachi omume dị njọ hyperensitivity, gụnyere anaphylaxis na angioedema n'oge a na-eji saagliptin na-ere ahịa. Ọ bụrụ na oke mmeghachi omume hypersensitivity malitere, ị kwesịrị ịkwụsị ị usingụ ọgwụ ahụ, nyochaa ihe ndị ọzọ nwere ike ịkpalite mmepe ahụ, ma depụta usoro ọgwụgwọ ọrịa shuga mellitus ọzọ (lee akụkụ "Contraindications" na "Effects Side").

Ọrịa mgbu

N'ụghachite azụmaahịa nke saxagliptin, a natala ozi mkpesa gbasara ikpe gbasara ọrịa akwara. Ekwesịrị ịgwa ndị ọrịa na-ewere Combogliz Prolong® banyere njirimara akparamagwa nke nnukwu ọrịa pancreatitis: ogologo oge, nnukwu ihe mgbu na afọ. Ọ bụrụ na ị na-enyo enyo mmepe nke pancreatitis, ị kwesịrị ịkwụsị ị Comụ ọgwụ Combogliz Prolong® (lee akụkụ "Na-akpachara anya" na "Mmetụta akụkụ").
Ọnụ ọgụgụ ọrịa pancreatitis na ọmụmụ SAVOR, gosipụtara dị ka usoro ọmụmụ ahụ si dị, 0.3% dị na saxagliptin na placebo dị na onu ogugu ndị ọrịa niile nwere usoro.

Ndị okenye na-arịa ọrịa

N'ime ndị ọrịa 16492 gbara ghaara ọmụmụ ihe SAVOR, ndị ọrịa 8561 (51.9%) dị afọ 65 ma ọ bụ karịa, na ndị ọrịa 2330 (14.1%) dị afọ 75 ma ọ bụ karịa. N'ime ndị a, ndị ọrịa 4290 dị afọ 65 gbagoro na ndị ọrịa 1169 dị afọ 75 na karịa natara saxagliptin. Dika ihe omumu nke ulo ogwu, ihe oma na nchedo ndi n’eme ka ndi oria di iri-isii n’a karia, iri-asaa na iri n’abu iche na ndi ozo egosiputara ya n’ebe ndi oria di.

Obi ada mba

Ọmụmụ ihe SAVOR gosipụtara mmụba nke ụlọ ọgwụ maka nkụchi obi na otu saxagliptin ma e jiri ya tụnyere otu placebo, ọ bụ ezie esighi etolite mmekọrịta na-akpata ahụ. Ekwesịrị iji nlezianya mee ihe mgbe ị na-eji Combogliz Prolong® na ndị ọrịa nwere ihe ndị dị ize ndụ maka nkụchi obi, dịka akụkọ akụrụngwa na-akụ afọ n’ala. Ekwesịrị ịgwa ndị ọrịa banyere njiri mara njiri mara nke nkụda obi na mkpa ọ dị ịkọ akụkọ ndị ahụ ozugbo (lee Pharmacodynamics, Nrụpụta Ọrịa na Nchekwa).

Arthralgia

Nkwupụta azụmaahịa na-akọwa mgbu nkwonkwo, gụnyere nnukwu ihe mgbu, mgbe ị na-eji ndị na-egbochi DPP-4. N'ime ndị ọrịa, a hụrụ enyemaka mgbaàmà mgbe ịkwụsị ọgwụ ahụ, na n'ime ndị ọrịa n'otu n'otu, a hụrụ nlọghachi nke mgbaàmà mgbe ịmaliteghachi otu ihe ahụ ma ọ bụ onye ọzọ na-egbochi DPP-4. Mmalite nke mgbaàmà mgbe ịmalitere iji ọgwụ ahụ nwere ike ngwa ngwa ma ọ bụ mara megide ndabere nke usoro ọgwụgwọ ogologo oge. Site na mmepe nke mgbu nkwonkwo siri ike, ekwesịrị ịgakwuru maka ịgabiga ọgwụ ahụ n'ọnọdụ ọ bụla (lee akụkụ “Side Side”).

NKP ONR ON THEKW ONKWỌ TOB TOR TO IVEB VR V VREH VREH ỌR AND NA-EKWU EGO

Emebeghị nnyocha banyere mmetụta saxagliptin na ikike ịkwọ ụgbọala na usoro nchịkwa. Buru n’uche na saxagliptin nwere ike ibute isi ọwụwa.

Mlọ ọgwụ

Combogliz Prolong na - ejikọta ndị hypoglycemic abụọ na usoro njikọta ọnụ nke ime ihe iji meziwanye njikwa glycemic na ndị ọrịa nwere ụdị ọrịa shuga 2 (ụdị 2 ọrịa shuga): saxagliptin, onye na - egbochi DPP-4 (dipeptidyl peptidase 4), na metformin, nke bụ nke klas ahụ. biguanides.

Saxagliptin

Site na obere eriri afọ, na nzaghachi maka nri oriri, homonụ, ọgwụ ndị dị ka GLP-1 (glucagon-like peptide-1) na HIP (glucose na-adabere insulinotropic polypeptide) na-abanye n'ọbara.

Hormones-incretins na-akwalite mwepụta nke insulin site na mkpụrụ ndụ beta nke pancreas, nke dabere na nchịkọta glucose dị n'ọbara, mana enzyme DPP-4 na - agbagide ha. Ebumnuche nke GLP-1 na-achọkwa iweda nzuzo nke glucagon n'ime mkpụrụ ndụ alị, nke na-eduga n'ịbelata mmepụta glucose na imeju. Ọkpụkpụ nke GLP-1 n'ime ndị ọrịa nwere ụdị shuga 2 belatara, mana azịza insulin na GLP-1 na-echekwa. Saxagliptin, dị ka onye na-egbochi DPP-4, na-ebelata mmelata nke homonụ dị adị, si otú a na-abawanye itinye uche ha n'ọbara, ma na-eduga n'ịbelata glucose ma na afọ efu na mgbe nri gasịrị.

Metformin bụ ọgwụ hypoglycemic na-eme ka nnabata glucose dị n'etiti ndị ọrịa nwere ụdị ọrịa shuga 2 (site na ịbelata basal glucose na postprandial glucose).

Effectivegwọ arụmọrụ nke metformin bụ iji belata imeju glucose site na imeju, ime ka nnabata nke glucose dị na eriri afọ, ma mee ka mmata insulin (akụkụ na ojiji nke glucose na-abawanye).

Metformin, n'adịghị ka nkwadebe nke sulfonylurea, anaghị akpata hyperinsulinemia na hypoglycemia na ndị ọrịa nwere ọrịa shuga 2 ma ọ bụ ndị nwere ahụike (ma e wezụga ya bụ ọnọdụ pụrụ iche). Thezochi insulin n'oge ọgwụgwọ metformin anaghị agbanwe agbanwe, n’agbanyeghi na enwere ike ibelata insulin mkpokoro n’afọ na-enweghị isi na nzaghachi nri n’ụbọchị.

ISI AKA

1000 mbadamba ihe-ọhụụ edepụtara

7 mbadamba kwa aluminom foil ọnya, 4 ma ọ bụ 8 blisters ọ bụla nwere ntuziaka

maka iji ya na igbe kaadiboodu nke na-ejikwa oghere mbu.

500 mg + 5 mg mbadamba ihe nkiri
7 mbadamba ụrọ n'otu tebụl aluminom, 4 blisters nwere ntuziaka maka iji ya na igbe kaadiboodu na-ejikwa oghere mbụ.

1000 mg + 5 mg mbadamba ihe mkpuchi fim
7 mbadamba ụrọ n'otu tebụl aluminom, 4 blisters nwere ntuziaka maka iji ya na igbe kaadiboodu na-ejikwa oghere mbụ.

Mgbe okpomọkụ adịghị karịa 30 Celsius. Ekwela ka ụmụaka ghara iru ya.

AKW MANKWỌ, AKILLKỌ (MAKA IMBỌRIM IMBỌR)), AKPARA (AKW (KWỌ NSỌ (INWETA)).

AstraZeneca Pharmaceuticals LP, USA
4601 Highway 62 East, Ugwu Vernon, Indiana, 47620, USA
AstraZeneca Pharmaceuticals LP, USA
4601 Highway 62 East, Ugwu Vernon, Indiana, 47620, USA

Aha, adreesị nke nzukọ enyere ikike ma ọ bụ onye nwe ya akwụkwọ ndebanye aha nke ọgwụ ọgwụ maka iji ọgwụ na-anabata nnabata n'aka ndị ahịa:

Onyinye nke AstraZeneca UK Limited, UK, na Moscow na AstraZeneca Pharmaceuticals LLC
125284 Moscow, abụrụ. Gba ọsọ, 3, p.

Njirimara ọgwụ ọgwụ

Combogliz Prolong bụ ngwongwo ziri ezi nke saxagliptin na metformin, na-enye ndị dibịa na ndị ọrịa shuga ohere ọhụrụ iji chịkwaa profaịlụ glycemic ha.

Combogliz Prolong: ntuziaka maka ojiji

Dọkịta ahụ na-ahọpụta usoro nhazi na usoro onyonyo n'otu n'otu, na-eburu n'uche ihe ngosipụta nke glucometer, ahụike izugbe, afọ nke ọrịa mamịrị, mmeghachi omume nke mbadamba ihe. Na mkpokọta, ntụziaka ahụ na-enye ụdị ndụmọdụ a.

A na-ewerekarị ọgwụ ogologo oge ka ụbọchị 1 / ụbọchị. n'otu oge.

Na-a aụ otu mbadamba n'ụtụtụ ma ọ bụ na mgbede, na-enweghị mkpị. Maka usoro eji ahapụ ngwa agha, nguzosi ike nke shei na-arụ ọrụ pụrụ iche.

Usoro onunu ogwu bu mmadu, dika mmalite monotherapy o nwere ike ibu 1 mbadamba (500 mg nke metformin + 2.5 mg nke saxagliptin), oburu n’enweghi ike ịchịkwa glycemic zuru oke, a na-abawanye ogwu a rue mbadamba abuo (1000 mg nke metformin + 5 mg nke saxagliptin).

Site n’otu oge eji ọgwụ eme ihe maka ịgwọ ọrịa na-efe efe, ekwesịrị ibute nsonaazụ ha na ntanetị. Na nkenke, jiri otu oge nke inhibitors nke CYP3A4 / 5 isoenzymes (Indinavir, Ketoconazole, Nefazodon, Itraconazole, Atazanavir), a na-atụkwa obere akara nke saxagliptin - 2.5 mg.

Ọgwụ Metformin nwere ogologo oge nke mmetụta na-adịghị mma n'ụdị nkwarụ dyspeptik dị nnọọ ntakịrị karịa analogues na ntọhapụ ngwa ngwa. Nke mere na ahu na - emeghari onodu ohuru, o nweghi ihe nro maka ntu ogugu, a ga-ebu ụzọ tinye otu ụzọ kwesiri iji nwayọ, izu abụọ ọ bụla.

Ekwesiri iburu ngbanwe ndu o bula n’eme ihe banyere ogwu a, ya mere odi nkpa igwa ndi dọkịta banyere ha n’oge.

Analogs Kombiglyce Prolong

Maka Combogliz Prolong, analog nwere otu ụdị ihe eji arụ ọrụ nwere ike ịbụ Comboglis XR, nke emepụtara na Italytali na UK. Ọnụahịa nke analog sitere na 1650 rubles. (28 mbadamba 1000 mg nke metformin na 2.5 mg nke saxagliptin).

Ngwakọta ọgwụgwọ nke Avandamet, Yanumet, Glimecomb, GalvusMet na Bagomet gbakwunyere na-enwe mmetụta ọgwụgwọ ahụ yiri ya.

Denye ọgwụ ike dabere na otu akụrụngwa na-arụ ọrụ dịka Glyformin Prolong, Glucofage, Metadiene, Sofamet, Diaformin Od, Ongliza, Matospanin, Metfogamma, Siofora.

Onye egosiri ogwu

Edere Combogliz ogologo maka ụdị shuga 2 iji mee ka njikwa glycemic dị ka mgbakwunye nri nri dị ala na mmega ahụ zuru oke, ma ọ bụrụ na mgbanwe ndụ adịghị enye nsonaazụ achọrọ yana nchikota saxagliptin na metformin kwesịrị ekwesị maka onye ọrịa.

Ekeresimesi na nso contraindications

Ọbụna ọgwụ nke nwere nchekwa nchekwa dị elu, nke bụ Combogliz Prolong, enyeghị ya iwu maka ntachi obi na mmetụta nke onye ahụ.

E gosiputara ogwu ahu nye ndi nne di ime ma na-enye nwa ara (a na-ebuga ya na insulin) nwa oge, n'ihi enweghi ihe akaebe zuru oke maka oru ya, enyeghi ya umuaka.
Ọgwụ a adabaghị maka ndị ọrịa mamịrị nwere oria nke 1.
Na dysfunctions renal, yana ọnọdụ ndị na-akpasu ha iwe, egosighi ọgwụ a.
Ejila ọgwụ ịgwọ ndị ọrịa nwere ọrịa na-akpata ụnwụ oxygen nke anụ ahụ.
Site na ketoacidosis (ụdị ọrịa mamịrị) na ma ọ bụ na-enweghị coma, a naghị ewere ọgwụ ahụ nwa oge.
A na-akagbu ọgwụ mgbe a na-arụ ọrụ, ya na nnukwu mmerụ ahụ, na-agba nnukwu ọkụ. Nnyocha X-ray nwere akara ayodiin n’ime ọrịa mamịrị nwere ike imebi akụrụ, ya mere agbanwere ya ka bụrụ insulin. Na mkpokọta, a na - egosi ọgwụ insulin maka awa 48 tupu yana awa 48 ka usoro ndị ahụ gachara, ọkachasị, ọ dabere na ọnọdụ akụrụ na ọdịmma ndị ọrịa niile.
Ọrịa imeju, lactic acidosis na ị alcoholụbiga mmanya ókè sokwa na listi contraindications. Can nweghị ike ịkọwa ọgwụ ahụ nye ndị ọrịa nwere ọrịa anagide mkpụrụ ndụ galactose.

E kwesịrị ị attentiona ntị na ndị ọrịa shuga tozuru oke, ọkachasị na nri na-edozi ahụ, ọrịa akwara na enweghi mmega ahụ zuru oke nke nwere ike ịkpalite hypoglycemia.

Effects nwere ike ịchọpụta mmetụta na-achọghị na ị overụbiga mmanya ókè

Saxagliptin nwere ogo ịdị iche iche nwere ike ibute ọnọdụ:

Ọrịa Sinusitis
Ọrịa mamịrị
Ha zara ọnụ ya na ihu,
Ọrịa mgbu
Urticaria.

Ihe omumu ihe omumu gosiputara mbelata vitamin B12 site na iji ogwu ogologo oge, yana mbelata onu ogugu nke lymphocytes. Ọnọdụ nke ịdoụbiga mmanya ókè bụ alụghị di ma ọ bụ nwunye, na-abakarị na iji ogologo oge nke iji ọrụ ahụ emeju. Ọgwụ anaghị akpata egbu egbu, yana oke ọgwụ ahụ, hemodialysis dị irè. N’ime ya, a na-eme ọgwụgwọ symptomatic.

Formdoụ ọgwụ metformin karịrị akarị, ihe kachasị njọ bụ lactic acidosis.. Nwere ike ịmata ọnọdụ ahụ site na akara ndị a:

Ndakpọ
Ntutu ume
Ihe mgbu
Ọbara mgbali elu
Hypothermia,
Akwara ahu
Obi ọgba aghara.

N’ọnọdụ siri ike, nsogbu adịghịzi, ike ọgwụgwụ, precoma na coma na-etolite. Onye merụrụ ahụ chọrọ ụlọ ọgwụ ngwa ngwa, n'enweghị nlekọta ahụike zuru oke, ọ nwere ike ịnwụ. Wepu metformin bupụrụ site na hemodialysis, ọ dị mkpa ịtụle na mwepu creatinine ruru 170 ml / min.

Ka ịrịa ọrịa shuga na-emezu ihe ndị dọkịta gwara gị, belata obere ihe ọghọm. N'ihe banyere Combogliz ruo ogologo oge, ọ bụghị ihe siri ike ịgbaso usoro nke ị theụ ọgwụ.

Nhọrọ maka iso ọgwụ ndị ọzọ na-emekọrịta

Mgbe ị na-etolite usoro ọgwụgwọ na Combogliz Prolong, ọ dị mkpa ịdọ ndị endocrinologist aka na ntị gbasara ọgwụ niile onye ọrịa shuga na-ewere iji gwọọ ọrịa na-efe efe. Offọdụ n'ime ha nwere ike welie ike ịbelata ike nke Comboglize, ndị ọzọ na-egbochi ọrụ ya.

Maka echiche n'ozuzu, ị nwere ike ịnyagharịa tebụl.

Mmetụta hyperglycemic

Rifampicin, Pioglitazone, Magnesium na Aluminom Hydroxides / SimethiconeGCS, diuretics, nicotinic acid

homonụ thyroid, estoniazid, sympathomimetics, phenothiazines, estrogens, phenytoin, ndị na-egbochi calcium Channel.

Na-akpalite ọnọdụ hypoglycemic

Amprenavir, Diltiazem, Erythromycin, Fluconazole, Aprepitant, Verapamil, mmanya mkpụrụ osisi, Ketoconazole, sulfonylurea ọgwụ, Glibenclamide, Ketoconazole, CYP3A 4/5 isoenzymes, FamotidineỌgwụ cationic, Furosemide, ethanol na ọgwụ, Nifedipine

Amprenavir, Diltiazem, Erythromycin, Fluconazole, Aprepitant, Verapamil, mmanya mkpụrụ osisi, Ketoconazole, sulfonylurea ọgwụ, Glibenclamide, Ketoconazole, CYP3A 4/5 isoenzymes, Famotidine
Ọgwụ cationic, Furosemide, ethanol na ọgwụ, Nifedipine

O doro anya na nnwale na nyocha nke onwe ya na ọgwụ onwe ya na Combogliz Prolong nwere ike ibute nsonaazụ ahụike.

Combogliz Prolong: nyocha nke ndị ọrịa mamịrị

Ndị dọkịta na-ahụ maka ịdị irè nke ọgwụgwọ Combogliz Prolong na-ahụ maka ịpụ iche ya, ndị ọrịa mamịrị enweghị obi abụọ n'ike ya.

Ijikwa ọrịa shuga zuru ezu chọrọ usoro agbakwunyere: nri obere obere carb, ihe nlele kwa ụbọchị nke ọgụgụ glucose, mmega ahụ zuru oke na nkwado ọgwụ. Naanị na nchikota a ka anyị nwere ike ịtụkwasị obi na nsonaazụ 100% nke Combogliz Prolong.

Na vidiyo ahụ, prọfesọ-endocrinologist A.S. Ametov na-ekwu maka ụkpụrụ ọhụụ nke njikwa ụdị shuga 2.

Mlọ ọgwụ

Ejiri mara bioequivalence na mmetụta nri dị na ngwakọta nke ihe ndị na-arụ ọrụ nke Comboglize Prolong bụ ndị ọrịa na-agbaso nri kalori, nke nyere 324 kcal ihe oriri ma nwee: protein - 11.1%, abụba - 10.5%, carbohydrates - 78.4%. N'okpuru ọnọdụ nri ndị a, n'ihe ọmụmụ, dị ka nsonaazụ nyocha siri gosipụta, bioequivalence nke pharmacokinetics nke njikọta metformin + saxagliptin na mbadamba nkume na mbadamba ụrọ nke nnweghari ziri ezi nke satagliptin na metformin na usoro ọgwụgwọ ndị ahụ.

Ọnọdụ pụrụ iche

A naghị atụ aro iji Combogliz Prolong na akụrụ akwara na arụ ọrụ imeju.

Ọrịa afọ 65-80 ekpughebeghị ọgwụgwọ dị iche iche dị na ọgwụ ọgwụ nke saxagliptin ma e jiri ya tụnyere ndị ọrịa dị obere (afọ 18-40), yabụ, ọchọghị nhazigharị ọgwụ na ndị ọrịa agadi. Agbanyeghị, ekwesịrị iburu n'uche na na ụdị ndị ọrịa a, mbelata ọrụ ọrụ gbasara akụrụ nwere ike yikarịrị. Na afọ ọ bụla, ọ dịghị mkpa iji kọwaa Combogliz Prolong ruo mgbe emere nkwenye ọrụ akụrụ.

A na-egbochi ndị ọrịa karịa afọ 80 na ị theụ ọgwụ, belụsọ ma egosiputara ọrụ mkpụmkpụ nkịtị site na nha nhapụta nwebipụta creatinine.

Emebeghị nnyocha nke pharmacokinetics nke ihe Comboglyz Prolong n'ime ụmụaka.

Mmeghachi omume ọjọọ na saxagliptin edere na ọmụmụ SAVOR

Ogo nke ndị ọrịa toro nnukwu hypoglycemia n'oge ọgwụgwọ (hypoglycemia, nke chọrọ enyemaka nke ndị ọzọ) dị elu na otu saxagliptin ma e jiri ya tụnyere otu placebo.

Ihe ọghọm nke ịbawanye hypoglycemia n'ozuzu ya, yana ọrịa hypoglycemia dị ukwuu na saxagliptin otu, ka etinyere na ndị ọrịa natara nkwanye sulfonylurea, mana ọ bụghị na ndị ọrịa natara metformin ma ọ bụ insulin dịka isi ọgwụgwọ.

Na mkpokọta, enwere ike ịbawanye hypoglycemia, yana ọrịa hypoglycemia, ka akachasị bụrụ na ndị ọrịa nwere usoro haemoglobin (HbAlc) na-erughị 7%.

Ngwa ahia mgbere

N'oge nlere azụmaahịa azụmaahịa, edepụtara mmepe nke mmeghachi omume ọjọọ ndị a: nnukwu pancreatitis, mmeghachi omume hypersensitivity (gụnyere anaphylaxis, angioedema, ihe ọkụ na urticaria) na arthralgia. O bu ihe anaghi ekwe omume itule ugboro ole mmepe ndi a di.

Site n'iji saxagliptin, a na-achọpụta mbelata nke na-agbadata ọnụ ọgụgụ nke lymphocytes zuru oke.N'ọtụtụ oge, iji ojiji nke saxagliptin ugboro ugboro, ọ nweghị nlọghachi ọ bụla, ọ bụ ezie na ụfọdụ ndị ọrịa ọnụ ọgụgụ lymphocytes belatara ọzọ mgbe ịmaliteghachi usoro ọgwụgwọ na saxagliptin, nke dugara ịkwụsị ọgwụ. Nbelata ọnụọgụ nke lymphocytes esoghị ihe ngosi ọgwụgwọ. Amabeghị ihe kpatara mmebi iwu a. N'ihe banyere ọrịa ogologo oge ma ọ bụ nke na-adịghị ahụkebe, ịkwesịrị ịlele ọnụọgụ nke lymphocytes. Achọpụtaghị mmetụta nke saxagliptin na ọnụọgụ nke lymphocytes na ndị ọrịa nwere ọrịa na-enweghị nsogbu na ọnụ ọgụgụ ha (gụnyere nje immunodeficiency virus mmadụ).

Na omumu ihe omumu nke metformin, ihe dika 7% nke ndi oria gosiputara mbelata nke otutu ihe omimi vitamin B₁₂ (nke dị na mbụ) na ụkpụrụ ndị na-abụghị ihe ngosipụta ụlọ ọgwụ na-esoghị. Ọzọkwa, ụdị mmebi a na mmepe anaemia na-esokarị ụkọ, mgbe mkpochapụ nke metformin ma ọ bụ nweta vitamin C ọzọ.₁₂ gbakere ngwa ngwa.

Na arụ ọrụ ezumike ọrụ

Ihe mgbochi iji Comboglize Prolong si n'akụkụ ọrụ ọrụ akwara:

ọrụ ezigharị arụmọrụ (serum creatinine: men ≥ 1.5 mg / dl, ụmụ nwanyị ≥1.4 mg / dl ma ọ bụ nwechapụ ikike nke creatinine), gụnyere ndị metụtara septicemia, infarction acyo nke myocardial, nnukwu ọrịa obi (ọdịda). ,
ajọ ọrịa, nke enwere nsogbu ihe gbasara ọrụ gbasara akụrụngwa.