FrancophonIA/ELRC3.0 huggingface dataset:
English: Clinical studies conducted to support the efficacy and safety of Vipdomet involved the co-administration of alogliptin and metformin as separate tablets.
Slovenian: Klinične študije, izvedene z namenom ugotovitve učinkovitosti in varnosti zdravila Vipdomet, so vrednotile sočasno uporabo alogliptina in metformina v obliki ločenih tablet.
English: For patients inadequately controlled on dual combination therapy with insulin and the maximal tolerated dose of metformin, the dose of Vipdomet should provide alogliptin dosed at 12.5 mg twice daily (25 mg total daily dose) and a dose of metformin similar to the dose already being taken.
Slovenian: Pri bolnikih z neustrezno urejeno sladkorno boleznijo pri dvojnem kombiniranem zdravljenju z insulinom in metforminom v največjem odmerku, ki ga prenašajo, je treba z odmerkom zdravila Vipdomet zagotoviti alogliptin v odmerku 12,5 mg dvakrat na dan (skupni dnevni odmerek 25 mg) in metformin v enakem odmerku, ki ga bolnik že jemlje.
English: PHARMACEUTICAL FORM AND CONTENTS 98 film-coated tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA 98 filmsko obloženih tablet Večodmernega pakiranja ne bo na trgu.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/843/001-026
Slovenian: EU/1/13/843/001-026
English: For patients switching from separate tablets of alogliptin and metformin (as dual therapy or as part of triple therapy with insulin), both alogliptin and metformin should be dosed at the total daily dose already being taken; the individual dose of alogliptin should be halved as it will be taken twice daily whilst the dosing of metformin should remain unchanged.
Slovenian: Pri bolnikih, ki prehajajo z ločenih tablet alogliptina in metformina (kombinirano zdravljenje ali del trotirnega zdravljenja z insulinom), je treba tako odmerek alogliptina kot odmerek metformina določiti na osnovi skupnega dnevnega odmerka, ki ga bolnik že jemlje.
English: Special caution should be exercised in situations where renal function may become impaired, for example when initiating antihypertensive or diuretic therapy or when starting treatment with a nonsteroidal anti-inflammatory drug (NSAID).
Slovenian: V primerih, ko lahko pride do oslabljenega delovanja ledvic, na primer po uvedbi zdravljenja z antihipertenzivi, diuretiki ali nesteroidnimi protivnetnimi zdravili (NSAID), je potrebna posebna previdnost.
English: Significantly more patients receiving 12.5 mg alogliptin and 1.000 mg metformin hydrochloride twice daily (59.5%) achieved target HbA1c levels of < 7.0% compared to those receiving either 12.5 mg alogliptin twice daily alone (20.2%, p<0.001) or 1,000 mg metformin hydrochloride twice daily alone (34.3%, p<0.001) at Week 26.
Slovenian: V 26. tednu je ciljne vrednosti HbA1c <7,0 % doseglo pomembno več bolnikov, ki so prejemali alogliptin v odmerku 12,5 mg in metforminijev klorid v odmerku 1.000 mg dvakrat na dan (59,5 %), v primerjavi z bolniki, ki so prejemali samo alogliptin v odmerku 12,5 mg dvakrat na dan (20,2 %, p<0,001) ali samo metforminijev klorid v odmerku 1.000 mg dvakrat na dan (34,3 %, p<0,001).
English: Hepatic impairment Vipdomet should not be used in patients with hepatic impairment (see section 4.2).
Slovenian: Okvara jeter Pri bolnikih z okvaro jeter se zdravila Vipdomet ne sme uporabljati (glejte poglavje 4.2).
English: Due to the increased risk of hypoglycaemia in combination with pioglitazone, a lower dose of pioglitazone may be considered to reduce the risk of hypoglycaemia when this medicinal product is used in combination with Vipdomet (see section 4.2).
Slovenian: Zaradi zmanjšanja tveganja za pojav hipoglikemije bo tako morda treba razmisliti o zmanjšanju odmerka pioglitazona, če se zdravilo uporablja v kombinaciji z zdravilom Vipdomet (glejte poglavje 4.2).
English: Vipdomet is not known to affect your ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ni znano, če zdravilo Vipdomet vpliva na sposobnost za vožnjo in upravljanje s stroji.
English: Factors that may increase the risk of lactic acidosis (see section 4.4) should be reviewed before considering initiation of metformin in patients with GFR<60 mL/min.
Slovenian: Pri bolnikih z GFR <60 ml/min je treba pred uvedbo metformina pregledati dejavnike, ki lahko povečajo tveganje za laktacidozo (glejte poglavje 4.4).
English: - by reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis.
Slovenian: - z zaviranjem glukoneogeneze in glikogenolize zmanjšuje nastajanje glukoze v jetrih.
English: Therefore, close monitoring of glycaemic control, dose adjustment within the recommended posology and changes in diabetic treatment should be considered when cationic medicinal products that are eliminated by renal tubular secretion are co-administered.
Slovenian: Pri sočasni uporabi kationskih zdravil, ki se izločajo z ledvično tubulno sekrecijo, je zato treba skrbno nadzirati urejenost glikemije in razmisliti o prilagoditvi odmerka znotraj priporočenega odmerjanja in spremembah zdravljenja sladkorne bolezni.
English: Clinical studies conducted to support the efficacy of Vipdomet involved the co-administration of alogliptin and metformin as separate tablets.
Slovenian: Klinične študije, izvedene z namenom ugotovitve učinkovitosti zdravila Vipdomet, so vrednotile sočasno uporabo alogliptina in metformina v obliki ločenih tablet.
English: The pharmacokinetics of alogliptin in children and adolescents <18 years old has not been established.
Slovenian: Farmakokinetika alogliptina pri otrocih in mladostnikih, mlajših od 18 let, ni bila raziskana.
English: INFORMATION IN BRAILLE Vipdomet 12.5 mg/850 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Vipdomet 12,5 mg/850 mg
English: In addition, mean change from baseline in FPG at Week 52 for 25 mg alogliptin plus 30 mg pioglitazone and metformin was significantly greater than that for 45 mg pioglitazone and metformin (p<0.001).
Slovenian: Poleg tega je bila povprečna sprememba vrednosti glukoze v plazmi na tešče glede na izhodiščno vrednost v 52. tednu pri uporabi alogliptina v odmerku 25 mg v kombinaciji s 30 mg pioglitazona in z metforminom pomembno večja od tiste pri uporabi 45 mg pioglitazona in metformina (p<0,001).
English: Liver function test abnormalities very rare hepatic dysfunction including hepatic failure not known
Slovenian: Bolezni jeter, žolčnika in žolčevodov hepatitis zelo redki nenormalnosti pri preiskavah delovanja jeter zelo redki okvara delovanja jeter, vključno z odpovedjo jeter neznana
English: In rats no treatment-related foetal abnormalities occurred following concomitant administration at exposure margins of approximately 28- to 29-fold for alogliptin and 2- to 2.5-fold for metformin at the maximum recommended human dose of 25 mg/day and 2,000 mg/day, respectively.
Slovenian: Pri podganah pri mejah izpostavljenosti, ki so bile približno 28- do 29-krat večje od izpostavljenosti človeka pri priporočenem odmerku alogliptina 25 mg/dan in 2- do 3-krat večje od izpostavljenosti človeka pri priporočenem odmerku metformina 2.000 mg/dan niso ugotovili z uporabo zdravila povezanih nepravilnosti pri plodovih.
English: Microcrystalline cellulose Povidone K30
Slovenian: Jedro tablete manitol mikrokristalna celuloza povidon K30 krospovidon Tipa A magnezijev stearat
English: No adverse effects on fertility were observed in animal studies conducted with alogliptin or with metformin (see section 5.3).
Slovenian: Pri študijah z alogliptinom ali metforminom na živalih niso opazili neželenih učinkov na plodnost (glejte poglavje 5.3).
English: Co-administration of 12.5 mg alogliptin and 1,000 mg metformin hydrochloride twice daily resulted in statistically significant improvements from baseline in HbA1c and fasting plasma glucose at Week 26 when compared to either 12.5 mg alogliptin twice daily alone or 1,000 mg metformin hydrochloride twice daily alone.
Slovenian: Pri sočasni uporabi alogliptina v odmerku 12,5 mg in metforminijevega klorida v odmerku 1.000 mg dvakrat na dan, so bila v 26. tednu dosežena statistično pomembna izboljšanja glede na izhodiščne vrednosti HbA1c in vrednosti glukoze v plazmi na tešče, in sicer tako v primerjavi z uporabo samega alogliptina v odmerku 12,5 mg dvakrat na dan kot tudi samega metforminijevega klorida v odmerku 1.000 mg dvakrat na dan.
English: Not known: - Liver problems such as nausea or vomiting, stomach pain, unusual or unexplained tiredness,
Slovenian: Neznana pogostnost: - Težave z jetri, kot so siljenje na bruhanje, bruhanje, bolečina v trebuhu, neobičajna ali nepojasnjena utrujenost, izguba apetita, temen urin ali rumeno obarvanje kože ali očesnih beločnic.
English: Very rare: - Decreased vitamin B12 levels or anaemia; symptoms include tiredness, lethargy, feeling faint,
Slovenian: Zelo redki: - Znižane vrednosti vitamina B12 ali anemija.
English: If pancreatitis is suspected, Vipdomet should be discontinued; if acute pancreatitis is confirmed, Vipdomet should not be restarted.
Slovenian: Če je akutno vnetje trebušne slinavke potrjeno, se zdravljenja z zdravilom Vipdomet ne sme več uvesti.
English: Based on mean dialysate concentrations, approximately 7% of the active substance was removed during a 3-hour haemodialysis session.)
Slovenian: Na osnovi povprečnih koncentracij dializata se je med 3-urnim postopkom dialize odstranilo približno
English: More patients receiving 25 mg alogliptin and metformin (48.5%) achieved target HbA1c levels of ≤7.0% compared to those receiving glipizide and metformin (42.8%) (p=0.004).
Slovenian: Ciljne vrednosti HbA1c ≤7,0 % je doseglo več bolnikov, ki so prejemali alogliptin v odmerku 25 mg in metformin (48,5 %), v primerjavi z bolniki, ki so prejemali glipizid in metformin (42,8 %) (p=0,004).
English: No metabolites have been identified in humans.
Slovenian: Njegovih presnovkov pri človeku niso ugotovili.
English: What Vipdomet is used for
Slovenian: Za kaj uporabljamo zdravilo Vipdomet
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON (WITHOUT BLUE BOX) MULTIPACKS ONLY (2X98 TABLETS)
Slovenian: ŠKATLA V VEČODMERNEM PAKIRANJU (BREZ MODREGA OKENCA) SAMO VEČODMERNO PAKIRANJE (2X98 TABLET)
English: Significantly more patients receiving 25 mg alogliptin plus 30 mg pioglitazone and metformin (33.2%) achieved target HbA1c levels of ≤7.0% compared to those receiving 45 mg pioglitazone and metformin (21.3%) at Week 52 (p<0.001).
Slovenian: V 52. tednu je ciljne vrednosti HbA1c ≤7,0 % doseglo pomembno več bolnikov, ki so prejemali alogliptin v odmerku 25 mg v kombinaciji s 30 mg pioglitazona in z metforminom (33,2 %), v primerjavi z bolniki, ki so prejemali 45 mg pioglitazona in metformin (21,3 %) (p<0,001).
English: When renal function is impaired, renal clearance is decreased in proportion to that of creatinine and, thus, the elimination half-life is prolonged leading to increased levels of metformin in the plasma.
Slovenian: Razpolovni čas izločanja se tako podaljša, kar vodi v zvišanje vrednosti metformina v plazmi.
English: INFORMATION IN BRAILLE Vipdomet 12.5 mg/1000 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Vipdomet 12,5 mg/1000 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL (WITH BLUE BOX) MULTIPACKS ONLY (2X98 TABLETS)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA (Z MODRIM OKENCEM) SAMO VEČODMERNO PAKIRANJE ( 2X98 TABLET)
English: The combination revealed teratogenic potential in small numbers of foetuses (microphthalmia, small eye bulge and cleft palate) at higher doses of metformin (exposure margins of approximately 20-fold and 5- to 6-fold the maximum recommended human dose for alogliptin and metformin, respectively).
Slovenian: Pri večjih odmerkih metformina (meje izpostavljenosti približno 20-krat večje od izpostavljenosti človeka pri priporočenem odmerku alogliptina in 5- do 6-krat večje od izpostavljenosti človeka pri priporočenem odmerku metformina) je kombinacija pokazala majhen teratogeni potencial pri manjšem številu plodov (mikroftalmija, majhna očesna izboklina in palatoshiza).
English: INFORMATION IN BRAILLE Vipdomet 12.5 mg/1,000 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Vipdomet 12,5 mg/1.000 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON (WITH BLUE BOX) (EXCLUDING MULTIPACKS)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA (Z MODRIM OKENCEM) (BREZ VEČODMERNEGA PAKIRANJA)
English: Each 12.5 mg/850 mg film-coated tablet contains alogliptin benzoate equivalent to 12.5 mg alogliptin and 850 mg metformin hydrochloride.
Slovenian: Ena 12,5 mg/850 mg filmsko obložena tableta vsebuje alogliptinijev benzoat v količini, ki ustreza 12,5 mg alogliptina, in 850 mg metforminijevega klorida.
English: - Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 or history of a serious hypersensitivity reaction, including anaphylactic reaction, anaphylactic shock, and angioedema, to any dipeptidyl-peptidase-4 (DPP-4) inhibitor (see sections 4.4 and 4.8) - Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis) - Diabetic pre-coma - Severe renal failure (GFR <30 mL/min) - Acute conditions with the potential to alter renal function such as: - dehydration - severe infection - shock - Acute or chronic disease which may cause tissue hypoxia (see section 4.4) such as: - cardiac or respiratory failure - recent myocardial infarction - shock - Hepatic impairment (see section 4.4) - Acute alcohol intoxication, alcoholism (see sections 4.4 and 4.5)
Slovenian: - Preobčutljivost na učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1, ali anamneza hude preobčutljivostne reakcije, vključno z anafilaktično reakcijo, anafilaktičnim šokom in angioedemom po uporabi katerega koli zaviralca dipeptidil-peptidaze (DPP-4dipeptidyl-peptidase) (glejte poglavji 4.4 in 4.8).
English: - if you have a severe infection or are seriously dehydrated (have lost a lot of water from your body) - if you recently had a heart attack or have severe circulatory problems including shock - if you have severe breathing difficulties - if you have liver disease - if you drink alcohol excessively (either every day or in large quantities only from time to time)
Slovenian: - če ste pred kratkim doživeli srčni napad ali imate hude težave s krvnim obtokom, vključno s šokom.
English: What Vipdomet looks like and contents of the pack - Vipdomet 12.5 mg/850 mg film-coated tablets (tablets) are light yellow, oblong (approximately 21.0 mm long by 10.1 mm wide), biconvex, film-coated tablets with “12.5/850” debossed on one side and “322M” debossed on the other side.
Slovenian: Izgled zdravila Vipdomet in vsebina pakiranja - Vipdomet 12,5 mg/850 mg filmsko obložene tablete (tablete) so svetlo rumene, podolgovate (približno 21,0 mm dolge in 10,1 mm široke), obojestransko izbočene, filmsko obložene tablete z vtisnjeno oznako “12.5/850” na eni in “322M” na drugi strani.
English: Alogliptin has not been studied in patients with severe hepatic impairment (Child-Pugh score >9).
Slovenian: Pri bolnikih s hudo okvaro jeter (ocena po Child-Pugh-u >9) uporabe alogliptina niso raziskovali.
English: Due to its metformin component, Vipdomet should not be used in patients with severe renal impairment, or end-stage renal disease requiring dialysis (see section 4.2).
Slovenian: Pri bolnikih s hudo okvaro ledvic in bolnikih s končno ledvično odpovedjo, ki potrebujejo dializo, se zdravila Vipdomet zaradi vsebnosti metformina ne sme uporabljati (glejte poglavje 4.2).
English: Each 12.5 mg/1,000 mg film-coated tablet contains alogliptin benzoate equivalent to 12.5 mg alogliptin and 1,000 mg metformin hydrochloride.
Slovenian: Ena 12,5 mg/1.000 mg filmsko obložena tableta vsebuje alogliptinijev benzoat v količini, ki ustreza 12,5 mg alogliptina, in 1.000 mg metforminijevega klorida.
English: The pharmacokinetics of Vipdomet in children and adolescents <18 years old has not been established.
Slovenian: Farmakokinetika zdravila Vipdomet pri otrocih in mladostnikih, mlajših od 18 let, ni bila raziskana.
English: More patients receiving 25 mg alogliptin (7.8%) achieved target HbA1c levels of ≤7.0% compared to those receiving placebo (0.8%) at Week 26.
Slovenian: V 26. tednu je ciljne vrednosti HbA1c ≤ 7,0 % doseglo več bolnikov, ki so prejemali alogliptin v odmerku 25 mg (7,8 %), v primerjavi z bolniki, ki so prejemali placebo (0,8 %).
English: Significantly more patients receiving 25 mg alogliptin (49.2%) achieved target HbA1c levels of ≤7.0% compared to those receiving placebo (34.0%) at Week 26 (p=0.004).
Slovenian: V 26. tednu je ciljne vrednosti HbA1c ≤7,0 % doseglo pomembno več bolnikov, ki so prejemali alogliptin v odmerku 25 mg (49,2 %), v primerjavi z bolniki, ki so prejemali placebo (34,0 %) (p=0,004).
English: becoming breathless - Liver problems (hepatitis or liver function test abnormalities) - Erythema (redness of skin).
Slovenian: - Težave z jetri (vnetje jeter, nenormalni izvidi preiskav delovanja jeter).
English: However, mean peak plasma concentrations of alogliptin and metformin were decreased by 13% and 28% when Vipdomet was administered with food, respectively.
Slovenian: Vendar pa so se pri uporabi zdravila Vipdomet skupaj s hrano povprečne največje koncentracije alogliptina v plazmi zmanjšale za 13 %, povprečne največje koncentracije metformina v plazmi pa zmanjšale za 28 %.
English: You should not use Vipdomet if you are pregnant.
Slovenian: Med nosečnostjo zdravila Vipdomet ne smete jemati.
English: Alogliptin as add-on therapy to metformin with a thiazolidinedione The addition of 25 mg alogliptin once daily to pioglitazone therapy (mean dose = 35.0 mg, with or without metformin or a sulphonylurea) resulted in statistically significant improvements from baseline in HbA1c and fasting plasma glucose at Week 26 when compared to the addition of placebo (Table 2).
Slovenian: Alogliptin kot dodatek k zdravljenju z metforminom in s tiazolidindionom Dodatek alogliptina v odmerku 25 mg enkrat na dan k zdravljenju s pioglitazonom (povprečni odmerek = 35,0 mg, v kombinaciji z metforminom ali s sulfonilsečnino ali brez) je v 26. tednu povzročil statistično pomembna izboljšanja glede na izhodiščne vrednosti HbA1c in vrednosti glukoze v plazmi na tešče v primerjavi z dodatkom placeba (tabela 2).
English: - Vipdomet 12.5 mg/1,000 mg film-coated tablets (tablets) are pale yellow, oblong (approximately 22.3 mm long by 10.7 mm wide), biconvex, film-coated tablets with “12.5/1000” debossed on one side and “322M” debossed on the other side.
Slovenian: - Vipdomet 12,5 mg/1.000 mg filmsko obložene tablete (tablete) so bledo rumene, podolgovate (približno 22,3 mm dolge in 10,7 mm široke), obojestransko izbočene, filmsko obložene tablete z vtisnjeno oznako “12.5/1000” na eni in “322M” na drugi strani.
English: Vipdomet 12.5 mg/850 mg film-coated tablets Vipdomet 12.5 mg/1000 mg film-coated tablets alogliptin/metformin hydrochloride
Slovenian: Vipdomet 12,5 mg/850 mg filmsko obložene tablete Vipdomet 12,5 mg/1.000 mg filmsko obložene tablete alogliptin/metforminijev klorid
English: Hepatobiliary disorders hepatitis very rare
Slovenian: zelo redki hipoglikemija pogosti pogosti
English: Significantly more patients receiving 25 mg alogliptin (44.4%) achieved target HbA1c levels of ≤7.0% compared to those receiving placebo (18.3%) at Week 26 (p<0.001).
Slovenian: V 26. tednu je ciljne vrednosti HbA1c ≤7,0 % doseglo pomembno več bolnikov, ki so prejemali alogliptin v odmerku 25 mg (44,4 %), v primerjavi z bolniki, ki so prejemali placebo (18,3 %) (p<0,001).
English: Alogliptin as add-on therapy to metformin with insulin The addition of 25 mg alogliptin once daily to insulin therapy (mean dose = 56.5 IU, with or without metformin) resulted in statistically significant improvements from baseline in HbA1c and FPG at Week 26 when compared to the addition of placebo (Table 2).
Slovenian: Alogliptin kot dodatek k zdravljenju z metforminom in insulinom Dodatek alogliptina v odmerku 25 mg enkrat na dan k zdravljenju z insulinom (povprečni odmerek = 56,5 i.e., z metforminom ali brez) je v 26. tednu povzročil statistično pomembna izboljšanja glede na izhodiščne vrednosti HbA1c in vrednosti glukoze v plazmi na tešče v primerjavi z dodatkom placeba (tabela 2).
English: If necessary, the dose of Vipdomet should be adjusted during therapy with the other medicinal product and upon its discontinuation.
Slovenian: Med zdravljenjem in po prekinitvi zdravljenja z drugim zdravilom bo odmerek zdravila Vipdomet morda treba prilagoditi.
English: How to store Vipdomet
Slovenian: Shranjevanje zdravila Vipdomet
English: NAME OF THE MEDICINAL PRODUCT Vipdomet 12.5 mg/1,000 mg tablets alogliptin/metformin hydrochloride
Slovenian: IME ZDRAVILA Vipdomet 12,5 mg/1.000 mg tablete alogliptin/metforminijev klorid
English: This has been shown at therapeutic doses in controlled, medium-term or long-term clinical studies; metformin reduces total cholesterol, LDL cholesterol and triglyceride levels.
Slovenian: To je bilo dokazano ob terapevtskih odmerkih v nadzorovanih srednjeročnih ali dolgoročnih kliničnih študijah.
English: - Keep this leaflet.
Slovenian: - Izpuščaj.
English: It is especially important to mention the following: - hydrocortisone and prednisolone (corticosteroids), used to treat diseases that involve inflammation like asthma and arthritis - cimetidine, used to treat stomach problems - bronchodilators (beta-2 agonists), used to treat asthma - medicines which increase urine production (diuretics) - medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib), - certain medicines used for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists) - medicines containing alcohol.
Slovenian: Posebno pomembno je omeniti naslednje: - hidrokortizon in prednizolon (kortikosteroida), ki ju uporabljamo za zdravljenje bolezni, ki vključujejo vnetja, kot sta astma in artritis.
English: NAME OF THE MEDICINAL PRODUCT Vipdomet 12.5 mg/850 mg tablets alogliptin/metformin hydrochloride
Slovenian: IME ZDRAVILA Vipdomet 12,5 mg/850 mg tablete alogliptin/metforminijev klorid
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg alogliptin (as benzoate) and 850 mg metformin hydrochloride.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 12,5 mg alogliptina (v obliki benzoata) in 850 mg metforminijevega klorida.
English: NAME OF THE MEDICINAL PRODUCT Vipdomet 12.5 mg/850 mg film-coated tablets Vipdomet 12.5 mg/1,000 mg film-coated tablets
Slovenian: Vipdomet 12,5 mg/850 mg filmsko obložene tablete Vipdomet 12,5 mg/1.000 mg filmsko obložene tablete
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/843/026 196 (2x98) film-coated tablets (multipack)
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/843/026 196 (2x98) filmsko obloženih tablet (večodmerno pakiranje)
English: No studies in lactating animals have been conducted with the combined active substances of Vipdomet.
Slovenian: Študije s kombinacijo zdravilnih učinkovin zdravila Vipdomet pri živalih med laktacijo niso bile izvedene.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/843/025 196 (2x98) film-coated tablets (multipack)
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/843/025 196 (2x98) filmsko obloženih tablet (večodmerno pakiranje)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/843/025 2x98 film-coated tablets
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/843/025 2x98 filmsko obloženih tablet
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg alogliptin (as benzoate) and 1,000 mg metformin hydrochloride.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena tableta vsebuje 12,5 mg alogliptina (v obliki benzoata) in 1000 mg metforminijevega klorida.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/843/026 2x98 film-coated tablets
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/13/843/026 2x98 filmsko obloženih tablet
English: After administration of single oral doses of up to 800 mg in healthy subjects, alogliptin was rapidly absorbed with peak plasma concentrations occurring 1 to 2 hours (median Tmax) after dosing.
Slovenian: Največje koncentracije v plazmi so bile dosežene 1 do 2 uri (mediana vrednost Tmax) po odmerku.