FrancophonIA/ELRC3.0 huggingface dataset:
English: Incresync is not recommended for patients with severe renal impairment or end-stage renal disease requiring dialysis.
Slovak: Incresync sa neodporúča pacientom s vážnou poruchou funkcie obličiek alebo ochorením obličiek v terminálnom štádiu vyžadujúcim dialýzu.
English: No clinically relevant accumulation after multiple dosing was observed in either healthy subjects or in patients with type 2 diabetes mellitus.
Slovak: U zdravých účastníkov ani u pacientov s ochorením diabetes mellitus 2. typu nebola pozorovaná žiadna klinicky významná akumulácia po viacnásobnom podaní lieku.
English: Alogliptin is primarily excreted unchanged in the urine and metabolism by the cytochrome (CYP) P450 enzyme system is negligible (see section 5.2).
Slovak: Alogliptín sa primárne vylučuje nezmenený v moči a jeho metabolizmus enzýmovým systémom cytochrómu (CYP)
English: Proportional increases of the serum concentration were observed for doses from 2-60 mg. Steady-state is achieved after 4-7 days of dosing.
Slovak: Rovnovážny stav sa dosiahne po 4 - 7 dňoch dávkovania.
English: Incresync 12.5 mg/30 mg film-coated tablets Incresync 12.5 mg/45 mg film-coated tablets Incresync 25 mg/30 mg film-coated tablets Incresync 25 mg/45 mg film-coated tablets alogliptin/pioglitazone
Slovak: Incresync 12,5 mg/30 mg filmom obalené tablety Incresync 12,5 mg/40 mg filmom obalené tablety Incresync 25 mg/30 mg filmom obalené tablety Incresync 25 mg/45 mg filmom obalené tablety alogliptín/pioglitazón
English: A cardiovascular outcome study of pioglitazone has been performed in patients under 75 years with type 2 diabetes mellitus and pre-existing major macrovascular disease.
Slovak: U pacientov mladších ako 75 rokov s ochorením diabetes mellitus 2. typu a závažným makrovaskulárnym ochorením v minulosti bola vykonaná kardiovaskulárna dopadová štúdia pioglitazónu.
English: Uncommon (may affect up to 1 in 100 people): - Symptoms of bladder cancer including blood in your urine, pain when urinating or a sudden need to urinate.
Slovak: Príznaky rakoviny močového mechúra vrátane krvi v moči, bolesti pri močení alebo náhlej potreby močiť.
English: Nonfatal Stroke *Overall there were 153 subjects (5.7%) in the alogliptin group and 173 subjects (6.5%) in the placebo group who died (all-cause mortality)
Slovak: *Celkovo zomrelo (všetky príčiny) 153 pacientov (5,7
English: Therefore, one tablet of 12.5 mg/30 mg or 12.5 mg/45 mg once daily, depending on the dose of pioglitazone already being taken, is recommended in patients with moderate renal impairment (see section 5.2).
Slovak: U pacientov so stredne ťažkou poruchou obličiek sa preto odporúča podávať jednu tabletu 12,5 mg/30 mg alebo 12,5 mg/45 mg raz denne v závislosti na dennej dávke pioglitazónu, ktorá sa už užíva (pozri časť 5.2).
English: No environmental impact is anticipated from the clinical use of pioglitazone.
Slovak: Klinické používanie pioglitazónu nepredpokladá žiadne negatívne vplyvy na životné prostredie.
English: Two minor metabolites were detected following administration of an oral dose of [14C] alogliptin, N-demethylated alogliptin, M-I (< 1% of the parent compound), and N-acetylated alogliptin, M-II (< 6% of the parent compound).
Slovak: Po podaní perorálnej dávky [14C] alogliptínu boli zistené dva vedľajšie metabolity - N-demetylovaný alogliptín, M-I (<
English: INFORMATION IN BRAILLE Incresync 25 mg/45 mg
Slovak: INFORMÁCIE V BRAILLOVOM PÍSME Incresync 25 mg/45 mg
English: In clinical studies of up to two years duration, pioglitazone reduced total plasma triglycerides and free fatty acids, and increased HDL-cholesterol levels compared to placebo, metformin or gliclazide.
Slovak: Pri porovnaní s placebom, metformínom a gliklazidom v klinických štúdiách trvajúcich až dva roky pioglitazón redukoval celkové plazmatické hladiny triglyceridov a voľných mastných kyselín a zvyšoval hladinu HDL cholesterolu.
English: Alogliptin has not been studied in patients with severe hepatic impairment (Child-Pugh score > 9).
Slovak: Použitie alogliptínu u pacientov so závažnou poruchou funkcie pečene (Childovo-Pughovo skóre >
English: Therapy with Incresync should not be initiated in patients with increased baseline liver enzyme levels (ALT > 2.5 x upper limit of normal) or with any other evidence of liver disease.
Slovak: Liečbu Incresyncom nie je možné začať u pacientov so zvýšenými východiskovými hladinami pečeňových enzýmov (ALT >
English: Post-marketing reports of new-onset or worsening diabetic macular oedema with decreased visual acuity have been reported with thiazolidinediones, including pioglitazone.
Slovak: Počas sledovania boli v súvislosti s tiazolidíndiónmi, vrátane pioglitazónu zaznamenané hlásenia vzniku alebo zhoršenia diabetického makulárneho edému so zníženou ostrosťou videnia.
English: There have been spontaneously reported adverse reactions of acute pancreatitis in the post-marketing setting.
Slovak: Po uvedení na trh došlo k spontánnemu hláseniu nežiaducich reakcií akútnej pankreatitídy.
English: Time-dependency
Slovak: Čas použiteľnosti
English: - Liver problems such as nausea or vomiting, stomach pain, unusual or unexplained tiredness,
Slovak: - Problémy s pečeňou, ako napr. nevoľnosť alebo vracanie, bolesť žalúdka, nezvačajná alebo nevysvetliteľná únava, strata chuti do jedla, tmavý moč alebo zažltnutie pokožky či očných bielok.
English: No dose adjustment of Incresync for patients with mild renal impairment is necessary (see section 4.2).
Slovak: U pacientov s miernou poruchou funkcie obličiek úprava dávky Incresyncu nie je potrebná (pozri časť 4.2).
English: No increase in fracture rates was observed in men treated with pioglitazone (1.3%) versus comparator (1.5%).
Slovak: Zvýšenie početnosti výskytu fraktúr nebolo pozorované u mužov liečených pioglitazónom (1,3
English: Incresync should be discontinued if any deterioration in cardiac status occurs.
Slovak: Pri akejkoľvek progresii srdcového zlyhania sa Incresync musí vysadiť.
English: Post marketing cases of peripheral oedema and cardiac failure have also been reported in patients with concomitant use of pioglitazone and nonsteroidal anti-inflammatory drugs (NSAIDs), including selective COX-2 inhibitors.
Slovak: U pacientov, ktorí súbežne užívajú pioglitazón a nesteroidné protizápalové lieky (NSAIDs) vrátane selektívnych inhibítorov COX-2, boli hlásené aj prípady periférneho edému a zlyhania srdca po uvedení lieku na trh.
English: In the 3.5 year PROactive study, 44/870 (5.1%) of pioglitazone-treated female patients experienced fractures compared to 23/905 (2.5%) of female patients treated with comparator.
Slovak: V 3,5-ročnej štúdii PROactive došlo k fraktúram u 44 z 870 pacientok liečených pioglitazónom (5,1
English: In the alogliptin group, 12.7% (344 subjects) experienced an event within the secondary MACE composite endpoint, compared with 13.4% (359 subjects) in the placebo group [Hazard Ratio = 0.95; 1-sided 99% Confidence Interval: 0-1.14].
Slovak: % (359) pacientov v skupine s placebom [pomer rizika = 0,95; 1-stranný 99 % interval spoľahlivosti: 0 - 1,14].
English: INFORMATION IN BRAILLE Incresync 12.5 mg/45 mg
Slovak: INFORMÁCIE V BRAILLOVOM PÍSME Incresync 12,5 mg/45 mg
English: INFORMATION IN BRAILLE Incresync 12.5 mg/30 mg
Slovak: INFORMÁCIE V BRAILLOVOM PÍSME Incresync 12,5 mg/30 mg
English: Current bladder cancer or a history of bladder cancer (see section 4.4) Uninvestigated macroscopic haematuria (see section 4.4)
Slovak: Nepreskúmaná makroskopická hematúria (pozri časť 4.4)
English: Similar changes were seen in metformin- (haemoglobin 3-4% and haematocrit 3.6-4.1% relative reductions) and to a lesser extent sulphonylurea- and insulin- (haemoglobin 1-2% and haematocrit 1-3.2% relative reductions) treated patients in comparative-controlled studies with pioglitazone.
Slovak: %) a do menšej miery so sulfonylureou a inzulínom (relatívny pokles: hemoglobín 1 - 2 % a hematokrit 1 - 3,2
English: INFORMATION IN BRAILLE Incresync 25 mg/30 mg
Slovak: INFORMÁCIE V BRAILLOVOM PÍSME Incresync 25 mg/30 mg
English: (1-sided CI)
Slovak: (1-stranný interval spoľahlivosti (CI))
English: In vitro data indicate that CYP2D6 and CYP3A4 contribute to the limited metabolism of alogliptin.
Slovak: M-II nevykazuje žiadnu inhibičnú aktivitu voči DPP-4 ani enzýmom súvisiacim s DPP. In vitro údaje indikujú, že CYP2D6 a CYP3A4 prispievajú k limitovanému metabolizmu alogliptínu.
English: TAKEDA ΕΛΛΑΣ Α.Ε Tel: +30 210 6387800 gr.info@takeda.com
Slovak: +30 210 6387800 gr.info@takeda.com
English: - The other ingredients are mannitol, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, lactose monohydrate, hypromellose, talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), macrogol 8000, shellac and black iron oxide (E172).
Slovak: - Ďalšie zložky sú: manitol, mikrokryštalická celulóza, hydroxypropylcelulóza, kroskarmelóza sodná soľ, stearan horečnatý, monohydrát laktózy, hypromelóza, mastenec, oxid titaničitý (E171), železitá žltá (E172), železitá červená (E172), makrogol 8000, šelak a železitá čierna (E172).
English: Marketing Authorisation Holder Takeda Pharma A/S Dybendal Alle 10
Slovak: Držiteľ rozhodnutia o registrácii Takeda Pharma A/S
English: - The other ingredients are mannitol, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, magnesium stearate, lactose monohydrate, hypromellose, talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), macrogol 8000, shellac, carnauba wax and glycerol mono-oleate.
Slovak: - Ďalšie zložky sú: manitol, mikrokryštalická celulóza, hydroxypropylcelulóza, kroskarmelóza sodná soľ, stearan horečnatý, monohydrát laktózy, hypromelóza, mastenec, oxid titaničitý (E171), železitá žltá (E172), železitá červená (E172), makrogol 8000, šelak, vosk karnaubský a glycerol monooleát.
English: In addition, 25 mg alogliptin alone and in combination with 30 mg pioglitazone produced statistically significant (p<0.001) reductions in total triglycerides at Week 16 as measured by postprandial incremental AUC(0-8) change from baseline compared to placebo.
Slovak: 0,001) zníženia celkových triglyceridov pri návšteve v týždni 16 namerané podľa postprandiálnej prírastkovej zmeny AUC(0-8) z prvej návštevy v porovnaní s placebom.
English: Table 1: Adverse reactions System organ class Adverse reaction
Slovak: Tabuľka 1: Nežiaduce reakcie
English: Red, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets with both “A/P” and “25/45” printed in grey ink on one side.
Slovak: Červené, okrúhle (s priemerom približne 8,7 mm), bikonvexné, filmom obalené tablety s označením „A/P“ a „25/45“ vytlačeným v sivej farbe na jednej strane.
English: A single dose of 50 mg alogliptin was administered to 4 groups of patients with varying degrees of renal impairment (CrCl using the Cockcroft-Gault formula): mild (CrCl = > 50 to ≤ 80 mL/min), moderate (CrCl = ≥ 30 to ≤ 50 mL/min), severe (CrCl = < 30 mL/min) and end-stage renal disease on haemodialysis.
Slovak: Jednorazová dávka 50 mg alogliptínu bola podaná 4 skupinám pacientov s rôznymi stupňami poruchy funkcie obličiek (CrCl pomocou Cockcroftho a Gaultovho vzorca):
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Slovak: Ak užívate alebo ste v poslednom čase užívali, či práve budete užívať ďalšie lieky, povedzte to svojmu lekárovi alebo lekárnikovi.
English: For patients with moderate renal impairment (CrCl ≥ 30 to ≤ 50 mL/min), one-half of the recommended dose of alogliptin should be administered.
Slovak: 50 ml/min.) je nutné podávať polovicu odporúčanej dávky alogliptínu.
English: België/Belgique/Belgien/ Luxembourg/Luxemburg Takeda Belgium Tél/Tel: +32 2 464 06 11 takeda-belgium@takeda.com
Slovak: +32 2 464 06 11 takeda-belgium@takeda.com
English: No increase in fracture rates was observed in men treated with pioglitazone (1.7%) versus comparator (2.1%).
Slovak: Zvýšenie početnosti výskytu fraktúr nebolo pozorované u mužov liečených pioglitazónom (1,7
English: For patients with mild renal impairment (creatinine clearance (CrCl) > 50 to ≤ 80 mL/min), no dose adjustment of Incresync is necessary (see section 5.2).
Slovak: 80 ml/min.) nie je nutná úprava dávky Incresyncu (pozri časť 5.2).
English: The risk of fractures should be considered in the long-term care of patients treated with Incresync (see section 4.8).
Slovak: Incresyncom treba zvážiť riziko fraktúr (pozri časť 4.8).
English: 12.5 mg/45 mg film-coated tablets
Slovak: 12,5 mg/45 mg filmom obalené tablety
English: In the 3.5 year cardiovascular risk PROactive study, 44/870 (5.1%; 1.0 fractures per 100 patient years) of pioglitazone-treated female patients experienced fractures compared to 23/905 (2.5%; 0.5 fractures per 100 patient years) of female patients treated with comparator.
Slovak: %; 1,0 fraktúr na 100 pacientorokov) v porovnaní s 23 z 905 pacientok liečených komparátorom (2,5
English: 12.5 mg/30 mg film-coated tablets
Slovak: 12,5 mg/30 mg filmom obalené tablety
English: Incresync 25 mg/30 mg film-coated tablets
Slovak: Incresync 25 mg/30 mg filmom obalené tablety
English: Incresync 25 mg/45 mg film-coated tablets
Slovak: Incresync 25 mg/45 mg filmom obalené tablety
English: No dose adjustment is necessary based on age (see section 4.4).
Slovak: Úprava dávky pre starších pacientov nie je nutná (pozri časť 4.4).
English: Intrinsic clearance is, therefore, reduced coupled with a higher unbound fraction of pioglitazone (see section 4.2).
Slovak: Z tohto dôvodu je vlastný klírens znížený spolu s vyšším podielom voľnej frakcie pioglitazónu.
English: Carnauba wax Glycerol mono-oleate Glycerol mono-oleate
Slovak: Glycerol monooleát
English: Each tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 25 mg alogliptin and 45 mg pioglitazone.
Slovak: Každá tableta obsahuje alogliptín benzoát a pioglitazón hydrochlorid zodpovedajúci 25 mg alogliptínu a 45 mg pioglitazónu.
English: 25 mg/30 mg film-coated tablets
Slovak: 25 mg/30 mg filmom obalené tablety
English: 25 mg/45 mg film-coated tablets
Slovak: 25 mg/45 mg filmom obalené tablety
English: Each 25 mg/45 mg film-coated tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 25 mg alogliptin and 45 mg pioglitazone.
Slovak: Každá filmom obalená tableta 25 mg/45 mg obsahuje alogliptín benzoát a pioglitazón hydrochlorid zodpovedajúci 25 mg alogliptínu a 45 mg pioglitazónu.
English: Placebo-corrected change from baseline in HbA1c (%)†
Slovak: Placebom korigovaná zmena HbA1c od prvej návštevy
English: Therefore, no dose adjustment of alogliptin is necessary for patients with mild to moderate hepatic impairment (Child-Pugh scores of 5 to 9).
Slovak: U pacientov s miernou až stredne závažnou poruchou funkcie pečene (Childovo-Pughovo skóre 5 až 9) preto nie je nutná úprava dávky alogliptínu.
English: - Incresync 25 mg/45 mg film-coated tablets (tablets) are red, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets, with both “A/P” and “25/45” printed in grey ink on one side.
Slovak: Incresync 25 mg/45 mg filmom obalené tablety (tablety) sú červené, okrúhle (s priemerom približne 8,7 mm), bikonvexné, filmom obalené tablety s označením „A/P“ a „25/45“ vytlačeným v sivej farbe na jednej strane.
English: Foetal growth restriction was apparent in animal studies with pioglitazone.
Slovak: Štúdie pioglitazónu na zvieratách preukázali zjavnú reštrikciu rastu plodu.
English: Each tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 25 mg alogliptin and 30 mg pioglitazone.
Slovak: Každá tableta obsahuje alogliptín benzoát a pioglitazón hydrochlorid zodpovedajúci 25 mg alogliptínu a 30 mg pioglitazónu.
English: LOCF = last observation carried forward * Non inferiority and superiority statistically demonstrated † Least squares means adjusted for prior antihyperglycaemic therapy status and baseline values
Slovak: † Metóda najmenších štvorcov prispôsobená na stav pred antihyperglykemickou liečbou a hodnoty pri prvej návšteve
English: Fasting and postprandial glycaemic control is improved following treatment with pioglitazone in patients with type 2 diabetes mellitus.
Slovak: 2. typu sa vplyvom liečby pioglitazónom zlepšuje kontrola glykémie nalačno aj po jedle.
English: Mean baseline HbA1c (%) (SD)
Slovak: %) dosiahlo cieľové hladiny HbA1c ≤
English: Each 12.5 mg/45 mg film-coated tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 12.5 mg alogliptin and 45 mg pioglitazone.
Slovak: Každá filmom obalená tableta 12,5 mg/45 mg obsahuje alogliptín benzoát a pioglitazón hydrochlorid zodpovedajúci 12,5 mg alogliptínu a 45 mg pioglitazónu.
English: Each 25 mg/30 mg film-coated tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 25 mg alogliptin and 30 mg pioglitazone.
Slovak: Každá filmom obalená tableta 25 mg/30 mg obsahuje alogliptín benzoát a pioglitazón hydrochlorid zodpovedajúci 25 mg alogliptínu a 30 mg pioglitazónu.
English: BATCH NUMBER Lot
Slovak: Placebo N =
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 25 mg alogliptin (as benzoate) and 45 mg pioglitazone (as hydrochloride).
Slovak: Každá tableta obsahuje 25 mg alogliptínu (ako benzoát) a 45 mg pioglitazónu (ako hydrochlorid).
English: Treatment-corrected change from baseline in HbA1c (%)†
Slovak: Tabuľka 3: Zmena v hladine HbA1c
English: An increased incidence of hyperplasia (males and females) and tumours (males) of the urinary bladder epithelium was apparent in rats treated with pioglitazone for up to 2 years.
Slovak: U potkanov liečených pioglitazónom v trvaní až 2 roky sa pozorovala zvýšená incidencia hyperplázie (u samcov a samíc) a nádorov výstelky močového mechúra (u samcov).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg alogliptin (as benzoate) and 30 mg pioglitazone (as hydrochloride).
Slovak: Každá tableta obsahuje 12,5 mg alogliptínu (ako benzoát) a 30 mg pioglitazónu (ako hydrochlorid).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg alogliptin (as benzoate) and 45 mg pioglitazone (as hydrochloride).
Slovak: Každá tableta obsahuje 12,5 mg alogliptínu (ako benzoát) a 45 mg pioglitazónu (ako hydrochlorid).
English: NAME OF THE MEDICINAL PRODUCT Incresync 12.5 mg/45 mg tablets alogliptin/pioglitazone
Slovak: Incresync 12,5 mg/45 mg tablety alogliptín/pioglitazón
English: - Incresync 12.5 mg/45 mg film-coated tablets (tablets) are pale red, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets, with both “A/P” and “12.5/45” printed in red ink on one side.
Slovak: Incresync 12,5 mg/45 mg filmom obalené tablety (tablety) sú bledočervené, okrúhle (s priemerom približne 8,7 mm), bikonvexné, filmom obalené tablety s označením „A/P“ a „12.5/45“ vytlačeným v červenej farbe na jednej strane.
English: NAME OF THE MEDICINAL PRODUCT Incresync 25 mg/45 mg film-coated tablets alogliptin/pioglitazone
Slovak: Incresync 25 mg/45 mg filmom obalené tablety alogliptín/pioglitazón
English: Alogliptin as add-on therapy to pioglitazone with metformin The addition of 25 mg alogliptin once daily to 30 mg pioglitazone in combination with metformin hydrochloride therapy (mean dose = 1,867.9 mg) resulted in improvements from baseline in HbA1c at Week 52 that were both non-inferior and statistically superior to those produced by 45 mg pioglitazone in combination with metformin hydrochloride therapy (mean dose = 1,847.6 mg, Table 3).
Slovak: 1 867,9 mg) boli zlepšenia od prvej návštevy, čo sa týka hladiny HbA1c pri návšteve v týždni 52, ktoré boli neinferiórne, ako aj štatisticky superiórne, zlepšeniam vyvolaným liečbou 45 mg pioglitazónu v kombinácii s metformínom vo forme hydrochloridu (stredná hodnota dávky =
English: A higher rate of fractures was observed in women taking pioglitazone (2.6%) versus comparator (1.7%).
Slovak: Bol pozorovaný zvýšený výskyt fraktúr u žien užívajúcich pioglitazón (2,6
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 25 mg alogliptin (as benzoate) and 30 mg pioglitazone (as hydrochloride).
Slovak: Každá tableta obsahuje 25 mg alogliptínu (ako benzoát) a 30 mg pioglitazónu (ako hydrochlorid).
English: EU/1/13/842/028 10 film-coated tablets EU/1/13/842/029 14 film-coated tablets EU/1/13/842/030 28 film-coated tablets EU/1/13/842/031 30 film-coated tablets EU/1/13/842/032 56 film-coated tablets EU/1/13/842/033 60 film-coated tablets EU/1/13/842/034 90 film-coated tablets EU/1/13/842/035 98 film-coated tablets EU/1/13/842/036 100 film-coated tablets
Slovak: EU/1/13/842/028 10 filmom obalených tabliet EU/1/13/842/029 14 filmom obalených tabliet EU/1/13/842/030 28 filmom obalených tabliet EU/1/13/842/031 30 filmom obalených tabliet EU/1/13/842/032 56 filmom obalených tabliet EU/1/13/842/033 60 filmom obalených tabliet EU/1/13/842/034 90 filmom obalených tabliet EU/1/13/842/035 98 filmom obalených tabliet EU/1/13/842/036 100 filmom obalených tabliet
English: NAME OF THE MEDICINAL PRODUCT Incresync 12.5 mg/30 mg tablets alogliptin/pioglitazone
Slovak: Incresync 12,5 mg/30 mg tablety alogliptín/pioglitazón
English: NAME OF THE MEDICINAL PRODUCT Incresync 25 mg/30 mg film-coated tablets alogliptin/pioglitazone
Slovak: Incresync 25 mg/30 mg filmom obalené tablety alogliptín/pioglitazón
English: NAME OF THE MEDICINAL PRODUCT Incresync 25 mg/45 mg tablets alogliptin/pioglitazone
Slovak: Incresync 25 mg/45 mg tablety alogliptín/pioglitazón
English: EU/1/13/842/001 10 film-coated tablets EU/1/13/842/002 14 film-coated tablets EU/1/13/842/003 28 film-coated tablets EU/1/13/842/004 30 film-coated tablets EU/1/13/842/005 56 film-coated tablets EU/1/13/842/006 60 film-coated tablets EU/1/13/842/007 90 film-coated tablets EU/1/13/842/008 98 film-coated tablets EU/1/13/842/009 100 film-coated tablets
Slovak: 10 filmom obalených tabliet EU/1/13/842/002 14 filmom obalených tabliet EU/1/13/842/003 28 filmom obalených tabliet EU/1/13/842/004 30 filmom obalených tabliet EU/1/13/842/005 56 filmom obalených tabliet EU/1/13/842/006 60 filmom obalených tabliet EU/1/13/842/007 90 filmom obalených tabliet EU/1/13/842/008 98 filmom obalených tabliet EU/1/13/842/009 100 filmom obalených tabliet
English: Cardiac failure or history of cardiac failure (NYHA stages I to IV; see section 4.4) Hepatic impairment (see section 4.4)
Slovak: Poruchy funkcie pečene (pozri časť 4.4)
English: - Incresync 12.5 mg/30 mg film-coated tablets (tablets) are pale peach, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets, with both “A/P” and “12.5/30” printed in red ink on one side.
Slovak: Incresync 12,5 mg/30 mg filmom obalené tablety (tablety) sú bledobroskyňové, okrúhle (s priemerom približne 8,7 mm), bikonvexné, filmom obalené tablety s označením „A/P“ a „12.5/30“ vytlačeným v červenej farbe na jednej strane.
English: NAME OF THE MEDICINAL PRODUCT Incresync 12.5 mg/45 mg film-coated tablets alogliptin/pioglitazone
Slovak: Incresync 12,5 mg/45 mg filmom obalené tablety alogliptín/pioglitazón
English: The overall incidence of episodes of severe hypoglycaemia was comparable in patients treated with 25 mg alogliptin or 12.5 mg alogliptin,
Slovak: Celková incidencia epizód ťažkej hypoglykémie bola porovnateľná u pacientov liečených 25 mg alogliptínu alebo 12,5 mg alogliptínu a nižšia ako incidencia u pacientov liečených aktívnou kontrolou alebo placebom (0,1
English: In the alogliptin group, 11.3% of patients experienced a MACE compared to 11.8% of patients in the placebo group.
Slovak: V skupine s alogliptínom sa udalosť MACE vyskytla u 11,3
English: NAME OF THE MEDICINAL PRODUCT Incresync 25 mg/30 mg tablets alogliptin/pioglitazone
Slovak: Incresync 25 mg/30 mg tablety alogliptín/pioglitazón
English: NAME OF THE MEDICINAL PRODUCT Incresync 12.5 mg/30 mg film-coated tablets alogliptin/pioglitazone
Slovak: Incresync 12,5 mg/30 mg filmom obalené tablety alogliptín/pioglitazón
English: Each12.5 mg/30 mg film-coated tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 12.5 mg alogliptin and 30 mg pioglitazone.
Slovak: Incresync 12,5 mg/30 mg filmom obalené tablety Každá tableta obsahuje alogliptín benzoát a pioglitazón hydrochlorid zodpovedajúci 12,5 mg alogliptínu a 30 mg pioglitazónu.