FrancophonIA/ELRC3.0 huggingface dataset:
English: Co-administration of pioglitazone with rifampicin (an inducer of cytochrome P450 2C8) is reported to result in a 54% decrease in AUC for pioglitazone.
Croatian: Prijavljeno je da istodobna primjena pioglitazona s rifampicinom (induktor citokroma P450 2C8) rezultira smanjenjem AUC-a pioglitazona za 54%.
English: Based on mean dialysate concentrations, approximately 7% of the active substance was removed during a 3-hour haemodialysis session.
Croatian: Temeljem srednjih vrijednosti koncentracija dijalizata, u 3-satnoj hemodijalizi ukloni se približno 7% lijeka.
English: This indicates no time-dependency in the kinetics of alogliptin after multiple dosing.
Croatian: To ukazuje da kinetika alogliptina ne ovisi o vremenu ni nakon višekratnog doziranja.
English: The following section outlines the pharmacokinetic properties of the individual components of Incresync (alogliptin/pioglitazone) as reported in their respective Summary of Product Characteristics.
Croatian: U sljedećem dijelu navedene se farmakokinetička svojstva pojedinačnih sastojaka Incresynca (alogliptin/pioglitazon) kako su navedene u Sažetku opisa svojstava lijeka svakog od njih.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Takeda
Croatian: ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Takeda
English: Clinical studies conducted to support the efficacy of Incresync involved the co-administration of alogliptin and pioglitazone as separate tablets.
Croatian: Klinička ispitivanja provedena za potvrdu djelotvornosti Incresynca uključivala su istodobnu primjenu alogliptina i pioglitazona kao zasebnih tableta.
English: In toxicology studies, plasma volume expansion with haemodilution, anaemia and reversible eccentric cardiac hypertrophy was consistently apparent after repeated dosing of mice, rats, dogs and monkeys.
Croatian: U toksikološkim ispitivanjima nakon ponovljenog doziranja u miševa, štakora, pasa i majmuna dosljedno su primijećeni povećanje volumena plazme s hemodilucijom, anemija i reverzibilna ekscentrična hipertrofija srca.
English: The significant reductions in HbA1c observed with 25 mg alogliptin plus 30 mg pioglitazone and metformin were consistent over the entire 52-week treatment period compared to 45 mg pioglitazone and metformin (p<0.001 at all time points).
Croatian: Značajna sniženja HbA1c opažena s 25 mg alogliptina s 30 mg pioglitazona i metforminom u usporedbi s 45 mg pioglitazona s metforminom bio je dosljedno tijekom čitavog 52-tjednog razdoblja liječenja (p<0,001 u svim vremenskim točkama).
English: Although fertility was not affected, a slight, statistical increase in the number of abnormal sperm was observed in males at an exposure far above the human exposure at the recommended dose.
Croatian: Iako plodnost nije bila oštećena, u mužjaka pri izloženosti koja je daleko iznad izloženosti kod ljudi pri preporučenoj dozi opaženo je blago, statističko povećanje broja abnormalnih spermija.
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).
Croatian: Stoga se bolesnicima s umjerenim oštećenjem bubrega preporučuje jedna tableta od 12,5/30 mg ili 12,5/45 mg jedanput na dan, ovisno o dozi pioglitazona koju bolesnik već uzima (vidjeti dio 5.2).
English: How to store Incresync
Croatian: Kako čuvati Incresync
English: For the different dose regimens Incresync is available in strengths of 25 mg/30 mg, 25 mg/45 mg, 12.5 mg/30 mg and 12.5 mg/45 mg film-coated tablets.
Croatian: Za različite režime doziranja Incresync je dostupan kao filmom obložene tablete u jačinama od 25 mg/30mg, 25 mg/45 mg, 12,5 mg/30 mg i 12,5 mg/45 mg.
English: In addition, mean change from baseline in fasting plasma glucose 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).
Croatian: Dodatno, srednja vrijednost promjene od početne vrijednosti glukoze u plazmi natašte bila je u 52. tjednu značajno veća s 25 mg alogliptina i 30 mg pioglitazona i metforminom nego za 45 mg pioglitazona s metforminom (p<0,001).
English: No dose adjustment of Incresync for patients with mild renal impairment is necessary (see section 4.2).
Croatian: Nije potrebna prilagodba doze u bolesnika s blagim oštećenjem bubrega (vidjeti dio 4.2)
English: Infections and infestations upper respiratory tract infections common common common nasopharyngitis common sinusitis uncommon common
Croatian: Infekcije i infestacije Infekcije gornjeg respiratornog trakta
English: - Liver problems such as nausea or vomiting, stomach pain, unusual or unexplained tiredness,
Croatian: • problemi s jetrom poput mučnine ili povraćanja, boli u trbuhu, neobičnog ili neobjašnjivog umora, gubitka teka, tamne mokraće ili žutila kože i bjeloočnica.
English: Concomitant administration of pioglitazone with gemfibrozil (an inhibitor of cytochrome P450 2C8) or with rifampicin (an inducer of cytochrome P450 2C8) is reported to increase or decrease, respectively, the serum concentration of pioglitazone (see section 4.5).
Croatian: Opaženo je da istodobna primjena pioglitazona s gemfibrozilom (inhibitor citokroma P450 2C8) povećava, a s rifampicinom (induktor citokroma P450 2C8) snižava koncentracije pioglitazona u serumu (vidjeti dio 4.5).
English: Therefore, in order to maintain systemic exposures to alogliptin that are similar to those observed in patients with normal renal function, lower doses of alogliptin should be used in patients with moderate or severe renal impairment, or end-stage renal disease requiring dialysis (see above and section 4.2).
Croatian: Kako bi se održala sistemska izloženost alogliptinu slična onoj opaženom u bolesnika s normalnom funkcijom bubrega, u bolesnika s umjerenim i teškim oštećenjem bubrega, te završnim stadijem bolesti bubrega na dijalizi, potrebno je primijeniti nižu dozu alogliptina (vidjeti dio
English: A higher rate of fractures was observed in women taking pioglitazone (2.6%) versus comparator (1.7%).
Croatian: Viša stopa prijeloma bila je primijećena u žena koje su uzimale pioglitazon (2,6%) naspram usporednog lijeka (1,7%).
English: It is unknown whether alogliptin and pioglitazone are excreted in human milk.
Croatian: Nije poznato izlučuju li se alogliptin i pioglitazon u majčino mlijeko kod ljudi.
English: Marketing Authorisation Holder Takeda Pharma A/S Dybendal Alle 10
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Takeda Pharma A/S
English: Incresync is not recommended for patients with severe renal impairment or end-stage renal disease requiring dialysis.
Croatian: Incresync se ne preporučuje bolesnicima s teškim oštećenjem bubrega ili završnim stadijem bolesti bubrega koji zahtijeva dijalizu.
English: Skin and subcutaneous tissue disorders pruritus common common rash common exfoliative skin conditions including StevensJohnson syndrome not known erythema multiforme not known angioedema not known urticaria not known
Croatian: Poremećaji kože i potkožnog tkiva Eksfolijativna stanja kože uključujući Stevens-Johnsonov sindrom Erythema multiforme
English: Co-administration of pioglitazone with gemfibrozil (an inhibitor of cytochrome P450 2C8) is reported to result in a 3-fold increase in AUC for pioglitazone.
Croatian: Prijavljeno je da istodobna primjena pioglitazona s gemfibrozilom (inhibitor citokroma P450 2C8) rezultira 3 puta povećanjem AUC-a pioglitazona.
English: The results of bioequivalence studies in healthy subjects demonstrated that Incresync film-coated tablets are bioequivalent to the corresponding doses of alogliptin and pioglitazone co-administered as separate tablets.
Croatian: Rezultati ispitivanja bioekvivalencije u zdravih ispitanika pokazuju da su Incresync filmom obložene tablete bioekvivalentne odgovarajućim dozama alogliptina i pioglitazona primijenjenim istodobno kao zasebne tablete.
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).
Croatian: U 26. tjednu je ciljne razine HbA1c od ≤7,0% postiglo značajno više bolesnika koji su primali alogliptin (49,2%) nego oni koji su primali placebo (34,0%) (p<0,004).
English: Add-on combination therapy studies Alogliptin 25 mg once daily with pioglitazone + metformin vs titrating pioglitazone + metformin
Croatian: Alogliptin 25 mg jedanput na dan s pioglitazonom + metformin ili sulfonilurejom
English: MACE Reported in cardiovascular outcomes study Number of Patients (%)
Croatian: MACE prijavljeni u ispitivanju kardiovaskularnih ishoda
English: Takeda UAB Tel: +370 521 09 070 lt-info@takeda.com
Croatian: Lietuva ”Takeda” UAB Tel: +370 521 09 070 info@nycomed.lt
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
Croatian: Incresync 12,5 mg/30 mg filmom obložene tablete Incresync 12,5 mg/45 mg filmom obložene tablete Incresync 25 mg/30 mg filmom obložene tablete Incresync 25 mg/45 mg filmom obložene tablete
English: There are no data from the use of alogliptin in pregnant women.
Croatian: Nema podataka o primjeni alogliptina u trudnica.
English: Both 25 mg alogliptin alone and in combination with 30 mg pioglitazone demonstrated significant decreases in postprandial glucose and postprandial glucagon whilst significantly increasing postprandial active GLP-1 levels at Week 16 compared to placebo (p<0.05).
Croatian: U 16. tjednu primjene 25 mg alogliptina, samog i u kombinaciji s 30 mg pioglitazona, postiže se u usporedbi s placebom značajno smanjenje postprandijalne glukoze i postprandijalnog glukagona uz značajni porast postprandijalnih razina aktivnog GLP-1 (p<0,05).
English: Add-on combination therapy placebo-controlled studies Alogliptin 25 mg once daily with pioglitazone ± metformin or a sulphonylurea (n=195) FAS = full analysis set LOCF = last observation carried forward † Least squares means adjusted for prior antihyperglycaemic therapy status and baseline values * p<0.001 compared to placebo or placebo+combination treatment
Croatian: FAS = analiza svih uključenih bolesnika (engl. full analysis set) LOCF = zadnje opažanje preneseno nadalje (engl. last observation carried forward) †Srednja vrijednost metodom najmanjih kvadrata prilagođena prvobitnom antihiperglikemijskom terapijskom statusu i početnim vrijednostima * p<0,001 u usporedbi s placebom ili liječenjem placebom+kombinacijom
English: However, the results of bioequivalence studies have demonstrated that Incresync film-coated tablets are bioequivalent to the corresponding doses of alogliptin and pioglitazone co-administered as separate tablets.
Croatian: Međutim, rezultati ispitivanja bioekvivalencije dokazali su da su Incresync filmom obložene tablete bioekvivalentne odgovarajućim dozama alogliptina i pioglitazona istodobno primijenjenim kao zasebne tablete.
English: Risk related to pioglitazone
Croatian: Rizik vezan uz pioglitazon
English: Date of latest renewal:
Croatian: ROK VALJANOSTI Rok valjanosti:
English: In patients with moderate or severe renal impairment, or end-stage renal disease on haemodialysis, an increase in systemic exposure to alogliptin of approximately 2- and 4-fold was observed, respectively.
Croatian: U bolesnika s umjerenim ili teškim oštećenjem bubrega, ili završnim stadijem bolesti bubrega na hemodijalizi, opaženo je povećanje sistemske izloženosti alogliptinu od približno 2, odnosno 4 puta. (Bolesnici sa završnim stadijem bolesti bubrega su podvrgnuti hemodijalizi odmah nakon doziranja alogliptina.
English: Rare cases of elevated liver enzymes and hepatocellular dysfunction have occurred in post-marketing experience.
Croatian: Nakon stavljanja lijeka u promet bilo je rijetkih slučajeva povišenih jetrenih enzima i hepatocelularne disfunkcije.
English: INFORMATION IN BRAILLE Incresync 25 mg/45 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Incresync 25 mg/45 mg
English: Table 1: Adverse reactions System organ class Adverse reaction
Croatian: Tablica 1: Nuspojave opažene objedinjenim pivotalnim kontroliranim ispitivanjima faze 3 Organski sustav
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).
Croatian: U 52. tjednu je ciljne razine HbA1c od ≤7,0% postiglo značajno više bolesnika koji su uzimali 25 mg alogliptina s 30 mg pioglitazona i metforminom (33,2%) nego oni koji su uzimali 45 mg pioglitazona s metforminom (21,3%) (p<0,001).
English: A higher number of bone fractures was seen in patients, particularly women taking pioglitazone.
Croatian: U bolesnika, posebno u žena koje su uzimale pioglitazon primijećen je povećan broj prijeloma kostiju.
English: The studies included 1,269 patients with mild renal impairment and 161 patients with moderate renal impairment treated with alogliptin/pioglitazone.
Croatian: U ispitivanja je alogliptinom/pioglitazonom liječeno 1269 bolesnika s blagim oštećenjem bubrega i 161 bolesnik s umjerenim oštećenjem bubrega.
English: Therefore, no dose adjustment of alogliptin is necessary for patients with mild to moderate hepatic impairment (Child-Pugh scores of 5 to 9).
Croatian: Stoga u bolesnika s blagim do umjerenim oštećenjem jetre (Child-Pugh indeks 5 do 9) nije potrebna prilagodba doze.
English: What Incresync looks like and contents of the pack - Incresync 25 mg/30 mg film-coated tablets (tablets) are peach, round (approximately 8.7 mm in diameter), biconvex, film-coated tablets, with both “A/P” and “25/30” printed in grey ink on one side.
Croatian: Kako Incresync izgleda i sadržaj pakiranja - Incresync 25 mg/30 mg filmom obložene tablete (tablete) su okrugle (promjera oko 8,7 mm), bikonveksne filmom obložene tablete boje breskve, s oznakama „A/P“ i „25/30“ otisnutim sivom tintom na jednoj strani.
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
Croatian: Incresync 25 mg/30 mg filmom obložene tablete Incresync 25 mg/45 mg filmom obložene tablete Incresync 12,5 mg/30 mg filmom obložene tablete Incresync 12,5 mg/45 mg filmom obložene tablete alogliptin/pioglitazon
English: INFORMATION IN BRAILLE Incresync 12.5 mg/30 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Incresync 12,5 mg/30 mg
English: INFORMATION IN BRAILLE Incresync 12.5 mg/45 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Incresync 12,5 mg/45 mg
English: No increase in fracture rates was observed in men treated with pioglitazone (1.3%) versus comparator (1.5%).
Croatian: Nije bilo primijećeno povećanje stopa prijeloma u muškaraca liječenih pioglitazonom (1,3%) naspram usporednog lijeka (1,5%).
English: Slight changes in cell counts may show up in blood tests.
Croatian: U krvnim nalazima su moguća manja odstupanja u broju stanica.
English: Effects of alogliptin on other medicinal products
Croatian: Učinci alogliptina na druge lijekove
English: INFORMATION IN BRAILLE Incresync 25 mg/30 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Incresync 25 mg/30 mg
English: Mean change from baseline in HbA1c (%)† (SE)
Croatian: Srednja promjena od početne vrijednosti HbA1c (%) (SE)
English: Incresync is used to lower blood sugar levels in adults with type 2 diabetes.
Croatian: Incresync je koristi za snižavanje razina šećera u krvi u odraslih bolesnika sa šećernom bolešću tipa 2. Šećerna bolest tipa 2 zove se i inzulin neovisni dijabetes melitus.
English: Appropriate assessment of renal function is recommended prior to initiation of Incresync and periodically thereafter (see section 4.4).
Croatian: Prije početka liječenja i povremeno tijekom liječenja Incresyncom preporučuje se procijeniti funkciju bubrega (vidjeti dio 4.4).
English: Your weight should be checked at regular intervals; if your weight increases, tell your doctor.
Croatian: Ako Vam se tjelesna težina poveća, obavijestite o tome liječnika.
English: LOCF = last observation carried forward * Non inferiority and superiority statistically demonstrated † Least squares means adjusted for prior antihyperglycaemic therapy status and baseline values
Croatian: PPS = bolesnici koji su završili ispitivanje po protokolu (engl. per protocol set) LOCF = zadnje opažanje preneseno nadalje (engl. last observation carried forward) * Dokazana je statistička neinferiornost i superiornost
English: Warnings and precautions Talk to your doctor or pharmacist before taking Incresync: - if you have type 1 diabetes (your body does not produce insulin).
Croatian: • ako imate šećernu bolest tipa 1 (tijelo ne stvara inzulin)
English: There have been post-marketing cases of cardiac failure reported when pioglitazone was used in combination with insulin or in patients with a history of cardiac failure.
Croatian: Nakon stavljanja lijeka u promet bilo je prijava slučajeva zatajenja srca kada se pioglitazon primjenjivao ili u bolesnika sa zatajenjem srca u anamnezi ili u kombinaciji s inzulinom.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Croatian: Tablete Incresync sadrže laktozu i stoga se ne smiju primjenjivati u bolesnika s rijetkim nasljednim poremećajima nepodnošenja galaktoze, nedostatka Lapp laktaze ili malapsorpcijom glukoze i galaktoze.
English: • The package leaflet
Croatian: • zamućen ili iskrivljen vid
English: There have been spontaneously reported adverse reactions of acute pancreatitis in the post-marketing setting.
Croatian: Nakon stavljanja lijeka u promet bilo je spontano prijavljenih nuspojava akutnog pankreatitisa.
English: No increase in fracture rates was observed in men treated with pioglitazone (1.7%) versus comparator (2.1%).
Croatian: Nije bilo primijećeno povećanje stopa prijeloma u muškaraca liječenih pioglitazonom (1,7%) naspram onih liječenih usporednim lijekom (2,1%).
English: Current bladder cancer or a history of bladder cancer (see section 4.4) Uninvestigated macroscopic haematuria (see section 4.4)
Croatian: • Postojeći ili rak mokraćnog mjehura u anamnezi (vidjeti dio 4.4)
English: Placental transfer of alogliptin occurs in rats.
Croatian: U štakora alogliptin prolazi posteljicu.
English: Incresync 25 mg/45 mg film-coated tablets
Croatian: Incresync 25 mg/45 mg filmom obložene tablete
English: Musculoskeletal and connective tissues disorders myalgia common fracture bone common
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva Prijelom kosti
English: NN:
Croatian: Nepoznato:
English: Clinically meaningful reductions in HbA1c compared to control were also observed regardless of baseline background medicinal product dose.
Croatian: U skupini liječenoj s 25 mg alogliptina klinički značajna sniženja HbA1c također su opažena bez obzira na osnovnu terapijsku dozu.
English: Incresync 25 mg/30 mg film-coated tablets
Croatian: Incresync 25 mg/30 mg filmom obložene tablete
English: and lower than the incidence in patients treated with active-control or placebo (0.1%, 0.1%, 0.4% and 0.4%, respectively).
Croatian: Ukupna incidencija epizoda teške hipoglikemije bila je usporediva u bolesnika liječenih s 25 mg alogliptina ili 12,5 mg alogliptina, te niža od incidencije u bolesnika liječenih aktivnom kontrolom ili placebom (0,1%, 0,1%, 0,4% i 0,4%, istim redoslijedom).
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.
Croatian: - Incresync 25 mg/45 mg filmom obložene tablete (tablete) su okrugle (promjera oko 8,7 mm), bikonveksne filmom obložene tablete crvene boje, s oznakama „A/P“ i „25/45“ otisnutim sivom tintom na jednoj strani.
English: 25 mg/30 mg film-coated tablets
Croatian: 25 mg/30 mg filmom obložene tablete
English: Postmarketing reports of hepatic dysfunction including hepatic failure have been received for alogliptin.
Croatian: Nakon stavljanja alogliptina u promet također su primljene prijave slučajeva poremećaja funkcije jetre uključujući zatajenje jetre.
English: Each 25 mg/45 mg film-coated tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 25 mg alogliptin and 45 mg pioglitazone.
Croatian: Svaka filmom obložena tableta od 25 mg/45 mg sadrži alogliptinbenzoat i pioglitazonklorid koji odgovaraju 25 mg alogliptina i 45 mg pioglitazona.
English: 12.5 mg/45 mg film-coated tablets
Croatian: 12,5 mg/45 mg filmom obložene tablete
English: 12.5 mg/30 mg film-coated tablets
Croatian: 12,5 mg/30 mg filmom obložene tablete
English: Printing ink 12.5 mg/30 mg film-coated tablets
Croatian: Tinta za označavanje 12,5 mg/30 mg filmom obložene tablete
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.
Croatian: - Incresync 12,5 mg/30 mg filmom obložene tablete (tablete) su okrugle (promjera oko 8,7 mm), bikonveksne filmom obložene tablete svijetle boje breskve, s oznakama „A/P“ i „12.5/30“ otisnutim crvenom tintom na jednoj strani.
English: Incresync 12.5 mg/30 mg film-coated tablets
Croatian: Incresync 12,5 mg/30 mg filmom obložene tablete
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.
Croatian: Svaka filmom obložena tableta od 12,5 mg/45 mg sadrži alogliptinbenzoat i pioglitazonklorid koji odgovaraju 12,5 mg alogliptina i 45 mg pioglitazona.
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.
Croatian: - Incresync 12,5 mg/45 mg filmom obložene tablete (tablete) su okrugle (promjera oko 8,7 mm), bikonveksne filmom obložene tablete blijedo crvene boje, s oznakama „A/P“ i „12.5/45“ otisnutim crvenom tintom na jednoj strani.
English: Diabetic ketoacidosis
Croatian: Gastroezofagealni refluks
English: Incresync 12.5 mg/45 mg film-coated tablets
Croatian: Incresync 12,5 mg/45 mg filmom obložene tablete
English: Hepatobiliary disorders hepatic dysfunction including hepatic failure not known
Croatian: Poremećaji jetre i žuči Poremećaj funkcije jetre uključujući zatajenje jetre
English: NAME OF THE MEDICINAL PRODUCT Incresync 25 mg/30 mg tablets alogliptin/pioglitazone
Croatian: NAZIV LIJEKA Incresync 25 mg/30 mg tablete alogliptin/pioglitazon
English: Each 25 mg/30 mg film-coated tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 25 mg alogliptin and 30 mg pioglitazone.
Croatian: Svaka filmom obložena tableta od 25 mg/30 mg sadrži alogliptinbenzoat i pioglitazonklorid koji odgovaraju 25 mg alogliptina i 30 mg pioglitazona.
English: Each tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 12.5 mg alogliptin and 45 mg pioglitazone.
Croatian: Jedna tableta sadrži alogliptinbenzoat i pioglitazonklorid koji odgovaraju 12,5 mg alogliptina i 45 mg pioglitazona.
English: Each tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 12.5 mg alogliptin and 30 mg pioglitazone.
Croatian: Jedna tableta sadrži alogliptinbenzoat i pioglitazonklorid koji odgovaraju 12,5 mg alogliptina i 30 mg pioglitazona.
English: Each tablet contains alogliptin benzoate and pioglitazone hydrochloride equivalent to 25 mg alogliptin and 45 mg pioglitazone.
Croatian: Jedna tableta sadrži alogliptinbenzoat i pioglitazonklorid koji odgovaraju 25 mg alogliptina i 45 mg pioglitazona.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 12.5 mg alogliptin (as benzoate) and 45 mg pioglitazone (as hydrochloride).
Croatian: Jedna tableta sadrži 12,5 mg alogliptina (u obliku alogliptinbenzoata) i 45 mg pioglitazona (u obliku pioglitazonklorida)