FrancophonIA/ELRC3.0 huggingface dataset:
English: Pack sizes of 30x1 and 90x1 film-coated tablets in perforated unit dose blisters.
Croatian: Veličine pakiranja od 30x1 i 90x1 filmom obloženih tableta u perforiranim blisterima s jediničnim dozama.
English: In subjects with mild (Child-Pugh Class A), moderate (Child-Pugh Class B), or severe (Child-Pugh Class C) hepatic impairment the exposures to saxagliptin were 1.1-, 1.4- and 1.8-fold higher, respectively, and the exposures to BMS-510849 were 22%, 7%, and 33% lower, respectively, than those observed in healthy subjects.
Croatian: Izloženost saksagliptinu u ispitanika s blagim (Child-Pugh stadij A), umjerenim (Child-Pugh stadij B) odnosno teškim (Child-Pugh stadij C) oštećenjem jetre, bila je 1,1-, 1,4- i 1,8- puta veća u odnosu na izloženost saksagliptinu zdravih ispitanika, dok je izloženost BMS-510849 bila 22%, 7% odnosno 33% niža od one kod zdravih ispitanika.
English: • Study CV181057: add-on to insulin (+/-metformin) Overall population (n=300)
Croatian: • Ispitivanje CV181057: dodatak inzulinu (+/-metformin) Ukupna populacija (n=300)
English: Effects on fertility were observed in male and female rats at high doses producing overt signs of toxicity (see section 5.3).
Croatian: Opaženi su učinci na plodnost u mužjaka i ženki štakora pri visokim dozama koje su uzrokovale vidljive znakove toksičnosti (vidjeti dio 5.3).
English: The corresponding plasma Cmax values were 24 ng/ml and 47 ng/ml, respectively.
Croatian: Odgovarajuće plazmatske vrijednosti Cmax iznosile su 24 ng/ml za saksagliptin i 47 ng/ml za njegov glavni metabolit.
English: Adverse reactions were identified through postmarketing surveillance.
Croatian: Nuspojave su prepoznate kroz praćenje nakon stavljanja lijeka u promet.
English: If you forget to take Onglyza
Croatian: Ako ste zaboravili uzeti lijek Onglyza
English: Table 2 Key efficacy results of Onglyza 5 mg per day in placebo-controlled monotherapy trials and in add-on combination therapy trials
Croatian: Tablica 2 Ključni rezultati placebom kontroliranih ispitivanja djelotvornosti lijeka Onglyza u dozi od 5 mg dnevno kao monoterapija i kao dodatak kombiniranoj terapiji
English: If you stop taking Onglyza
Croatian: Ako prestanete uzimati lijek Onglyza
English: The no effect level (NOEL) for the lesions is 1 and 2 times the human exposure of saxagliptin and the major metabolite respectively, at the recommended human dose of 5 mg/day (RHD).
Croatian: Razina bez učinka (engl. no effect level, NOEL) za lezije jednaka je izloženosti ljudi saksagliptinu, te 2 puta veća od izloženosti ljudi njegovom glavnom metabolitu pri preporučenoj dozi od 5 mg na dan u ljudi (RHD).
English: Indigo carmine aluminium lake (E132)
Croatian: Tinta za označavanje: šelak boja Indigo carmine aluminium lake (E132)
English: • Study D1680L00006: add-on to metformin plus SU (n=257)
Croatian: • Ispitivanje D1680L00006: dodatak metforminu i SU (n=257)
English: Mechanism of action and pharmacodynamic effects Saxagliptin is a highly potent (Ki: 1.3 nM), selective, reversible, competitive, DPP4 inhibitor.
Croatian: Saksagliptin je potentni (Ki: 1,3 nm), selektivni, reverzibilni, kompetitivni inhibitor enzima DPP-4.
English: The tablets contain lactose monohydrate.
Croatian: Tablete sadrže laktozu hidrat.
English: Across clinical studies, the incidence of laboratory adverse events was similar in patients treated with saxagliptin 5 mg compared to patients treated with placebo.
Croatian: U kliničkim ispitivanjima, incidencija štetnih događaja prema laboratorijskim nalazima u bolesnika liječenih saksagliptinom od 5 mg bila je slična onoj u bolesnika koji su primali placebo.
English: Patients treated with saxagliptin exhibited a significant decrease from baseline in body weight compared to a weight gain in patients administered glipizide (-1.1 vs. +1.1 kg).
Croatian: U bolesnika liječenih saksagliptinom zabilježeno je značajno smanjenje početne tjelesne težine u usporedbi s povećanjem tjelesne težine u bolesnika koji su primali glipizid (-1,1 kg naspram +1,1 kg).
English: Reductions in HbA1c from baseline to Week 24 were observed in all evaluated subgroups defined by baseline HbA1c, with greater reductions observed in patients with a baseline HbA1c ≥ 10% (see Table 2).
Croatian: Smanjenje HbA1c do 24. tjedna u odnosu na početne vrijednosti opaženo je u svim podskupinama koje su se formirale na temelju početnih vrijednosti HbA1c, pri čemu je smanjenje bilo veće u bolesnika s početnom vrijednošću HbA1c ≥ 10% (vidjeti tablicu 3).
English: • 2.5 mg film-coated tablets are pale yellow to light yellow, biconvex, round.
Croatian: • Filmom obložene tablete od 2,5 mg su blijedožute do svijetložute boje, bikonveksne, okrugle.
English: Do not take Onglyza
Croatian: Nemojte uzimati lijek Onglyza
English: Adverse reactions reported in ≥ 5% of patients treated with saxagliptin 5 mg and more commonly than in patients treated with placebo or that were reported in ≥ 2% of patients treated with saxagliptin 5 mg and ≥ 1% more frequently compared to placebo from the pooled analysis of five studies of glycaemic control, plus an additional active-controlled study of initial combination with metformin are shown in Table 1.
Croatian: Tablici 1 prikazane su nuspojave zabilježene u ≥ 5% bolesnika liječenih saksagliptinom od 5 mg i češće nego u bolesnika koji su primali placebo, ili one prijavljene u ≥ 2% bolesnika liječenih saksagliptinom od 5 mg i ≥ 1% češće nego u onih koji su primali placebo u analizi objedinjenih podataka iz pet ispitivanja regulacije glikemije i jednog dodatnog, aktivnim lijekom kontroliranog ispitivanja početne kombinacije s metforminom.
English: Some patients have had the following additional side effects while taking Onglyza alone: • Common: dizziness, diarrhoea and stomach ache.
Croatian: Neki bolesnici imali su sljedeće dodatne nuspojave dok su uzimali samo lijek Onglyza: Često: omaglica, proljev i bol u želucu.
English: Mean change
Croatian: Prosječna promjena
English: Saxagliptin in combination with a fixed, intermediate dose of a sulphonylurea (glibenclamide 7.5 mg) was compared to titration to a higher dose of glibenclamide (approximately 92% of patients in the placebo plus glibenclamide group were uptitrated to a final total daily dose of 15 mg).
Croatian: Saksagliptin u kombinaciji s fiksnom, srednje visokom dozom sulfonilureje (glibenklamid 7,5 mg) uspoređivao se s glibenklamidom čija doza se titracijski povećavala (u približno 92% bolesnika u skupini koja je primala placebo i glibenklamid doza se titracijski povećavala do konačne ukupne dnevne doze od 15 mg).
English: Onglyza contains less than 1 mmol sodium (23 mg) per dose, i.e. is essentially ‘sodium-free'.
Croatian: Onglyza sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
English: Also reported during postmarketing surveillance (see section 4.4).
Croatian: Vidjeti dijelove 4.3 i 4.4 Prijavljena također i tijekom praćenja nakon stavljanja lijeka u promet (vidjeti dio 4.4).
English: Individuals treated with saxagliptin added to dapagliflozin and metformin (n=153) achieved statistically significantly (p-value < 0.0001) greater reductions in HbA1c versus the group with placebo added to dapagliflozin plus metformin (n=162) at 24 weeks (see Table 2).
Croatian: Pojedinci liječeni saksagliptinom kao dodatkom terapiji dapagliflozinom i metforminom (n=153) postigli su statistički značajno (p-vrijednost < 0,0001) veće sniženje HbA1c u usporedbi sa skupinom u kojoj je placebo pridodan dapagliflozinu plus metforminu (n=162) u 24. tjednu (vidjeti tablicu 2).
English: Saxagliptin 5 mg add-on to insulin with or without metformin provided significant improvements after 24 weeks in HbA1c and PPG compared with placebo add-on to insulin with or without metformin.
Croatian: Saksagliptin od 5 mg kao dodatak inzulinu sa ili bez metformina doveo je do značajnog poboljšanja vrijednosti HbA1c i PPG-a nakon 24 tjedna u usporedbi s placebom kao dodatkom inzulinu sa ili bez metformina
English: Onglyza 5 mg tablets are pink, biconvex, round, film-coated tablets, with “5” printed on one side and “4215” printed on the other side, in blue ink.
Croatian: Onglyza 5 mg tablete su ružičaste, bikonveksne, okrugle filmom obložene tablete, koje imaju plavom tintom otisnutu oznaku „5“ s jedne strane i „4215“ s druge strane.
English: Mean HbA1c change is the difference between the saxagliptin+dapagliflozin+metformin and dapagliflozin+metformin groups (p< 0.0001).
Croatian: Prosječna promjena vrijednosti HbA1c odnosi se na razliku između skupine koja je primala saksagliptin+dapagliflozin+metformin i skupine koja je primala dapagliflozin+metformin (p<0,0001).
English: Onglyza is not recommended for patients with end-stage renal disease (ESRD) requiring haemodialysis (see section 4.4).
Croatian: Onglyza se ne preporučuje u bolesnika u završnom stadiju bolesti bubrega kojima je potrebna hemodijaliza (vidjeti dio 4.4).
English: The recommended dose of Onglyza is 5 mg once a day.
Croatian: Preporučena doza lijeka Onglyza je 5 mg jedanput dnevno.
English: Because the dose should be limited to 2.5 mg based upon renal function, assessment of renal function is recommended prior to initiation of treatment, and, in keeping with routine care, renal assessment should be done periodically thereafter (see sections 4.4 and 5.2).
Croatian: Prije početka liječenja, preporučuje se procijeniti bubrežnu funkciju, budući da se doza mora ograničiti na 2,5 mg na temelju bubrežne funkcije, i nakon toga treba povremeno procijeniti bubrežnu funkciju, u skladu s rutinskom skrbi (vidjeti dijelove 4.4 i 5.2).
English: MONOTHERAPY STUDIES
Croatian: ISPITIVANJA MONOTERAPIJE
English: Decreased lymphocyte counts were reported in 0.5% of Onglyza treated patients and 0.4% of placebotreated patients.
Croatian: Smanjen broj limfocita prijavljen je u 0,5% bolesnika liječenih lijekom Onglyza te u 0,4% bolesnika koji su primali placebo.
English: Two double-blind, placebo-controlled studies of 24-week duration were conducted to evaluate the efficacy and safety of saxagliptin monotherapy in patients with type 2 diabetes.
Croatian: Provedena su dva dvostruko slijepa, placebom kontrolirana ispitivanja u trajanju od 24-tjedna da bi se ocijenila djelotvornost i sigurnost monoterapije saksagliptinom u bolesnika sa šećernom bolešću tipa 2.
English: Concomitant administration of saxagliptin with the potent CYP3A4/5 inducer rifampicin, reduced Cmax and AUC of saxagliptin by 53% and 76%, respectively.
Croatian: Istodobna primjena saksagliptina s potentnim induktorom CYP3A4/5 rifampicinom smanjila je Cmax saksagliptina za 53%, a AUC za 76%.
English: Following a 5 mg single oral dose of saxagliptin to healthy subjects, the mean plasma AUC values for saxagliptin and its major metabolite were 78 ng·h/ml and 214 ng·h/ml, respectively.
Croatian: Nakon jednokratne peroralno primijenjene doze saksagliptina od 5 mg u zdravih ispitanika, prosječan AUC saksagliptina u plazmi iznosio je 78 ng·h/ml, a njegovog glavnog metabolita 214 ng·h/ml.
English: The recommended dose of Onglyza is one 5 mg tablet once a day.
Croatian: Preporučena doza lijeka Onglyza je jedna tableta od 5 mg jedanput dnevno.
English: Treatment with saxagliptin 5 mg once daily produced clinically relevant and statistically significant improvements in haemoglobin A1c (HbA1c), fasting plasma glucose (FPG) and postprandial glucose (PPG) compared to placebo in monotherapy, in combination with metformin (initial or add-on therapy), in combination with a sulphonylurea, and in combination with a thiazolidinedione (see Table 2).
Croatian: Liječenje saksagliptinom u dozi od 5 mg jedanput dnevno dovelo je do klinički relevantnih i statistički značajnih poboljšanja vrijednosti hemoglobina A1c (HbA1c), glukoze u plazmi natašte (engl. fasting plasma glucose, FPG) te glukoze nakon obroka (engl. postprandial glucose, PPG) u usporedbi s placebom, bilo da je primijenjen u monoterapiji, u kombinaciji s metforminom (početna ili dodatak terapiji), u kombinaciji sa sulfonilurejom i u kombinaciji s tiazolidindionom (vidjeti tablicu 2).
English: Improvements from baseline HbA1c were sustained in the saxagliptin add-on to insulin group compared to the placebo add-on to insulin group with or without metformin at Week 52.
Croatian: Poboljšanje u odnosu na početne vrijednosti HbA1c održalo se u skupini koja je primala saksagliptin kao dodatak inzulinu u usporedbi sa skupinom koja je primala placebo pridodan inzulinu sa ili bez metformina sve do 52. tjedna.
English: In a pooled analysis of 1,681 patients with type 2 diabetes including 882 patients treated with Onglyza 5 mg, randomised in five double-blind, placebo-controlled clinical safety and efficacy studies conducted to evaluate the effects of saxagliptin on glycaemic control, the overall incidence of adverse events in patients treated with saxagliptin 5 mg was similar to placebo.
Croatian: U analizi objedinjenih podataka prikupljenih u 1681 bolesnika sa šećernom bolešću tipa 2, uključujući 882 bolesnika liječena saksagliptinom u dozi od 5 mg, koji su bili randomizirani u pet dvostruko slijepih, placebom kontroliranih kliničkih ispitivanja sigurnosti i djelotvornosti provedenih s ciljem ocjenjivanja učinaka saksagliptina na kontrolu glikemije, ukupna incidencija nuspojava u bolesnika liječenih saksagliptinom od 5 mg bila je slična onoj s placebom.
English: In randomised, controlled, double-blind clinical trials (including developmental and postmarketing experience), over 17,000 patients with type 2 diabetes have been treated with Onglyza.
Croatian: U randomiziranim, kontroliranim, dvostruko slijepim kliničkim ispitivanjima (uključujući razdoblje tijekom razvoja lijeka i nakon njegova stavljanja u promet) lijekom Onglyza je liječeno više od 17 000 bolesnika sa šećernom bolešću tipa 2.
English: ADD-ON/COMBINATION STUDIES
Croatian: ISPITIVANJA DODATKA TERAPIJI/ KOMBINIRANA TERAPIJA
English: The exposure of the active metabolite and the plasma DPP4 activity inhibition over a dose interval were not influenced by rifampicin (see section 4.4).
Croatian: Rifampicin nije utjecao na izloženost aktivnom metabolitu ni inhibiciju aktivnostiDPP-4 u plazmi tijekom intervala doziranja (vidjeti dio 4.4).
English: • 5 mg tablets are available in pack sizes of 14, 28, 56, or 98 film-coated tablets in non-perforated blisters, 14, 28, 56, or 98 film-coated tablets in non-perforated calendar blisters and 30x1 or 90x1 film-coated tablets in perforated unit dose blisters.
Croatian: • Tablete od 5 mg su dostupne su u pakiranjima od 14, 28, 56 ili 98 filmom obloženih tableta u neperforiranim blisterima, 14, 28, 56 ili 98 filmom obloženih tableta u neperforiranim kalendarski označenim blisterima te u pakiranjima od 30x1 ili 90x1 filmom obloženih tableta u perforiranim blisterima s jediničnim dozama.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say it is essentially ‘sodium-free'.
Croatian: Sadržaj natrija Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
English: In rabbits, the effects of saxagliptin were limited to minor skeletal variations observed only at maternally toxic doses (NOEL 158 and 224 times the human exposure for saxagliptin and the major metabolite, respectively at RHD).
Croatian: U kunića su učinci saksagliptina bili ograničeni na manje skeletalne varijacije primijećene samo pri toksičnima dozama za majku (NOEL 158 puta veća od ljudske izloženosti saksagliptinu, odnosno 224 puta veća od izloženosti njegovu glavnom metabolitu pri RHD).
English: A1C was lower with saxagliptin compared to placebo in an exploratory analysis.
Croatian: U eksploracijskoj je analizi A1C bio niži uz primjenu saksagliptina nego uz primjenu placeba.
English: • 2.5 mg tablets are available in pack sizes of 14, 28, or 98 film-coated tablets in non-perforated calendar blisters and 30x1 or 90x1 film-coated tablets in perforated unit dose blisters.
Croatian: • Tablete od 2,5 mg su dostupne u pakiranjima od 14, 28, ili 98 filmom obloženih tableta u neperforiranim kalendarski označenim blisterima te u pakiranjima od 30x1 ili 90x1 filmom obloženih tableta u perforiranim blisterima s jediničnim dozama.
English: The saxagliptin and dapagliflozin group achieved significantly greater reductions in HbA1c versus either the saxagliptin group or dapagliflozin group at 24 weeks (see Table 3).
Croatian: Skupina koja je primala saksagliptin i dapagliflozin postigla je značajno veće sniženje HbA1c u usporedbi sa skupinom koja je primala saksagliptin ili sa skupinom koja je primala dapagliflozin u 24. tjednu (vidjeti tablicu 3.).
English: 14 film-coated tablets 28 film-coated tablets 30x1 film-coated tablets 90x1 film-coated tablets 98 film-coated tablets
Croatian: 14 filmom obloženih tableta 28 filmom obloženih tableta 30x1 filmom obložena tableta 90x1 filmom obložena tableta 98 filmom obloženih tableta
English: The incidence of diarrhoea was 4.1% (36/882) in the saxagliptin 5 mg group and 6.1% (49/799) in the placebo group.
Croatian: Učestalost proljeva je bila 4,1% (36/882) u grupi tretiranoj saksagliptinom 5 mg i 6,1% u grupi tretiranoj placebom.
English: Onglyza 2.5 mg tablets are pale yellow to light yellow, biconvex, round, film-coated tablets, with “2.5” printed on one side and “4214” printed on the other side, in blue ink.
Croatian: Onglyza 2,5 mg tablete su blijedožute do svijetložute, bikonveksne, okrugle filmom obložene tablete, koje imaju plavom tintom otisnutu oznaku „2.5“ s jedne strane i „4214“ s druge strane.
English: 14 film-coated tablets 28 film-coated tablets 30x1 film-coated tablets 56 film-coated tablets 90x1 film-coated tablets 98 film-coated tablets
Croatian: 14 filmom obloženih tableta 28 filmom obloženih tableta 30x1 filmom obložena tableta 56 filmom obloženih tableta 90x1 filmom obložena tableta 98 filmom obloženih tableta
English: Saxagliptin (n=127) provided significant improvements in HbA1c and PPG compared with the placebo (n=128).
Croatian: Saksagliptin (n=127) je značajno poboljšao vrijednosti HbA1c i PPG-a u usporedbi s placebom (n=128).
English: Saxagliptin add-on to glibenclamide therapy
Croatian: Saksagliptin kao dodatak terapiji glibenklamidom
English: Use with medicinal products known to cause hypoglycaemia Sulphonylureas and insulin are known to cause hypoglycaemia.
Croatian: Poznato je da sulfonilureje i inzulin izazivaju hipoglikemiju.
English: A 12-week, multi-centre, randomised, double-blind, placebo-controlled study was conducted to evaluate the treatment effect of saxagliptin 2.5 mg once daily compared with placebo in 170 patients (85 patients on saxagliptin and 85 on placebo) with type 2 diabetes (HbA1c 7.0-11%) and renal impairment (moderate [n=90]; severe [n=41]; or ESRD [n=39]).
Croatian: Multicentrično, randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje u trajanju od 12 tjedana provedeno je, da bi se ocijenio terapijski učinak saksagliptina u dozi od 2,5 mg jedanput dnevno u odnosu na placebo u 170 bolesnika (85 bolesnika na saksagliptinu i 85 bolesnika na placebu) sa šećernom bolešću tipa 2 (HbA1c 7,0%-11%) i oštećenom bubrežnom funkcijom (umjereno [n=90], teško [n=41] ili ESRD [n=39]).
English: After 52 weeks, the saxagliptin and glipizide groups had similar mean reductions from baseline in HbA1c in the per-protocol analysis (-0.7% vs. -0.8%, respectively, mean baseline HbA1c of 7.5% for both groups).
Croatian: U analizama propisanim planom ispitivanja, nakon 52 tjedna, saksagliptin i glipizid skupine imale su slično prosječno smanjenje HbA1c u odnosu na početne (-0,7% nasuprot -0,8%; u obje je skupine srednja početna vrijednost HbA1c bila 7,5%).
English: In randomised, controlled, double-blind clinical trials (including developmental and postmarketing experience), over 17,000 patients with type 2 diabetes have been treated with saxagliptin.
Croatian: U randomiziranim, kontroliranim, dvostruko slijepim kliničkim ispitivanjima (uključujući razdoblje tijekom razvoja lijeka i nakon njegova stavljanja u promet) saksagliptinom je liječeno više od 17 000 bolesnika sa šećernom bolešću tipa 2.
English: In subjects with moderate or severe renal impairment or in subjects with ESRD on haemodialysis, the AUC values of saxagliptin and its major metabolite were up to 2.1- and 4.5-fold higher, respectively, than AUC values in subjects with normal renal function.
Croatian: U ispitanika s umjerenim ili teškim oštećenjem bubrega,ili bolesnika s ESRD koji su na hemodijalizi, AUC saksagliptina bio je do 2,1 puta, a njegova glavnog metabolita do 4,5 puta viši od AUC-a u ispitanika s normalnom funkcijom bubrega.
English: Concomitant administration of saxagliptin with the moderate inhibitor of CYP3A4/5 diltiazem, increased the Cmax and AUC of saxagliptin by 63% and 2.1-fold, respectively, and the corresponding values for the active metabolite were decreased by 44% and 34%, respectively.
Croatian: Istodobna primjena saksagliptina s umjerenim inhibitorom CYP3A4/5, diltiazemom, povisila je Cmax saksagliptina za 63%, a AUC za 2,1 puta, dok su se te vrijednosti za aktivni metabolit smanjile za 44% odnosno 34%.
English: At high doses in rats, saxagliptin caused reduced ossification (a developmental delay) of the foetal pelvis and decreased foetal body weight (in the presence of maternal toxicity), with a NOEL 303 and 30 times the human exposure for saxagliptin and the major metabolite, respectively, at RHD.
Croatian: U štakora, saksagliptin je u visokim dozama uzrokovao smanjenu osifikaciju (zakašnjeli razvoj) fetalnih zdjeličnih kostiju i smanjenu tjelesnu težinu fetusa (kad je bila prisutna toksičnosti za majku), uz NOEL 303 puta veći od ljudske izloženosti saksagliptinu i 30 puta veći od izloženosti njegovu glavnom metabolitu pri preporučenoj dozi za ljude (RHD).
English: • Film-coating: polyvinyl alcohol; macrogol 3350; titanium dioxide (E171); talc (E553b) and iron oxide yellow (E172).
Croatian: • Film ovojnica: poli(vinilni alkohol); makrogol 3350; titanijev dioksid (E171); talk (E553b) i žuti željezov oksid (E172).
English: The HbA1c change for the saxagliptin group (n=244) compared to placebo (n=124) was -0.4% at Week 52.
Croatian: Promjena HbA1c u skupini koja je uzimala saksagliptin (n=244) u odnosu na placebo (n=124) iznosila je -0,4% u 52. tjednu.
English: Saxagliptin is not recommended for use in patients with end-stage renal disease (ESRD) requiring haemodialysis.
Croatian: Primjena saksagliptina se ne preporučuje u bolesnika u završnom stadiju bolesti bubrega kojima je potrebna hemodijaliza.
English: Saxagliptin should be used with caution in patients with moderate hepatic impairment, and is not recommended for use in patients with severe hepatic impairment (see section 4.2).
Croatian: Saksagliptin je potrebno primjenjivati s oprezom u bolesnika s umjerenim oštećenjem jetrene funkcije, a ne preporučuje se njegova primjena u bolesnika s teškim oštećenjem jetre (vidjeti dio 4.2).
English: • if you have type 1 diabetes (your body does not produce any insulin) or diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss, nausea or vomiting).
Croatian: • ako imate šećernu bolest tipa 1 (Vaše tijelo uopće ne stvara inzulin) ili dijabetičku ketoacidozu
English: Concomitant administration of saxagliptin with the potent inhibitor of CYP3A4/5 ketoconazole, increased the Cmax and AUC of saxagliptin by 62% and 2.5-fold, respectively, and the corresponding values for the active metabolite were decreased by 95% and 88%, respectively.
Croatian: Istodobna primjena saksagliptina sa potentnim inhibitorom CYP3A4/5, ketokonazolom, povisila je Cmax saksagliptina za 62%, a AUC za 2,5 puta, dok su se te vrijednosti za aktivni metabolit smanjile za 95% odnosno 88%.
English: • Film-coating: polyvinyl alcohol; macrogol 3350; titanium dioxide (E171); talc (E553b) and iron oxide red (E172).
Croatian: • Film ovojnica: poli(vinilni alkohol); makrogol 3350; titanijev dioksid (E171); talk (E553b) i crveni željezov oksid (E172).
English: Postmarketing reports of rash have been described in the DPP4 inhibitor class.
Croatian: Zabilježeni su slučajevi osipa nakon stavljanja u promet lijekova iz skupine inhibitora DPP-4.