FrancophonIA/ELRC3.0 huggingface dataset:
English: The clinical relevance of the skin lesions is not known, however, clinical correlates to skin lesions in monkeys have not been observed in human clinical trials of saxagliptin.
Croatian: Klinički značaj kožnih lezija nije poznat, no u kliničkim ispitivanjima saksagliptina u ljudi nisu opaženi klinički korelati kožnih lezija u majmuna.
English: No data are available with regard to overdose of Komboglyze.
Croatian: Nema podatka o predoziranju lijekom Komboglyze.
English: Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose.
Croatian: Metformin je bigvanid s antihiperglikemijskim učincima koji snižava glukozu u plazmi u bazalnim uvjetima i postprandijalno.
English: Nervous system disorders Headache
Croatian: Poremećaji živčanog sustava glavobolja često
English: The results of bioequivalence studies in healthy subjects demonstrated that Komboglyze combination tablets are bioequivalent to co-administration of corresponding doses of saxagliptin and metformin hydrochloride as individual tablets.
Croatian: Rezultati ispitivanja bioekvivalencije u zdravih ispitanika pokazali su da su Komboglyze kombinirane tablete bioekvivalentne s istodobnom primjenom pojedinačnih tableta saksagliptina i metforminklorida u odgovarajućim dozama.
English: • Printing ink: shellac, indigo carmine aluminium lake (E132).
Croatian: • Tinta za označavanje: šelak, boja indigo carmine aluminium lake (E132)
English: Following administration of a dose of 850 mg, a 40% lower plasma peak concentration, a 25% decrease in AUC and a 35 min prolongation of time to peak plasma concentration was observed.
Croatian: Nakon primjene doze od 850 mg opažena je 40% niža vršna koncentracija lijeka u plazmi, smanjenje AUC-a za 25% te produljenje vremena do postizanja vršne koncentracije u plazmi za 35 min.
English: When used as add-on to insulin (with or without metformin), the overall incidence of reported hypoglycaemia was 18.4% for saxagliptin 5 mg and 19.9% for placebo.
Croatian: Kada se saksagliptin primjenjivao kao dodatak inzulinu (sa ili bez metformina), ukupna incidencija prijavljene hipoglikemije iznosila je 18,4% za saksagliptin od 5 mg i 19,9% za placebo.
English: It is unknown whether saxagliptin is excreted in human milk, but metformin is excreted in human milk in small amounts.
Croatian: Nije poznato izlučuje li se saksagliptin u majčino mlijeko u ljudi, a metformin se u njega izlučuje u malim količinama.
English: There have been no therapeutic clinical trials conducted with Komboglyze tablets, however, bioequivalence of Komboglyze with co-administered saxagliptin and metformin has been demonstrated (see section 5.2).
Croatian: Nisu provedena terapijska klinička ispitivanja s Komboglyze tabletama, međutim, utvrđena je bioekvivalencija lijeka Komboglyze sa saksagliptinom i metforminom primijenjenima istodobno (vidjeti dio 5.2).
English: No appreciable accumulation of either saxagliptin or its major metabolite was observed with repeated once-daily dosing at any dose level.
Croatian: Nije opaženo značajnije nakupljanje ni saksagliptina ni njegova glavnog metabolita kod višekratne primjene jedanput dnevno u bilo kojoj dozi.
English: Pack sizes of 14, 28, 56 and 60 film-coated tablets in non-perforated blisters.
Croatian: Veličine pakiranja od 14, 28, 56 i 60 filmom obloženih tableta u neperforiranim blisterima.
English: Saxagliptin was not teratogenic at any doses evaluated in rats or rabbits.
Croatian: Saksagliptin se nije pokazao teratogenim ni pri jednoj dozi ispitanoj u štakora ili kunića.
English: Indigo carmine aluminium lake (E132)
Croatian: Tinta za označavanje šelak boja indigo carmine aluminium lake (E132)
English: In cynomolgus monkeys saxagliptin produced reversible skin lesions (scabs, ulcerations and necrosis) in extremities (tail, digits, scrotum and/or nose) at doses ≥ 3 mg/kg/day.
Croatian: Saksagliptin je izazvao reverzibilne kožne lezije (kraste, ulceracije i nekrozu) na ekstremitetima makaki majmuna (repu, prstima, skrotumu i/ili nosu) pri dozama od ≥ 3 mg/kg na dan.
English: The percent of subjects with reported on-treatment events of major hypoglycaemia (defined as an event that required assistance of another person) was higher in the saxagliptin group than in the placebo group (2.1% and 1.6%, respectively).
Croatian: Postotak ispitanika s prijavljenim događajima teške hipoglikemije (definira se kao događaj koji zahtjeva pomoć druge osobe) tijekom liječenja bio je veći u skupini koja je primala saksagliptin nego u onoj koja je primala placebo (2,1% naspram 1,6%).
English: Saxagliptin improves glycaemic control by reducing fasting and postprandial glucose concentrations in patients with type 2 diabetes.
Croatian: Saksagliptin poboljšava kontrolu glikemije snižavanjem koncentracije glukoze natašte i postprandijalno u bolesnika sa šećernom bolešću tipa 2.
English: Administration with food (a high-fat meal) resulted in no change in saxagliptin Cmax and a 27% increase in AUC compared with the fasted state.
Croatian: Primjena s hranom (punomasnim obrokom) nije promijenila Cmax saksagliptina, dok se AUC povećala za 27% u usporedbi s primjenom natašte.
English: If you forget to take Komboglyze
Croatian: Ako ste zaboravili uzeti Komboglyze
English: The reductions from baseline in HbA1c respectively for saxagliptin and sitagliptin in the primary per-protocol analysis were -0.5% (mean and median) and -0.6% (mean and median).
Croatian: Smanjenja HbA1c u odnosu na početne vrijednosti za saksagliptin i sitagliptin u osnovnim analizama prema planu ispitivanja iznosile su -0,5% (srednja vrijednost i medijan) i -0,6% (srednja vrijednost i medijan).
English: • infection of the upper airways
Croatian: • infekcija gornjih dišnih putova
English: If you are not sure, talk to your doctor or pharmacist before taking this medicine.
Croatian: Ako niste sigurni, provjerite sa svojim liječnikom ili ljekarnikom prije nego uzmete ovaj lijek.
English: However, subjects on saxagliptin with a history of heart failure or impaired renal function at baseline were not at an increased risk relative to placebo for the primary or secondary composite endpoints or all-cause mortality.
Croatian: Međutim, u bolesnika sa zatajenjem srca u anamnezi ili oštećenjem bubrežne funkcije na početku ispitivanja koji su primali saksagliptin nije postojao povećan rizik u odnosu na placebo s obzirom na primarnu ili sekundarnu kompozitnu mjeru ishoda ili smrt zbog bilo kojeg uzroka.
English: Primary composite endpoint: MACE Secondary composite endpoint: MACE plus All-cause mortality
Croatian: Sekundarna kompozitna mjera ishoda: MACE plus povezani događaji
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 mužjaka i ženki štakora pri visokim dozama koje su proizvele vidljive znakove toksičnosti (vidjeti dio 5.3).
English: Alcohol intoxication is associated with an increased risk of lactic acidosis, particularly in the case of fasting, malnutrition or hepatic impairment due to the metformin active substance of Komboglyze (see section 4.4).
Croatian: Intoksikacija alkoholom povezana je s povećanim rizikom od laktacidoze, osobito u slučajevima gladovanja, pothranjenosti ili oštećenja funkcije jetre. izazvane metforminom kao djelatnom tvari u lijeku Komboglyze (vidjeti dio 4.4).
English: Saxagliptin (N=8280)
Croatian: Mjera ishoda saksagliptin (N=8280)
English: In addition, patients should be alerted to the risk of hypoglycaemia when Komboglyze is used in combination with other antidiabetic medicinal products known to cause hypoglycaemia (e.g. insulin, sulphonylureas).
Croatian: Osim toga, bolesnike treba upozoriti na rizik od hipoglikemije kod istodobne primjene lijeka Komboglyze s drugim antidijabeticima za koje se zna da uzrokuju hipoglikemiju (npr. inzulinom, sulfonilurejama).
English: Therefore, in keeping with routine care of the diabetic patient, monitoring for skin disorders, such as blistering, ulceration or rash, is recommended.
Croatian: Stoga se u sklopu redovite skrbi o bolesniku sa šećernom bolešću preporučuje pratiti eventualne poremećaje kože, poput mjehurića, ulceracija ili osipa.
English: Caution is warranted if this medicinal product is used in patients who have known risk factors for hospitalisation for heart failure, such as a history of heart failure or moderate to severe renal impairment.
Croatian: Potreban je oprez ako se ovaj lijek primjenjuje u bolesnika s poznatim čimbenicima rizika za hospitalizaciju zbog zatajenja srca, kao što je anamneza zatajenja srca ili umjereno do teško oštećenje funkcije bubrega.
English: The inhibition of plasma DPP4 activity by saxagliptin for at least 24 hours after oral administration of saxagliptin is due to high potency, high affinity, and extended binding to the active site.
Croatian: Inhibicija plazmatske DPP-4 aktivnosti saksagliptinom tijekom najmanje 24 sata nakon peroralne primjene posljedica je njegove visoke potentnosti, visokog afiniteta i produženog vezivanja za aktivno mjesto.
English: After oral administration, metformin absorption is saturable and incomplete.
Croatian: Apsorpcija metformina je nakon peroralne primjene saturabilna i nepotpuna.
English: • muscle pain (myalgia)
Croatian: • bol u mišićima (mialgija)
English: Table 3 Frequency of additional adverse reactions by system organ class
Croatian: Tablica 3 Učestalost dodatnih nuspojava prema organskim sustavima
English: Another secondary endpoint, all-cause mortality, occurred at a rate of 5.1% in the saxagliptin group and 4.6% in the placebo group (see Table 7).
Croatian: Stopa drugog sekundarnog ishoda, smrti zbog bilo kojeg uzroka, bila je 5,1% u skupini liječenoj saksagliptinom i 4,6% u skupini liječenoj placebom (vidjeti Tablicu 7).
English: The major metabolite of saxagliptin is also a selective, reversible, competitive DPP4 inhibitor, half as potent as saxagliptin.
Croatian: Glavni metabolit saksagliptina također je selektivan, reverzibilan, kompetitivan inhibitor DPP-4, dvostruko manje potentan od saksagliptina.
English: Saxa 5 mg daily add-on to metformin plus sulphonylurea;
Croatian: Saksagliptin 5 mg na dan kao dodatak metforminu i sulfonilureji;
English: So it is important to keep following the advice about diet and exercise from your doctor or nurse.
Croatian: Stoga je važno da se pridržavate uputa o prehrani i tjelovježbi koje su Vam dali Vaš liječnik ili medicinska sestra.
English: The biotransformation of saxagliptin is primarily mediated by cytochrome P450 3A4/5 (CYP3A4/5).
Croatian: Biotransformacija saksagliptina primarno se odvija putem citokroma P450 3A4/5 (CYP3A4/5).
English: Saxagliptin and metformin work together to control your blood sugar.
Croatian: Saksagliptin i metformin djeluju zajedno i reguliraju razinu šećera u krvi.
English: Change from baseline (adjusted mean (95% Confidence interval [CI]) Difference from saxagliptin + metformin (adjusted mean (95% CI)
Croatian: Promjena od početne vrijednosti (prilagođena srednja vrijednost (95% Interval pouzdanosti [CI]) Razlika u odnosu na saksagliptin + metformin (prilagođena srednja vrijednost (95% CI)
English: If this happens you must stop taking Komboglyze and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.
Croatian: Ako Vam se to dogodi, morate prestati uzimati lijek Komboglyze i odmah se obratiti liječniku ili otići u najbližu bolnicu, jer laktacidoza može dovesti do kome.
English: Change in clinical status of patients with previously controlled type 2 diabetes As this medicinal product contains metformin, a patient with type 2 diabetes previously well controlled on Komboglyze who develops laboratory abnormalities or clinical illness (especially vague and poorly defined illness) should be evaluated promptly for evidence of ketoacidosis or lactic acidosis.
Croatian: Promjene u kliničkom statusu bolesnika s prethodno kontroliranom šećernom bolešću tipa 2 Budući da ovaj lijek sadrži metformin, u bolesnika sa šećernom bolešću tipa 2 u kojeg je glikemija ranije bila dobro kontrolirana ovim lijekom, a u kojeg se razviju odstupanja laboratorijskih nalaza ili klinička bolest (a posebice nejasna ili slabo definirana), moraju se odmah procijeniti znakovi ketoacidoze ili laktacidoze.
English: Using CYP3A4 inducers like carbamazepine, dexamethasone, phenobarbital, phenytoin, and rifampicin may reduce the glycaemic lowering effect of saxagliptin (see section 4.5).
Croatian: Primjena induktora CYP3A4 poput karbamazepina, deksametazona, fenobarbitala, fenitoina i rifampicina može umanjiti učinak saksagliptina na sniženje glikemije (vidjeti dio 4.5).
English: During post-approval use of saxagliptin, additional side effects have been reported that include serious allergic reactions (anaphylaxis), and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing.
Croatian: Nakon stavljanja saksagliptina u promet, prijavljene su dodatne nuspojave koje uključuju teške alergijske reakcije (anafilaksija) i oticanje lica, usana, jezika i grla što može otežati disanje ili gutanje.
English: In the confirmatory full analysis set, mean reductions were -0.4% and -0.6% respectively for saxagliptin and sitagliptin, with median reductions of -0.5% for both groups.
Croatian: U potvrdnom cjelovitom setu analiza prosječno smanjenje uz primjenu saksagliptina iznosilo je -0,4%, a uz primjenu sitagliptina -0,6%, dok je medijan sniženja bio -0,5% u obje skupine.
English: Includes saxagliptin in add-on to metformin and initial combination with metformin.
Croatian: Uključuje saksagliptin kao dodatak metforminu i početnu kombiniranu terapiju s metforminom.
English: Therefore, a lower dose of insulin or sulphonylurea may be required to reduce the risk of hypoglycaemia when used in combination with Komboglyze.
Croatian: Stoga će možda biti potrebna niža doza inzulina ili sulfonilureje kada se primjenjuju u kombinaciji s lijekom Komboglyze kako bi se smanjio rizik od hipoglikemije.
English: The Cmax and AUC values of saxagliptin and its major metabolite increased proportionally with the increment in the saxagliptin dose, and this dose-proportionality was observed in doses up to 400 mg.
Croatian: Vrijednosti Cmax i AUC-a saksagliptina i njegova glavnog metabolita povećavale su se proporcionalno povećanju doze saksagliptina, a ta je proporcionalnost doza opažena za doze do 400 mg.
English: The time for saxagliptin to reach Cmax (Tmax) was increased by approximately 0.5 hours with food compared with the fasted state.
Croatian: Vrijeme potrebno da saksagliptin postigne Cmax (Tmax) produljilo se za približno 0,5 sati kod primjene s hranom u usporedbi s primjenom natašte.
English: After an oral glucose load, this DPP4 inhibition resulted in a 2- to 3-fold increase in circulating levels of active incretin hormones, including glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), decreased glucagon concentrations and increased glucose-dependent beta-cell responsiveness, which resulted in higher insulin and C-peptide concentrations.
Croatian: Nakon oralnog opterećenja glukozom ta je inhibicija DPP-4 uzrokovala dvostruki do trostruki porast cirkulirajućih razina aktivnih inkretinskih hormona, uključujući glukagonu sličan peptid 1 (engl. glucagon-like peptide 1, GLP-1) te inzulinotropni polipeptid ovisan o glukozi (engl. glucose-dependent insulinotropic polypeptide, GIP), sniženje koncentracija glukagona te povećanje o glukozi ovisnog odgovora beta stanica, zbog čega su se povećale koncentracije inzulina i C-peptida.
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 aktivnosti DPP4 u plazmi tijekom doznog intervala (vidjeti dio 4.4).
English: Skin lesions were not observed at an increased incidence in clinical trials.
Croatian: U kliničkim ispitivanjima nije opažena povećana učestalost kožnih lezija.
English: The metabolism of saxagliptin is primarily mediated by cytochrome P450 3A4/5 (CYP3A4/5).
Croatian: Metabolizam saksagliptina prvenstveno se odvija posredstvom citokroma P450 3A4/5 (CYP3A4/5).
English: Subjects at higher risk for hospitalisation for heart failure, irrespective of treatment assignment, could be identified by known risk factors for heart failure such as baseline history of heart failure or impaired renal function.
Croatian: Ispitanike u kojih postoji povećan rizik od hospitalizacije zbog zatajenja srca, neovisno o dodijeljenome liječenju, moguće je odrediti prema poznatim faktorima rizika za zatajenje srca, poput zatajenja srca u anamnezi ili oštećenja bubrežne funkcije na početku ispitivanja.
English: Saxagliptin plus metformin was not associated with significant changes from baseline in fasting serum lipids compared to metformin alone.
Croatian: Kombinacija saksagliptina i metformina nije bila povezana sa značajnim promjenama od početne vrijednosti lipida u serumu natašte u usporedbi s monoterapijom metforminom.
English: As add-on to metformin and a sulphonylurea: dizziness (common), fatigue (common) and flatulence (common).
Croatian: Kao dodatak metforminu i sulfonilureji: omaglica (često), umor (često) i flatulencija (često).
English: The overall incidence of AEs in patients treated with saxagliptin in this trial was similar to placebo (72.5% versus 72.2%, respectively).
Croatian: Ukupna incidencija nuspojava u bolesnika liječenih saksagliptinom u tom ispitivanju bila je slična onoj primijećenoj u bolesnika koji su primali placebo (72,5% naspram 72,2%).
English: Saxagliptin (n=186) provided significant improvements in HbA1c, FPG, and PPG compared to placebo (n=175).
Croatian: Saksagliptin (n=186) je značajno poboljšao vrijednosti HbA1c, FPG-a i PPG-a u usporedbi s placebom (n=175).
English: The rise in insulin from pancreatic beta-cells and the decrease in glucagon from pancreatic alpha-cells were associated with lower fasting glucose concentrations and reduced glucose excursion following an oral glucose load or a meal.
Croatian: Pojačano lučenje inzulina iz beta stanica gušterače i smanjeno lučenje glukagona iz alfa stanica gušterače bili su povezani s nižim koncentracijama glukoze natašte i manjim skokovima glukoze nakon oralnog opterećenja glukozom, odnosno nakon obroka.
English: Table 5 Key efficacy results in placebo-controlled, combination therapy studies of saxagliptin and metformin
Croatian: Tablica 5 Najvažniji rezultati djelotvornosti dobiveni u placebom kontroliranim ispitivanjima kombinirane terapije saksagliptinom i metforminom
English: What Komboglyze is used for This medicine is used to treat a type of diabetes called ‘type 2 diabetes'.
Croatian: Ovaj lijek se koristi za liječenje jedne vrste šećerne bolesti koja se naziva ‘šećerna bolest tipa 2'.
English: Nervous system disorders Metallic taste
Croatian: Poremećaji živčanog sustava metalni okus često
English: For the major metabolite, renal clearance values were comparable to estimated glomerular filtration rate.
Croatian: Vrijednosti bubrežnog klirensa glavnog metabolita bile su slične procijenjenoj brzini glomerularne filtracije.
English: Other side effects of Komboglyze include:
Croatian: Ostale nuspojave Komboglyze tableta uključuju:
English: The intra-subject coefficients of variation for saxagliptin Cmax and AUC were less than 12%.
Croatian: Koeficijenti varijacije unutar ispitanika za Cmax i AUC saksagliptina bili su manji od
English: When this medicinal product is used in combination with insulin, a lower dose of insulin may be required to reduce the risk of hypoglycaemia (see section 4.4).
Croatian: Kad se ovaj lijek uzima u kombinaciji s inzulinom, možda će biti potrebno smanjiti dozu inzulina kako bi se umanjio rizik od hipoglikemije (vidjeti dio 4.4).
English: The SAVOR trial included 8240 patients treated with saxagliptin 5 mg or 2.5 mg once daily and 8173 patients on placebo.
Croatian: U ispitivanju SAVOR sudjelovalo je 8240 bolesnika liječenih saksagliptinom u dozi od 5 mg ili 2,5 mg jedanput dnevno te 8173 bolesnika koja su primala placebo.
English: If you have uncontrolled diabetes, with, for example, severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) or ketoacidosis.
Croatian: ako ste ikada bili u dijabetičkoj komi; ako imate nekontroliranu šećernu bolest uz, primjerice, tešku hiperglikemiju (visoka razina glukoze u krvi), mučninu, povraćanje, proljev, brz gubitak tjelesne težine, laktacidozu (vidjeti „Rizik od laktacidoze” niže) ili ketoacidozu.
English: EU/1/11/731/007 28 film-coated tablets EU/1/11/731/008 56 film-coated tablets EU/1/11/731/009 60 film-coated tablets EU/1/11/731/010 112 (2 packs of 56) film-coated tablets EU/1/11/731/011 196 (7 packs of 28) film-coated tablets EU/1/11/731/012 60x1 film-coated tablets EU/1/11/731/014 14 film-coated tablets
Croatian: EU/1/11/731/007 28 filmom obloženih tableta EU/1/11/731/008 56 filmom obloženih tableta EU/1/11/731/009 60 filmom obloženih tableta EU/1/11/731/010 112 (2 pakiranja s 56) filmom obloženih tableta EU/1/11/731/011 196 (7 pakiranja s 28) filmom obloženih tableta EU/1/11/731/012 60x1 filmom obložena tableta EU/1/11/731/014 14 filmom obloženih tableta
English: Stop taking Komboglyze and contact a doctor or the nearest hospital immediately if you experience some of the symptoms of lactic acidosis, as this condition may lead to coma.
Croatian: Prestanite uzimati lijek Komboglyze i odmah se obratite liječniku ili otiđite u najbližu bolnicu ako osjetite neke od simptoma laktacidoze, jer to stanje može dovesti do kome.
English: The overall incidence of reported hypoglycaemia (recorded in daily patient diaries) was 17.1% in subjects treated with saxagliptin and 14.8% among patients treated with placebo.
Croatian: Ukupna incidencija prijavljene hipoglikemije (zabilježene u dnevnicima bolesnika) iznosila je 17,1% u ispitanika liječenih saksagliptinom te 14,8% u bolesnika koji su primali placebo.
English: The following data are based on the findings in the studies with saxagliptin and metformin individually.
Croatian: Podaci koji slijede temelje se na rezultatima ispitivanja provedenih zasebno sa saksagliptinom i metforminom.
English: The co-administration of saxagliptin and CYP3A4/5 inducers, other than rifampicin (such as carbamazepine, dexamethasone, phenobarbital and phenytoin) have not been studied and may result in decreased plasma concentration of saxagliptin and increased concentration of its major metabolite.
Croatian: Istodobna primjena saksagliptina s induktorima CYP3A4/5 osim rifampicina (npr. karbamazepinom, deksametazonom, fenobarbitalom i fenitoinom) nije ispitivana, a može rezultirati sniženjem koncentracije saksagliptina te povećanjem koncentracije njegova glavnog metabolita u plazmi.
English: The mean plasma terminal half-life (t1/2) values for saxagliptin and its major metabolite are 2.5 hours and 3.1 hours respectively, and the mean t1/2 value for plasma DPP4 inhibition was 26.9 hours.
Croatian: Srednja vrijednost poluvijeka (t½) saksagliptina u plazmi iznosi 2,5 sati, a njegova glavnog metabolita 3,1 sat, dok je prosječna vrijednost t½ za inhibiciju DPP-4 u plazmi bila 26,9 sati.
English: A single-dose, open-label study was conducted to evaluate the pharmacokinetics of a 10 mg oral dose of saxagliptin in subjects with varying degrees of chronic renal impairment compared to subjects with normal renal function.
Croatian: Provedeno je otvoreno ispitivanje jednokratne doze da bi se procijenila farmakokinetika peroralno primjenjenog saksagliptina u dozi od 10 mg u ispitanika s različitim stupnjevima kroničnog oštećenja funkcije bubrega u usporedbi s ispitanicima s normalnom bubrežnom funkcijom.
English: Rash is also noted as an adverse event (AE) for saxagliptin (see section 4.8).
Croatian: Osip je zabilježen i kao nuspojava saksagliptina (vidjeti dio 4.8).
English: How Komboglyze works
Croatian: Kako Komboglyze djeluje