FrancophonIA/ELRC3.0 huggingface dataset:
English: Onglyza must not be used in patients who have had any serious hypersensitivity reaction to a dipeptidyl peptidase-4 (DPP4) inhibitor (see section 4.3).
Croatian: Onglyza se ne smije primjenjivati u bolesnika koji su imali ozbiljnu reakciju preosjetljivosti na neki inhibitor dipeptidil-peptidaze 4 (DPP-4) (vidjeti dio 4.3).
English: This is one 2.5 mg tablet once a day.
Croatian: Ta je doza jedna tableta od 2,5 mg jedanput dnevno.
English: In postmarketing experience of saxagliptin, there have been spontaneously reported adverse reactions of acute pancreatitis.
Croatian: Nakon stavljanja saksagliptina u promet bile su spontano prijavljene nuspojave akutnog pankreatitisa.
English: The pharmacokinetics of saxagliptin and its major metabolite were similar in healthy subjects and in patients with type 2 diabetes.
Croatian: Farmakokinetika saksagliptina i njegova glavnog metabolita u zdravih ispitanika bila je slična onoj u bolesnika sa šećernom bolešću tipa 2.
English: The dose should be reduced to 2.5 mg once daily in patients with moderate renal impairment that have GFR < 45 mL/min and in patients with severe renal impairment.
Croatian: Dozu treba smanjiti na 2,5 mg jedanput dnevno u bolesnika s umjerenim oštećenjem bubrežne funkcije koji imaju GFR < 45 ml/min i u bolesnika s teškim oštećenjem bubrežne funkcije.
English: • 5 mg film-coated tablets are pink, biconvex, round.
Croatian: • Filmom obložene tablete od 5 mg su ružičaste, bikonveksne, okrugle.
English: Caution is warranted if Onglyza 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 Onglyza 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 incidence of confirmed hypoglycaemia was uncommon for Onglyza 5 mg (0.8%) and placebo (0.7%).
Croatian: Incidencija potvrđene hipoglikemije bila je manje česta za lijek Onglyza 5 mg (0,8%) i za placebo (0,7%).
English: Skin lesions were not observed at an increased incidence in clinical trials.
Croatian: U kliničkim ispitivanjima nije opažena povećana incidencija kožnih lezija.
English: The average renal clearance of saxagliptin (~230 ml/min) was greater than the average estimated glomerular filtration rate (~120 ml/min), suggesting some active renal excretion.
Croatian: Prosječni bubrežni klirens saksagliptina (~230 ml/min) bio je veći od prosječne procijenjene brzine glomerularne filtracije (~120 ml/min), ukazujući na donekle aktivno izlučivanje putem bubrega.
English: The safety and efficacy of saxagliptin as triple oral therapy in combination with metformin and a thiazolidinedione have not been established.
Croatian: Nisu ustanovljene sigurnost i djelotvornost saksagliptina u trojnoj peroralnoj terapiji u kombinaciji s metforminom i tiazolidindionom.
English: • Printing ink: shellac; indigo carmine aluminium lake (E132).
Croatian: • Tinta za označavanje: šelak; indigo carmine aluminium lake (E132).
English: The study population included those ≥65 years (n=8561) and ≥ 75 years (n=2330), with normal or mild renal impairment (n=13,916) as well as moderate (n=2240) or severe (n=336) renal impairment.
Croatian: Ispitivana populacija uključivala je osobe u dobi od ≥ 65 godina (n=8561) i ≥ 75 godina (n=2330) s normalnom ili blago oštećenom bubrežnom funkcijom (n=13 916), kao i one s umjereno (n=2240) ili teško (n=336) oštećenom bubrežnom funkcijom.
English: No appreciable accumulation of either saxagliptin or its major metabolite was observed with repeated once-daily dosing at any dose level.
Croatian: Nije opažena značajnija kumulacija saksagliptina i njegova glavnog metabolita pri ponovljenom doziranju jedanput dnevno pri svakoj razini doze.
English: Saxagliptin also resulted in a significantly lower proportion of patients with hypoglycaemia, 3% (19 events in 13 subjects) vs. 36.3% (750 events in 156 patients) for glipizide.
Croatian: Primjena saksagliptina rezultirala je i značajno manjim udjelom bolesnika s hipoglikemijama, 3% (19 događaja u 13 bolesnika) nasuprot 36,3% (750 događaja u 56 bolesnika).kod glipizida.
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: Prema potvrdnom cjelovitom setu analiza prosječno smanjenje iznosilo je -0,4% i-0,6% za saksagliptin i sitagliptin sa medijanom smanjenja od -0,5% za obje skupine.
English: Onglyza is used alone or together with insulin or other anti-diabetic medicines.
Croatian: Onglyza se koristi samostalno ili zajedno s inzulinom ili nekim drugim antidijabetikom.
English: No dose adjustment is necessary for patients with mild or moderate hepatic impairment (see section 5.2).
Croatian: Nije potrebna prilagodba doze u bolesnika s blagim ili umjerenim oštećenjem jetrene funkcije (vidjeti dio 5.2).
English: Table 1 Frequency of adverse reactions by system organ class from clinical trials and postmarketing experience
Croatian: Tablica 1 Učestalost nuspojava prema klasifikaciji organskih sustava iz kliničkih ispitivanja i razdoblja nakon stavljanja lijeka u promet
English: When used as add-on to insulin (with or without metformin), the overall incidence of reported hypoglycaemia was 18.4% for Onglyza 5 mg and 19.9% for placebo.
Croatian: Kad se davao kao dodatak inzulinu (sa ili bez metformina), ukupna incidencija prijavljene hipoglikemije bila je 18,4% za Onglyza 5 mg i 19,9% za placebo.
English: You should not take this medicine if you are breast-feeding or plan to breast-feed.
Croatian: Ne smijete uzeti ovaj lijek ukoliko dojite ili planirate dojiti.
English: The study included patients with renal impairment classified on the basis of creatinine clearance as mild (approximately GFR ≥ 45 to < 90 mL/min), moderate (approximately GFR ≥ 30 to < 45 mL/min), or severe (approximately GFR < 30 mL/min), as well as patients with ESRD on haemodialysis.
Croatian: Ispitivanje je uključilo bolesnike s oštećenjem funkcije bubrega klasificiranim na temelju klirensa kreatinina kao blago (GFR približno ≥ 45 do < 90 ml/min), umjereno (GFR približno ≥ 30 do < 45 ml/min) ili teško (GFR približno < 30 ml/min), kao i u bolesnika ESRD koji su na hemodijalizi.
English: The overall incidence of adverse events in patients treated with Onglyza in this trial was similar to placebo (72.5% versus 72.2%, respectively).
Croatian: Ukupna incidencija nuspojava u bolesnika liječenih lijekom Onglyza u tom ispitivanju bila je slična onoj primijećenoj u bolesnika koji su primali placebo (72,5% naspram 72,2%).
English: The most commonly reported adverse reactions in placebo-controlled trials reported in ≥5% of patients treated with Onglyza 5 mg and more commonly than in patients treated with placebo are upper respiratory tract infection (7.7%), urinary tract infection (6.8%) and headache (6.5%).
Croatian: Najčešće nuspojave u placebom-kontroliranim ispitivanjima kod ≥5% bolesnika liječenih lijekom Onglyza 5 mg, te češće nego kod bolesnika liječenih placebom su infekcije gornjeg dišnog sustava (7,7%), infekcije mokraćnog sustava (6,8%) i glavobolja (6,5%).
English: If a serious hypersensitivity reaction to saxagliptin is suspected, Onglyza should be discontinued, assess for other potential causes for the event, and institute alternative treatment for diabetes (see section 4.8).
Croatian: Posumnja li se na ozbiljnu reakciju preosjetljivosti na saksagliptin, treba obustaviti primjenu lijeka Onglyza, ispitati druge moguće uzroke nuspojave te uvesti neki drugi lijek za liječenje šećerne bolesti (vidjeti dio 4.8).
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: Smanjenje 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: 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 njegov AUC povećao za 27% u usporedbi sa stanjem natašte.
English: You should stop taking Onglyza and see your doctor immediately if you experience the following symptoms of low blood sugar: trembling, sweating, anxiety, blurred vision, tingling lips, paleness, mood change, vagueness or confusion (hypoglycaemia): Seen very commonly (may affect more than 1 in 10 people).
Croatian: Morate prestati uzimati lijek Onglyza i odmah se javite svom liječniku ako osjetite sljedeće simptome niskog šećera u krvi: drhtanje, znojenje, tjeskoba, zamagljen vid, trnci u usnicama, bljedilo, promjena raspoloženja, rastresenost ili smetenost (hipoglikemija): pojavljuje se vrlo često (može se javiti u više od 1 na 10 osoba).
English: A total of 22% of the administered radioactivity was recovered in faeces representing the fraction of the saxagliptin dose excreted in bile and/or unabsorbed medicinal product from the gastrointestinal tract.
Croatian: Ukupno se 22% primijenjene radioaktivnosti otkrilo u fecesu, što je bio udio doze saksagliptina izlučenog putem u žuči i/ili neapsorbirani lijek iz gastrointestinalnog trakta.
English: Rash has been seen with Onglyza (see section 4) and with certain anti-diabetic medicines in the same class as Onglyza.
Croatian: Zabilježen je osip kod primjene lijeka Onglyza (vidjeti dio 4) i nekih drugih antidijabetika koji pripadaju istoj skupini lijekova kao i Onglyza.
English: Metformin was uptitrated from 500 to 2000 mg per day as tolerated.
Croatian: Doza metformina titrirana je na višu od 500 do 2000 mg a dnevno, ovisno o podnošljivosti.
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 lezije kože (kraste, ulceracije i nekrozu) na ekstremitetima makaki majmuna (rep, prsti, skrotum i/ili nos) pri dozama od ≥ 3 mg/kg na dan.
English: The increased risk of overall and major hypoglycaemia was primarily observed in subjects with A1C <7% at baseline.
Croatian: Povećan rizik od ukupne i teške hipoglikemije prvenstveno je primijećen u ispitanika koji su na početku ispitivanja imali A1C od < 7%.
English: It is not known if Onglyza passes into human breast milk.
Croatian: Nije poznato izlučuje li se Onglyza u majčino mlijeko.
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 sa stanjem 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 ova je inhibicija DPP-4 uzrokovala dvostruki do trostruki porast razina aktivnih hormona inkretina u cirkulaciji uključujući sličan glukagonu peptid-1 (engl. glucagon-like peptide 1, GLP-1) i inzulinotropni polipeptid ovisan o glukozi (engl. glucose-dependent insulinotropic polypeptide, GIP), sniženje koncentracija glukagona i pojačan odgovor o glukozi ovisnih beta-stanica, što je rezultiralo povišenjem koncentracije inzulina i C-peptida.
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 povisile su se proporcionalno povišenju doze saksagliptina, a ta proporcionalnost dozi bila je primijećena za doze do 400 mg.
English: Rash is also noted as an adverse reaction for Onglyza (see section 4.8).
Croatian: Osip je također zabilježen i kao nuspojava kod primjene lijeka Onglyza (vidjeti dio 4.8).
English: If you have severe liver problems, then Onglyza is not recommended for you.
Croatian: Ako imate teške probleme s jetrom, Onglyza Vam se ne preporučuje.
English: In both studies, once-daily treatment with saxagliptin provided significant improvements in HbA1c (see Table 2).
Croatian: U oba ispitivanja, primjena saksagliptina jedanput dnevno dovela je do značajnog poboljšanja vrijednosti HbA1c (vidjeti Tablicu 3).
English: Assessment of renal function is recommended prior to initiation of Onglyza, and in keeping with routine care, renal assessment should be done periodically thereafter (see sections 4.2 and 5.2).
Croatian: Preporučuje se ocijeniti bubrežnu funkciju prije početka liječenja lijekom Onglyza i nakon toga, u skladu s rutinskom skrbi, povremeno procjenjivati bubrežnu funkciju (vidjeti dijelove 4.2 i 5.2).
English: Using CYP3A4 inducers like carbamazepine, dexamethasone, phenobarbital, phenytoin, and rifampicin may reduce the glycaemic lowering effect of Onglyza (see section 4.5).
Croatian: Primjena induktora CYP3A4 poput karbamazepina, deksametazona, fenobarbitala, fenitoina i rifampicina može umanjiti učinak lijeka Onglyza na sniženje glikemije (vidjeti dio 4.5).
English: Each tablet contains 99 mg lactose (as monohydrate).
Croatian: Jedna tableta sadrži 99 mg laktoze (u obliku hidrata).
English: The intra-subject coefficients of variation for saxagliptin Cmax and AUC were less than 12%.
Croatian: Intraindividualni koeficijenti varijacije za Cmax i AUC saksagliptina bili su manji od
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: Povećano lučenje inzulina iz beta-stanica gušterače i smanjeno lučenje glukagona iz alfa-stanica gušterače bilo je povezano s nižim koncentracijama glukoze natašte te smanjenim amplitudama glukoze nakon oralnog opterećenja glukozom ili obroka.
English: The SAVOR trial included 8240 patients treated with Onglyza 5 mg or 2.5 mg once daily and 8173 patients on placebo.
Croatian: U ispitivanju SAVOR sudjelovalo je 8240 bolesnika liječenih lijekom Onglyza u dozi od 5 mg ili 2,5 mg jedanput dnevno te 8173 bolesnika koja su primala placebo.
English: Saxagliptin was not teratogenic at any doses evaluated in rats or rabbits.
Croatian: Saksagliptin nije imao teratogeni učinak niti u jednoj ispitivanoj dozi u štakora ili kunića.
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 4).
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 4).
English: Saxagliptin improves glycaemic control by reducing fasting and postprandial glucose concentrations in patients with type 2 diabetes.
Croatian: Saksagliptin poboljšava regulaciju glikemije smanjenjem koncentracije glukoze natašte i nakon obroka u bolesnika sa šećernom bolešću tipa 2.
English: Saxagliptin significantly decreased HbA1c compared with placebo; the HbA1c change for saxagliptin was -0.9% at Week 12 (HbA1c change of -0.4% for placebo).
Croatian: Saksagliptin je značajno smanjio HbA1c u usporedbi s placebom; promjena vrijednosti HbA1c uz saksagliptin iznosila je -0,9% u 12. tjednu (promjena HbA1c od -0,4% za placebo).
English: Placebo-corrected mean change in HbA1c (%) at Week 24 (95% CI)
Croatian: Placebo-korigirana prosječna promjena vrijednosti HbA1c (%) u 24. tjednu (95% CI)
English: Onglyza should not be used in place of insulin;
Croatian: Onglyza se ne smije uzimati umjesto inzulina.
English: If you take more Onglyza than you should If you take more tablets than you should, talk to a doctor straight away.
Croatian: Ako uzmete više tableta nego što ste trebali, odmah se javite liječniku.
English: Diabetic skin lesions are a common complication of diabetes.
Croatian: Kožne promjene u bolesnika sa šećernom bolešću su česta komplikacija te bolesti.
English: Improvements in HbA1c following treatment with saxagliptin 2.5 mg were sustained up to Week 52, however, the number of patients who completed 52 weeks without modification of other antihyperglycaemic treatment was low (26 subjects in the saxagliptin group versus 34 subjects in the placebo group).
Croatian: Poboljšane vrijednosti HbA1c nakon liječenja saksagliptinom od 2,5 mg održale su se do 52. tjedna, međutim, malen je broj bolesnika završio 52 tjedna ispitivanja bez prilagodbe drugih antihiperglikemijskih lijekova (26 ispitanika u skupini koja je primala saksagliptin nasuprot 34 ispitanika u placebo skupini).
English: • Uncommon: tiredness, abnormal lipid (fatty acids) levels (dyslipidaemia, hypertriglyceridaemia).
Croatian: • Manje često: umor, poremećene vrijednosti lipida (masnih kiselina) (dislipidemija, hipertrigliceridemija).
English: No dose adjustment is recommended for patients with mild renal impairment or in patients with moderate renal impairment that have GFR ≥ 45 mL/min.
Croatian: Ne preporučuje se prilagodba doze u bolesnika s blagim oštećenjem bubrežne funkcije ili u bolesnika s umjerenim oštećenjem bubrežne funkcije koji imaju GFR ≥ 45 ml/min.
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 primijenjenog saksagliptina u dozi od 10 mg u ispitanika s različitim stupnjem kroničnog oštećenja funkcije bubrega u usporedbi s ispitanicima s normalnom funkcijom bubrega.
English: When used as add-on combination therapy with metformin plus sulphonylurea, the overall incidence of reported hypoglycaemia was 10.1% for Onglyza 5 mg and 6.3% for placebo.
Croatian: Kad se davao kao dodatak kombiniranoj terapiji metforminom i sulfonilurejom, ukupna incidencija prijavljene hipoglikemije bila je 10,1% za Onglyza 5 mg i 6,3% za placebo.
English: • Study CV181168: sequential add-on to dapagliflozin + metformin (n=315)
Croatian: • Ispitivanje CV181168: sekvencijski dodatak dapagliflozinu + metforminu (n=315)
English: These may be used to control fits (seizures) or chronic pain.
Croatian: Oni se mogu koristiti za kontrolu napadaja (konvulzija)
English: Initial therapy with the combination of saxagliptin 5 mg plus metformin (n=306) provided significant improvements in HbA1c, FPG, and PPG compared to with either saxagliptin (n=317) or metformin alone (n=313) as initial therapy.
Croatian: Početna terapija kombinacijom saksagliptina od 5 mg i metformina (n=306) dovelo je do značajnog poboljšanja vrijednosti HbA1c, FPG-a i PPG-a u usporedbi sa samim saksagliptinom (n=317) ili metforminom (n=313) kao inicijalnom terapijom.
English: Similar HbA1c reductions versus placebo were achieved for patients receiving saxagliptin 5 mg add-on to insulin regardless of metformin use (−0.4% for both subgroups).
Croatian: . Slično smanjenje vrijednosti HbA1c u odnosu na placebo bilo je postignuto u bolesnika koji su primali saksagliptin 5 mg kao dodatak inzulinu bez obzira na uzimanje metformina (-0,4% za obje podskupine).
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: Prosječan krajnji poluvijek (t½) saksagliptina u plazmi iznosi 2,5 sati, a njegova glavnog metabolita 3,1 sat, dok je srednja vrijednost t½ za inhibiciju DPP-4 u plazmi iznosila 26,9 sati.
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 visoke potentnosti, visokog afiniteta i produženog vezivanja saksagliptina za aktivno mjesto.
English: Dipeptidyl peptidase 4 (DPP4) inhibitors, ATC code: A10BH03
Croatian: Farmakoterapijska skupina: Lijekovi za liječenje šećerne bolesti, inhibitori dipeptidil-peptidaze 4 (DPP-4), ATK oznaka: A10BH03.
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 drugim induktorima CYP3A4/5 osim rifampicina (kao što su karbamazepin, deksametazon, fenobarbital i fenitoin) nije ispitivana, i mogla bi dovesti do smanjene koncentracije saksagliptina i povišene koncentracije njegovog glavnog metabolita u plazmi.
English: Discontinuation of therapy due to adverse events was higher in patients who received saxagliptin 5 mg as compared to placebo (3.3% as compared to 1.8%).
Croatian: Prekid liječenja zbog nuspojava bio je češći u bolesnika koji su primali saksagliptin od 5 mg nego u onih koji su primali placebo (3,3% u usporedbi s 1,8%).
English: Saxagliptin was rapidly absorbed after oral administration in the fasted state, with maximum plasma concentrations (Cmax) of saxagliptin and its major metabolite attained within 2 and 4 hours (Tmax), respectively.
Croatian: Saksagliptin se brzo apsorbirao nakon peroralne primjene natašte, pri čemu su vršne koncentracije saksagliptina u plazmi (Cmax) postignute za 2 sata, a njegova glavnog metabolita za 4 sata (Tmax).
English: The overall incidence of reported hypoglycaemia (recorded in daily patient diaries) was 17.1% in subjects treated with Onglyza and 14.8% among patients treated with placebo.
Croatian: Ukupna incidencija prijavljene hipoglikemije (zabilježene u dnevnicima bolesnika) iznosila je 17,1% u ispitanika liječenih lijekom Onglyza te 14,8% u bolesnika koji su primali placebo.
English: United Kingdom AstraZeneca UK Ltd Tel: +44 1582 836 836
Croatian: AstraZeneca UK Ltd Tel: +44 1582 836 836
English: p-value < 0.0001. p-value=0.0166.
Croatian: Srednja vrijednost dobivena metodom najmanjih kvadrata prilagođena za početnu vrijednost p-vrijednost < 0,0001 p-vrijednost = 0,0166
English: Ulcerative and necrotic skin lesions have been reported in extremities of monkeys in non-clinical toxicology studies (see section 5.3).
Croatian: U nekliničkim toksikološkim istraživanjima prijavljene su ulcerozne i nekrotične kožne lezije na ekstremitetima majmuna (vidjeti dio 5.3).
English: Lactose monohydrate Cellulose, microcrystalline (E460i) Croscarmellose sodium (E468) Magnesium stearate
Croatian: Jezgra tablete laktoza hidrat celuloza, mikrokristalična (E460i) karmelozanatrij, umrežena (E468) magnezijev stearat
English: Immune related findings of minimal, nonprogressive, lymphoid hyperplasia in spleen, lymph nodes and bone marrow with no adverse sequelae have been reported in all species tested at exposures starting from 7 times the RHD.
Croatian: Promjene na imunološkom sustavu, kao što su minimalna, neprogresivna, limfoidna hiperplazija u slezeni, limfnim čvorovima i koštanoj srži, bez štetnih posljedica zabilježene su u svih ispitanih vrsta pri izloženosti koja je bila najmanje 7 puta veća od RHD.
English: Method of administration The tablets can be taken with or without a meal at any time of the day.
Croatian: Tablete se mogu uzimati neovisno o obroku, u bilo koje doba dana.
English: The metabolism of saxagliptin is primarily mediated by cytochrome P450 3A4/5 (CYP3A4/5).
Croatian: Metabolizam saksagliptina primarno se odvija putem citokroma P450 3A4/5 (CYP3A4/5)