FrancophonIA/ELRC3.0 huggingface dataset:
English: The tablet film coating contains: poly(vinyl alcohol), macrogol 3350, talc (E553b), titanium dioxide (E171), red iron oxide (E172), and yellow iron oxide (E172).
Croatian: Film ovojnica tablete sadrži: poli(vinilni alkohol), makrogol 3350, talk (E553b), titanijev dioksid (E171), crveni željezov oksid (E172) i žuti željezov oksid (E172).
English: The Trial Evaluating Cardiovascular Outcomes with sitagliptin (TECOS) included 7,332 patients treated with sitagliptin, 100 mg daily (or 50 mg daily if the baseline eGFR was ≥ 30 and < 50 mL/min/1.73 m2), and 7,339 patients treated with placebo in the intention-to-treat population.
Croatian: Trial Evaluating Cardiovascular Outcomes with Sitagliptin, TECOS) uključivalo je 7332 bolesnika liječena sitagliptinom u dozi od 100 mg na dan (ili 50 mg na dan ako je početni eGFR bio ≥ 30 i < 50 ml/min/1,73 m2) i 7339 bolesnika koji su primali placebo u populaciji bolesnika predviđenoj za liječenje.
English: A 24-week active (metformin)-controlled study was designed to evaluate the efficacy and safety of sitagliptin 100 mg once daily (N=528) compared to metformin (N=522) in patients with inadequate glycaemic control on diet and exercise and who were not on anti-hyperglycaemic therapy (off therapy for at least 4 months).
Croatian: U aktivno (metforminom) kontroliranom ispitivanju koje je trajalo 24 tjedna ispitivana je djelotvornost i sigurnost sitagliptina u dozi od 100 mg jedanput na dan (n=528) u odnosu na metformin (n=522) u bolesnika u kojih glikemija nije odgovarajuće kontrolirana samo dijetom i tjelovježbom, a koji nisu na antihiperglikemijskoj terapiji (bez terapije najmanje 4 mjeseca).
English: HbA1c (%) at week 24.
Croatian: HbA1c (%) u 24. tjednu.
English: In vitro studies indicated that the primary enzyme responsible for the limited metabolism of sitagliptin is CYP3A4, with contribution from CYP2C8.
Croatian: Istraživanja in vitro ukazuju na to da je za ograničeni metabolizam sitagliptina primarno odgovoran CYP3A4, uz doprinos CYP2C8.
English: For patients with moderate renal impairment (GFR  30 to < 45 mL/min), the dose of Ristaben is 50 mg once daily.
Croatian: U bolesnika s umjerenim oštećenjem funkcije bubrega (GFR ≥ 30 do < 45 ml/min) doza lijeka Ristaben je 50 mg jedanput na dan.
English: Patients with an eGFR < 30 mL/min/1.73 m2 were not to be enrolled in the study.
Croatian: U ispitivanje se nisu smjeli uključiti bolesnici kojima je eGFR bio < 30 ml/min/1,73 m2.
English: After 54 weeks, the mean reduction from baseline in HbA1c was -0.72 % with sitagliptin and -0.87 % with glipizide.
Croatian: Nakon 54 tjedna srednja vrijednost sniženja HbA1c u odnosu na početne vrijednosti bila je -0,72% uz sitagliptin te -0,87% uz glipizid.
English: Tablet core: microcrystalline cellulose (E460) calcium hydrogen phosphate, anhydrous (E341) croscarmellose sodium (E468) magnesium stearate (E470b) sodium stearyl fumarate
Croatian: Jezgra tablete: celuloza, mikrokristalična (E460) kalcijev hidrogenfosfat, bezvodni (E341) karmelozanatrij, umrežena (E468) magnezijev stearat (E470b) natrijev stearilfumarat
English: Some patients have experienced the following side effects while taking sitagliptin and pioglitazone: Common: flatulence, swelling of the hands or legs
Croatian: Pri uzimanju sitagliptina zajedno s pioglitazonom u nekih su bolesnika nastupile sljedeće nuspojave: Često: vjetrovi, oticanje ruku ili nogu
English: The study included patients with mild, moderate, and severe renal impairment, as well as patients with ESRD on haemodialysis.
Croatian: U ispitivanje su uključeni bolesnici s blagim, umjerenim i teškim oštećenjem funkcije bubrega, kao i bolesnici na hemodijalizi u završnoj fazi bubrežne bolesti.
English: In a study comparing the efficacy and safety of the addition of sitagliptin 100 mg once daily or glipizide (a sulphonylurea) in patients with inadequate glycaemic control on metformin monotherapy, sitagliptin was similar to glipizide in reducing HbA1c.
Croatian: U ispitivanju u kojemu se uspoređivala djelotvornost i sigurnost dodanog liječenja sitagliptinom u dozi od 100 mg jedanput na dan u odnosu na glipizid (sulfonilureja) u bolesnika u kojih glikemija nije odgovarajuće kontrolirana monoterapijom metforminom, sitagliptin i glipizid bili su slično djelotvorni u snižavanju HbA1c.
English: Metformin: Co-administration of multiple twice-daily doses of 1,000 mg metformin with 50 mg sitagliptin did not meaningfully alter the pharmacokinetics of sitagliptin in patients with type 2 diabetes.
Croatian: Metformin: U bolesnika s dijabetesom tipa 2 istodobna primjena višekratnih doza metformina od 1000 mg dvaput na dan i sitagliptina u dozi od 50 mg dvaput na dan nije značajnije promijenila farmakokinetiku sitagliptina.
English: Secondary cardiovascular endpoints included the first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke; first occurrence of the individual components of the primary composite; all-cause mortality; and hospital admissions for congestive heart failure.
Croatian: Sekundarne kardiovaskularne mjere ishoda uključivale su prvi nastup smrti zbog kardiovaskularnog uzroka, infarkta miokarda bez smrtnog ishoda ili nastup moždanog udara bez smrtnog ishoda; prva pojava pojedinih elemenata primarne mjere ishoda; smrt zbog bilo kojeg uzroka; te hospitalizaciju zbog kongestivnog zatajenja srca.
English: Rates of Composite Cardiovascular Outcomes and Key Secondary Outcomes
Croatian: Tablica 3. Stope objedinjenih kardiovaskularnih ishoda i ključnih sekundarnih ishoda sitagliptin 100 mg
English: • metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.
Croatian: • s metforminom kada dijeta i tjelovježba uz samo metformin ne omogućuju odgovarajuću regulaciju glikemije.
English: How to take Ristaben
Croatian: Kako uzimati lijek Ristaben
English: Least squares means adjusted for prior antihyperglycaemic therapy status and baseline value.
Croatian: Srednje vrijednosti najmanjih kvadratnih pogrešaka prilagođenih prema dosadašnjoj antihiperglikemijskoj terapiji i vrijednosti na početku liječenja.
English: The study population included 2,004 patients ≥ 75 years of age and 3,324 patients with renal impairment (eGFR < 60 mL/min/1.73 m
Croatian: 2004 bolesnika u dobi od ≥ 75 godina te 3324 bolesnika s oštećenjem funkcije bubrega (eGFR < 60 ml/min/1,73 m
English: Ristaben should not be used during breast-feeding.
Croatian: Ristaben se ne smije uzimati tijekom dojenja.
English: It is unknown whether sitagliptin is excreted in human breast milk.
Croatian: Nije poznato izlučuje li se sitagliptin u majčino mlijeko.
English: Respiratory, thoracic and mediastinal disorders interstitial lung disease
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja intersticijska bolest pluća nepoznata učestalost
English: A study comparing sitagliptin at 25 or 50 mg once daily to glipizide at 2.5 to 20 mg/day was conducted in patients with moderate to severe renal impairment.
Croatian: Jedno ispitivanje u kojemu se uspoređivao sitagliptin u dozi od 25 ili 50 mg jedanput na dan s glipizidom u dozi od 2,5 do 20 mg/dan provedeno je u bolesnika s umjerenim do teškim oštećenjem funkcije bubrega.
English: Another study comparing sitagliptin at 25 mg once daily to glipizide at 2.5 to 20 mg/day was conducted in 129 patients with ESRD who were on dialysis.
Croatian: Drugo ispitivanje u kojemu se uspoređivao sitagliptin u dozi od 25 mg jedanput na dan s glipizidom u dozi od 2,5 do 20 mg/dan provedeno je u 129 bolesnika u završnoj fazi bubrežne bolesti koji su bili na dijalizi.
English: - The other ingredients are: In the tablet core: microcrystalline cellulose (E460), calcium hydrogen phosphate, anhydrous (E341), croscarmellose sodium (E468), magnesium stearate (E470b), and sodium stearyl fumarate.
Croatian: Drugi sastojci su: u jezgri tablete: mikrokristalična celuloza (E460), bezvodni kalcijev hidrogenfosfat (E341), umrežena karmelozanatrij (E468), magnezijev stearat (E470b) i natrijev stearilfumarat.
English: The addition of sitagliptin to pioglitazone and metformin provided significant improvements in glycaemic parameters.
Croatian: Dodavanje sitagliptina pioglitazonu i metforminu značajno je poboljšalo glikemijske parametre.
English: In this study, the efficacy and safety profile of sitagliptin at 25 or 50 mg once daily was generally similar to that observed in other monotherapy studies in patients with normal renal function.
Croatian: U ovom je ispitivanju profil djelotvornosti i sigurnosti sitagliptina u dozi od 25 ili 50 mg jedanput na dan općenito bio sličan onomu opaženom u drugim ispitivanjima monoterapije u bolesnika s normalnom funkcijom bubrega.
English: Round, beige film-coated tablet with “277” on one side.
Croatian: Okrugla, bež, filmom obložena tableta s oznakom "277" na jednoj strani.
English: For patients with mild renal impairment (glomerular filtration rate [GFR]  60 to < 90 ml/min), no dose adjustment is required.
Croatian: U bolesnika s blagim oštećenjem funkcije bubrega (brzina glomerularne filtracije [GFR] ≥ 60 do < 90 ml/min) nije potrebna prilagodba doze.
English: For patients with moderate renal impairment (GFR  45 to < 60 mL/min), no dosage adjustment is required.
Croatian: U bolesnika s umjerenim oštećenjem funkcije bubrega (GFR ≥ 45 do < 60 ml/min) nije potrebna prilagodba doze.
English: A 24-week placebo-controlled study was designed to evaluate the efficacy and safety of sitagliptin (100 mg once daily) added to insulin (at a stable dose for at least 10 weeks) with or without metformin (at least 1,500 mg).
Croatian: U 24-tjednom placebom kontroliranom ispitivanju cilj je bio ocijeniti djelotvornost i sigurnost sitagliptina (100 mg jedanput na dan) kao dodatka inzulinu (u stabilnoj dozi tijekom najmanje 10 tjedana), s ili bez metformina (najmanje 1500 mg).
English: It is important to stay on the diet and exercise recommended by your doctor while taking Ristaben.
Croatian: Dok uzimate lijek Ristaben, važno je da se pridržavate preporuka svog liječnika o dijeti i tjelovježbi.
English: Uncommon: dizziness, constipation, itching
Croatian: Manje često: omaglica, zatvor, svrbež
English: In this study, the efficacy and safety profile of sitagliptin at 25 mg once daily was generally similar to that observed in other monotherapy studies in patients with normal renal function.
Croatian: U ovom je ispitivanju profil djelotvornosti i sigurnosti sitagliptina u dozi od 25 mg jedanput na dan općenito bio sličan onomu opaženom u drugim ispitivanjima monoterapije u bolesnika s normalnom funkcijom bubrega.
English: Česká republika Merck Sharp & Dohme s.r.o.
Croatian: Slovenská republika Merck Sharp & Dohme, s. r. o.
English: The addition of sitagliptin to insulin provided significant improvements in glycaemic parameters.
Croatian: Dodavanje sitagliptina inzulinu značajno je poboljšalo glikemijske parametre.
English: The overall incidence of serious adverse events in patients receiving sitagliptin was similar to that in patients receiving placebo.
Croatian: Ukupna incidencija ozbiljnih nuspojava u bolesnika liječenih sitagliptinom bila je slična onoj u bolesnika koji su primali placebo.
English: Adverse reactions were identified through postmarketing surveillance.
Croatian: Nuspojave su otkrivene praćenjem nakon stavljanja lijeka u promet.
English: A 26-week placebo-controlled study was designed to evaluate the efficacy and safety of sitagliptin (100 mg once daily) added to the combination of pioglitazone and metformin.
Croatian: U 26-tjednom placebom kontroliranom ispitivanju cilj je bio ocijeniti djelotvornost i sigurnost sitagliptina (100 mg jedanput na dan) kao dodatka kombinaciji pioglitazona i metformina.
English: • a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
Croatian: • sa sulfonilurejom i metforminom kada dijeta i tjelovježba uz dvojnu terapiju ovim lijekovima ne omogućuju odgovarajuću regulaciju glikemije.
English: The TECOS was a randomised study in 14,671 patients in the intention-to-treat population with an HbA1c of ≥ 6.5 to 8.0 % with established CV disease who received sitagliptin (7,332) 100 mg daily (or 50 mg daily if the baseline eGFR was ≥ 30 and < 50 mL/min/1.73 m2) or placebo (7,339) added to usual care targeting regional standards for HbA1c and CV risk factors.
Croatian: Ispitivanje TECOS bilo je randomizirano ispitivanje provedeno u 14 671 bolesnika, koji pripadaju populaciji bolesnika predviđenoj za liječenje, s vrijednostima HbA1c od ≥ 6,5 do 8,0% i potvrđenom KV bolesti te su primali sitagliptin (7332) u dozi od 100 mg na dan (ili 50 mg na dan ako je početni eGFR bio ≥ 30 i < 50 ml/min/1,73 m2) ili placebo (7339) kao dodatak standardnom liječenju usmjerenom na regionalne standardne vrijednosti HbA1c i faktore KV rizika.
English: Round, pink film-coated tablet with “221” on one side.
Croatian: Okrugla, ružičasta, filmom obložena tableta s oznakom "221" na jednoj strani.
English: Nervous system disorders headache
Croatian: Poremećaji živčanog sustava glavobolja često omaglica manje često
English: Tell your doctor if you have or have had: - a disease of the pancreas (such as pancreatitis) - gallstones, alcohol dependence or very high levels of triglycerides (a form of fat) in your blood.
Croatian: - Žučne kamence, ovisnost o alkoholu ili vrlo visoke razine triglicerida (vrsta masnoća) u Vašoj krvi.
English: The reduction in HbA1c in patients treated with sitagliptin and insulin (with or without metformin) was -1.31 % compared to -0.87 % in patients treated with placebo and insulin (with or without metformin), a difference of -0.45 % [95 % CI: -0.60, -0.29].
Croatian: Sniženje vrijednosti HbA1c u bolesnika liječenih sitagliptinom i inzulinom (s metforminom ili bez njega) iznosilo je -1,31% u usporedbi s -0,87% u bolesnika koji su liječeni placebom i inzulinom (s metforminom ili bez njega), što predstavlja razliku od -0,45% [95 % CI: -0,60; -0,29]. Incidencija hipoglikemije bila je 25,2% u bolesnika liječenih sitagliptinom i inzulinom (s metforminom ili bez njega), a 36,8% u bolesnika koji su liječeni placebom i inzulinom (s metforminom ili bez njega).
English: The addition of sitagliptin to either glimepiride alone or to glimepiride and metformin provided significant improvements in glycaemic parameters.
Croatian: Dodavanje sitagliptina glimepiridu ili kombinaciji glimepirida s metforminom značajno je poboljšalo glikemijske parametre.
English: There is no experience with doses above 800 mg in clinical studies.
Croatian: 800 mg u kliničkim ispitivanjima.
English: • a PPAR agonist and metformin when use of a PPAR agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
Croatian: • s agonistom PPAR i metforminom kada je primjena agonista PPAR primjerena te kada dijeta i tjelovježba uz dvojnu terapiju ovim lijekovima ne omogućuju odgovarajuću regulaciju glikemije.
English: After 54 weeks, the mean reduction from baseline in HbA1c was -0.76 % with sitagliptin and -0.64 % with glipizide (Per-Protocol Analysis).
Croatian: Nakon 54 tjedna liječenja prosječno sniženje HbA1c u odnosu na početne vrijednosti iznosilo je -0,76% uz sitagliptin te -0,64% uz glipizid (analiza po realiziranom planu ispitivanja).
English: To achieve plasma concentrations of sitagliptin similar to those in patients with normal renal function, lower dosages are recommended in patients with GFR < 45 mL/min (see section 4.2).
Croatian: Kako bi se postigle koncentracije sitagliptina u plazmi slične onima u bolesnika s normalnom funkcijom bubrega, preporučuje se primjena nižih doza lijeka u bolesnika s GFR-om < 45 ml/min (vidjeti dio 4.2).
English: Blood and lymphatic system disorders thrombocytopenia
Croatian: Poremećaji krvi i limfnog sustava trombocitopenija rijetko
English: The primary cardiovascular endpoint was a composite of the first occurrence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina.
Croatian: Primarna kardiovaskularna mjera ishoda bila je sastavljena od prvog nastupa smrti zbog kardiovaskularnog uzroka, infarkta miokarda bez smrtnog ishoda, moždanog udara bez smrtnog ishoda, ili hospitalizacije zbog nestabilne angine.
English: If bullous pemphigoid is suspected, Ristaben should be discontinued.
Croatian: Pri sumnji na bulozni pemfigoid treba prekinuti liječenje lijekom Ristaben.
English: All stroke (fatal and non-fatal)
Croatian: Svi slučajevi moždanog udara (sa smrtnim ishodom i bez njega)
English: Mean change from baseline HbA1c (%)
Croatian: Srednja vrijednost promjene u odnosu na početni HbA1c (%)
English: Mean baseline HbA1c (%)
Croatian: Srednja vrijednost početnog HbA1c (%)
English: A 24-week placebo-controlled study involving 660 patients was designed to evaluate the insulin-sparing efficacy and safety of sitagliptin (100 mg once daily) added to insulin glargine with or without metformin (at least 1,500 mg) during intensification of insulin therapy.
Croatian: U placebom kontroliranom ispitivanju koje je trajalo 24 tjedna i uključivalo 660 bolesnika ispitivane su djelotvornost sitagliptina u uštedi inzulina i sigurnost primjene sitagliptina (100 mg jedanput na dan) dodanog glargin inzulinu s metforminom (najmanje 1500 mg) ili bez njega tijekom intenziviranja inzulinske terapije.
English: Body weight did not increase from baseline with sitagliptin therapy in either study, compared to a small reduction in patients given placebo.
Croatian: Ni u jednom ispitivanju nije došlo do povećanja tjelesne težine u odnosu na početnu u bolesnika na terapiji sitagliptinom, dok je u ispitanika koji su primali placebo došlo do malog smanjenja tjelesne težine.
English: Study
Croatian: Ispitivanje
English: A 24-week placebo-controlled study was designed to evaluate the efficacy and safety of sitagliptin (100 mg once daily) added to glimepiride alone or glimepiride in combination with metformin.
Croatian: U 24-tjednom placebom kontroliranom ispitivanju cilj je bio ocijeniti djelotvornost i sigurnost sitagliptina (100 mg jedanput na dan) dodanog glimepiridu ili glimepiridu u kombinaciji s metforminom.
English: To achieve plasma concentrations of sitagliptin similar to those in patients with normal renal function, lower dosages are recommended in patients with GFR < 45 mL/min, as well as in ESRD patients requiring haemodialysis or peritoneal dialysis (see section 4.2 and 5.2).
Croatian: Kako bi se postigle koncentracije sitagliptina u plazmi slične onima u bolesnika s normalnom funkcijom bubrega, preporučuju se niže doze u bolesnika s GFR-om < 45 ml/min kao i u bolesnika u završnoj fazi bubrežne bolesti kojima je potrebna hemodijaliza ili peritonealna dijaliza (vidjeti dio 4.2 i 5.2).
English: In addition, the effects of renal impairment on sitagliptin pharmacokinetics in patients with type 2 diabetes and mild, moderate, or severe renal impairment (including ESRD) were assessed using population pharmacokinetic analyses.
Croatian: Osim toga, pomoću populacijskih farmakokinetičkih analiza procijenjeni su učinci oštećenja funkcije bubrega na farmakokinetiku sitagliptina u bolesnika sa šećernom bolešću tipa 2 i blagim, umjerenim ili teškim oštećenjem funkcije bubrega (uključujući završnu fazu bubrežne bolesti).
English: Change from baseline in body weight was similar for patients treated with sitagliptin relative to placebo.
Croatian: Promjena tjelesne težine od početne vrijednosti bila je slična u bolesnika liječenih sitagliptinom u odnosu na one koji su primali placebo.
English: Compared to normal healthy control subjects, plasma AUC of sitagliptin was increased by approximately 1.2-fold and 1.6-fold in patients with mild renal impairment (GFR ≥ 60 to < 90 mL/min) and patients with moderate renal impairment (GFR ≥ 45 to < 60 mL/min), respectively.
Croatian: U usporedbi sa zdravim kontrolnim ispitanicima, u bolesnika s blagim oštećenjem funkcije bubrega (GFR od ≥ 60 do < 90 ml/min) i bolesnika s umjerenim oštećenjem funkcije bubrega (GFR ≥ 45 do < 60 ml/min) AUC sitagliptina u plazmi je bio povišen 1,2 puta odnosno 1,6 puta.
English: Sitagliptin accumulates only minimally with multiple doses.
Croatian: Akumulacija sitagliptina nakon višekratnih doza je minimalna.
English: No adverse effects upon fertility were observed in male and female rats given sitagliptin prior to and throughout mating.
Croatian: Kod mužjaka i ženki štakora koji su sitagliptin dobivali prije i tijekom parenja nisu zamijećeni štetni učinci na plodnost.
English: The incidence of hypoglycaemia was also similar in patients treated with sitagliptin or placebo.
Croatian: Incidencija hipoglikemije također je bila slična u bolesnika liječenih sitagliptinom i onih koji su primali placebo.
English: Ristaben 25 mg tablets Sitagliptin
Croatian: Ristaben 25 mg tablete sitagliptin
English: Primary Composite Endpoint (Cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina)
Croatian: Primarna objedinjena mjera ishoda (smrt zbog kardiovaskularnog uzroka, infarkt miokarda bez smrtnog ishoda, moždani udar bez smrtnog ishoda ili hospitalizacija zbog nestabilne angine)
English: Marketing Authorisation Holder Merck Sharp & Dohme B.V. Waarderweg 39
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Merck Sharp & Dohme B.V.
English: Prolonged haemodialysis may be considered if clinically appropriate.
Croatian: Ako je to klinički opravdano, može se razmotriti produljenje hemodijalize.
English: EU/1/10/621/013 EU/1/10/621/014 EU/1/10/621/015 EU/1/10/621/016 EU/1/10/621/017 EU/1/10/621/018 EU/1/10/621/023 EU/1/10/621/024
Croatian: EU/1/10/621/015 EU/1/10/621/016 EU/1/10/621/017 EU/1/10/621/018 EU/1/10/621/023 EU/1/10/621/024
English: EU/1/10/621/001 EU/1/10/621/002 EU/1/10/621/003 EU/1/10/621/004 EU/1/10/621/005 EU/1/10/621/006 EU/1/10/621/019 EU/1/10/621/020
Croatian: EU/1/10/621/003 EU/1/10/621/004 EU/1/10/621/005 EU/1/10/621/006 EU/1/10/621/019 EU/1/10/621/020
English: Ristaben 100 mg tablets Sitagliptin
Croatian: Ristaben 100 mg tablete sitagliptin
English: These characteristics had no clinically meaningful effect on the pharmacokinetics of sitagliptin based on a composite analysis of Phase I pharmacokinetic data and on a population pharmacokinetic analysis of Phase I and Phase II data.
Croatian: Prema kompozitnoj analizi farmakokinetičkih podataka faze I kao i podataka o populacijskoj farmakokinetici faze I i faze II, ove osobitosti bolesnika nemaju klinički značajnog učinka na farmakokinetiku sitagliptina.
English: Merck Sharp & Dohme B.V. Tel.: 0800 9999000 (+31 23 5153153) medicalinfo.nl@merck.com
Croatian: Tel.: 0800 9999000 (+31 23 5153153) medicalinfo.nl@merck.com
English: The observed incidence of hypoglycaemia in patients treated with sitagliptin was similar to placebo.
Croatian: Incidencija hipoglikemije opažena u bolesnika liječenih sitagliptinom bila je slična onoj u skupini koja je primala placebo.
English: Some patients have experienced the following side effects while taking sitagliptin in combination with insulin (with or without metformin):
Croatian: Pri uzimanju sitagliptina u kombinaciji s inzulinom (sa ili bez metformina) u nekih su bolesnika nastupile sljedeće nuspojave:
English: Ristaben 50 mg tablets Sitagliptin
Croatian: Ristaben 50 mg tablete sitagliptin
English: In these studies there was a similar incidence of hypoglycaemia reported for patients treated with sitagliptin or placebo.
Croatian: U ovim je ispitivanjima incidencija prijavljene hipoglikemije bila slična u bolesnika liječenih sitagliptinom u odnosu na one koji su primali placebo.
English: EU/1/10/621/007 EU/1/10/621/008 EU/1/10/621/009 EU/1/10/621/010 EU/1/10/621/011 EU/1/10/621/012 EU/1/10/621/021 EU/1/10/621/022
Croatian: EU/1/10/621/009 EU/1/10/621/010 EU/1/10/621/011 EU/1/10/621/012 EU/1/10/621/021 EU/1/10/621/022
English: Frequency not known fatal and non-fatal haemorrhagic and necrotizing pancreatitis
Croatian: Poremećaji probavnog sustava konstipacija manje često povraćanje nepoznata učestalost akutni pankreatitis nepoznata učestalost hemoragijski i nekrotizirajući pankreatitis sa ili bez smrtnog ishoda nepoznata učestalost