FrancophonIA/ELRC3.0 huggingface dataset:
English: Because renal function abnormalities can occur after initiating ertugliflozin, and sitagliptin is known to be substantially excreted by the kidneys, renal function should be assessed more frequently in elderly patients.
Croatian: Budući da nakon uvođenja ertugliflozina mogu nastupiti poremećaji funkcije bubrega, a poznato je da se sitagliptin u značajnoj mjeri izlučuje putem bubrega, u starijih je bolesnika potrebno češće kontrolirati funkciju bubrega.
English: It is not known if Steglujan can harm your unborn baby.
Croatian: Nije poznato može li Steglujan naškoditi nerođenom djetetu.
English: In patients with normal renal function, metabolism, including via CYP3A4, plays only a small role in the clearance of sitagliptin.
Croatian: U bolesnika s normalnom funkcijom bubrega metabolizam, uključujući i onaj putem CYP3A4, ima malu ulogu u klirensu sitagliptina.
English: No drug interactions studies have been performed with Steglujan and other medicinal products; however, such studies have been conducted with the individual active substances.
Croatian: Nisu provedena ispitivanja interakcija lijeka Steglujan s drugim lijekovima; međutim, takva su ispitivanja provedena s pojedinačnim djelatnim tvarima.
English: Approximately 79% of sitagliptin is excreted unchanged in the urine.
Croatian: Približno se 79% sitagliptina izluči mokraćom u neizmijenjenom obliku.
English: Since hepatotoxicity has been shown to correlate with induction of hepatic neoplasia in rats, this increased incidence of hepatic tumours in rats was likely secondary to chronic hepatic toxicity at this high dose.
Croatian: Budući da je utvrđena korelacija između hepatotoksičnosti lijeka i nastanka neoplazija jetre u štakora, ovo povećanje incidencije tumora jetre u štakora vjerojatno je posljedica kroničnog toksičnog djelovanja na jetru pri ovako visokoj dozi.
English: In vitro data suggest that sitagliptin does not inhibit or induce CYP450 isoenzymes.
Croatian: Podaci iz ispitivanja in vitro ukazuju na to da sitagliptin ne inhibira niti inducira izoenzime CYP450.
English: Sitagliptin prevents the hydrolysis of incretin hormones by DPP-4, thereby increasing plasma concentrations of the active forms of GLP-1 and GIP.
Croatian: Sitagliptin sprječava hidrolizu inkretinskih hormona koju uzrokuje DPP-4 te tako povećava koncentracije aktivnih oblika GLP-1 i GIP-a u plazmi.
English: OAT3 mediated transport of sitagliptin was inhibited in vitro by probenecid, although the risk of clinically meaningful interactions is considered to be low.
Croatian: Probenecid je in vitro inhibirao transport sitagliptina posredovan OAT3, premda se rizik od klinički značajnih interakcija smatra malim.
English: Contact a doctor or the nearest hospital straight away if you have any of the following serious side effects:
Croatian: Odmah se javite liječniku ili otiđite u najbližu bolnicu ako primijetite bilo koju od sljedećih ozbiljnih nuspojava:
English: Treatment with GLP-1 or with DPP-4 inhibitors in animal models of type 2 diabetes has been demonstrated to improve beta cell responsiveness to glucose and stimulate insulin biosynthesis and release.
Croatian: Liječenje GLP-1 ili inhibitorima DPP-4 u životinjskim modelima dijabetesa tipa 2 dokazano je poboljšalo odgovor beta stanica na glukozu i potaknulo biosintezu i otpuštanje inzulina.
English: If you take more Steglujan than you should If you take too much Steglujan, talk to a doctor or pharmacist straight away.
Croatian: Ako uzmete više lijeka Steglujan nego što ste trebali, odmah se obratite liječniku ili ljekarniku.
English: Dose-response modelling indicates that ertugliflozin 5 mg and 15 mg result in near maximal urinary glucose excretion (UGE) in patients with type 2 diabetes mellitus, providing 87% and 96% of maximal inhibition, respectively.
Croatian: Model odgovora s obzirom na dozu ukazuje na to da ertugliflozin u dozi od 5 mg, odnosno 15 mg dovodi do gotovo maksimalnog izlučivanja glukoze mokraćom (engl. urinary glucose excretion,UGE) u bolesnika s dijabetes mellitusom tipa 2, uzrokujući maksimalnu inhibiciju od 87% odnosno 96%.
English: Sitagliptin is a potent and highly selective inhibitor of the enzyme DPP-4 and does not inhibit the closely-related enzymes DPP-8 or DPP-9 at therapeutic concentrations.
Croatian: Sitagliptin je potentan i visokoselektivan inhibitor enzima DPP-4, koji pri terapijskim koncentracijama ne inhibira njemu vrlo srodne enzime DPP-8 ili DPP-9.
English: Reproductive toxicity studies showed a slight treatment-related increased incidence of foetal rib malformations (absent, hypoplastic and wavy ribs) in the offspring of rats at systemic exposure levels more than 29 times the human exposure levels.
Croatian: Ispitivanja reproduktivne toksičnosti ukazala su na neznatno veću incidenciju prenatalnih malformacija rebara povezanih s liječenjem (nedostatak, nerazvijenost i valovita rebra) u mladunčadi štakora pri razinama sistemske izloženosti 29 puta većima od razina izloženosti u ljudi.
English: Mean plasma AUC of sitagliptin was 8.52 M•hr and Cmax was 950 nM.
Croatian: Srednja vrijednost AUC-a sitagliptina u plazmi iznosila je 8,52 µM•h, a Cmax 950 nM.
English: In patients with type 2 diabetes with hyperglycaemia, these changes in insulin and glucagon levels lead to lower haemoglobin A1c (HbA1c) and lower fasting and post-prandial glucose concentrations.
Croatian: U bolesnika s dijabetesom tipa 2 i hiperglikemijom te promjene razina inzulina i glukagona dovode do sniženja razina hemoglobina A1c (HbA1c) te sniženja koncentracija glukoze natašte i nakon obroka.
English: Experience in New York Heart Association (NYHA) class I-II is limited, and there is no experience in clinical studies with Steglujan in NYHA class III-IV.
Croatian: New York Heart Association) stupnja I-II je ograničeno, dok nema iskustva iz kliničkih ispitivanja lijeka Steglujan u bolesnika sa zatajenjem srca NYHA stupnja III-IV.
English: The activity of GLP-1 and GIP is limited by the DPP-4 enzyme, which rapidly hydrolyses the incretin hormones to produce inactive products.
Croatian: Aktivnost GLP-1 i GIP-a ograničava enzim DPP-4, koji uzrokuje brzu hidrolizu inkretinskih hormona i stvara neaktivne spojeve.
English: In clinical studies, approximately 13.5% of the dose was removed over a 3- to 4-hour haemodialysis session.
Croatian: U kliničkim je ispitivanjima hemodijalizom u trajanju od 3 do 4 sata uklonjeno približno 13,5% doze lijeka.
English: • The recommended dose of Steglujan is one tablet once a day.
Croatian: Koliko lijeka uzeti • Preporučena doza lijeka Steglujan je jedna tableta jedanput na dan.
English: The combination of ertugliflozin and sitagliptin resulted in significantly greater reductions in FPG compared to sitagliptin or ertugliflozin alone or placebo.
Croatian: Kombinacija ertugliflozina i sitagliptina dovela je do značajno većih sniženja FPG-a u usporedbi sa sitagliptinom ili ertugliflozinom primijenjenima samostalno, odnosno u usporedbi s placebom.
English: Sitagliptin is also a substrate of P-gp, which may also be involved in mediating the renal elimination of sitagliptin.
Croatian: Sitagliptin je i supstrat P-gp-a, koji bi također mogao biti uključen u posredovanje u bubrežnoj eliminaciji sitagliptina.
English: In addition to the adverse reactions described in the table above, adverse experiences reported regardless of causal relationship to medication and occurring in at least 5% and more commonly in patients treated with sitagliptin included upper respiratory tract infection and nasopharyngitis.
Croatian: Osim nuspojava opisanih u prethodnoj tablici, nuspojave prijavljene bez obzira na uzročnu povezanost s lijekom koje su se javile u najmanje 5% bolesnika i bile češće u bolesnika liječenih sitagliptinom uključivale su infekciju gornjih dišnih puteva i nazofaringitis.
English: In rats, there was an increased incidence of hepatic adenomas and carcinomas at systemic exposure levels 58 times the human exposure level.
Croatian: U štakora je zabilježena povećana incidencija adenoma i karcinoma jetre pri razinama sistemske izloženosti 58 puta većima od razina izloženosti u ljudi.
English: There were no additional adverse reactions identified in these three trials that included sitagliptin relative to the three placebocontrolled studies with ertugliflozin (see below).
Croatian: U ta tri ispitivanjima koja su uključivala sitagliptin nisu utvrđene dodatne nuspojave u odnosu na one zabilježene u trima placebom kontroliranim ispitivanjima ertugliflozina (vidjeti u nastavku).
English: EU/1/18/1266/007 (14 film-coated tablets) EU/1/18/1266/008 (28 film-coated tablets) EU/1/18/1266/009 (30 film-coated tablets) EU/1/18/1266/010 (30x1 film-coated tablets) EU/1/18/1266/011 (84 film-coated tablets) EU/1/18/1266/012 (90 film-coated tablets) EU/1/18/1266/014 (98 film-coated tablets)
Croatian: EU/1/18/1266/007 (14 filmom obloženih tableta) EU/1/18/1266/008 (28 filmom obloženih tableta) EU/1/18/1266/009 (30 filmom obloženih tableta) EU/1/18/1266/010 (30 x 1 filmom obložena tableta) EU/1/18/1266/011 (84 filmom obložene tablete) EU/1/18/1266/012 (90 filmom obloženih tableta) EU/1/18/1266/014 (98 filmom obloženih tableta)
English: Not known
Croatian: • nesvjesticu,
English: In addition, very slight to slight skeletal muscle degeneration was also observed histologically at doses resulting in systemic exposure levels of approximately 23 times the human exposure level.
Croatian: Osim toga, histološki je opažena neznatna ili vrlo mala degeneracija skeletnih mišića pri dozama koje su dovele do razina sistemske izloženosti oko 23 puta većih od razine izloženosti u ljudi.
English: • You need to keep following your food and exercise plan while taking Steglujan.
Croatian: • Dok uzimate Steglujan, trebate se i dalje pridržavati svog plana prehrane i tjelovježbe.
English: Some studies indicate that taking ertugliflozin may have contributed to an increase in cases of lower limb amputation (mainly of the toe).
Croatian: Neka ispitivanja ukazuju na to da primjena ertugliflozina može pridonijeti porastu slučajeva amputacije donjih (prvenstveno prsta).
English: Decreased glucagon concentrations, along with higher insulin levels, lead to reduced hepatic glucose production, resulting in a decrease in blood glucose levels.
Croatian: Snižene koncentracije glukagona, zajedno s povišenim razinama inzulina, uzrokuju smanjenje proizvodnje glukoze u jetri, što dovodi do sniženja razine glukoze u krvi.
English: EU/1/18/1266/001 (14 film-coated tablets) EU/1/18/1266/002 (28 film-coated tablets) EU/1/18/1266/003 (30 film-coated tablets) EU/1/18/1266/004 (30x1 film-coated tablets) EU/1/18/1266/005 (84 film-coated tablets) EU/1/18/1266/006 (90 film-coated tablets) EU/1/18/1266/013 (98 film-coated tablets)
Croatian: EU/1/18/1266/001 (14 filmom obloženih tableta) EU/1/18/1266/002 (28 filmom obloženih tableta) EU/1/18/1266/003 (30 filmom obloženih tableta) EU/1/18/1266/004 (30 x 1 filmom obložena tableta) EU/1/18/1266/005 (84 filmom obložene tablete) EU/1/18/1266/006 (90 filmom obloženih tableta) EU/1/18/1266/013 (98 filmom obloženih tableta)
English: • if you are allergic to ertugliflozin or sitagliptin or any of the other ingredients of this medicine
Croatian: • ako ste alergični na ertugliflozin, sitagliptin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Sitagliptin is primarily eliminated unchanged in urine, and metabolism is a minor pathway.
Croatian: Sitagliptin se primarno eliminira u neizmijenjenom obliku mokraćom, a tek manji dio se metabolizira.
English: Sitagliptin is not a substrate for OCT2 or OAT1 or peptide transporter 1/2 (PEPT1/2) transporters.
Croatian: Sitagliptin nije supstrat prijenosnika OCT2, OAT1 ili peptidnog prijenosnika 1/2 (PEPT1/2).
English: • Sitagliptin belongs to a group of medicines called DPP-4 (dipeptidyl peptidase-4) inhibitors.
Croatian: • Sitagliptin pripada skupini lijekova koji se zovu inhibitori DPP-4 (inhibitori dipeptidil peptidaze-4).
English: Due to the mechanism of action of ertugliflozin, patients taking Steglujan will test positive for glucose in their urine.
Croatian: Zbog mehanizma djelovanja ertugliflozina, bolesnici koji uzimaju lijek Steglujan imat će pozitivan nalaz testa na glukozu u mokraći.
English: For both GLP-1 and GIP, stimulation of insulin release is enhanced as glucose rises above normal concentrations.
Croatian: I GLP-1 i GIP jače potiču otpuštanje inzulina kada se razina glukoze povisi iznad normalnih koncentracija.
English: Following oral administration of a 100-mg dose to healthy subjects, sitagliptin was rapidly absorbed, with peak plasma concentrations (median Tmax) occurring 1 to 4 hours post-dose.
Croatian: Nakon peroralne primjene doze od 100 mg u zdravih ispitanika, sitagliptin se brzo apsorbirao, a vršne koncentracije u plazmi (medijan Tmax) nastupile su 1 - 4 sata nakon primjene doze.
English: The analysis of hospitalisation for heart failure was adjusted for a history of heart failure at baseline.
Croatian: Analiza hospitalizacije zbog zatajenja srca prilagođena je za zatajenje srca u anamnezi na početku ispitivanja.
English: During controlled clinical trials in healthy subjects, single doses of up to 800 mg sitagliptin were administered.
Croatian: U kontroliranim kliničkim ispitivanjima zdravim su ispitanicima davane jednokratne doze do 800 mg sitagliptina.
English: • upper respiratory infection
Croatian: • infekcija gornjih dišnih putova
English: In vitro transport studies showed that sitagliptin is a substrate for P-gp and OAT3.
Croatian: Ispitivanja prijenosa in vitro pokazala su da je sitagliptin supstrat P-gp-a i prijenosnika OAT3.
English: In the event of an overdose with Steglujan, employ the usual supportive measures (e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring including obtaining an electrocardiogram, and institute supportive treatment) as dictated by the patient's clinical status.
Croatian: U slučaju predoziranja lijekom Steglujan treba primijeniti uobičajene potporne mjere (npr. ukloniti neapsorbirani materijal iz probavnog sustava, uvesti kliničko praćenje, uključujući elektrokardiogram, i po potrebi započeti potpornu terapiju) u skladu s bolesnikovim kliničkim statusom.
English: Interaction studies conducted in patients with type 2 diabetes or healthy volunteers suggest that metformin and ciclosporin had no clinically relevant effect on the pharmacokinetics of sitagliptin.
Croatian: Ispitivanja interakcija provedena u bolesnika s dijabetesom tipa 2 ili zdravih dobrovoljaca ukazuju na to da metformin i ciklosporin nisu imali klinički značajnog učinka na farmakokinetiku sitagliptina.
English: • nausea/vomiting
Croatian: • mučnina/povraćanje
English: In patients with type 2 diabetes treated with ertugliflozin in combination with sitagliptin, the improvement in HbA1c was similar across subgroups defined by age, sex, and race, and duration of type 2 diabetes mellitus.
Croatian: U bolesnika s dijabetesom tipa 2 liječenih ertugliflozinom u kombinaciji sa sitagliptinom, poboljšanje vrijednosti HbA1c bilo je slično u svim podskupinama definiranima prema dobi, spolu, rasi i trajanju dijabetes mellitusa tipa 2.
English: Steglujan combines two antihyperglycaemic agents with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: ertugliflozin, a SGLT2 inhibitor, and sitagliptin phosphate, a DPP-4 inhibitor.
Croatian: Steglujan je kombinacija dva antihiperglikemijska lijeka s komplementarnim mehanizmima djelovanja koji poboljšavaju regulaciju glikemije u bolesnika s dijabetesom tipa 2: ertugliflozina, koji je inhibitor SGLT2, i sitagliptinfosfata, koji je inhibitor DPP-4.
English: Hypersensitivity reactions including anaphylactic responses*
Croatian: Poremećaji imunološkog sustava nepoznato reakcije preosjetljivosti uključujući anafilaktičke odgovore*
English: The effects of a high-fat meal on the pharmacokinetics of ertugliflozin and sitagliptin when administered as Steglujan tablets are comparable to those reported for the individual tablets.
Croatian: Učinci punomasnog obroka na farmakokinetiku ertugliflozina i sitagliptina kada se primjenjuju u obliku Steglujan tableta usporedivi su s onima opaženima kod njihove primjene u zasebnim tabletama.
English: What Steglujan contains
Croatian: Što Steglujan sadrži
English: Since coadministration of a high-fat meal with sitagliptin had no effect on the pharmacokinetics, Steglujan may be administered with or without food.
Croatian: Budući da istodobna primjena sitagliptina s punomasnim obrokom nije imala učinka na farmakokinetiku, Steglujan se može uzimati s hranom ili bez nje.
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 moždanog udara bez smrtnog ishoda; prvu pojavu pojedinih elemenata primarne mjere ishoda; smrt zbog bilo kojeg uzroka; te hospitalizaciju zbog kongestivnog zatajenja srca.
English: Because of how Steglujan works, your urine will test positive for sugar (glucose) while you are on this medicine.
Croatian: Zbog načina na koji lijek Steglujan djeluje, nalazi pretraga mokraće bit će pozitivni na šećer (glukozu) dok uzimate ovaj lijek.
English: • in patients already being treated with the combination of ertugliflozin and sitagliptin as separate tablets.
Croatian: • u bolesnika koji se već liječe kombinacijom ertugliflozina i sitagliptina u zasebnim tabletama.
English: • swelling of the hands or legs
Croatian: • bolovi u rukama ili nogama
English: The recommended starting dose is 5 mg ertugliflozin/100 mg sitagliptin once daily.
Croatian: Preporučena početna doza je 5 mg ertugliflozina/100 mg sitagliptina jedanput na dan.
English: • Steglujan can be used instead of taking both ertugliflozin and sitagliptin as separate tablets.
Croatian: • Steglujan se može uzimati umjesto zasebnih tableta ertugliflozina i sitagliptina.
English: When blood glucose concentrations are normal or elevated, GLP-1 and GIP increase insulin synthesis and release from pancreatic beta cells by intracellular signalling pathways involving cyclic AMP.
Croatian: Kad su koncentracije glukoze u krvi normalne ili povišene, GLP-1 i GIP povećavaju sintezu inzulina i njegovo otpuštanje iz beta stanica gušterače, i to unutarstaničnim signalnim putovima koji uključuju ciklički adenozin monofosfat (engl. adenosine monophosphate, AMP).
English: The glucose-dependent mechanism of sitagliptin is distinct from the mechanism of sulphonylureas, which increase insulin secretion even when glucose levels are low and can lead to hypoglycaemia in patients with type 2 diabetes and in normal subjects.
Croatian: O glukozi ovisan mehanizam sitagliptina razlikuje se od mehanizma sulfonilureja, koje pojačavaju lučenje inzulina čak i kada su razine glukoze niske te mogu uzrokovati hipoglikemiju u bolesnika s dijabetesom tipa 2 i zdravih ispitanika.
English: In Phase 1 multiple-dose studies, there were no dose-related clinical adverse reactions observed with sitagliptin with doses of up to 600 mg per day for periods of up to 10 days and 400 mg per day for periods of up to 28 days.
Croatian: U ispitivanjima višekratnih doza faze I nisu zamijećene o dozi ovisne klinički značajne nuspojave uz sitagliptin u dozama do 600 mg na dan tijekom najdulje 10 dana odnosno u dozi do 400 mg na dan tijekom najdulje 28 dana.
English: The effects of GLP-1 and GIP are glucose-dependent such that when blood glucose concentrations are low, stimulation of insulin release and suppression of glucagon secretion by GLP-1 are not observed.
Croatian: Učinci GLP-1 i GIP-a ovisni su o glukozi, tako da se pri niskim koncentracijama glukoze u krvi ne opaža da GLP-1 potiče oslobađanje inzulina i smanjuje lučenje glukagona.
English: Administration of Steglujan with food decreased ertugliflozin Cmax by 29% and had no meaningful effect on ertugliflozin AUCinf, or on sitagliptin AUCinf and Cmax.
Croatian: Primjena lijeka Steglujan s hranom snizila je Cmax ertugliflozina za 29%, no nije značajno utjecala na AUCinf ertugliflozina, kao ni na AUCinf i Cmax sitagliptina.
English: Compared to normal healthy control subjects, plasma AUC of sitagliptin was increased modestly in patients with GFR ≥ 45 to < 90 mL/min.
Croatian: U usporedbi sa zdravim kontrolnim ispitanicima, AUC sitagliptina u plazmi blago se povećao u bolesnika kojima je GFR bio ≥ 45 i < 90 ml/min.
English: After 26-weeks of treatment, the combination of ertugliflozin 5 mg or 15 mg and sitagliptin 100 mg resulted in statistically significant reductions in systolic blood pressure (SBP) compared to sitagliptin alone (-2.8 and -3.0 mmHg for E5/S100 and E15/S100 respectively) or placebo (-4.4 and -6.4 mmHg for E5/S100 and E15/S100, respectively).
Croatian: Nakon 26 tjedana liječenja, kombinacija ertugliflozina u dozi od 5 mg ili 15 mg sa sitagliptinom u dozi od 100 mg dovela je do statistički značajnih sniženja sistoličkog krvnog tlaka u usporedbi sa sitagliptinom primijenjenim samostalno (-2,8 mmHg uz E5/S100 odnosno -3,0 mmHg uz E15/S100) ili placebom (-4,4 mmHg uz E5/S100 odnosno -6,4 mmHg uz E15/S100).
English: What Steglujan is used for
Croatian: Za što se Steglujan koristi
English: How to store Steglujan
Croatian: Kako čuvati Steglujan
English: • Ertugliflozin belongs to a group of medicines called sodium glucose co-transporter-2 (SGLT2)
Croatian: • Ertugliflozin pripada skupini lijekova koji se zovu inhibitori suprijenosnika natrija i glukoze 2 (engl. sodium glucose co-transporter-2, SGLT2).
English: Elderly patients are more likely to have decreased renal function.
Croatian: U starijih bolesnika veća je vjerojatnost smanjene funkcije bubrega.
English: The incidence of adjudication-confirmed pancreatitis events was 0.3% in sitagliptin-treated patients and 0.2% in placebo-treated patients.
Croatian: Incidencija neovisno potvrđenih slučajeva pankreatitisa iznosila je 0,3% u bolesnika liječenih sitagliptinom i 0,2% u onih koji su primali placebo.
English: Secondary Outcome Cardiovascular death
Croatian: Smrt zbog kardiovaskularnog uzroka
English: • interstitial lung disease
Croatian: • intersticijska bolest pluća
English: In patients tolerating the starting dose, the dose may be increased to 15 mg ertugliflozin/100 mg sitagliptin, once daily, if additional glycaemic control is needed.
Croatian: U bolesnika koji podnose početnu dozu, doza se može povećati na 15 mg ertugliflozina/100 mg sitagliptina jedanput na dan ako je potrebna dodatna regulacija glikemije.
English: In addition, GLP-1 lowers glucagon secretion from pancreatic alpha cells.
Croatian: Nadalje, GLP-1 smanjuje lučenje glukagona iz alfa stanica gušterače.
English: Post-marketing reports of serious hypersensitivity reactions in patients treated with sitagliptin have been reported (see section 4.8).
Croatian: Nakon stavljanja lijeka u promet, u bolesnika liječenih sitagliptinom prijavljene su ozbiljne reakcije preosjetljivosti (vidjeti dio 4.8).
English: Assessment of renal function is recommended prior to initiation of Steglujan and periodically thereafter (see section 4.4).
Croatian: Preporučuje se ocijeniti funkciju bubrega prije uvođenja lijeka Steglujan i periodički nakon toga (vidjeti dio 4.4).
English: Hypoglycaemia has been observed when sitagliptin was used in combination with insulin or a sulphonylurea.
Croatian: Opaženi su slučajevi hipoglikemije kada se sitagliptin primjenjivao u kombinaciji s inzulinom ili sulfonilurejom.
English: Before initiating Steglujan, factors in the patient history that may predispose to ketoacidosis should be considered.
Croatian: Prije uvođenja lijeka Steglujan potrebno je u bolesnikovoj anamnezi razmotriti čimbenike koji bi mogli stvoriti predispoziciju za ketoacidozu.
English: How to take Steglujan
Croatian: Kako uzimati Steglujan