FrancophonIA/ELRC3.0 huggingface dataset:
English: The Cmax for vildagliptin and the area under the plasma concentrations versus time curves (AUC) increased in an approximately dose proportional manner over the therapeutic dose range.
Croatian: Cmax vildagliptina i površina ispod krivulja koncentracija - vrijeme (AUC) povećali su se približno proporcionalno dozi unutar terapijskog raspona doza.
English: A GFR should be assessed before initiation of treatment with metformin-containing products and at least annually thereafter.
Croatian: GFR treba procijeniti prije početka liječenja lijekovima koji sadrže metformin te najmanje jedanput godišnje nakon toga.
English: Results from clinical trials conducted with the oral antidiabetics pioglitazone, metformin and glyburide in combination with vildagliptin have shown no clinically relevant pharmacokinetic interactions in the target population.
Croatian: Rezultati kliničkih ispitivanja provedenih s oralnim antidijabeticima pioglitazonom, metforminom i gliburidom u kombinaciji s vildagliptinom nisu pokazali klinički značajne farmakokinetičke interakcije u ciljnoj populaciji.
English: The active substances of Zomarist, vildagliptin and metformin, belong to a group of medicines called “oral antidiabetics”.
Croatian: Djelatne tvari Zomariste, vildagliptin i metformin pripadaju skupini lijekova koji se nazivaju „oralni antidijabetici”.
English: Not all pack sizes and tablet strengths may be marketed.
Croatian: Na tržištu se ne moraju nalaziti sve veličine pakiranja i jačine tableta.
English: Stop taking Zomarist 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 Zomarist i odmah se obratite liječniku ili otiđite u najbližu bolnicu ako osjetite neke od simptoma laktacidoze, jer to stanje može dovesti do kome.
English: Gender: No clinically relevant differences in the pharmacokinetics of vildagliptin were observed between male and female healthy subjects within a wide range of age and body mass index (BMI).
Croatian: Spol: u farmakokinetici vildagliptina nisu zapažene klinički značajne razlike između zdravih ispitanika muškog i ženskog spola unutar širokog raspona dobi i indeksa tjelesne mase (BMI).
English: Hypromellose Titanium dioxide (E 171) Iron oxide, yellow (E 172) Macrogol 4000
Croatian: Film-ovojnica hipromeloza titanijev dioksid (E 171) željezov oksid, žuti (E 172) makrogol 4000 talk
English: Clinical trials of up to more than 2 years' duration did not show any additional safety signals or unforeseen risks when vildagliptin was added on to metformin.
Croatian: Klinička ispitivanja koja su trajala više od 2 godine nisu pokazala dodatne sigurnosne signale ili nepredviđene rizike kada je vildagliptin bio dodan metforminu.
English: 10 film-coated tablets 30 film-coated tablets 60 film-coated tablets 120 film-coated tablets 180 film-coated tablets 360 film-coated tablets
Croatian: 10 filmom obloženih tableta 30 filmom obloženih tableta 60 filmom obloženih tableta 120 filmom obloženih tableta 180 filmom obloženih tableta 360 filmom obloženih tableta
English: **Isolated cases of liver function test abnormalities or hepatitis resolving upon metformin discontinuation have been reported.
Croatian: **Prijavljeni su izolirani slučajevi abnormalnih testova jetrene funkcije ili hepatitisa koji su se povukli nakon prestanka primjene metformina.
English: However, bioequivalence of Zomarist with co-administered vildagliptin and metformin has been demonstrated (see section 5.2).
Croatian: Međutim, bioekvivalencija Zomariste s istodobno primijenjenim vildagliptinom i metforminom je dokazana (vidjeti dio 5.2).
English: - Store in the original package (blister) in order to protect from moisture.
Croatian: - Čuvati u originalnom pakiranju (blisteru) radi zaštite od vlage.
English: Food slightly delays and decreases the extent of the absorption of metformin.
Croatian: Hrana neznatno odgađa i smanjuje opseg apsorpcije metformina.
English: Therefore, a lower dose of sulphonylurea may be considered to reduce the risk of hypoglycaemia.
Croatian: Stoga, niža doza sulfonilureje se može razmotriti kako bi se smanjio rizik od hipoglikemije.
English: Nausea, gastro-oesophageal reflux disease
Croatian: Mučnina, gastroezofagealna refluksna bolest
English: If this happens you must stop taking Zomarist 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 Zomarist i odmah se obratiti liječniku ili otići u najbližu bolnicu, jer laktacidoza može dovesti do kome.
English: Renal impairment: In subjects with mild, moderate, or severe renal impairment, systemic exposure to vildagliptin was increased (Cmax 8-66%; AUC 32-134%) and total body clearance was reduced compared to subjects with normal renal function.
Croatian: Oštećenje funkcije bubrega: u ispitanika s blagim, umjerenim ili teškim oštećenjem bubrega sustavna je izloženost vildagliptinu bila povećana (Cmax 8-66%; AUC 32-134%), a ukupan tjelesni klirens smanjen u usporedbi s ispitanicima s normalnom funkcijom bubrega.
English: Patients who develop jaundice or other signs suggestive of liver dysfunction should discontinue Zomarist.
Croatian: U bolesnika koji razviju žuticu ili druge znakove koji upućuju na poremećaj jetrene funkcije treba prekinuti liječenje Zomaristom.
English: • Lactic acidosis (very rare: may affect up to 1 user in 10,000): Zomarist may cause a very rare, but very serious side effect called lactic acidosis (see section “Warnings and precautions”).
Croatian: • Laktacidoza (vrlo rijetko: može se javiti u manje od 1 na 10 000 osoba): Zomarist može uzrokovati vrlo rijetku, ali vrlo ozbiljnu nuspojavu koja se naziva laktacidoza (vidjeti dio “Upozorenja i mjere opreza”).
English: A pre- and postnatal development study was performed in rats.
Croatian: Na štakorima je provedena studija prenatalnog i postnatalnog razvoja.
English: If you forget to take Zomarist
Croatian: Ako ste zaboravili uzeti Zomarist
English: Metformin stimulates intracellular glycogen synthesis by acting on glycogen synthase and increases the transport capacity of specific types of membrane glucose transporters (GLUT-1 and GLUT-4).
Croatian: Metformin potiče unutarstaničnu sintezu glikogena djelujući na glikogen sintazu i povećava prijenosni kapacitet specifičnih tipova membranskih prijenosnika za glukozu (GLUT-1 i GLUT-4).
English: Patients who develop increased transaminase levels should be monitored with a second liver function evaluation to confirm the finding and be followed thereafter with frequent LFTs until the abnormality(ies) return(s) to normal.
Croatian: Bolesnike u kojih se pojave povišene vrijednosti transaminaza treba pratiti provođenjem druge procjene jetrene funkcije s ciljem potvrđivanja nalaza te nakon toga kontrolirati čestim testovima jetrene funkcije sve dok se abnormalna(e) vrijednost(i) ne vrati(e) na normalu.
English: At 600 mg, one subject experienced oedema of the feet and hands, and increases in creatine phosphokinase (CPK), AST, C-reactive protein (CRP) and myoglobin levels.
Croatian: Pri dozi od 600 mg u jednog je ispitanika došlo do edema stopala i šaka te porasta razina kreatin fosfokinaze (CPK), AST, Creaktivnog proteina (CRP) i mioglobina.
English: No studies on the effect on human fertility have been conducted for Zomarist (see section 5.3).
Croatian: Nisu provedena nikakva ispitivanja o učinku Zomariste na plodnost u ljudi (vidjeti dio 5.3).
English: Store in the original package (blister) in order to protect from moisture.
Croatian: Čuvati u originalnom pakiranju (blisteru) radi zaštite od vlage.
English: • Liver disease (hepatitis) (rare): Symptoms include yellow skin and eyes, nausea, loss of appetite or dark-coloured urine, which may indicate liver disease (hepatitis).
Croatian: • Bolest jetre (hepatitis) (rijetko): simptomi uključuju žutu boju kože i očiju, mučninu, gubitak apetita ili tamno obojenu mokraću, što može upućivati na bolest jetre (hepatitis).
English: Hepatitis (reversible upon discontinuation of the medicinal product) Abnormal liver function tests (reversible upon discontinuation of the medicinal product)
Croatian: Hepatitis (reverzibilan po prekidu uzimanja lijeka) Poremećeni rezultati testova jetrene funkcije (reverzibilan po prekidu uzimanja lijeka)
English: Following withdrawal of treatment with Zomarist and LFT normalisation, treatment with Zomarist should not be re-initiated.
Croatian: Nakon prekida liječenja sa Zomaristom i normalizacije testova jetrene funkcije, liječenje sa Zomaristom se ne smije ponovno započeti.
English: The mean elimination half-life after intravenous administration is approximately 2 hours.
Croatian: Srednja vrijednost poluvremena eliminacije nakon intravenske primjene iznosi oko 2 sata.
English: Some patients have experienced the following side effects while taking Zomarist and a sulphonylurea: • Common: dizziness, tremor, weakness, low blood glucose, excessive sweating.
Croatian: Neki su bolesnici imali sljedeće nuspojave kada su uzimali Zomarist i sulfonilureju: • često: omaglica, tremor, slabost, niska razina glukoze u krvi, pojačano znojenje.
English: Upper respiratory tract infection
Croatian: Infekcija gornjih dišnih puteva
English: Clinical trials of up to 2 years' duration did not show any additional safety signals or unforeseen risks with vildagliptin monotherapy.
Croatian: Klinička ispitivanja koja su trajala do 2 godine nisu pokazala dodatne sigurnosne signale ili nepredviđene rizike s vildagliptinom u monoterapiji.
English: Due to both the potential risk of neonate hypoglycaemia related to metformin and the lack of human data with vildagliptin, Zomarist should not be used during breast-feeding (see section 4.3).
Croatian: Zbog mogućeg rizika za hipoglikemiju u novorođenčeta vezanu uz metformin kao i zbog nedovoljno podataka u ljudi vezanih za vildagliptin, Zomarist se ne smije primjenjivati tijekom dojenja (vidjeti dio 4.3).
English: After intravenous administration to healthy subjects, the total plasma and renal clearances of vildagliptin are 41 and 13 l/h, respectively.
Croatian: Nakon intravenske primjene u zdravih ispitanika ukupni plazmatski i bubrežni klirens vildagliptina je 41, odnosno 13 l/h.
English: • Very rare (may affect up to 1 in 10,000 people): sore throat, runny nose, fever; signs of a high level of lactic acid in the blood (known as lactic acidosis) such as drowsiness or dizziness, severe nausea or vomiting, abdominal pain, irregular heart beat or deep, rapid breathing; redness of the skin, itching; decreased vitamin B12 levels (paleness, tiredness, mental symptoms such as confusion or memory disturbances).
Croatian: • vrlo rijetko (mogu se javiti u do 1 na 10 000 osoba): grlobolja, curenje iz nosa, vrućica; znakovi visoke razine mliječne kiseline u krvi (poznato kao laktacidoza), kao što su omamljenost ili omaglica, jaka mučnina ili povraćanje, bol u trbuhu, nepravilni otkucaji srca ili duboko, ubrzano disanje; crvenilo kože, svrbež; snižena razina vitamina B12 (bljedilo, umor, psihički simptomi kao što su smetenost ili poremećaji pamćenja).
English: At 400 mg, there were three cases of muscle pain, and individual cases of mild and transient paraesthesia, fever, oedema and a transient increase in lipase levels.
Croatian: Pri dozi od 400 mg pojavila su se tri slučaja bolova u mišićima te pojedinačni slučajevi blage i prolazne parestezije, vrućice, edema i prolazno povećanje razina lipaze.
English: Another two-year carcinogenicity study was conducted in mice at oral doses up to 1000 mg/kg.
Croatian: Druga je dvogodišnja studija kancerogenosti provedena na miševima s oralnim dozama do 1000 mg/kg.
English: At 5 mg/kg/day (approximately equivalent to human AUC exposure at the 100 mg dose), only blisters were observed.
Croatian: Pri dozi od 5 mg/kg/dan (otprilike odgovara AUC izloženosti u ljudi pri dozi od 100 mg), zapaženi su samo mjehurići.
English: Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose.
Croatian: Metformin je bigvanid s antihiperglikemijskim učinkom koji smanjuje i bazalnu i postprandijalnu glukozu u plazmi.
English: Metabolism is the major elimination pathway for vildagliptin in humans, accounting for 69% of the dose.
Croatian: Glavni put eliminacije vildagliptina u ljudi je metaboliziranje, na koje otpada 69% doze.
English: Necrotic lesions of the tail were observed at ≥ 80 mg/kg/day.
Croatian: Nekrotične lezije repa zapažene su pri dozi ≥80 mg/kg/dan.
English: In these studies, no clinically relevant pharmacokinetic interactions were observed after co-administration with vildagliptin.
Croatian: U ovim ispitivanjima nisu zapažene nikakve klinički značajne farmakokinetičke interakcije nakon istodobne primjene s vildagliptinom.
English: For vildagliptin studies in animals have shown reproductive toxicity at high doses.
Croatian: Ispitivanja vildagliptina na životinjama pokazala su reproduktivnu toksičnost pri visokim dozama.
English: It is unknown whether vildagliptin is excreted in human milk, but metformin is excreted in human milk in low amounts.
Croatian: Nije poznato izlučuje li se vildagliptin u majčino mlijeko, ali se metformin izlučuje u malim količinama u majčino mlijeko u ljudi.
English: For metformin, studies in animals have not shown reproductive toxicity.
Croatian: Ispitivanja metformina na životinjama ne ukazuju na reproduktivnu toksičnost.
English: Studies in animals performed with vildagliptin and metformin have not shown evidence of teratogenicity, but foetotoxic effects at maternotoxic doses (see section 5.3).
Croatian: Ispitivanja vildagliptina i metformina na životinjama nisu pokazala teratogenost, ali je toksični učinak na fetus dokazan pri dozama toksičnim za majku (vidjeti dio 5.3).
English: Therefore, close monitoring of glycaemic control, dose adjustment within the recommended posology and changes in diabetic treatment should be considered when cationic medicinal products that are eliminated by renal tubular secretion are co-administered (see section 4.4).
Croatian: Stoga treba pažljivo pratiti glikemiju, prilagođavati dozu unutar preporučenog doziranja te razmotriti promjenu liječenja šećerne bolesti ako se istodobno primjenjuju kationski lijekovi koji se eliminiraju renalom tubularnom sekrecijom (vidjeti dio 4.4).
English: Also if you are taking an anti-diabetic medicine known as a sulphonylurea your doctor may prescribe a lower dose.
Croatian: Isto tako, ako uzimate lijek za šećernu bolest koji se zove sulfonilureja, liječnik Vam može propisati nižu dozu.
English: Following oral administration in the fasting state, vildagliptin is rapidly absorbed with peak plasma concentrations observed at 1.7 hours.
Croatian: Nakon peroralne primjene natašte vildagliptin se brzo apsorbira pri čemu su vršne koncentracije u plazmi zapažene nakon 1,7 sati.
English: Liver enzyme monitoring
Croatian: Praćenje jetrenih enzima
English: It does not stimulate insulin secretion and therefore does not produce hypoglycaemia or increased weight gain.
Croatian: Ne potiče lučenje inzulina te tako ne dovodi do hipoglikemije ili povećanja tjelesne težine.
English: The majority of adverse reactions were mild and transient, not requiring treatment discontinuations.
Croatian: Većina je nuspojava bila blaga i prolazna te nije bilo potrebno prekidati liječenje.
English: The composite endpoint of adjudicated major adverse cardiovascular events (MACE) including acute myocardial infarction, stroke or cardiovascular death was similar for vildagliptin versus combined active and placebo comparators [Mantel-Haenszel risk ratio (M-H RR) 0.82 (95% CI 0.61-1.11)].
Croatian: Kompozitna mjera ishoda utvrđenih velikih neželjenih kardiovaskularnih događaja (engl. major adverse cardiovascular events, MACE), koja uključuje akutni infarkt miokarda, moždani udar ili kardiovaskularnu smrt, bila je slična za vildagliptin u usporedbi s kombiniranim aktivnim i placebo komparatorima [omjer rizika po Mantel-Haenszelovoj metodi (M-H RR) 0,82 (95% interval pouzdanosti 0,61-1,11)].
English: The safety and efficacy of vildagliptin and metformin as triple oral therapy in combination with a thiazolidinedione have not been established.
Croatian: Nije ustanovljena sigurnost i djelotvornost vildagliptina i metformina kao trojne oralne terapije u kombinaciji s tiazolidindionom.
English: • Inflammation of the pancreas (pancreatitis) (frequency not known): Symptoms include severe and persistent pain in the abdomen (stomach area), which might reach through to your back, as well as nausea and vomiting.
Croatian: • Upala gušterače (pankreatitis) (učestalost nepoznata): simptomi uključuju jaku i upornu bol u trbuhu (područje trbuha), koja bi se mogla proširiti do leđa te mučninu i povraćanje.
English: Patients receiving vildagliptin in combination with a sulphonylurea may be at risk for hypoglycaemia.
Croatian: Bolesnici koji primaju vildagliptin u kombinaciji sa sulfonilurejom mogu biti izloženi riziku hipoglikemije.
English: The enhanced increase in the insulin/glucagon ratio during hyperglycaemia due to increased incretin hormone levels results in a decrease in fasting and postprandial hepatic glucose production, leading to reduced glycaemia.
Croatian: Pojačani porast omjera inzulina/glukagona tijekom hiperglikemije uslijed povišenih razina inkretinskih hormona rezultira smanjenjem produkcije glukoze u jetri natašte i postprandijalno, što dovodi do smanjene glikemije.
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 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: FOLDING BOX FOR UNIT PACK
Croatian: KUTIJA ZA JEDINIČNO PAKIRANJE
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis) Diabetic pre-coma Severe renal failure (GFR < 30 ml/min) (see section 4.4) Acute conditions with the potential to alter renal function, such as: dehydration, severe infection, shock, intravascular administration of iodinated contrast agents (see section 4.4).
Croatian: Preosjetljivost na djelatne tvari ili neku od pomoćnih tvari navedenih u dijelu 6.1 Bilo koja vrsta akutne metaboličke acidoze (kao što je laktacidoza, dijabetička ketoacidoza) Dijabetička pretkoma Teško zatajenje bubrega (GFR<30 ml/min) (vidjeti dio 4.4) Akutna stanja koja mogu promijeniti funkciju bubrega, kao što su: dehidracija, teška infekcija, šok, intravaskularna primjena jodnih kontrasta (vidjeti dio 4.4).
English: It is especially important to mention the following: - glucocorticoids generally used to treat inflammation - beta-2 agonists generally used to treat respiratory disorders - other medicines used to treat diabetes - medicines which increase urine production (diuretics) - medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib) - certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II
Croatian: Osobito je važno spomenuti sljedeće: glukokortikoide koji se obično koriste za liječenje upala - beta-2 agoniste koji se obično koriste za liječenje poremećaja disanja - druge lijekove koji se koriste za liječenje šećerne bolesti - lijekove koji povećavaju stvaranje mokraće (diuretici) - lijekove koji se primjenjuju za liječenje boli i upale (NSAIL i COX-2-inhibitori, kao što su ibuprofen i celekoksib) - određene lijekove za liječenje povišenog krvnog tlaka (ACE inhibitori i antagonisti receptora angiotenzina II)neke lijekove koji utječu na štitnjaču, ili - neke lijekove koji utječu na živčani sustav.
English: Vildagliptin, a member of the islet enhancer class, is a potent and selective dipeptidyl-peptidase-4 (DPP-4) inhibitor.
Croatian: Vildagliptin, pripadnik skupine stimulatora Langerhansovih otočića gušterače, jaki je i selektivni inhibitor dipeptidil peptidaze-4 (DPP-4).
English: Zomarist should not be used in patients with hepatic impairment, including those with pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal (ULN) (see sections 4.3, 4.4 and 4.8).
Croatian: Zomarist se ne smije primjenjivati u bolesnika s oštećenjem jetre, uključujući u kojih su vrijednosti alanin aminotransferaze (ALT) ili aspartat aminotransferaze (AST) prije početka liječenja bile >3 vrijednosti gornje granice normale (GGN) (vidjeti dijelove 4.3, 4.4 i 4.8).
English: A meta-analysis of independently and prospectively adjudicated cardiovascular events from 37 phase III and IV monotherapy and combination therapy clinical studies of up to more than 2 years duration (mean exposure 50 weeks for vildagliptin and 49 weeks for comparators) was performed and showed that vildagliptin treatment was not associated with an increase in cardiovascular risk versus comparators.
Croatian: Provedena je meta-analiza neovisno i prospektivno utvrđenih kardiovaskularnih događaja iz 37 kliničkih ispitivanja faze III i IV s monoterapijom i kombiniranom terapijom, trajanja do više od 2 godine (srednja izloženost 50 tjedana za vildagliptin i 49 tjedana za komparatore) koja je pokazala da liječenje vildagliptinom nije bilo povezano s povećanjem kardiovaskularnog rizika u usporedbi s komparatorima.
English: Liver function test abnormalities or hepatitis** Skin and subcutaneous tissue disorders Very rare
Croatian: Abnormalni testovi jetrene funkcije ili hepatitis** Poremećaji kože i potkožnog tkiva Vrlo rijetko
English: Hydroxypropylcellulose Magnesium stearate
Croatian: Jezgra tablete hidroksipropilceluloza magnezijev stearat
English: - For patients switching from co-administration of vildagliptin and metformin as separate tablets: Zomarist should be initiated at the dose of vildagliptin and metformin already being taken.
Croatian: U bolesnika koji prelaze s istodobne primjene vildagliptina i metformina kao zasebnih tableta: Zomarist je potrebno započeti u dosadašnjim dozama vildagliptina i metformina.
English: Studies in animals have shown excretion of both metformin and vildagliptin in milk.
Croatian: Ispitivanja na životinjama pokazala su da se i metformin i vildagliptin izlučuju u mlijeko.
English: Cationic active substances that are eliminated by renal tubular secretion (e.g. cimetidine) may interact with metformin by competing for common renal tubular transport systems and hence delay the elimination of metformin, which may increase the risk of lactic acidosis.
Croatian: Kationske djelatne tvari koje se eliminiraju bubrežnom tubularnom sekrecijom (npr. cimetidin) mogu ući u interakciju s metforminom nadmećući se za zajednički bubrežni tubularni transportni sustav i posljedično usporiti eliminaciju metformina, što može povećati rizik za laktacidozu.
English: Drug-drug interaction studies with digoxin (P-glycoprotein substrate) and warfarin (CYP2C9 substrate) in healthy subjects have shown no clinically relevant pharmacokinetic interactions after coadministration with vildagliptin.
Croatian: Ispitivanja interakcija među lijekovima s digoksinom (P-glikoproteinski supstrat) i varfarinom (CYP2C9 supstrat) na zdravim ispitanicima nisu pokazala klinički značajne farmakokinetičke interakcije nakon istodobne primjene s vildagliptinom.
English: • Angioedema (rare: may affect up to 1 in 1,000 people): Symptoms include swollen face, tongue or throat, difficulty swallowing, difficulty breathing, sudden onset of rash or hives, which may indicate a reaction called “angioedema”.
Croatian: • Angioedem (rijetko: mogu se javiti u do 1 na 1000 osoba): simptomi uključuju otečeno lice, jezik ili grlo, otežano gutanje, otežano disanje, iznenadno izbijanje osipa ili koprivnjače, što može upućivati na reakciju zvanu „angioedem”.
English: The majority of events were mild in severity and resolved with ongoing vildagliptin treatment.
Croatian: Većina je događaja bila blagog intenziteta i povukla se tijekom daljnjeg liječenja vildagliptinom.