natgillin/translations-raw huggingface dataset:
Furthermore, there have been post-marketing reports of bullous and exfoliative skin lesions. 
Nadalje, nakon stavljanja lijeka u promet postoje izvješća o buloznim i eksfolijativnim kožnim lezijama.
Angiotensin converting enzyme (ACE) inhibitors may decrease the blood glucose levels. 
Inhibitori angiotenzin konvertirajućeg enzima (ACE) mogu sniziti razinu glukoze u krvi.
Factors that may increase the risk of lactic acidosis (see section 4.4) should be reviewed before considering initiation of metformin in patients with GFR<60 ml/min. 
Čimbenike koji mogu povećati rizik od laktacidoze (vidjeti dio 4.4) potrebno je provjeriti prije nego što se počne razmatrati uvođenje metformina u bolesnika s GFR<60 ml/min.
The following statements reflect the pharmacokinetic properties of the individual active substances of Zomarist. 
Izjave u nastavku odražavaju farmakokinetička svojstva pojedinih djelatnih tvari u Zomaristi.
The European Medicines Agency has waived the obligation to submit the results of studies with vildagliptin in combination with metformin in all subsets of the paediatric population with type 2 diabetes mellitus (see section 4.2 for information on paediatric use). 
Europska agencija za lijekove je izuzela je obvezu podnošenja rezultata ispitivanja lijeka vildagliptin u kombinaciji s metforminom u svim podskupinama pedijatrijske populacije za šećernu bolest tipa 2 (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
In controlled clinical trials, maximum metformin plasma levels (Cmax) did not exceed 4 µg/ml, even at maximum doses. 
U kontroliranim kliničkim ispitivanjima najviše razine metformina u plazmi (Cmax) nisu prelazile 4 µg/ml, čak i pri najvišim dozama.
No dose adjustment. 
Nema prilagodbe doze.
There have been no formal interaction studies for Zomarist. 
Nisu provedena formalna ispitivanja interakcija za Zomarist.
A MACE occurred in 83 out of 9,599 (0.86%) vildagliptin-treated patients and in 85 out of 7,102 (1.20%) comparator-treated patients. 
MACE se javio u 83 od 9599 (0,86%) bolesnika liječenih vildagliptinom i u 85 od 7102 (1,20%) bolesnika liječenih komparatorom.
In case of dehydration (severe diarrhoea or vomiting, fever, or reduced fluid intake), metformin should be temporarily discontinued and contact with a healthcare professional is recommended. 
U slučaju dehidracije (teški proljev ili povraćanje, vrućica ili smanjen unos tekućine), potrebno je privremeno prekinuti primjenu metformina i preporučuje se obratiti se zdravstvenom radniku.
Stop taking Zomarist for a short time if you have a condition that may be associated with dehydration (significant loss of body fluids) such as severe vomiting, diarrhoea, fever, exposure to heat or if you drink less fluid than normal. 
Prestanite nakratko uzimati Zomarist ako imate stanje koje može biti povezano s dehidracijom (značajan gubitak tjelesnih tekućina) kao što je jako povraćanje, proljev, vrućica, izloženost toplini ili ako pijete manje tekućine nego obično.
Hepatic impairment (see sections 4.2, 4.4 and 4.8) Acute alcohol intoxication, alcoholism Breast-feeding (see section 4.6) 
Oštećenje jetre (vidjeti dijelove 4.2, 4.4 i 4.8) Akutna intoksikacija alkoholom, alkoholizam Dojenje (vidjeti dio 4.6).
Renal clearance of metformin is > 400 ml/min, indicating that metformin is eliminated by glomerular filtration and tubular secretion. 
Bubrežni klirens metformina je >400 ml/min što upućuje da se metformin uklanja glomerularnom filtracijom i tubularnom sekrecijom.
In a 13-week toxicology study in cynomolgus monkeys, skin lesions have been recorded at doses ≥ 5 mg/kg/day. 
U toksikološkom ispitivanju u trajanju od 13 tjedana u cynomolgus majmuna zabilježene su kožne lezije pri dozama ≥5 mg/kg/dan.
Pharmacotherapeutic group: Drugs used in diabetes, combinations of oral blood glucose lowering drugs, ATC code: A10BD08 
Farmakoterapijska skupina: Pripravci za liječenje šećerne bolesti, kombinacije oralnih lijekova za snižavanje glukoze u krvi, ATK oznaka: A10BD08
This has been shown at therapeutic doses in controlled, medium-term or long-term clinical studies: metformin reduces serum levels of total cholesterol, LDL cholesterol and triglycerides. 
To je dokazano uz terapijske doze u kontroliranim kliničkim ispitivanjima srednjeg i dugog trajanja: metformin smanjuje razine ukupnog kolesterola, LDL kolesterola i triglicerida u serumu.
The major metabolite (LAY 151) is pharmacologically inactive and is the hydrolysis product of the cyano moiety, accounting for 57% of the dose, followed by the amide hydrolysis product (4% of dose). 
Glavni metabolit (LAY 151) je farmakološki neaktivan i produkt je hidrolize cijano- dijela molekule, na što otpada 57% doze, nakon čega slijedi produkt hidrolize amida (4% doze).
There are no adequate data from the use of Zomarist in pregnant women. 
Nema odgovarajućih podataka o primjeni Zomariste u trudnica.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP. 
Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), a koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a
How Zomarist works 
Kako Zomarist djeluje
Consideration of such aetiology is recommended if a patient presents with megaloblastic anaemia. 
Preporučuje se uzeti u obzir ovu etiologiju u bolesnika s megaloblastičnom anemijom.
- Do not use this medicine after the expiry date which is stated on the blister and carton after 
- Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji iza
What Zomarist contains - The active substances are vildagliptin and metformin hydrochloride. 
Što Zomarist sadrži - Djelatne tvari su vildagliptin i metforminklorid.
Glucocorticoids, beta-2-agonists, and diuretics have intrinsic hyperglycaemic activity. 
Glukokortikoidi, beta-2-agonisti i diuretici posjeduju intrinzičko hiperglikemijsko djelovanje.
At the usual metformin doses and dosing schedules, steady state plasma concentrations are reached within 24-48 h and are generally less than 1 µg/ml. 
Pri uobičajenim dozama i shemama doziranja metformina koncentracije u plazmi u stanju dinamičke ravnoteže postižu se unutar 24-48 sati i općenito su manje od 1 µg/ml.
The increased incidence of these tumours in mice is considered not to represent a significant risk to humans based on the lack of genotoxicity of vildagliptin and its principal metabolite, the occurrence of tumours only in one species, and the high systemic exposure ratios at which tumours were observed. 
Smatra se da povećana incidencija tih tumora u miševa ne predstavlja značajan rizik za ljude na temelju nepostojanja genotoksičnosti vildagliptina i njegovog glavnog metabolita, zbog pojave tumora samo u jedne vrste te velikih omjera sustavne izloženosti kod kojih su tumori zapaženi.
This type of diabetes is also known as non-insulin-dependent diabetes mellitus. 
Ovaj tip šećerne bolesti je također poznat kao dijabetes melitus neovisan o inzulinu.
Administration of vildagliptin with food resulted in a decreased Cmax (19%) compared to dosing in the fasting state. 
Primjena vildagliptina s hranom rezultira smanjenim Cmax (19%) u usporedbi s primjenom natašte.
Patients who may experience dizziness as an adverse reaction should avoid driving vehicles or using machines. 
Bolesnici koji osjete omaglicu kao nuspojavu trebaju izbjegavati upravljanje vozilima ili rad na strojevima.
As metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking Zomarist should have their renal function monitored regularly (see sections 4.4 and 5.2). 
Budući da se metformin izlučuje putem bubrega, a stariji bolesnici imaju sklonost smanjenju bubrežne funkcije, u starijih bolesnika koji primaju Zomarist treba redovito pratiti funkciju bubrega (vidjeti dijelove 4.4 i 5.2).
A greater proportion of cases were reported when vildagliptin was administered in combination with an ACE inhibitor. 
Veći udio slučajeva je zabilježen kada se vildagliptin davao u kombinaciji s ACE inhibitorom.
The mean volume of distribution of vildagliptin at steady-state after intravenous administration (Vss) is 71 litres, suggesting extravascular distribution. 
Srednji volumen distribucije vildagliptina u stanju dinamičke ravnoteže nakon intravenske primjene (Vss) je 71 litru, što upućuje na ekstravaskularnu raspodjelu.
Sulphonylureas are known to cause hypoglycaemia. 
Poznato je da sulfonilureje izazivaju hipoglikemiju.
Adults with normal renal function (GFR ≥ 90 ml/min) The dose of antihyperglycaemic therapy with Zomarist should be individualised on the basis of the patient's current regimen, effectiveness and tolerability while not exceeding the maximum recommended daily dose of 100 mg vildagliptin. 
Odrasli s normalnom funkcijom bubrega (GFR≥90 ml/min) Doza antihiperglikemijske terapije Zomaristom mora biti individualizirana prema bolesnikovom postojećem režimu, učinkovitosti i podnošljivosti, ne prelazeći pritom najvišu preporučenu dnevnu dozu od 100 mg vildagliptina.
Urticaria Exfoliative and bullous skin lesions, including bullous pemphigoid 
Urtikarija Eksfolijativne i bulozne kožne lezije, uključujući bulozni pemfigoid
If you have reduced kidney function, your doctor may prescribe a lower dose. 
Ako imate smanjenu funkciju bubrega, liječnik Vam može propisati nižu dozu.
Taking Zomarist with or just after food may reduce gastrointestinal symptoms associated with metformin (see also section 5.2). 
Uzimanje Zomariste uz obrok ili neposredno nakon njega može ublažiti gastrointestinalne simptome povezane s metforminom (vidjeti dio 5.2).
The following statements reflect the information available on the individual active substances. 
Sljedeći navodi odražavaju informacije dostupne za svaku pojedinačnu djelatnu tvar.
Glucagon triggers the liver to make sugar, causing the blood sugar level to rise. 
Glukagon potiče stvaranje šećera u jetri, što uzrokuje porast razine šećera u krvi.
Please also see information about this in section “Warnings and precautions”. 
Također molimo pogledajte informacije o tome u dijelu „Upozorenja i mjere opreza”. - ako imate problema s jetrom.
The rate and extent of absorption of metformin from Zomarist 50 mg/1000 mg were decreased when given with food as reflected by the decrease in Cmax by 26%, AUC by 7% and delayed Tmax (2.0 to 4.0 h). 
Brzina i opseg apsorpcije metformina iz Zomariste 50 mg/1000 mg se smanjuju kada se daje s hranom što se odražava sniženjem Cmax za 26%, AUC za 7% i odgođenim Tmax (2,0 do 4,0 h).
A large overdose of metformin (or co-existing risk of lactic acidosis) may lead to lactic acidosis, which is a medical emergency and must be treated in hospital. 
Znatno predoziranje metforminom (ili istodobno prisutan rizik za razvoj laktacidoze) može dovesti do laktacidoze, što je medicinski hitno stanje i mora se liječiti u bolnici.
Metformin may exert its glucose-lowering effect via three mechanisms: - by reduction of hepatic glucose production through inhibition of gluconeogenesis and glycogenolysis; - in muscle, by modestly increasing insulin sensitivity, improving peripheral glucose uptake and utilisation; - by delaying intestinal glucose absorption. 
Metformin može vršiti svoj učinak na smanjenje glukoze putem tri mehanizma: - smanjenjem hepatičke proizvodnje glukoze inhibicijom glukoneogeneze i glikogenolize; - u mišićima umjerenim povećanjem osjetljivosti na inzulin, poboljšavajući periferni unos i korištenje glukoze; - odgađanjem intestinalne apsorpcije glukoze.
A study in healthy volunteers showed that cimetidine, administered as 400 mg twice daily, increased metformin systemic exposure (AUC) by 50%. 
Ispitivanje na zdravim dobrovoljcima je pokazalo da cimetidin primijenjen u dozi od 400 mg dvaput na dan povećava sistemsku izloženost (AUC) metforminu za 50%.
Age: In healthy elderly subjects (≥ 70 years), the overall exposure of vildagliptin (100 mg once daily) was increased by 32%, with an 18% increase in peak plasma concentration as compared to young healthy subjects (18-40 years). 
Dob: u zdravih starijih ispitanika (≥70 godina) ukupna izloženost vildagliptinu (100 mg jedanput na dan) bila je povećana za 32%, uz 18%-tni porast vršne koncentracije u plazmi u usporedbi s mladim zdravim ispitanicima (18-40 godina).
A two-year carcinogenicity study was conducted in rats at oral doses up to 900 mg/kg (approximately 200 times human exposure at the maximum recommended dose). 
Dvogodišnje ispitivanje kancerogenosti provedeno je na štakorima s oralnim dozama do 900 mg/kg (oko 200 puta veća izloženost od izloženosti u ljudi pri maksimalno preporučenoj dozi).
Drug-drug interaction studies in healthy subjects were conducted with amlodipine, ramipril, valsartan and simvastatin. 
Ispitivanja interakcija među lijekovima u zdravih ispitanika provedena su s amlodipinom, ramiprilom, valsartanom i simvastatinom.
In non-diabetic (normal glycaemic) individuals, vildagliptin does not stimulate insulin secretion or reduce glucose levels. 
U pojedinaca koji nisu dijabetičari (normalne vrijednosti glukoze), vildagliptin ne stimulira sekreciju inzulina, niti snižava razine glukoze.
Since vildagliptin is not a cytochrome P (CYP) 450 enzyme substrate and does not inhibit or induce CYP 450 enzymes, it is not likely to interact with active substances that are substrates, inhibitors or inducers of these enzymes. 
S obzirom da vildagliptin nije supstrat enzima citrokroma P (CYP) 450 i ne inhibira niti inducira CYP 450 enzime, nije vjerojatno da će ući u interakciju s djelatnim tvarima koje su supstrati, inhibitori ili induktori tih enzima.
Two patients reported severe hypoglycaemic events in the vildagliptin group, and 6 patients in the placebo group. 
Dva bolesnika prijavila su teške hipoglikemijske događaje u skupini liječenoj vildagliptinom, a 6 bolesnika u skupini liječenoj placebom.
Talk to your doctor, pharmacist or nurse before taking Zomarist if you are taking an anti-diabetic medicine known as a sulphonylurea. 
Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Zomarist ako uzimate antidijabetički lijek iz skupine sulfonilureja.
Metformin is contraindicated in patients with GFR <30 ml/min and should be temporarily discontinued in the presence of conditions that alter renal function (see section 4.3). 
Metformin je kontraindiciran u bolesnika s GFR<30 ml/min i njegovu je primjenu potrebno privremeno prekinuti ako su prisutna stanja koja mijenjaju funkciju bubrega, (vidjeti dio 4.3).
There have been no therapeutic clinical trials conducted with Zomarist. 
Nisu provedena terapijska klinička ispitivanja sa Zomaristom.
If necessary, the dosage of the antihyperglycaemic medicinal product should be adjusted during therapy with the other medicinal product and on its discontinuation. 
Ako je potrebno, dozu antihiperglikemijskog lijeka treba prilagoditi tijekom terapije s drugim lijekom te nakon njenog završetka.
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. 
Cmax vildagliptina i površina ispod krivulja koncentracija - vrijeme (AUC) povećali su se približno proporcionalno dozi unutar terapijskog raspona doza.
A GFR should be assessed before initiation of treatment with metformin-containing products and at least annually thereafter. 
GFR treba procijeniti prije početka liječenja lijekovima koji sadrže metformin te najmanje jedanput godišnje nakon toga.
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. 
Rezultati kliničkih ispitivanja provedenih s oralnim antidijabeticima pioglitazonom, metforminom i gliburidom u kombinaciji s vildagliptinom nisu pokazali klinički značajne farmakokinetičke interakcije u ciljnoj populaciji.
The active substances of Zomarist, vildagliptin and metformin, belong to a group of medicines called “oral antidiabetics”. 
Djelatne tvari Zomariste, vildagliptin i metformin pripadaju skupini lijekova koji se nazivaju „oralni antidijabetici”.
Not all pack sizes and tablet strengths may be marketed. 
Na tržištu se ne moraju nalaziti sve veličine pakiranja i jačine tableta.
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. 
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.
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). 
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).
Hypromellose Titanium dioxide (E 171) Iron oxide, yellow (E 172) Macrogol 4000 
Film-ovojnica hipromeloza titanijev dioksid (E 171) željezov oksid, žuti (E 172) makrogol 4000 talk
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. 
Klinička ispitivanja koja su trajala više od 2 godine nisu pokazala dodatne sigurnosne signale ili nepredviđene rizike kada je vildagliptin bio dodan metforminu.
10 film-coated tablets 30 film-coated tablets 60 film-coated tablets 120 film-coated tablets 180 film-coated tablets 360 film-coated tablets 
10 filmom obloženih tableta 30 filmom obloženih tableta 60 filmom obloženih tableta 120 filmom obloženih tableta 180 filmom obloženih tableta 360 filmom obloženih tableta
**Isolated cases of liver function test abnormalities or hepatitis resolving upon metformin discontinuation have been reported. 
**Prijavljeni su izolirani slučajevi abnormalnih testova jetrene funkcije ili hepatitisa koji su se povukli nakon prestanka primjene metformina.
However, bioequivalence of Zomarist with co-administered vildagliptin and metformin has been demonstrated (see section 5.2). 
Međutim, bioekvivalencija Zomariste s istodobno primijenjenim vildagliptinom i metforminom je dokazana (vidjeti dio 5.2).
- Store in the original package (blister) in order to protect from moisture. 
- Čuvati u originalnom pakiranju (blisteru) radi zaštite od vlage.
Food slightly delays and decreases the extent of the absorption of metformin. 
Hrana neznatno odgađa i smanjuje opseg apsorpcije metformina.
Therefore, a lower dose of sulphonylurea may be considered to reduce the risk of hypoglycaemia. 
Stoga, niža doza sulfonilureje se može razmotriti kako bi se smanjio rizik od hipoglikemije.
Nausea, gastro-oesophageal reflux disease 
Mučnina, gastroezofagealna refluksna bolest
If this happens you must stop taking Zomarist and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma. 
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.
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. 
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.
Patients who develop jaundice or other signs suggestive of liver dysfunction should discontinue Zomarist. 
U bolesnika koji razviju žuticu ili druge znakove koji upućuju na poremećaj jetrene funkcije treba prekinuti liječenje Zomaristom.
• 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”). 
• 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”).
A pre- and postnatal development study was performed in rats. 
Na štakorima je provedena studija prenatalnog i postnatalnog razvoja.
If you forget to take Zomarist 
Ako ste zaboravili uzeti Zomarist
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). 
Metformin potiče unutarstaničnu sintezu glikogena djelujući na glikogen sintazu i povećava prijenosni kapacitet specifičnih tipova membranskih prijenosnika za glukozu (GLUT-1 i GLUT-4).
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. 
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.
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. 
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.
No studies on the effect on human fertility have been conducted for Zomarist (see section 5.3). 
Nisu provedena nikakva ispitivanja o učinku Zomariste na plodnost u ljudi (vidjeti dio 5.3).
Store in the original package (blister) in order to protect from moisture. 
Čuvati u originalnom pakiranju (blisteru) radi zaštite od vlage.
• Liver disease (hepatitis) (rare): Symptoms include yellow skin and eyes, nausea, loss of appetite or dark-coloured urine, which may indicate liver disease (hepatitis). 
• 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).
Hepatitis (reversible upon discontinuation of the medicinal product) Abnormal liver function tests (reversible upon discontinuation of the medicinal product) 
Hepatitis (reverzibilan po prekidu uzimanja lijeka) Poremećeni rezultati testova jetrene funkcije (reverzibilan po prekidu uzimanja lijeka)
Following withdrawal of treatment with Zomarist and LFT normalisation, treatment with Zomarist should not be re-initiated. 
Nakon prekida liječenja sa Zomaristom i normalizacije testova jetrene funkcije, liječenje sa Zomaristom se ne smije ponovno započeti.
The mean elimination half-life after intravenous administration is approximately 2 hours. 
Srednja vrijednost poluvremena eliminacije nakon intravenske primjene iznosi oko 2 sata.
Some patients have experienced the following side effects while taking Zomarist and a sulphonylurea: • Common: dizziness, tremor, weakness, low blood glucose, excessive sweating. 
Neki su bolesnici imali sljedeće nuspojave kada su uzimali Zomarist i sulfonilureju: • često: omaglica, tremor, slabost, niska razina glukoze u krvi, pojačano znojenje.
Upper respiratory tract infection 
Infekcija gornjih dišnih puteva
Clinical trials of up to 2 years' duration did not show any additional safety signals or unforeseen risks with vildagliptin monotherapy. 
Klinička ispitivanja koja su trajala do 2 godine nisu pokazala dodatne sigurnosne signale ili nepredviđene rizike s vildagliptinom u monoterapiji.