FrancophonIA/ELRC3.0 huggingface dataset:
English: Ketoacidosis is a condition in which substances called ketone bodies accumulate in the blood and which can lead to diabetic pre-coma.
Croatian: Ketoacidoza je stanje u kojem se tvari koje se nazivaju ketonska tijela“nakupljaju u krvi i mogu dovesti do dijabetičke predkome.
English: Zomarist is not a substitute for insulin in insulin-requiring patients and should not be used in patients with type 1 diabetes.
Croatian: Zomarist nije zamjena za inzulin u bolesnika koji trebaju inzulin i ne smije se primjenjivati u bolesnika sa šećernom bolešću tipa 1.
English: If pancreatitis is suspected, vildagliptin should be discontinued if acute pancreatitis is confirmed, vildagliptin should not be restarted.
Croatian: Ako postoji sumnja na pankreatitis, treba prestati uzimati vildagliptin; ako je akutni pankreatitis potvrđen, vildagliptin se ne smije ponovo uzimati.
English: Information on the likely symptoms of overdose with vildagliptin was taken from a rising dose tolerability study in healthy subjects given vildagliptin for 10 days.
Croatian: Informacije o mogućim simptomima predoziranja s vildagliptinom uzete su iz ispitivanja podnošljivosti povećanja doze u zdravih ispitanika koji su primali vildagliptin tijekom 10 dana.
English: In vitro studies demonstrated that vildagliptin does not inhibit/induce CYP 450 enzymes.
Croatian: Studije in vitro pokazale su da vildagliptin ne inhibira/inducira CYP 450 enzime.
English: Characteristics in patients
Croatian: Karakteristike u bolesnika
English: Zomarist may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly.
Croatian: Zomarist može uzrokovati vrlo rijetku, ali vrlo ozbiljnu nuspojavu koja se naziva laktacidoza, osobito ako Vam bubrezi ne rade ispravno.
English: Vildagliptin Information regarding overdose with vildagliptin is limited.
Croatian: Informacije o predoziranju vildagliptinom su ograničene.
English: Vildagliptin has a low potential for interactions with co-administered medicinal products.
Croatian: Vildagliptin ima nizak potencijal za interakcije s lijekovima s kojima se istodobno primjenjuje.
English: D-90429 Nürnberg Germany
Croatian: D-90429 Nürnberg Njemačka
English: Following administration of a dose of 850 mg, the plasma peak concentration was 40% lower, AUC was decreased by 25% and time to peak plasma concentration was prolonged by 35 minutes.
Croatian: Nakon primjene doze od 850 mg vršna koncentracija u plazmi je bila 40% niža, AUC je bio smanjen za 25%, a vrijeme do postizanja vršne koncentracije u plazmi je bilo produženo za 35 minuta.
English: The safety and efficacy of Zomarist in children and adolescents (< 18 years) have not been established.
Croatian: Sigurnost i djelotvornost Zomariste u djece i adolescenata (<18 godina) nisu ustanovljene.
English: You may need more frequent blood glucose and kidney function tests or your doctor may need to adjust the dosage of Zomarist.
Croatian: Možda ćete češće morati raditi pretrage glukoze u krvi ili testove funkcije bubrega ili će Vam liječnik trebati prilagoditi dozu lijeka Zomarist.
English: Findings were only observed in association with maternal toxicity at ≥ 150 mg/kg and included a transient decrease in body weight and reduced motor activity in the F1 generation.
Croatian: Učinci su zapaženi samo u vezi s toksičnošću po majku pri ≥150 mg/kg, a uključivali su prolazno smanjenje tjelesne težine i smanjenu motoričku aktivnost u generaciji F1.
English: Gastrointestinal adverse reactions occur most frequently during initiation of therapy and resolve spontaneously in most cases.
Croatian: Nuspojave probavnog sustava pojavljuju se najčešće na početku liječenja i spontano se povlače u većini slučajeva.
English: If you forget to take a tablet, take it with your next meal unless you are due to take one then anyway.
Croatian: Ako ste zaboravili uzeti tabletu, uzmite ju uz sljedeći obrok, osim ako već nije vrijeme za uzimanje nove tablete.
English: INTERMEDIATE CARTON OF MULTIPACKS (WITHOUT BLUE BOX)
Croatian: MEĐUPAKIRANJE VIŠESTRUKOG PAKIRANJA (BEZ PLAVOG OKVIRA)
English: Food does not affect the extent and rate of absorption of vildagliptin from Zomarist.
Croatian: Hrana ne utječe na opseg i brzinu apsorpcije vildagliptina iz Zomariste.
English: Diarrhoea, flatulence
Croatian: Proljev, flatulencija
English: Metformin acts primarily by decreasing endogenous hepatic glucose production.
Croatian: Metformin prvenstveno djeluje smanjenjem endogene hepatičke proizvodnje glukoze.
English: Some patients have had the following side effects while taking Zomarist and insulin:
Croatian: Neki su bolesnici imali sljedeće nuspojave kada su uzimali Zomarist i inzulin:
English: Use of vildagliptin has beenassociated with a risk of developing of acute pancreatitis.
Croatian: Primjena vildagliptina bila je povezana s rizikom od razvoja akutnog pankreatitisa.
English: The plasma protein binding of vildagliptin is low (9.3%) and vildagliptin distributes equally between plasma and red blood cells.
Croatian: Vezanje vildagliptina na proteine plazme je nisko (9,3%) i vildagliptin se jednako raspodjeljuje između plazme i eritrocita.
English: Pregnancy and breast-feeding - If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Croatian: - Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku za savjet prije nego uzmete ovaj lijek.
English: You should stop taking Zomarist and see your doctor immediately if you experience the following side effects:
Croatian: Prestanite uzimati Zomarist i odmah otiđite svom liječniku ako osjetite sljedeće nuspojave:
English: At study endpoint (2 years), the HbA1c was similar to baseline values in both treatment groups and the body weight changes and hypoglycaemia differences were maintained.
Croatian: Na ishodu ispitivanja (2 godine) HbA1c je bio sličan početnim vrijednostima u obje skupine liječenih uz održane promjene tjelesne težine i razlike u hipoglikemiji.
English: Zomarist is not recommended for use in children and adolescents (< 18 years).
Croatian: Zomarist se ne preporučuje za primjenu u djece i adolescenata (<18 godina).
English: Diagnostic laboratory findings are decreased blood pH (< 7.35), increased plasma lactate levels (> 5 mmol/l) and an increased anion gap and lactate/pyruvate ratio.
Croatian: Dijagnostički laboratorijski nalazi pokazuju snižen pH krvi (<7,35), povišene razine laktata u plazmi (>5 mmol/l) i povećan anionski procjep te omjer laktata i piruvata.
English: Adverse reactions listed in Table 5 are based on information available from the metformin Summary of Product Characteristics available in the EU.
Croatian: Nuspojave prikazane u Tablici 5 temelje se na informacijama dostupnim iz Sažetka opisa svojstava lijeka za metformin dostupnog u EU.
English: Skin lesions were not reversible in the monkeys treated at 160 mg/kg/day during a 4-week recovery period.
Croatian: Kožne lezije nisu bile reverzibilne u majmuna liječenih dozom od 160 mg/kg/dan tijekom 4-tjednog razdoblja oporavka.
English: Therefore, vildagliptin is not likely to affect metabolic clearance of co-medications metabolised by CYP 1A2, CYP 2C8, CYP 2C9, CYP 2C19, CYP 2D6, CYP 2E1 or CYP 3A4/5.
Croatian: Zbog toga nije vjerojatno da će vildagliptin utjecati na metabolički klirens istodobno primijenjenih lijekova koji se metaboliziraju putem CYP 1A2, CYP 2C8, CYP 2C9, CYP 2C19, CYP 2D6, CYP 2E1 ili CYP 3A4/5.
English: A fertility and early embryonic development study in rats revealed no evidence of impaired fertility, reproductive performance or early embryonic development due to vildagliptin.
Croatian: Ispitivanje plodnosti i ranog embrionalnog razvoja u štakora nije pokazalo da dolazi do oštećenja plodnosti, reproduktivne sposobnosti ili ranog embrionalnog razvoja zbog vildagliptina.
English: Therefore, in keeping with routine care of the diabetic patient, monitoring for skin disorders, such as blistering or ulceration, is recommended.
Croatian: Zbog toga se, provodeći rutinsku skrb za dijabetičkog bolesnika, preporučuje praćenje kožnih poremećaja, kao što je pojava mjehurića ili ulceracija.
English: Furthermore, there have been post-marketing reports of bullous and exfoliative skin lesions.
Croatian: Nadalje, nakon stavljanja lijeka u promet postoje izvješća o buloznim i eksfolijativnim kožnim lezijama.
English: Angiotensin converting enzyme (ACE) inhibitors may decrease the blood glucose levels.
Croatian: Inhibitori angiotenzin konvertirajućeg enzima (ACE) mogu sniziti razinu glukoze u krvi.
English: 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.
Croatian: 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.
English: The following statements reflect the pharmacokinetic properties of the individual active substances of Zomarist.
Croatian: Izjave u nastavku odražavaju farmakokinetička svojstva pojedinih djelatnih tvari u Zomaristi.
English: 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).
Croatian: 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).
English: In controlled clinical trials, maximum metformin plasma levels (Cmax) did not exceed 4 µg/ml, even at maximum doses.
Croatian: U kontroliranim kliničkim ispitivanjima najviše razine metformina u plazmi (Cmax) nisu prelazile 4 µg/ml, čak i pri najvišim dozama.
English: No dose adjustment.
Croatian: Nema prilagodbe doze.
English: There have been no formal interaction studies for Zomarist.
Croatian: Nisu provedena formalna ispitivanja interakcija za Zomarist.
English: 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.
Croatian: MACE se javio u 83 od 9599 (0,86%) bolesnika liječenih vildagliptinom i u 85 od 7102 (1,20%) bolesnika liječenih komparatorom.
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: Hepatic impairment (see sections 4.2, 4.4 and 4.8) Acute alcohol intoxication, alcoholism Breast-feeding (see section 4.6)
Croatian: Oštećenje jetre (vidjeti dijelove 4.2, 4.4 i 4.8) Akutna intoksikacija alkoholom, alkoholizam Dojenje (vidjeti dio 4.6).
English: Renal clearance of metformin is > 400 ml/min, indicating that metformin is eliminated by glomerular filtration and tubular secretion.
Croatian: Bubrežni klirens metformina je >400 ml/min što upućuje da se metformin uklanja glomerularnom filtracijom i tubularnom sekrecijom.
English: In a 13-week toxicology study in cynomolgus monkeys, skin lesions have been recorded at doses ≥ 5 mg/kg/day.
Croatian: U toksikološkom ispitivanju u trajanju od 13 tjedana u cynomolgus majmuna zabilježene su kožne lezije pri dozama ≥5 mg/kg/dan.
English: Pharmacotherapeutic group: Drugs used in diabetes, combinations of oral blood glucose lowering drugs, ATC code: A10BD08
Croatian: Farmakoterapijska skupina: Pripravci za liječenje šećerne bolesti, kombinacije oralnih lijekova za snižavanje glukoze u krvi, ATK oznaka: A10BD08
English: 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.
Croatian: 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.
English: 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).
Croatian: 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).
English: There are no adequate data from the use of Zomarist in pregnant women.
Croatian: Nema odgovarajućih podataka o primjeni Zomariste u trudnica.
English: 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.
Croatian: 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
English: How Zomarist works
Croatian: Kako Zomarist djeluje
English: Consideration of such aetiology is recommended if a patient presents with megaloblastic anaemia.
Croatian: Preporučuje se uzeti u obzir ovu etiologiju u bolesnika s megaloblastičnom anemijom.
English: - Do not use this medicine after the expiry date which is stated on the blister and carton after
Croatian: - Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji iza
English: What Zomarist contains - The active substances are vildagliptin and metformin hydrochloride.
Croatian: Što Zomarist sadrži - Djelatne tvari su vildagliptin i metforminklorid.
English: Glucocorticoids, beta-2-agonists, and diuretics have intrinsic hyperglycaemic activity.
Croatian: Glukokortikoidi, beta-2-agonisti i diuretici posjeduju intrinzičko hiperglikemijsko djelovanje.
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: This type of diabetes is also known as non-insulin-dependent diabetes mellitus.
Croatian: Ovaj tip šećerne bolesti je također poznat kao dijabetes melitus neovisan o inzulinu.
English: Administration of vildagliptin with food resulted in a decreased Cmax (19%) compared to dosing in the fasting state.
Croatian: Primjena vildagliptina s hranom rezultira smanjenim Cmax (19%) u usporedbi s primjenom natašte.
English: Patients who may experience dizziness as an adverse reaction should avoid driving vehicles or using machines.
Croatian: Bolesnici koji osjete omaglicu kao nuspojavu trebaju izbjegavati upravljanje vozilima ili rad na strojevima.
English: 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).
Croatian: 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).
English: A greater proportion of cases were reported when vildagliptin was administered in combination with an ACE inhibitor.
Croatian: Veći udio slučajeva je zabilježen kada se vildagliptin davao u kombinaciji s ACE inhibitorom.
English: The mean volume of distribution of vildagliptin at steady-state after intravenous administration (Vss) is 71 litres, suggesting extravascular distribution.
Croatian: Srednji volumen distribucije vildagliptina u stanju dinamičke ravnoteže nakon intravenske primjene (Vss) je 71 litru, što upućuje na ekstravaskularnu raspodjelu.
English: Sulphonylureas are known to cause hypoglycaemia.
Croatian: Poznato je da sulfonilureje izazivaju hipoglikemiju.
English: 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.
Croatian: 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.
English: Urticaria Exfoliative and bullous skin lesions, including bullous pemphigoid
Croatian: Urtikarija Eksfolijativne i bulozne kožne lezije, uključujući bulozni pemfigoid
English: If you have reduced kidney function, your doctor may prescribe a lower dose.
Croatian: Ako imate smanjenu funkciju bubrega, liječnik Vam može propisati nižu dozu.
English: Taking Zomarist with or just after food may reduce gastrointestinal symptoms associated with metformin (see also section 5.2).
Croatian: Uzimanje Zomariste uz obrok ili neposredno nakon njega može ublažiti gastrointestinalne simptome povezane s metforminom (vidjeti dio 5.2).
English: The following statements reflect the information available on the individual active substances.
Croatian: Sljedeći navodi odražavaju informacije dostupne za svaku pojedinačnu djelatnu tvar.
English: Glucagon triggers the liver to make sugar, causing the blood sugar level to rise.
Croatian: Glukagon potiče stvaranje šećera u jetri, što uzrokuje porast razine šećera u krvi.
English: Please also see information about this in section “Warnings and precautions”.
Croatian: Također molimo pogledajte informacije o tome u dijelu „Upozorenja i mjere opreza”. - ako imate problema s jetrom.
English: 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).
Croatian: 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).
English: 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.
Croatian: 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.
English: 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.
Croatian: 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.
English: A study in healthy volunteers showed that cimetidine, administered as 400 mg twice daily, increased metformin systemic exposure (AUC) by 50%.
Croatian: Ispitivanje na zdravim dobrovoljcima je pokazalo da cimetidin primijenjen u dozi od 400 mg dvaput na dan povećava sistemsku izloženost (AUC) metforminu za 50%.
English: 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).
Croatian: 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).
English: 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).
Croatian: 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).
English: Drug-drug interaction studies in healthy subjects were conducted with amlodipine, ramipril, valsartan and simvastatin.
Croatian: Ispitivanja interakcija među lijekovima u zdravih ispitanika provedena su s amlodipinom, ramiprilom, valsartanom i simvastatinom.
English: In non-diabetic (normal glycaemic) individuals, vildagliptin does not stimulate insulin secretion or reduce glucose levels.
Croatian: U pojedinaca koji nisu dijabetičari (normalne vrijednosti glukoze), vildagliptin ne stimulira sekreciju inzulina, niti snižava razine glukoze.
English: 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.
Croatian: 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.
English: Two patients reported severe hypoglycaemic events in the vildagliptin group, and 6 patients in the placebo group.
Croatian: Dva bolesnika prijavila su teške hipoglikemijske događaje u skupini liječenoj vildagliptinom, a 6 bolesnika u skupini liječenoj placebom.
English: Talk to your doctor, pharmacist or nurse before taking Zomarist if you are taking an anti-diabetic medicine known as a sulphonylurea.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Zomarist ako uzimate antidijabetički lijek iz skupine sulfonilureja.
English: 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).
Croatian: 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).
English: There have been no therapeutic clinical trials conducted with Zomarist.
Croatian: Nisu provedena terapijska klinička ispitivanja sa Zomaristom.
English: If necessary, the dosage of the antihyperglycaemic medicinal product should be adjusted during therapy with the other medicinal product and on its discontinuation.
Croatian: Ako je potrebno, dozu antihiperglikemijskog lijeka treba prilagoditi tijekom terapije s drugim lijekom te nakon njenog završetka.