FrancophonIA/ELRC3.0 huggingface dataset:
English: • Take Jalra every day for as long as your doctor tells you.
Croatian: • Jalru uzimajte svaki dan onoliko dugo koliko Vam liječnik kaže.
English: You are also advised to pay particular attention to new onset of blisters or ulcers while taking Jalra.
Croatian: Također Vam se savjetuje da posvetite posebnu pozornost novoj pojavi mjehurića ili čireva dok uzimate Jalru.
English: • The active substance is vildagliptin.
Croatian: • Djelatna stvar je vildagliptin.
English: • if you are on dialysis.
Croatian: • ako ste na dijalizi.
English: Jalra is not a substitute for insulin in insulin-requiring patients.
Croatian: Jalra nije zamjena za inzulin u bolesnika koji trebaju inzulin.
English: Administration of vildagliptin with food resulted in a decreased Cmax (19%).
Croatian: Primjena vildagliptina s hranom rezultira smanjenim Cmax (19%).
English: Digoxin (Pgp substrate), warfarin (CYP2C9 substrate)
Croatian: Digoksin (Pgp supstrat), varfarin (CYP2C9 supstrat)
English: • if you have type 1 diabetes (i.e. your body does not produce insulin) or if you have a condition called diabetic ketoacidosis.
Croatian: • ako imate šećernu bolest tipa 1 (odnosno Vaše tijelo ne stvara inzulin) ili ako imate stanje koje se zove dijabetička ketoacidoza
English: It is used when diabetes cannot be controlled by diet and exercise alone.
Croatian: Primjenjuje se kada se šećerna bolest ne može kontrolirati samo dijetom i tjelovježbom.
English: One side is debossed with “NVR”, and the other side with “FB”.
Croatian: Na jednoj je strani utisnuta oznaka „NVR“, a na drugoj strani „FB“.
English: What Jalra is and what it is used for What you need to know before you take Jalra How to take Jalra
Croatian: Što je Jalra i za što se koristi Što morate znati prije nego počnete uzimati Jalru
English: However, the major hydrolysis metabolite (LAY 151) can be removed by haemodialysis.
Croatian: No, glavni se metabolit hidrolize (LAY 151) može ukloniti hemodijalizom.
English: Insulin is a substance which helps to lower the level of sugar in the blood, especially after meals.
Croatian: Inzulin je tvar koja pomaže u snižavanju razine šećera u krvi, osobito poslije obroka.
English: Talk to your doctor, pharmacist or nurse before taking Jalra.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Jalru
English: What Jalra looks like and contents of the pack
Croatian: Kako Jalra izgleda i sadržaj pakiranja
English: Some symptoms need immediate medical attention: You should stop taking Jalra and see your doctor immediately if you experience the following side effects:
Croatian: Neki simptomi zahtijevaju hitnu medicinsku pomoć: Prestanite uzimati Jalru i odmah otiđite svom liječniku ako osjetite sljedeće nuspojave:
English: Embryo-foetal toxicity was evaluated in rats and rabbits.
Croatian: Embriofetalna toksičnost je ispitivana u štakora i kunića.
English: Your doctor may wish to alter your dose of Jalra if you are taking other medicines such as: - thiazides or other diuretics (also called water tablets) - corticosteroids(generally used to treat inflammation) - thyroid medicines - certain medicines affecting the nervous system.
Croatian: Liječnik će Vam možda željeti promijeniti dozu Jalre ako uzimate druge lijekove kao što su: - tijazidi ili drugi diuretici (također se zovu tablete za vodu) - kortikosteroidi (općenito se koristeza liječenje upale) - lijekovi za liječenje štitnjače - određeni lijekovi koji utječu na živčani sustav.
English: This medicine has been shown to reduce blood sugar, which may help to prevent complications from your diabetes.
Croatian: Pokazalo se da ovaj lijek smanjuje razinu šećera u krvi, što bi moglo pomoći u sprečavanju komplikacija uzrokovanih šećernom bolešću.
English: Studies in animals have shown reproductive toxicity at high doses (see section 5.3).
Croatian: Ispitivanja na životinjama pokazala su reproduktivnu toksičnost pri visokim dozama (vidjeti dio 5.3).
English: Information regarding overdose with vildagliptin is limited.
Croatian: Informacije o predoziranju vildagliptinom su ograničene.
English: Due to lack of human data, Jalra should not be used during pregnancy.
Croatian: Zbog nedovoljno podataka u ljudi, Jalra se ne smije primjenjivati tijekom trudnoće.
English: Vildagliptin cannot be removed by haemodialysis.
Croatian: Vildagliptin se ne može ukloniti hemodijalizom.
English: If you stop taking Jalra
Croatian: Ako prestanete uzimati Jalru
English: Other medicines and Jalra
Croatian: Drugi lijekovi i Jalra
English: • if you suffer from heart failure.
Croatian: • ako bolujete od zatajivanja srca.
English: If you think you may be allergic to vildagliptin or any of the other ingredients of Jalra, do not take this medicine and talk to your doctor.
Croatian: Ako mislite da biste mogli biti alergični na vildagliptin ili bilo koji od ostalih sastojaka Jalre, nemojte uzeti ovaj lijek i porazgovarajte sa svojim liječnikom.
English: C] vildagliptin, approximately 85% of the dose was excreted into the urine and 15% of the dose is recovered in the faeces.
Croatian: C] vildagliptina oko 85% doze se izlučuje u mokraću, a 15% doze pronađeno je u stolici.
English: Information on the likely symptoms of overdose was taken from a rising dose tolerability study in healthy subjects given Jalra for 10 days.
Croatian: Informacije o mogućim simptomima predoziranja uzete su iz ispitivanja podnošljivosti povećanja doze u zdravih ispitanika koji su primali Jalru tijekom 10 dana.
English: OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX)
Croatian: KUTIJA VIŠESTRUKOG PAKIRANJA (UKLJUČUJUĆI PLAVI OKVIR)
English: In vitro data in human kidney microsomes suggest that the kidney may be one of the major organs contributing to the hydrolysis of vildagliptin to its major inactive metabolite, LAY151.
Croatian: In vitro podaci na humanim bubrežnim mikrosomima navode na zaključak da bubreg može biti jedan od glavnih organa koji doprinosi hidrolizi vildagliptina u njegov glavni neaktivni metabolit, LAY151.
English: INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX)
Croatian: MEĐUPAKIRANJE VIŠESTRUKOG PAKIRANJA (BEZ PLAVOG OKVIRA)
English: Jalra is not recommended for use in children and adolescents (< 18 years).
Croatian: Jalra se ne preporučuje za primjenu u djece i adolescenata (<18 godina).
English: Jalra contains lactose (milk sugar).
Croatian: Jalra sadrži laktozu (mliječni šećer).
English: Pharmacotherapeutic group: Drugs used in diabetes, dipeptidyl peptidase 4 (DPP-4) inhibitors, ATC code: A10BH02
Croatian: Farmakoterapijska skupina: Lijekovi za liječenje šećerne bolesti, inhibitori dipeptidil peptidaze 4 (DPP-4), ATK oznaka: A10BH02
English: • if you have moderate or severe kidney disease (you will need to take a lower dose of Jalra).
Croatian: • ako imate umjerenu do tešku bolest bubrega (trebat ćete uzeti nižu dozu Jalre).
English: • Do not use this medicine after the expiry date which is stated on the blister and the carton after
Croatian: • Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na blisteru i kutiji iza
English: What Jalra contains
Croatian: Što Jalra sadrži
English: The active substance of Jalra, vildagliptin, belongs to a group of medicines called “oral antidiabetics”.
Croatian: Djelatna tvar Jalre, vildagliptin, pripada skupini lijekova koji se nazivaju „oralni antidijabetici“.
English: Vildagliptin is indicated in the treatment of type 2 diabetes mellitus in adults:
Croatian: Vildagliptin je indiciran u liječenju šećerne bolesti tipa 2 u odraslih:
English: Use of vildagliptin has been associated with a risk of developing acute pancreatitis.
Croatian: Primjena vildagliptina bila je povezana s rizikom od razvoja akutnog pankreatitisa.
English: Excipient with known effect: Each tablet contains 47.82 mg lactose (anhydrous).
Croatian: Pomoćna tvar s poznatim učinkom: svaka tableta sadrži 47,82 mg laktoze (bezvodne).
English: How Jalra works
Croatian: Kako Jalra djeluje
English: Jalra 50 mg tablets are round, white to light yellowish and flat, with “NVR” on one side and “FB” on the other.
Croatian: Jalra 50 mg tablete su okrugle, bijele do svijetložućkaste i ravne, s oznakom „NVR“ na jednoj strani i „FB“ na drugoj strani.
English: * p< 0.05 for comparison versus placebo
Croatian: * p< 0,05 za usporedbu naspram placeba
English: Oral use Jalra can be administered with or without a meal (see also section 5.2).
Croatian: Jalra se može uzimati uz obrok ili bez obroka (vidjeti također dio 5.2).
English: • Store in the original package in order to protect from moisture.
Croatian: • Čuvati u originalnom pakiranju radi zaštite od vlage.
English: LAY151 concentrations were approximately 2-3-fold higher than in patients with severe renal impairment.
Croatian: Koncentracije LAY151 bile su otprilike 2-3 puta više nego u bolesnika s teškim oštećenjem bubrega.
English: A greater proportion of cases were reported when vildagliptin was administered in combination with an angiotensin converting enzyme inhibitor (ACE-Inhibitor).
Croatian: Veći udio slučajeva je zabilježen kada se vildagliptin davao u kombinaciji s inhibitorom angiotenzin konvertirajućeg enzima (ACE-inhibitor).
English: White to light yellowish, round (8 mm diameter), flat-faced, bevelled-edge tablet.
Croatian: Bijela do svijetložućkasta, okrugla (promjera 8 mm), ravna tableta sa zaobljenim rubovima.
English: 7 tablets 14 tablets 28 tablets 30 tablets 56 tablets 60 tablets 90 tablets 112 tablets 180 tablets 336 tablets
Croatian: 7 tableta 14 tableta 28 tableta 30 tableta 56 tableta 60 tableta 90 tableta 112 tableta 180 tableta 336 tableta
English: The European Medicines Agency has waived the obligation to submit the results of studies with vildagliptin 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 izuzela je obvezu podnošenja rezultata ispitivanja lijeka vildagliptin u svim podskupinama pedijatrijske populacije za šećernu bolest tipa 2 (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Monotherapy placebo controlled studies
Croatian: Ispitivanja monoterapije kontrolirane placebom
English: It helps to control the level of sugar in the blood.
Croatian: Pomaže u kontroliranju razine šećera u krvi.
English: Patients who 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: * p< 0.05 for comparison versus placebo + comparator
Croatian: * p<0,05 za usporedbu naspram placebo + komparator
English: Glucagon is a substance which triggers the production of sugar by the liver, causing the blood sugar level to rise.
Croatian: Glukagon je tvar koja potiče stvaranje šećera u jetri, što uzrokuje porast razine šećera u krvi.
English: Animal studies have shown excretion of vildagliptin in milk.
Croatian: Ispitivanja na životinjama pokazala su da se vildagliptin izlučuje u mlijeko.
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: Jalra should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Croatian: Jalra se ne smije primjenjivati u bolesnika sa šećernom bolešću tipa 1 ili za liječenje dijabetičke ketoacidoze.
English: The safety and efficacy of vildagliptin as triple oral therapy in combination with metformin and a thiazolidinedione have not been established.
Croatian: Nije ustanovljena sigurnost i djelotvornost vildagliptina kao trojne oralne terapije u kombinaciji s metforminom i tiazolidindionom.
English: The safety and efficacy of Jalra in children and adolescents (< 18 years) have not been established.
Croatian: Sigurnost i djelotvornost Jalre u djece i adolescenata (<18 godina) nisu još ustanovljene.
English: Vildagliptin was not associated with a change in left-ventricular function or worsening of pre-existing CHF.
Croatian: Vildagliptin nije bio povezan s promjenom u funkciji lijeve klijetke ili pogoršanjem već postojećeg KZS-a.
English: Vildagliptin was removed by haemodialysis to a limited extent (3% over a 3-4 hour haemodialysis session starting 4 hours post dose).
Croatian: Vildagliptin je bio uklonjen hemodijalizom u ograničenoj mjeri (3% tijekom hemodijalize u trajanju od 3-4 sata, a koja je počela 4 sata nakon doziranja).
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: 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 liver function tests 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: Following oral administration of [
Croatian: Nakon peroralne primjene [
English: In the subgroup with NYHA class III, the decrease in HbA1c compared to placebo was lower (difference 0.3%) but this conclusion is limited by the small number of patients (n=44).
Croatian: U podskupini s NYHA klasom III, smanjenje HbA1c u usporedbi s placebom bilo je manje (razlika 0,3%), ali taj je zaključak ograničen malim brojem bolesnika (n=44).
English: • Do not use any Jalra pack that is damaged or shows signs of tampering.
Croatian: • Jalra se ne smije upotrijebiti ako je kutija oštećena ili postoje vidljivi znakovi otvaranja.
English: Therefore Jalra should be used with caution in these patients (see also sections 4.2, 5.1 and 5.2).
Croatian: Zbog toga se u tih bolesnika Jalra treba primjenjivati s oprezom (vidjeti također dijelove 4.2, 5.1 i 5.2).
English: At 600 mg, one subject experienced oedema of the feet and hands, and increases in creatine phosphokinase (CPK), aspartate aminotransferase (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), aspartat aminotransferaze (AST), C-reaktivnog proteina (CRP) i mioglobina.
English: Do not take Jalra:
Croatian: Nemojte uzimati Jalru:
English: • Angioedema (rare: may affect up to 1 in 1,000 people): Symptoms include swollen face, tongue or throat, difficulty swallowing, difficulties breathing, sudden onset rash or hives, which may indicate a reaction called “angioedema”.
Croatian: • Angioedem (rijetko: mogu se javiti u do 1 in 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: Clinical experience in patients with NYHA functional class III treated with vildagliptin is still limited and results are inconclusive (see section 5.1).
Croatian: Klinička iskustva u bolesnika s NYHA funkcionalnom klasom III liječenih vildagliptinom još uvijek su ograničena te se na temelju rezultata ne mogu donositi zaključci (vidjeti dio 5.1).
English: Ethnic group Limited data suggest that race does not have any major influence on vildagliptin pharmacokinetics.
Croatian: Ograničeni podaci navode na zaključak da rasa nema nikakav značajniji utjecaj na farmakokinetiku vildagliptina.
English: Some patients have had the following side effects while taking Jalra, metformin and a sulphonylurea: • Common: Dizziness, tremor, weakness, low blood glucose, excessive sweating
Croatian: Neki su bolesnici imali sljedeće nuspojave kada su uzimali Jalru, metformin i sulfonilureju: • Često: omaglica, tremor, slabost, niska razina glukoze u krvi, pojačano znojenje
English: 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: 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: 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 glucuronide (BQS867) and the amide hydrolysis products (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 glukuronid (BQS867) i produkt hidrolize amida (4% doze).
English: There are no adequate data from the use of vildagliptin in pregnant women.
Croatian: Nema odgovarajućih podataka o primjeni vildagliptina u trudnica.
English: There is no experience of vildagliptin use in clinical trials in patients with NYHA functional class IV and therefore use is not recommended in these patients.
Croatian: Ne postoji iskustvo s primjenom vildagliptina u kliničkim ispitivanjima u bolesnika s IV. funkcijskim stupnjem prema NYHA pa se zbog toga primjena u tih bolesnika ne preporučuje.
English: If you forget to take Jalra
Croatian: Ako ste zaboravili uzeti Jalru
English: Patients who develop jaundice or other signs suggestive of liver dysfunction should discontinue Jalra.
Croatian: U bolesnika koji razviju žuticu ili druge znakove koji upućuju na poremećaj jetrene funkcije treba prekinuti liječenje Jalrom.
English: • 50 mg daily in the morning if you have moderate or severe kidney disease or if you are on dialysis.
Croatian: • 50 mg na dan, ujutro, ako imate umjerenu ili tešku bolest bubrega ili ako ste na dijalizi.
English: Some patients have had the following side effects while taking Jalra and insulin (with or without metformin):
Croatian: Neki su bolesnici imali sljedeće nuspojave kada su uzimali Jalru i inzulin (sa ili bez metformina):
English: Of these patients, 2,264 patients received vildagliptin as monotherapy and 1,520 patients received vildagliptin in combination with another medicinal product.
Croatian: Od tih je bolesnika njih 2264 primalo vildagliptin kao monoterapiju, a njih 1520 je primalo vildagliptin u kombinaciji s drugim lijekom.
English: Patients treated with vildagliptin reported significantly lower incidences of gastrointestinal adverse reactions versus those treated with metformin.
Croatian: Bolesnici liječeni vildagliptinom prijavili su značajno niže incidencije gastrointestinalnih nuspojava u odnosu na one liječene metforminom.
English: You should not use Jalra during pregnancy.
Croatian: Ne smijete uzimati Jalru tijekom trudnoće.
English: The administration of vildagliptin results in a rapid and complete inhibition of DPP-4 activity, resulting in increased fasting and postprandial endogenous levels of the incretin hormones GLP-1 (glucagon-like peptide 1) and GIP (glucose-dependent insulinotropic polypeptide).
Croatian: Primjena vildagliptina rezultira brzom i potpunom inhibicijom aktivnosti DPP-4, koja dovodi do povišene endogene razine natašte i postprandijalno inkretinskih hormona GLP-1 (glukagonu sličan peptid 1) i GIP (inzulinotropni polipeptid ovisan o glukozi).
English: Vildagliptin is also indicated for use in combination with insulin (with or without metformin) when diet and exercise plus a stable dose of insulin do not provide adequate glycaemic control.
Croatian: Vildagliptin je također indiciran za uporabu u kombinaciji s inzulinom (sa ili bez metformina) kad prehrana i tjelovježba povrh stabilne doze inzulina ne omogućuju odgovarajuću kontrolu glikemije.
English: Vildagliptin, a member of the islet enhancer class, is a potent and selective DPP-4 inhibitor.
Croatian: Vildagliptin, pripadnik skupine stimulatora Langerhansovih otočića gušterače, jaki je i selektivni DPP-4 inhibitor.
English: No dose adjustments are necessary in elderly patients (see also sections 5.1 and 5.2).
Croatian: U starijih bolesnika nije potrebno prilagođavati dozu (vidjeti također dijelove 5.1 i 5.2).
English: Your doctor will prescribe Jalra either alone or together with certain other antidiabetic medicines which you will already be taking, if these have not proved sufficiently effective to control diabetes.
Croatian: Liječnik će Vam propisati Jalru bilo kao monoterapiju ili u kombinaciji s nekim drugim lijekovima za liječenje šećerne bolesti koje već uzimate ako se ti drugi lijekovi nisu pokazali dostatno djelotvornima u kontroli šećerne bolesti.
English: Combination with ACE-inhibitors
Croatian: Kombinacija s ACE inhibitorima
English: Combination with pioglitazone, metformin and glyburide
Croatian: Kombinacija s pioglitazonom, metforminom i gliburidom
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: The exposure to vildagliptin after a single dose in patients with mild and moderate hepatic impairment was decreased (20% and 8%, respectively), while the exposure to vildagliptin for patients with severe impairment was increased by 22%.
Croatian: Izloženost vildagliptinu nakon jednokratne doze u bolesnika s blagim i umjerenim oštećenjem jetre bila je smanjena (20%, odnosno 8%), dok je izloženost vildagliptinu u bolesnika s teškim oštećenjem bila povećana za 22%.
English: Jalra works by making the pancreas produce more insulin and less glucagon.
Croatian: Jalra djeluje tako da gušterača stvara više inzulina, a manje glukagona.
English: 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: 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: Adverse reactions reported in patients who received Jalra in double-blind studies as monotherapy and add-on therapies are listed below for each indication by system organ class and absolute frequency.
Croatian: Nuspojave zabilježene u bolesnika koji su primali Jalru u dvostruko slijepim ispitivanjima kao monoterapiju i kao dodatnu terapiju navedene su niže za svaku indikaciju prema klasifikaciji organskih sustava i apsolutnoj učestalosti.
English: • 50 mg daily taken as one dose in the morning if you are taking Jalra with another medicine called a sulphonylurea.
Croatian: • 50 mg na dan, što se uzima kao jedna doza ujutro ako uzimate Jalru s drugim lijekom koji se zove sulfonilureja.
English: How long to take Jalra
Croatian: Koliko dugo uzimati Jalru
English: Decreased blood glucose
Croatian: niska razina glukoze u krvi
English: The pancreas makes both of these substances.
Croatian: Obje te tvari stvara gušterača.