FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, the PRAC was of the view that the contra-indication in patients with uncontrolled hypertension, hypertensive disorders of pregnancy (including eclampsia, pre-eclampsia or pregnancyinduced hypertension), hypertension post-partum and in the puerperium, and patients with a history of coronary artery disease or other severe cardiovascular conditions, or symptoms/history of severe psychiatric disorders, already partially in place in most member states should be implemented across all Member States.
Croatian: Pored toga, PRAC je smatrao da kontraindikaciju kod bolesnika s nekontroliranom hipertenzijom, hipertenzivnim poremećajem uzrokovanim trudnoćom (uključujući eklampsiju, predeklampsiju ili trudnoćom induciranu hipertenziju), postpartalnom hipertenzijom te hipertenzijom tijekom babinja te bolesnika s anamnezom bolesti koronarnih arterija ili drugim teškim kardiovaskularnim stanjima ili simptomima/anamnezom teških psihijatrijskih poremećaja, već djelomično utvrđenu kod većine država članica, treba provesti u svim državama članicama.
English: Therefore the PRAC recommended that safety information be included in the SmPC across the Member States.
Croatian: Stoga je PRAC preporučio da se u svim državama članicama u sažetak opisa svojstava lijeka uključe sigurnosne informacije.
English: The PRAC reviewed the efficacy and safety data following oral treatment with bromocriptine in postpartum inhibition of lactation, in particular data related to the risk of cardiovascular, vascular neurological and psychiatric adverse events.
Croatian: PRAC je pregledao podatke o djelotvornosti i sigurnosti peroralne terapije bromokriptinom u postapartalnoj inhibiciji laktacije, posebice podatke povezane s rizikom od kardiovaskularnih, vaskularnih, neuroloških te psihijatrijskih nuspojava.
English: • In addition, the PRAC recommended all strengths of these products to be contraindicated in patients with uncontrolled hypertension, hypertensive disorders of pregnancy (including eclampsia, pre-eclampsia or pregnancy-induced hypertension), hypertension post-partum and puerperium as well as in patients with a history of coronary artery disease or other severe cardiovascular conditions, or symptoms/history of severe psychiatric disorders;
Croatian: • Pored toga, PRAC je preporučio kontraindikaciju tih jačina kod bolesnika s nekontroliranom hipertenzijom, hipertenzivnim poremećajem uzrokovanim trudnoćom (uključujući eklampsiju, predeklampsiju ili trudnoćom induciranu hipertenziju), postpartalnom hipertenzijom te hipertenzijom tijekom babinja te bolesnika s anamnezom bolesti koronarnih arterija ili drugim teškim kardiovaskularnim stanjima, odnosno simptomima/anamnezom teških psihijatrijskih poremećaja.
English: The PRAC, as a consequence, concluded that the benefit-risk balance of oral bromocriptine-containing medicinal products in the post-partum inhibition of lactation identified in Annex I remains favourable, subject to the agreed changes to the product information including restrictions and warnings.
Croatian: PRAC je posljedično zaključio da omjer koristi i rizika peroralnih lijekova koji sadrže bromokriptin u postpartalnoj inhibiciji laktacije identificiran u prilogu I. ostaje povoljan te podložan dogovorenim promjenama u informacijama o lijeku, uključujući ograničenja i upozorenja.
English: Finally, the PRAC considered that, to avoid medication errors or misuse, the indication for inhibition of post-partum lactation, should be removed from the product information of the 5 mg and 10 mg strengths.
Croatian: Naposljetku, PRAC je smatrao da u svrhu izbjegavanja pogrešnog doziranja ili zlouporabe indikaciju za inhibiciju postpartalne laktacije treba ukloniti iz informacija o lijeku za jačine od 5 i 10 mg.
English: For that reason the PRAC considered that to avoid medication errors or misuse of the products the indication of inhibition of lactation should be removed from the PI of the 5 mg and 10 mg strengths.
Croatian: Zbog toga je PRAC smatrao da u svrhu izbjegavanja pogrešnog doziranja ili zlouporabe, indikaciju za inhibiciju postpartalne laktacije treba ukloniti iz informacija o lijeku za jačine od 5 i 10 mg.
English: Date of first authorisation: 14 November 2007 Date of latest renewal: 23 July 2012
Croatian: Datum prvog odobrenja: 14. studenog 2007. Datum posljednje obnove odobrenja: 23. srpnja 2012.
English: The amount of Eucreas that people have to take varies depending on their condition.
Croatian: Količina Eucreasa koju ljudi moraju uzimati ovisi o njihovu stanju.
English: Eucreas with alcohol
Croatian: Eucreas s alkoholom
English: Your doctor will discuss with you the potential risk of taking Eucreas during pregnancy.
Croatian: Vaš liječnik će s Vama razgovarati o mogućim rizicima uzimanja Eucreasa tijekom trudnoće.
English: - Do not use Eucreas if you are pregnant or breast-feeding (see also “Do not take Eucreas”).
Croatian: - Nemojte uzimati Eucreas ako ste trudni ili dojite (također pogledajte „Nemojte uzimati Eucreas“).
English: If you take more Eucreas than you should
Croatian: Ako uzmete više Eucreas nego što ste trebali
English: Do not stop taking Eucreas unless your doctor tells you to.
Croatian: Nemojte prestati uzimati Eucreas ako Vam to nije rekao Vaš liječnik.
English: Eucreas is not a substitute for insulin.
Croatian: Eucreas nije zamjena za inzulin.
English: When and how to take Eucreas - Swallow the tablets whole with a glass of water, - Take one tablet in the morning and the other in the evening with or just after food.
Croatian: Kada i kako uzimati Eucreas - Tablete progutajte cijele sa čašom vode, - Uzmite jednu tabletu ujutro i drugu navečer s obrokom ili odmah nakon obroka.
English: What Eucreas is and what it is used for
Croatian: Što je Eucreas i za što se koristi
English: Other medicines and Eucreas
Croatian: Drugi lijekovi i Eucreas
English: You are also advised to pay particular attention to new onset of blisters or ulcers while taking Eucreas.
Croatian: Također Vam se savjetuje da posvetite posebnu pozornost novoj pojavi mjehurića ili čireva dok uzimate Eucreas.
English: If you take too many Eucreas tablets, or if someone else takes your tablets, talk to a doctor or pharmacist immediately.
Croatian: Ako uzmete previše tableta Eucreasa, ili ako je netko drugi uzeo Vaše tablete, odmah se obratite liječniku ili ljekarniku.
English: Do not take Eucreas - if you are allergic to vildagliptin, metformin or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati Eucreas - ako ste alergični na vildagliptin, metformin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Eucreas should not be used during pregnancy.
Croatian: Eucreas se ne smije primjenjivati tijekom trudnoće.
English: What Eucreas is and what it is used for What you need to know before you take Eucreas How to take Eucreas
Croatian: Što je Eucreas i za što se koristi Što morate znati prije nego počnete uzimati Eucreas Kako uzimati Eucreas
English: Your doctor will tell you exactly the dose of Eucreas to take.
Croatian: Liječnik će Vam reći točno koliko tableta Eucreasa trebate uzimati.
English: During treatment with Eucreas, your doctor will check your kidney function at least once a year or more frequently if you are elderly and/or have worsening renal function.
Croatian: Tijekom liječenja lijekom Eucreas, liječnik će Vam provjeravati funkciju bubrega najmanje jedanput godišnje ili češće ako ste starija osoba i/ili ako Vam se funkcija bubrega pogoršava.
English: If you need to have an injection of a contrast medium that contains iodine into your bloodstream, for example in the context of an X-ray or scan, you must stop taking Eucreas before or at the time of the injection.
Croatian: Ako trebate dobiti injekciju kontrastnog sredstva koje sadrži jod u krvnu žilu, na primjer, u sklopu rendgenskog snimanja ili skeniranja, morate prestati uzimati lijek Eucreas prije ili u vrijeme injekcije.
English: Your doctor will decide when you must stop and when to restart your treatment with Eucreas.
Croatian: Liječnik će odlučiti kada morate prekinuti i kada ćete nastaviti s liječenjem lijekom Eucreas.
English: Food does not affect the extent and rate of absorption of vildagliptin from Eucreas.
Croatian: Hrana ne utječe na opseg i brzinu apsorpcije vildagliptina iz Eucreasa.
English: Avoid excessive alcohol intake while taking Eucreas since this may increase the risk of lactic acidosis (please see section “Warnings and precautions”).
Croatian: Izbjegavajte prekomjerni unos alkohola dok uzimate Eucreas jer to može povećati rizik od laktacidoze (vidjeti dio „Upozorenja i mjere opreza”).
English: The following statements reflect the pharmacokinetic properties of the individual active substances of Eucreas.
Croatian: Izjave u nastavku odražavaju farmakokinetička svojstva pojedinih djelatnih tvari u Eucreasu.
English: Eucreas may cause a very rare, but very serious side effect called lactic acidosis, particularly if your kidneys are not working properly.
Croatian: Eucreas može uzrokovati vrlo rijetku, ali vrlo ozbiljnu nuspojavu koja se naziva laktacidoza, osobito ako Vam bubrezi ne rade ispravno.
English: If no adequate strength of Eucreas is available, individual monocomponents should be used instead of the fixed dose combination.
Croatian: Ako nije dostupna odgovarajuća jačina lijeka Eucreas, potrebno je primijeniti pojedinačne komponente zasebno umjesto fiksne kombinacije.
English: You may need more frequent blood glucose and kidney function tests, or your doctor may need to adjust the dosage of Eucreas.
Croatian: Možda ćete češće morati raditi pretrage glukoze u krvi ili testove funkcije bubrega ili će Vam liječnik trebati prilagoditi dozu lijeka Eucreas.
English: Eucreas is not a substitute for insulin in insulin-requiring patients and should not be used in patients with type 1 diabetes.
Croatian: Eucreas nije zamjena za inzulin u bolesnika koji trebaju inzulin i ne smije se primjenjivati u bolesnika sa šećernom bolešću tipa 1.
English: If you need to have major surgery you must stop taking Eucreas during and for some time after the procedure.
Croatian: Ako se morate podvrgnuti velikom kirurškom zahvatu, morate prestati uzimati lijek Eucreas tijekom i još neko vrijeme nakon zahvata.
English: Some patients have had the following side effects while taking Eucreas and insulin:
Croatian: Neki su bolesnici imali sljedeće nuspojave kada su uzimali Eucreas i inzulin:
English: The safety and efficacy of Eucreas in children and adolescents (< 18 years) have not been established.
Croatian: Sigurnost i djelotvornost Eucreasa u djece i adolescenata (<18 godina) nisu ustanovljene.
English: There have been no therapeutic clinical trials conducted with Eucreas.
Croatian: Nisu provedena terapijska klinička ispitivanja s Eucreasom.
English: There have been no formal interaction studies for Eucreas.
Croatian: Nisu provedena formalna ispitivanja interakcija za Eucreas.
English: What you need to know before you take Eucreas
Croatian: Što morate znati prije nego počnete uzimati Eucreas
English: Eucreas is not recommended for use in children and adolescents (< 18 years).
Croatian: Eucreas se ne preporučuje za primjenu u djece i adolescenata (<18 godina).
English: Stop taking Eucreas 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 Eucreas 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: 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 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: As metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking Eucreas 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 Eucreas treba redovito pratiti funkciju bubrega (vidjeti dijelove 4.4 i 5.2).
English: What Eucreas contains - The active substances are vildagliptin and metformin hydrochloride.
Croatian: Što Eucreas sadrži - Djelatne tvari su vildagliptin i metforminklorid.
English: The active substances of Eucreas, vildagliptin and metformin, belong to a group of medicines called “oral antidiabetics”.
Croatian: Djelatne tvari Eucreasa, vildagliptin i metformin pripadaju skupini lijekova koji se nazivaju „oralni antidijabetici”.
English: There are no adequate data from the use of Eucreas in pregnant women.
Croatian: Nema odgovarajućih podataka o primjeni Eucreasa u trudnica.
English: You should stop taking Eucreas and see your doctor immediately if you experience the following side effects:
Croatian: Prestanite uzimati Eucreas i odmah otiđite svom liječniku ako osjetite sljedeće nuspojave:
English: Adults with normal renal function (GFR ≥ 90 ml/min) The dose of antihyperglycaemic therapy with Eucreas 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 Eucrasom mora biti individualizirana prema bolesnikovom postojećem režimu, učinkovitosti i podnošljivosti, ne prelazeći pritom najvišu preporučenu dnevnu dozu od 100 mg vildagliptina.
English: Following withdrawal of treatment with Eucreas and LFT normalisation, treatment with Eucreas should not be re-initiated.
Croatian: Nakon prekida liječenja sa Eucreasom i normalizacije testova jetrene funkcije, liječenje sa Eucreasom se ne smije ponovno započeti.
English: However, bioequivalence of Eucreas with co-administered vildagliptin and metformin has been demonstrated (see section 5.2).
Croatian: Međutim, bioekvivalencija Eucreasa s istodobno primijenjenim vildagliptinom i metforminom je dokazana (vidjeti dio 5.2).
English: The rate and extent of absorption of metformin from Eucreas 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 Eucreasa 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: No studies on the effect on human fertility have been conducted for Eucreas (see section 5.3).
Croatian: Nisu provedena nikakva ispitivanja o učinku Eucreasa na plodnost u ljudi (vidjeti dio 5.3).
English: Talk to your doctor, pharmacist or nurse before taking Eucreas if you are taking an anti-diabetic medicine known as a sulphonylurea.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Eucreas ako uzimate antidijabetički lijek iz skupine sulfonilureja.
English: Taking Eucreas with or just after food may reduce gastrointestinal symptoms associated with metformin (see also section 5.2).
Croatian: Uzimanje Eucreasa uz obrok ili neposredno nakon njega može ublažiti gastrointestinalne simptome povezane s metforminom (vidjeti dio 5.2).
English: • Lactic acidosis (very rare: may affect up to 1 user in 10,000): Eucreas 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): Eucreas može uzrokovati vrlo rijetku, ali vrlo ozbiljnu nuspojavu koja se naziva laktacidoza (vidjeti dio “Upozorenja i mjere opreza”).
English: Patients who develop jaundice or other signs suggestive of liver dysfunction should discontinue Eucreas.
Croatian: U bolesnika koji razviju žuticu ili druge znakove koji upućuju na poremećaj jetrene funkcije treba prekinuti liječenje Eucreasom.
English: Due to both the potential risk of neonate hypoglycaemia related to metformin and the lack of human data with vildagliptin, Eucreas 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, Eucreas se ne smije primjenjivati tijekom dojenja (vidjeti dio 4.3).
English: Should an increase in AST or in ALT of 3x ULN or greater persist, withdrawal of Eucreas therapy is recommended.
Croatian: Potraju li povišene vrijednosti AST-a ili ALT-a na razini od 3x GGN ili većoj, preporučuje se prekinuti terapiju Eucreasom.
English: Some patients have experienced the following side effects while taking Eucreas and a sulphonylurea: • Common: dizziness, tremor, weakness, low blood glucose, excessive sweating.
Croatian: Neki su bolesnici imali sljedeće nuspojave kada su uzimali Eucreas i sulfonilureju: • često: omaglica, tremor, slabost, niska razina glukoze u krvi, pojačano znojenje.
English: Stop taking Eucreas 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 Eucreas i odmah se obratite liječniku ili otiđite u najbližu bolnicu ako osjetite neke od simptoma laktacidoze, jer to stanje može dovesti do kome.
English: If you stop taking Eucreas
Croatian: Ako prestanete uzimati Eucreas
English: How Eucreas works
Croatian: Kako Eucreas djeluje
English: If this happens you must stop taking Eucreas 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 Eucreas i odmah se obratiti liječniku ili otići u najbližu bolnicu, jer laktacidoza može dovesti do kome.
English: If you forget to take Eucreas
Croatian: Ako ste zaboravili uzeti Eucreas
English: - For patients switching from co-administration of vildagliptin and metformin as separate tablets: Eucreas 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: Eucreas je potrebno započeti u dosadašnjim dozama vildagliptina i metformina.
English: When Eucreas is used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be considered to reduce the risk of hypoglycaemia.
Croatian: Kad se Eucreas primjenjuje u kombinaciji sa sulfonilurejom, može se razmotriti niža doza sulfonilureje kako bi se smanjio rizik od hipoglikemije.
English: Driving and using machines If you feel dizzy while taking Eucreas, do not drive or use any tools or machines.
Croatian: Ako osjećate omaglicu dok uzimate Eucreas, nemojte upravljati vozilima niti raditi s alatima ili strojevima.
English: Eucreas 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: Eucreas 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: 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/metformin 50 mg/1000 mg twice daily reduced HbA1c by -1.82% ,vildagliptin/metformin 50 mg/500 mg twice daily by -1.61%, metformin 1000 mg twice daily by -1.36% and vildagliptin 50 mg twice daily by -1.09% from a mean baseline HbA1c of 8.6%.
Croatian: Kombinacija vildagliptin/metformin u dozi od 50 mg/1000 mg dva puta na dan snizila je HbA1c za -1,82%, kombinacija vildagliptin/metformin u dozi od 50 mg/500 mg dva puta na dan za -1,61%, metformin 1000 mg dva puta na dan za -1,36%, a vildagliptin 50 mg dva puta na dan za -1,09% od početne srednje vrijednosti HbA1c od 8,6%.
English: Therefore, you should not receive Eucreas for the treatment of type 1 diabetes.
Croatian: Stoga ne smijete uzimati Eucreas za liječenje šećerne bolesti tipa
English: If necessary, the dosage of Eucreas may need to be adjusted during concomitant therapy and on its discontinuation.
Croatian: Ako je potrebno, dozu Eucreasa treba prilagoditi za vrijeme istodobne primjene te nakon njenog završetka.
English: Children and adolescents The use of Eucreas in children and adolescents up to 18 years of age is not recommended.
Croatian: Djeca i adolescenti Eucreas se ne preporučuje za primjenu u djece i adolescenata ispod 18 godina.
English: Liver function should be monitored during treatment with Eucreas at three-month intervals during the first year and periodically thereafter.
Croatian: Jetrenu funkciju treba pratiti tijekom liječenja Eucreasom u razmacima od tri mjeseca tijekom prve godine liječenja te povremeno nakon toga.
English: Eucreas is indicated in the treatment of type 2 diabetes mellitus: - Eucreas is indicated in the treatment of adult patients who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone or who are already treated with the combination of vildagliptin and metformin as separate tablets.
Croatian: Eucreas je indiciran u liječenju šećerne bolesti tipa 2: - Eucreas je indiciran u liječenju odraslih bolesnika u kojih se ne može postići zadovoljavajuća kontrola glikemije primjenom oralnog metformina u maksimalno podnošljivoj dozi ili u bolesnika koji se već liječe kombinacijom odvojenih tableta vildagliptina i metformina.
English: Eucreas combines two antihyperglycaemic agents with complimentary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: vildagliptin, a member of the islet enhancer class, and metformin hydrochloride, a member of the biguanide class.
Croatian: Eucreas sadrži kombinaciju dviju antihiperglikemijskih tvari s komplementarnim mehanizmima djelovanja za poboljšanje kontrole glikemije u bolesnika sa šećernom bolešću tipa 2: vildagliptin, pripadnik skupine stimulatora Langerhansovih otočića gušterače i metforminklorid, pripadnik skupine bigvanida.
English: - For patients inadequately controlled on dual combination therapy with insulin and the maximal tolerated dose of metformin:
Croatian: U bolesnika u kojih nije postignuta zadovoljavajuća kontrola dvojnom kombiniranom terapijom inzulinom i najvišom podnošljivom dozom metformina:
English: In particular, if you are following a diabetic weight control diet, continue with this while you are taking Eucreas.
Croatian: Ako se trebate pridržavati dijabetičke dijete za kontrolu tjelesne težine, onda svakako nastavite s njom i za vrijeme uzimanja Eucreasa.