FrancophonIA/ELRC3.0 huggingface dataset:
English: Each pre-filled syringe contains 75 mg of risankizumab in 0.83 ml solution.
Croatian: Jedna napunjena štrcaljka sadrži 75 mg risankizumaba u 0,83 ml otopine.
English: The solution should be colourless to slightly yellow and clear to slightly opalescent.
Croatian: Otopina mora biti bezbojna do svjetložuta te bistra do blago opalescentna.
English: PASI Percent Change from Baseline
Croatian: Postotna promjena PASI rezultata od početne vrijednosti
English: • Do not use if the liquid is cloudy or contains flakes or large particles
Croatian: • Nemojte primijeniti lijek ako je tekućina mutna ili ako sadrži pahuljice ili velike čestice.
English: st dose Further doses 150 mg (two 75 mg injections) Every 12 weeks starting after 2
Croatian: Daljnje doze 150 mg (dvije injekcije od 75 mg)
English: The solution is colourless to slightly yellow and clear to slightly opalescent.
Croatian: Otopina je bezbojna do svjetložuta te bistra do blago opalescentna.
English: - The active substance is risankizumab.
Croatian: - Djelatna tvar je risankizumab.
English: Disodium succinate hexahydrate Succinic acid
Croatian: 6.1 Popis pomoćnih tvari dinatrijev sukcinat heksahidrat sukcinatna kiselina sorbitol polisorbat 20 voda za injekcije
English: Tel: +48 22 372 78 00
Croatian: AbbVie Polska Sp. z o.o. Tel: +48 22 372 78 00
English: Drug interactions
Croatian: Interakcije s drugim lijekovima
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, applicants / marketing authorisation holders in the Member States
Croatian: Popis s imenima, farmaceutskim oblicima, jačinama lijekova, putovima primjene, podnositeljima zahtjeva / nositeljima odobrenja u državama članicama.
English: • Risk Management plan (RMP)
Croatian: Plan upravljanja rizikom (RMP)
English: You should continue to take Vimpat until your doctor tells you to stop.
Croatian: Vimpat morate nastaviti uzimati sve dok Vam liječnik ne odredi da prestanete.
English: Vimpat may be used on its own or with other antiepileptic medicines.
Croatian: • Vimpat se može koristiti samostalno ili s drugim antiepileptičkim lijekovima.
English: Vimpat is used as a long term treatment.
Croatian: Vimpat se koristi za dugotrajno liječenje.
English: The bottle containing Vimpat syrup should be shaken well before use.
Croatian: Boca koja sadrži Vimpat sirup mora se dobro protresti prije uporabe.
English: Other medicines and Vimpat
Croatian: Drugi lijekovi i Vimpat
English: If you take more Vimpat than you should
Croatian: Ako uzmete više Vimpata nego što ste trebali
English: This pack (treatment initiation pack) is used when you start your treatment with Vimpat.
Croatian: Ovo pakiranje (pakiranje za početak liječenja) se koristi kada započinjete Vaše liječenje Vimpatom.
English: What Vimpat looks like and contents of the pack
Croatian: Kako Vimpat izgleda i sadržaj pakiranja
English: Date of first authorisation: 29 August 2008 Date of latest renewal: 31 July 2013
Croatian: Datum prvog odobrenja: 29. kolovoza 2008.
English: It may harm them, even if their signs of illness are the same as yours.
Croatian: Ako se bilo koja od gornjih tvrdnji odnosi na Vas (ili niste sigurni u to), obratite se svom liječniku ili ljekarniku prije nego uzmete Vimpat.
English: Not known: frequency cannot be estimated from available data
Croatian: Nepoznato: učestalost se ne može procijeniti iz dostupnih podataka
English: Each package contains a different dosage strength of Vimpat, so you will increase your dose gradually.
Croatian: Svako pakiranje sadrži drugu jačinu doze Vimpata, tako da ćete Vašu dozu postupno povećavati.
English: For longer term treatment Vimpat tablets and syrup are available.
Croatian: Za dugotrajnije liječenje dostupne su Vimpat tablete i sirup.
English: If you have taken more Vimpat than you should, contact your doctor immediately.
Croatian: Ako ste uzeli više Vimpata nego što ste smjeli, odmah se obratite liječniku.
English: Each vial of Vimpat solution for infusion must be used only once (single use).
Croatian: Vimpat otopine za infuziju smije se upotrijebiti samo jednom (jednokratna uporaba).
English: Vimpat treatment initiation pack contains 4 different packages (one for each tablet strength) with 14 tablets each, for the first 2 to 4 weeks of therapy depending on the patient's response and tolerability.
Croatian: Vimpat pakiranje za početak liječenja sadrži 4 različita pakiranja (jedno za svaku jačinu tablete), svako s 14 tableta, za prva 2 do 4 tjedna terapije ovisno o odgovoru i podnošljivosti bolesnika.
English: Do not drive, cycle or use any tools or machines until you know how this medicine affects you.
Croatian: Nemojte voziti automobil ili bicikl, niti koristiti alate ili strojeve dok ne znate kako ovaj lijek utječe na
English: Syrup.
Croatian: Sirup.
English: The safety and efficacy of lacosamide in children aged below 4 years have not yet been established.
Croatian: Sigurnost i djelotvornost lakozamida u djece mlađe od 4 godina nisu još ustanovljene.
English: Follow these steps each time you take Vimpat:
Croatian: Slijedite ove korake pri svakoj uporabi Vimpata:
English: Swallow the Vimpat tablet with a glass of water.
Croatian: • Progutajte tabletu Vimpata uz čašu vode.
English: This dose is called a maintenance dose and will depend on how you respond to Vimpat.
Croatian: Ta doza naziva se dozom održavanja i ovisit će o Vašem odgovoru na Vimpat.
English: It should be administered under medical supervision with consideration of the potential for increased incidence of serious cardiac arrhythmia and central nervous system adverse reactions (see section 4.8).
Croatian: Treba je primijeniti pod liječničkim nadzorom, uzimajući u obzir potencijal za povećanu incidenciju ozbiljne srčane aritmije i nuspojava središnjeg živčanog sustava (vidjeti dio 4.8).
English: • Convulsion.
Croatian: • Konvulzije.
English: Do not use Vimpat if any of the above applies to you.
Croatian: Nemojte upotrebljavati Vimpat ako se na Vas odnosi bilo koja od gornjih tvrdnji.
English: Vimpat syrup contains aspartame (E951), a source of phenylalanine, which may be harmful for people with phenylketonuria.
Croatian: Vimpat sirup sadrži aspartam (E951), izvor fenilalanina, koji može biti štetan u osoba s fenilketonurijom.
English: Do not stop taking Vimpat without talking to your doctor, as your epilepsy may come back again or become worse.
Croatian: Vimpata bez savjetovanja s liječnikom jer bi se epilepsija mogla ponovno pojaviti ili pogoršati.
English: When you take Vimpat with other antiepileptic medicines - Start of the treatment (the first 4 weeks)
Croatian: Kad uzimate Vimpat s drugim antepileptičkim lijekovima Početak liječenja (prva 4 tjedna)
English: Follow these steps the first time you take Vimpat:
Croatian: Slijedite ove korake pri prvoj uporabi Vimpata:
English: Taking Vimpat on its own - This is for information only.
Croatian: Kada se uzima samo Vimpat- ovo je samo informativno.
English: Vimpat solution for infusion is available in packages of 1 vial and 5 vials.
Croatian: Vimpat otopina za infuziju je dostupna u pakiranjima od 1 bočice i 5 bočica.
English: This is because Vimpat may make you feel dizzy or cause blurred vision.
Croatian: Vas jer Vimpat može uzrokovati omaglicu ili zamućen vid.
English: Vimpat is available in a bottle of 200 ml.
Croatian: • Vimpat je dostupan u bocama od 200 ml.
English: Vimpat may make you dizzy - this could increase the risk of accidental injury or a fall.
Croatian: Vimpat može kod Vas izazvati omaglicu - to može povećati rizik od slučajne ozljede ili pada.
English: As a safety precaution do not take Vimpat with alcohol.
Croatian: Vimpat s alkoholom Kao sigurnosnu mjeru opreza ne uzimajte Vimpat s alkoholom.
English: Lacosamide syrup must be taken orally.
Croatian: Način primjene Lakozamid sirup se mora uzeti oralno.
English: It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
Croatian: Može Vam naškoditi ako bolujete od fenilketonurije, rijetkog genetskog poremećaja kod kojeg dolazi do nakupljanja fenilalanina jer ga tijelo ne može ukloniti na odgovarajući način.
English: You will start your treatment with a low dose of Vimpat, usually 50 mg twice a day, and increase it week by week.
Croatian: Vaše liječenje ćete započeti niskom dozom Vimpata, obično 50 mg dvaput na dan, i povećavati je iz tjedna u tjedan.
English: It is not recommended to take Vimpat if you are pregnant or breast-feeding, as the effects of Vimpat on pregnancy and the unborn baby or the new-born child are not known.
Croatian: Ne preporučuje se uzimanje Vimpata ako ste trudni ili dojite jer nisu poznati učinci Vimpata na trudnoću i na plod ili novorođenče.
English: Vimpat is available in packs of 14, 28, 56, 60, 14 x 1 and 56 x 1 film-coated tablets.
Croatian: Vimpat je dostupan u pakiranjima od 14, 28, 56, 60, 14 x 1 i 56 x 1 filmom obloženih tableta.
English: Vimpat can be started by: - taking the medicine by mouth or - by being given as an intravenous infusion (sometimes called an “IV infusion”) where the medicine is given into your vein by a doctor or nurse.
Croatian: • Primjenu Vimpata moguće je započeti: uzimanjem lijeka kroz usta ili davanjem lijeka u obliku intravenske infuzije (koja se ponekad naziva „i.v. infuzija“), pri čemu Vam lijek u venu primjenjuje liječnik ili medicinska sestra / medicinski tehničar.
English: Do not take Vimpat if any of the above applies to you.
Croatian: Nemojte uzimati Vimpat ako se na Vas odnosi bilo koja od gornjih tvrdnji.
English: Vimpat syrup contains sorbitol (E420).
Croatian: Vimpat sirup sadrži sorbitol (E420).
English: Outer carton - treatment initiation pack containing 4 cartons of 14 film-coated tablets
Croatian: LIJEČENJA Vanjska kutija - pakiranje za početak liječenja koje sadrži 4 kutije s 14 filmom obloženih tableta
English: UCB Magyarország Kft. Tel.: + 36-(1) 391 0060
Croatian: Magyarország UCB Magyarország Kft. Tel.: + 36-(1) 391 0060
English: There is experience with twice daily infusions of Vimpat for up to 5 days.
Croatian: Postoji iskustvo s infuzijom Vimpata dvaput na dan do 5 dana.
English: Vimpat 10 mg/ml solution for infusion is an alternative for patients when oral administration is temporarily not feasible.
Croatian: Vimpat 10 mg/ml otopina za infuziju alternativa je za bolesnike u kojih peroralna primjena privremeno nije moguća.
English: (3) Reported in open-label studies.
Croatian: Prijavljeno u otvorenim ispitivanjima.
English: This medicine contains 59.8 mg sodium (main component of cooking/table salt) in each vial.
Croatian: Ovaj lijek sadrži 59,8 mg natrija (glavni sastojak kuhinjske soli) u jednoj bočici.
English: Vimpat tablets and syrup are bioequivalent.
Croatian: Vimpat tablete i sirup su bioekvivalentni.
English: What Vimpat is and what it is used for What you need to know before you take Vimpat How to take Vimpat
Croatian: Što je Vimpat i za što se koristi Što morate znati prije nego počnete uzimati Vimpat Kako uzimati Vimpat
English: Drug reaction with eosinophilia and systemic symptoms (DRESS) (1,2)
Croatian: Reakcija na lijek s eozinofilijom i sustavnim simptomima (DRESS)
English: Vimpat tablets and oral syrup are bioequivalent.
Croatian: Vimpat tablete i oralni sirup su bioekvivalentni.
English: Depending on response and tolerability, Vimpat 150 mg tablets may be taken twice a day during the third week and Vimpat 200 mg tablets twice a day during the fourth week.
Croatian: Ovisno o odgovoru i podnošljivosti, Vimpat tablete od 150 mg mogu se uzimati dvaput na dan tijekom trećeg tjedna i Vimpat tablete od 200 mg dvaput na dan tijekom četvrtog tjedna.
English: Vimpat is used in adults, adolescents and children aged 4 years and older.
Croatian: • Vimpat se koristi u odraslih, adolescenata i djece od navršenih 4 godine života.
English: This is equivalent to 0.07 % of the recommended maximum daily dietary intake of sodium for an adult.
Croatian: To odgovara 0,07% preporučenog maksimalnog dnevnog unosa soli za odraslu osobu.
English: Contains sodium chloride, hydrochloric acid, water for injections.
Croatian: Sadrži natrijev klorid, kloridnu kiselinu, vodu za injekcije.
English: Sorbitol may cause gastrointestinal discomfort and mild laxative effect.
Croatian: Sorbitol može uzrokovati gastrointestinalnu nelagodu te može imati blagi laksativni učinak.
English: Name and address of the manufacturer responsible for batch release Aesica Pharmaceuticals GmbH or
Croatian: PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet Aesica Pharmaceuticals GmbH ili
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients water for injections sodium chloride hydrochloric acid (for pH adjustment)
Croatian: 6.1 Popis pomoćnih tvari voda za injekcije natrijev klorid kloridna kiselina (za podešavanje pH)
English: Vimpat 10 mg/ml syrup is a slightly viscous clear, colourless to yellow-brown liquid.
Croatian: • Vimpat 10 mg/ml sirup je blago viskozna, bistra, bezbojna do žutosmeđa tekućina.
English: Stevens-Johnson syndrome(1) Toxic epidermal necrolysis(1)
Croatian: StevensJohnsonov sindrom Toksična epidermalna nekroliza(1)
English: This is equivalent to 3 % of the recommended maximum daily dietary intake of sodium for an adult.
Croatian: To odgovara 3% preporučenog maksimalnog dnevnog unosa soli za odraslu osobu.
English: Vimpat syrup contains 1.42 mg sodium per ml, equivalent to 0.07 % of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Croatian: Vimpat sirup sadrži 1,42 mg natrija po 1 ml, što odgovara 0,07% doze od 2 grama natrija koju Svjetska zdravstvena organizacija preporučuje kao najviši dnevni unos za odrasle osobe.
English: What Vimpat is used for
Croatian: Za što se Vimpat koristi
English: Vimpat contains sorbitol, sodium, sodium methyl parahydroxybenzoate, aspartame and propylene glycol
Croatian: Vimpat sadrži sorbitol, natrij, natrijev metilparahidroksibenzoat, aspartam i propilenglikol
English: Rapid and uncontrollable movements of the eyes (nystagmus), blurred vision; A spinning sensation (vertigo), feeling drunk;
Croatian: • brzi i nekontrolirani pokreti očiju (nistagmus), zamućen vid;
English: (4) Local adverse reactions associated with intravenous administration.
Croatian: Lokalne nuspojave povezane s intravenskom primjenom.
English: Sodium (salt): This medicine contains 1.42 mg sodium (main component of cooking/table salt) in each ml.
Croatian: • natrij (sol): Ovaj lijek sadrži 1,42 mg natrija (glavni sastojak kuhinjske soli) u jednom ml.
English: Take Vimpat twice each day - once in the morning and once in the evening.
Croatian: • Primjenjujte Vimpat dvaput na dan - jednom ujutro i jednom navečer.
English: During the second week, the patient takes Vimpat 100 mg tablets twice a day.
Croatian: Tijekom drugog tjedna bolesnik uzima Vimpat tabletu 100 mg dvaput na dan.
English: (2) See Description of selected adverse reactions.
Croatian: Vidjeti Opis izdvojenih nuspojava.
English: What Vimpat is and what it is used for What Vimpat is
Croatian: Što je Vimpat i za što se koristi
English: Elevations of ALT to ≥ 3x ULN occurred in 0.7 % (7/935) of Vimpat patients and 0 % (0/356) of placebo patients.
Croatian: Povišene vrijednosti ALT-a do ≥ 3 x od gornje granice normale (GGN) zabilježene su u 0,7 % (7/935) bolesnika koji su uzimali Vimpat i u 0 % (0/356) bolesnika koji su uzimali placebo.
English: Bradycardia(1,2) Atrial Fibrillation
Croatian: Bradikardija(1,2) Fibrilacija atrija Undulacija atrija
English: If you forget to take Vimpat
Croatian: Ako ste zaboravili uzeti Vimpat
English: Listed below are the normal recommended doses of Vimpat for different age groups and weights.
Croatian: U nastavku su navedene uobičajene preporučene doze Vimpata za različite dobne skupine i tjelesne težine.
English: The adjusted absolute difference between treatments was -1.3 % (95 % CI: -5.5, 2.8).
Croatian: Prilagođena apsolutna razlika između liječenja bila je -1,3 % (95 % CI:5,5, 2,8).
English: The carton boxes of Vimpat syrup contain a 30 ml measuring cup with graduation marks and a 10 ml oral syringe.
Croatian: Kartonske kutije Vimpat sirupa sadrže mjernu čašu od 30 ml s odmjernim oznakama i štrcaljku za usta od 10 ml.
English: If your doctor decides to stop your treatment with Vimpat, they will tell you how to decrease the dose step by step.
Croatian: • Ako liječnik odluči prekinuti Vaše liječenje Vimpatom, dat će Vam upute kako postupno smanjivati dozu.
English: Aesica Pharmaceuticals GmbH, Alfred-Nobel Strasse 10, D-40789 Monheim am Rhein, Germany or
Croatian: Aesica Pharmaceuticals GmbH, Alfred-Nobel Strasse 10, D-40789 Monheim am Rhein, Njemačka ili
English: The safety profile of lacosamide in placebo-controlled (see study details in section 5.1) and in openlabel studies (n=408) in adjunctive therapy in children from 4 years of age was consistent with the safety profile observed in adults although the frequency of some adverse reactions (somnolence, vomiting and convulsion) was increased and additional adverse reactions (nasopharyngitis, pyrexia, pharyngitis, decreased appetite, lethargy and abnormal behaviour) have been reported in paediatric patients: nasopharyngitis (15.7 %), vomiting (14.7 %), somnolence (14.0 %), dizziness (13.5 %), pyrexia (13.0 %), convulsion (7.8 %), decreased appetite (5.9 %), pharyngitis (4.7 %), lethargy (2.7 %) and abnormal behaviour (1.7 %).
Croatian: Sigurnosni profil lakozamida u placebom kontroliranim (vidjeti pojedinosti o ispitivanju u dijelu 5.1) i otvorenim ispitivanjima (n=408) u dodatnoj terapiji u djece u dobi od navršene 4 godine starosti podudarao se sa sigurnosnim profilom zabilježenim u odraslih iako je učestalost nekih nuspojava (somnolencija, povraćanje i konvulzije) bila povećana i prijavljene su dodatne nuspojave (nazofaringitis, pireksija, faringitis, smanjenje teka, letargija i abnormalno ponašanje) u pedijatrijskih bolesnika: nazofaringitis (15,7 %), povraćanje (14,7 %), somnolencija (14,0 %), omaglica (13,5 %), pireksija (13,0 %), konvulzije (7,8 %), oslabljen apetit (5,9 %), faringitis (4,7 %), letargija (2,7 %) i abnormalno ponašanje (1,7 %).
English: They will help you decide if you should take Vimpat or not.
Croatian: Liječnik će Vam pomoći u donošenju odluke trebate li uzimati Vimpat ili ne.
English: The treatment initiation pack contains 4 cartons, each carton with 14 Vimpat film-coated tablets of 50 mg, 100 mg, 150 mg and 200 mg.
Croatian: Pakiranje za početak liječenja sadrži 4 kutije, svaka kutija s 14 filmom obloženih tableta od Vimpat 50 mg, 100 mg, 150 mg i 200 mg.
English: UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium.
Croatian: 0 UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgija ili
English: Vimpat solution for infusion was found to be physically compatible and chemically stable when mixed with the following diluents for at least 24 hours and stored in glass or PVC bags at temperatures up to 25°C.
Croatian: Za Vimpat otopinu za infuziju se pokazalo da je fizikalno kompatibilna i kemijski stabilna kada se miješa sa sljedećim otopinama za razrjeđivanje kroz barem 24 sata i kada se čuva u staklu ili PVC vrećama na temperaturama do 25°C.
English: If your doctor decides to stop your treatment with Vimpat, they will decrease the dose step by step.
Croatian: Ako liječnik odluči prekinuti Vaše liječenje Vimpatom, dozu će smanjiti postupno.
English: Use the oral syringe and the adaptor provided in this pack.
Croatian: • Koristite štrcaljku za usta i nastavak isporučene u ovom pakiranju.
English: Aspartame (E951): This medicine contains 0.032 mg aspartame in each ml.
Croatian: • aspartam (E951): Ovaj lijek sadrži 0,032 aspartama u jednom ml. Aspartam je izvor fenilalanina.
English: 1 x 20 ml solution for infusion 200 mg/20 ml
Croatian: 1x20 ml otopina za infuziju 200 mg/20 ml
English: Propylene glycol (E1520): This medicine contains 2.14 mg propylene glycol in each ml.
Croatian: • Propilenglikol (E1520): Ovaj lijek sadrži 2,14 mg propilenglikola u jednom ml.
English: Each ml of Vimpat syrup contains 187 mg sorbitol (E420), 2.60 mg sodium methyl parahydroxybenzoate (E219), 2.14 mg propylene glycol (E1520), 1.42 mg sodium, and 0.032 mg aspartame (E951).
Croatian: Jedan ml Vimpat sirupa sadrži 187 mg sorbitola (E420), 2,60 mg natrijeva metilparahidroksibenzoata (E219), 2,14 mg propilenglikola (E1520), 1,42 mg natrija i 0,032 mg aspartama (E951).
English: If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.
Croatian: Vam je dijagnosticirano nasljedno nepodnošenje fruktoze, rijetki nasljedni poremećaj kod kojeg bolesnik ne može razgraditi fruktozu, obratite se liječniku prije nego Vi (ili Vaše dijete) uzmete (uzme) ili primite (primi) ovaj lijek.
English: No second- or higher degree AV Block was seen in these studies.
Croatian: U tim ispitivanjima nije zabilježena pojava AVbloka drugog ili višeg stupnja.
English: Vimpat is indicated as monotherapy and adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 4 years of age with epilepsy.
Croatian: Vimpat je indiciran kao monoterapija i dodatna terapija u liječenju parcijalnih napadaja sa sekundarnom generalizacijom ili bez nje u odraslih, adolescenata i djece od navršenih 4 godine života s epilepsijom.
English: Vimpat syrup contains propylene glycol (E1520).
Croatian: Vimpat sirup sadrži propilenglikol (E1520).
English: If you stop taking Vimpat
Croatian: Ako prestanete uzimati Vimpat
English: This medicinal product contains 59.8 mg sodium per vial, equivalent to 3% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Croatian: Lijek sadrži 59,8 mg natrija po bočici, što odgovara 3% doze od 2 grama natrija koju Svjetska zdravstvena organizacija preporučuje kao najviši dnevni unos za odrasle osobe.
English: Treatment initiation pack (in adolescent and children weighing 50 kg or more and adults only) Vimpat 50 mg film-coated tablets
Croatian: Pakiranje za početak liječenja (samo za adolescente i djecu tjelesne težine veće od 50 kg, te odrasle) Vimpat 50 mg filmom obložene tablete
English: Put the oral syringe into the adaptor opening (figure 4).
Croatian: • Postavite štrcaljku za usta u otvor nastavka (slika 4).
English: They will help you decide if you should use Vimpat or not.
Croatian: Liječnik će Vam pomoći u donošenju odluketrebate li upotrebljavati Vimpat ili ne.
English: Vimpat syrup contains sodium methyl parahydroxybenzoate (E219), which may cause allergic reactions (possibly delayed).
Croatian: Pomoćne tvari koje mogu uzrokovati nepodnošenje Vimpat sirup sadrži natrijev metilparahidroksibenzoat (E219) koji može uzrokovati alergijske reakcije (moguće i odgođene).
English: If you are taking Vimpat and you are experiencing symptoms of abnormal heartbeat (such as slow, rapid or irregular heartbeat, palpitations, shortness of breath, feeling lightheaded, fainting), seek medical advice immediately (see section 4).
Croatian: Ako tijekom uzimanja Vimpata primijetite simptome poremećaja otkucaja srca (kao što su usporeni, ubrzani ili nepravilni otkucaji srca, osjećaj lupanja srca, nedostatak zraka, osjećaj ošamućenosti, nesvjestica), odmah potražite liječničku pomoć (pogledajte dio 4).
English: You may take Vimpat with or without food.
Croatian: Lakozamid se može uzeti sa ili bez hrane.
English: Packs of 60 film-coated tablets in HDPE bottle with a child-resistant closure.
Croatian: Pakiranje od 60 filmom obloženih tableta u HDPE boci sa zatvaračem sigurnim za djecu.
English: Instructions for use: measuring cup Adolescents and children weighing 50 kg or more and adults
Croatian: Upute za uporabu: mjerna čaša Adolescenti i djeca tjelesne težine 50 kg ili više i odrasli