FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/00/146/006 10 tablets EU/1/00/146/007 20 tablets EU/1/00/146/008 30 tablets EU/1/00/146/009 50 tablets EU/1/00/146/010 60 tablets EU/1/00/146/011 100 tablets EU/1/00/146/012 120 tablets EU/1/00/146/013 200 tablets (2 packs of 100) EU/1/00/146/035 100 x 1 tablets
Croatian: EU/1/00/146/006 10 tableta EU/1/00/146/007 20 tableta EU/1/00/146/008 30 tableta EU/1/00/146/009 50 tableta EU/1/00/146/010 60 tableta EU/1/00/146/011 100 tableta EU/1/00/146/012 120 tableta EU/1/00/146/013 200 tableta (2 pakiranja od 100) EU/1/00/146/035 100 x 1 tableta
English: Clear, colourless, liquid.
Croatian: Bistra, bezbojna tekućina.
English: The 150 ml glass bottle of Keppra (for infants and young children aged from 6 months to less than 4 years) is packed in a cardboard box containing a 3 ml oral syringe (graduated every 0.1 ml) and an adaptor for the syringe.
Croatian: Staklena boca od 150 ml Keppre (za dojenčad i malu djecu u dobi od 6 mjeseci do manje od 4 godine) pakirana je u kartonsku kutiju koja još sadrži štrcaljku za usta od 3 ml (s oznakom na svakih 0,1 ml) i nastavak za štrcaljku.
English: NextPharma SAS
Croatian: Oralna otopina NextPharma SAS
English: anger, confusion, panic attack, emotional instability/mood swings, agitation;
Croatian: halucinacije, srditost, smetenost, napadaj panike, emocionalna nestabilnost/promjene raspoloženja, uznemirenost;
English: Do not use this medicine after the expiry date stated on the carton box and blister after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake „Rok valjanosti“ ili „EXP:“.
English: Keppra 750 mg film-coated tablets are orange, 18 mm oblong, scored and debossed with the code “ucb” and “750” on one side.
Croatian: Keppra 750 mg filmom obložene tablete su narančaste, duguljaste, od 18 mm s razdjelnom crtom i utisnutim oznakama „ucb“ i „750“ na jednoj strani.
English: With continued long-term treatment, 28.6 % of the patients were free of myoclonic seizures for at least 6 months and 21.0 % were free of myoclonic seizures for at least 1 year.
Croatian: S nastavkom dugotrajnog liječenja 28,6% bolesnika bilo je barem 6 mjeseci i 21,0% barem 1. godinu bez miokloničkih napadaja.
English: Keppra 1000 mg film-coated tablets are white, 19 mm oblong, scored and debossed with the code “ucb” and“1000” on one side.
Croatian: Keppra 1000 mg filmom obložene tablete su bijele, duguljaste, od 19 mm s razdjelnom crtom i utisnutim oznakama „ucb” i „1000“ na jednoj strani.
English: A 750 mg loading dose is recommended on the first day of treatment with levetiracetam.
Croatian: (1) Prvog dana liječenja levetiracetamom preporučuje se udarna doza od 750 mg.
English: Polyvinyl alcohol-part. hydrolyzed Titanium dioxide (E171) Macrogol 3350
Croatian: Film ovojnica polivinilni alkohol, djelomično hidroliziran titanijev dioksid (E171) makrogol 3350 talk
English: 150 ml oral solution
Croatian: OBLIK I SADRŽAJ 150 ml oralna otopina
English: If levetiracetam has to be discontinued it is recommended to withdraw it gradually (e.g. in adults and adolescents weighing more than 50 kg: 500 mg decreases twice daily every two to four weeks; in infants older than 6 months, children and adolescents weighting less than 50 kg: dose decrease should not exceed 10 mg/kg twice daily every two weeks; in infants (less than 6 months): dose decrease should not exceed 7 mg/ kg twice daily every two weeks).
Croatian: Ako treba prekinuti liječenje levetiracetamom, preporučuje se postupni prekid (npr. u odraslih i adolescenata tjelesne težine veće od 50 kg: smanjenje za 500 mg dva puta na dan svaka dva do četiri tjedna; u dojenčadi starije od 6 mjeseci, djece i adolescenata tjelesne težine manje od 50 kg: smanjenje doze ne smije biti veće od 10 mg/kg dva puta na dan svaka dva tjedna; u dojenčadi (mlađe od 6 mjeseci): smanjenje doze ne smije biti veće od 7 mg/kg dva puta dnevno svaka dva tjedna).
English: One tablet of Keppra 500 mg contains 500 mg of levetiracetam.
Croatian: Jedna tableta Keppre 500 mg sadrži 500 mg levetiracetama.
English: The administration of levetiracetam to patients with renal impairment may require dose adjustment.
Croatian: U bolesnika s oštećenjem bubrega može biti potrebno prilagođavanje dozelevetiracetama.
English: Children and adolescents • Keppra is not indicated in children and adolescents below 16 years on it's own (monotherapy)
Croatian: • U djece i adolescenata mlađih od 16 godina Keppra se ne primjenjuje samostalno
English: If levetiracetam has to be discontinued it is recommended to withdraw it gradually (e.g. in adults and adolescents weighing more than 50 kg: 500 mg decreases twice daily every two to four weeks; in infants older than 6 months, children and adolescents weighting less than 50 kg: dose decrease should not exceed 10 mg/kg twice daily every two weeks; in infants (less than 6 months): dose decrease should not exceed 7 mg/kg twice daily every two weeks).
Croatian: Ako treba prekinuti liječenje levetiracetamom, preporučuje se postupni prekid (npr. u odraslih i adolescenata tjelesne težine veče od 50 kg: smanjenje za 500 mg dva puta na dan svaka dva do četiri tjedna; u dojenčadi starije od 6 mjeseci, djece i adolescenata tjelesne težine manje od 50 kg: smanjenje doze ne smije biti veće od 10 mg/kg dva puta na dan svaka dva tjedna; u dojenčadi (mlađe od 6 mjeseci): smanjenje doze ne smije biti veće od 7 mg/kg dva puta dnevno svaka dva tjedna).
English: Blue, 13mm oblong, scored and debossed with the code “ucb” and “250” on one side.
Croatian: Plava, duguljasta tableta od 13 mm s razdjelnom crtom i utisnutim oznakama „ucb” i „250“ na jednoj strani.
English: Keppra 100 mg/ml oral solution
Croatian: NAZIV LIJEKA Keppra 100 mg/ml oralna otopina
English: 300 ml oral solution
Croatian: OBLIK I SADRŽAJ 300 ml oralna otopina
English: One tablet of Keppra 250 mg contains 250 mg of levetiracetam.
Croatian: Jedna tableta Keppre 250 mg sadrži 250 mg levetiracetama.
English: CLcr (ml/min/1.73 m 2) = ---------------------------- x 1.73 BSA subject (m
Croatian: CLcr (ml/min) CLcr (ml/min/1.73 m2) = ------------------------------ x 1,73 PT bolesnika (m2)
English: One tablet of Keppra 750 mg contains 750 mg of levetiracetam.
Croatian: Jedna tableta Keppre 750 mg sadrži 750 mg levetiracetama.
English: • as an add-on to other antiepileptic medicines to treat: ▪ partial onset seizures with or without generalisation in adults, adolescents, children and infants from one month of age ▪ myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy ▪ primary generalised tonic-clonic seizures(major fits, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).
Croatian: • kao dodatna terapija uz druge antiepileptike u liječenju: ▪ parcijalnih napadaja sa sekundarnom generalizacijom ili bez nje u odraslih, adolescenata, djece i dojenčadi od prvog mjeseca života ▪ miokloničkih napadaja (kratki, iznenadni trzaji mišića ili skupine mišića) u odraslih i adolescenata starijih od 12. godine života s juvenilnom miokloničkom epilepsijom ▪ primarno generaliziranih toničko-kloničkih napadaja (veliki napadaji, uključujući gubitak svijesti) u odraslih i adolescenata starijih od 12. godine života s idiopatskom generaliziranom epilepsijom (oblik epilepsije za koji se smatra da je genetski uvjetovan).
English: EU/1/00/146/021 EU/1/00/146/022 EU/1/00/146/023 EU/1/00/146/024 EU/1/00/146/025 EU/1/00/146/026 EU/1/00/146/037
Croatian: EU/1/00/146/020 EU/1/00/146/021 EU/1/00/146/022 EU/1/00/146/023 EU/1/00/146/024 EU/1/00/146/025 EU/1/00/146/026 EU/1/00/146/037
English: White, 19 mm oblong, scored and debossed with the code “ucb” and “1000” on one side.
Croatian: Bijela, duguljasta tableta od 19 mm s razdjelnom crtom i utisnutim oznakama „ucb” i „1000“ na jednoj strani.
English: Somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma were observed with Keppra overdoses.
Croatian: Kod predoziranja Keppre primijećena je somnolencija, agitacija, agresivnost, smanjena razina svijesti, depresija disanja i koma.
English: Keppra 500 mg film-coated tablets are yellow, 16 mm oblong, scored and debossed with the code “ucb” and “500” on one side.
Croatian: Keppra 500 mg filmom obložene tablete su žute, duguljaste, od 16 mm s razdjelnom crtom i utisnutim oznakama „ucb“ i „500“ na jednoj strani.
English: Orange, 18 mm oblong, scored and debossed with the code “ucb” and “750” on one side.
Croatian: Narančasta, duguljasta tableta od 18 mm s razdjelnom crtom i utisnutim oznakama „ucb” i „750“ na jednoj strani.
English: Citric acid monohydrate Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) Ammonium glycyrrhizate Glycerol (E422)
Croatian: 6.1 Popis pomoćnih tvari natrijev citrat citratna kiselina hidrat metilparahidroksibenzoat (E218) propilparahidroksibenzoat (E216) amonijev glicirizat glicerol (E422) maltitol, tekući (E965) acesulfamkalij (E950) aroma grožđa voda, pročišćena
English: Dosing adjustment for adult and adolescents patients weighing more than 50 kg with impaired renal function:
Croatian: Prilagođavanje doze za odrasle bolesnike i adolescente tjelesne težine veće od 50 kg s oštećenom bubrežnom funkcijom:
English: Children 25 kg or less should preferably start the treatment with Keppra 100 mg/ml oral solution.
Croatian: 1500 mg dva puta na dan (1) U djece od 25 kg ili manje liječenje je najbolje započeti Keppra 100 mg/ml oralnom otopinom.
English: Yellow, 16 mm oblong, scored and debossed with the code “ucb” and “500” on one side.
Croatian: Žuta, duguljasta tableta od 16 mm s razdjelnom crtom i utisnutim oznakama „ucb” i „500“ na jednoj strani.
English: Do not use this medicine after the expiry date stated on the cardboard box and bottle after EXP: The expiry date refers to the last day of the month.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i boci iza oznake „Rok valjanosti“ ili „EXP:“.
English: 7 to 14 mg/kg (0.07 to 0.14 ml/kg) once daily
Croatian: 7 do 14 mg/kg (0,07 do 0,14 ml/kg) jedanput na dan
English: The safety and efficacy of Keppra in children and adolescents below 16 years as monotherapy treatment have not been established.
Croatian: Kod monoterapije u djece i adolescenata mlađih od 16 godina sigurnost i djelotvornost Keppre nije dokazana.
English: 300 ml amber glass bottle (type III) with a white child resistant closure (polypropylene) in a cardboard box also containing a 10 ml graduated oral syringe (polypropylene, polyethylene) and an adaptor for the syringe (polyethylene).
Croatian: Smeđa staklena boca od 300 ml (staklo tip III) s bijelim sigurnosnim zatvaračem za djecu (polipropilen) u kartonskoj kutiji koja također sadrži graduiranu plastičnu štrcaljku za usta od 10 ml (polipropilen, polietilen) i nastavak za štrcaljku (polietilen).
English: Keppra 750 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Keppra 750 mg
English: Each film-coated tablet contains 1,000 mg levetiracetam.
Croatian: TVARI Jedna filmom obložena tableta sadrži 1000 mg levetiracetama.
English: Dosing adjustment for infants, children and adolescents patients weighing less than 50 kg with impaired renal function:
Croatian: Prilagođavanje doze kod dojenčadi, djece i adolescenata s manje od 50 kg tjelesne težine s oštećenom bubrežnom funkcijom:
English: Linear and dose proportional increases were observed for peak plasma concentration and area under the curve.
Croatian: Za vršne koncentracije u plazmi i površinu ispod krivulje primijećena su linearna povećanja i proporcionalna s dozom.
English: EU/1/00/146/018 80 tablets
Croatian: EU/1/00/146/018 80 tableta
English: • in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy.
Croatian: • u liječenju miokloničkih napadaja u odraslih i adolescenata od 12. godine života s juvenilnom miokloničkom epilepsijom
English: Keppra 1000 mg film-coated tablets Levetiracetam
Croatian: Keppra 1000 mg filmom obložene tablete levetiracetam
English: EU/1/00/146/019 100 tablets
Croatian: EU/1/00/146/019 100 tableta
English: EU/1/00/146/022 30 tablets
Croatian: EU/1/00/146/022 30 tableta
English: 150 ml amber glass bottle (type III) with a white child resistant closure (polypropylene) in a cardboard box also containing a 1 ml graduated oral syringe (polypropylene, polyethylene) and an adaptor for the syringe (polyethylene).
Croatian: Smeđa staklena boca od 150 ml (staklo tip III) s bijelim sigurnosnim zatvaračem za djecu (polipropilen) u kartonskoj kutiji koja također sadrži graduiranu plastičnu štrcaljku od 1 ml za usta (polipropilen, polietilen) i nastavak za štrcaljku (polietilen).
English: 150 ml amber glass bottle (type III) with a white child resistant closure (polypropylene) in a cardboard box also containing a 3 ml graduated oral syringe (polypropylene, polyethylene) and an adaptor for the syringe (polyethylene).
Croatian: Smeđa staklena boca od 150 ml (staklo tip III) s bijelim sigurnosnim zatvaračem za djecu (polipropilen) u kartonskoj kutiji koja također sadrži graduiranu plastičnu štrcaljku za usta od 3 ml (polipropilen, polietilen) i nastavak za štrcaljku (polietilen).
English: EU/1/00/146/015 30 tablets
Croatian: EU/1/00/146/015 30 tableta
English: Keppra 250 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Keppra 250 mg
English: Keppra oral solution should be used for doses under 250 mg, for doses not multiple of 250 mg when dosing recommendation is not achievable by taking multiple tablets and for patients unable to swallow tablets.
Croatian: (1) Za doze ispod 250 mg, za doze koje nisu višekratnici od 250 mg, odnosno kada preporučeno doziranje ne može biti postignuto uzimanjem većeg broja tableta i kod bolesnika koji ne mogu gutati tablete treba koristiti Keppra oralnu otopinu.
English: EU/1/00/146/025 100 tablets
Croatian: EU/1/00/146/025 100 tableta
English: EU/1/00/146/017 60 tablets
Croatian: EU/1/00/146/017 60 tableta
English: Keppra 1000 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Keppra 1000 mg
English: EU/1/00/146/024 60 tablets
Croatian: EU/1/00/146/024 60 tableta
English: EU/1/00/146/023 50 tablets
Croatian: EU/1/00/146/023 50 tableta
English: EU/1/00/146/006 EU/1/00/146/007 EU/1/00/146/008 EU/1/00/146/009 EU/1/00/146/010 EU/1/00/146/011 EU/1/00/146/012 EU/1/00/146/013 EU/1/00/146/035
Croatian: EU/1/00/146/008 EU/1/00/146/009 EU/1/00/146/010 EU/1/00/146/011 EU/1/00/146/012 EU/1/00/146/013 EU/1/00/146/035
English: Keppra 500 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Keppra 500 mg
English: Levetiracetam efficacy was established in a 24-week double-blind, placebo-controlled study, which included adults, adolescents and a limited number of children suffering from idiopathic generalized epilepsy with primary generalized tonic-clonic (PGTC) seizures in different syndromes (juvenile myoclonic epilepsy, juvenile absence epilepsy, childhood absence epilepsy, or epilepsy with Grand Mal seizures on awakening).
Croatian: Djelotvornost levetiracetama dokazana je u dvostruko slijepoj i placebom kontroliranoj studiji u trajanju od 24 tjedna, koja je uključivala odrasle, adolescente i ograničeni broj djece s idiopatskom generaliziranom epilepsijom s primarno generaliziranim toničko-kloničkim (PGTK) napadajima kod različitih sindroma (juvenilna mioklonična epilepsija, epilepsija s apsansima dječje i juvenilne dobi ili epilepsija s grand mal napadajima kod buđenja).
English: 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: Dodatna terapija u liječenju parcijalnih napadaja sa sekundarnom generalizacijom ili bez nje u odraslih, adolescenata i djece od navršene 4. godine života s epilepsijom.
English: EU/1/00/146/016 50 tablets
Croatian: EU/1/00/146/016 50 tableta
English: Starting dose: 7 mg/kg twice daily
Croatian: Početna doza: 7 mg/kg dva puta na dan
English: MARKETING AUTHORISATION NUMBER(S) EU/1/00/146/014 20 tablets
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/00/146/032
English: Keppra 750 mg film-coated tablets Levetiracetam
Croatian: Keppra 750 mg filmom obložene tablete levetiracetam
English: • 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: • u liječenju parcijalnih napadaja sa sekundarnom generalizacijom ili bez nje u odraslih, adolescenata i djece od 4. godine života s epilepsijom.
English: What Keppra looks like and contents of the pack Keppra 100 mg/ml oral solution is a clear liquid.
Croatian: Keppra 100 mg/ml oralna otopina je bistra tekućina.
English: Maximum dose: 21 mg/kg twice daily
Croatian: Najveća doza: 21 mg/kg dva puta na dan
English: 200 mg (2 ml) twice daily 600 mg (6 ml) twice daily
Croatian: 600 mg (6 ml) dva puta na dan
English: What Keppra looks like and contents of the pack Keppra 250 mg film-coated tablets are blue, 13 mm oblong, scored and debossed with the code “ucb” and “250” on one side.
Croatian: Keppra 250 mg filmom obložene tablete su plave, duguljaste, od 13 mm s razdjelnom crtom i utisnutim oznakama „ucb“ i „250“ na jednoj strani.
English: Keppra 250 mg film-coated tablets Levetiracetam
Croatian: Keppra 250 mg filmom obložene tablete levetiracetam
English: EU/1/00/146/020 10 tablets
Croatian: EU/1/00/146/020 10 tableta
English: Keppra 500 mg film-coated tablets Levetiracetam
Croatian: Keppra 500 mg filmom obložene tablete levetiracetam
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use
Croatian: NAČIN I PUT(EVI) PRIMJENE LIJEKA Za primjenu u venu
English: Each film-coated tablet contains 750 mg levetiracetam.
Croatian: TVARI Jedna filmom obložena tableta sadrži 750 mg levetiracetama.
English: EU/1/00/146/021 20 tablets
Croatian: EU/1/00/146/021 20 tableta
English: Keppra may impair your ability to drive or operate any tools or machinery, as it may make you feel sleepy.
Croatian: Ako vozite ili upravljate alatima ili vozilima potreban je oprez jer se pri uzimanju Keppre može javiti osjećaj pospanosti.
English: Silica colloidal anhydrous.
Croatian: OBLIK Oralna otopina.
English: Each film-coated tablet contains 250 mg levetiracetam.
Croatian: TVARI Jedna filmom obložena tableta sadrži 250 mg levetiracetama.
English: Keppra 750 mg film-coated tablets
Croatian: NAZIV LIJEKA Keppra 750 mg filmom obložene tablete
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM I UNUTARNJEM PAKIRANJU Boca od 300 ml
English: Keppra 1000 mg Justification for not including Braille accepted 100 x 1 tablets
Croatian: Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma za 100 x 1 tableta
English: Each film-coated tablet contains 500 mg levetiracetam.
Croatian: TVARI Jedna filmom obložena tableta sadrži 500 mg levetiracetama.
English: EU/1/00/146/014 20 tablets
Croatian: EU/1/00/146/014 20 tableta
English: 100 mg (1 ml) twice daily 300 mg (3 ml) twice daily
Croatian: 300 mg (3 ml) dva puta na dan
English: Keppra oral solution is the preferred formulation for use in this population.
Croatian: Najprikladniji farmaceutski oblik za primjenu u toj populaciji je Keppra oralna otopina.
English: Keppra 1000 mg film-coated tablets
Croatian: NAZIV LIJEKA Keppra 1000 mg filmom obložene tablete
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
Croatian: PODACI KOJE MORA NAJMANJE SDRŽAVATI MALO UNUTARNJE PAKIRANJE Bočica od 5 ml
English: Keppra 100 mg/ml only for the outer carton
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Keppra 100 mg/ml samo za vanjsku kutiju
English: • 250 mg: 20, 30, 50, 60, 100 x 1, 100 film-coated tablets and multipacks containing 200 (2 packs of 100) film-coated tablets
Croatian: • 250 mg: 20, 30, 50, 60, 100 x 1, 100 filmom obloženih tableta i višestruka pakiranja koja sadrže 200 (2 pakiranja od 100) filmom obloženih tableta
English: Box of 10, 20, 30, 50, 60, 100, 100 (100 x 1), 120
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija od 10, 20, 30, 50, 60, 100, 100 (100 x 1), 120 tableta
English: UCB Pharma S.A. Allée de la Recherche 60, B-1070 Brussels, Belgium.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet UCB Pharma SA, Allée de la Recherche 60, B-1070 Brussels, Belgija.
English: • 750 mg: 20, 30, 50, 60, 80, 100 x 1, 100 film-coated tablets and multipacks containing 200 (2 packs of 100) film-coated tablets
Croatian: • 750 mg: 20, 30, 50, 60, 80, 100 x 1, 100 filmom obloženih tableta i višestruka pakiranja koja sadrže 200 (2 pakiranja od 100) filmom obloženih tableta
English: • 500 mg: 10, 20, 30, 50, 60, 100 x 1, 100, 120 film-coated tablets and multipacks containing 200 (2 packs of 100) film-coated tablets
Croatian: • 500 mg: 10, 20, 30, 50, 60, 100 x 1, 100, 120 filmom obloženih tableta i višestruka pakiranja koja sadrže 200 (2 pakiranja od 100) filmom obloženih tableta
English: Name and address of the manufacturers responsible for batch release
Croatian: PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET Nazivi i adrese proizvođača odgovornih za puštanje serije lijeka u promet Filmom obložene tablete
English: • 1000 mg: 10, 20, 30, 50, 60, 100 x 1, 100 film-coated tablets and multipacks containing 200 (2 packs of 100) film-coated tablets
Croatian: • 1000 mg: 10, 20, 30, 50, 60, 100 x 1, 100 filmom obloženih tableta i višestruka pakiranja koja sadrže 200 (2 pakiranja od 100) filmom obloženih tableta
English: Lifepharma (Z.A.M.)
Croatian: Astenija/umor
English: Keppra 250 mg film-coated tablets
Croatian: NAZIV LIJEKA Keppra 250 mg filmom obložene tablete
English: Starting dose: 0.1 ml/kg twice daily Maximum dose: 0.3 ml/kg twice daily
Croatian: Početna doza: 0,1 ml/kg dva puta na dan
English: Keppra 500 mg film-coated tablets
Croatian: NAZIV LIJEKA Keppra 500 mg filmom obložene tablete
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija sa 10 bočica
English: Box of 200 (2 x 100) with blue box
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU Kutija od 200 (2 x 100) tableta, s plavim okvirom
English: Sunset yellow FCF aluminium lake (E110) Iron oxide red (E172)
Croatian: Film ovojnica polivinilni alkohol, djelomično hidroliziran titanijev dioksid (E171) makrogol 3350 talk sunset yellow FCF aluminium lake (E110) željezov oksid, crveni (E172)
English: Six-month seizure freedom was achieved in 73.0 % of levetiracetam-treated patients and 72.8 % of carbamazepine-CR treated patients; the adjusted absolute difference between treatments was 0.2%
Croatian: 73,0% bolesnika liječenih levetiracetamom i 72,8% bolesnika liječenih karbamazepinom s kontroliranim otpuštanjem (CR) bilo je šest mjeseci bez napadaja: prilagođena apsolutna razlika između liječenja bila je 0,2% (95% CI: 7,8 8,2).
English: Weight decreased , weight increase
Croatian: Gubitak tjelesne težine, povećanje tjelesne težine hiponatrijemija
English: 10 film-coated tablets 20 film-coated tablets 30 film-coated tablets 50 film-coated tablets 60 film-coated tablets 100 film-coated tablets 100 x 1 film-coated tablets 120 film-coated tablets
Croatian: 10 filmom obloženih tableta 20 filmom obloženih tableta 30 filmom obloženih tableta 50 filmom obloženih tableta 60 filmom obloženih tableta 100 filmom obloženih tableta 100 x 1 filmom obloženih tableta 120 filmom obloženih tableta
English: Aluminium/PVC blisters placed into cardboard boxes containing 10, 20, 30, 50, 60, 100, 120 filmcoated tablets and multipacks containing 200 (2 packs of 100) film-coated tablets.
Croatian: Aluminij/PVC blisteri umetnuti u kartonske kutije koje sadrže 10, 20, 30, 50, 60, 100, 120 filmom obloženih tableta i višestruka pakiranja koja sadrže 200 (2 pakiranja od 100) filmom obloženih tableta.
English: Tel: + 48 22 696 99 20
Croatian: UCB Pharma Sp. z o.o. Tel: + 48 22 696 99 20