FrancophonIA/ELRC3.0 huggingface dataset:
English: Matever is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy.
Croatian: Matever je indiciran kao monoterapija u liječenju parcijalnih napadaja sa sekundarnom generalizacijom ili bez nje u odraslih i adolescenata od 16. godine života s novodijagnosticiranom epilepsijom.
English: Matever is for intravenous use.
Croatian: Matever se daje u venu.
English: Creatinine clearance (ml/min/1.73 m
Croatian: Klirens kreatinina (ml/min/1,73m
English: Each ml contains 3.81 mg sodium.
Croatian: Pomoćna tvar s poznatim učinkom Jedan ml sadrži 3,81 mg natrija.
English: • skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (StevensJohnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis);
Croatian: jako rasprostranjen osip s mjehurićima i kožom koja se ljušti, osobito oko usta, nosa, očiju i genitalija (Stevens-Johnsonov sindrom), i mnogo teži oblik koji uzrokuje ljuštenje kože na više od 30% površine tijela (toksična epidermalna nekroliza);
English: Neonatal and juvenile animal studies in rats and dogs demonstrated that there were no adverse reactions seen in any of the standard developmental or maturation endpoints at doses up to 1800 mg/kg/day (x 6-17 the MRHD on a mg/m2 basis)
Croatian: Neonatalne i juvenilne studije na štakorima i psima pokazale su da nema nuspojava u uobičajenim mjerama ishoda razvoja ili sazrijevanja kod primjene doza do 1800 mg/kg/dan (6-erostruka do 17erostruka vrijednost najveće preporučene doze za čovjeka izražena u mg/m2).
English: Matever 1000 mg film-coated tablets contain lactose.
Croatian: Matever 1000 mg filmom obložene tablete sadrže laktozu.
English: Each film-coated tablet contains 0.08 mg sunset yellow FCF aluminum lake (E110).
Croatian: Jedna filmom obložena tableta sadrži 0,08 mg bojila sunset yellow FCF aluminium lake (E110).
English: Serum Creatinine (mg/dl) ks= 0.55 in Children to less than 13 years and in adolescent female; ks= 0.7 in adolescent male
Croatian: ks = 0,55 za djecu mlađu od 13 godina i za adolescente ženskog spola; ks = 0,7 za adolescente muškog spola
English: Film-coating: hypromellose (E464), titanium dioxide (E171), hydroxypropyl cellulose (E463), propylene glycol (E1520), sorbic acid (E200), sorbitan monooleate (E494), vanillin, colourants*.
Croatian: Film-ovojnica: hipromeloza (E464), titanijev dioksid (E171), hidroksipropilceluloza (E463), propilenglikol (E1520), quinoline yellow aluminium lake (E104), sorbatna kiselina (E200), sorbitanmonooleat (E494), vanilin bojila*.
English: (1)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: 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: Each film-coated tablet contains 0.0025 mg sunset yellow FCF aluminum lake (E110).
Croatian: Jedna filmom obložena tableta sadrži 0,0025 mg bojila sunset yellow FCF aluminium lake (E110).
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 navršene 12. godine života s juvenilnom miokloničkom epilepsijom.
English: The CLcr in ml/min/1.73 m may be estimated from serum creatinine (mg/dl) determination, for young adolescents, children and infants, using the following formula (Schwartz formula):
Croatian: Klirens kreatinina u ml/min/1,73 m2 može se za mlade adolescente, djecu i dojenčad procijeniti iz vrijednosti serumskoga kreatinina (mg/dl) s pomoću sljedeće formule (Schwartzova formula):
English: The NOAEL (No Observed Adverse Effect Level) was 3600 mg/kg/day for pregnant female rats (x 12 the MRHD on a mg/m basis) and 1200 mg/kg/day for fetuses.
Croatian: NOAEL (No Observed Adverse Effect Level, razina pri kojoj se ne uočava štetni učinak) za gravidne štakorice iznosila je 3600 mg/kg/dan, a za fetuse 1200 mg/kg/dan (12-erostruka vrijednost najveće preporučene doze za čovjeka izražena u mg/m2).
English: 1500 mg 15 ml (three 5 ml vials) 100 ml
Croatian: 5 ml) 1500 mg 15 ml (tri bočice od 5 ml) 100 ml
English: Tablet core: calcium hydrogen phosphate dihydrate, cellulose microcrystalline, crospovidone type A, hydroxypropylcellulose (L).
Croatian: Jezgra tablete: kalcijev hidrogenfosfat dihidrat, mikrokristalična celuloza, krospovidon tipa
English: One tablet of Matever 1000 mg contains 1000 mg of levetiracetam.
Croatian: Jedna tableta Matevera 1000 mg sadrži 1000 mg levetiracetama.
English: What you need to know before you take Matever
Croatian: Što morate znati prije nego počnete uzimati Matever Nemojte uzimati Matever
English: One tablet of Matever 750 mg contains 750 mg of levetiracetam.
Croatian: Jedna tableta Matevera 750 mg sadrži 750 mg levetiracetama.
English: Film-coating: hypromellose (E464), iron oxide red (E172), macrogol/PEG 4000, titanium dioxide (E171), colourants*.
Croatian: Film-ovojnica: hipromeloza (E464), crveni željezov oksid (E172), makrogol/PEG 4000, titanijev dioksid (E171).
English: • amnesia (loss of memory),memory impairment (forgetfulness), abnormal coordination/ataxia
Croatian: • amnezija (gubitak pamćenja), smetnje pamćenja (zaboravljivost), poremećaj koordinacije/ataksija (poremećaj koordinacije pokreta), parestezije (trnci), smetnje u koncentraciji (gubitak koncentracije);
English: One tablet of Matever 500 mg contains 500 mg of levetiracetam.
Croatian: Jedna tableta Matevera 500 mg sadrži 500 mg levetiracetama.
English: confusion, panic attack, emotional instability/mood swings, agitation;
Croatian: srditost, smetenost, napadaj panike, emocionalna nestabilnost/promjene raspoloženja,
English: Following dialysis, a 3.5 to 7 mg/kg (0.035 to 0.07 ml/kg) supplemental dose is recommended.
Croatian: (4) Nakon dijalize preporučuje se dodatna doza od 3,5 do 7 mg/kg (0,035 do 0,07 ml/kg).
English: One tablet of Matever 250 mg contains 250 mg of levetiracetam.
Croatian: Jedna tableta Matevera 250 mg sadrži 250 mg levetiracetama.
English: Levetiracetam 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 250 mg,gdje preporučeno doziranje ne može biti postignuto uzimanjem većeg broja tableta i kod bolesnika koji ne mogu gutati tablete treba koristiti levetiracetam oralnu otopinu.
English: How Matever is given
Croatian: Kako se Matever daje
English: • convulsion, balance disorder (equilibrium disorder), dizziness (sensation of unsteadiness),
Croatian: • konvulzije, poremećaj ravnoteže, omaglica (osjećaj nestabilnosti), bezvoljnost (nedostatak energije i volje), tremor (nevoljno drhtanje);
English: Glenmark Pharmaceuticals B.V. Tel: 0031 76 596 1937
Croatian: Tel: 0031 76 596 1937
English: Method and route of administration
Croatian: Način i put primjene:
English: Children from 4 years and adolescents weighing less than 50 kg
Croatian: Doza i učestalost primjene Djeca od 4. godine i adolescenti teški manje od 50 kg
English: Somnolence, agitation, aggression, depressed level of consciousness, respiratory depression and coma were observed with Matever overdoses.
Croatian: Kod predoziranja Matevera primijećena je somnolencija, agitacija, agresivnost, smanjena razina svijesti, depresija disanja i koma.
English: • Matever is not indicated in children and adolescents below 16 years on it's own (monotherapy) Other medicines and Matever
Croatian: • U djece i adolescenata mlađih od 16 godina Matever se ne primjenjuje samostalno (kao monoterapija).
English: Following dialysis, a 5 to 10 mg/kg (0.05 to 0.10 ml/kg) supplemental dose is recommended.
Croatian: (2) Nakon dijalize preporučuje se dodatna doza od 5 do 10 mg/kg (0,05 do 0,10 ml/kg).
English: How to store Matever
Croatian: Kako čuvati Matever
English: 1500 mg 15 ml (three 5 ml vials)
Croatian: 1500 mg 15 ml (tri bočice od 5 ml)
English: 80 film-coated tablets
Croatian: 80 filmom obloženih tableta
English: Calcium hydrogen phosphate dihydrate Microcrystalline cellulose Crospovidone type A Hydroxypropylcellulose (L)
Croatian: 6.1 Popis pomoćnih tvari Jezgra kalcijev hidrogenfosfat dihidrat celuloza, mikrokristalična krospovidon tipa
English: • as an add-on to other antiepileptic medicines to treat: partial onset seizures with or without generalisation in adults, adolescents and children from 4 years 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.
Croatian: • kao dodatna terapija uz druge antiepileptike u liječenju: djelomičnih napadaja sa sekundarnom generalizacijom ili bez nje u odraslih, adolescenata i djece od 4. godine života miokloničkih napadaja (kratki, iznenadni trzaj mišića ili skupine mišića) u odraslih i adolescenata starijih od navršene 12. godine života s juvenilnom miokloničkom epilepsijom primarno generaliziranih toničko-kloničkih napadaja (veliki napadaji, uključujući gubitak svijesti) u odraslih i adolescenata od navršene 12. godine života s idiopatskom generaliziranom epilepsijom (oblik epilepsije za koji se smatra da je genetski uvjetovan).
English: Matever 1000 mg: The film-coated tablets are white, oblong, biconvex.
Croatian: Matever 1000 mg: Filmom obložene tablete su bijele, duguljaste, bikonveksne.
English: PHARMACEUTICALPARTICULARS
Croatian: FARMACEUTSKI
English: Matever 750 mg: The film-coated tablets are pink, oblong, biconvex.
Croatian: Matever 750 mg: Filmom obložene tablete su ružičaste, duguljaste, bikonveksne.
English: Matever 500 mg: The film-coated tablets are yellow, oblong, biconvex.
Croatian: Matever 500 mg: Filmom obložene tablete su žute, duguljaste, bikonveksne.
English: Puh/Tel: +358 10 4261
Croatian: Suomi/Finland Orion Pharma Puh/Tel: +358 10 4261
English: Matever 1000 mg film-coated tablets
Croatian: Matever 1000 mg filmom obložene tablete
English: Film-coating: hypromellose (E464), lactose monohydrate,macrogol/PEG 4000, titanium dioxide (E171).
Croatian: 1000 mg: Film-ovojnica: hipromeloza (E464), laktoza hidrat, makrogol/PEG 4000, titanijev dioksid (E171).
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: Matever 750 mg film-coated tablets
Croatian: Matever 750 mg filmom obložene tablete
English: A 15 mg/kg (0.15 ml/kg) loading dose is recommended on the first day of treatment with levetiracetam.
Croatian: (1) Prvog dana liječenja levetiracetamom preporučuje se udarna doza od 15 mg/kg (0,15 ml/kg).
English: • There is no experience with administration of intravenous levetiracetam for a longer period than
Croatian: Trajanje liječenja: • Nema iskustva s levetiracetamom primijenjenim intravenski u razdoblju duljem od 4 dana.
English: • in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents, children and infants from 1 month of age with epilepsy.
Croatian: • u liječenju parcijalnih napadaja sa sekundarnom generalizacijom ili bez nje u odraslih, adolescenata, djece i dojenčadi od navršenog 1. mjeseca života s epilepsijom.
English: Film-coating: hypromellose (E464), titanium dioxide (E171), talc, propylene glycol (E1520) colourants*.
Croatian: 250 mg: Film-ovojnica: hipromeloza (E464), titanijev dioksid (E171), talk, propilenglikol (E1520), bojila*.
English: The safety and efficacy of Matever 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 Matevera nije dokazana.
English: Coating agent (yellow) consisting of: Hydroxypropylcellulose (E463) Hypromellose (E464) Propylene glycol (E1520) Quinoline yellow aluminium lake (E104) Sorbic acid (E200)
Croatian: Sredstvo za oblaganje (žuti) se sastoji od: hidoksipropilceluloza (E463) hipromeloza (E464) propilenglikol (E1520) bojilo quinoline yellow aluminium lake (E104) sorbatna kiselina (E200) sorbitanmonooleat (E494) titanijev dioksid (E171) vanilin
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 navršene 4. godine života s epilepsijom.
English: The CLcr in ml/min/1.73 m may be estimated from serum creatinine (mg/dl) determination, for young adolescents and children using the following formula (Schwartz formula):
Croatian: Klirens kreatinina u ml/min/1,73 m može se za mlade adolescente i djecu procijeniti iz vrijednosti serumskoga kreatinina (mg/dl) s pomoću sljedeće formule (Schwartzova formula): Visina (cm) x ks
English: Matever 250 mg film-coated tablets
Croatian: Matever 250 mg filmom obložene tablete
English: In vitro studies show that levetiracetam affects intraneuronal Ca levels by partial inhibition of N-type Ca2+ currents and by reducing the release of Ca2+ from intraneuronal stores.
Croatian: N tip protoka Ca2+ i smanjuje otpuštanje Ca2+ iz skladišta u neuronima.
English: Matever 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 Matevera može javiti osjećaj pospanosti.
English: A 10.5 mg/kg (0.105 ml/kg) loading dose is recommended on the first day of treatment with levetiracetam.
Croatian: (2) Prvog dana liječenja levetiracetamom preporučuje se udarna doza od 10,5 mg/kg (0,105 ml/kg).
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: Matever 750 mg film-coated tablets levetiracetam2.
Croatian: Matever 750 mg filmom obložene tablete levetiracetam
English: Matever 500 mg film-coated tablets
Croatian: Matever 500 mg filmom obložene tablete
English: • 250 mg: 20, 30, 50, 60, 100 and multipack of 200 (2 packs of 100) film-coated tablets.
Croatian: • 250 mg: 20, 30, 50, 60, 100 i višestruka pakiranja od 200 (2 pakiranja od 100) filmom obloženih tableta.
English: Matever 1000 mg film-coated tablets levetiracetam2.
Croatian: Matever 1000 mg filmom obložene tablete levetiracetam
English: • 750 mg: 20, 30, 50, 60, 80, 100, 120 and multipack of 200 (2 packs of 100) film-coated tablets.
Croatian: • 750 mg: 20, 30, 50, 60, 80, 100, 120 i višestruka pakiranja od 200 (2 pakiranja od 100) filmom obloženih tableta.
English: Talk to your doctor before you are given Matever
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku prije nego počnete dobivati Matever
English: • 1000 mg: 10, 20, 30, 50, 60, 100 and multipack of 200 (2 packs of 100) film-coated tablets.
Croatian: • 1000 mg: 10, 20, 30, 50, 60, 100 i višestruka pakiranja od 200 (2 pakiranja od 100) filmom obloženih tableta.
English: 10 to 20 mg/kg (0.10 to 0.20 ml/kg) once daily
Croatian: 10 do 20 mg/kg (0,10 do 0,20 ml/kg) jednaput na dan
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Croatian: A hidroksipropilceluloza (L)
English: Matever 250 mg film-coated tablets levetiracetam2.
Croatian: Matever 250 mg filmom obložene tablete levetiracetam
English: Nasopharyngit is
Croatian: Prijavljivanje nuspojava
English: • 500 mg: 10, 20, 30, 50, 60, 100, 120 and multipack of 200 (2 packs of 100) film-coated tablets.
Croatian: • 500 mg: 10, 20, 30, 50, 60, 100, 120 i višestruka pakiranja od 200 (2 pakiranja od 100) filmom obloženih tableta.
English: Dosing adjustment for children and adolescents patients weighing less than 50 kg with impaired renal function
Croatian: Prilagođavanje doze kod djece i adolescenata s manje od 50 kg tjelesne težine s oštećenom bubrežnom funkcijom:
English: Coating agent (white) consisting of: Hypromellose (E464) Lactose monohydrate Macrogol/PEG 4000
Croatian: Sredstvo za oblaganje (bijeli) se sastoji od: hipromeloza (E464) laktoza hidrat makrogol/PEG 4000 titanijev dioksid (E171)
English: Adjunctive therapy in the treatment of partial onset seizures with or without secondary generalisation in adults, adolescents, children and infants from 1 month of age with epilepsy:
Croatian: Dodatna terapija djelomičnih napadaja sa sekundarnom generalizacijom ili bez nje u odraslih, adolescenata, djece i dojenčadi od navršenog 1. mjeseca života nadalje koji pate od epilepsije.
English: What you need to know before you are given Matever
Croatian: Što morate znati prije nego primite Matever Nemojte koristiti Matever
English: Matever 500 mg film-coated tablets levetiracetam2.
Croatian: Matever 500 mg filmom obložene tablete levetiracetam
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 djelomičnih napadaja sa sekundarnom generalizacijom ili bez nje u odraslih, adolescenata i djece od navršene 4. godine života nadalje koji pate od epilepsije.
English: Box of 20, 30, 50, 60, 80, 100, 120 multipack containing 200 (2 x 100) [with Blue Box]
Croatian: Kutija od 20, 30, 50, 60, 80, 100, 120 višestruko pakiranje sadrži 200 (2 x 100) [s plavim okvirom]
English: The 5 ml vial contains 500 mg of levetiracetam.
Croatian: Jedna bočica od 5 ml sadrži 500 mg levetiracetama.
English: Box of 10, 20, 30, 50, 60, 100, 120 multipack containing 200 (2 x 100) [with Blue Box]
Croatian: Kutija od 10, 20, 30, 50, 60, 100, 120 višestruko pakiranje sadrži 200 (2 x 100) [s plavim okvirom]
English: Box of 20, 30, 50, 60, 100 multipack containing 200 (2 x 100) [with Blue Box]
Croatian: Kutija od 20, 30, 50, 60, 100 višestruko pakiranje sadrži 200 (2 x 100) [s plavim okvirom]
English: Diluents:
Croatian: Tel.:
English: Box of 10, 20, 30, 50, 60, 100 multipack containing 200 (2 x 100) [with Blue Box]
Croatian: Kutija od 10, 20, 30, 50, 60, 100 višestruko pakiranje sadrži 200 (2 x 100) [s plavim okvirom]
English: Aluminium/PVC/PE/PVDC blisters placed into cardboard boxes containing 20, 30, 50, 60, 80, 100, 120 and multipack containing 200 (2 packs of 100) film-coated tablets.
Croatian: Aluminij/PVC/PE/PVDC blisteri umetnuti u kartonske kutije koje sadrže 20, 30, 50, 60, 80, 100, 120 i višestruka pakiranja koja sadrže 200 (2 pakiranja od 100) filmom obloženih tableta.
English: OTHER SPECIALWARNING(S), IF NECESSARY
Croatian: OD LIJEKA, AKO JE POTREBNO
English: Aluminium/PVC/PE/PVDC blisters placed into cardboard boxes containing 10, 20, 30, 50, 60, 100, 120 and multipack containing 200 (2 packs of 100) film-coated tablets.
Croatian: Aluminij/PVC/PE/PVDC blisteri umetnuti u kartonske kutije koje sadrže 10, 20, 30, 50, 60, 100, 120 i višestruka pakiranja koja sadrže 200 (2 pakiranja od 100) filmom obloženih tableta.
English: Aluminium/PVC/PE/PVDC blisters placed into cardboard boxes containing 20, 30, 50, 60, 100 and multipack containing 200 (2 packs of 100) film-coated tablets.
Croatian: Aluminij/PVC/PE/PVDC blisteri umetnuti u kartonske kutije koje sadrže 20, 30, 50, 60, 100 i višestruka pakiranja koja sadrže 200 (2 pakiranja od 100) filmom obloženih tableta.
English: Aluminium/PVC/PE/PVDC blisters placed into cardboard boxes containing 10, 20, 30, 50, 60, 100 and multipack containing 200 (2 packs of 100) film-coated tablets.
Croatian: Aluminij/PVC/PE/PVDC blisteri umetnuti u kartonske kutije koje sadrže 10, 20, 30, 50, 60, 100 i višestruka pakiranja koja sadrže 200 (2 pakiranja od 100) filmom obloženih tableta.
English: • Dose in infants (1 month to 23 months), children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg:
Croatian: • Doza u dojenčadi (1 mjesec do 23 mjeseca), djece (2 do 11 godina) i adolescenata (12 do 17 godina) koji imaju manje od 50 kg: Liječnik će propisati najprikladniji farmaceutski oblik Matevera sukladno dobi, tjelesnoj težini i dozi.
English: The recommended dose must be diluted in at least 100 ml of a compatible diluent and infused over 15 minutes.
Croatian: Preporučena doza mora biti razrijeđena u najmanje 100 ml kompatibilne otopine za razrjeđivanje i nakon toga primjenjena infuzijom kroz 15 minuta.Za liječnike i medicinske sestre, detaljnija uputa za pravilnu primjenu Matevera nalazi se u poglavlju 6.
English: Weight decreased, weight increase
Croatian: Gubitak tjelesne težine, povećanje tjelesne težine hiponatrijemija
English: Coating agent (blue) consisting of: Hypromellose (E464) Titanium dioxide (E171) Talc
Croatian: Sredstvo za oblaganje (plavi) se sastoji od: hipromeloza (E464) titanijev dioksid (E171) talk propilenglikol (E1520) bojilo indigo carmine aluminium lake (E132)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/711/014
Croatian: Matever 750 mg filmom obložene tablete EU/1/11/711/015
English: Deutschland
Croatian: United Kingdom
English: Matever 250 mg: The film-coated tablets are blue, oblong, biconvex.
Croatian: Kako Matever izgleda i sadržaj pakiranja Matever 250 mg: Filmom obložene tablete su plave, duguljaste, bikonveksne.
English: It is available as capsules (4 and 8 mg).
Croatian: Dostupan je kao kapsule (4 i 8 mg).
English: The patients rated the severity of their symptoms themselves.
Croatian: Bolesnici su sami ocijenili ozbiljnost svojih simptoma.
English: The capsules should be taken with food, preferably at the same time every day.
Croatian: Kapsule je potrebno uzeti s hranom, po mogućnosti svaki dan u isto vrijeme.
English: The full EPAR for Silodyx can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Croatian: Cjeloviti EPAR za lijek Silodyx nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This may be increased to 8 mg once a day after a week.
Croatian: Ova se doza može povećati na 8 mg na dan nakon tjedan dana.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Silodyx on 29 January 2010.
Croatian: Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Silodyx na snazi u Europskoj uniji od 29. siječnja 2010.
English: The main measure of effectiveness in all three studies was the improvement of the patients' international prostate symptom score (IPSS) after 12 weeks of treatment.
Croatian: Glavna mjera djelotvornosti u sva tri ispitivanja bilo je poboljšanje rezultata međunarodnog indeksa simptoma prostate (IPSS) u bolesnika nakon 12 tjedana liječenja.
English: They should be swallowed whole, preferably with a glass of water.
Croatian: Kapsule se moraju progutati cijele, po mogućnosti s čašom vode.
English: The effects of Silodyx were first tested in experimental models before being studied in humans.
Croatian: Djelovanje lijeka Silodyx po prvi put je testirano u eksperimentalnim modelima prije nego što je provedeno ispitivanje na ljudima.
English: When enlarged, it can cause problems with the flow of urine.
Croatian: Ako je povećana, može uzrokovati problem s protokom urina.
English: In the two studies where Silodyx was compared only with placebo, the IPSS was around 21 points at the start of the study.
Croatian: U dva ispitivanja u kojima je Silodyx uspoređen samo s placebom, IPSS je iznosio otprilike 21 bod u početku ispitivanja.