FrancophonIA/ELRC3.0 huggingface dataset:
English: It is recommended that patients treated with substances that are metabolised by the CYP3A4 enzyme system are to be carefully monitored for two weeks at the start of, or after the end of treatment with rufinamide, or after any marked change in the dose.
Croatian: Preporučuje se pažljivo pratiti bolesnike liječene tvarima koje metabolizira sustav enzima CYP3A4, u razdoblju od dva tjedna nakon početka ili prestanka liječenja rufinamidom ili nakon bilo koje izrazitije promjene doze.
English: This indicates minimal risk of drug-drug interactions by displacement from binding sites during concomitant administration of other substances.
Croatian: To pokazuje da, tijekom istodobne primjene, postoji minimalni rizik od interakcija s drugim lijekovima putem istiskivanja s mjesta vezanja.
English: If the recommended calculated dose of Inovelon is not achievable, the dose should be given to the nearest whole 100 mg tablet.
Croatian: Ukoliko se preporučena izračunata doza Inovelona ne može postići, potrebno je dati dozu zaokruženu na najbliži višekratnik doze od 100 mg.
English: Taken in two equal doses, half in the morning and the other half in the evening.
Croatian: Uzima se podijeljeno u dvije jednake doze, pola doze ujutro i pola navečer.
English: The most frequently reported TEAEs in the rufinamide treatment group (occurring in ≥ 10% of subjects) were upper respiratory tract infection and vomiting (28.0% each), pneumonia and somnolence (20.0% each), sinusitis, otitis media, diarrhoea, cough and pyrexia (16.0% each), and bronchitis, constipation, nasal congestion, rash, irritability and decreased appetite (12.0% each).
Croatian: Najčešće zabilježene nuspojave opažene tijekom liječenja u skupini liječenoj rufinamidom (koje su nastale u ≥ 10% ispitanika) bile su infekcije gornjih dišnih putova i povraćanje (svaka u 28,0%), pneumonija i somnolencija (svaka u 20,0%), sinusitis, upala srednjeg uha, proljev, kašalj i pireksija (svaka u 16,0%) te bronhitis, zatvor, kongestija nosa, osip, razdražljivost i smanjeni apetit (svaka u 12,0%).
English: Insert the syringe into the opening of the adaptor as far as possible.
Croatian: Umetnite štrcaljku u otvor na nastavku što dublje.
English: In a multicentre, open-label study comparing the addition of rufinamide to any other AED of the investigator's choice to the existing regimen of 1 to 3 AEDs in paediatric patients, 1 to less than 4 years of age with inadequately controlled LGS, 25 patients, of which 10 subjects were aged 1 to 2 years, were exposed to rufinamide as adjunctive therapy for 24 weeks at a dose of up to 45 mg/kg/day, in 2 divided doses.
Croatian: U multicentričnom otvorenom ispitivanju u kojem se uspoređivalo dodavanje rufinamida s dodavanjem nekog drugog antiepileptičkog lijeka po izboru ispitivača postojećem režimu koji se sastojao od 1 do 3 antiepileptička lijeka u pedijatrijskih bolesnika u dobi od 1 do manje od 4 godine s neodgovarajuće kontroliranim Lennox-Gastautovim sindromom, 25 bolesnika, od kojih je 10 bilo u dobi od 1 do 2 godine, bilo je izloženo rufinamidu kao dodatnoj terapiji tijekom 24 tjedna u dozi do 45 mg/kg na dan podijeljenoj u dvije doze.
English: It comes in a bottle of 460 ml with two identical syringes and a push in bottle adaptor (PIBA).
Croatian: Dolazi u boci od 460 ml s dvije jednake štrcaljke i nastavkom koji se utisne u otvor boce.
English: Each carton contains one bottle, two identical calibrated oral dosing syringes and a press-in-bottle adapter (PIBA).
Croatian: Jedna kartonska kutija sadrži jednu bocu, dvije jednake kalibrirane štrcaljke za oralno doziranje i nastavak koji se utisne u otvor boce (PIBA).
English: No evidence of an associated risk was identified in the rat and monkey repeat dose toxicity studies.
Croatian: U ispitivanjima toksičnosti ponovljene doze u štakora i majmuna nije pronađen nikakav dokaz s time povezanog rizika.
English: Treatment should be initiated at a daily dose of 200 mg (5 ml dosing suspension given as two 2.5 ml doses, one in the morning and one in the evening).
Croatian: Liječenje treba započeti dnevnom dozom od 200 mg (5 ml doze suspenzije koja se daje podijeljena u dvije doze od 2,5 ml, jedna ujutro i druga navečer).
English: Adults, adolescents and children weighing 30 kg or over
Croatian: Odrasli, adolescenti i djeca tjelesne težine od 30 kg ili više
English: The antiepileptic drug (AED) hypersensitivity syndrome occurred in close temporal association to the initiation of rufinamide therapy and in the paediatric population.
Croatian: Nastanak sindroma preosjetljivosti na antiepileptičke lijekove usko je vremenski povezan s početkom terapije rufinamidom te s pedijatrijskom populacijom.
English: If you have any further questions on the use of this product, ask the doctor or pharmacist.
Croatian: U slučaju bilo kakvih pitanja u vezi s primjenom ovog lijeka, obratite se liječniku ili ljekarniku.
English: E. SPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Croatian: POSEBNE OBVEZE ZA PROVEDBE MJERA NAKON DAVANJA ODOBRENJA KOD ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET U IZNIMNIM OKOLNOSTIMA
English: Inovelon 40 mg/ml oral suspension Rufinamide
Croatian: Inovelon 40 mg/ml oralna suspenzija rufinamid
English: Regarding the immunotoxic potential, small thymus and thymic involution were observed in dogs in a 13-week study with significant response at the high dose in male.
Croatian: U pogledu imunotoksičnog potencijala, u 13-tjednom ispitivanju u pasa opaženi su mali timus i involucija timusa, sa značajnim odgovorom pri visokim dozama u mužjaka.
English: The suspension should be taken twice daily in the morning and in the evening, in two equally divided doses.
Croatian: Suspenziju treba uzimati dvaput na dan, ujutro i navečer, tako da je ukupna dnevna doza razdijeljena u dvije jednake doze.
English: The dosing syringe should be inserted into the PIBA and the dose withdrawn from the inverted bottle.
Croatian: Štrcaljku za doziranje treba uvesti u nastavak i iz boce okrenute naopako izvući dozu lijeka.
English: The most common adverse reactions resulting in discontinuation from the rufinamide treatment group were rash and vomiting.
Croatian: Najčešće nuspojave, koje su rezultirale prekidom u skupini liječenoj rufinamidom bile su osip i povraćanje.
English: Rufinamide is for oral use.
Croatian: Rufinamid je namijenjen za peroralnu primjenu.
English: 1 bottle contains 18400 mg rufinamide.
Croatian: 1 boca sadrži 18 400 mg rufinamida.
English: 5 ml contains 200 mg rufinamide.
Croatian: 5 ml sadrži 200 mg rufinamida.
English: 1 bottle of 460 ml contains 18400 mg rufinamide.
Croatian: Jedna boca od 460 ml sadrži 18 400 mg rufinamida.
English: They are available as packs of 10, 30, 50, 60,100 and 200 film-coated tablets.
Croatian: Dostupne su u pakiranjima od 10, 30, 50, 60,100 i 200 filmom obloženih tableta.
English: Treatment should be initiated at a daily dose of 400 mg.
Croatian: Liječenje treba započeti dnevnom dozom od 400 mg.
English: Treatment should be initiated at a daily dose of 400 mg (10 ml dosing suspension given as two 5 ml doses).
Croatian: Liječenje treba započeti dnevnom dozom od 400 mg (10 ml suspenzije koja se daje podijeljena u dvije doze od 5 ml).
English: Patients not receiving valproate:
Croatian: Bolesnici koji ne primaju valproat:
English: Treatment should be initiated at a daily dose of 200 mg.
Croatian: Liječenje treba započeti dnevnom dozom od 200 mg.
English: Use in patients with severe hepatic impairment is not recommended.
Croatian: Ne preporučuje se primjena u bolesnika s teškim oštećenjem jetre.
English: - The other ingredients are microcrystalline cellulose and carmellose sodium, anhydrous citric acid, simeticone emulsion 30% (containing benzoic acid, cyclotetrasiloxane, dimethicone, glycol stearate and glyceryl distearate, methylcellulose, PEG-40 stearate [polyethylene glycol stearate], polysorbate 65, silica gel, sorbic acid, sulphuric acid and water), poloxamer 188, hydroxyethylcellulose, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), potassium sorbate, propylene glycol (E1520), sorbitol, liquid (non-crystallising), orange flavour and water.
Croatian: - Ostali sastojci su mikrokristalična celuloza i karmelozanatrij, bezvodna citratna kiselina, 30% -tna simetikon emulzija (koja sadrži benzoatnu kiselinu, ciklotetrasiloksan, dimetikon, glikolstearat i glicerildistearat, metilcelulozu, PEG-40 stearat [polietilenglikolstearat], polisorbat 65, gel silicijevog dioksida, sorbatnu kiselinu, sulfatnu kiselinu i vodu), poloksamer 188, hidroksietilceluloza, metilparahidroksibenzoat (E218), propilparahidroksibenzoat (E216), kalijev sorbat (E202), propilenglikol (E1520), sorbitol tekući (nekristalizirajući), aroma naranče i voda.
English: Adverse reactions reported with an incidence greater than placebo, during the Lennox-Gastaut syndrome double-blind studies or in the overall rufinamide-exposed population, are listed in the table below by MedDRA preferred term, system organ class and by frequency.
Croatian: Nuspojave za koje je zabilježena incidencija veća od one uz placebo, u dvostruko slijepim ispitivanjima u bolesnika s Lennox-Gastautovim sindromom i ukupnoj populaciji izloženoj rufinamidu, navedene su u sljedećoj tablici, prema MedDRA standardnim izrazima, klasifikaciji organskih sustava i učestalosti.
English: Also contains methyl parahydroxybenzoate (E218) propyl parahydroxybenzoate (E216) sorbitol (E420)
Croatian: Također sadrži metilparahidroksibenzoat (E218) propilparahidroksibenzoat (E216) sorbitol (E420)
English: Withdrawal of rufinamide
Croatian: Prestanak primjene rufinamida
English: For rufinamide, no clinical data on exposed pregnancies are available.
Croatian: Nema dostupnih kliničkih podataka o izloženosti rufinamidu u trudnoći.
English: 10 film-coated tablets 30 film-coated tablets 50 film-coated tablets 60 film-coated tablets 100 film-coated tablets 200 film-coated tablets
Croatian: 10 filmom obloženih tableta 30 filmom obloženih tableta 50 filmom obloženih tableta 60 filmom obloženih tableta 100 filmom obloženih tableta 200 filmom obloženih tableta
English: Nervous system Somnolence* Status epilepticus*
Croatian: Psihijatrijski poremećaji somnolencija* epileptički status* glavobolja
English: 10 film-coated tablets 30 film-coated tablets 50 film-coated tablets 60 film-coated tablets 100 film-coated tablets
Croatian: 10 filmom obloženih tableta 30 filmom obloženih tableta 50 filmom obloženih tableta 60 filmom obloženih tableta 100 filmom obloženih tableta
English: Turn upright and remove the syringe
Croatian: Okrenite bocu uspravno i izvucite štrcaljku.
English: A recent population PK analysis of rufinamide on data pooled from 139 subjects (115 LGS patients and 24 healthy subjects), including 83 paediatric LGS patients (10 patients aged 1 to < 2 years, 14 patients aged 2 to < 4 years, 14 patients aged 4 to < 8 years, 21 patients aged 8 to < 12 years and 24 patients aged 12 to < 18 years) indicated that when rufinamide is dosed on a mg/kg/day basis in LGS subjects aged 1 to < 4 years, comparable exposure to that in LGS patients aged ≥ 4 years, in which efficacy has been demostrated, is achieved.
Croatian: Nedavna populacijska farmakokinetička analiza rufinamida, napravljana na podacima prikupljenim od 139 ispitanika (115 bolesnika s Lennox-Gastautovim sindromom i 24 zdrava ispitanika), uključujući 83 pedijatrijska bolesnika s Lennox-Gastautovim sindromom (10 bolesnika u dobi od 1 do < 2 godine, 14 bolesnika u dobi od 2 to < 4 godine, 14 bolesnika u dobi od 4 to < 8 godina, 21 bolesnik u dobi od 8 do < 12 godina i 24 bolesnika u dobi od 12 do < 18 godina), pokazala je da se uz doziranje rufinamida po principu mg/kg/dan, u bolesnika s Lennox-Gastautovim sindromom u dobi od 1 do < 4 godine postiže izloženost usporediva s onom u bolesnika s Lennox-Gastautovim sindromom u dobi ≥ 4 godine, a u kojih je djelotvornost već ustanovljena.
English: Inovelon is used with other medicines to treat seizures associated with Lennox-Gastaut syndrome in adults, adolescents and children from 1 year of age.
Croatian: Inovelon se primjenjuje s drugim lijekovima za liječenje odraslih, adolescenata i djece od navršene 1 godine koji imaju napadaje povezane s Lennox-Gastautovim sindromom.
English: For this patient population, the maximum recommended dose is 45 mg/kg/day (1.125 ml/kg/day).
Croatian: Za ovu populaciju bolesnika, maksimalna preporučena doza je 45 mg/kg na dan (1,125 ml/kg na dan).
English: Discontinuation of rufinamide
Croatian: Prekid primjene rufinamida
English: The tablet should be taken twice daily with water in the morning and in the evening, in two equally divided doses.
Croatian: Tabletu treba uzimati dvaput na dan s vodom, ujutro i navečer, tako da je ukupna dnevna doza razdijeljena u dvije jednake doze.
English: Doses of up to 3,600 mg/day have been studied in a limited number of patients.
Croatian: Doze do 3600 mg na dan ispitane su na ograničenom broju bolesnika.
English: INFORMATION IN BRAILLE Inovelon 40 mg/ml
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Inovelon 40 mg/ml
English: If you are a woman of childbearing age, you must use contraceptive measures while taking Inovelon.
Croatian: Ako ste žena koja može zatrudnjeti, za vrijeme uzimanja Inovelona morate koristiti kontracepcijske metode.
English: The recommended starting dose is 400 mg (10 ml) a day.
Croatian: Preporučena početna doza je 400 mg (10 ml) na dan.
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 ml of Inovelon oral suspension contains 40 mg rufinamide.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI 1 ml Inovelon oralne suspenzije sadrži 40 mg rufinamida.
English: Each millilitre contains 40 mg of rufinamide.
Croatian: Jedan mililitar sadrži 40 mg rufinamida.
English: Rufinamide concentrations are not subject to clinically relevant changes on co-administration with known enzyme inducing antiepileptic medicinal products.
Croatian: Ne dolazi do klinički važnih promjena koncentracije rufinamida kod istodobne primjene antiepileptičkih lijekova za koje se zna da induciraju enzime.
English: They are available as packs of 10, 30, 50, 60 and 100 film-coated tablets.
Croatian: Dostupne su u pakiranjima od 10, 30, 50, 60 i 100 filmom obloženih tableta.
English: Conventional safety pharmacology studies revealed no special hazards at clinically relevant doses.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije pri klinički važnim dozama.
English: For this patient population, the maximum recommended dose is 30 mg/kg/day (0.75 ml/kg/day).
Croatian: Za ovu populaciju bolesnika, maksimalna preporučena doza je 30 mg/kg na dan (0,75 ml/kg na dan).
English: The recommended starting dose is 200 mg (5 ml) a day.
Croatian: Preporučena početna doza je 200 mg (5 ml) na dan.
English: Use in adults, adolescents and children 4 years of age or older of 30 kg or over
Croatian: Primjena u odraslih, adolescenata i djece u dobi od 4 ili više godina tjelesne težine od 30 kg ili više
English: Eating disorder Decreased appetite Anxiety
Croatian: Poremećaji metabolizma i prehrane poremećaj prehrane smanjen apetit anksioznost Nesanica
English: Doses of up to 4,000 mg/day (100 ml/day) in the 30 -50 kg range or 4,800 mg/day (120 ml/day) in the over 50 kg category have been studied in a limited number of patients.
Croatian: Doze do 4000 mg na dan (100ml na dan) u rasponu tjelesne težine od 30 - 50 kg ili 4800 mg na dan (120 ml na dan) u kategoriji tjelesne težine veće od 50 kg ispitane su na ograničenom broju bolesnika.
English: Tel: + 31 (0) 900 575 3340
Croatian: Tél/Tel: + 31 (0) 900 575 3340
English: A total of 12 patients received any-other AED at the investigator's discretion in the control arm.
Croatian: Ukupno je 12 bolesnika u kontrolnoj skupini primalo neki drugi antiepileptički lijek po izboru ispitivača.
English: Women of childbearing potential
Croatian: Žene koje mogu zatrudnjeti
English: Women of childbearing potential must use contraceptive measures during treatment with Inovelon.
Croatian: Žene reproduktivne dobi moraju primjenjivati kontracepcijske mjere tijekom liječenja Inovelonom.
English: Doses of up to 4,000 mg/day (in the 30 - -50 kg range) or 4,800 mg/day (in the over 50 kg) have been studied in a limited number of patients.
Croatian: Doze do 4000 mg na dan (u rasponu tjelesne težine od 30- - 50 kg) ili 4800 mg na dan (kod tjelesne težine veće od 50 kg) ispitane su na ograničenom broju bolesnika.
English: How to use Inovelon
Croatian: Kako uzimati Inovelon
English: Other associated manifestations included lymphadenopathy, liver function tests abnormalities, and haematuria.
Croatian: Drugi znakovi povezani s ovim poremećajem uključivali su limfadenopatiju, poremećene nalaze testova jetrene funkcije i hematuriju.
English: - The other ingredients are lactose monohydrate, microcrystalline cellulose, maize starch, croscarmellose sodium, hypromellose, magnesium stearate, sodium laurilsulfate and colloidal anhydrous silica.
Croatian: Drugi sastojci su laktoza hidrat, mikrokristalična celuloza, kukuruzni škrob, umrežena karmelozanatrij, hipromeloza, magnezijev stearat, natrijev laurilsulfat i koloidni bezvodni silicijev dioksid.
English: The most common adverse reactions observed at a higher incidence than placebo in patients with Lennox-Gastaut syndrome were somnolence and vomiting.
Croatian: U bolesnika s Lennox-Gastautovim sindromom, najčešće nuspojave koje su opažene u incidenciji većoj nego uz placebo bile su somnolencija i povraćanje.
English: The recommended starting dose is 10 mg for each kilogram of body weight, each day.
Croatian: Preporučena početna doza je 10 mg za svaki kilogram tjelesne težine, svaki dan.
English: Use in patients with hepatic impairment has not been studied.
Croatian: Primjena u bolesnika s oštećenjem funkcije jetre nije ispitana.
English: NAME OF THE MEDICINAL PRODUCT Inovelon 40 mg/ml oral suspension
Croatian: NAZIV LIJEKA Inovelon 40 mg/ml oralna suspenzija
English: In the 13-week study, female bone marrow and lymphoid changes are reported at the high dose with a weak incidence.
Croatian: U tom ispitivanju u trajanju od 13 tjedana, u ženki su kod visokih doza zabilježene promjene u koštanoj srži i limfoidne promjene, ali s niskom incidencijom.
English: Treatment should be initiated at a dose of 10 mg/kg/day (0.25 ml/kg/day) administered in two equally divided doses separated by approximately 12 hours.
Croatian: Liječenje treba započeti dnevnom dozom od 10 mg/kg (0,25 ml/kg na dan) koja se daje podijeljeno u dvije jednake doze u razmaku od približno 12 sati.
English: Maximum daily dose taking valproate is 600 mg each day.
Croatian: Maksimalna dnevna doza ako uzimate valproat je 600 mg svaki dan.
English: Doses of up to 3,600 mg/day (90 ml/day) have been studied in a limited number of patients.
Croatian: Doze do 3600 mg na dan (90 ml na dan) ispitane su na ograničenom broju bolesnika.
English: Maximum daily dose taking valproate is 600 mg (15 ml) each day.
Croatian: Maksimalna dnevna doza ako uzimate valproat je 600 mg (15 ml) svaki dan.
English: Maximum daily dose not taking valproate is 45 mg (1.125 ml) for each kilogram of body weight, each day.
Croatian: Maksimalna dnevna doza ako ne uzimate valproat je 45 mg (1,125 ml) za svaki kilogram tjelesne težine, svaki dan.
English: Hypromellose Macrogols (8000) Titanium dioxide (E171) Talc
Croatian: Film ovojnica hipromeloza makrogol (8000) titanijev dioksid (E171) talk željezov oksid, crveni (E172)
English: Treatment should be initiated at a dose of 10 mg/kg/day administered in two equally divided doses separated by approximately 12 hours.
Croatian: Liječenje treba započeti dnevnom dozom od 10 mg/kg, koja se daje podijeljeno u dvije jednake doze u razmaku od približno 12 sati.
English: The recommended starting dose is 10 mg (0.25 ml) for each kilogram of body weight, each day.
Croatian: Preporučena početna doza je 10 mg (0,25 ml) za svaki kilogram tjelesne težine, svaki dan.
English: 2,200 mg/day or 55 ml/day
Croatian: 2200 mg na dan ili 55 ml na dan
English: Maximum daily dose not taking valproate is 1,000 mg (25 ml) each day.
Croatian: Maksimalna dnevna doza ako ne uzimate valproat je 1000 mg (25 ml) svaki dan.
English: Maximum daily dose not taking valproate is 1,000 mg each day.
Croatian: Maksimalna dnevna doza ako ne uzimate valproat je 1000 mg svaki dan.
English: The dose will be calculated for you by the doctor and may be increased by 200 mg (5 ml) every third day.
Croatian: Dozu će izračunati liječnik i može je povećavati za 200 mg (5 ml) svaki treći dan.
English: Inovelon 100 mg film-coated tablets Inovelon 200 mg film-coated tablets Inovelon 400 mg film-coated tablets Rufinamide
Croatian: Inovelon 100 mg filmom obložene tablete Inovelon 200 mg filmom obložene tablete Inovelon 400 mg filmom obložene tablete rufinamid
English: The dose will be calculated for you by the doctor and may be increased by 400 mg (10 ml) every other day.
Croatian: Dozu će izračunati liječnik i može je povećavati za 400 mg (10 ml) svaki drugi dan.
English: As valproate significantly decreases clearance of rufinamide, a lower maximum dose of Inovelon is recommended for patients being co-administered valproate.
Croatian: Budući da valproat značajno smanjuje klirens rufinamida, u bolesnika kojima se istodobno daje valproat preporučuje se niža maksimalna doza Inovelona.
English: Maximum daily dose taking valproate is 30 mg (0.75 ml) for each kilogram of body weight, each day.
Croatian: Maksimalna dnevna doza ako uzimate valproat je 30 mg (0,75 ml) za svaki kilogram tjelesne težine, svaki dan.
English: For this patient population, the maximum recommended dose is 30 mg/kg/day.
Croatian: Za ovu populaciju bolesnika, maksimalna preporučena doza je 30 mg/kg na dan.
English: 3,200 mg/day or 80 ml/day
Croatian: 3200 mg na dan ili 80 ml na dan
English: Children 4 years of age or older weighing less than 30 kg
Croatian: Djeca u dobi od 4 ili više godina, tjelesne težina manje od 30 kg
English: 2,400 mg/day or 60 ml/day
Croatian: 2400 mg na dan ili 60 ml na dan
English: 1,200 mg/day or 30 ml/day
Croatian: 1200 mg na dan ili 30 ml na dan
English: Nasogastric tube (NG): Polyvinyl chloride (PVC) tube of not greater than 40 cm in length and diameter of tube 5 Fr. To ensure adequate dosing, after administration of the oral suspension, the enteral feeding tube must be flushed at least once with 1 ml of water.
Croatian: Nazogastrična sonda (NG): sonda od polivinil klorida (PVC) ne veća od 40 cm dužine i promjera sonde 5 Fr.
English: Physicians should try to ensure that appropriate contraception is used, and should use clinical judgement when assessing whether oral contraceptives, or the doses of the oral contraceptive components, are adequate, based on the individual patients clinical situation (see sections 4.5 and 4.6).
Croatian: Liječnici trebaju pokušati osigurati da se koristi odgovarajuća kontracepcija i na temelju kliničke procjene odlučiti jesu li oralni kontraceptivi ili doze komponenti oralnih kontraceptiva odgovarajući za pojedinu bolesnicu, s obzirom na njezinu kliničku situaciju (vidjeti dijelove 4.5 i 4.6).
English: EXPIRY DATE EXP (MM/YYYY)
Croatian: ROK VALJANOSTI Rok valjanosti (MM/GGGG)
English: Physicians should try to ensure that appropriate contraception is used, and should use clinical judgement when assessing whether oral contraceptives, or the doses of the oral contraceptive components, are adequate based on the individual patients clinical situation (see sections 4.4 and 4.5).
Croatian: Liječnici bi trebali pokušati osigurati da se koristi odgovarajuća kontracepcija i na temelju kliničke procjene odlučiti jesu li oralni kontraceptivi ili doze komponenti oralnih kontraceptiva odgovarajući za pojedinu bolesnicu s obzirom na njezinu kliničku situaciju (vidjeti dijelove 4.4 i 4.5).
English: For this patient population, the maximum recommended dose is 45 mg/kg/day.
Croatian: Za ovu populaciju bolesnika, maksimalna preporučena doza je 45 mg/kg na dan.
English: As valproate significantly decreases clearance of rufinamide, a lower maximum dose of Inovelon is recommended for patients < 30 kg being co-administered valproate.
Croatian: Budući da valproat značajno smanjuje klirens rufinamida, u bolesnika s tjelesnom težinom < 30 kg kojima se istodobno daje valproat preporučuje se niža maksimalna doza Inovelona.