FrancophonIA/ELRC3.0 huggingface dataset:
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).
Slovenian: Zdravniki morajo poskusiti zagotoviti, da bolnice uporabljajo ustrezno kontracepcijo, in naj pri ocenjevanju, ali zadostujejo peroralni kontraceptivi oziroma odmerki posameznih sestavin v peroralnih kontraceptivih, uporabljajo klinično presojo na podlagi kliničnega položaja posameznih bolnic (glejte poglavji 4.5 in 4.6).
English: Rufinamide was not teratogenic in mice, rats or rabbits.
Slovenian: Pri miših, podganah in kuncih rufinamid ni bil teratogen.
English: Tel: + 31 (0) 900 575 3340
Slovenian: Tél/Tel: + 31 (0) 900 575 3340
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).
Slovenian: Zdravniki morajo poskusiti zagotoviti, da bolnice uporabljajo ustrezno kontracepcijo, in naj pri ocenjevanju, ali zadostujejo peroralni kontraceptivi oziroma odmerki posameznih sestavin v peroralnih kontraceptivih, uporabljajo klinično presojo na podlagi kliničnega položaja posameznih bolnic (glejte poglavje 4.4 in 4.5).
English: Each millilitre contains 40 mg of rufinamide.
Slovenian: En mililiter vsebuje 40 mg rufinamida.
English: Each carton contains one bottle, two identical calibrated oral dosing syringes and a press-in-bottle adapter (PIBA).
Slovenian: Ena škatla vsebuje eno plastenko, dve identični umerjeni brizgi za peroralno odmerjanje in vtisljivi nastavek PIBA.
English: For this patient population, the maximum recommended dose is 30 mg/kg/day (0.75 ml/kg/day).
Slovenian: Pri tej populaciji bolnikov je največji priporočeni odmerek 30 mg/kg/dan (0,75 ml/kg/dan).
English: Problems associated with the stomach including: stomach pain, constipation, indigestion, loose stools (diarrhoea), loss or change in appetite, weight loss.
Slovenian: težave, povezane z želodcem, med drugim: bolečine v želodcu, zaprtje, prebavne motnje, redko blato (driska), izguba ali sprememba teka, izguba telesne mase.
English: How to store Inovelon
Slovenian: Kako jemati zdravilo Inovelon
English: Adults, adolescents and children weighing 30 kg or over
Slovenian: Odrasli, mladostniki in otroci s telesno maso 30 kg ali več
English: They are available as packs of 10, 30, 50, 60 and 100 film-coated tablets.
Slovenian: Na voljo so v škatlah, v katerih je po 10, 30, 50, 60 ali 100 filmsko obloženih tablet.
English: Caution and careful dose titration is recommended when treating patients with mild to moderate hepatic impairment.
Slovenian: Pri zdravljenju bolnikov z blago do zmerno okvaro jeter priporočamo previdnost in skrbno titriranje odmerka.
English: Oligomenorrhoea
Slovenian: Okvara ledvic
English: Rufinamide is metabolised by hydrolysis, and is not metabolised to any notable degree by cytochrome P450 enzymes.
Slovenian: Rufinamid se presnavlja s hidrolizo, encimi s citokromom P450 pa ga ne presnavljajo v znatnejši meri.
English: Treatment should be initiated at a daily dose of 400 mg (10 ml dosing suspension given as two 5 ml doses).
Slovenian: Zdravljenje je treba začeti z dnevnim odmerkom 400 mg (odmerek 10 ml suspenzije v obliki dveh 5 ml odmerkov).
English: Rufinamide is almost exclusively eliminated by metabolism.
Slovenian: Rufinamid se odstranjuje iz telesa skoraj samo s presnovo.
English: Tell the doctor if you are taking the blood thinner - warfarin.
Slovenian: Obvestite svojega zdravnika, če jemljete zdravilo za redčenje krvi varfarin.
English: Maximum daily dose taking valproate is 600 mg each day.
Slovenian: Največji dnevni odmerek, če jemljete valproat, je 600 mg na dan.
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.
Slovenian: Pediatrična populacija (starost od 1 do manj kot 4 leta) V multicentrični, odprti študiji, v kateri so primerjali dodatek rufinamida s katerim koli drugim antiepileptičnim zdravilom po presoji raziskovalca obstoječi shemi 1 do 3 antiepileptičnih zdravil pri pediatričnih bolnikih, starih od 1 do manj kot 4 leta, z nezadostno kontroliranim LGS, je bilo 25 bolnikov, od katerih je bilo 10 bolnikov starih 1 do 2 leti, 24 tednov izpostavljenih rufinamidu kot adjuvantnemu zdravilu v odmerku do 45 mg/kg/dan v 2 razdeljenih odmerkih.
English: Maximum daily dose not taking valproate is 45 mg (1.125 ml) for each kilogram of body weight, each day.
Slovenian: Največji dnevni odmerek, če ne jemljete valproata, je 45 mg (1,125 ml) na kilogram telesne mase vsak dan.
English: Treatment should be initiated at a dose of 10 mg/kg/day administered in two equally divided doses separated by approximately 12 hours.
Slovenian: Zdravljenje je treba začeti z odmerkom 10 mg/kg/dan, ki ga dajemo v dveh enakomerno razdeljenih odmerkih s presledkom približno 12 ur.
English: In the 13-week study, female bone marrow and lymphoid changes are reported at the high dose with a weak incidence.
Slovenian: V 13-tedenski študiji so pri visokih odmerkih z nizko incidenco poročali o spremembah kostnega mozga pri ženskih osebkih in o limfoidnih spremembah.
English: Maximum daily dose taking valproate is 30 mg (0.75 ml) for each kilogram of body weight, each day.
Slovenian: Največji dnevni odmerek, če jemljete valproat, je 30 mg (0,75 ml) na kilogram telesne mase vsak dan.
English: The pharmacokinetics of a single 400 mg dose of rufinamide were not altered in subjects with chronic and severe renal failure compared to healthy volunteers.
Slovenian: V primerjavi z zdravimi prostovoljci se pri osebah s kronično in težko ledvično odpovedjo farmakokinetika enkratnega 400-miligramskega odmerka rufinamida ni spremenila.
English: NAME OF THE MEDICINAL PRODUCT Inovelon 40 mg/ml oral suspension
Slovenian: IME ZDRAVILA Inovelon 40 mg/ml peroralna suspenzija
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 ml of Inovelon oral suspension contains 40 mg rufinamide.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN 1 ml peroralne suspenzije zdravila Inovelon vsebuje 40 mg rufinamida.
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.
Slovenian: Zdravljenje je treba začeti z odmerkom 10 mg/kg/dan (0,25 ml/kg/dan), ki ga dajemo v dveh enakomerno razdeljenih odmerkih s presledkom približno 12 ur.
English: Hypromellose Macrogols (8000) Titanium dioxide (E171) Talc
Slovenian: Filmska obloga hipromeloza makrogoli (8000) titanov dioksid (E171) smukec rdeči železov oksid (E172)
English: Maximum daily dose taking valproate is 600 mg (15 ml) each day.
Slovenian: Največji dnevni odmerek, če jemljete valproat, je 600 mg (15 ml) na dan.
English: EU/1/06/378/011-016
Slovenian: EU/1/06/378/001-005 EU/1/06/378/006-010 EU/1/06/378/011-016
English: Turn upright and remove the syringe
Slovenian: Plastenko obrnite v navpičen položaj in izvlecite brizgo.
English: Warnings and precautions Talk to your doctor or pharmacist if: - you have Congenital Short QT Syndrome or a family history of such a syndrome (electrical disturbance of the heart), as taking rufinamide could make it worse.
Slovenian: Posvetujte se z zdravnikom ali farmacevtom, če: - imate sindrom prirojenega kratkega intervala QT ali družinsko anamnezo tega sindroma
English: For this patient population, the maximum recommended dose is 30 mg/kg/day.
Slovenian: Pri tej populaciji bolnikov je največji priporočeni odmerek 30 mg/kg/dan.
English: Alternatively, use the score line to break the tablet into two equal halves.
Slovenian: Druga možnost je razdelitev tablete na zarezi na enaki polovici.
English: - If you get any side effects, talk to the doctor or pharmacist.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom ali farmacevtom.
English: Maximum daily dose not taking valproate is 1,000 mg each day.
Slovenian: Največji dnevni odmerek, če ne jemljete valproata, je 1.000 mg na dan.
English: 1 bottle contains 18400 mg rufinamide.
Slovenian: 1 plastenka vsebuje 18.400 mg rufinamida.
English: Doses of up to 3,600 mg/day (90 ml/day) have been studied in a limited number of patients.
Slovenian: Pri omejenem številu bolnikov so proučevali odmerke do 3.600 mg/dan (90 ml/dan).
English: The dose will be calculated for you by the doctor and may be increased by 400 mg every other day.
Slovenian: Odmerek bo izračunal zdravnik in ga lahko vsak drugi dan poveča v korakih po 400 mg.
English: Maximum daily dose not taking valproate is 1,000 mg (25 ml) each day.
Slovenian: Največji dnevni odmerek, če ne jemljete valproata, je 1.000 mg (25 ml) na dan.
English: What Inovelon contains
Slovenian: Kaj vsebuje zdravilo Inovelon
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.
Slovenian: Pri omejenem številu bolnikov so proučevali odmerke do 4.000 mg/dan (v razponu telesne mase 30 - 50 kg) oziroma do 4.800 mg/dan (preko 50 kg).
English: The dose will be calculated for you by the doctor and may be increased by 10 mg (0.25 ml) for each kilogram of body weight, every third day.
Slovenian: Odmerek bo izračunal zdravnik in ga lahko vsak tretji dan poveča v korakih po 10 mg (0,25 ml) na kilogram telesne mase.
English: As valproate significantly decreases clearance of rufinamide, a lower maximum dose of Inovelon is recommended for patients < 30 kg being co-administered valproate.
Slovenian: Ker valproat signifikantno zmanjša očistek rufinamida, priporočamo bolnikom s telesno maso, manjšo od 30 kg, ki sočasno jemljejo valproat, manjši maksimalni odmerek zdravila Inovelon.
English: Inovelon 100 mg film-coated tablets Inovelon 200 mg film-coated tablets Inovelon 400 mg film-coated tablets Rufinamide
Slovenian: Inovelon 100 mg filmsko obložene tablete Inovelon 200 mg filmsko obložene tablete Inovelon 400 mg filmsko obložene tablete rufinamid
English: The cap should be replaced after each use.
Slovenian: Po vsaki uporabi ponovno namestite zaporko.
English: 2,200 mg/day or 55 ml/day
Slovenian: 2.200 mg/dan ali 55 ml/dan
English: Suicidal ideation and behaviour have been reported in patients treated with antiepileptic agents in several indications.
Slovenian: Pri bolnikih, zdravljenih z antiepileptiki, so za številne indikacije poročali o samomorilnih mislih in vedenju.
English: The dose will be calculated for you by the doctor and may be increased by 200 mg every third day.
Slovenian: Odmerek bo izračunal zdravnik in ga lahko vsak tretji dan poveča v korakih po 200 mg.
English: For this patient population, the maximum recommended dose is 45 mg/kg/day.
Slovenian: Pri tej populaciji bolnikov je največji priporočeni odmerek 45 mg/kg/dan.
English: Very common (more than 1 in 10 patients) side effects of Inovelon are:
Slovenian: Obvestite svojega zdravnika, če opazite katerega od spodaj navedenih neželenih učinkov: Zelo pogosti neželeni učinki (pojavijo se pri več kot 1 od 10 bolnikov) zdravila Inovelon so:
English: Musculoskeletal and connective tissue and bone disorders
Slovenian: Bolezni mišično-skeletne ga sistema, vezivnega tkiva in kosti bolečina v hrbtu
English: 1,800 mg/day or 45 ml/day
Slovenian: 1.800 mg/dan ali 45 ml/dan
English: Also contains methyl parahydroxybenzoate (E218) propyl parahydroxybenzoate (E216) sorbitol (E420)
Slovenian: Vsebuje tudi metilparahidroksibenzoat (E218), propilparahidroksibenzoat (E216), sorbitol (E420).
English: According to clinical response and tolerability, the dose may be increased by 400 mg/day increments, as frequently as every other day, up to a maximum recommended dose as indicated in the table below.
Slovenian: Glede na klinični odziv in prenašanje zdravila lahko odmerek postopoma povečujemo po 400 mg/dan celo vsak drugi dan do največjega priporočenega odmerka, navedenega v spodnji preglednici.
English: Maximum daily dose taking valproate is no more than 2,200 mg (55 ml), depending on body weight.
Slovenian: Največji dnevni odmerek, če jemljete valproat, je 2.200 mg (55 ml), odvisno od vaše telesne mase.
English: Children 4 years of age or older weighing less than 30 kg
Slovenian: Otroci, stari 4 leta ali več, s telesno maso manjšo od 30 kg
English: 2,400 mg/day or 60 ml/day
Slovenian: 2.400 mg/dan ali 60 ml/dan
English: According to clinical response and tolerability, the dose may be increased by 200 mg/day increments, as frequently as every third day, up to a maximum recommended dose of 1,000 mg/day (25 ml/day).
Slovenian: Glede na klinični odziv in prenašanje zdravila lahko odmerek postopoma povečujemo po 200 mg/dan celo vsak tretji dan do največjega priporočenega odmerka 1.000 mg/dan (25 ml/dan).
English: Conventional safety pharmacology studies revealed no special hazards at clinically relevant doses.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti ne kažejo posebnega tveganja za človeka.
English: Maximum daily dose not taking valproate is no more than 3,200 mg (80 ml), depending on body weight.
Slovenian: Največji dnevni odmerek, če ne jemljete valproata, je 3.200 mg (80 ml), odvisno od vaše telesne mase.
English: Maximum daily dose taking valproate is 30 mg for each kilogram of body weight, each day.
Slovenian: Največji dnevni odmerek, če jemljete valproat, je 30 mg na kilogram telesne mase vsak dan.
English: 3,200 mg/day or 80 ml/day
Slovenian: 3.200 mg/dan ali 80 ml/dan
English: 1,800 mg/day
Slovenian: 1.800 mg/dan
English: The dose will be calculated for you by the doctor and may be increased by 10 mg for each kilogram of body weight, every third day.
Slovenian: Odmerek bo izračunal zdravnik in ga lahko vsak tretji dan poveča v korakih po 10 mg na kilogram telesne mase.
English: Each 200 mg film-coated tablet contains 40 mg lactose (as monohydrate).
Slovenian: Ena 200-miligramska filmsko obložena tableta vsebuje 40 mg laktoze (v obliki monohidrata).
English: Each 100 mg film-coated tablet contains 20 mg lactose (as monohydrate).
Slovenian: Ena 100-miligramska filmsko obložena tableta vsebuje 20 mg laktoze (v obliki monohidrata).
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.
Slovenian: Priporočamo, da v začetku in po koncu zdravljenja z rufinamidom ter po vsaki večji spremembi odmerka dva tedna skrbno spremljate bolnike, zdravljene z učinkovinami, ki jih presnavlja encimski sistem CYP3A4.
English: Maximum daily dose not taking valproate is 45 mg for each kilogram of body weight, each day.
Slovenian: Največji dnevni odmerek, če ne jemljete valproata, je 45 mg na kilogram telesne mase vsak dan.
English: Each 400 mg film-coated tablet contains 80 mg lactose (as monohydrate).
Slovenian: Ena 400-miligramska filmsko obložena tableta vsebuje 80 mg laktoze (v obliki monohidrata).
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.
Slovenian: Pri omejenem številu bolnikov so proučevali odmerke do 4.000 mg/dan (100 ml/dan) pri bolnikih z razponom telesne mase 30 - 50 kg oziroma do 4.800 mg/dan (120 ml/dan) pri bolnikih s telesno maso več kot 50 kg.
English: 1,200 mg/day or 30 ml/day
Slovenian: 1.200 mg/dan ali 30 ml/dan
English: There are insufficient data on the withdrawal of concomitant antiepileptic medicinal products once seizure control has been achieved with the addition of rufinamide.
Slovenian: V kliničnih študijah so dosegli ukinitev zdravila tako, da so odmerek zmanjševali za približno 25 % vsak drugi dan. O ukinjanju sočasnih antiepileptičnih zdravil, potem ko obvladamo epileptične napade z dodatkom rufinamida, ni na voljo dovolj podatkov.
English: INFORMATION IN BRAILLE Inovelon 200 mg tablets
Slovenian: PODATKI V BRAILLOVI PISAVI Inovelon 200 mg tablete
English: Croscarmellose sodium Hypromellose Magnesium stearate Sodium laurilsulfate Silica colloidal, anhydrous
Slovenian: Jedro laktoza monohidrat mikrokristalna celuloza koruzni škrob premreženi natrijev karmelozat hipromeloza magnezijev stearat natrijev lavrilsulfat brezvodni koloidni silicijev dioksid
English: Tremor Diplopia Vision blurred
Slovenian: Očesne bolezni dvojni vid zamegljen vid
English: INFORMATION IN BRAILLE Inovelon 400 mg tablets
Slovenian: PODATKI V BRAILLOVI PISAVI Inovelon 400 mg tablete
English: Cytochrome P450-mediated metabolism is very minor.
Slovenian: Presnova, ki jo posreduje citokrom P450, je komaj pomembna.
English: According to clinical response and tolerability, the dose may be increased by up to 10 mg/kg/day (0.25 ml/kg/day) every third day to a target dose of 45 mg/kg/day (1.125 ml/kg/day) administered in two equally divided doses separated by approximately 12 hours.
Slovenian: Odmerek se lahko glede na klinični odziv in prenašanje poveča do 10 mg/kg/dan (0,25 ml/kg/dan) vsak tretji dan do ciljnega odmerka 45 mg/kg/dan (1,125 ml/kg/dan), ki se daje v dveh enakomerno razdeljenih odmerkih s presledkom približno 12 ur.
English: 1,600 mg/day or 40 ml/day
Slovenian: 1.600 mg/dan ali 40 ml/dan
English: Use in children 4 years of age or older and less than 30 kg
Slovenian: Uporaba pri otrocih, starih 4 leta ali starejših, katerih telesna masa ne presega 30 kg
English: 2,400 mg/day
Slovenian: 2.400 mg/dan
English: You are advised not to breast-feed while taking Inovelon, as it is not known if rufinamide will be present in breast milk.
Slovenian: Ker ni znano, ali je rufinamid prisoten v materinem mleku, se dojenje v času jemanja zdravila Inovelon odsvetuje.
English: INFORMATION IN BRAILLE Inovelon 100 mg tablets
Slovenian: PODATKI V BRAILLOVI PISAVI Inovelon 100 mg tablete
English: 1,600 mg/day
Slovenian: 1.600 mg/dan
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/378/001-005
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/06/378/001-005
English: Reproductive system and breast disorders
Slovenian: Motnje reprodukcije in dojk oligomenoreja
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/378/011-016
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/06/378/011-016
English: According to clinical response and tolerability, after a minimum of 2 days the dose may be increased by 200 mg/day, to the maximum recommended dose of 600 mg/day (15 ml/day).
Slovenian: Zdravljenje je treba začeti z dnevnim odmerkom 200 mg. Glede na klinični odziv in prenašanje zdravila lahko čez najmanj 2 dni odmerek povečamo za 200 mg/dan do največjega priporočenega odmerka, ki je 600 mg/dan (15 ml/dan).
English: Leave the adaptor in place and replace cap on bottle.
Slovenian: Nastavek pustite v plastenki in jo zaprite z zaporko.
English: According to clinical response and tolerability, the dose may be increased by up to 10 mg/kg/day (0.25 ml/kg/day) every third day to a target dose of 30 mg/kg/day (0.75 ml/kg/day) administered in two equally divided doses separated by approximately 12 hours.
Slovenian: Odmerek se lahko glede na klinični odziv in prenašanje poveča do 10 mg/kg/dan (0,25 ml/kg/dan) vsak tretji dan do ciljnega odmerka 30 mg/kg/dan (0,75 ml/kg/dan), ki se daje v dveh enakomerno razdeljenih odmerkih s presledkom približno 12 ur.
English: Inovelon 400 mg film-coated tablets
Slovenian: Inovelon 400 mg filmsko obložene tablete rufinamid
English: 400 mg: Pink, ‘ovaloid', slightly convex, approximately 18.2 mm in length, scored on both sides, embossed ‘Є263' on one side and blank on the other side.
Slovenian: 400 mg: rožnata, približno ovalna, rahlo konveksna, dolga približno 18,2 mm, z zarezo na obeh straneh, z vtisnjenim napisom ‘Є263' na eni strani in brez napisa na drugi strani.
English: Somnolence* Status epilepticus* Convulsion
Slovenian: Psihiatrične motnje epileptični status* konvulzije motena koordinacija* nistagmus psihomotorična hiperaktivnost
English: 3,200 mg/day
Slovenian: 3.200 mg/dan
English: Inovelon 200 mg film-coated tablets
Slovenian: Inovelon 200 mg filmsko obložene tablete rufinamid
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/378/006-010
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/06/378/006-010
English: Nervous system disorders
Slovenian: Bolezni živčevja tremor
English: 200 mg: Pink, ‘ovaloid', slightly convex, approximately 15.2 mm in length, scored on both sides, embossed ‘Є262' on one side and blank on the other side.
Slovenian: 200 mg: rožnata, približno ovalna, rahlo konveksna, dolga približno 15,2 mm, z zarezo na obeh straneh, z vtisnjenim napisom ‘Є262' na eni strani in brez napisa na drugi strani.
English: 1,200 mg/day
Slovenian: 1.200 mg/dan
English: Patients < 30 kg not receiving valproate:
Slovenian: Bolniki s telesno maso, manjšo od 30 kg, ki ne prejemajo valproata:
English: 100 mg: Pink, ‘ovaloid', slightly convex, approximately 10.2 mm in length, scored on both sides, embossed ‘Є261' on one side and blank on the other side.
Slovenian: 100 mg: rožnata, približno ovalna, rahlo konveksna, dolga približno 10,2 mm, z zarezo na obeh straneh, z vtisnjenim napisom ‘Є261' na eni strani in brez napisa na drugi strani.
English: Problems associated with nerves including: difficulty walking, abnormal movement, convulsions/seizures, unusual eye movements, blurred vision, trembling.
Slovenian: težave, povezane z želodcem, med drugim: bolečine v želodcu, zaprtje, prebavne motnje, redko blato (driska), izguba ali sprememba teka, hujšanje.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/378/017
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/06/378/017
English: - Inovelon 400 mg tablets are pink, oval, slightly convex film-coated tablets, scored on both sides, embossed ‘Є263' on one side and blank on the other side.
Slovenian: - Inovelon 400 mg tablete so rožnate, ovalne, rahlo konveksne filmsko obložene tablete, z zarezo na obeh straneh, z vtisnjenim napisom ‘Є263' na eni strani in brez napisa na drugi strani.
English: Maximum daily dose not taking valproate is no more than 3,200 mg, depending on body weight.
Slovenian: Največji dnevni odmerek, če ne jemljete valproata, je 3.200 mg na dan, odvisno od vaše telesne mase.
English: - Inovelon 100 mg tablets are pink, oval, slightly convex film-coated tablets, scored on both sides, embossed ‘Є261' on one side and blank on the other side.
Slovenian: - Inovelon 100 mg tablete so rožnate, ovalne, rahlo konveksne filmsko obložene tablete, z zarezo na obeh straneh, z vtisnjenim napisom ‘Є261' na eni strani in brez napisa na drugi strani.
English: Each 400 mg film-coated tablet contains 400 mg of rufinamide.
Slovenian: Ena 400-miligramska filmsko obložena tableta vsebuje 400 mg rufinamida.
English: Each 200 mg film-coated tablet contains 200 mg of rufinamide.
Slovenian: Ena 200-miligramska filmsko obložena tableta vsebuje 200 mg rufinamida.
English: Each 100 mg film-coated tablet contains 100 mg of rufinamide.
Slovenian: Ena 100-miligramska filmsko obložena tableta vsebuje 100 mg rufinamida.
English: According to clinical response and tolerability, the dose may be increased by up to 10 mg/kg/day every third day to a target dose of 30 mg/kg/day administered in two equally divided doses separated by approximately 12 hours.
Slovenian: Odmerek se lahko glede na klinični odziv in prenašanje poveča do 10 mg/kg/dan vsak tretji dan do ciljnega odmerka 30 mg/kg/dan, ki se daje v dveh enakomerno razdeljenih odmerkih s presledkom približno 12 ur.