FrancophonIA/ELRC3.0 huggingface dataset:
English: These recommendations should also be considered when rufinamide is used concomitantly with substances with a narrow therapeutic window such as warfarin and digoxin.
Slovenian: Ta priporočila veljajo tudi takrat, ko se rufinamid uporablja sočasno z učinkovinami z majhno terapevtsko širino, na primer z varfarinom in digoksinom.
English: If you experience side effects, your doctor may increase the dose more slowly.
Slovenian: Če opazite neželene učinke, vam lahko zdravnik povečuje odmerek počasneje.
English: Turn upside down and withdraw the prescribed amount of Inovelon from the bottle.
Slovenian: Plastenko obrnite navzdol in izvlecite predpisano količino zdravila Inovelon iz plastenke.
English: Furthermore, rufinamide does not inhibit the activity of cytochrome P450 enzymes (see section 5.2).
Slovenian: Nadalje rufinamid ne zavira aktivnosti encimov s citokromom P450 (glejte poglavje 5.2).
English: - Inovelon is a white slightly viscous suspension.
Slovenian: - Zdravilo Inovelon je bela, nekoliko viskozna suspenzija.
English: Population pharmacokinetic/pharmacodynamic modelling demonstrated that the reduction of total and tonic-atonic seizure frequencies, the improvement of the global evaluation of seizure severity and the increase in probability of reduction of seizure frequency were dependent on rufinamide concentrations.
Slovenian: Populacijsko modeliranje farmakokinetike/farmakodinamike je pokazalo, da je bilo zmanjšanje pogostnosti vseh napadov in tonično-atoničnih napadov, izboljšanje globalne ocene teže napadov in zvečanje verjetnosti zmanjšanja pogostnosti napadov odvisno od koncentracij rufinamida.
English: The mean CYP3A4 activity, assessed as clearance of triazolam, was increased by 55% after 11 days of treatment with rufinamide 400 mg twice daily.
Slovenian: Povprečna aktivnost CYP3A4, ocenjena kot očistek triazolama, se je po 11 dneh zdravljenja z rufinamidom v odmerku 400 mg dvakrat na dan zvišala za 55 %.
English: If you take more Inovelon than you should
Slovenian: Če ste vzeli večji odmerek zdravila Inovelon, kot bi smeli
English: Other antiepileptic medicinal products
Slovenian: Druga antiepileptična zdravila
English: Oriented-polyethylene terephthalate (o-PET) bottle with a child-resistant polypropylene (PP) closure; each bottle contains 460 ml of suspension in an outer cardboard carton.
Slovenian: Plastenka iz orientiranega polietilen tereftalata (o-PET) z za otroke varno polipropilensko (PP) zaporko; ena plastenka vsebuje 460 ml suspenzije v zunanji kartonasti škatli.
English: The prescribed dose of Inovelon oral suspension can be administered via an enteral feeding tube.
Slovenian: Predpisani odmerek peroralne suspenzije Inovelon se lahko daje prek cevke za enteralno hranjenje.
English: In clinical trials rufinamide discontinuation was achieved by reducing the dose by approximately 25% every two days (see section 4.4).
Slovenian: V kliničnih preskušanjih so dosegli ukinitev rufinamida tako, da so odmerek zmanjševali za približno 25 % vsak drugi dan (glejte poglavje 4.4).
English: Tell the doctor if you are taking hormonal/oral contraceptives, e.g., “The pill”.
Slovenian: Obvestite svojega zdravnika, če jemljete hormonske/peroralne kontraceptive, na primer »tabletko«.
English: What Inovelon is and what it is used for
Slovenian: Kaj je zdravilo Inovelon in za kaj ga uporabljamo
English: - you experience difficulty walking, abnormal movement, dizziness or sleepiness inform the doctor, if any of these happen.
Slovenian: - opazite težave s hojo, neobičajne gibe, omotičnost ali zaspanost, to povejte zdravniku, če se zgodi kaj od navedenega.
English: Marketing Authorisation Holder: Eisai GmbH
Slovenian: Imetnik dovoljenja za promet: Eisai GmbH
English: - if you are allergic to rufinamide or triazole derivatives or any of the other ingredients of Inovelon (listed in section 6).
Slovenian: - če ste alergični na rufinamid ali derivate triazola ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Status epilepticus cases have been observed during treatment with rufinamide in clinical development studies, whereas no such cases were observed with placebo.
Slovenian: V kliničnih razvojnih študijah so med zdravljenjem z rufinamidom zasledili primere epileptičnega statusa, medtem ko takih primerov pri placebu niso zasledili.
English: The most commonly reported adverse reactions overall were headache, dizziness, fatigue, and somnolence.
Slovenian: Neželeni učinki, o katerih so na splošno najpogosteje poročali, so bili glavobol, omotica, utrujenost in zaspanost.
English: Maximum plasma levels are reached approximately 6 hours after administration.
Slovenian: Najvišje koncentracije v plazmi so dosežene približno 6 ur po uporabi zdravila.
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.
Slovenian: Neželeni učinki z incidenco, večjo od placeba, v dvojno slepih študijah Lennox-Gastautovega sindroma ali v celotni populaciji, izpostavljeni rufinamidu, so navedeni v spodnji preglednici po imenih, organskih sistemih in pogostnosti, ki jih predpisuje MedDRA.
English: Rufinamide should be withdrawn gradually to reduce the possibility of seizures on withdrawal.
Slovenian: Rufinamid moramo ukinjati postopoma, da zmanjšamo možnost napadov krčev ob ukinitvi zdravila.
English: When rufinamide treatment is to be discontinued, it should be withdrawn gradually.
Slovenian: Ko želimo zdravljenje z rufinamidom prekiniti, moramo to storiti postopoma.
English: A study in patients with severe renal impairment indicated that no dose adjustments are required for these patients (see section 5.2).
Slovenian: Študija pri bolnikih s hudo okvaro ledvic je pokazala, da prilagajanje odmerkov pri teh bolnikih ni potrebno (glejte poglavje 5.2).
English: Lennox-Gastaut syndrome is the name given to a group of severe epilepsies in which you may experience repeated seizures of various types.
Slovenian: Lennox-Gastautov sindrom je poimenovanje skupine hude epilepsije, ko doživljate ponavljajoče se epileptične napade različnih vrst.
English: If the recommended calculated dose of Inovelon is not achievable, the dose should be given to the nearest 0.5 ml of rufinamide.
Slovenian: Če priporočenega izračunanega odmerka zdravila Inovelon ni mogoče doseči, moramo dati odmerek, ki je najbližji 0,5 ml rufinamida.
English: Hypersensitivity*
Slovenian: Sindrom preobčutljivosti*
English: You must only take Inovelon during your pregnancy if the doctor tells you to.
Slovenian: Med nosečnostjo lahko zdravilo Inovelon jemljete le, če vam to svetuje zdravnik.
English: An adverse effect not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to human use, was myelofibrosis of the bone marrow in the mouse carcinogenicity study.
Slovenian: Neželen učinek, ki ga niso opažali v kliničnih študijah, ugotovili pa so ga pri živalih pri izpostavljenostih, ki so bile podobne kot klinična izpostavljenost in z možno relevantnostjo za uporabo pri ljudeh, je bila mielofibroza kostnega mozga v študiji kancerogenosti pri miših.
English: It belongs to a group of medicines called antiepileptics, which are used to treat epilepsy (a condition where someone has seizures or fits).
Slovenian: Sodi v skupino zdravil, imenovanih antiepileptiki, ki se uporabljajo za zdravljenje epilepsije (bolezen z epileptičnimi napadi ali krči).
English: Inovelon may cause dizziness, somnolence and blurred vision.
Slovenian: Inovelon lahko povzroči vrtoglavost, zaspanost in zamegljen vid.
English: Preparation: The press-in-bottle adapter (PIBA) which is supplied in the product carton should be inserted firmly into the neck of the bottle before use and remain in place for the duration of the usage of the bottle.
Slovenian: Priprava: Vtisljivi nastavek PIBA, priložen v škatli z zdravilom, pred uporabo čvrsto vstavite v grlo plastenke, kjer naj ostane ves čas uporabe plastenke.
English: The most common adverse reactions resulting in discontinuation from the rufinamide treatment group were rash and vomiting.
Slovenian: Najpogostejša neželena učinka, ki sta povzročila izključitev iz skupine zdravljenja z rufinamidom, sta bila izpuščaj in bruhanje.
English: Antiepileptic medicines and Inovelon
Slovenian: Antiepileptična zdravila in zdravilo Inovelon
English: Peak concentration (Cmax) and plasma AUC of rufinamide increase less than proportionally with doses in both fasted and fed healthy subjects and in patients, probably due to dose-limited absorption behaviour.
Slovenian: Najvišja koncentracija (Cmax) in plazemska AUC rufinamida se zvečata manj kot sorazmerno odmerkom pri zdravih preiskovancih tako na tešče kot po obroku hrane in pri bolnikih, verjetno zato, ker je absorpcija omejena z odmerkom.
English: In the treated population, an increase in malformations has been noted with polytherapy; however, the extent to which the treatment and/or the illness is responsible has not been elucidated.
Slovenian: Pri zdravljeni populaciji so pri sočasnem zdravljenju z več različnimi zdravili opazili zvečanje pogostnosti malformacij; vendar ni jasno, koliko sta za to kriva zdravljenje in/ali bolezen.
English: If the patient has difficulty with swallowing, tablets can be crushed and administered in half a glass of water.
Slovenian: Bolnik, ki ima težave s požiranjem, lahko tablete zdrobi in vzame s polovico kozarca vode.
English: Therefore, it is recommended that you use an additional safe and effective contraceptive method (such as a barrier method, e.g., condoms) when taking Inovelon.
Slovenian: Zato vam med jemanjem zdravila Inovelon priporočamo uporabo dodatnih varnih in učinkovitih kontracepcijskih metod (kot so pregradne metode, na primer kondom).
English: Studies in new-born infants or infants and toddlers under 1 year of age have not been conducted.
Slovenian: Študij pri novorojenčkih, dojenčkih in malih otrocih do 1 leta starosti niso opravili.
English: If they happen to you tell your doctor or go to a hospital immediately:
Slovenian: Če se pojavijo, o tem takoj obvestite svojega zdravnika ali pojdite v bolnišnico.
English: If patients develop new seizure types and/or experience an increased frequency of status epilepticus that is different from the patient's baseline condition, then the benefit-risk ratio of the therapy should be reassessed.
Slovenian: Če se pri bolnikih pojavi nova vrsta napadov in/ali imajo pogosteje epileptični status kot sicer, ki se razlikuje od stanja ob izhodišču, je treba ponovno pretehtati razmerje med koristjo in tveganjem zdravljenja.
English: AED treatment during pregnancy should be carefully discussed with the treating physician.
Slovenian: O zdravljenju z antiepileptičnimi zdravili v nosečnosti se je treba natančno pogovoriti z lečečim zdravnikom.
English: If you forget to take Inovelon
Slovenian: Če ste pozabili vzeti zdravilo Inovelon
English: Ask the doctor or pharmacist for advice before taking any medicine at the same time as Inovelon.
Slovenian: Posvetujte se z zdravnikom ali s farmacevtom, preden sočasno z zdravilom Inovelon vzamete katero koli zdravilo.
English: Potential for rufinamide to affect other medicinal products
Slovenian: Možnost, da bi rufinamid vplival na druga zdravila
English: If you have difficulty swallowing, you can crush the tablet, then mix the powder in about half a glass (100 ml) of water and drink immediately.
Slovenian: Nato prašek zamešajte v približno pol kozarca (100 ml) vode in takoj spijte.
English: The adverse event profile was similar to that in children 4 years of age and older, adolescents, and adults.
Slovenian: Profil neželenih učinkov je bil podoben tistemu pri otrocih, starih 4 leta ali starejših, mladostnikih in odraslih.
English: Reversibility of all findings was demonstrated after stopping treatment.
Slovenian: Po prekinitvi zdravljenja so dokazali reverzibilnost vseh ugotovitev.
English: If you stop taking Inovelon
Slovenian: Če ste prenehali jemati zdravilo Inovelon
English: What you need to know before you take Inovelon
Slovenian: Kaj morate vedeti, preden boste vzeli zdravilo Inovelon
English: If you may have taken more Inovelon than you should, tell the doctor or pharmacist immediately, or contact your nearest hospital casualty department, taking the medicine with you.
Slovenian: Če ste mogoče vzeli več zdravila Inovelon, kot bi smeli, to nemudoma povejte zdravniku ali farmacevtu ali pojdite na nezgodni oddelek najbližje bolnišnice, zdravilo pa vzemite s seboj.
English: Do not use this medicine after the expiry date which is stated on the bottle label and carton.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki plastenke in kartonski škatli.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Oral Tablet
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Peroralna tableta
English: Benign bone neoplasms (osteomas) and hyperostosis seen in mice were considered a result of the activation of a mouse specific virus by fluoride ions released during the oxidative metabolism of rufinamide.
Slovenian: Pojavljanje benignih kostnih tumorjev (osteomov) in hiperostoze, ki so jo opazili pri miših, so razlagali kot posledico aktivacije virusa, specifičnega za miši, s fluoridnimi ioni, ki se sproščajo med oksidativno presnovo rufinamida.
English: Rufinamide is for oral use.
Slovenian: Rufinamid je za peroralno uporabo.
English: Use in patients with severe hepatic impairment is not recommended.
Slovenian: Uporaba zdravila pri bolnikih s hudo okvaro jeter ni priporočljiva.
English: You can also break the tablets into two equal halves and swallow with water.
Slovenian: Tablete lahko tudi razdelite na enaki polovici, ki ju pogoltnete z vodo.
English: Push down and turn cap to open bottle
Slovenian: Zaporko potisnite navzdol in obrnite, da plastenko odprete.
English: SPECIAL STORAGE CONDITIONS Do not store above 30ºC.
Slovenian: POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte pri temperaturi do 30 ºC.
English: Use in patients with hepatic impairment has not been studied.
Slovenian: Uporabe zdravila pri bolnikih z okvaro jeter niso proučevali.
English: If the recommended calculated dose of Inovelon is not achievable, the dose should be given to the nearest whole 100 mg tablet.
Slovenian: Če priporočenega izračunanega odmerka zdravila Inovelon ni mogoče doseči, moramo dati odmerek, ki je najbližji 100-miligramski tableti.
English: Toxicities observed in dogs at levels similar to human exposure at the maximum recommended dose were liver changes, including bile thrombi, cholestasis and liver enzyme elevations thought to be related to increased bile secretion in this species.
Slovenian: Toksični učinki, ki so jih ugotovili pri psih pri izpostavljenosti, podobni človeški izpostavljenosti pri največjem priporočenem odmerku, so bile spremembe jeter, vključno z žolčnimi trombi, holestazo in zvišanjem jetrnih encimov, za katere mislijo, da so povezani z zvečanim izločanjem žolča pri tej vrsti.
English: Pneumonia Influenza Nasopharyngitis Ear infection Sinusitis
Slovenian: Redki pljučnica gripa nazofaringitis okužba ušesa sinusitis
English: Infections: ear infection, flu, nasal congestion, chest infection.
Slovenian: okužbe: okužbe ušes, gripa, nahod, okužbe pljuč.
English: When given twice daily at 12-hourly intervals, rufinamide accumulates to the extent predicted by its terminal half-life, indicating that the pharmacokinetics of rufinamide are time-independent (i.e. no autoinduction of metabolism).
Slovenian: Če rufinamid dajemo dvakrat na dan v 12-urnih presledkih, se kopiči v obsegu, ki ga napoveduje njegov končni razpolovni čas, kar kaže, da je farmakokinetika rufinamida neodvisna od časa (t.j., ni avtoindukcije presnove).
English: Studies in animals revealed no teratogenic effect, but foetotoxicity in the presence of maternal toxicity was observed (see section 5.3).
Slovenian: Študije na živalih niso pokazale nikakršnega teratogenega učinka, pač pa so opazili toksičnost za plod ob sočasni toksičnosti za mater (glejte poglavje 5.3).
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.
Slovenian: Zdravilo Inovelon se uporablja z drugimi zdravili za zdravljenje epileptičnih napadov, povezanih z Lennox-Gastautovim sindromom pri odraslih, mladostnikih in otrocih, starih več kot 1 leto.
English: Coordination Abnormal* Nystagmus Psychomotor hyperactivity disorders
Slovenian: motena koordinacija* nistagmus psihomotorična hiperaktivnost
English: Inovelon (rufinamide tablets) was administered in a double blind, placebo-controlled study, at doses of up to 45 mg/kg/day for 84 days, to 139 patients with inadequately controlled seizures associated with Lennox-Gastaut Syndrome (including both atypical absence seizures and drop attacks).
Slovenian: Zdravilo Inovelon (tablete rufinamida) so dajali v dvojno slepi, s placebom kontrolirani študiji v odmerkih do 45 mg/kg/dan 84 dni 139 bolnikom z nezadostno kontroliranimi epileptičnimi napadi (tako z atipičnimi absencami kot drop atakami), povezanimi z Lennox-Gastautovim sindromom.
English: In addition, the study investigated the cognitive development, behaviour and language development of subjects treated with rufinamide compared to subjects receiving any-other-AED.
Slovenian: Poleg tega so v študiji raziskovali kognitivni razvoj, vedenje in razvoj govora pri bolnikih, zdravljenih z rufinamidom, v primerjavi z bolniki, ki so prejemali katero koli drugo antiepileptično zdravilo.
English: The suspension should be taken twice daily in the morning and in the evening, in two equally divided doses.
Slovenian: Suspenzijo je treba vzeti dvakrat na dan, zjutraj in zvečer, razdeljeno na dva enaka odmerka.
English: Withdrawal of rufinamide
Slovenian: Ukinjanje rufinamida
English: Patients receiving valproate:
Slovenian: Bolniki, ki prejemajo valproat:
English: Rufinamide has demonstrated little or no significant capacity in -vitro to act as a competitive or mechanism-based inhibitor of the following human P450 enzymes: CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4/5 or CYP4A9/11-2.
Slovenian: Rufinamid kaže malo ali nič signifikantne sposobnosti za delovanje in- vitro kot kompetitiven zaviralec ali zaviralec na podlagi mehanizma naslednjih človeških encimov, odvisnih od P450: CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4/5 ali CYP4A9/11-2.
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.
Slovenian: Nazogastrična cevka: cevka iz polivinilklorida (PVC), dolga največ 40 cm, s premerom cevke 5 Fr. Za zagotovitev pravilnega odmerka je treba po dajanju peroralne suspenzije cevko za enteralno hranjenje vsaj enkrat sprati z 1 ml vode.
English: Rufinamide has been shown to induce the cytochrome P450 enzyme CYP3A4 and may therefore reduce the plasma concentrations of substances which are metabolised by this enzyme.
Slovenian: Pokazalo se je, da rufinamid inducira encim CYP3A4 citokroma P450, in zato lahko zniža plazemske koncentracije učinkovin, ki jih presnavlja ta encim.
English: Inovelon tablets must be taken twice daily with water, in the morning and in the evening.
Slovenian: Zdravilo Inovelon tablete morate jemati z vodo dvakrat na dan, zjutraj in zvečer.
English: Cytochrome P450 enzymes
Slovenian: Encimi s citokromom P450
English: The Least Square mean change of the Child Behaviour Checklist (CBCL) Total Problems score after 2 years of treatment were 53.75 for the any other AED group and 56.35 for the rufinamide group (LS mean difference [95% CI] +2.60 [-10.5,15.7]; p=0.6928), and the difference between treatments was -2.776 (95% CI: -13.3, 7.8, p=0.5939).
Slovenian: Povprečna sprememba z metodo najmanjših kvadratov pri rezultatu vseh težav na ocenjevalni lestvici vedenja za otroke (Child Behaviour Checklist (CBCL) Total Problems score) po 2 letih zdravljenja je bila 53,75 v skupini s katerim koli drugim antiepileptičnim zdravilom in 56,35 za skupino z rufinamidom (povprečna razlika z metodo najmanjših kvadratov [95 % IZ] +2,60 [-10,5, 15,7]; p=0,6928), razlika med zdravili pa je bila -2,776 (95 % IZ: -13,3, 7,8, p=0,5939).
English: The dose will be calculated for you by the doctor and will depend on your age, weight and whether you are taking Inovelon with another medicine called valproate.
Slovenian: Odmerek bo določil zdravnik glede na vašo starost, telesno maso in sočasno zdravljenje z drugim zdravilom, imenovanim valproat.
English: Co-administration of rufinamide 800 mg twice daily and a combined oral contraceptive (ethinyloestradiol 35 μg and norethindrone 1 mg) for 14 days resulted in a mean decrease in the ethinyl estradiol AUC0-24 of 22% and in norethindrone AUC0-24 of 14%.
Slovenian: Sočasna 14-dnevna uporaba rufinamida v odmerku 800 mg dvakrat na dan in kombiniranega peroralnega kontraceptiva (etinilestradiola v odmerku 35 μg in noretindrona v odmerku 1 mg) je povzročila povprečno zmanjšanje AUC0-24 etinilestradiola za 22 % in AUC0-24 noretindrona za 14 %.
English: Potential for other medicinal products to affect rufinamide
Slovenian: Možnost, da bi druga zdravila vplivala na rufinamid
English: If you are a woman of childbearing age, you must use contraceptive measures while taking Inovelon.
Slovenian: Če ste ženska v rodni dobi, morate tačas, ko jemljete zdravilo Inovelon, uporabljati kontracepcijo.
English: Dizziness, headache, nausea, vomiting, sleepiness, fatigue.
Slovenian: omotica, glavobol, navzea, bruhanje, zaspanost, utrujenost.
English: In rats, decreased cellularity of the bone marrow and thymic atrophy were observed only in the carcinogenicity study.
Slovenian: Pri podganah so zmanjšano celičnost kostnega mozga in atrofijo timusa opazili samo v študiji kancerogenosti.
English: Due to the potential harmful effects for the breast-fed infant, breast-feeding should be avoided during maternal treatment with rufinamide.
Slovenian: Zaradi možnih škodljivih učinkov na dojenčka naj mati med zdravljenjem z rufinamidom preneha dojiti.
English: There is limited information on the use of rufinamide in older people.
Slovenian: Podatki o uporabi rufinamida pri starejših bolnikih so omejeni.
English: Tell your doctor if you are taking valproate as the dose of Inovelon may need to be reduced by your doctor.
Slovenian: Povejte zdravniku, če jemljete valproat, ker vam bo mogoče zdravnik moral zmanjšati odmerek zdravila Inovelon.
English: Follow the manufacturer's instructions for the feeding tube to administer the medicine.
Slovenian: Pri dajanju zdravila upoštevajte navodila proizvajalca cevke za hranjenje.
English: Other medicines and Inovelon
Slovenian: Druga zdravila in zdravilo Inovelon
English: No data on the interaction of rufinamide with alcohol are available.
Slovenian: Podatkov o medsebojnem delovanju rufinamida z alkoholom ni na voljo.
English: Do not use this medicine after the expiry date which is stated on the blister and carton.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in kartonski škatli.
English: Each carton contains 1 bottle, 2 syringes and 1 press-in-bottle adapter (PIBA).
Slovenian: Ena škatla vsebuje 1 steklenico, 2 brizgi in 1 vtisljivi nastavek (PIBA).
English: The discontinuation rate in Lennox-Gastaut syndrome due to adverse reactions was 8.2% for patients receiving rufinamide and 0% for patients receiving placebo.
Slovenian: Zaradi neželenih učinkov je od bolnikov z Lennox-Gastautovim sindromom prekinilo zdravljenje 8,2 % bolnikov, ki so dobivali rufinamid, in 0 % tistih, ki so jemali placebo.
English: 30.0 - 50.0 kg
Slovenian: razpon telesne mase 30,0 - 50,0 kg
English: Use in children from 1 year to less than 4 years of age
Slovenian: Uporaba pri otrocih, starih od 1 leta do 4 let