FrancophonIA/ELRC3.0 huggingface dataset:
English: Serious antiepileptic medicinal product hypersensitivity syndrome including DRESS (Drug Reaction with Eosinophilia and Systemic Symptoms) and Stevens-Johnson syndrome have occurred in association with rufinamide therapy.
Slovenian: Med zdravljenjem z rufinamidom so se pojavili hudi preobčutljivostni sindromi, povezani z uporabo antiepileptičnega zdravila, vključno s pojavom DRESS (“Drug Reaction with Eosinophilia and Systemic Symptoms”) ter Stevens-Johnsonovim sindromom.
English: If women treated with rufinamide plan to become pregnant, the continued use of this product should be carefully weighed.
Slovenian: Če ženska, ki se zdravi z rufinamidom, želi zanositi, je treba skrbno pretehtati nadaljnje jemanje tega zdravila.
English: Rufinamide appears not to have a clinically relevant effect on carbamazepine, lamotrigine, phenobarbital, topiramate, phenytoin or valproate steady state concentrations.
Slovenian: Zdi se, da rufinamid ni klinično pomembno vplival na koncentracije karbamazepina, lamotrigina, fenobarbitala, topiramata, fenitoina ali valproata v stanju dinamičnega ravnovesja.
English: Children aged between 1 and 4 years of age
Slovenian: Otroci, stari od 1 do 4 let
English: The cap fits properly when the PIBA is in place.
Slovenian: Zaporka se prilega, ko je vtisljivi nastavek PIBA nameščen.
English: Hypersensitivity to the active substance, triazole derivatives or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost za zdravilno učinkovino, triazolne derivate ali katero koli pomožno snov, navedeno v poglavju 6.1.
English: For rufinamide, no clinical data on exposed pregnancies are available.
Slovenian: Za rufinamid ni na voljo kliničnih podatkov za nosečnice, ki so bile izpostavljene zdravilu.
English: A total of 12 patients received any other AED at the investigator's discretion in the control arm.
Slovenian: Vsega skupaj 12 bolnikov v kontrolni skupini je prejelo katero koli drugo antiepiletično zdravilo po presoji raziskovalca.
English: Inovelon contains sorbitol
Slovenian: Zdravilo Inovelon vsebuje sorbitol
English: Weight decrease Head injury
Slovenian: Preiskave hujšanje poškodbe glave
English: Reporting of side effects If you get any side effects, talk to your doctor.
Slovenian: Poročanje o neželenih učinkih Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom.
English: What Inovelon looks like and contents of the pack
Slovenian: Izgled zdravila Inovelon in vsebina pakiranja
English: Inovelon should be administered with food (see section 5.2).
Slovenian: Zdravilo Inovelon je treba jemati s hrano (glejte poglavje 5.2).
English: Inovelon contains a medicine called rufinamide.
Slovenian: Zdravilo Inovelon vsebuje zdravilno učinkovino, imenovano rufinamid.
English: - If you have any further questions, ask the doctor or pharmacist.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
English: 1.2 mg methyl parahydroxybenzoate (E218), 0.3 mg propyl parahydroxybenzoate (E216), 250 mg sorbitol (E420)
Slovenian: 1,2 mg metilparahidroksibenzoata (E218), 0,3 mg propilparahidroksibenzoata (E216), 250 mg sorbitola (E420).
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.
Slovenian: Nedavna analiza populacijske farmakokinetike rufinamida na podlagi podatkov, zbranih pri 139 preiskovancih (115 bolnikov z LGS in 24 zdravih preiskovancev), vključno s 83 pediatričnimi bolniki z LGS (10 bolnikov, starih od 1 do < 2 leti, 14 bolnikov, starih od 2 do < 4 let, 14 bolnikov, starih od 4 do < 8 let, 21 bolnikov, starih od 8 do < 12 let, in 24 bolnikov, starih od 12 do < 18 let), je pokazala, da pri odmerjanju rufinamida na osnovi mg/kg/dan pri osebah z LGS, starih od 1 do < 4 let, dosežemo primerljivo izpostavljenost kot pri bolnikih z LGS, starih ≥ 4 leta, pri katerih je bila učinkovitost dokazana.
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.
Slovenian: V zvezi z imunotoksičnim potencialom so pri psih v 13-tedenski študiji opazili majhen timus in involucijo timusa s signifikantnim odzivom na visok odmerek pri moških osebkih.
English: - you suffer an increase in the number or severity or duration of your seizures, you should contact the doctor immediately if this happens.
Slovenian: - se vam poveča število ali trajanje napadov ali če vaši napadi postanejo hujši, to nemudoma povejte zdravniku.
English: - you get a skin rash or fever.
Slovenian: - dobite kožni izpuščaj ali povišano telesno temperaturo.
English: The film-coating consists of hypromellose, macrogols (8000), titanium dioxide (E171), talc and ferric oxide red (E172).
Slovenian: Filmsko oblogo sestavljajo hipromeloza, makrogoli (8000), titanov dioksid (E171), smukec in rdeči železov oksid (E172).
English: Status epilepticus
Slovenian: Epileptični status
English: Population pharmacokinetic modelling has been used to evaluate the influence of sex on the pharmacokinetics of rufinamide.
Slovenian: Za oceno vpliva spola na farmakokinetiko rufinamida so uporabili populacijsko modeliranje farmakokinetike.
English: Additional information on special populations
Slovenian: Dodatni podatki o posebnih skupinah bolnikov
English: Thus, clinically significant interactions mediated through inhibition of cytochrome P450 system by rufinamide are unlikely to occur.
Slovenian: Zato ni verjetno, da bi nastopile klinično pomembne interakcije, ki bi jih posredovala inhibicija sistema citokroma P450 z rufinamidom.
English: Adverse reactions were usually mild to moderate in severity.
Slovenian: Neželeni učinki so bili po izraženosti navadno blagi do zmerni.
English: EXPIRY DATE EXP (MM/YYYY)
Slovenian: DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP (MM/LLLL)
English: Inovelon oral suspension and Inovelon film-coated tablets may be interchanged at equal doses.
Slovenian: Zdravilo Inovelon peroralna suspenzija in zdravilo Inovelon filmsko obložene tablete sta v enakih odmerkih zamenljiva.
English: Women of childbearing potential must use contraceptive measures during treatment with rufinamide.
Slovenian: Ženske v rodni dobi morajo med zdravljenjem z rufinamidom uporabljati kontracepcijo.
English: Like all medicines, Inovelon can cause side effects, although not everybody gets them.
Slovenian: Možni neželeni učinki Kot vsa zdravila ima lahko tudi zdravilo Inovelon neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Male and female patients (between 4 and 30 years of age) were eligible if they had a history of multiple seizure types, which had to include atypical absence seizures and drop attacks (i.e., tonic-atonic or astatic seizures); were being treated with 1 to 3 concomitant fixed dose antiepileptic medicinal products; a minimum of 90 seizures in the month before the 28-day baseline period; an EEG within 6 months of study entry demonstrating a pattern of slow spike-and-wave complexes (2.5 Hz); a weight of at least 18 kg; and a CT scan or MRI study confirming the absence of a progressive lesion.
Slovenian: Bolniki obeh spolov (stari od 4 do 30 let) so bili primerni, če so imeli anamnezo več vrst napadov, med katerimi so morale biti tudi atipične absence in drop atake (tj., tonično-atonični ali astatični napadi); če so se sočasno zdravili z 1 do 3 antiepileptičnimi zdravili v stalno enakih odmerkih; če so imeli vsaj 90 napadov v mesecu pred 28-dnevnim izhodiščnim obdobjem; če so imeli v 6 mesecih po vključitvi v študijo EEG, ki je kazal vzorec počasnih kompleksov trn-val (2,5 Hz); če so tehtali vsaj 18 kg; in če je slikanje s CT ali MRI potrdilo odsotnost progresivne lezije.
English: Patients not receiving valproate:
Slovenian: Bolniki, ki ne prejemajo valproata:
English: Inovelon may make you feel dizzy, drowsy and affect your vision, particularly at the beginning of treatment or after a dose increase.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Inovelon lahko povzroči omotičnost, zaspanost in zamegljen vid, zlasti na začetku zdravljenja ali po povečanju odmerka.
English: You may experience the following side effects with this medicine.
Slovenian: Pri jemanju tega zdravila boste morda imeli naslednje neželene učinke.
English: Insert the syringe into the opening of the adaptor as far as possible.
Slovenian: V odprtino nastavka vstavite brizgo tako daleč, kot gre.
English: The tablet should be taken twice daily with water in the morning and in the evening, in two equally divided doses.
Slovenian: Tableto je treba vzeti dvakrat na dan z vodo, zjutraj in zvečer, v dveh enakih odmerkih.
English: The most common adverse reactions observed at a higher incidence than placebo in patients with Lennox-Gastaut syndrome were somnolence and vomiting.
Slovenian: Najpogostejša neželena učinka, ki sta se pri bolnikih z Lennox-Gastautovim sindromom pojavljala z incidenco, ki je bila večja kot pri placebu, sta bila zaspanost in bruhanje.
English: The syringes are graduated in 0.5 ml increments.
Slovenian: Oznake na brizgi naraščajo po 0,5 mililitra.
English: Inovelon should be taken with food.
Slovenian: Zdravilo Inovelon je treba jemati s hrano.
English: The dosing syringe should be inserted into the PIBA and the dose withdrawn from the inverted bottle.
Slovenian: Brizgo za odmerjanje vstavite v vtisljivi nastavek PIBA in izvlecite odmerek iz obrnjene plastenke.
English: Aluminium/aluminium blisters, packs of 10, 30, 50, 60 and 100 film-coated tablets.
Slovenian: Pretisni omoti iz aluminija/aluminija, škatle z 10, 30, 50, 60 in 100 filmsko obloženimi tabletami.
English: In addition, patients have experienced: anxiety, insomnia, nose bleeds, acne, rash, back pain, infrequent periods, bruising, head injury (as a result of accidental injury during a seizure).
Slovenian: Poleg tega so bolniki opazili še: tesnobo, nespečnost, krvavitve iz nosu, akne, izpuščaj, bolečine v hrbtu, neredne menstruacije, modrice, poškodbe glave (kot posledica poškodbe med epileptičnim napadom).
English: 1 bottle of 460 ml contains 18400 mg rufinamide.
Slovenian: 1 steklenica s 460 ml vsebuje 18400 mg rufinamida.
English: Inovelon is indicated as adjunctive therapy in the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 1 year of age and older.
Slovenian: Zdravilo Inovelon je indicirano kot pomožno zdravilo pri zdravljenju epileptičnih napadov, povezanih z Lennox-Gastautovim sindromom (LGS), pri bolnikih, starih 1 leto ali starejših.
English: If you miss taking more than one dose, seek advice from the doctor.
Slovenian: Če pozabite vzeti dva ali več odmerkov, poprosite za nasvet zdravnika.
English: The addition or withdrawal of these medicinal products or adjusting of the dose of these medicinal products during rufinamide therapy may require an adjustment in dosage of rufinamide (see section 4.2).
Slovenian: Če med zdravljenjem z rufinamidom katero od teh zdravil dodamo ali ukinemo ali prilagodimo njegov odmerek, bo mogoče treba prilagoditi odmerjanje rufinamida (glejte poglavje 4.2).
English: What Inovelon is and what it is used for What you need to know before you take Inovelon How to use Inovelon
Slovenian: Kaj je zdravilo Inovelon in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Inovelon Kako jemati zdravilo Inovelon Možni neželeni učinki
English: The antiepileptic drug (AED) hypersensitivity syndrome occurred in close temporal association to the initiation of rufinamide therapy and in the paediatric population.
Slovenian: Ta preobčutljivostni sindrom, povezan z uporabo antiepileptičnega zdravila, se je pojavljal v tesni časovni zvezi z uvedbo zdravljenja z rufinamidom in pri pediatrični populaciji.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml of oral suspension contains 40 mg rufinamide.
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA En ml peroralne suspenzije vsebuje 40 mg rufinamida.
English: Additionally, Inovelon (rufinamide oral suspension) was administered in a multicentre, open-label study comparing the addition of rufinamide to the addition of 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.
Slovenian: Poleg tega so dajali zdravilo Inovelon (peroralno suspenzijo rufinamida) v multicentrični, odprti študiji, v kateri so primerjali dodatek rufinamida z dodatkom katerega koli drugega antiepileptičnega zdravila 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.
English: If you have any suspension left in the bottle more than 90 days after it was first opened, do not use it. Do not use the suspension if you notice that the appearance or smell of your medicine has changed.
Slovenian: Če v plastenki ostane suspenzija dlje kot 90 dni po prvem odprtju, je ne uporabite.
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).
Slovenian: Zdravljenje je treba začeti z dnevnim odmerkom 200 mg (odmerek 5 ml suspenzije v obliki dveh 2,5 ml odmerkov, en zjutraj in en zvečer).
English: A dose adjustment of the concomitantly administered medicinal product may need to be considered.
Slovenian: Mogoče bo treba pretehtati možnost prilagoditve odmerka zdravila, ki ga bolnik sočasno jemlje.
English: Inovelon oral suspension must be taken twice every day, once in the morning and once in the evening.
Slovenian: Peroralno suspenzijo Inovelon morate jemati dvakrat na dan, zjutraj in zvečer.
English: See section 3 - ‘How to use Inovelon' for advice on taking Inovelon with food and drink.
Slovenian: Za nasvete o jemanju zdravila Inovelon skupaj s hrano in pijačo glejte poglavje 3 »Kako jemati zdravilo Inovelon«.
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.
Slovenian: - Druge sestavine zdravila so mikrokristalna celuloza in natrijev karmelozat, brezvodna citronska kislina, 30-odstotna simetikonska emulzija (vsebuje benzojsko kislino, ciklotetrasiloksan, dimetikon, glikol stearat in gliceril distearat, metilcelulozo, PEG-40 stearat [polietilen glikol stearat], polisorbat 65, silicijev dioksid, sorbinsko kislino, žveplovo kislino in vodo), poloksamer 188, hidroksietilcelulozo, metilparahidroksibenzoat (E218), propilparahidroksibenzoat (E216), kalijev sorbat, propilenglikol (E1520), sorbitol, tekoči (nekristalizirajoči), aromo pomaranče in vodo.
English: For dosing, please use the syringe and adaptor provided.
Slovenian: Za odmerjanje uporabite priloženo brizgo in nastavek.
English: - The active substance is rufinamide.
Slovenian: - Zdravilna učinkovina je rufinamid.
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).
Slovenian: Neželeni učinki zaradi zdravljenja, o katerih so najpogosteje poročali v skupini, zdravljeni z rufinamidom (pojavljali so se pri ≥10 % bolnikov), so bili okužbe zgornjih dihal in bruhanje (vsak po 28,0 %), pljučnica in somnolenca (vsak po 20,0 %), sinuzitis, vnetje srednjega ušesa, driska, kašelj in zvišana telesna temperatura (vsak po 16,0 %) in bronhitis, zaprtje, kongestija nosne sluznice, izpuščaj, razdražljivost in zmanjšan apetit (vsak po 12,0 %).
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
Slovenian: 10 filmsko obloženih tablet 30 filmsko obloženih tablet 50 filmsko obloženih tablet 60 filmsko obloženih tablet 100 filmsko obloženih tablet 200 filmsko obloženih tablet
English: 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.
Slovenian: Simetikonska emulzija, 30-odstotna, ki vsebuje benzojsko kislino, ciklotetrasiloksan, dimetikon, glikol stearat in gliceril distearat, metilcelulozo, PEG-40 stearat (polietilen glikol stearat), polisorbat 65, silicijev dioksid, sorbinsko kislino, žveplovo kislino in vodo.
English: 10 film-coated tablets 30 film-coated tablets 50 film-coated tablets 60 film-coated tablets 100 film-coated tablets
Slovenian: 10 filmsko obloženih tablet 30 filmsko obloženih tablet 50 filmsko obloženih tablet 60 filmsko obloženih tablet 100 filmsko obloženih tablet
English: Eating disorder Decreased appetite Anxiety
Slovenian: Presnovne in prehranske motnje motnja hranjenja zmanjšan apetit anksioznost nespečnost
English: Injury, poisoning and procedural complications
Slovenian: Poškodbe in zastrupitve in zapleti pri posegih kontuzije
English: No evidence of an associated risk was identified in the rat and monkey repeat dose toxicity studies.
Slovenian: V raziskavah toksičnosti ponavljajočih se odmerkov pri podganah in opicah niso ugotovili znakov nevarnosti, povezanih z zdravilom.
English: No data are available on the effects on fertility following treatment with rufinamide.
Slovenian: Podatki o vplivu zdravljenja z rufinamidom na plodnost niso na voljo.
English: Women of childbearing potential must use contraceptive measures during treatment with Inovelon.
Slovenian: Ženske v rodni dobi morajo med zdravljenjem z zdravilom Inovelon uporabljati kontracepcijo.
English: 5 ml contains 200 mg rufinamide.
Slovenian: 5 ml vsebuje 200 mg rufinamida.
English: For patients on Inovelon treatment who have administration of valproate initiated, significant increases in rufinamide plasma concentrations may occur.
Slovenian: Pri bolnikih, ki se zdravijo z zdravilom Inovelon in jim uvedejo še valproat, se lahko pomembno zviša plazemska koncentracija rufinamida.
English: A significant improvement was observed for all three primary variables: the percentage change in total seizure frequency per 28 days during the maintenance phase relative to baseline (-35.8% on Inovelon vs. -1.6% on placebo, p=0.0006), the number of tonic-atonic seizures (-42.9% on Inovelon vs. 2.2% on placebo, p=0.0002), and the seizure severity rating from the Global Evaluation performed by the parent/guardian at the end of the double-blind phase (much or very much improved in 32.2% on Inovelon vs. 14.5% on the placebo arm, p=0.0041).
Slovenian: Ugotovili so signifikantno izboljšanje vseh treh primarnih spremenljivk: spremembe celotne pogostnosti epileptičnih napadov v odstotkih na 28 dni v vzdrževalni fazi glede na izhodišče (-35,8 % pri zdravilu Inovelon v primerjavi z -1,6 % pri placebu, p=0,0006), števila tonično-atoničnih napadov (-42,9 % pri zdravilu Inovelon v primerjavi z 2,2 % pri placebu, p=0,0002) in ocene teže epileptičnih napadov iz globalne ocene, ki jo je opravil eden od staršev ali skrbnik na koncu dvojno slepe faze (precejšnje ali zelo veliko izboljšanje pri 32,2 % pri zdravilu Inovelon v primerjavi s 14,5 % v kraku s placebom, p=0,0041).
English: Therefore, consideration should be given to a dose reduction of Inovelon in patients who are initiated on valproate therapy (see section 4.2).
Slovenian: Zato je treba pri bolnikih, ko jim uvedemo zdravljenje z valproatom, pretehtati možnost zmanjšanja odmerka zdravila Inovelon (glejte poglavje 4.2).
English: They are available as packs of 10, 30, 50, 60,100 and 200 film-coated tablets.
Slovenian: Na voljo so v škatlah, v katerih je po 10, 30, 50, 60,100 ali 200 filmsko obloženih tablet.
English: Inovelon 40 mg/ml oral suspension Rufinamide
Slovenian: Inovelon 40 mg/ml peroralna suspenzija rufinamid
English: No studies have been performed in patients with hepatic impairment and therefore Inovelon should not be administered to patients with severe hepatic impairment (see section 4.2).
Slovenian: Pri bolnikih z okvarami jeter študij niso opravili, zato pri bolnikih s težkimi okvarami jeter zdravila Inovelon ne smemo uporabljati (glejte poglavje 4.2).
English: It comes in a bottle of 460 ml with two identical syringes and a push in bottle adaptor (PIBA).
Slovenian: Na voljo je v plastenkah po 460 ml z dvema identičnima brizgama in vtisljivim nastavkom (PIBA).
English: The oral dosing syringes are graduated in 0.5 ml increments.
Slovenian: Oznake na brizgi za peroralno odmerjanje naraščajo po 0,5 mililitra.
English: If you have any further questions on the use of this product, ask the doctor or pharmacist.
Slovenian: Če imate dodatna vprašanja o jemanju zdravila, se posvetujte z zdravnikom ali s farmacevtom.
English: Use in adults, adolescents and children 4 years of age or older of 30 kg or over
Slovenian: Uporaba pri odraslih, mladostnikih in otrocih, starih 4 leta ali starejših, ki tehtajo 30 kg ali več
English: For this patient population, the maximum recommended dose is 45 mg/kg/day (1.125 ml/kg/day).
Slovenian: Pri tej populaciji bolnikov je največji priporočeni odmerek 45 mg/kg/dan (1,125 ml/kg/dan).
English: Inovelon oral suspension and Inovelon film-coated tablets have been demonstrated to be bioequivalent.
Slovenian: Dokazano je bilo, da sta zdravilo Inovelon peroralna suspenzija in zdravilo Inovelon filmsko obložene tablete bioekvivalentna.
English: As valproate significantly decreases clearance of rufinamide, a lower maximum dose of Inovelon is recommended for patients being co-administered valproate.
Slovenian: Ker valproat bistveno zmanjša očistek rufinamida, je pri bolnikih, ki sočasno uporabljajo valproat, priporočljiv manjši maksimalni odmerek zdravila Inovelon.
English: - The other ingredients are lactose monohydrate, microcrystalline cellulose, maize starch, croscarmellose sodium, hypromellose, magnesium stearate, sodium laurilsulfate and colloidal anhydrous silica.
Slovenian: - Druge sestavine zdravila so laktoza monohidrat, mikrokristalna celuloza, koruzni škrob, premreženi natrijev karmezolat, hipromeloza, magnezijev stearat, natrijev lavrilsulfat in brezvodni koloidni silicijev dioksid.
English: INFORMATION IN BRAILLE Inovelon 40 mg/ml
Slovenian: PODATKI V BRAILLOVI PISAVI Inovelon 40 mg/ml
English: Inovelon contains lactose
Slovenian: Zdravilo Inovelon vsebuje laktozo
English: Other associated manifestations included lymphadenopathy, liver function tests abnormalities, and haematuria.
Slovenian: Med drugimi pojavi, povezanimi s tem sindromom, so bili limfadenopatija, nenormalnosti jetrnih funkcijskih testov in hematurija.
English: Rufinamide concentrations are not subject to clinically relevant changes on co-administration with known enzyme inducing antiepileptic medicinal products.
Slovenian: Spremembe koncentracije rufinamida pri sočasnem dajanju z antiepileptiki, za katere je znano, da inducirajo encim, niso klinično pomembne.
English: Doses of up to 3,600 mg/day have been studied in a limited number of patients.
Slovenian: Pri omejenem številu bolnikov so proučevali odmerke do 3.600 mg/dan.