FrancophonIA/ELRC3.0 huggingface dataset:
English: Oligomenorrhoea
Maltese: Oligomenorreja
English: The film-coating consists of hypromellose, macrogols (8000), titanium dioxide (E171), talc and ferric oxide red (E172).
Maltese: Il-kisi tar-rita tikkonsisti minn hypromellose, macrogols (8000), titanium dioxide (E171), talkum u ferric oxide aħmar (E172).
English: See section 6.6 for further details.
Maltese: Ara sezzjoni 6.6 għal aktar dettalji.
English: INFORMATION IN BRAILLE Inovelon 40 mg/ml
Maltese: INFORMAZZJONI BIL-BRAILLE Inovelon 40 mg/ml
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.
Maltese: Rufinamide wera ftit jew xejn kapaċità sinifikanti in -vitro sabiex jaġixxi bħala impeditur kompettiv jew wieħed ibbażżat fuq mekkaniżmu ta' l-enżimi umani P450 li ġejjin: CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4/5 jew CYP4A9/11-2.
English: A pharmacokinetic study in older healthy volunteers did not show a significant difference in pharmacokinetic parameters compared with younger adults.
Maltese: Studju farmakokinetiku f'voluntiera b'saħħithom akbar fl-età ma weriex differenza sinifikanti fil-parametri farmakokinetiċi meta mqabbla ma' adulti iżgħar.
English: Cytochrome P450 enzymes
Maltese: Enzimi ta' ċitokrom P450
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.
Maltese: - Is-sustanzi l-oħra huma microcrystalline cellulose u carmellose sodium, anhydrous citric acid, simeticone emulsion 30% (li fih benzoic acid, cyclotetrasiloxane, dimethicone, glycol stearate u glyceryl distearate, methylcellulose, PEG-40 stearate [polyethylene glycol stearate], polysorbate 65, silica gel, sorbic acid, sulphuric acid u ilma), poloxamer 188, hydroxyethylcellulose, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), potassium sorbate, propylene glycol (E1520), sorbitol, likwidu (non-crystallising), togħma tal-larinġ u ilma.
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000).
Maltese: Il-frekwenzi huma definiti bħala: komuni ħafna (≥ 1/10); komuni (≥ 1/100 sa < 1/10); mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000)
English: The clinical development program has included over 1,900 patients, with different types of epilepsy, exposed to rufinamide.
Maltese: Il-programm ta' żvilupp kliniku inkluda 'l fuq minn 1,900 pazjent, b'tipi differenti ta' epilessija, esposti għal rufinamide.
English: - Inovelon is a white slightly viscous suspension.
Maltese: - Inovelon hu suspensjoni bajda ftit viskuża.
English: Coordination Abnormal* Nystagmus Psychomotor hyperactivity disorders
Maltese: Koordinazzjoni Anormali* Nystagmus
English: Risk related to epilepsy and antiepileptic medicinal products in general:
Maltese: Riskju relatat mal-epilessija u prodotti mediċinali antiepilettiċi b'mod ġenerali:
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%.
Maltese: L-għoti ta' rufinamide 800 mg darbtejn kuljum flimkien ma' kontraċettiv orali kkombinat (ethinyloestradiol 35 μg u norethindrone 1 mg) għal 14-il jum irriżulta fi tnaqqis medju fl-ethinyl estradiol AUC0-24 ta' 22% u norethindrone AUC0-24 ta' 14%.
English: Tremor Diplopia Vision blurred
Maltese: Rogħda Diplopja Vista mċajpra
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.
Maltese: Il-każijiet ta' sindromu serju ta' sensittività eċċessiva għall-prodott mediċinali antiepilettiku li jinkludu DRESS (Reazzjoni tal-Mediċina b'Eosinofilija u Sintomi Sistemiċi) u s-sindromu ta' Stevens-Johnson ġew assoċjati mat-terapija b'rufinamide.
English: The main pathway of metabolism is hydrolysis of the carboxylamide group to the pharmacologically inactive acid derivative CGP 47292.
Maltese: Il-passaġġ ewlieni tal-metaboliżmu huwa l-idroliżi tal-grupp carboxylamide għad-derivat farmakoloġikament inattiv ta' l-aċidu CGP 47292.
English: The exposure of triazolam was reduced by 36%.
Maltese: L-espożizzjoni ta' triazolam tnaqqset b'36%.
English: Adults, adolescents and children weighing 30 kg or over
Maltese: Adulti, adolexxenti u tfal li jiżnu aktar minn 30 kg
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.7
English: Reproductive system and breast disorders
Maltese: Disturbi tas-sistema riproduttiva u tas-sider
English: Environmental risk assessment studies have shown that rufinamide is very persistent in the environment (see section 6.6).
Maltese: Studji ta' valutazzjoni tar-riskji ambjentali wrew li rufinamide hija persistenti ħafna fl-ambjent (ara sezzjoni 6.6).
English: It comes in a bottle of 460 ml with two identical syringes and a push in bottle adaptor (PIBA).
Maltese: Jiġi fi flixkun ta' 460 ml b'żewġ siringi identiċi u press-in-bottle adapter (PIBA).
English: Hypersensitivity to the active substance, triazole derivatives or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva, derivattivi ta' triazole jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: Inovelon 100 mg film-coated tablets Inovelon 200 mg film-coated tablets Inovelon 400 mg film-coated tablets Rufinamide
Maltese: Inovelon 100 mg pilloli miksija b'rita Inovelon 200 mg pilloli miksija b'rita Inovelon 400 mg pilloli miksija b'rita
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).
Maltese: Titjib sinifikanti kien muri fit-tliet varjabbli primarji: il-bidla perċentwali fil-frekwenza totali ta' aċċessjonijiet kull 28 jum waqt il-fażi ta' manteniment relattiva għal-linja bażi ta' riferiment (-35.8% fuq Inovelon vs. -1.6% fuq placebo, p=0.0006), l-għadd ta' aċċessjonijiet toniċi-atoniċi (-42.9% fuq Inovelon vs. 2. 2% fuq placebo, p=0.0002), u r-rata tas-severità ta' l-aċċessjoni mill-Evalwazzjoni Globali mwettqa mill-ġenitur/gwardjan fl-aħħar tal-fażi double-blind (titjib tajjeb u tajjeb ħafna fi 32,2% fuq Inovelon vs. 14.5% fuq il-placebo arm, p=0.0041).
English: Inovelon contains a medicine called rufinamide.
Maltese: Inovelon fih mediċina msejħa rufinamide.
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.
Maltese: Intwera li rufinamide jinduċi l-enzima CYP3A4 ta' ċitokrom P450, u għalhekk jista' jnaqqas il-konċentrazzjonijiet ta' sustanzi fil-plażma li jiġu metabolizzati minn din l-enzima.
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.
Maltese: Inovelon huwa indikat bħala terapija aġġuntiva fit-trattament ta' aċċessjonijiet assoċjati mas-sindromu Lennox-Gastaut (LGS) f'pazjenti li għandhom sena jew aktar.
English: - The other ingredients are lactose monohydrate, microcrystalline cellulose, maize starch, croscarmellose sodium, hypromellose, magnesium stearate, sodium laurilsulfate and colloidal anhydrous silica.
Maltese: - Is-sustanzi l-oħra huma lactose monohydrate, microcrystalline cellulose, lamtu tal-qamħirrun, croscarmellose sodium, hypromellose, magnesium stearate, sodium laurilsulfate u silika kollojdali anidra.
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).
Maltese: [-10.5,15.7]; p=0.6928), u d-differenza bejn il-kuri kienet ta' -2.776 (95% CI: -13.3, 7.8, p=0.5939).
English: These events led to rufinamide discontinuation in 20% of the cases.
Maltese: Dawn il-każijiet wasslu għal waqfien ta' rufinamide f'20% tal-pazjenti.
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.
Maltese: Dożi sa 4,000 mg/kuljum (100 ml/kuljum) (f'piż ta' bejn 30 - 50 kg jew 4,800 mg/kuljum (120 ml/kuljum) fil-kategorija ta' persuni li jiżnu iktar minn 50 kg ġew studjati f'numru limitat ta' pazjenti.
English: Furthermore, rufinamide does not inhibit the activity of cytochrome P450 enzymes (see section 5.2).
Maltese: Barra minn hekk, rufinamide ma jwaqqafx l-attività tal-enzimi ta' ċitokrom P450 (ara sezzjoni 5.2).
English: Croscarmellose sodium Hypromellose Magnesium stearate Sodium laurilsulfate Silica colloidal, anhydrous
Maltese: Lactose monohydrate Cellulose, microcrystalline Lamtu tal-qamħirrun Croscarmellose sodium Hypromellose Magnesium stearate Sodium laurilsulfate Silika kollojdali, anidru
English: Each ml of oral suspension contains:
Maltese: Kull ml ta' suspensjoni orali fih:
English: Somnolence* Status epilepticus* Convulsion
Maltese: Status epilepticus* Aċċessjoni
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).
Maltese: L-aktar TEAEs (treatment-emergent adverse events, avvenimenti avversi li jiżviluppaw mill-kura) frekwenti fil-grupp ta' kura b'rufinamide (li seħħew f'≥ 10% tal-individwi) kienu infezzjonijiet fil-parti ta' fuq tal-passaġġ respiratorju u rimettar (28.0% kull wieħed), pnewmonja u ngħas (20.0% kull wieħed), sinusite, otitis media, dijarea, sogħla u deni (16.0% kull wieħed), u bronkite, stitikezza, konġestjoni nażali, raxx, irritabilità u tnaqqis fl-aptit (12.0% kull wieħed).
English: 3,200 mg/day or 80 ml/day
Maltese: 3,200 mg/kuljum jew 80 ml/kuljum
English: Rash* Acne
Maltese: Ir-Renju Unit
English: Rufinamide is almost exclusively eliminated by metabolism.
Maltese: Rufinamide jiġi kważi kollu eliminat bil-metaboliżmu.
English: Age characterisation in patients less than 4 years was not identified in the limited safety database due to small number of patients in the study.
Maltese: Il-karatterizzazzjoni tal-età f'pazjenti iżgħar minn 4 snin ma ġietx identifikata fid-database limitata tas-sigurtà minħabba n-numru żgħir ta' pazjenti fl-istudju.
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.
Maltese: Dożi sa 4,000 mg kuljum (pazjenti li jiżnu bejn 30 - 50 kg) jew 4,800 mg kuljum ('il fuq minn 50 kg) ġew studjati f'numru limitat ta' pazjenti.
English: For this patient population, the maximum recommended dose is 45 mg/kg/day (1.125 ml/kg/day).
Maltese: Għal din il-popolazzjoni ta' pazjenti, id-doża massima rakkomandata hija ta' 45 mg/kg/jum (1.125 mL/kg/jum).
English: Rufinamide appears not to have a clinically relevant effect on carbamazepine, lamotrigine, phenobarbital, topiramate, phenytoin or valproate steady state concentrations.
Maltese: Rufinamide jidher li ma kellu l-ebda effett klinikament relevanti fuq konċentrazzjonijiet ta' fissi ta' carbamazepine, lamotrigine, phenobarbital, topiramate, phenytoin jew valproate.
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).
Maltese: Inovelon (pilloli rufinamide) ingħata fi studju double-blind, ikkontrollat bi plaċebo, f'dożi sa 45 mg/kg/kuljum għal 84 jum, lil 139 pazjent b'aċċessjonijiet ikkontrollati b'mod inadegwat assoċjati mas-sindrome ta' Lennox-Gastaut (li jinkludu kemm aċċessjonijiet ta' assenza atipika u attakki ta' waqgħat).
English: Also contains methyl parahydroxybenzoate (E218) propyl parahydroxybenzoate (E216) sorbitol (E420)
Maltese: Fih ukoll methyl parahydroxybenzoate (E218) propyl parahydroxybenzoate (E216) sorbitol (E420)
English: After single doses, food increases the bioavailability (AUC) of rufinamide by approximately 34% and the peak plasma concentration by 56%.
Maltese: Wara dożi waħdiet, l-ikel iżid il-bijodisponibilità (AUC) ta' rufinamide b'madwar 34%, u l-ogħla konċentrazzjoni fil-plażma b'56%.
English: Detailed information on this product is available on the European Medicines Agency website http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini http://www.ema.europa.eu/.
English: - you suffer from liver problems.
Maltese: - tbati minn problemi tal-fwied.
English: Maximum daily dose taking valproate is 600 mg (15 ml) each day.
Maltese: Id-doża massima ta' kuljum jekk wieħed ikun qed jieħu valproate hija ta' 600 mg (15 mL) kuljum.
English: Inovelon may make the pill not effective at preventing pregnancy.
Maltese: Inovelon jista' jagħmel il-pillola li tipprevjeni t-tqala mhux effettiva.
English: INFORMATION IN BRAILLE Inovelon 200 mg tablets
Maltese: INFORMAZZJONI BIL-BRAILLE Inovelon 200 mg pilloli
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 ml of Inovelon oral suspension contains 40 mg rufinamide.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA 1 ml ta' Inovelon suspensjoni orali fih 40 mg ta' rufinamide. 1 flixkun fih 18,400 mg ta' rufinamide.
English: Inovelon contains methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) These ingredients may cause allergic reactions (possibly delayed).
Maltese: Inovelon fih methyl parahydroxybenzoate (E218) u propyl parahydroxybenzoate (E216) Dawn is-sustanzi jistgħu jikkawżaw reazzjonijiet allerġiċi (possibbilment ittardjati).
English: Doses of up to 3,600 mg/day (90 ml/day) have been studied in a limited number of patients.
Maltese: Dożi sa 3,600 mg/kuljum (90 ml/kuljum) ġew studjati f'għadd limitat ta' pazjenti.
English: As such, drop attacks were used as one of the primary end points.
Maltese: Bħala tali, drop attacks intużaw bħala wieħed mill-punti aħħarin primarji.
English: 1,200 mg/day or 30 ml/day
Maltese: 1,200 mg/kuljum jew 30 mL/kuljum
English: Inovelon contains lactose, therefore patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Inovelon fih lactose, għalhekk pazjenti bi problemi ereditarji rari ta' intolleranza għal galactose, li jbatu mil-Lapp lactase deficiency jew minn malassorbiment ta' glucose-galactose m'għandhomx jieħdu din il-medicina.
English: Aluminium/aluminium blisters, packs of 10, 30, 50, 60 and 100 film-coated tablets.
Maltese: Dawn jistgħu jinkisbu f'pakketti ta' 10, 30, 50, 60, u 100 pillola miksija b'rita.
English: Film-coated tablet.
Maltese: U KWANTITATTIVA Pillola Orali
English: Inovelon oral suspension contains parahydroxybenzoates which may cause allergic reactions (possibly delayed).
Maltese: Inovelon suspensjoni orali fiha parahydroxybenzoates li jistgħu jikkawżaw reazzjonijiet allerġiċi (possibbilment ittardjati).
English: A specific interaction study in healthy subjects revealed no influence of rufinamide at a dose of 400 mg twice daily on the pharmacokinetics of olanzapine, a CYP1A2 substrate.
Maltese: Studju fuq interazzjoni speċifika fuq suġġetti b'saħħithom ma wera l-ebda influwenza ta' rufinamide f'doża ta' 400 mg darbtejn kuljum fuq il-farmakokinetika ta' olanzapine, li huwa sottostrat ta' CYP1A2.
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.
Maltese: Flixkun oriented-polyethylene terephthalate (o-PET) b'tapp tal-polypropylene (PP) li ma jistax jinfetaħ mit-tfal; kull flixkun fih 460 ml ta' suspensjoni f'kaxxa ta' barra tal-kartun.
English: Infections: ear infection, flu, nasal congestion, chest infection.
Maltese: Infezzjonijiet: infezzjonijiet tal-widnejn, mnieħer miżdud, infezzjoni fil-pulmun.
English: No data on the interaction of rufinamide with alcohol are available.
Maltese: M'hemm l-ebda dejta disponibbli dwar l-interazzjoni ta' rufinamide mal-alkoħol.
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.
Maltese: Pazjenti rġiel u nisa (li kellhom bejn 4 u 30 sena) kienu eliġibbli jekk kellhom storja medika ta' tipi ta' aċċessjonijiet multipli, li kellhom jinkludu aċċessjonijiet ta' assenza atipika u drop attacks (i.e., aċċessjonijiet toniċi-atoniċi jew aċċessjonijiet astatiċi); li kienu qed jiġu kkurati b'minn 1 sa 3 dożi fissi ta' prodotti mediċinali antiepilettiċi fl-istess ħin; minimu ta' 90 aċċessjoni fix-xahar ta' qabel il-perjodu ta' 28 jum fil-linja bażi; EEG fi żmien 6 xhur mid-dħul fl-istudju li juri xejra ta' kumplessi spike-and-wave (2.5
English: The toxicity profile of rufinamide in juvenile animals was similar to that in adult animals.
Maltese: Il-profil tat-tossiċità ta' rufinamide f'annimali ġuvenili kien simili għal dak f'annimali adulti.
English: NAME OF THE MEDICINAL PRODUCT Inovelon 40 mg/ml oral suspension
Maltese: Inovelon 40 mg/ml suspensjoni orali
English: Each 400 mg film-coated tablet contains 80 mg lactose (as monohydrate).
Maltese: Kull pillola miksija b'rita ta' 400 mg fiha 80 mg lactose (bħala monohydrate).
English: 2,200 mg/day or 55 ml/day
Maltese: 40 mL/kuljum2,200 mg/kuljum jew 55 mL/kuljum
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.
Maltese: Analiżi riċenti tal-PK fil-popolazzjoni ta' rufinamide fuq dejta miġbura minn 139 individwu (115-il pazjent b'LGS u 24 individwi b'saħħithom), inklużi 83 pazjent pedjatriku b'LGS (10 pazjenti li kellhom bejn sena u <sentejn, 14-il pazjent li kellhom bejn sentejn u < 4 snin, 14-il pazjent li kellhom bejn 4 u < 8 snin, 21 pazjent li kellhom bejn 8 u < 12-il sena u 24 pazjent li kellhom bejn 12 u < 18-il sena) indikat li meta rufinamide jingħata bħala doża fuq bażi ta' mg/kg/jum f'individwi b'LGS li jkollhom bejn sena u < 4 snin, esponiment komparabbli għal dak f'pazjenti b'LGS li jkollhom ≥ 4 snin, fejn ġiet murija l-effikaċja, jintlaħaq.
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.
Maltese: Mudelli farmakokinetiċi/farmakodinamiċi tal-popolazzjoni wrew tnaqqis fil-frekwenza ta' aċċessjonijiet totali u toniċi-atoniċi, it-titjib fl-evalwazzjoni totali tas-severità ta' l-aċċessjoni u ż-żieda fil-probabbiltà ta' tnaqqis ta' frekwenza ta' l-aċċessjoni kienu dipendenti fuq il-konċentrazzjonijiet ta' rufinamide.
English: INFORMATION IN BRAILLE Inovelon 400 mg tablets
Maltese: INFORMAZZJONI BIL-BRAILLE Inovelon 400 mg pilloli
English: Conventional safety pharmacology studies revealed no special hazards at clinically relevant doses.
Maltese: Studji konvenzjonali ta' sigurtà farmakoloġika ma wrew l-ebda perikli b'dożi klinikament rilevanti.
English: Rufinamide treatment has been associated with dizziness, somnolence, ataxia and gait disturbances, which could increase the occurrence of accidental falls in this population (see section 4.8).
Maltese: Il-kura b'rufinamide ġiet assoċjata ma' sturdament, ngħas, atassija u disturbi fil-mixi, li jistgħu jżidu l-okkorrenza ta' waqgħat aċċidentali f'din il-popolazzjoni (ara sezzjoni 4.8).
English: Patients receiving valproate:
Maltese: Pazjenti li jirċievu valproate:
English: Hypromellose Macrogols (8000) Titanium dioxide (E171) Talc
Maltese: Titanium dioxide (E171)
English: The adverse event profile was similar to that in children 4 years of age and older, adolescents, and adults.
Maltese: Il-profil tal-effetti avversi kien simili għal dik fi tfal li kellhom 4 snin u aktar, adolexxenti, u adulti.
English: INFORMATION IN BRAILLE Inovelon 100 mg tablets
Maltese: INFORMAZZJONI BIL-BRAILLE Inovelon 100 mg pilloli
English: For this patient population, the maximum recommended dose is 30 mg/kg/day (0.75 ml/kg/day).
Maltese: Għal din il-popolazzjoni ta' pazjenti, id-doża massima rakkomandata hija ta' 30 mg/kg/jum (0.75 mL/kg/jum).
English: The pharmacokinetic interactions between rufinamide and other antiepileptic medicinal products have been evaluated in patients with epilepsy, using population pharmacokinetic modelling.
Maltese: L-interazzjonijiet farmakokinetici bejn rufinamide u prodotti mediċinali antiepilettiċi oħrajn ġew evalwati f'pazjenti bl-epilessija billi ntuża mmudellar farmakokinetiku fuq il-popolazzjoni.
English: Each 200 mg film-coated tablet contains 40 mg lactose (as monohydrate).
Maltese: Kull pillola miksija b'rita ta' 200 mg fiha 40 mg lactose (bħala monohydrate).
English: As valproate significantly decreases clearance of rufinamide, a lower maximum dose of Inovelon is recommended for patients < 30 kg being co-administered valproate.
Maltese: Peress li valproate inaqqas b'mod sinifikanti t-tneħħija ta' rufinamide, doża massima mnaqqsa ta' Inovelon hi rrakkomandata għal pazjenti < 30 kg li jingħataw valproate ukoll.
English: Nervous system disorders
Maltese: Disturbi tas-sistema nervuża