FrancophonIA/ELRC3.0 huggingface dataset:
English: Each carton contains one bottle, two identical calibrated oral dosing syringes and a press-in-bottle adapter (PIBA).
Maltese: Kull kaxxa tal-kartun fiha flixkun wieħed, żewġ siringi identiċi kkalibrati għal dożaġġ orali u press-in-bottle adapter (PIBA).
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.
Maltese: L-ogħla konċentrazzjoni (Cmax) u l-AUC fil-plażma ta' rufinamide jiżdiedu proporzjonalment inqas b'dożi f'individwi u f'pazjenti fl-istat sajjem u dawk li jkunu kielu, probabbilment minħabba l-imġiba tal-assorbiment limitat mid-doża.
English: Problems associated with nerves including: difficulty walking, abnormal movement, convulsions/seizures, unusual eye movements, blurred vision, trembling.
Maltese: Problemi assoċjati man-nervi li jinkludu: diffikultà biex timxi, moviment anormali, aċċessjonijiet/attakki ta' puplesija, movimenti tal-għajnejn mhux tas-soltu, vista mċajpra, tertir ta' bard.
English: The formation of small amounts of glutathione conjugates cannot be completely excluded.
Maltese: Il-formazzjoni ta' ammonti żgħar ta' konjugati ta' glutathione ma tistax tiġi eskluża kompletament.
English: Withdrawal of rufinamide
Maltese: Rufinamide
English: Pneumonia Influenza Nasopharyngitis Ear infection Sinusitis
Maltese: Pnewmonja Influwenza Nażofarinġite Infezzjoni fil-widnejn Sinusite
English: Lennox-Gastaut syndrome is the name given to a group of severe epilepsies in which you may experience repeated seizures of various types.
Maltese: Is-sindromu ta' Lennox-Gastaut hu l-isem mogħti lil grupp ta' epilessiji severi li fihom jista' jkollok aċċessjonijiet ripetuti ta' diversi tipi.
English: In a radiotracer study in three healthy volunteers, the parent compound (rufinamide) was the main radioactive component in plasma, representing about 80% of the total radioactivity, and the metabolite CGP 47292 constituting only about 15%.
Maltese: Fi studju li sar b'radiotracer fuq tliet voluntieri b'saħħithom, il-kompost ewlieni (rufinamide) kien il-komponent radjuattiv ewlieni fil-plażma li jirrapreżenta madwar 80% tar-radjuattività totali, u b'madwar 15% biss ikun magħmul mill-metabolit CGP 47292.
English: Therefore, consideration should be given to a dose reduction of Inovelon in patients who are initiated on valproate therapy (see section 4.2).
Maltese: Għalhekk għandha tingħata konsiderazzjoni għal tnaqqis fid-doża ta' Inovelon f'pazjenti li jinbdew fuq it-terapija b'valproate (ara sezzjoni 4.2).
English: Cytochrome P450-mediated metabolism is very minor.
Maltese: Il-metaboliżmu medjat minn ċitokrom P450 hu minuri ħafna.
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).
Maltese: Skont ir-rispons kliniku u t-tollerabiltà, wara minimu ta' jumejn, id-doża tista' tiżdied b'200 mg/kuljum, sad-doża massima rrakkomandata ta' 600 mg/kuljum (15 ml/kuljum).
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.
Maltese: Reazzjonijiet avversi rrappurtati, b'inċidenza ikbar mill-plaċebo, waqt l-istudji double-blind li saru f'pazjenti bis-sindrome ta' Lennox-Gastaut jew fil-popolazzjoni totali esposta għal rufinamide, huma elenkati fit-tabella hawn taħt skont it-terminoloġija ppreferuta edDRA, il-klassi tal-organi tas-sistema u l-frekwenza.
English: 1,600 mg/day
Maltese: 1,600 mg/kuljum jew
English: Other associated manifestations included lymphadenopathy, liver function tests abnormalities, and haematuria.
Maltese: Manifestazzjonijiet assoċjati oħrajn jinkludu limfadenopatija, testijiet tal-funzjoni tal-fwied b'riżultat mhux normali, u ematurja.
English: Inovelon oral suspension also contains sorbitol and, therefore, should not be administered to patients with rare hereditary problems of fructose intolerance.
Maltese: Inovelon suspensjoni orali fih ukoll sorbitol u, għalhekk, m'għandux jingħata lil pazjenti bi problemi ereditarji rari ta' intolleranza għal fructose.
English: Tell the doctor if you are taking hormonal/oral contraceptives, e.g., “The pill”.
Maltese: Għid lit-tabib tiegħek jekk qed tieħu pilloli kontraċettivi ormonali, eż., “Il-pillola”.
English: Women of child-bearing potential using hormonal contraceptives are advised to use an additional safe and effective contraceptive method (see sections 4.4 and 4.6).
Maltese: Nisa li jista' jkollhom it-tfal li jkunu qed jużaw ormoni kontraċettivi huma avżati biex jużaw metodu kontraċettiv addizzjonali li jkun sikur u effettiv (ara sezzjonijiet 4.4 u 4.6).
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.
Maltese: 200 mg: Pillola roża, forma ovali, b'tul ta' madwar 15.2 mm, daqsxejn imżaqqa, imnaqqxa fuq iż-żewġ naħat, fuq naħa minnhom hemm ‘Є262' imbuzzati u xejn fuq in-naħa l-oħra.
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
Maltese: 10 pilloli miksija b'rita 30 pillola miksija b'rita 50 pillola miksija b'rita 60 pillola miksija b'rita 100 pillola miksija b'rita 200 pillola miksija b'rita
English: Each 100 mg film-coated tablet contains 20 mg lactose (as monohydrate).
Maltese: Kull pillola miksija b'rita ta' 100 mg fiha 20 mg lactose (bħala monohydrate).
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).
Maltese: Meta jingħata darbtejn kuljum f'intervalli ta' 12-il siegħa, rufinamide jakkumula sa fejn hemm previst fil-half life terminali tiegħu, li jindika li l-farmakokinetika ta' rufinamide hija dipendenti fuq il-ħin (i.e. m'hemm l-ebda awto-induzzjoni tal-metaboliżmu).
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).
Maltese: Skont ir-rispons kliniku u t-tollerabbiltà, id-doża tista' tiżdied b'inkrementi ta' 200 mg/kuljum, frekwenti daqs kulltielet jum, sa doża massima rakkomandata ta' 1,000 mg/kuljum (25 ml/kuljum).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/378/006-010
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/06/378/006-010
English: - 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.
Maltese: - għandek Sindromu Konġenitali ta' QT Qasir jew storja medika tal-familja ta' sindromu bħal dan (disturb elettriku tal-qalb), għax jekk tieħu rufinamide tista' tmur għall-agħar.
English: Gait disturbance*
Maltese: Disturbi fil-pass*
English: Due to the potential harmful effects for the breast-fed infant, breast-feeding should be avoided during maternal treatment with rufinamide.
Maltese: Minħabba l-effetti ta' ħsara potenzjali għat-tarbija li tkun qed tiġi mredda', it-treddigħ għandu jiġi evitat waqt it-trattament tal-omm b'rufinamide.
English: If the doctor advises stopping treatment, follow their instructions concerning the gradual reduction of Inovelon in order to lower the risk of an increase in seizures.
Maltese: Jekk it-tabib jirrakkomandalek sabiex twaqqaf it-trattament, segwi l-istruzzjonijiet tiegħu dwar it-tnaqqis gradwali ta' Inovelon sabiex jitnaqqas ir-riskju ta' żieda fl-aċċessjonijiet.
English: The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for Inovelon.
Maltese: Il-mekkaniżmu ta' dan ir-riskju mhux magħruf u d-dejta disponibbli ma teskludix il-possibbiltà ta' żieda fir-riskju għal Inovelon.
English: Headache Dizziness*
Maltese: DATA TA' SKADENZA
English: For this patient population, the maximum recommended dose is 45 mg/kg/day.
Maltese: Għal din il-popolazzjoni ta' pazjenti, id-doża massima rakkomandata hija ta' 45 mg/kg/jum.
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.
Maltese: L-attività medja ta' CYP3A4, imkejla bħala r-rata ta' l-tneħħija ta' triazolam, żdiedet b'55% wara trattament ta' 11-il jum b'rufinamide 400 mg darbtejn kuljum.
English: 1 bottle of 460 ml contains 18400 mg rufinamide.
Maltese: U KWANTITATTIVA Kull ml ta' suspensjoni orali fih 40 mg ta' rufinamide. 1 flixkun ta' 460 ml fih 18,400 mg ta' rufinamide.
English: They are available as packs of 10, 30, 50, 60,100 and 200 film-coated tablets.
Maltese: Dawn jistgħu jinkisbu f'pakketti ta' 10, 30, 50, 60, 100 u 200 pillola miksija b'rita.
English: In clinical trials rufinamide discontinuation was achieved by reducing the dose by approximately 25% every two days (see section 4.4).
Maltese: Fil-provi kliniċi, rufinamide twaqqaf billi d-doża tnaqqset b'madwar 25% kull jumejn (ara sezzjoni 4.4).
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.
Maltese: Tubu tal-polyvinyl chloride (PVC) ta' mhux akbar minn 40 cm fit-tul u dijametru tat-tubu ta' 5
English: Since the pharmacokinetics of rufinamide are not altered in older people (see section 5.2), dosage adjustment is not required in patients over 65 years of age.
Maltese: Peress li l-farmakokinetika ta' rufinamide ma tinbidelx f'persuni akbar fl-età (ara sezzjoni 5.2), aġġustament fid-doża mhuwiex meħtieġ f'pazjenti ta' iktar minn 65 sena.
English: 10 film-coated tablets 30 film-coated tablets 50 film-coated tablets 60 film-coated tablets 100 film-coated tablets
Maltese: 10 pilloli miksija b'rita 30 pillola miksija b'rita 50 pillola miksija b'rita 60 pillola miksija b'rita 100 pillola miksija b'rita
English: The recommended starting dose is 400 mg (10 ml) a day.
Maltese: Id-doża rakkomandata tal-bidu hi ta' 400 mg (10 mL) kuljum.
English: Thus, clinically significant interactions mediated through inhibition of cytochrome P450 system by rufinamide are unlikely to occur.
Maltese: Għalhekk, interazzjonijiet klinikament sinifikattivi li jsiru permezz ta' l-impediment tas-sistema ċitokromju P450 minn rufinamide, aktarx li mhux se jseħħu.
English: In this study, 25 patients were exposed to rufinamide as adjunctive therapy for 24 weeks at a dose of up to 45 mg/kg/day, in 2 divided doses.
Maltese: F'dan l-istudju, 25 pazjent ġew esposti għal rufinamide bħala terapija miżjuda għal 24 ġimgħa f'doża ta' sa 45 mg/kg/jum, f'2 dożi maqsumin.
English: Patients with rare, hereditary problems of fructose intolerance should not take this medicine.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-fructose, m'għandhomx jieħdu din il-mediċina.
English: Uncommon (between 1 in a 100 and 1 in a 1000 patients) side effects of Inovelon are: Allergic reactions and an increase in markers of liver function (hepatic enzyme increase).
Maltese: Mhux komuni (bejn 1 pazjent f'100 u 1 f'1,000) effetti kollaterali ta' Inovelon huma:
English: If the recommended calculated dose of Inovelon is not achievable, the dose should be given to the nearest 0.5 ml of rufinamide.
Maltese: Jekk id-doża kkalkulata rakkomandata ta' Inovelon ma tkunx tista' tintlaħaq, id-doża għandha tingħata sal-eqreb 0.5 mL ta' rufinamide.
English: The oral dosing syringes are graduated in 0.5 ml increments.
Maltese: Is-siringi huma ggradwati f'inkrementi ta' 0.5 ml.
English: There is limited information on the use of rufinamide in older people.
Maltese: Hemm informazzjoni limitata fuq l-użu ta' rufinamide f'persuni akbar fl-età.
English: Each 400 mg film-coated tablet contains 400 mg of rufinamide.
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull pillola fiha 400 mg rufinamide.
English: 5 ml contains 200 mg rufinamide.
Maltese: Kull millilitru fih 40 mg ta' rufinamide. 5 ml fihom 200 mg ta' rufinamide.
English: Dizziness, headache, nausea, vomiting, sleepiness, fatigue.
Maltese: Sturdament, uġigħ ta' ras, dardir, rimettar, ħedla, għeja.
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.
Maltese: Għalhekk, hu rrakkommandat li tuża metodu kontraċettiv addizzjonali sigur u effettiv (bħal metodu li jostakola, eż., kondoms) meta tieħu Inovelon.
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.
Maltese: 400 mg: Pillola roża, forma ovali, daqsxejn imżaqqa, b'tul ta' madwar 18.2 mm, imnaqqxa fuq iż-żewġ naħat, fuq naħa minnhom hemm ‘Є263' imbuzzati u xejn fuq in-naħa l-oħra.Il-pillola tista' tinqasam f'dożi ndaqs.
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.
Maltese: Il-farmakokinetika ta' doża waħda ta' 400 mg ta' rufinamide ma ġietx mibdula f'suġġetti li għandhom indeboliment tal-kliewi kroniku jew sever meta mqabbel ma' voluntieri b'saħħithom.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/378/011-016
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/06/378/011-016
English: The recommended starting dose is 200 mg (5 ml) a day.
Maltese: Id-doża rrakkomandata tal-bidu hi ta' 200 mg (5 mL) kuljum.
English: Inovelon contains lactose
Maltese: GĦAMLA KWALITATTIVA
English: Contusion
Maltese: Disturbi
English: Patients > 30 kg not receiving valproate:
Maltese: Pazjenti > 30 kg li jirċievu wkoll valproate:
English: Maximum daily dose not taking valproate is 1,000 mg (25 ml) each day.
Maltese: Id-doża massima ta' kuljum jekk wieħed ma jkunx qed jieħu valproate hija ta' 1,000 mg (25 mL) kuljum.
English: What is in this leaflet:
Maltese: DATA TA' SKADENZA JIS:
English: Maximum daily dose taking valproate is 30 mg (0.75 ml) for each kilogram of body weight, each day.
Maltese: Id-doża massima ta' kuljum jekk wieħed ikun qed jieħu valproate hija ta' 30 mg (0.75 mL) għal kull kilogramma ta' piż tal-ġisem, kuljum.
English: Each 200 mg film-coated tablet contains 200 mg of rufinamide.
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull pillola fiha 200 mg rufinamide.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/378/001-005
Maltese: NUMRU TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/06/378/001-005
English: Rufinamide is metabolised by hydrolysis, and is not metabolised to any notable degree by cytochrome P450 enzymes.
Maltese: Rufinamide jiġi mmetabolizzat b'idrolisi u ma jiġix immetabolizzat għal xi grad notevoli minn enzimi ta' ċitokrom P450.
English: Each 100 mg film-coated tablet contains 100 mg of rufinamide.
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull pillola fiha 100 mg rufinamide.
English: Dizziness*
Maltese: Ħedla*
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.
Maltese: Neoplażmi beninnji tal-għadam (osteomi) u iperstosi osservati fil-ġrieden, kienu kkunsidrati bħala riżultat tal-attivazzjoni ta' virus speċifiku fil-ġrieden minn joni tal-fluoride li jiġu rilaxxati waqt il-metaboliżmu ossidattiv ta' rufinamide.
English: The bioavailability of rufinamide is dependent on dose.
Maltese: Il-biodisponibilità ta' rufinamide hija dipendenti fuq id-doża.
English: 1,800 mg/day or 45 ml/day
Maltese: 1,800 mg/kuljum 2,400 mg/kuljum 3,200 mg/kuljum
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.
Maltese: - Il-pilloli Inovelon 400 mg huma pilloli roża, ta' forma ovali, daqsxejn mżaqqa, minquxa fuq iż-żewġ naħat, fuq naħa minnhom hemm l-karattri ‘Є263' imbuzzati u xejn fuq in-naħa l-oħra.
English: 1,600 mg/day or 40 ml/day
Maltese: 1,200 mg/kuljum 1,600 mg/kuljum 2,200 mg/kuljum
English: Maximum daily dose taking valproate is no more than 2,200 mg (55 ml), depending on body weight.
Maltese: Id-doża massima ta' kuljum jekk wieħed ikun qed jieħu valproate ma tkunx iktar minn 2,200 mg (55 mL), skont il-piż tal-ġisem.
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.
Maltese: Ukoll, Inovelon (rufinamide suspensjoni orali) ingħata fi studju multiċentriku, open-label, li qabbel iż-żieda ta' rufinamide maż-żieda ta' kwalunkwe AED ieħor tal-għażla tal-investigatur mal-kors eżistenti ta' minn 1 sa 3 AEDs f'pazjenti pedjatriċi, li kellhom minn sena sa inqas minn 4 snin, b'LGS li ma kinux ikkontrollati b'mod adegwat.
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.
Maltese: Ir-rata ta' twaqqif tal-mediċina minħabba r-reazzjonijiet avversi f'pazjenti bis-sindrome ta' Lennox-Gastaut kienet ta' 8.2% għal pazjenti li kien qed jieħdu rufinamide u 0% għal pazjenti li kienu qegħdin jieħdu l-plaċebo.
English: However, plasma levels were reduced by approximately 30% when haemodialysis was applied after administration of rufinamide, suggesting that this may be a useful procedure in case of overdose (see sections 4.2 and 4.9).
Maltese: Madankollu, il-livelli fil-plażma tnaqqsu b'madwar 30% meta ġiet applikata l-emodijalisi wara l-għoti ta' rufinamide, u dan jissuġġerixxi li din tkun proċedura utli f'każ ta' doża eċċessiva (ara sezzjonijiet 4.2 u 4.9).
English: Maximum daily dose not taking valproate is 45 mg (1.125 ml) for each kilogram of body weight, each day.
Maltese: Id-doża massima ta' kuljum jekk wieħed ma jkunx qed jieħu valproate hija ta' 45 mg (1.125 mL) għal kull kilogramma ta' piż tal-ġisem, kuljum.
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.
Maltese: Jekk ikollok xi diffikultà biex tibla', tista' tfarrak il-pillola, u mbagħad tħallat it-trab f'madwar nofs tazza (100 ml) ilma, u ixrobha immedjatament.
English: No data are available (see section 5.2).
Maltese: M'hemm l-ebda data disponibbli (ara sezzjoni 5.2).
English: It may not be excluded that rufinamide may also decrease the exposure of substances metabolised by other enzymes, or transported by transport proteins such as P-glycoprotein.
Maltese: Ma jistax jiġi eskluż li rufinamide jista' jnaqqas ukoll l-espożizzjoni ta' sustanzi mmetabolizzati minn enzimi oħrajn, jew ittrasportati minn proteini tat-trasport bħal P-glikoproteina.
English: Dyspepsia Diarrhoea
Maltese: Stitikezza Dispepsja
English: For this patient population, the maximum recommended dose is 30 mg/kg/day.
Maltese: Għal din il-popolazzjoni ta' pazjenti, id-doża massima rakkomandata hija ta' 30 mg/kg/jum.
English: Adverse reactions were usually mild to moderate in severity.
Maltese: Ir-reazzjonijiet avversi kienu ġeneralment minn ħfief sa moderati fis-severità tagħhom.
English: Inovelon oral suspension and Inovelon film-coated tablets have been demonstrated to be bioequivalent.
Maltese: Intwera li Inovelon suspensjoni orali u Inovelon pilloli miksija b'rita huma bijoekwivalenti.
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.
Maltese: Popolazzjoni Pedjatrika (età minn sena sa inqas minn 4 snin) Fi studju multiċentriku, open-label, li qabbel iż-żieda ta' rufinamide ma' kwalunkwe AED ieħor tal-għażla tal-investigatur mal-kors eżistenti ta' minn 1 sa 3 AEDs f'pazjenti pedjatriċi, li kellhom minn sena sa inqas minn 4 snin, b'LGS (Lennox-Gastaut syndrome, sindromu ta' Lennox-Gastaut) li ma kinux ikkontrollati b'mod adegwat, 25 pazjent, li minnhom 10 individwi kellhom bejn sena u sentejn, ġew esposti għal rufinamide bħala terapija miżjuda għal 24 ġimgħa f'doża ta' sa 45 mg/kg/jum, f'2 dożi maqsumin.
English: Patients > 30 kg also receiving valproate:
Maltese: Pazjenti li jiżnu < 30 kg li jirċievu wkoll valproate:
English: The recommended starting dose is 10 mg (0.25 ml) for each kilogram of body weight, each day.
Maltese: Id-doża rrakkomandata tal-bidu hija ta' 10 mg (0.25 mL) għal kull kilogramma ta' piż tal-ġisem, kuljum.
English: If you stop taking Inovelon
Maltese: Mediċini oħra u Inovelon
English: Rufinamide is for oral use.
Maltese: Għal użu orali.
English: Musculoskeletal and connective tissue and bone disorders
Maltese: Disturbi muskolu-skeletriċ i u tat-tessuti konnettivi
English: - Inovelon 200 mg tablets are pink, oval, slightly convex film-coated tablets, scored on both sides, embossed ‘Є262' on one side and blank on the other side.
Maltese: - Il-pilloli Inovelon 200 mg huma pilloli roża, ta' forma ovali, daqsxejn mżaqqa, miksijin b'rita, minquxa fuq iż-żewġ naħat, fuq naħa minnhom hemm l-karattri ‘Є262' imbuzzati u xejn fuq in-naħa l-oħra.
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.
Maltese: Skont ir-rispons kliniku u t-tollerabbiltà, id-doża tista' tiżdied b'200 mg/kuljum, fi frekwenza ta' kull tielet jum, sa doża massima rrakkomandata ta' 1,000 mg/kuljum.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/378/017
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/06/378/017
English: Potential for rufinamide to affect other medicinal products
Maltese: Il-potenzjal ta' rufinamide li jaffettwa prodotti mediċinali oħrajn
English: Doses of up to 3,600 mg/day have been studied in a limited number of patients.
Maltese: Dożi sa 3,600 mg/kuljum ġew studjati f'għadd limitat ta' pazjenti.
English: NAME OF THE MEDICINAL PRODUCT Inovelon 200 mg film-coated tablets Rufinamide
Maltese: Inovelon 200 mg pilloli miksija b'rita Rufinamide
English: Such evaluations indicate that sex does not affect the pharmacokinetics of rufinamide to a clinically relevant extent.
Maltese: Evalwazzjonijiet bħal dawn jindikaw li s-sess ma jaffettwax il-farmakokinetika ta' rufinamide b'mod klinikament rilevanti.
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.
Maltese: Skont ir-rispons kliniku u t-tollerabbiltà, id-doża tista' tiżdied sa 10 mg/kg/jum (0.25 mL/kg/jum) kull tielet jum għal doża fil-mira ta' 45 mg/kg/jum (1.125 mL/kg/jum) li tingħata f'żewġ dożi maqsumin l-istess u li bejniethom ikun hemm intervall ta' madwar 12-il siegħa.
English: NAME OF THE MEDICINAL PRODUCT Inovelon 400 mg film-coated tablets Rufinamide
Maltese: Inovelon 400 mg pilloli miksija b'rita Rufinamide
English: In a thorough QT study, rufinamide produced a decrease in QTc interval proportional to concentration.
Maltese: Rufinamide ma kienx ġenotossiku u ma kellux potenzjal karċinoġeniku.
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.
Maltese: - Il-pilloli Inovelon 100 mg huma pilloli roża, ta' forma ovali, daqsxejn mżaqqa, miksijin b'rita, minquxa fuq iż-żewġ naħat, fuq naħa minnhom hemm l-karattri ‘Є261' imbuzzati, u xejn fuq in-naħa l-oħra.