FrancophonIA/ELRC3.0 huggingface dataset:
English: Janssen-Cilag S.A. - ES Paseo de las DoceEstrellas, 5-7 28042 Madrid, Spain
Maltese: Janssen-Cilag S.A. - ES Paseo de las DoceEstrellas, 5-7 28042 Madrid, Spanja
English: Hammerbakken 19, 3460 Birkerød, Denmark
Maltese: Hammerbakken 19, 3460 Birkerød, IdDanimarka
English: 824 78 Bratislava
Maltese: Plynárenská 7/B 824 78 Bratislava
English: Czech Republic Janssen-Cilag s.r.o - CZ Karla Engliše 3201/6
Maltese: Ir-Repubblika Ċeka Janssen-Cilag s.r.o - CZ Karla Engliše 3201/6
English: {Name and address} <{tel}> <{fax}> <{e-mail}>
Maltese: { Isem u indirizz} <{telefon}> <{fax}> <{e-mail}>
English: Janssen-Cilag AS - NO Hoffsveien 1D 0275 Oslo Norway
Maltese: Janssen-Cilag AS - NO Hoffsveien 1D 0275 Oslo In-Norveġja
English: Mood disturbances/depression
Maltese: Disturbi fil-burdata/depressjoni
English: Slovak Republic Johnson & Johnson, s.r.o - SK
Maltese: Johnson & Johnson, s.r.o - SK
English: Janssen-Cilag AB - SE Box 7073 192 07 Sollentuna, Sverige
Maltese: Janssen-Cilag AB - SE Box 7073 192 07 Sollentuna, L-Isvezja
English: 4.2 - Posology
Maltese: 4.2 - Pożoloġija
English: {Name and address} <{tel}> <{fax}> <{e-mail}>]
Maltese: {Isem u indirizz} <{telefon}> <{fax}> <{e-mail}>
English: Janssen-Cilag International NV - BE Turnhoutseweg 30, B-2340 Beerse, Belgium
Maltese: Janssen-Cilag International NV - BE Turnhoutseweg 30, B-2340 Beerse, IlBelġju
English: Janssen-Cilag A/S - DK Hammerbakken 19, 3460 Birkerød, Denmark
Maltese: Id-Danimarka Janssen-Cilag A/S - DK Hammerbakken 19, 3460 Birkerød, IdDanimarka
English: CNS depressants
Maltese: Depressanti tas-CNS
English: Table 1: Topiramate Adverse Drug Reactions
Maltese: Tabella 1: Reazzjonijiet Avversi tal-Mediċina Topiramate
English: Systemic exposure of the active metabolites, 4-trans-hydroxy-glyburide (M1) and 3-cis-hydroxyglyburide (M2), were also reduced by 13% and 15%, respectively.
Maltese: Esponiment sistemiku tal-metaboliti attivi 4-trans-hydroxy-glyburide (M1) u 3-cis-hydroxyglyburide (M2), kienu wkoll imnaqqsa bi 13% u 15% rispettivament.
English: • Tissue calcification (calcinosis).
Maltese: • Kalċifikazzjoni tat-tessuti (kalċinożi).
English: 20% increase in AUC
Maltese: żieda ta' 20% fl-AUC
English: Bradycardia, sinus bradycardia, palpitations
Maltese: Bradikardija, bradikardija tassinus, palpitazzjonijiet
English: Roderveldlaan 1 B-2600 Berchem, Belgium
Maltese: Roderveldlaan 1 B-2600 Berchem, IlBelġju
English: Topiramate inhibits the enzyme CYP 2C19 and may interfere with other substances metabolized via this enzyme (e.g., diazepam, imipramin, moclobemide, proguanil, omeprazol).
Maltese: Topiramate jimpedixxi l-enzima CYP 2C19 u jista' jinterferixxi ma' sustanzi oħra mmetabolizzati permezz ta' din l-enzima (eż., diazepam, imipramin, moclobemide, proguanil, omeprazol).
English: Box 7073 192 07 Sollentuna, Sverige filmdragerade
Maltese: Box 7073 192 07 Sollentuna, L-Isvezja hårda
English: In addition, a 13% and 16% decrease in Cmax,ss and AUCτ,ss respectively, of the active hydroxy-metabolite was noted as well as a 60% decrease in Cmax,ss and AUCτ,ss of the active keto-metabolite.
Maltese: Flimkien ma' dan, kien innutat tnaqqis ta' 13% u 16% fis-Cmax,ss u l-AUCτ,ss rispettivament tal-metabolit-hydroxy attiv kif ukoll tnaqqis ta' 60% fis-Cmax,ss u l-AUCτ,ss tal-metabolit-keto attiv.
English: High Wycombe Buckinghamshire HP14 4HJ United Kingdom
Maltese: High Wycombe Buckinghamshire HP14 4HJ Ir-Renju Unit
English: The active substance is topiramate.
Maltese: Is-sustanza attiva hija topiramate.
English: The safety of topiramate was evaluated from a clinical trial database consisting of 4,111 patients (3,182 on topiramate and 929 on placebo) who participated in 20 double-blind trials and 2,847 patients who participated in 34 open-label trials, respectively, for topiramate as adjunctive treatment of primary generalized tonic-clonic seizures, partial onset seizures, seizures associated with Lennox-Gastaut syndrome, monotherapy for newly or recently diagnosed epilepsy or migraine prophylaxis.
Maltese: Is-sigurtà ta' topiramate kienet evalwata minn database ta' provi kliniċi li kienet tikkonsisti f'4,111-il pazjent (3,182 fuq topiramate u 929 fuq plaċebo) li pparteċipaw f'20 prova double-blind u 2,847 pazjent li pparteċipaw f'34 prova open-label, rispettivament għal topiramate bħala kura miżjuda ta' aċċessjonijiet primarji ġġeneralizzati tonic-clonic, attakki ta' aċċessjonijiet parzjali, aċċessjonijiet assoċjati mas-sindrome ta' Lennox-Gastaut, monoterapija għal epilessija li għadha kemm saret jew li riċentemet saret dijanjosi tagħha jew għal profilassi ta' l-emigranja.
English: Overall numbers of fetal malformations in mice were increased for all drug-treated groups (20, 100 and 500 mg/kg/day).
Maltese: In-numri globali ta' malformazzjonijiet tal-feti filġrieden żdiedu għall-gruppi kollha kkurati bil-mediċina (20, 100 u 500 mg/kg/jum).
English: • Disturbances in sexual function (erectile dysfunction, loss of libido)
Maltese: • Disturbi fil-funzjoni sesswali (disfunzjoni erettili, tnaqis fil-libido)
English: Janssen-Cilag A/S - DK
Maltese: Id-Danimarka Janssen-Cilag A/S - DK
English: An effective dose range of 200-400mg/day for adults was endorsed by the CHMP.
Maltese: Medda ta' doża effikaċi ta' 200-400 mg kuljum għall-adulti ġiet approvata mill-CHMP.
English: The harmonisation of topiramate marketed in the EU Member States, Norway and Iceland applies to two formulations: - tablets (25 mg, 50 mg, 100 mg, 200 mg) - capsules (15 mg, 25 mg, 50 mg)
Maltese: L-armonizzazzjoni ta' topiramate li tqiegħed fis-suq fl-Istati Membri tal-UE, fin-Norveġja u fl-Iżlanda tapplika għal żewġ formulazzjonijiet: - pilloli (25 mg, 50 mg, 100 mg, 200 mg) - kapsuli (15 mg, 25 mg, 50 mg)
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskoluskeletriki u tat-tessuti konnettivi
English: Vision blurred, diplopia, visual disturbance
Maltese: Vista mċajpra, diplopja, disturb filvista
English: ↔ 20% increase in Cmax and AUC of nortriptyline metabolite
Maltese: ↔ żieda ta' 20% fis-Cmax u lAUC tal-metabolit nortriptyline
English: Key secondary outcomes (responder rate, migraine attack rate, use of rescue medication) demonstrated a consistent response.
Maltese: Eżiti sekondarji ewlenin (rata ta' risposta, rata ta' attakki ta' emigranja, użu ta' medikazzjoni ta' salvataġġ) urew risposta konsistenti.
English: ↔ 17% increase in Cmax for 4OH propranolol (TPM 50 mg q12h)
Maltese: ↔ żieda ta' 17% fis-Cmax għal 4-OH propranolol (TPM 50 mg q12h)
English: LT-08104 Vilnius Lithuania
Maltese: LT-08104
English: AED = antiepileptic drug
Maltese: AED = Mediċina kontra l-epilessija
English: Seizures associated with Lennox-Gastaut syndrome
Maltese: Attakki assoċjati mas-sindromu Lennox-Gastaut
English: In one of the studies (TOPMAT-MIGR-003), which compared topimarate to propranolol, a similar efficacy profile was observed.
Maltese: F'wieħed mill-istudji (TOPMAT-MIGR-003), li qabbel topimarate ma' propranolol, ġie osservat profil ta' effikaċja simili.
English: Leucopenia, thrombocytopenia lymphadenopathy, eosinophilia
Maltese: Lewkopenja, tromboċitopenja, limfadenopatija, eosinofilja
English: This is possibly due to inhibition of a specific enzyme polymorphic isoform (CYP2C19).
Maltese: Dan jista' jkun imħabba impediment ta' isoforma polimorfika ta' enzima speċifika (CYP2C19).
English: UAB Johnson & Johnson - LT Geležinio Vilko g. 18A LT-08104 Vilnius Lithuania
Maltese: UAB Johnson & Johnson - LT Geležinio Vilko g. 18A LT-08104 Vilnius Il-Litwanja
English: Carbamazepine (CBZ) Valproic acid Lamotrigine Phenobarbital
Maltese: Carbamazepine (CBZ) Valproic acid
English: Effects of other antiepileptic medicinal products on Topamax
Maltese: Effetti ta' prodotti mediċinali oħra kontra l-epilessija fuq Topamax
English: Janssen-Cilag Pharma GmbHPfarrgasse 75 A-1232 Wien, Austria
Maltese: Janssen-Cilag Pharma GmbHPfarrgasse 75 A-1232 Wien, L-Awstrija
English: Janssen-Cilag SpA - IT Via Michelangelo Buonarroti n. 23 Cologno Monzese, 20093, Milano, Italy
Maltese: Janssen-Cilag SpA - IT Via Michelangelo Buonarroti n. 23 Cologno Monzese, 20093, Milano, LItalja
English: Acute myopia and secondary angle closure glaucoma
Maltese: Mijopija akuta u glawkoma sekondarja tat-tip angle closure
English: Janssen-Cilag Pharma GmbH Pfarrgasse 75 A-1232 Wien, Austria
Maltese: Janssen-Cilag Pharma GmbH Pfarrgasse 75 A-1232 Wien, L-Awstrija
English: These effects of topiramate were concentrationdependent over a range of 1 µM to 200 µM, with minimum activity observed at 1 µM to 10 µM.
Maltese: Dawn l-effetti ta' topiramate kienu dipendenti mill-konċentrazzjoni fuq medda ta' 1 µM sa 200 µM, bl-attività minima osservata bejn 1 µM u 10 µM.
English: Alopecia, rash, pruritus
Maltese: Alopeċja, raxx, ħakk
English: There was a 25% reduction in glyburide AUC24 during topiramate administration.
Maltese: Kien hemm tnaqqis ta' 25% fl-AUC24 ta' glyburide waqt li kien qed jingħata topiramate.
English: 4.3 - Contraindications
Maltese: 4.3 - Kontra-indikazzjonijiet
English: Erectile dysfunction, sexual dysfunction
Maltese: Disfunzjoni erettili, disfunzjoni sesswali
English: Nephrolithiasis, pollakiuria, dysuria
Maltese: Nefrolitijasi, pollakijurja, disurja,
English: Angle closure glaucoma*, Maculopathy* , eye movement disorder*
Maltese: Glawkom a tat-tip angle closure*, makulopa tija*, disturb talmovimen t talgħajn*
English: Topiramate enhances γ-aminobutyrate-activated chloride channels and inhibits excitatory neurotransmission, through actions on kainate subtypes of glutamate receptors and ∝-amino-3-hydroxy-5-methylisoxazole-4-propionic acid receptors.
Maltese: Topiramate jsaħħaħ il-kanali tal-klorur li huma attivati b'aminobutyrate-γ u jinibixxi n-newrotrasmissjoni eċitatorja, permezz ta' azzjonijiet fuq subtipi kajnate ta' riċetturi ta' glutamate u riċetturi ta' ∝-amino-3-hydroxy-5-methylisoxazole-4propionic acid.
English: The most frequently reported AE's when topiramate was added to risperidone treatment were: somnolence (27% and 12%), paraesthesia (22% and 0%) and nausea (18% and 9% respectively).
Maltese: L-aktar effetti avversi rrappurtati b'mod frekwenti meta topiramate żdied ma' kura b'risperidone kienu: ħedla tan-ngħas (27% u 12%), parestesija (22% u 0%) ) u tqalligħ (18% u 9% rispettivament).
English: In this leaflet:
Maltese: JIS:
English: Allergic oedema*, conjunctival oedema*
Maltese: Edima allerġika *, edima konjunkti vali*
English: The results of covariate analyses in the studies TOPMAT-EPMN-104, TOPMAT-EPMN-105 and TOPMAT-EPMN-106 indicate that the efficacy of topiramate monotherapy did not differ as a function of age.
Maltese: Ir-riżultati ta' analiżi kovarjati fl-istudji TOPMAT-EPMN-104, TOPMAT-EPMN-105 u TOPMAT-EPMN-106 jindikaw li l-effikaċja tal-monoterapija b'topiramate ma kinitx differenti bħala funzjoni tal-età.
English: J.C. Healthcare srl - IT Via Michelangelo Buonarroti n. 23 Cologno Monzese, 20093, Milano, Italy
Maltese: Healthcare srl - IT Via Michelangelo Buonarroti n. 23 Cologno Monzese, 20093, Milano, L-Italja
English: Belgium Janssen-Cilag NV - BE
Maltese: Il-Lussemburgu Janssen-Cilag NV - BE
English: <{Name of the Member State}> <{Name of the medicinal product}> <{Name of the Member State}> <{Name of the medicinal product}>
Maltese: <{Isem ta' l-Istat Membru}> <{ Isem tal-prodott mediċinali}>
English: • Musculoskeletal stiffness
Maltese: • Ebusija muskoluskeletrali
English: In another study, exposure to EE was statistically significantly decreased at doses of 200, 400, and 800 mg/day (18%, 21%, and 30%, respectively) when given as adjunctive therapy in epilepsy patients taking valproic acid.
Maltese: Fi studju ieħor, esponiment għal EE kien imnaqqas b'mod statistikament sinifikanti f'dożi ta' 200, 400, u 800 mg/jum (18%, 21%, u 30%, rispettivament) meta ngħata bħala kura miżjuda f'pazjenti bl-epilessija li kienu qed jieħdu valproic acid.
English: 16% increase in AUC (TPM 50 mg q12h)
Maltese: Venlafaxine Flunarizine żieda ta' 16% fl-AUC (TPM 50 mg q12h)
English: Anorexia, decreased appetite
Maltese: Anoressija, tnaqqis flaptit
English: ↔ 31% increase in AUC of the reduced metabolite
Maltese: ↔ żieda ta' 31% fl-AUC talmetabolit mibdul
English: Indication Epilepsy
Maltese: Indikazzjoni l-Epilessija
English: The frequency of possible side effects listed below is defined using the following convention: very common (affects more than 1 user in 10) common (affects 1 to 10 users in 100) uncommon (affects 1 to 10 users in 1,000) rare (affects 1 to 10 users in 10,000) very rare (affects less than 1 user in 10,000) not known (frequency cannot be estimated from the available data).
Maltese: Il-frekwenza tal-effetti sekondarji elenkati hawn taħt, li jistgħu jiġru, hija ddefinita bl-użu talkonvenzjoni li ġejja: komuni ħafna (jolqtu iktar minn persuna 1 minn kull 10 li jużawh) komuni (jolqtu minn persuna 1 sa 10 persuni minn kull 100 li jużawh) mhux komuni (jolqtu minn persuna 1 sa 10 persuni minn kull 1,000 li jużawh) rari (jolqtu minn persuna 1 sa 10 persuni minn kull 10,000 li jużawh) rari ħafna (jolqtu inqas minn persuna 1 minn kull 10,000 jużawh) mhux magħruf (il-frekwenza ma tistax tiġi stmata mid-data disponibbli).
English: When administered concomitantly with topiramate at escalating doses of 100, 250 and 400 mg/day there was a reduction in risperidone (administered at doses ranging from 1 to 6 mg/day) systemic exposure (16% and 33% for steady-state AUC at the 250 and 400 mg/day doses, respectively).
Maltese: Meta ngħata flimkien ma' topiramate f'dożi dejjem jikbru ta' 100, 250 u 400 mg/jum kien hemm tnaqqis flesponiment sistemiku (16% u 33% għall-AUC fl-istat fiss għad-dożi ta' 250 u 400 mg kuljum, rispettivament) ta' risperidone (mogħti f'dożi fuq medda minn 1sa 6 mg/jum).
English: A drug-drug interaction study conducted in healthy volunteers evaluated the steady-state pharmacokinetics of HCTZ (25 mg q24h) and topiramate (96 mg q12h) when administered alone and concomitantly.
Maltese: Studju ta' azzjoni reċiproka bejn żewġ mediċini li sar fuq voluntiera b'saħħithom, evalwa lfarmakokinetika ta' HCTZ (25 mg q24h) u ta' topiramate (96 mg q12h) fl-istat fiss meta kienu mogħtija waħidhom u flimkien.
English: Other medicines you should discuss with your doctor or pharmacist include other antiepileptic medicines, risperidone, lithium, hydrochlorothiazide, metformin, pioglitazone, glyburide, amitriptyline, propranolol, diltiazem, venlafaxine, flunarazine
Maltese: Mediċini oħra li għandek tiddiskuti mat-tabib jew mal-ispiżjar tiegħek jinkludu mediċini oħra kontra lepilessija, risperidone, lithium, hydrochlorothiazide, metformin, pioglitazone, glyburide, amitriptyline, propranolol, diltiazem, venlafaxine, flunarazine.
English: Following twice a day dosing with 50 mg and 100 mg of topiramate the mean renal clearance was approximately 18 ml/min and 17 ml/min, respectively.
Maltese: Wara ddożar b'50 mg u 100 mg topiramate darbtejn kuljum it-tneħħija medja mill-kliewi kienet bejn wieħed u ieħor ta' 18 ml/min u 17 ml/min, rispettivament.
English: Stevens-Johnson syndrome* erythema multiforme*, skin odour abnormal, periorbital oedema*, urticaria localised
Maltese: Sindrome ta' StevensJohnson*, eritema multiforme*, riħa mhux normali filġilda, nefħa mad-dawra tal-għajn*, urtikarja lokalizzata
English: Slovak Republic Johnson & Johnson, s.r.o - SK Plynárenská 7/B
Maltese: Johnson & Johnson, s.r.o - SK Plynárenská 7/B 824 78 Bratislava
English: 20 hard capsules 28 hard capsules 50 hard capsules 60 hard capsules 100 hard capsules
Maltese: 20 kapsula iebsa 28 kapsula iebsa 50 kapsula iebsa 60 kapsula iebsa 100 kapsula iebsa
English: In double blind clinical trials, suicide related events (SREs) (suicidal ideation, suicide attempts and suicide) occurred at a frequency of 0.5% in topiramate treated patients (46 out of 8,652 patients treated) and at a nearly 3 fold higher incidence than those treated with placebo (0.2%; 8 out of 4,045 patients treated).
Maltese: Fi provi kliniċi double-blind, każijiet relatati ma' suwiċidju (SREs) (ħsibijiet ta' suwiċidju, attentati ta' suwiċidju u suwiċidju) seħħew bi frekwenza ta' 0.5% f'pazjenti kkurati b'topiramate (46 minn 8,652 pazjent ikkurat) u bi kważi inċidenza ta' 3-darbiet ogħla minn dawk ikkurati bi plaċebo (0.2%, 8 minn 4,045 pazjent ikkurat).
English: 9% and17% increase in AUC (40 and 80 mg propranolol q12h respectively)
Maltese: żieda ta' 9% u 16% fis-Cmax, żieda ta' 9% u 17% fl-AUC (40 mg u 80 mg propranolol q12h rispettivament)
English: • Restlessness or increased mental and physical activity
Maltese: • Nuqqas ta' kwiet, jew żieda fl-attività mentali u fiżika
English: Dyspnoea , epistaxis, nasal congestion, rhinorrhoea
Maltese: Dispnea, epistassi, konġestjoni fl-imnieħer, rinorea
English: Acidosis hyperchloraemic
Maltese: Aċidożi iperkloremika
English: Topamax contains lactose.
Maltese: Topamax fih lactose.
English: The embryofetal studies show clear evidence of the teratogenic potential of topiramate.
Maltese: L-istudji embrijofetali juru evidenza ċara tal-potenzjal teratoġeniku ta' topiramate.
English: Pharmacotherapeutic group: other antiepileptics, antimigraine preparations, ATC code: N03AX11
Maltese: Kategorija farmakoterapewtika: mediċini oħrajn kontra l-epilessija, mediċini kontra l-emigranja, Kodiċi ATC:
English: Topiramate is a sulfamate-substituted monosaccharide.
Maltese: Topiramate huwa kklissifikat bħala monosaccharide sostitwit b'sulfamate.
English: The MAH provided a review of data collections from J&J PRD's own pharmacovigilance database and prospective pregnancy registries, which identified potential risks to the foetus of pregnant women treated with topiramate.
Maltese: Il-MAH ipprovda reviżjoni ta' kollezzjonijiet ta' dejta mid-database tal-farmakoviġilanza u r-reġistri tat-tqala prospettivi tal-J&J PRD stess, li identifikaw riskji potenzjali għall-fetu ta' nisa tqal li jkunu qegħdin jiġu trattati b'topiramate.
English: Hyperchloremic, non-anion gap, metabolic acidosis (i.e. decreased serum bicarbonate below the normal reference range in the absence of respiratory alkalosis) is associated with topiramate treatment.
Maltese: Aċidożi metabolika, iperkloremika, non-anion gap (i.e bikarbonat tas-serum imnaqqas li jaqa' taħt ilmedda normali ta' riferenza fin-nuqqas ta' alkalożi respiratorja) hija assoċjata ma' kura b'topiramate.
English: The usual daily dose is 200-400 mg in two divided doses.”
Maltese: Id-doża normali ta' kuljum hija ta' 200-400 mg f'żewġ dożi diviżi.”
English: Sprinkle capsule
Maltese: Grani ġo kapsula
English: In a pharmacokinetic interaction study in healthy volunteers with a concomitantly administered combination oral contraceptive product containing 1 mg norethindrone (NET) plus 35 µg ethinyl estradiol (EE), Topamax given in the absence of other medications at doses of 50 to 200 mg/day was not associated with statistically significant changes in mean exposure (AUC) to either component of the oral contraceptive.
Maltese: Fi studju ta' azzjoni farmakokinetika reċiproka f'voluntiera b'saħħithom li ngħataw b'mod konkomitanti prodott kontraċettiv orali li kien fih 1 mg norethindrone (NET) u 35 µg ethinyl estradiol (EE), Topamax mogħti fin-nuqqas ta' mediċini oħra f'dożi ta' 50 mg sa 200 mg/jum ma kienx assoċjat ma' tibdil statistikament sinifikanti fl-esponiment medju (AUC) għal kull wieħed mill-komponenti talkontraċettiv orali.
English: • Each Topamax film-coated tablet contains 25, 50, 100, 200 mg of topiramate.
Maltese: • Kull pillola ta' Topamax miksija b'rita fiha 25, 50, 100, 200 mg ta' topiramate.
English: Activated charcoal has been shown to adsorb topiramate in vitro.
Maltese: Faħam tal-kannol attivat intwera li jassorbi topiramate in vitro.
English: - SI Smartinska cesta 53, Ljubljana,
Maltese: Johnson & Johnson, d.o.o. - SI Smartinska cesta 53, Ljubljana,
English: Minimal alterations in the pharmacokinetics of the total active moiety (risperidone plus 9hydroxyrisperidone) and no alterations for 9-hydroxyrisperidone were observed.
Maltese: Kien osservat tibdil minimu fil-farmakokinetika tat-total tal-parti attiva (risperidone u 9-hydroxyrisperidone) u ma kien osservat l-ebda tibdil għal 9hydroxyrisperidone.
English: Buckinghamshire HP 14 4HJ United Kingdom
Maltese: High-Wycombe Buckinghamshire HP 14 4HJ Ir-Renju Unit
English: Topamax and associated names (see Annex I) 25, 50, 100 and200 mg film-coated tablets Topamax and associated names 15, 25 and 50 mg hard capsules
Maltese: Topamax u ismijiet assoċjati miegħu (ara Anness I) pilloli ta' 25, 50, 100 u 200 mg miksijin b'rita Topamax u ismijiet assoċjati miegħu kapsuli iebsin ta' 15, 25 u 50 mg
English: In healthy volunteers, there was an observed reduction (18% for AUC) in systemic exposure for lithium during concomitant administration with topiramate 200 mg/day.
Maltese: F'voluntiera b'saħħithom, kien osservat tnaqqis (18% għall-AUC) fl-esponiment sistemiku għal lithium meta ngħata flimkien ma' topiramate f'doża ta' 200 mg/jum.
English: Patients have received a total daily dose up to 200 mg/day.
Maltese: Pazjenti rċievew doża totali sa 200 mg/jum.
English: The 200 mg dose did not appear to provide additional benefit.
Maltese: Id-doża ta' 200 mg ma dehritx li tipprovdi benefiċċju addizzjonali.
English: Topiramate is contraindicated in pregnancy, and in women of childbearing potential if an effective method of contraception is not used (see section 4.3 and 4.5 Interactions with oral contraceptives).
Maltese: Topiramate huwa kontraindikat waqt it-tqala, u f'nisa li jista' jkollhom it-tfal jekk ma jintużax metodu effettiv ta' kontraċezzjoni (ara sezzjonijiet 4.3 u 4.5
English: “Topiramate is indicated in adults for the prophylaxis of migraine headache after careful evaluation of possible alternative treatment options.
Maltese: “Topiramate huwa indikat fl-adulti għall-profilassi tal-uġigħ ta' ras tal-emigranja wara evalwazzjoni bir-reqqa ta' opzjonijiet ta' trattament alternattivi possibbli.
English: Visual acuity reduced, scotoma, myopia*, abnormal sensation in eye*, dry eye, photophobia, blepharospasm, lacrimation increased, photopsia, mydriasis, presbyopia
Maltese: Akutezza mnaqqsa tal-vista, skotoma, miopija*, sensazzjoni mhux normali fl-għajn*, għajn xotta, fotofobija, blefarospażmu, żieda fid-dmugħ, fotopsja, midrijasi, presbijopija,
English: When enzyme inducing medicinal products are withdrawn, topiramate levels will increase.
Maltese: Meta prodotti mediċinali indutturi tal-enzimi jitwaqqfu, il-livelli ta' topiramate se jiżdiedu.
English: Belgium Janssen-Cilag NV - BE Roderveldlaan 1 B-2600 Berchem, Belgium
Maltese: Janssen-Cilag NV - BE Roderveldlaan 1 B-2600
English: • Toxic epidermal necrolysis which is a more severe form of Stevens-Johnson syndrome (see uncommon side effects).
Maltese: • Nekroliżi tossika tal-epidermide li hija forma aktar qawwija tas-sindrome ta' Stevens-Johnson
English: Neutropenia*
Maltese: Newtropenja*
English: The pharmacokinetic profile of topiramate compared to other antiepileptic drugs shows a long plasma halflife, linear pharmacokinetics, predominantly renal clearance, absence of significant protein binding, and lack of clinically relevant active metabolites.
Maltese: Il-profil farmakokinetiku ta' topiramate meta mqabbel ma' mediċini oħrajn kontra l-epilessija juri half-life twila fil-plasma, farmakokinetika lineari, tneħħija l-biċċa l-kbira mill-kliewi, nuqqas ta' twaħħil b'mod sinifikanti mal-proteini, u nuqqas ta' metaboliti attivi klinikament rilevanti.
English: Paediatric population (children over 6 years of age)
Maltese: Tfal (tfal li għandhom età ta' iktar minn 6 snin)
English: Although not achieving statistical significance in a given age group 2-5 yrs, 6-9 yrs, 10-15 yrs and ≥16 yrs, the general trend is toward numerical superiority to placebo in each age group.
Maltese: Għalkemm ma kisbitx sinifikanza statistika fi grupp speċifiku ta' età ta' 2-5 snin, 6-9 snin, 10-15-il sena u ≥16-il sena, it-tendenza ġenerali tersaq lejn superjorità numerika għall-plaċebo f'kull grupp t'età.
English: Dyspnoea exertional, Paranasal sinus hypersecretion, dysphonia
Maltese: Dispnea ma' listrapazz, ipersekrezzjoni mis-sinus paranażali, disfonja
English: • Each Topamax hard capsule contains 15, 25, 50 mg of topiramate.
Maltese: • Kull kapsula iebsa ta' Topamax fiha 15, 25, 50 mg ta' topiramate.
English: • Visual disturbance, blurred vision, double vision
Maltese: • Disturb fil-vista, vista mċajpra, vista doppja