FrancophonIA/ELRC3.0 huggingface dataset:
English: Mood disturbances/depression and suicidal tendency, acute myopia and secondary angle closure glaucoma and metabolic acidosis have been included and identified as an important risk in the Risk Management Plan (RMP).
Maltese: 4.4 - Twissijiet speċjali u prekawzjonijiet għall-użu Disturbi fil-burdata/depressjoni u tendenza għas-suwiċidju, mijopija akuta u glawkoma sekondarja b'angolu magħluq u aċidożi metabolika ġew inklużi u identifikati bħala riskju importanti fil-Pjan talĠesjoni tar-Riskji (Risk Management Plan - RMP).
English: Topamax and associated names (see Annex I) 15 mg hard capsules Topamax and associated names (see Annex I) 25 mg hard capsules Topamax and associated names (see Annex I) 50 mg hard capsules [See Annex I - To be completed nationally]
Maltese: Topamax u ismijiet assoċjati miegħu (ara Anness I) kapsuli iebsin ta' 15 mg Topamax u ismijiet assoċjati miegħu (ara Anness I) kapsuli iebsin ta' 25 mg Topamax u ismijiet assoċjati miegħu (ara Anness I) kapsuli iebsin ta' 50 mg
English: TOPAMAX MIGRÄNE 25 mg Hartkapseln
Maltese: MIGRÄNE 25 mg Hartkapseln
English: In rats, dosage-related maternal and embryo/fetal toxicity (reduced fetal weights and/or skeletal ossification) were observed down to 20 mg/kg/day with teratogenic effects (limb and digit defects) at 400 mg/kg/day and above.
Maltese: Fil-firien, tossiċità tal-omm u tal-embriju/fetu relatata mad-doża (tnaqqis fil-piżijiet tal-feti u/jew flossifikazzjoni skeletrali) baqgħu jiġu osservati sad-doża li tbaxxiet sa 20 mg/kg/jum b'effetti teratoġeniċi (difetti fid-dirgħajn, fis-saqajn u fis-swaba) b'doża ta' 400 mg/kg/jum u aktar.
English: TOPAMAX 100 tablets 100 milligram(s)
Maltese: TOPAMAX 100 tablets 100 milligramma
English: Topiramate is not intended for acute treatment.
Maltese: Topiramate mhuwiex intenzjonat għattrattament akut.
English: TOPAMAX 25 tablets 25 milligram(s)
Maltese: TOPAMAX 25 tablets 25 milligramma
English: In a single-dose study, serum digoxin area under plasma concentration curve (AUC) decreased 12% due to concomitant administration of Topamax.
Maltese: Fi studju b'doża waħda, l-erja ta' taħt il-kurva tal-konċentrazzjoni ta'digoxin fil-plasma (AUC) naqas bi 12% imħabba l-għoti konkomitanti ta' Topamax.
English: There is evidence of renal tubular reabsorption of topiramate.
Maltese: Hemm evidenza ta' assorbiment ta' topiramate lura għal ġot-tubuli tal-kliewi.
English: The pharmacokinetics of topiramate in children, as in adults receiving add-on therapy, are linear, with clearance independent of dose and steady-state plasma concentrations increasing in proportion to dose.
Maltese: Il-farmakokinetika ta' topiramete fit-tfal, bħal fl-adulti li qed jirċievu terapija miżjuda, hija lineari, bittneħħija indipendenti mid-doża u konċentrazzjonijiet tal-plasma fl-istat fiss li jiżdiedu fi proporzjon mad-doża.
English: Topamax 25mg tabletten 25 milligram(s)
Maltese: Topamax 25mg tabletten 25 milligramma
English: • Hold the hard capsule upright so that you can read the word “TOP”
Maltese: • Żomm il-kapsula iebsa wieqfa b'tali mod li inti tkun tista' taqra l-kelma “TOP”
English: In rabbits, dosage-related maternal toxicity was noted down to 10 mg/kg/day with embryo/fetal toxicity (increased lethality) down to 35 mg/kg/day, and teratogenic effects (rib and vertebral malformations) at 120 mg/kg/day.
Maltese: Fil-fniek, tossiċità tal-omm relatata mad-doża baqgħet tiġi osservata sad-doża li tbaxxiet sa 10 mg/kg/jum b'tossiċità għall-embriju/fetu (żieda fl-ikkaġunar tal-mewt) sad-doża li tbaxxiet sa 35 mg/kg/jum, u effetti teratoġeniċi (malformazzjonijiet fil-kustilji u s-sinsla) b'doża ta' 120 mg/kg/jum.
English: TOPAMAX DISPERSABLE 50 mg, cápsulas
Maltese: DISPERSABLE 50 mg, cápsulas
English: • Ear pain
Maltese: • Għejja
English: Topamax 50mg tabletten 50 milligram(s)
Maltese: Topamax 50mg tabletten 50 milligramma
English: Hypokalaemia, increased appetite, polydipsia
Maltese: Aċidożi metabolika, ipokalimja, żieda fl-aptit, polidipsja
English: Calculus ureteric, renal tubular acidosis*
Maltese: Kalkulu taluretru, aċidożi tat-tubi talkliewi*
English: • Crystals in the urine
Maltese: • Kristalli fl-awrina
English: The mean apparent volume of distribution was 0.80 to 0.55 l/kg for a single dose range of 100 to 1200 mg. An effect of gender on the volume of distribution was detected, with values for females circa 50% of those for males.
Maltese: Il-medja tal-volum ta' distribuzzjoni li dehret kienet bejn 0.80 u 0.55 l/kg għal doża waħda f'medda bejn 100 u 1200 mg.
English: The results from the ANCOVA models indicate that age did not have an impact on treatment effect (pvalue>=0.20) for all three seizure types (POS, PGTS, or LGS).
Maltese: Ir-riżulati mill-mudelli ANCOVA jindikaw li l-età ma kellhiex impatt fuq l-effett tat-trattament (valurp>=0.20) għat-tliet tipi ta' attakki kollha (POS, PGTS, jew LGS).
English: Depending on underlying conditions, appropriate evaluation including serum bicarbonate levels is recommended with topiramate therapy.
Maltese: Skond kundizzjonijiet oħra li diġà jeżistu, evalwazzjoni xierqa inkluż livelli ta' bikarbonat fis-serum hija rakkommandata b'kura ta' topiramate.
English: Sumatriptan (Oral and Subcutaneous)
Maltese: Sumatriptan (mill-Ħalq u Taħt il-Ġilda)
English: Adjunctive therapy epilepsy (partial onset seizures with or without secondary generalization, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome)
Maltese: Epilessija b'kura miżjuda (attakki ta' aċċessjonijiet parzjali b'ġeneralizzazzjoni sekondarja jew mingħajrha, aċċessjonijiet tonic-clonic primarjament ġeneralizzati, jew aċċessjonijiet assoċjati massindrome Lennox-Gastaut)
English: Partial onset seizures (POS) with or without secondary generalization in Adults and Children The results of 6 controlled studies indicate that adjunctive therapy in adults with topiramate has significant therapeutic benefit in controlling partial onset seizures with or without secondary generalisation.
Maltese: Ir-riżultati ta' 6 studji kkontrollati jindikaw li t-terapija aġġuntiva fl-adulti b'topiramate għandha benefiċċju terapewtiku sinifikanti fil-kontroll tal-attakki parzjali tal-bidu bi jew mingħajr ġeneralizzazzjoni sekondarja.
English: TOPAMAX DISPERSABLE 25 mg, cápsulas
Maltese: DISPERSABLE 25 mg, cápsulas
English: These decreases are usually mild to moderate (average decrease of 4 mmol/l at doses of 100 mg/day or above in adults and at approximately 6 mg/kg/day in paediatric patients).
Maltese: Dan it-tnaqqis huwa l-biċċa l-kbira ħafif sa moderat (tnaqqis medju ta' 4 mmol/l f'dożi ta' 100 mg/jum jew aktar fl-adulti u bejn wieħed u ieħor b'6mg/kg/jum fit-tfal).
English: This syndrome may be associated with supraciliary effusion resulting in anterior displacement of the lens and iris, with secondary angle closure glaucoma.
Maltese: Dan is-sindrome jista' jkun assoċjat ma' effużjoni supraċiljari li jwassal għal spostament anterjuri tal-lenti u l-iris, bi glawkoma sekondarja tat-tip angle closure.
English: Depressed level of consciousness, grand mal convulsion, visual field defect, complex partial seizures, speech disorder, psychomotor hyperactivity, syncope, sensory disturbance, drooling, hypersomnia, aphasia, repetitive speech, hypokinesia, dyskinesia, dizziness postural, poor quality sleep, burning sensation, sensory loss, parosmia, cerebellar syndrome, dysaesthesia, hypogeusia, stupor, clumsiness, aura, ageusia, dysgraphia, dysphasia, neuropathy peripheral, presyncope, dystonia,
Maltese: Livell depressat ta' koxjenza, konvulżjoni grand mal, difett filqasam viżiv, aċċessjonijiet parzjali kumplessi, disturb fit-taħdit, attività eċċessiva psikomutura, sinkope, disturb tas-sensi, tlegħib, ipersomnija, afasja, taħdit ripetittiv, ipokajniżja, diskajniżja, sturdament malwaqqaf, irqad ta' kwalità ħażina, sensazzjoni ta' ħruq, telf tassensazzjoni, parosmija, sindrome ċerebellari, disestesija, ipogużja, stat ta' koxjenza mnaqqsa, guffaġni, awra, agużja, disgrafja, disfasja, newropatija
English: A number of areas of disharmony in the product information for topirmate have been evaluated by the CHMP and the revised Product Information (PI) was adopted.
Maltese: Numru ta' oqsma b'nuqqas ta' armonizzazzjoni fl-informazzjoni dwar il-prodott għal topirmate ġew evalwati mill-CHMP u ġie adottat it-Tagħrif dwar il-Prodott (Product Information - PI) rivedut.
English: 20 film-coated tablets with desiccant 28 film-coated tablets with desiccant 50 film-coated tablets with desiccant 56 film-coated tablets with desiccant 60 film-coated tablets with desiccant 100 film-coated tablets with desiccant
Maltese: 20 pillola miksija b'rita b'desikkant 28 pillola miksija b'rita b'desikkant 50 pillola miksija b'rita b'desikkant 56 pillola miksija b'rita b'desikkant 60 pillola miksija b'rita b'desikkant 100 pillola miksija b'rita b'desikkant
English: ADRs identified in clinical trials, and during post-marketing experience (as indicated by “*”) are listed by their incidence in clinical trials in Table 1.
Maltese: L-ADRs identifikati fil-provi kliniċi u waqt l-esperjenza ta' wara t-tqegħid fis-suq (kif indikat b' “*”) huma mniżżla f'Tabella 1 skond l-inċidenza tagħhom filprovi kliniċi.
English: TOPAMAX Sprinkle Capsules 15 mg.
Maltese: Sprinkle Capsules 15 mg.
English: Proper hydration prior to and during activities such as exercise or exposure to warm temperatures may reduce the risk of heat-related adverse reactions (see section 4.8).
Maltese: Idratazzjoni kif imiss qabel u waqt attività bħal eżerċizzju jew esponiment għal temperaturi sħan tista' tnaqqas ir-riskju ta' reazzjonijiet avversi li għadhom x'jaqsmu mas-sħana (ara sezzjoni 4.8).
English: • Tingling in the arms and legs
Maltese: • Tnemnim fid-dirgħajn u fir-riġlejn
English: Nasopharyngitis
Maltese: Nefrolitijasi
English: Take the medicine pack with you.
Maltese: Ħu il-pakkett tal-mediċina miegħek.
English: TOPAMAX DISPERSABLE 15 mg, cápsulas
Maltese: DISPERSABLE 15 mg, cápsulas
English: Therefore the harmonised indication for topiramate adjunctive therapy in partial onset seizures with or without secondary generalization or primary generalized tonic-clonic seizures in adults and in the paediatric population was supported by the CHMP:
Maltese: Għalhekk l-indikazzjoni armonizzata għat-terapija aġġuntiva b'topiramate f'attakki parzjali tal-bidu bi jew mingħajr ġeneralizzazzjoni sekondarja jew attakki toniċi-kloniċi ġeneralizzati primarji fl-adulti u fil-popolazzjoni pedjatrika ġiet appoġġjata mill-CHMP:
English: TOPAMAX MIGRÄNE 100 mg Filmtabletten
Maltese: MIGRÄNE 100 mg Filmtabletten
English: 4.5 - Interaction with other medicinal products and other forms of interaction Data supporting the proposed text on the potential interactions of topiramate with oral contraceptives and risperidone have been presented.
Maltese: Ġiet ippreżentata dejta li tappoġġja t-test propost dwar l-interazzjonijiet possibbli ta' topiramate ma' kontraċettivi orali u risperidone.
English: ADRs reported more frequently (≥2-fold) in children than in adults in double-blind controlled studies include: decreased appetite, increased appetite, acidosis hyperchloraemic, hypokalaemia, abnormal behaviour, aggression, apathy, initial insomnia, suicidal ideation, disturbance in attention, lethargy, circadian rhythm sleep disorder, poor quality sleep, lacrimation increased, sinus bradycardia, feeling abnormal, and gait disturbance.
Maltese: ADRs irrappurtati aktar frekwenti (≥2 aktar) fit-tfal milli fl-adulti fi studji double-blind kkontrollati jinkludu: tnaqqis fl-aptit, żieda fl-aptit, aċidożi iperkloremika, ipokalimja, komportament mhux normali, aggressjoni, apatija, insomnja fil-bidu tar-raqda, ħsibijiet ta' suwiċidju, disturb fl-attenzjoni, letarġija, disturb tar-ritmu ċirkadjan ta' l-irqad, irqad ta' kwalità ħażina, żieda fid-dmugħ, bradikardija tas-sinus, ma tħossokx normali, u disturb fil-mixi.
English: The results have been presented for the entire cohort, demonstrating a statistically significant treatment effect over the whole paediatric patient group.
Maltese: Ir-riżultati ġew ippreżentati għall-koorti kollha, u urew effett ta' trattament statistikament sinifikanti fil-grupp ta' pazjenti pedjatriċi kollu.
English: Examples are applesauce, custard, ice cream, porridge, pudding or yogurt.
Maltese: Eżempji huma zalza tat-tuffieħ, kastard, poriġ, pudina u jogurt.
English: The recommended initial target dose for topiramate monotherapy in adults is 100 mg/day to 200 mg/day in 2 divided doses.
Maltese: Id-doża tal-bidu rakkommandata li trid tinkiseb għal monoterapija b'topiramate fl-adulti hija ta'100 mg sa 200 mg maqsuma f'darbtejn kuljum.
English: • Breath odour
Maltese: • Ħalq xott
English: Some patients with refractory forms of epilepsy have tolerated topiramate monotherapy at doses of 1,000 mg/day.
Maltese: Xi pazjenti b'forom ta' epilessija refrattorja ttolleraw monoterapija b'topirammate f'dożi ta' 1,000 mg kuljum.
English: The mean Cmax following multiple, twice a day oral doses of 100 mg to healthy subjects was 6.76 µg/ml.
Maltese: Il-medja tas-Cmax wara ħafna dożi, ta' 100mg mogħtija darbtejn kuljum mill-ħalq lill-individwi b'saħħithom kienet ta' 6.76 µg/ml.
English: Topimax 25 mg tabletter, 25 milligram(s)
Maltese: Topimax 25 mg kapslar, 25 milligramma
English: In clinical trials, daily dosages were decreased in weekly intervals by 50-100 mg in adults with epilepsy and by 25-50 mg in adults receiving topiramate at doses up to 100 mg/day for migraine prophylaxis.
Maltese: Fi provi kliniċi, dożi mogħtija kuljum kienu jiġu mnaqqsa b'50-100 mg kull ġimgħa fl-adulti bl-epilessija u b'25-50 mg f'adulti li kienu qed jirċievu dożi sa 100 mg/jum għal profilassi tal-emigranja.
English: Agents predisposing to nephrolithiasis
Maltese: Funzjoni mnaqqsa tal-fwied
English: TOPAMAX MIGRÄNE 25 mg Filmtabletten
Maltese: MIGRÄNE 25 mg Filmtabletten
English: A risk of decreased plasma concentrations resulting in a loss of efficacy could be observed with coadministration of topiramate and St John's Wort.
Maltese: Riskju ta' konċentrazzjonijiet imnaqqsa fil-plażma li jwasslu għal telf ta' effikaċja jistgħu jiġu osservati bl-għoti flimkien ta' topiramate u St John's Wort.
English: Show this list to your doctor and pharmacist before you start a new medicine.
Maltese: Żomm lista ta' mediċini li inti tieħu.
English: TOPAMAX 50 tablets 50 milligram(s)
Maltese: TOPAMAX 50 tablets 50 milligramma
English: HOW TO STORE TOPAMAX
Maltese: Tieħux Topamax
English: A pharmacokinetic interaction study of patients with epilepsy indicated the addition of topiramate to lamotrigine had no effect on steady state plasma concentration of lamotrigine at topiramate doses of 100 to 400 mg/day.
Maltese: Studju ta' interazzjoni farmakokinetika ta' pazjenti bl-epilessija indika li ż-żieda ta' topiramate ma' lamotrigine ma kellha l-ebda effett fuq il-konċentrazzjonijiet fl-istat fiss ta' lamotrigine fil-plasma b'dożi ta' topiramate minn 100 sa 400 mg/jum.
English: Topiramate overdose can result in severe metabolic acidosis (see section 4.4).
Maltese: Doża eċċessiva ta' topiramate tista' twassal għal aċidożi metabolika qawwija (ara sezzjoni 4.4).
English: Study TOPMAT-EPMN-105 provided evidence to support the extension to the wider ‘epilepsy' indication as this is the only study which included patients with a variety of seizure syndromes other than partial onset seizures.
Maltese: L-istudju TOPMATEPMN-105 ipprovda evidenza li tappoġġa l-estensjoni għall-indikazzjoni usa' ta' ‘epilessija' għaliex dan huwa l-uniku studju li nkluda pazjenti b'varjetà ta' sindromi ta' attakki minbarra l-attakki parzjali tal-bidu.
English: TOPAMAX MIGRÄNE 50 mg Filmtabletten
Maltese: MIGRÄNE 50 mg Filmtabletten
English: The addition of Topamax to other antiepileptic drugs (phenytoin, carbamazepine, valproic acid, phenobarbital, primidone) has no effect on their steady-state plasma concentrations, except in the occasional patient, where the addition of Topamax to phenytoin may result in an increase of plasma concentrations of phenytoin.
Maltese: Iż-żieda ta' Topamax ma' mediċini oħra kontra l-epilessija (phenytoin, carbamazepine, valproic acid, phenobarbital, primidone) m'għandu l-ebda effett fuq il-konċentrazzjonijiet tagħhom fl-istat fiss talplasma, minbarra f'xi pazjent li kultant, iż-żieda ta' Topamax ma' phenytoin tista' twassal għal żieda fil-konċentrazzjonijiet ta' phenytoin fil-plasma.
English: Dose recommendations for the renally impaired have been stated.
Maltese: Dożi eċċessivi ta' topiramate kienu rrappurtati.
English: Patients with normal renal function may take 4 to 8 days to reach steady-state plasma concentrations.
Maltese: Pazjenti b'funzjoni normali tal-kliewi jistgħu jieħdu minn 4 sa 8 ijiem biex jilħqu konċentrazzjonijiet fl-istat fiss fil-plasma.
English: In situations where rapid withdrawal of topiramate is medically required, appropriate monitoring is recommended (see section 4.2 for further details).
Maltese: F'sitwazzjonijiet fejn għal raġuni medika jkun meħtieġ it-twaqqif malajr ta' topiramate, monitoraġġ xieraq huwa rakkommandat (ara sezzjoni 4.2 għal aktar dettalji).
English: Six metabolites, formed through hydroxylation, hydrolysis and glucuronidation, have been isolated, characterized and identified from plasma, urine and faeces of humans.
Maltese: Sitt metaboliti, iffurmati minn idroksilazzjoni, idroliżi u glukuronidazzjoni, kienu iżolati, ikkaratterizzati u identifikati mill-plasma, l-awrina u lippurgar tal-bnedmin.
English: In contrast to primary narrow angle glaucoma, which is rare under 40 years of age, secondary angle closure glaucoma associated with topiramate has been reported in paediatric patients as well as adults.
Maltese: F'kuntrast ma' glawkoma primarja tat-tip narrow angle, li hija rari taħt l-40 sena, glawkoma sekondarja tat-tip angle closure assoċjata ma' topiramate kienet irrappurtata fi tfal kif ukoll fl-adulti.
English: Pregnancy registry data suggest that there may be an association between the use of Topamax during pregnancy and congenital malformations (e.g., craniofacial defects, such as cleft lip/palate, hypospadias, and anomalies involving various body systems).
Maltese: Tagħrif minn registru dwar tqaliet jissuġġerixxi li jista' jkun hemm assoċjazzjoni bejn l-użu ta' Topamax waqt it-tqala u formazzjonijiet konġenitali difettużi (eż., difetti tal-kranju u l-wiċċ, bħal ma hija qasma fix-xoffa/saqaf tal-ħalq, hypospadias u anomaliji li jinvolvu sistemi diversi tal-ġisem).
English: Titration should begin at 25 mg (or less, based on a range of 1 to 3 mg/kg/day) nightly for the first week.
Maltese: Titrazzjoni għandha tibda b'25 mg (jew anqas, fuq bażi ta' medda bejn 1 u 3 mg/kg/jum) kull lejl għall-ewwel ġimgħa.
English: Topamax and associated names (see Annex I) 200 mg film-coated tablets [See Annex I - To be completed nationally] topiramate
Maltese: Topamax u ismijiet assoċjati miegħu (ara Anness I) pilloli ta' 200 mg miksijin b'rita [Ara Anness I - Biex timtela mill-pajjiż partikolari] topiramate
English: Topiramate is not a potent inducer of drug metabolizing enzymes, can be administered without regard to meals, and routine monitoring of plasma topiramate concentrations is not necessary.
Maltese: Topiramate m'huwiex induttur potenti ta' enzimi li jimmetabolizzaw il-mediċini, jista' jingħata mingħajr il-bżonn li jitiieħed ma' l-ikel, u monitoraġġ regolari ta' konċentrazzjonijiet ta' topiramate fil-plasma m'humiex meħtieġa.
English: The clinical relevance of this observation has not been established.
Maltese: Ir-rilevanza klinika ta' din l-osservazzjoni ma ġietx stabbilita.
English: A drug-drug interaction study conducted in healthy volunteers evaluated the steady-state pharmacokinetics of metformin and topiramate in plasma when metformin was given alone and when metformin and topiramate were given simultaneously.
Maltese: Studju ta' azzjoni reċiproka bejn żewġ mediċini li sar fuq voluntiera b'saħħithom evalwa ilfarmakokinetika ta' metformin u ta' topiramate fl-istat fiss fil-plasma meta metformin ingħata għalih waħdu u meta metformin u topiramate ingħataw f'daqqa.
English: TOPAMAX MIGRÄNE 200 mg Filmtabletten
Maltese: MIGRÄNE 200 mg Filmtabletten
English: Common side effects include:
Maltese: Effetti sekondarji komuni jinkludu:
English: Monotherapy in adults, adolescents and children over 6 years of age with partial seizures with or without secondary generalised seizures, and primary generalised tonic-clonic seizures.
Maltese: Monoterapija fl-adulti, fl-adoloxxenti u fit-tfal li għandhom aktar minn 6 snin b'aċċessjonijiet parzjali b'aċċessjonijiet sekondarji ġeneralizzati jew mingħajrhom, u aċċessjonijiet primarji ġeneralizzati tonic-clonic.
English: It is recommended that Topamax not be used concomitantly with alcohol or other CNS depressant medicinal products.
Maltese: Huwa rrakkommandat li Topamax ma jiġix użat flimkien ma' l-alkoħol jew ma' prodotti mediċinali oħra li jiddepressaw is-CNS.
English: This indication is endorsed by the current recommendations of the European Federation of Neurological Societies (EFNS) task force (2006) where topiramate is considered an appropriate first-line prophylactic migraine medication based on scientific evidence from clinical trials and on expert consensus of the EFNS.
Maltese: Din lindikazzjoni hija approvata mir-rakkomandazzjonijiet attwali tat-task force tal-Federazzjoni Ewropea tas-Soċjetajiet Newroloġiċi (European Federation of Neurological Societies - EFNS) (2006) fejn topiramate huwa kkunsidrat bħala medikazzjoni profilattika xierqa tal-ewwel linja għall-emigranja fuq il-bażi ta' evidenza xjentifika minn provi kliniċi u fuq kunsens espert tal-EFNS.
English: There is currently no evidence that migraine prophylaxis during pregnancy reduces the risk of stroke.
Maltese: Attwalment m'hemm ebda evidenza li lprofilassi tal-emigranja matul it-tqala tnaqqas ir-riskju ta' attakk ta' puplesija.
English: Topamax comprimés 50 mg
Maltese: Topamax comprimés 50 50 milligramma
English: Topamax and associated names (see Annex I) 15 mg hard capsules [See Annex I - To be completed nationally] topiramate
Maltese: Topamax u ismijiet assoċjati miegħu (ara Anness I) kapsuli iebsin ta' 15 mg [Ara Anness I - Biex timtela mill-pajjiż partikolari] topiramate
English: • Odour
Maltese: • Rimettar
English: An increased incidence of mood disturbances and depression has been observed during topiramate treatment.
Maltese: Inċidenza ogħla ta' disturbi fil-burdata u depressjoni ġew osservati waqt kura b'topiramate.
English: Topamax and associated names (see Annex I) 25 mg film-coated tablets [See Annex I - To be completed nationally] topiramate
Maltese: Topamax u ismijiet assoċjati miegħu (ara Anness I) pilloli ta' 25 mg miksijin b'rita [Ara Anness I - Biex timtela mill-pajjiż partikolari] topiramate
English: It is metabolized up to 50% in patients receiving concomitant antiepileptic therapy with known inducers of drug metabolizing enzymes.
Maltese: Huwa mmetabolizzat sa 50% f'pazjenti li qed jirċievu kura kontra l-epilessija konkomitanti b'indutturi magħrufa ta' enzemi li jimetabolizzaw il-mediċini.
English: Treatment
Maltese: Konkomitanti
English: TOPAMAX 15 mg kapsule hard capsule
Maltese: TOPAMAX 15 mg kapsule
English: TOPAMAX Sprinkle Capsules 25 mg.
Maltese: Sprinkle Capsules 25 mg.
English: Batch
Maltese: Billi
English: Although not achieving statistical significance in a given paediatric age group, the general trend is toward numerical superiority to placebo in each age group.
Maltese: Għalkemm ma nkisibx sinifikat statistiku fi grupp pedjatriku partikolari, it-tendenza ġenerali tersaq lejn superjorità numerika għall-plaċebo f'kull grupp ta' età.
English: “Monotherapy in adults, adolescents and children over 6 years of age with partial seizures with or without secondary generalised seizures, and primary generalised tonic-clonic seizures.”
Maltese: “Monoterapija fl-adulti, fl-adoloxxenti u fit-tfal ta' età ta' aktar minn 6 snin b'attakki parzjali bi jew mingħajr attakki ġeneralizzati sekondarji, u attakki toniċi-kloniċi ġeneralizzati primarji”
English: • Heartburn
Maltese: • Tqalligħ
English: Topamax and associated names (see Annex I) 50 mg hard capsules [See Annex I - To be completed nationally] topiramate
Maltese: Topamax u ismijiet assoċjati miegħu (ara Anness I) kapsuli iebsin ta' 50 mg [Ara Anness I - Biex timtela mill-pajjiż partikolari] topiramate