FrancophonIA/ELRC3.0 huggingface dataset:
English: A syndrome consisting of acute myopia associated with secondary angle closure glaucoma has been reported in adult and paediatric patients receiving zonisamide.
Maltese: Ġie rrappurtat sindrome li jikkonsisti f'mijopija akuta u glawkoma tat-tip angle closure sekondarja f'pazjenti adulti u pedjatriċi li kienu qed jirċievu zonisamide.
English: Class (MedDRA terminology)
Maltese: Organi (Terminoloġija
English: In paediatric patients (aged 6 years and above), efficacy has been demonstrated with zonisamide in a double-blind, placebo-controlled study, which included 207 subjects and had a treatment duration of up to 24 weeks.
Maltese: F'pazjenti pedjatriċi (li kellhom 6 snin u aktar), l-effikaċja ntweriet b'zonisamide fi studju doubleblind, ikkontrollati bi plaċebo, li kien jinkludi 207 individwi u li kellhom tul ta' żmien ta' kura sa 24 ġimgħa.
English: Angle closure glaucoma Eye pain
Maltese: Uġigħ fl-għajnejn Vista qasira
English: Caution should be used in adults when Zonegran is prescribed with other medicinal products that predispose patients to heat related disorders; these include carbonic anhydrase inhibitors and medicinal products with anticholinergic activity (see also section 4.4 Paediatric population).
Maltese: Għandha tingħata attenzjoni fl-adulti meta tingħata riċetta għal Zonegran ma' prodotti mediċinali oħrajn li jippredisponu lil pazjenti għal mard assoċjat mas-sħana; dawn jinkludu inibituri ta' carbonic anhydrase u prodotti mediċinali b'attività antikolinerġika (ara wkoll sezzjoni 4.4
English: EU/1/04/307/001 EU/1/04/307/005 EU/1/04/307/002 EU/1/04/307/013
Maltese: EU/1/04/307/002 EU/1/04/307/013
English: 300 mg / day (once a day)
Maltese: 300 mg/kuljum (darba kuljum)
English: In children ages 6 - 17 years old, side effects were consistent with those described below with the following exceptions: pneumonia, dehydration, sweating decreased (common) and abnormal liver enzymes (uncommon).
Maltese: Fi tfal li jkollhom minn 6 - 17-il sena, l-effetti sekondarji kienu konsistenti ma' dawk deskritti hawn taħt, bl-eċċezzjonijiet li ġejjin: pnewmonja, deidratazzjoni, tnaqqis fl-għaraq (komuni) u enzimi mhux normali tal-fwied (mhux komuni).
English: Zonegran 25 mg hard capsules
Maltese: Zonegran 25 mg kapsuli ibsin
English: Excipient with known effect: Each hard capsule contains 3 mg hydrogenated vegetable oil (from soyabean)
Maltese: Kull kapsula iebsa fiha 3 mg ta' hydrogenated vegetable oil (mis-soyabean)
English: Each hard capsule contains 100 mg of zonisamide.
Maltese: Kull kapsula iebsa fiha 100 mg ta' zonisamide.
English: Paediatric population (aged 6 years and above) - recommended dosage escalation and maintenance regimen
Maltese: Tabella 3 Popolazzjoni pedjatrika (6 snin u aktar) - skeda rakkomandata ta' titrazzjoni 'l isfel Piż
English: Zonegran 50 mg hard capsules
Maltese: Zonegran 50 mg kapsuli ibsin
English: The amounts by which bicarbonate is decreased are usually small - moderate (average decrease of approximately 3.5 mEq/l at daily doses of 300 mg in adults); rarely patients can experience more severe decreases.
Maltese: L-ammonti li bihom il-bicarbonate jonqos ġeneralment huma ħfief - moderati (tnaqqis medju ta' madwar 3.5 mEq/l f'dożi ta' 300 mg kuljum fladulti); b'mod rari pazjenti għandhom mnejn jesperjenzaw tnaqqis aktar sever.
English: Additionally the 100 mg capsule shell contains sunset yellow FCF (E110) and allura red (E129).
Maltese: Flimkien ma' dan, il-qoxra tal-kapsula ta' 100 mg fiha sunset yellow FCF (E110) u allura red (E129).
English: Zonisamide caused developmental abnormalities in mice, rats, and dogs, and was embryolethal in monkeys, when administered during the period of organogenesis at zonisamide dosage and maternal plasma levels similar to or lower than therapeutic levels in humans.
Maltese: Zonisamide ikkawża anormalitajiet waqt l-iżvilupp fil-ġrieden, firien, u klieb, u kien embrijoletali fixxadini, meta mogħti matul il-perjodu tal-organoġenesi, fid-dożaġġ ta' zonisamide u livelli tal-plażma materni simili għal, jew iktar baxxi mil-livelli terapewtiċi fil-bnedmin.
English: • hallucinations, memory loss, coma, neuroleptic malignant syndrome (inability to move, sweating,
Maltese: • alluċinazzjonijiet, telf ta' memorja, koma, sindrome malinn newroleptiku (ma tkunx tista' titħarrek, għaraq, deni, inkontinenza), status epilepticus (attakki ta' puplesija fit-tul jew ripetuti).
English: Ataxia Dizziness Memory impairment Somnolence
Maltese: Jekk tieqaf tieħu Zonegran
English: A white opaque body and a white opaque cap printed with a logo and “ZONEGRAN 25” in black.
Maltese: Korp opak abjad b'għatu opak abjad li fuqu hemm stampat logo u “ZONEGRAN 25” bl-iswed.
English: Zonegran should not be used as co-medication in paediatric patients with other medicinal products that predispose patients to heat related disorders; these include carbonic anhydrase inhibitors and medicinal products with anticholinergic activity.
Maltese: Zonegran m'għandux jintuża bħala komedikazzjoni f'pazjenti pedjatriċi ma' prodotti mediċinali oħrajn li jippredisponu lil pazjenti għal disturbi assoċjati mas-sħana; dawn jinkludu inibituri ta' carbonic anhydrase u prodotti mediċinali b'attività antikolinerġika.
English: Each hard capsule contains 25 mg of zonisamide.
Maltese: Kull kapsula iebsa fiha 25 mg ta' zonisamide.
English: - CYP3A4 inhibition: Based upon clinical data, known specific and non-specific CYP3A4 inhibitors appear to have no clinically relevant effect on zonisamide pharmacokinetic exposure parameters.
Maltese: Ibbażat fuq informazzjoni klinika, inibituri magħrufa speċifiċi u mhux speċifiċi ta' CYP3A4 jidher li m'għandhom l-ebda effett klinikament rilevanti fuq il-parametri tal-esponiment farmakokinetiku ta' zonisamide.
English: Pruritus Ecchymosis
Maltese: Fażi ta' titrazzjoni
English: Zonisamide AUC and Cmax values increased almost linearly after single dose over the dose range of 100-800 mg and after multiple doses over the dose range of 100-400 mg once daily.
Maltese: Il-valuri tal-AUC u tas-Cmax ta' zonisamide żdiedu b'mod kważi lineari wara doża waħda fuq il-medda tad-doża ta' 100-800 mg u wara dożi multipli fuq il-medda tad-doża ta' 100-400 mg darba kuljum.
English: • With other antiepileptic medicines to treat seizures in adults, adolescents, and children aged
Maltese: • Ma' mediċini antiepilettiċi oħrajn għall-kura ta' puplesiji fl-adulti, adolexxenti u tfal li jkollhom
English: Each hard capsule contains 50 mg of zonisamide.
Maltese: Kull kapsula iebsa fiha 50 mg ta' zonisamide.
English: Withdrawal
Maltese: manteniment
English: Hyperchloraemic, non-anion gap, metabolic acidosis (i.e. decreased serum bicarbonate below the normal reference range in the absence of chronic respiratory alkalosis) is associated with Zonegran treatment.
Maltese: Aċidożi metabolika iperkloremika, bi spazju mhux anjoniku (i.e. tnaqqis fil-livell ta' bicarbonate fis-serum taħt il-firxa normali ta' riferiment fin-nuqqas ta' alkalożi respiratorja kronika) hi assoċjata mat-trattament ta' Zonegran.
English: • loss of appetite, decreased blood levels of bicarbonate (a substance that prevents your blood from becoming acidic)
Maltese: • nuqqas t'aptit, livelli mnaqqsa ta' bicarbonate fid-demm (sustanza li tevita li d-demm tiegħek issir aċiduż)
English: Agitation Depression Insomnia Mood swings Anxiety
Maltese: IT-TAGĦRIF GĦANDU JIDHER FUQ L-IMBALLAĠĠ ESTERN
English: In clinical studies co-administration of lamotrigine had no apparent effect on zonisamide pharmacokinetics.
Maltese: Fi studji kliniċi, l-għoti flimkien ta' lamotrigine ma kellu l-ebda effett apparenti fuq il-farmakokinetika ta' zonisamide.
English: • are pregnant or could become pregnant (see section ‘pregnancy, breast-feeding and fertility' for further information).
Maltese: • li huma tqal jew li jistgħu joħorġu tqal (ara sezzjoni ‘Tqala, treddigħ u fertilità' għal aktar informazzjoni).
English: Hypokalaemia Metabolic acidosis Renal tubular acidosis
Maltese: Ipokalemija Aċidożi metabolika Aċidożi tubulari tal-kliewi
English: How to store Zonegran 6.
Maltese: 6 snin jew aktar.
English: • swelling of the feet and legs.
Maltese: • nefħa tas-saqajn u tar-riġlejn.
English: - Zonegran 100 mg hard capsules have a white opaque body and a red opaque cap and are printed with a logo and “ZONEGRAN 100” in black.
Maltese: - Zonegran 100 mg kapsuli ibsin għandhom korp opak abjad u għatu opak aħmar u fuqhom hemm stampat bl-iswed il-logo u “ZONEGRAN 100”.
English: • have signs of overheating - high body temperature but little or no sweating, rapid heartbeat and breathing, muscle cramps, and confusion.
Maltese: • ikollok sinjali ta' sħana eċċessiva - temperatura tal-ġisem għolja, iżda bi ftit jew xejn għaraq, taħbit tal-qalb u nifs mgħaġġel, bugħawwieġ, u konfużjoni.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali wrew effett tossiku fuq issistema riproduttiva (ara 5.3).
English: • have pain in your muscles or a feeling of weakness, as this may be a sign of abnormal muscle breakdown which can lead to kidney problems.
Maltese: • ikollok uġigħ fil-muskoli jew sensazzjoni ta' dgħufija, għax dan jista' jkun sinjal ta' kollass anormali tal-muskoli li jista' jwassal għal problemi tal-kliewi.
English: What Zonegran contains The active substance in Zonegran is zonisamide.
Maltese: X'fih Zonegran Is-sustanza attiva f'Zonegran hija zonisamide.
English: 100 mg / day (in two divided doses)
Maltese: 100 mg/kuljum (f'żewġ dożi maqsuma)
English: You must only take Zonegran during your pregnancy if your doctor tells you to. Research has shown an increased risk of birth defects in children of women taking anti-epileptic medicines.
Maltese: Fatturi ta' riskju għal nefrolitijasi jinkludu l-formazzjoni ta' ġebel fil-passat, storja medika familjari ta' nefrolitijasi u iperkalċijurija.
English: • skin rashes, itching, allergic reactions, fever, tiredness, flu-like symptoms, hair loss.
Maltese: • raxx tal-ġilda, ħakk, reazzjonijiet allerġiċi, deni, għeja, sintomi bħal tal-influwenza, telf ta' xagħar.
English: Kidney stones have occurred in paediatric patients (see section 4.4 Kidney stones for full warning).
Maltese: Popolazzjoni pedjatrika u sezzjoni 4.5).
English: Cases of decreased sweating and elevated body temperature have been reported mainly in paediatric patients (see section 4.4 Paediatric population for full warning).
Maltese: Każijiet ta' nuqqas ta' għaraq u temperatura tal-ġisem għolja kienu rrappurtati primarjament f'pazjenti pedjatriċi (ara sezzjoni 4.4
English: In addition there has been extensive post-marketing experience with zonisamide in Japan since 1989 and in the USA since 2000.
Maltese: Flimkien ma' dan, kien hemm esperjenza estensiva ta' wara l-bejgħ b'zonisamide fil-Ġappun sa mill-1989 u fl-Istati Uniti sa mis-sena 2000.
English: 100 mg/day (once a day)
Maltese: 100 mg/kuljum (darba kuljum)
English: • gall bladder inflammation, gallstones.
Maltese: • ikollok problemi fl-għajnejn bħal glawkoma.
English: • Zonegran capsules must be swallowed whole with water.
Maltese: • Il-kapsuli Zonegran iridu jinbelgħu sħaħ flimkien mal-ilma.
English: • slowed thoughts, loss of concentration, speech abnormalities, abnormal skin sensation (pins and needles), tremor, involuntary movement of the eyes.
Maltese: • ħsibijiet li jdumu ma jiġu, telf ta' konċentrazzjoni, anormalitajiet fid-diskors, sensazzjoni anormali fil-ġilda (sensazzjoni bħal qisu xi ħadd qed iniggżek bil-labar), rogħda, moviment involontarju tal għajnejn.
English: Adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adolescent and paediatric patients (aged 6 years and above)
Maltese: Terapija addizzjonali fil-kura ta' aċċessjonijiet parzjali, bi jew mingħajr ġeneralizzazzjoni sekondarja, f'pazjenti adolexxenti u pedjatriċi (minn 6 snin 'il fuq)
English: PC:
Maltese: Eżempju:
English: Zonegran contains soya oil.
Maltese: Zonegran fih iż-żejt tas-sojja.
English: Zonegran should be used with caution in adult patients treated concomitantly with carbonic anhydrase inhibitors such as topiramate and acetazolamide, as there are insufficient data to rule out a possible pharmacodynamic interaction (see section 4.4).
Maltese: Zonegran għandu jintuża b'kawtela f'pazjenti adulti li jiġu kkurati b'mod konkomitanti b'impedituri ta' carbonic anhydrase bħal topiramate u acetazolamide, peress li m'hemmx biżżejjed informazzjoni li tista' teskludi xi interazzjoni farmakodinamika possibbli (ara sezzjoni 4.4).
English: Nystagmus Speech disorder Tremor
Maltese: Disturbi taddemm u tassistema limfatika
English: Zonegran 25 mg hard capsules contain 25 mg of zonisamide.
Maltese: Zonegran 25 mg kapsuli ibsin fihom 25 mg ta' zonisamide.
English: The safety and efficacy of Zonegran in children aged below 6 years or those below 20 kg have not yet been established.
Maltese: Is-sigurtà u l-effikaċja ta' Zonegran fit-tfal tal-età li għandhom inqas minn 6 snin jew dawk li jiżnu inqas minn 20 kg ma ġewx stabbiliti.
English: Abdominal pain
Maltese: Popolazzjoni PP
English: The mechanism of action of zonisamide is not fully elucidated, but it appears to act on voltage-sensitive sodium and calcium channels, thereby disrupting synchronised neuronal firing, reducing the spread of seizure discharges and disrupting subsequent epileptic activity.
Maltese: Il-mekkaniżmu tal-azzjoni ta' zonisamide mhuwiex spegat b'mod sħiħ, iżda jidher li jaġixxi fuq ilkanali tal-voltage-sensitive sodium u calcium, u b'hekk jinterrompi s-synchronised neuronal firing, u jnaqqas il-firxa tad-discharges tal-puplesiji u jinterrompi l-attività epilettika sussegwenti.
English: There are no clinical data available on the effects of zonisamide on human fertility.
Maltese: M'hemm l-ebda dejta klinika disponibbli dwar l-effetti ta' zonisamide fuq il-fertilità tal-bniedem.
English: Very rare side effects (may affect up to 1 in 10,000 people):
Maltese: Effetti sekondarji rari ħafna (jistgħu jaffettwaw sa 1 minn kull 10,000 persuna):
English: Children and adolescents (5-18 years): Limited data indicate that pharmacokinetics in children and adolescents dosed to steady state at 1, 7 or 12 mg/kg daily, in divided doses, are similar to those observed in adults, after adjustment for bodyweight.
Maltese: Informazzjoni limitata tindika li l-farmakokinetika fi tfal u adolexxenti li ngħataw doża ta' 1, 7 jew 12 mg/kg kuljum fl-istat fiss, f'dożi maqsumin, hi simili għal dawk osservati fl-adulti, wara aġġustament għall-piż tal-ġisem.
English: Ophthalmologic findings can include myopia, anterior chamber shallowing, and ocular hyperaemia (redness) and increased intraocular pressure.
Maltese: Is-sejbiet oftalmoloġiċi jistgħu jinkludu mijopija, tnaqqis tal-kompartiment anterjuri, u iperemija (ħmura) okulari u żieda fil-pressjoni intraokulari.
English: The elimination half-life was independent of dose and not affected by repeat administration.
Maltese: Il-half-life tal-eliminazzjoni kienet indipendenti mid-doża u ma kinitx affettwata minn għoti ripetut.
English: Propylene glycol Potassium hydroxide
Maltese: Il-potenzjal għal Zonegran li jaffettwa prodotti mediċinali oħrajn
English: A very high plasma concentration of 100.1 μg/ml zonisamide was recorded approximately 31 hours after a patient took an overdose of Zonegran and clonazepam; the patient became comatose and had respiratory depression, but recovered consciousness five days later and had no sequelae.
Maltese: 1 μg/ml zonisamide kienet irreġistrata madwar 31 siegħa wara li pazjent ħa doża eċċessiva ta' Zonegran u clonazepam; il-pazjent sar komatuż u kellu depressjoni respiratorja, iżda ġie f'sensih ħamest ijiem wara u ma ġarrab l-ebda kundizzjonijiet jew mard b'konsegwenza ta' dan.
English: Serious immune based adverse reactions that are associated with medicinal products containing a sulphonamide group include rash, allergic reaction and major haematological disturbances, including aplastic anaemia, which very rarely can be fatal.
Maltese: Reazzjonijiet avversi serji bbażati fuq l-immunità li huma assoċjati ma' prodotti mediċinali li fihom grupp sulphonamide jinkludu raxx, reazzjoni allerġika u disturbi maġġuri ematoloġiċi, li jinkludu anemija aplastika, li b'mod rari ħafna jistgħu jkunu fatali.
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 tirriżulta fl-ispostament anterjuri tal-lenti u tal-iris, bi glawkoma tat-tip angle closure sekondarja.
English: Zonegran 100 mg hard capsules contain 100 mg zonisamide.
Maltese: Zonegran 100 mg kapsuli ibsin fihom 100 mg ta' zonisamide.
English: A white opaque body and a red opaque cap printed with a logo and “ZONEGRAN 100” in black.
Maltese: Korp opak abjad b'għatu opak aħmar li fuqu hemm stampat logo u “ZONEGRAN 100” bl-iswed.
English: Risk factors for nephrolithiasis include prior stone formation, a family history of nephrolithiasis and hypercalciuria.
Maltese: Il-metaboliżmu first-pass hu maħsub li hu negliġibbli.
English: Renal and urinary disorders
Maltese: Dispepsija Dardir
English: Psychiatric Disorders
Maltese: Mard psikotiku
English: How to store Zonegran
Maltese: Kif gћandek tieћu Zonegran
English: Zonegran may be taken as monotherapy or added to existing therapy in adults.
Maltese: Zonegran jista' jittieħed bħala monoterapija jew jiżdied mat-terapija eżistenti fl-adulti.
English: • abnormal muscle breakdown (you may feel pain or weakness in your muscles) which can lead to kidney problems.
Maltese: • Kollass anormali tal-muskoli (tista' tħoss uġigħ jew dgħufija fil-muskoli tiegħek) li jista' twassal għal problemi tal-kliewi.
English: • This may be increased by up to 100 mg at intervals of one to two weeks.
Maltese: • Din tista' tiżdied sa 100 mg f'intervalli ta' ġimgħa jew ġimagħtejn.
English: • loss of weight, nausea, indigestion, stomach pains, diarrhoea (loose stools), constipation.
Maltese: • telf ta' piż, dardir, indiġestjoni, uġigħ fl-istonku, dijarea (ippurgar maħlul), stitikezza.
English: Oral use Read the package leaflet before use.
Maltese: Mhux id-daqsijiet kollha tal-pakkett jistgħu jitpoġġew fis-suq.
English: • This may be increased by up to 100 mg at intervals of two weeks.
Maltese: • Din tista' tiżdied b'sa 100 mg f'intervalli ta' ġimagħtejn.
English: The risk of zonisamide induced metabolic acidosis appears to be more frequent and severe in younger patients.
Maltese: Ir-risku ta' aċidożi metabolika indotta minn zonisamide tidher li hi aktar frekwenti u severa f'pazjenti iżgħar fl-età.
English: Although not formally studied for the treatment of overdose, haemodialysis reduced plasma concentrations of zonisamide in a patient with reduced renal function, and may be considered as treatment of overdose if clinically indicated.
Maltese: Indeboliment konoxxittiv f'pazjenti affettwati minn epilessija ġie assoċjat mal-patoloġija diġà eżistenti u/jew l-għoti ta' kura antiepilettika.
English: Findings not observed in clinical studies, but seen in the dog at exposure levels similar to clinical use, were liver changes (enlargement, dark-brown discolouration, mild hepatocyte enlargement with concentric lamellar bodies in the cytoplasm and cytoplasmic vacuolation) associated with increased metabolism.
Maltese: Is-sejbiet ma kinux osservati fl-istudji kliniċi, iżda kienu osservati fil-klieb f'livelli ta' esponiment simili għal dawk tal-użu kliniku, u dawn kienu bidliet fil-fwied (tkabbir, tibdil fil-kulur kannella skur, tkabbir ħafif tal-epatoċiti b'korpi lamellari konċentriċi fis-cytoplasm u fis-cytoplasmic vacuolation) assoċjat ma' żieda fil-metaboliżmu.
English: Recommended escalation and maintenance doses are given in Table 1.
Maltese: Żieda rakkomandata fid-dożaġġ u dożi ta' manteniment qed jingħataw f'Tabella 1.
English: • have previously suffered from kidney stones, as you may be at increased risk of developing more kidney stones.
Maltese: • fil-passat kellek ġebel fil-kliewi, għax jista' jkollok żieda fir-riskju li jiżviluppaw iktar ġebel filkliewi.
English: creatinine increased, lymphadenopathy, and thrombocytopenia.
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN.
English: • Zonegran should be used carefully in adults when taken with medicines that can cause kidney stones, like topiramate or acetazolamide.
Maltese: • Zonegran għandu jintuża b'attenzjoni fl-adulti meta jittieħed ma' mediċini, bħal topiramate jew acetazolamide.
English: In these cases it is therefore recommended that the Zonegran total dose should be rounded up or down to the nearest available dose that can be achieved with commercially available capsule strengths of Zonegran (25 mg, 50 mg and 100 mg).
Maltese: F'dawn il-każijiet, hu għalhekk rakkomandat li d-doża totali ta' Zonegran għandha tiġi mqarrba 'l fuq jew 'l isfel għall-eqreb doża disponibbli li tista' tintlaħaq mal-qawwiet tal-kapsula ta' Zonegran disponibbli kummerċjalment (25 mg, 50 mg u 100 mg).
English: Zonegran 100 mg hard capsules contain a yellow colour called sunset yellow FCF (E110), and a red colour called allura red AC (E129), which may cause allergic reactions.
Maltese: Zonegran 100 mg kapsuli ibsin fihom kulur isfar imsejjaħ sunset yellow FCF (E110), u kulur aħmar imsejjaħ allura red AC (E129), li jistgħu jikkawżaw reazzjonijiet allerġiċi.
English: • breathing disorders, shortness of breath, inflammation of the lungs.
Maltese: • disturbi biex tieħu n-nifs, qtugħ ta' nifs, infjammazzjoni tal-pulmun.
English: This metabolic acidosis is caused by renal bicarbonate loss due to the inhibitory effect of zonisamide on carbonic anhydrase.
Maltese: Dan l-aċidożi metabolika tiġi kkawżata b'telf ta' bicarbonate mill-kliewi minħabba l-effett impeditorju ta' zonisamide fuq carbonic anhydrase.
English: These effects are unlikely to be of clinical significance when Zonegran is added to existing therapy; however, changes in zonisamide concentrations may occur if concomitant CYP3A4-inducing anti-epileptic or other medicinal products are withdrawn, dose adjusted or introduced, an adjustment of the Zonegran dose may be required.
Maltese: Dawn l-effetti x'aktarx li mhumiex ser ikunu ta' rilevanza klinika meta Zonegran jiżdied mat-terapija eżistenti; madankollu, jista' jseħħ tibdil fil-konċentrazzjonijiet ta' zonisamide jekk l-użu fl-istess ħin ta' mediċini antiepilettiċi jew prodotti mediċinali oħrajn li jinduċu CYP3A4 jitwaqqfu, isirilhom aġġustament fid-doża jew jiġu introdotti, u aġġustament fid-doża ta' Zonegran jista' jkun meħtieġ.
English: • if you are allergic to other sulphonamide medicines.
Maltese: • jekk inti allerġiku għal mediċini tat-tip sulphonamides.
English: Recommended escalation and maintenance doses are given in Table 2.
Maltese: Żieda fid-dożaġġ u dożi ta' manteniment rakkomandati qed jingħataw f'Tabella 2.
English: • The starting dose is 50 mg daily taken in two equal doses of 25 mg.
Maltese: • Id-doża normali tal-bidu hi ta' 50 mg kuljum li tittieħed f'żewġ dożi ta' 25 mg.
English: • have eye problems such as glaucoma.
Maltese: • ġebel fil-kliewi.
English: EMA Number
Maltese: Numru tal-proċedura ta' l-EMA
English: Edurant rilpivirine
Maltese: Edurant rilpivirina
English: The full EPAR for Edurant can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It is available as tablets (25 mg).
Maltese: Jiġi bħala pilloli (25 mg).
English: Edurant is an antiviral medicine.
Maltese: Edurant huwa mediċina antivirali.
English: • carbamazepine, oxcarbazepine, phenobarbital, phenytoin (medicines for fits);
Maltese: • karbamazepina, okskarbazepina, fenobarbital, fenitoin (mediċini għall-konvulżjonijiet);
English: The active substance in Edurant, rilpivirine, is a non-nucleoside reverse transcriptase inhibitor (NNRTI).
Maltese: Is-sustanza attiva f'Edurant, ir-rilpivirina, hija inibitur mhux nukleosidiku tat-transkrittażi inversa (NNRTI).
English: Other information about Edurant
Maltese: Informazzjoni oħra dwar Edurant
English: The European Commission granted a marketing authorisation valid throughout the European Union for Edurant on 28 November 2011.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Edurant valida fl-Unjoni Ewropea kollha fit-28 ta' Novembru 2011.