FrancophonIA/ELRC3.0 huggingface dataset:
English: Pharmacotherapeutic group: Antiepileptics, other antiepileptics, ATC code: N03AX15
Maltese: Antiepilettiċi, antiepilettiċi oħra, Kodiċi ATC:
English: • adjunctive therapy in the treatment of partial seizures, with or without secondary generalisation, in adults, adolescents, and children aged 6 years and above.
Maltese: • terapija addizzjonali fil-kura ta' puplesiji parzjali, bi jew mingħajr ġeneralizzazzjoni sekondarja f'adulti, adolexxenti u tfal li jkollhom 6 snin jew aktar.
English: The apparent volume of distribution is about 1.1 - 1.7 l/kg in adults indicating that zonisamide is extensively distributed to tissues.
Maltese: Il-volum apparenti tad-distribuzzjoni hu ta' madwar 1.1 - 1.7 L/kg fl-adulti, li jindika li zonisamide hu ddistribwit b'mod estensiv lit-tessut.
English: Therefore, zonisamide is not expected to affect the pharmacokinetics of other medicinal products via cytochrome P450-mediated mechanisms, as demonstrated for carbamazepine, phenytoin, ethinylestradiol and desipramine in vivo.
Maltese: Għalhekk, zonisamide mhux mistenni li jaffettwa l-farmakokinetiċi ta' prodotti mediċinali oħrajn permezz ta' mekkaniżmi medjati minn cytochrome P450, kif muri għal carbamazepine, phenytoin, ethinylestradiol u desipramine in vivo.
English: Children and adolescents (5-18 years)
Maltese: Tfal u adolexxentis (5 snin-18-il sena)
English: Zonisamide is a benzisoxazole derivative, which contains a sulfonamide group.
Maltese: Zonisamide hu derivattiv ta' benzisoxazole li fih grupp ta' sulfonamide.
English: Zonisamide is metabolised partly by CYP3A4 (reductive cleavage), and also by N-acetyl-transferases and conjugation with glucuronic acid; therefore, substances that can induce or inhibit these enzymes may affect the pharmacokinetics of zonisamide:
Maltese: Zonisamide hu metabolat parzjalment minn CYP3A4 (reductive cleavage), u wkoll minn N-acetyltransferases u konjugazzjoni ma' glucuronic acid; għalhekk, sustanzi li jistgħu jikkaġunaw jew jinibixxu dawn l-enzimi, jistgħu jaffettwaw il-farmakokinetiċi ta' zonisamide:
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu/.
English: Zonisamide has a long elimination half-life so its effects may be persistent.
Maltese: Zonisamide għandu half-life ta' l-eliminazzjoni li hi twila, u għalhekk l-effetti tiegħu jistgħu jkunu persistenti.
English: In clinical studies of paediatric patients, down-titration was completed by dose reductions at weekly intervals in increments of about 2 mg/kg (i.e. in accordance with the schedule in Table 3).
Maltese: Fi studji kliniċi ta' pazjenti pedjatriċi, it-titrazzjoni 'l isfel twettqet permezz ta' tnaqqis fid-doża f'intervalli kull ġimgħa f'inkrementi ta' madwar 2 mg/kg (i.e. b'konformità mal-iskeda f'Tabella 3).
English: PVC-PVdC/Aluminium foil blisters in cardboard cartons containing 14, 28 and 56 capsules.
Maltese: Folji b'fojl tal-PVC-PVdC/Aluminju f'kaxxi tal-kartun li fihom 14, 28 u 56 kapsula.
English: The incidence of a decrease in body weight of 10% or more was 10.7% (see section 4.4).
Maltese: 7% (ara sezzjoni 4.4).
English: Cholecystitis Cholelithiasis
Maltese: Koleċistite Kolelitijasi
English: Monotherapy in partial seizures, with or without secondary generalisation Efficacy of zonisamide as monotherapy was established in a double-blind, parallel group, non-inferiority comparison to carbamazepine prolonged release (PR) in 583 adult subjects with newly diagnosed partial seizures with or without secondary generalised tonic-clonic seizures.
Maltese: Monoterapija f'puplesiji parzjali, bi jew mingħajr ġeneralizzazzjoni sekondarja L-effikaċja ta' zonisamide bħala monoterapija ġiet stabbilita f'paragun double-blind, grupp parallel, noninferjorità ma' carbamazepine li jerħi l-mediċina fuq tul ta' żmien (PR) f'583 adult b'puplesiji parzjali li ġew iddijanjostikati għall-ewwel darba bi jew mingħajr puplesiji toniċi-kloniċi ġeneralizzati sekondarji.
English: Among 465 subjects in the paediatric safety database (including a further 67 subjects from the extension phase of the controlled clinical trial) there were 7 deaths (1.5%; 14.6/1000 person-years): 2 cases of status epilepticus, of which one was related to severe weight loss (10% within 3 months) in an underweight subject and subsequent failure to take medication; 1 case of head injury/haematoma, and 4 deaths in subjects with pre-existing functional neurological deficits for various causes (2 cases of pneumonia-induced sepsis/organ failure, 1 SUDEP and 1 head injury).
Maltese: Fost 465 individwu fiddatabase pedjatrika tas-sigurtà (li jinkludu 67 individwu addizzjonali mill-fażi ta' estensjoni tal-prova klinika kkontrollata) kien hemm 7 imwiet (1.5%; 14.6/1000 sena ta' persuna):
English: Serious rashes occur in association with zonisamide therapy, including cases of Stevens-Johnson syndrome.
Maltese: Raxxijiet serji jseħħu b'rabta mat-terapija b'zonisamide, li jinkludu każijiet tas-sindrome ta' Stevens-Johnson.
English: A total of 70.4% of paediatric subjects who received ZNS in the controlled study or its open label extension had at least one treatment-emergent bicarbonate measurement below 22 mmol/L.
Maltese: Total ta' 70.4% tal-individwi pedjatriċi li rċivew ZNS fl-istudju kkontrollat jew l-estensjoni open-label tiegħu, kellhom mill-inqas kejl wieħed ta' bicarbonate taħt 22 mmol/L, li ħareġ mill-kura.
English: Zonisamide Mylan 25 mg hard capsules Zonisamide Mylan 50 mg hard capsules Zonisamide Mylan 100 mg hard capsules zonisamide
Maltese: Zonisamide Mylan 25 mg kapsuli iebsin Zonisamide Mylan 50 mg kapsuli iebsin Zonisamide Mylan 100 mg kapsuli iebsin zonisamide
English: Subjects were titrated to the initial target dose of 600 mg carbamazepine or 300 mg of zonisamide.
Maltese: L-individwi ġew ittitrati għal doża inizjali fil-mira ta' 600 mg carbamazepine jew 300 mg ta' zonisamide.
English: Zonisamide has been administered to over 1,200 patients in clinical studies, more than 400 of whom received zonisamide for at least 1 year.
Maltese: Zonisamide ingħata lil iktar minn 1,200 pazjent fi studji kliniċi, li iktar minn 400 minnhom irċivew zonisamide għal mill-inqas sena.
English: Serious immune based adverse reactions that are associated with medicinal products containing a sulfonamide group include rash, allergic reaction and major haematological disturbances including aplastic anaemia, which very rarely can be fatal (see section 4.4).
Maltese: Reazzjonijiet avversi serji bbażati fuq l-immunità li huma assoċjati ma' prodotti mediċinali li fihom grupp sulfonamide jinkludu raxx, reazzjoni allerġika u disturbi maġġuri ematoloġiċi li jinkludu anemija aplastika, li b'mod rari ħafna tista' tkun fatali (ara sezzjoni 4.4).
English: Zonisamide prevents maximal electroshock seizures and restricts seizure spread, including the propagation of seizures from cortex to sub-cortical structures and suppresses epileptogenic focus activity.
Maltese: Zonisamide jevita puplesiji tat-tip maximal electroshock u jnaqqas il-firxa tal-puplesiji, li jinkludu l-propagazzjoni ta' puplesiji mill-kortiċi sa l-istrutturi sotto-kortikali u jrażżan l-attività epilettoġenika tal-fokus.
English: These increases are from about 5% to 8% for LBW, from about 8% to 10% for pre-term birth and from about 7% to 12% for SGA, all compared with mothers treated with lamotrigine monotherapy.
Maltese: Dawn iż-żidiet huma minn madwar 5% sa 8% għal LBW, minn madwar 8% sa 10% għal twelid qabel iż-żmien, u minn madwar 7% sa 12% għal SGA, kollha pparagunati ma' ommijiet ikkurati b'lamotrigine waħdu.
English: In rats, decreased numbers of corpora lutea and implantation sites were observed at exposure levels equivalent to the maximum therapeutic dose in humans; irregular oestrus cycles and a decreased number of live foetuses were observed at exposure levels three times higher.
Maltese: Fil-firien, tnaqqis fin-numri ta' corpora lutea u siti tal-impjantazzjoni ġew osservati f'livelli ta' esponiment ekwivalenti għad-doża terapewtika massima fil-bnedmin; ċikli oestrus irregolari u tnaqqis fin-numru ta' feti ħajjin ġew osservati f'livelli ta' esponiment tliet darbiet ogħla.
English: There have been cases of accidental and intentional overdose in adult and paediatric patients.
Maltese: Kien hemm każijiet ta' doża eċċessiva aċċidentali u intenzjonata f'pazjenti adulti u pedjatriċi.
English: CYP3A4-inducing agents; or with renal or hepatic impairment
Maltese: - mingħajr mediċini li jinduċu CYP3A4; jew b'indeboliment tal-kliewi jew talfwied
English: Subjects who experienced a seizure were titrated to the next target dose i.e. 800 mg carbamazepine or 400 mg of zonisamide.
Maltese: Individwi li kellhom puplesija ġew ittitrati għad-doża li jmiss fil-mira, i.e. 800 mg ta' carbamazepine jew 400 mg ta' zonisamide.
English: 300 to 500 mg per day (once a day or two divided doses).
Maltese: 300 - 500 mg/jum (darba kuljum).
English: What Zonisamide Mylan contains:
Maltese: Tiħux Zonisamide Mylan:
English: Dizziness
Maltese: Dispnea
English: Agranulocytosis Aplastic anaemia Leucocytosis Leucopoenia Lymphadenopathy Pancytopenia, Thrombocytopenia
Maltese: Agranuloċitosi Anemija aplastika Lewkoċitosi Lewkopenja Limfadenopatija Panċitopenja Tromboċitopenja
English: J. Uriach y Compañía, S.A. Av. Camí Reial, 51-57
Maltese: The J. Uriach y Compañía, S.A. Av.
English: The most common adverse reactions in controlled adjunctive-therapy studies were somnolence, dizziness and anorexia.
Maltese: L-iktar reazzjonijiet avversi komuni fi studji kkontrollati dwar terapija addizzjonali kienu: ngħas, sturdament u anoreksja.
English: CLINICAL PARTICULARS
Maltese: Terapija addizzjonali
English: Paediatric population (aged 6 years and above)
Maltese: Popolazzjoni pedjatrika (6 snin jew aktar)
English: Hypokalaemia Metabolic acidosis Renal tubular acidosis
Maltese: Aċidożi metabolika Aċidożi tubulari talkliewi
English: The adverse event profile of zonisamide in paediatric patients aged 6 to 17 years in placebo-controlled clinical studies was consistent with that of adults.
Maltese: Il-profil tal-avveniment avversi ta' zonisamide f'pazjenti pedjatriċi li kellhom minn 6 sa 17-il sena fi studji kliniċi kkontrollati bi plaċebo kien konsistenti ma' dak tal-adulti.
English: Week 1 + 2 Week 3 + 4 Week 5 + 6
Maltese: Ġimgħa 1 + 2 Ġimgħa 3 + 4 Ġimgħa 5 + 6 100 mg/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), abnormal liver enzymes (uncommon), middle ear infection, sore throat, sinus and chest infections, cough, nosebleeds, runny nose, stomach pain, vomiting, rash, eczema and fever.
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, deidrazzjoni, tnaqqis fl-għaraq (komuni) u enzimi mhux normali tal-fwied (mhux komuni), infezzjoni fil-parti tan-nofs tal-widna, uġigħ fil-griżmejn, infezzjonijiet fis-sinus u fis-sider, sogħla, tinfaġar, imnieħer inixxi, uġigħ fl-istonku, rimettar, raxx, ekżema u deni.
English: Use in children (aged 6 to 11 years) and adolescents (aged 12 to 17 years) weighing at least 20 kg: - The starting dose is 1 mg per kg of body weight taken once a day.
Maltese: L-użu fit-tfal (li jkollhom minn 6 sa 11-il sena) u adolexxenti (li jkollhom minn 12 sa 17-il sena) li jiżnu mill-inqas 20 kg:
English: Efficacy results for Monotherapy Study 310 Zonisamide Carbamazepine n (ITT population) Six months seizure freedom
Maltese: Zonisamide Carbamazepine n (popolazzjoni ITT) Sitt xhur mingħajr attakki ta' puplesija
English: Anger
Maltese: Irritabilità
English: In other cases, the overdose was followed by symptoms such as somnolence, nausea, gastritis, nystagmus, myoclonus, coma, bradycardia, reduced renal function, hypotension and respiratory depression.
Maltese: F'każijiet oħrajn, id-doża eċċessiva kienet segwita minn sintomi bħal ngħas, dardir, gastrite, nystagmus, myoclonus, koma, bradikardija, funzjoni mnaqqsa tal-kliewi, pressjoni tad-demm baxxa ħafna u dipressjoni respiratorja.
English: Zonisamide Mylan 25 mg hard capsules Zonisamide Mylan 50 mg hard capsules Zonisamide Mylan 100 mg hard capsules
Maltese: Zonisamide Mylan 25 mg kapsuli iebsin Zonisamide Mylan 50 mg kapsuli ibsin Zonisamide Mylan 100 mg kapsuli iebsin
English: - Other medicines like phenytoin, carbamazepine, phenobarbitone and rifampicin can decrease your blood levels of Zonisamide Mylan, which may require an adjustment of your dose of Zonisamide Mylan.
Maltese: • Mediċini oħra bħal phenytoin, carbamazepine, phenobarbitone u rifampicin jistgħu jnaqqsu l-livelli ta' Zonisamide Mylan fid-demm tiegħek, li jista' jkun jeħtieġ aġġustament fid-doża tiegħek ta' Zonisamide Mylan.
English: - Zonisamide Mylan could possibly increase your blood levels of medicines like digoxin and quinidine, and so a reduction in their dose may be required.
Maltese: • Zonisamide Mylan jista' possibbilment iżid il-livelli ta' mediċini bħal digoxin u quinidine fid demm tiegħek, u għalhekk tnaqqis fid-doża jista' jkun meħtieġ.
English: Conditions or therapies that predispose to acidosis (such as renal disease, severe respiratory disorders, status epilepticus, diarrhoea, surgery, ketogenic diet, or medicinal products) may be additive to the bicarbonate lowering effects of zonisamide.
Maltese: Kundizzjonijiet jew terapiji li jippredisponu għal aċidożi (bħal mard tal-kliewi, disturbi respiratorji severi, stat epilettiku, dijarea, intervent kirurġiku, dieta ketoġenika, jew prodotti mediċinali) jistgħu jkunu addittivi għalleffetti ta' zonisamide li jbaxxu l-bikarbonat.
English: Memory impairment Somnolence Bradyphrenia Disturbance in attention Paraesthesia
Maltese: Bradifrenija Disturbi fl-attenzjoni Parestesija
English: Caution is advised when starting or stopping zonisamide treatment or changing the zonisamide dose in patients who are also receiving medicinal products which are P-gp substrates (e.g. digoxin, quinidine).
Maltese: L-attenzjoni hi rakkomandata meta tibda jew twaqqaf il-kura b'zonisamide jew meta tibdel id-doża ta' zonisamide f'pazjenti li qed jirċievu wkoll prodotti mediċinali li huma substrati ta' P-gp (eż. digoxin, quinidine).
English: What Zonisamide Mylan is and what it is used for Zonisamide Mylan contains the active substance zonisamide, and is used as an antiepileptic medicine.
Maltese: Zonisamide Mylan fih is-sustanza attiva zonisamide, u jintuża bħala mediċina antiepilettika.
English: An in vitro study shows that zonisamide is a weak inhibitor of P-gp (MDR1) with an IC50 of 267 µmol/l and there is the theoretical potential for zonisamide to affect the pharmacokinetics of substances which are P-gp substrates.
Maltese: Studju in vitro juri li zonisamide hu inibitur dgħajjef ta' P-gp (MDR1) b'IC50 ta' 267 µmol/L u hemm il-potenzjal teoretiku li zonisamide jaffettwa l-farmakokinetika ta' sustanzi li huma substrati ta' P-gp.
English: Potential for zonisamide to affect other medicinal products Anti-epileptic medicinal products
Maltese: Il-potenzjal għal zonisamide li jaffettwa prodotti mediċinali oħrajn Prodotti mediċinali anti-epilettiċi
English: Cases of agranulocytosis, thrombocytopenia, leucopenia, aplastic anaemia, pancytopenia and leucocytosis have been reported.
Maltese: Każijiet ta' agranuloċitosi, tromboċitopenja, leucopenia, anemija aplastika, panċitopenja u lewkoċitosi kienu rrappurtati.
English: Paediatric population (aged 6 years and above) - recommended down-titration schedule Weight
Maltese: Tabella 3. Popolazzjoni pedjatrika (6 snin u aktar) - skeda rakkomandata ta' titrazzjoni 'l isfel
English: Subjects who experienced a further seizure were titrated to the maximal target dose of 1200 mg carbamazepine or 500 mg zonisamide.
Maltese: Individwi li kellhom puplesija addizzjonali ġew ittitrati għad-doża massima fil-mira ta' 1200 mg ta' arbamazepine jew 500 mg ta' zonisamide.
English: 117 Allee des Parcs 69 800 Saint Priest France
Maltese: 69 800 Saint Priest
English: Paediatric population (aged 6 years and above) - recommended dosage escalation and maintenance regimen Treatment Regimen
Maltese: Popolazzjoni pedjatrika (6 snin u aktar) - żieda rakkomandata fid-dożaġġ u kors ta' manteniment
English: Ataxia
Maltese: Konvulżjoni
English: These studies show that the median reduction in partial seizure frequency is related to zonisamide dose with sustained efficacy at doses of 300-500 mg per day.
Maltese: Dawn l-istudji juru li t-tnaqqis medjan fil-frekwenza parzjali tal-puplesija hu relatat mad-doża ta' zonisamide, b'effikaċja sostnuta f'dożi ta' 300 - 500 mg kuljum.
English: Zonisamide Mylan is indicated as:
Maltese: Zonisamide Mylan jista' jintuża:
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 zonisamide treatment.
Maltese: Aċidożi metabolika iperkloremika, bi spazju mhux anjoniku (i.e. tnaqqis fil-livell ta' bikarbonat fisserum taħt il-firxa normali ta' riferiment fin-nuqqas ta' alkalosi respiratorja kronika) hi assoċjata mattrattament ta' zonisamide.
English: Bradyphrenia Disturbance in attention Nystagmus Paraesthesia Speech disorder Tremor
Maltese: Bradifrenija Disturbi flattenzjoni Nystagmus Parestesija Taħwid fid-diskors Rogħda
English: PVC-PVdC/Aluminium foil perforated unit dose blisters in cardboard cartons containing 14 x 1 capsules.
Maltese: Folji b'doża waħda li fihom fojl ipperforat tal-PVC-PVdC/Aluminju f'kaxxi tal-kartun li fihom 14 × 1 kapsula.
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-bikarbonat jonqos ġeneralment huma ħfief - moderati (tnaqqis medju ta' madwar 3.5 mEq/L għal dożi ta' 300 mg kuljum fl-adulti); b'mod rari pazjenti għandhom mnejn jesperjenzaw tnaqqis aktar sever.
English: CYP3A4-inducing agents
Maltese: - Inibizzjoni ta' CYP3A4:
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 ta' l-espożizzjoni farmakokinetika ta' zonisamide.
English: Nephrolithiasis Calculus urinary Hydronephrosis Renal failure
Maltese: Pnewmonja Infezzjoni flapparat tal-awrina
English: 200 mg/day (once a day)
Maltese: 200 mg/kuljum (darba kuljum).
English: Blisters:
Maltese: Eżempju:
English: 300 mg per day (once a day).
Maltese: 300 mg kuljum (darba kuljum).
English: There is no need for dose adjustment with any of the AEDs including CYP3A4 inducers.
Maltese: L-ebda aġġustament fid-doża ma huwa meħtieġ bi kwalunkwe AED inkluż l-indutturi ta' CYP3A4.
English: Adults - recommended dosage escalation and maintenance regimen
Maltese: Adulti - żieda rakkomandata fid-dożaġġ u kors ta' manteniment
English: The elimination half-life was independent of dose and not affected by repeat administration.
Maltese: Il-half life ta' l-eliminazzjoni kienet indipendenti mid-doża u ma kienitx affettwata minn għoti ripetut.
English: Symptoms include acute onset of decreased visual acuity and/or ocular pain.
Maltese: Sintomi jinkludu bidu akut ta' tnaqqis fl-akutezza viżiva u/jew uġigħ okulari.
English: The risk of birth defect is increased by factor 2 to 3 in the offspring of mothers treated with an antiepileptic medicinal product.
Maltese: Ir-riskju ta' difetti tat-twelid jiżdied b'fattur ta' minn 2 sa 3 fit-trabi ta' ommijiet ikkurati bi prodott mediċinali kontra l-epilessija.
English: In a repeated-dose oral toxicity study in juvenile rats, at exposure levels similar to those observed in paediatric patients at the maximum recommended dose, decreases in body weight and changes in renal histopathology and clinical pathology parameters and behavioural changes were observed.
Maltese: Fi studju dwar it-tossiċità minn dożi orali ripetuti f'firien ġuvenili, f'livelli ta' esponiment simili għal dawk osservati f'pazjenti pedjatriċi fid-doża massima rakkomandata, tnaqqis fil-piż tal-ġisem u tibdil fl-istopatoloġija tal-kliewi u fil-parametri tal-patoloġija klinika u tibdil fl-imġiba, ġew osservati.
English: Zonisamide Mylan 100 mg hard capsules zonisamide
Maltese: Zonisamide Mylan 100 mg kapsuli iebsin zonisamide
English: Zonisamide Mylan 25 mg hard capsules zonisamide
Maltese: Zonisamide Mylan 25 mg kapsuli iebsin zonisamide
English: Zonisamide should not be used as co-medication in paediatric patients with other carbonic anhydrase inhibitors such as topiramate and acetazolamide (see section 4.4: Paediatric population).
Maltese: Zonisamide m'għandux jintuża bħala komedikazzjoni f'pazjenti pedjatriċi ma' inibituri oħrajn ta' carbonic anhydrase bħal topiramate u acetazolamide (ara sezzjoni 4.4: Popolazzjoni pedjatrika).
English: Each hard capsule is approximately 14.4 mm in length.
Maltese: Kull kapsula iebsa hi twila madwar 14.4 mm.
English: 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-farmakokinetiċi fi tfal u adolexxenti li ngħataw doża fl-istat fiss f'1, 7 jew 12 mg/kg kuljum, f'dożi maqsumin, huma simili għal dawk osservati fl-adulti, wara aġġustament għall-piż tal-ġisem.
English: In adults, efficacy has been demonstrated with zonisamide in 4 double-blind, placebo-controlled studies of periods of up to 24 weeks with either once or twice daily dosing.
Maltese: Fl-adulti, l-effikaċja ntweriet b'zonisamide f'4 studji double-blind, ikkontrollati bil-plaċebo għal perjodi li damu sa 24 ġimgħa b'dożaġġ li ngħata jew darba jew darbtejn kuljum.
English: How to store Zonisamide Mylan
Maltese: Mediċini oħra u Zonisamide Mylan
English: Aggression Suicidal ideation Suicide attempt
Maltese: Aggressjoni Ħsibijiet suwiċidi Tentattiv ta' suwiċidju
English: Fatigue Pyrexia Irritability
Maltese: Disturbi psikjatriċi
English: • monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy (see section 5.1);
Maltese: f'adulti b'epilessija ddijanjostikata għall-ewwel darba (ara sezzjoni 5.1);
English: 300 mg/day (once a day)
Maltese: 300 mg/kuljum (darba kuljum).
English: Zonisamide Mylan 50 mg hard capsules zonisamide
Maltese: Zonisamide Mylan 50 mg kapsuli iebsin zonisamide
English: PVC-PVdC/Aluminium foil perforated unit dose blisters in cardboard cartons containing 56 x 1 capsules.
Maltese: Folji b'doża waħda li fihom fojl ipperforat tal-PVC-PVdC/Aluminju f'kaxxi tal-kartun li fihom 56 × 1 kapsula.
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 ta' l-AUC u tas-Cmax ta' zonisamide żdiedu b'mod kważi lineari wara doża waħda fuq ilmedda tad-doża ta' 100 - 800 mg u wara dożi multipli fuq il-medda tad-doża ta' 100 - 400 mg darba kuljum.
English: Status epilepticus
Maltese: Effetti farmakodinamiċi
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 fi spostament anterjuri tal-lenti u l-iris, bi glawkoma tat-tip angle closure sekondarja.
English: Unlike phenytoin and carbamazepine however, zonisamide acts preferentially on seizures originating in the cortex.
Maltese: Madankollu, b'kuntrast ma' phenytoin u carbamazepine, zonisamide jaġixxi b'mod preferenzjali fuq puplesiji li joriġinaw fil-kortiċi.