FrancophonIA/ELRC3.0 huggingface dataset:
English: Other medicines and Zonegran
Maltese: Mediċini oħra u Zonegran
English: Sulphonamide reactions
Maltese: Reazzjonijiet ta' sulphonamide
English: 300 - 500 mg/day (once a day)
Maltese: 300 - 500 mg/jum (darba kuljum)
English: Zonegran contains Hydrogenated vegetable oil (from soyabean).
Maltese: Zonegran fih hydrogenated vegetable oil (mis-soyabean).
English: Anti-epileptic medicinal products
Maltese: Prodotti mediċinali antiepilettiċi
English: Marketing Authorisation Holder Eisai GmbH, Lyoner Straße 36, 60528 Frankfurt am Main, Germanye-mail: medinfo_de@eisai.net
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Eisai GmbH, Lyoner Straße 36, 60528 Frankfurt am Main, Il-Ġermanja e-mail: medinfo_de@eisai.net
English: Acute myopia and secondary angle closure glaucoma
Maltese: Mijopija akuta u glawkoma tat-tip angle closure sekondarja
English: Erythema multiforme Stevens-Johnson syndrome Toxic epidermal necrolysis
Maltese: Eritema multiforme Sindrome ta' StevensJohnson
English: Increased levels of hepatobiliary parameters such as alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyltransferase (GGT) and bilirubin have occurred in paediatric and adolescent patients, without any consistent pattern in the observations of values above the upper limit of normal.
Maltese: Żieda fil-livelli ta' parametri epatobiljari bħal alanine aminotransferase (ALT), aspartate aminotransferease (AST), gamma-glutamyltransferase (GGT) u bilirubina, seħħew f'pazjenti pedjatriċi u adolexxenti, mingħajr l-ebda andament konsistenti fl-osservazzjonijiet tal-valuri ogħla mil-limitu ta' fuq tan-normal.
English: • vomiting.
Maltese: • rimettar.
English: Microcrystalline cellulose Hydrogenated vegetable oil (from soyabean) Sodium laurilsulfate
Maltese: Il-kontenut tal-kapsula Microcrystalline cellulose Hydrogenated vegetable oil (mis-soyabean) Sodium laurilsulfate
English: • poor muscle coordination, dizziness, poor memory, sleepiness, double vision
Maltese: • koordinazzjoni batuta tal-muskoli, sturdament, memorja batuta, ħedla, vista doppja
English: System Organ Class (MedDRA terminology†)
Maltese: Sistema tal-Klassifika tal-Organi (Terminoloġija MedDRA†)
English: Efficacy results for Monotherapy Study 310 Zonisamide Carbamazepine n (ITT population)
Maltese: Zonisamide Carbamazepine n (popolazzjoni ITT)
English: Investigations Decreased bicarbonate
Maltese: Investigazzjonijiet Tnaqqis fil-bicarbonate
English: Zonisamide is 40 - 50 % bound to human plasma proteins, with in vitro studies showing that this is unaffected by the presence of various antiepileptic medicinal products (i.e., phenytoin, phenobarbitone, carbamazepine, and sodium valproate).
Maltese: Zonisamide hu mwaħħal sa 40 - 50% mal-proteini tal-plażma tal-bniedem, bi studji in vitro li juru li dan ma jkunx affettwat mill-preżenza ta' diversi prodotti mediċinali antiepilettiċi (i.e., phenytoin, phenobarbitone, carbamazepine, u sodium valproate).
English: Renal clearance of unchanged zonisamide is relatively low (approximately 3.5 ml/min); about 15 - 30 % of the dose is eliminated unchanged.
Maltese: It-tneħħija mill-kliewi ta' zonisamide mhux mibdul hi relattivament baxxa (madwar 3.5 ml/min); madwar 15 - 30% tad-doża hi eliminata mhux mibdula.
English: - Enzyme induction: Exposure to zonisamide is lower in epileptic patients receiving CYP3A4-inducing agents such as phenytoin, carbamazepine, and phenobarbitone.
Maltese: - Induzzjoni tal-enzimi: L-esponiment għal zonisamide hi iktar baxxa f'pazjenti epilettiċi li jkunu qed jirċievu sustanzi li huma CYP3A4 inducing agents bħal phenytoin, carbamazepine, u phenobarbitone.
English: Eisai GmbH, Lyoner Straße 36, 60528 Frankfurt am Main, Germany
Maltese: Eisai GmbH, Lyoner Straße 36, 60528 Frankfurt am Main, Il-Ġermanja
English: The dose regime is 6-8 mg/kg/day up to a maximum dose of 500 mg/day.
Maltese: Il-kors ta' doża hu ta' 6-8 mg/kg/jum sa doża massima ta' 500 mg/jum.
English: • Seek urgent medical assistance.
Maltese: • Fittex għajnuna medika urġenti.
English: A pooled analysis of safety data on 420 paediatric subjects (183 subjects aged 6 to 11 years, and 237 subjects aged 12 to 16 years with a mean duration of exposure of approximately 12 months) has shown a relatively higher reporting frequency of pneumonia, dehydration, decreased sweating, abnormal liver function tests, otitis media, pharyngitis, sinusitis and upper respiratory tract infection, cough, epistaxis and rhinitis, abdominal pain, vomiting, rash and eczema, and fever compared to the adult population (particularly in subjects aged below 12 years) and, at a low incidence, amnesia, creatinine increased, lymphadenopathy, and thrombocytopenia.
Maltese: Analiżi miġbura ta' dejta dwar is-sigurtà fuq 420 individwu pedjatriku (183 individwu li kellhom minn 6 sa 11-il sena, u 237 individwu li kellhom minn 12 sa 16-il sena, b'medja ta' tul ta' żmien ta' esponiment ta' madwar 12-il xahar) uriet frekwenza ta' rappurtaġġ relattivament ogħla ta' pnewmonja, deidratazzjoni, tnaqqis fl-għaraq, testijiet tal-funzjoni tal-fwied b'riżultati anormali, infjammazzjoni tal-parti tan-nofs tal-widna, farinġite, sinusite u infezzjoni fil-parti ta' fuq tal-apparat respiratorju, sogħla, epistassi u rinite, uġigħ addominali, rimettar, raxx u ekżema, u deni meta mqabbla malpopolazzjoni adulta (partikularment f'individwi li kellhom inqas minn 12-il sena) u, f'inċidenza baxxa, amnesija, żieda fil-livell tal-kreatinina, limfadenopatija, u tromboċitopenija.
English: Elderly: No clinically significant differences were observed in the pharmacokinetics between young (aged 21-40 years) and elderly (65-75 years).
Maltese: L-ebda differenzi klinikament sinifikanti ma kienu osservati fil-farmakokinetika bejn persuni żgħażagħ (minn 21-40 sena) u anzjani (65-75 sena).
English: All generalized Tonic-Clonic Secondary Tonic-Clonic Generalized Tonic-Clonic
Maltese: Toniċi-Kloniċi sekondarji Toniċi-Kloniċi ġeneralizzati
English: The incidence of markedly abnormally low serum bicarbonate (a decrease to less than 17 mEq/l and by more than 5 mEq/l) was 3.8%.
Maltese: L-inċidenza ta' livelli baxxi anormali b'mod notevoli ta' serum bicarbonate (tnaqqis għal inqas minn 17 mEq/l u b'iktar minn 5 mEq/l) kienet ta' 3.8%.
English: 1 mg/kg/day (once a day)
Maltese: 1 mg/kg/jum (darba kuljum)
English: Drug-induced hypersensitivity syndrome Drug rash with eosinophilia and systemic symptoms
Maltese: Raxx minħabba l-mediċina b'eosinofilija u sintomi sistemiċi
English: Hypersensitivity to the active substance, to any of the excipients listed in section 6.1 or to sulphonamides.
Maltese: Ipersensittività għas-sustanza attiva, jew għal kwalunkwe eċċipjent elenkat fit-taqsima 6.1 jew sulfonamides.
English: The plasma AUC of zonisamide was increased by 35% in subjects with creatinine clearance < 20 ml/min.
Maltese: L-AUC tal-plażma ta' zonisamide żdiedet b'35% f'pazjenti bi tneħħija tal-kreatinina ta' < 20 ml/min.
English: Agranulocytosis Aplastic anaemia Leucocytosis Leucopoenia Lymphadenopathy Pancytopenia, Thrombocytopenia
Maltese: Agranuloċitożi Anemija aplastika Lewkoċitożi Lewkopenija Limfadenopatija Panċitopenija Tromboċitopenija
English: Table 5.
Maltese: Tabella 5
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit web tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu/.
English: Zonegran Capules:
Maltese: Zonegran kapsuli ibsin:
English: Use in children (aged 6 to 11 years) and adolescents (aged 12 to 17 years) weighing at least 20 kg:
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: See Section 2 for important information about the ingredients: sunset yellow FCF (E110) and allura red AC (E129) and hydrogenated vegetable oil (from soyabean).
Maltese: Ara Sezzjoni 2 għal informazzjoni importanti dwar is-siustanzi: sunset yellow FCF (E110) u allura red AC (E129) u hydrogenated vegetable oil (mis-soyabean).
English: Zonisamide is metabolised primarily through reductive cleavage of the benzisoxazole ring of the parent drug by CYP3A4 to form 2-sulphamoylacetylphenol (SMAP) and also by N-acetylation.
Maltese: Zonisamide hu metabolizzat primarjament minn ġor-reductive cleavage taċ-ċirku ta' benzisoxazole tal-mediċina prinċipali minn CYP3A4 biex jifforma 2-sulphamoylacetylphenol (SMAP) u wkoll minn N-acetylation.
English: Therefore, Zonegran 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, Zonegran mhux mistenni li jaffettwa l-farmakokinetika ta' prodotti mediċinali oħrajn permezz ta' mekkaniżmi medjati minn cytochrome P450, kif muri għal carbamazepine, phenytoin, ethinylestradiol u desipramine in vivo.
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 metabolizzat 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-farmakokinetika ta' zonisamide:
English: The plasma AUC of zonisamide was increased by 35% in subjects with creatinine clearance <20 ml/min (see also section 4.2.
Maltese: L-AUC tal-plażma ta' zonisamide żdiedet b'35% f'individwi bi tneħħija tal-kreatinina ta' < 20 ml/min (ara wkoll Sezzjoni 4.2).
English: In epileptic patients, steady-state dosing with Zonegran resulted in no clinically relevant pharmacokinetic effects on carbamazepine, lamotrigine, phenytoin, or sodium valproate.
Maltese: F'pazjenti epilettiċi, id-dożaġġ fl-istat fiss b'Zonegran ma rriżulta fl-ebda effetti farmakokinetiċi li kienu klinikament rilevanti fuq carbamazepine, lamotrigine, phenytoin, jew sodium valproate.
English: Zonegran is a benzisoxazole derivative, which contains a sulphonamide group.
Maltese: Zonegran hu derivattiv ta' benzisoxazole li fih grupp ta' sulphonamide.
English: A 50% or greater reduction from baseline in seizure frequency during the 12-week stable dose period was seen in 50% of the zonisamide-treated subjects and 31% of the patients on placebo.
Maltese: Tnaqqis ta' 50% jew aktar mil-linja bażi fil-frekwenza ta' attakk ta' puplesija matul il-perjodu ta' 12-il ġimgħa ta' doża stabbli ġie osservat f'50% tal-individwi kkurati b'zonisamide u f'31% talpazjenti fuq il-plaċebo.
English: Contains also hydrogenated vegetable oil (from soyabean), sunset yellow FCF (E110) and allura red AC (E129).
Maltese: Fih ukoll hydrogenated vegetable oil (mis-soyabean), sunset yellow FCF (E110), u allura red AC (E129).
English: Confusional state Acute psychosis Aggression Suicidal ideation Hallucination
Maltese: Stat ta' konfużjoni Psikożi akuta Aggressjoni Formazzjoni ta' ħsieb biex jitwettaq suwiċidju
English: Apparent clearance of zonisamide at steady-state after oral administration is about 0.70 l/h and the terminal elimination half-life is about 60 hours in the absence of CYP3A4 inducers.
Maltese: It-tneħħija apparent ta' zonisamide fl-istat fiss wara l-għoti mill-ħalq hi ta' madwar 0.70 l/h u l-halflife tal-eliminazzjoni terminali hi ta' madwar 60 siegħa fl-assenza ta' inducers ta' CYP3A4.
English: Complex partial All generalized Tonic-Clonic Secondary Tonic-Clonic Generalized Tonic-Clonic
Maltese: Kumplessi parzjali Toniċi-Kloniċi generalizzati kollha
English: • The other ingredients that are present in the capsule contents are: microcrystalline cellulose, hydrogenated vegetable oil (from soyabean) and sodium laurilsulfate.
Maltese: • L-ingredjenti l-oħra li hemm fil-kontenut tal-kapsula huma: microcrystalline cellulose, hydrogenated vegetable oil (mis-soyabean) u sodium laurilsulfate.
English: Steady-state dosing of either ketoconazole (400 mg/day) or cimetidine (1200 mg/day) had no clinically relevant effects on the single-dose pharmacokinetics of zonisamide given to healthy subjects.
Maltese: Id-dożaġġ fl-istat fiss ta' jew ketoconazole (400 mg/kuljum) jew cimetidine (1200 mg/kuljum) ma kellu l-ebda effetti klinikament rilevanti fuq il-farmakokinetika ta' doża waħda ta' zonisamide mogħtija lil persuni b'saħħithom.
English: thiazide diuretics, and sulfonylurea antidiabetes medicines,
Maltese: Eżempji jinkludu: antibijotiċi sulphonamide,dijuretiċi thiazide, u mediċini sulfonylurea kontra d-dijabete,
English: • Your child must not take these medicines: carbonic anhydrase inhibitors (like topiramate and acetazolamide), and anticholinergic agents (like clomipramine, hydroxyzine, diphenhydramine, haloperidol, imipramine and oxybutynin).
Maltese: • It-tifel/tifla m'għandhomx jieħu kwalunkwe minn dawn il-mediċini: inibituri ta' carbonic anhydrase (bħal topiramate u acetazolamide), u mediċini antikolinerġiċi (bħal clomipramine, hydroxyzine, diphenhydramine, haloperidol, imipramine and oxybutynin).
English: Zonisamide has a long elimination half-life so its effects may be persistent.
Maltese: Zonisamide għandu half-life tal-eliminazzjoni li hi twila, u għalhekk l-effetti tiegħu jistgħu jkunu persistenti.
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: Serious rashes occur in association with Zonegran therapy, including cases of Stevens-Johnson syndrome.
Maltese: Raxxijiet serji jseħħu b'rabta mat-terapija b'Zonegran, li jinkludu każijiet tas-sindrome ta' Stevens-Johnson.
English: • monotherapy in the treatment of partial seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy (see section 5.1);
Maltese: • monoterapija fil-kura ta' puplesiji parzjali, bi jew mingħajr ġeneralizzazzjoni sekondarja, f'adulti b'epilessija ddijanjostikata għall-ewwel darba (ara sezzjoni 5.1);
English: Excipient with known effect: Each hard capsule contains 0.75 mg hydrogenated vegetable oil (from soyabean)
Maltese: Kull kapsula iebsa fiha 0.75 mg ta' hydrogenated vegetable oil (mis-soyabean)
English: Pharmacotherapeutic group: Antiepileptics, other antiepileptics, ATC code: N03AX15
Maltese: Antiepilettiċi, antiepilettiċi oħra, kodiċi ATC:
English: - Zonegran 50 mg hard capsules have a white opaque body and a grey opaque cap and are printed with a logo and “ZONEGRAN 50” in black.
Maltese: - Zonegran 50 mg kapsuli ibsin għandhom korp opak abjad u għatu opak griż u fuqhom hemm stampat bl-iswed il-logo u “ZONEGRAN 50”.
English: Zonegran contains sunset yellow FCF (E110) and allura red AC (E129) 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 fih sunset yellow FCF (E110) u allura red AC (E129) Zonegran 100 mg kapsuli ibsin fihom kulur isfar imsejjaħ sunset yellow FCF (E110), u kulur aħmar li jissejjaħ allura red AC (E129), li jista' jikkawża reazzjonijiet allerġiċi.
English: Zonegran may be used:
Maltese: Tiħux Zonegran:
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 sottokortikali u jrażżan l-attività epilettoġenika tal-fokus.
English: • The child must not take any of these medicines: carbonic anhydrase inhibitors (like topiramate and acetazolamide), and anticholinergic agents (like clomipramine, hydroxyzine, diphenhydramine, haloperidol, imipramine and oxybutynin).
Maltese: • It-tifel/tifla tiegħek m'għandhomx jieħu kwalunkwe minn dawn il-mediċini: inibituri ta' carbonic anhydrase (bħal topiramate u acetazolamide), u mediċini antikolinerġiċi (bħal clomipramine, hydroxyzine, diphenhydramine, haloperidol, imipramine and oxybutynin).
English: EU/1/04/307/006 28 capsules EU/1/04/307/004 56 capsules EU/1/04/307/011 84 capsules EU/1/04/307/007 98 capsules EU/1/04/307/008 196 capsules
Maltese: EU/1/04/307/006 28 kapsula EU/1/04/307/004 56 kapsula EU/1/04/307/011 84 kapsula EU/1/04/307/007 98 kapsula EU/1/04/307/008 196 kapsula
English: Efficacy of zonisamide as monotherapy was established in a double-blind, parallel group, noninferiority comparison to carbamazepine prolonged release (PR) in 583 adult subjects with newly diagnosed partial seizures with or without secondary generalised tonic-clonic seizures.
Maltese: 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: EU/1/04/307/010 EU/1/04/307/009 EU/1/04/307/003 EU/1/04/307/012
Maltese: EU/1/04/307/009 EU/1/04/307/003 EU/1/04/307/012
English: Excipient with known effect: Each hard capsule contains 1.5 mg hydrogenated vegetable oil (from soyabean)
Maltese: Kull kapsula iebsa fiha 1.5 mg ta' hydrogenated vegetable oil (mis-soyabean)
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: Urinary tract infection Pneumonia
Maltese: Nekrolisi epidermali tossika
English: What Zonegran looks like and contents of the pack - Zonegran 25 mg hard capsules have a white opaque body and a white opaque cap and are printed with a logo and “ZONEGRAN 25” in black.
Maltese: Id-dehra ta' Zonegran u l-kontenut tal-pakkett - Zonegran 25 mg kapsuli ibsin għandhom korp opak abjad u għatu opak abjad u fuqhom hemm stampat bl-iswed il-logo u “ZONEGRAN 25”.
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 depressjoni respiratorja.
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-bicarbonate.
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 (see section 4.4).
Maltese: Reazzjonijiet avversi serji bbażati fuq l-immunità li huma assoċjati ma' prodotti mediċinali li fihom grupp ta' sulphonamide 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: Bradyphrenia Disturbance in attention Nystagmus Paraesthesia Speech disorder Tremor
Maltese: Bradifrenija Disturbi fl-attenzjoni Nystagmus Parestesija Taħwid fid-diskors Rogħda
English: Zonegran 100 mg hard capsules zonisamide
Maltese: Zonegran 100 mg kapsuli ibsin zonisamide
English: Zonegran contains the active substance zonisamide, and is used as an antiepileptic medicine.
Maltese: Zonegran fih is-sustanza attiva zonisamide, u jintuża bħala mediċina antiepilettika.
English: Weight decreased Blood creatinine phosphokinase increased Alanine aminotransferase increased
Maltese: Tnaqqis fil-piż Żieda fil-creatine phosphokinase fid-demm Żieda f'alanine aminotransferase Żieda f'aspartate aminotransferase
English: These studies show that the median reduction in partial seizure frequency is related to Zonegran dose with sustained efficacy at doses of 300-500 mg per day.
Maltese: Dawn l-istudji juru li ttnaqqis medjan fil-frekwenza parzjali tal-puplesija hu relatat mad-doża ta' Zonegran, b'effikaċja sostnuta f'dożi ta' 300-500 mg kuljum.
English: Nephrolithiasis Calculus urinary Hydronephrosis Renal failure
Maltese: Idronefrożi Insuffiċjenza renali Anormalità fl-awrina
English: Zonegran 25 mg hard capsules zonisamide
Maltese: Zonegran 25 mg kapsuli ibsin zonisamide
English: Potential medicinal product interactions affecting Zonegran
Maltese: Interazzjonijiet potenzjali tal-prodott mediċinali li jaffettwaw Zonegran
English: Breast-feeding
Maltese: Bradifrenija
English: Zonegran has been administered to over 1,200 patients in clinical studies, more than 400 of whom received Zonegran for at least 1 year.
Maltese: Zonegran ingħata lil iktar minn 1,200 pazjent fi studji kliniċi, li iktar minn 400 minnhom irċivew Zonegran għal mill-inqas sena.
English: Zonegran 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: Zonegran m'għandux jintuża bħala komedikazzjoni f'pazjenti pedjatriċi ma' inibituri oħrajn ta' carbonic anhydrase bħal topiramate u acetazolamide (ara sezzjoni 4.5).
English: EU/1/04/307/010 14 capsules EU/1/04/307/009 28 capsules EU/1/04/307/003 56 capsules EU/1/04/307/012 84 capsules
Maltese: EU/1/04/307/010 14-il kapsula EU/1/04/307/009 28 kapsula EU/1/04/307/003 56 kapsula EU/1/04/307/012 84 kapsula
English: Adjunctive therapy - with CYP3A4inducing agents
Maltese: Terapija addizzjonali - ma' mediċini li jinduċu CYP3A4
English: EU/1/04/307/001 14 capsules EU/1/04/307/005 28 capsules EU/1/04/307/002 56 capsules EU/1/04/307/013 84 capsules
Maltese: EU/1/04/307/001 14-il kapsula EU/1/04/307/005 28 kapsula EU/1/04/307/002 56 kapsula EU/1/04/307/013 84 kapsula
English: In adults, efficacy has been demonstrated with Zonegran 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'Zonegran 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: Cases of agranulocytosis, thrombocytopenia, leukopenia, aplastic anaemia, pancytopenia and leucocytosis have been reported.
Maltese: Każijiet ta' agranuloċitożi, tromboċitopenija, lewkopenija, anemija aplastika, panċitopenija u lewkoċitożi kienu rrappurtati.
English: Anger
Maltese: Anidrożi
English: Zonegran 100 mg hard capsules
Maltese: Zonegran 100 mg kapsuli ibsin
English: Zonegran 50 mg hard capsules zonisamide
Maltese: Zonegran 50 mg kapsuli ibsin zonisamide
English: Efficacy results for Monotherapy Study 310 Zonisamide Carbamazepine n (ITT population) Six months seizure freedom
Maltese: Tabella 6 Riżultati tal-effikaċja għall-Istudju 310 dwar il-Monoterapija Zonisamide Carbamazepine n (popolazzjoni ITT) Sitt xhur mingħajr attakki ta' puplesija
English: 200 mg /day (once a day)
Maltese: 200 mg/kuljum (darba kuljum)
English: EU/1/04/307/006 EU/1/04/307/004 EU/1/04/307/011 EU/1/04/307/007 EU/1/04/307/008
Maltese: EU/1/04/307/011 EU/1/04/307/007 EU/1/04/307/008
English: • The recommended dose is 300 mg once a day.
Maltese: • Id-doża rakkomandata hi ta' 300 mg kuljum.