FrancophonIA/ELRC3.0 huggingface dataset:
English: • simvastatin, lovastatin (used to lower cholesterol);
Maltese: • simvastatin, lovastatin (użati biex ibaxxu l-kolesterol);
English: It blocks protease, an enzyme involved in the reproduction of HIV.
Maltese: Din timblokka l-proteażi, enzima involuta fir-riproduzzjoni tal-HIV.
English: • ergot alkaloids, such as ergotamine, dihydroergotamine, ergonovine and methylergonovine (used to treat migraine headache);
Maltese: • alkalojdi tal-ergotina, bħal ergotamine, dihydroergotamine, ergonovine u methylergonovine (użati biex jikkuraw uġigħ ta' ras minħabba emigranja);
English: What are the risks associated with Invirase?
Maltese: X'inhuma r-riskji assoċjati ma' Invirase?
English: Invirase was found effective in the treatment of HIV infection in six main studies involving a total of 1,576 patients.
Maltese: Invirase nstab li huwa effettiv fil-kura ta' infezzjoni tal-HIV f'sitt studji ewlenin li involvew total ta' 1,576 pazjent.
English: Invirase received a marketing authorisation valid throughout the EU on 4 October 1996.
Maltese: Invirase rċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-EU kollha fl-4 ta' Ottubru 1996.
English: • lurasidone, quetiapine (used to treat psychiatric illness such as schizophrenia).
Maltese: • lurasidone, quetiapine (użati biex jikkuraw mard psikjatriku bħal skiżofrenja).
English: Invirase should only be used in combination with ritonavir (another antiviral medicine) and other antiviral medicines.
Maltese: Invirase għandu jintuża biss flimkien ma' ritonavir (mediċina antivirali oħra) u mediċini antivirali oħra.
English: Invirase in combination with ritonavir was as effective as indinavir but more effective than lopinavir in reducing the viral load to less than 50 copies/ml.
Maltese: Invirase flimkien ma' ritonavir kien effettiv daqs indinavir iżda iktar effettiv minn lopinavir fit-tnaqqis tat-tagħbija virali għal inqas minn 50 kopja/ml.
English: Invirase must not be used in patients who have severe problems with their liver, QT prolongation (an alteration of the electrical activity of the heart), abnormal levels of electrolytes in the blood (especially low potassium levels), bradycardia (slow heart rate) or heart failure (when the heart does not work as well as it should).
Maltese: Invirase m'għandux jintuża f'pazjenti li jkollhom problemi severi bil-fwied, titwil tal-QT (bidla tal-attività elettrika tal-qalb), livelli anormali ta' elettroliti fid-demm (speċjalment livelli baxxi tal-potassju), bradikardja (rata tat-taħbit tal-qalb bil-mod) jew insuffiċjenza tal-qalb (meta l-qalb ma taħdimx tajjeb kif suppost).
English: Two further studies involving 656 patients compared Invirase with indinavir or lopinavir (other HIV medicines).
Maltese: Żewġ studji oħra li invovlew 656 pazjent qabblu Invirase ma' indinavir jew lopinavir (mediċini oħra għall-HIV).
English: After 7 days, the recommended dose of Invirase is 1,000 mg twice daily with ritonavir 100 mg twice daily in combination with other HIV medicines.
Maltese: Wara 7 ijiem, id-doża rakkomandata ta' Invirase hija 1,000 mg darbtejn kuljum b'100 mg ritonavir darbtejn kuljum flimkien ma' mediċini oħra għall-HIV.
English: The most common side effects when taking Invirase in combination with ritonavir (which may affect more than 1 patient in 10) are diarrhoea, nausea (feeling sick), increased levels of liver enzymes, cholesterol and triglycerides (a type of fat) in the blood, and decreased levels of platelets in the blood (components that help blood to clot).
Maltese: L-effetti sekondarji l-aktar komuni meta jittieħed Invirase flimkien ma' ritonavir (li jistgħu jaffettwaw aktar minn pazjent 1 minn kull 10) huma dijarea, nawżja (tħossok ma tiflaħx), żieda fil-livelli tal-enżimi tal-fwied, kolesterol u trigliċeridi (tip ta' xaħam) fid-demm, u tnaqqis fil-livelli tal-pjastrini fid-demm (komponenti li jgħinu fit-tagħqid tad-demm).
English: • midazolam taken by mouth, triazolam (used to relieve anxiety or difficulty sleeping);
Maltese: • midazolam meħud mill-ħalq, triazolam (użati biex itaffu l-ansjetà jew diffikultà fl-irqad);
English: For patients already taking HIV medicines, the recommended dose of Invirase is 1,000 mg with 100 mg ritonavir twice daily.
Maltese: Għal pazjenti li diġà qegħdin jieħdu mediċini għall-HIV, id-doża rakkomandata ta' Invirase hija 1,000 mg b'100 mg ritonavir darbtejn kuljum.
English: As for all medicines, data on the use of Invirase are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Invirase hija ssorveljata kontinwament.
English: Ritonavir is another protease inhibitor that is used as a ‘booster'.
Maltese: Ritonavir huwa inibitur tal-proteażi ieħor li jintuża bħala “booster”.
English: For patients who are not taking HIV medicines, Invirase is started at 500 mg twice daily with ritonavir 100 mg twice daily for the first 7 days of treatment, given in combination with other HIV medicines.
Maltese: Għal pazjenti li mhumiex jieħdu mediċini għall-HIV, Invirase jinbeda b'500 mg darbtejn kuljum b'ritonavir 100 mg darbtejn kuljum għall-ewwel 7 ijiem tal-kura, mogħti flimkien ma' mediċini oħra tal-HIV.
English: These studies measured the viral load after 48 weeks.
Maltese: Dawn l-istudji kejlu t-tagħbija virali wara 48 ġimgħa.
English: What benefits of Invirase have been shown in studies?
Maltese: X'inhuma l-benefiċċji ta' Invirase li ħarġu mill-istudji?
English: For the full list of side effects of Invirase, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji ta' Invirase, ara lfuljett ta' tagħrif.
English: How is Invirase used?
Maltese: Kif jaħdem Invirase?
English: The medicines were given in combination with ritonavir and two other HIV medicines.
Maltese: Il-mediċini ngħataw flimkien ma' ritonavir u żewġ mediċini oħra għall-HIV.
English: Side effects reported with Invirase are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Invirase huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: This allows effective treatment while avoiding a higher dose of saquinavir.
Maltese: Dan jippermetti kura effettiva filwaqt li jevita doża ogħla ta' saquinavir.
English: Av Cami Reial 51-57
Maltese: Cami Reial 51-57
English: Posology - adults
Maltese: Pożoloġija - adulti
English: † MedDRA version 13.1
Maltese: MedDRA verżjoni 13.1
English: Possible Side Effects).
Maltese: Effetti Sekondarji Possibbli).
English: Usual Maintenance Dose
Maltese: Doża Normali ta' Manteniment
English: System Organ Class (MedDRA terminology)
Maltese: Sistema talKlassifika talOrgani (Terminoloġija MedDRA)
English: Decrease at weekly intervals in increments of: 20 - 28 kg 25 to 50 mg / day* 29 - 41 kg 50 to 75 mg / day* 42 - 55 kg 100 mg / day* >55 kg
Maltese: Naqqas f'intervalli ta' ġimgħa f'inkrementi ta': 20 - 28 kg 25 sa 50 mg/jum* 29 - 41 kg 50 sa 75 mg/jum* 42 - 55 kg 100 mg/jum* > 55 kg
English: 100 mg / day*
Maltese: 100 mg/jum*
English: Paediatric Population).
Maltese: Popolazzjoni Pedjatrika).
English: Absolute bioavailability is estimated to be approximately 100%.
Maltese: Il-bijodisponibilità assoluta hi stmata li hi ta' madwar 100%.
English: 08184 Palau-Solita i Plegamans - Barcelona Spain
Maltese: Palau-Solita i Plegamans - Barcelona Spanja
English: Date of first authorisation: 31 March 2016
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 31 ta' Marzu 2016
English: Patients of weight > 55 kg
Maltese: Pazjenti li jiżnu > 55 kg
English: Capsule contents Microcrystalline cellulose Sodium laurilsulfate Hydrogenated vegetable oil
Maltese: Kontenut tal-kapsula Microcrystalline cellulose Sodium laurilsulfate Hydrogenated vegetable oil
English: Carbonic anhydrase inhibitors
Maltese: Inibituri ta' carbonic anhydrase
English: Mylan S.A.S 117 allee des Parcs, 69 800 Saint Priest, France
Maltese: Mylan S.A.S 117 allee des Parcs, 69 800 Saint Priest, Franza
English: Respiratory disorder
Maltese: Disturb respiratorju
English: PP = Per Protocol Population; ITT = Intent To Treat Population *Primary endpoint
Maltese: PP = Popolazzjoni Skont il-Protokoll; ITT = Popolazzjoni b'Intenzjoni li Tiġi Kkurata *Punt aħħari primarju
English: 117 Allee des Parcs, 69 800 Saint Priest, France
Maltese: 117 Allee des Parcs, 69 800 Saint Priest, Franza
English: Cholecystitis acute
Maltese: Koleċistite akuta
English: Capsule shells Titanium dioxide (E171) Gelatin
Maltese: Qxur tal-kapsuli Titanium dioxide (E171) Ġelatin
English: 28 hard capsules 56 hard capsules 98 hard capsules 196 hard capsules
Maltese: 28 kapsula iebsa 56 kapsula iebsa 98 kapsula iebsa 196 kapsula iebsa
English: België/Belgique/Belgien Mylan bvba/sprl Tél/Tel: + 32 (0)2 658 61 00
Maltese: België/Belgique/Belgien Mylan bvba/sprl Tél/Tl: + 32 (0)2 658 61 00
English: incontinence), status epilepticus (prolonged or repeated seizures)
Maltese: inkontinenza), status epilepticus (attakki ta' puplesija fit-tul jew ripetuti).qtugħ ta' nifs,
English: ≥ 1/10,000 to < 1/1,000
Maltese: ≥ 1/10,000 sa < 1/1,000
English: Zonisamide is a benzisoxazole derivative.
Maltese: Zonisamide hu derivat ta' benzisoxazole.
English: Effect of zonisamide on cytochrome P450 enzymes
Maltese: L-effett ta' zonisamide fuq l-enzimi ta' cytochrome P450
English: General supportive care is indicated, including frequent monitoring of vital signs and close observation.
Maltese: Kura ġenerali ta' appoġġ hi indikata, li tinkludi monitoraġġ frekwenti ta' sinjali vitali u osservazzjoni millqrib.
English: Hard capsule.
Maltese: Kapsuli iebsin
English: ≥ 1/100 to < 1/10
Maltese: ≥ 1/100 sa < 1/10
English: In vitro studies using human liver microsomes show no or little (< 25%) inhibition of cytochrome P450 isozymes 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 or 3A4 at zonisamide levels approximately two-fold or greater than clinically relevant unbound serum concentrations.
Maltese: Studji in vitro bl-użu ta' mikrosomi tal-fwied uman juru ftit jew xejn (< 25%) inibizzjoni ta' cytochrome isozymes P450 1A2, 2A6, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1 jew 3A4 f'livelli ta' zonisamide ta' madwar id-doppju jew iktar mill-konċentrazzjonijiet mhux imwaħħlin fis-serum li huma klinikament rilevanti.
English: Week 1 + 2 Week 3 + 4 Week 5 to 10
Maltese: Ġimgħa 1 + 2 Ġimgħa 3 + 4 Ġimgħa 5 sa 10
English: ≥ 1/1,000 to < 1/100
Maltese: ≥ 1/1,000 sa < 1/100
English: Diplopia
Maltese: Diplopja
English: Uncommon Very Rare
Maltese: Rari Ħafna
English: 14 hard capsules 28 hard capsules 56 hard capsules
Maltese: 14-il kapsula iebsa 28 kapsula iebsa 56 kapsula iebsa
English: Week 1 + 2 Weeks ≥ 3
Maltese: Ġimgħa 1 + 2 Ġimgħat ≥ 3
English: 6 to 8 mg/kg/day (once a day)
Maltese: 6 sa 8 mg/kg/jum (darba kuljum).
English: Leucopenia Thrombocytopenia
Maltese: Lewkopenija Tromboċitopenija
English: Anhidrosis Erythema multiforme Stevens-Johnson syndrome
Maltese: Eritema multiforme Sindrome ta' Stevens-Johnson Nekrolisi epidermali tossika
English: P-gp substrate
Maltese: Substrati ta' P-gp
English: Pyrexia Oedema peripheral
Maltese: Edema periferali
English: Zonisamide Mylan 100 mg are available in blister packs of 28, 56, 98 and 196 capsules and perforated unit dose blister packs of 56 x 1 capsules.
Maltese: Zonisamide Mylan 100 mg huma disponibbli f'pakketti bil-folji ta' 28, 56, 98 u 196 kapsula u pakketti bil-folji perforati b'doża waħda ta' 56 × 1 kapsula.
English: Adjunctive therapy - with CYP3A4inducing agents (see section 4.5)
Maltese: - ma' mediċini li jinduċu CYP3A4 (ara sezzjoni 4.5)
English: Rhabdomyolysis
Maltese: Rabdomijolosi
English: Rifampicin is a potent CYP3A4 inducer.
Maltese: Rifampicin hu inducer qawwi ta' CYP3A4.
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 aminotransferease (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: Zonisamide Mylan 25 mg and 50 mg are available in blister packs of 14, 28, 56 capsules and perforated unit dose blister packs of 14 x 1 capsules.
Maltese: Zonisamide Mylan 25 mg u 50 mg huma disponibbli f'pakketti bil-folji ta' 14, 28, 56 kapsula u pakketti bil-folji perforati b'doża waħda ta' 14 × 1 kapsula.
English: Zonisamide lowers the 28-day average seizure frequency and the decrease is proportional (log-linear) to zonisamide average concentration.
Maltese: Zonisamide ibaxxi l-frekwenza tal-medja ta' attakki ta' puplesija fuq perjodu ta' 28 jum, u t-tnaqqis hu proporzjonali (log-linear) mal-konċentrazzjoni medja ta' zonisamide.
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 anti-epilettiċi (i.e., phenytoin, phenobarbitone, carbamazepine, u sodium valproate).
English: Aspartate aminotransferase increased
Maltese: Żieda f'alanine aminotransferase Żieda f'aspartate aminotransferase
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: It is an anti-epileptic medicine with weak carbonic anhydrase activity in-vitro.
Maltese: Hu mediċina antiepilettika b'attività dgħajfa in-vitro ta' carbonic anhydrase.
English: Infections and infestation
Maltese: Infezzjonijiet u infestazzjonijiet
English: Metabolic acidosis
Maltese: Aċidożi metabolika
English: Examples include: sulfonamide antibiotics, thiazide diuretics, and sulfonylurea antidiabetes medicines.
Maltese: Eżempji jinkludu: antibijotiċi sulfonamide,dijuretiċi thiazide, u mediċini sulfonylurea kontra d-dijabete.
English: Secondary Tonic-Clonic Generalized Tonic-Clonic
Maltese: Kumpless parzjali Toniċi-Kloniċi generalizzati kollha Toniċi-Kloniċi sekondarji Toniċi-Kloniċi ġeneralizzati
English: Hypersensitivity to the active substance, to any of the excipients listed in section 6.1 or to sulfonamides.
Maltese: Sensittività eċċessiva għas-sustanza attiva, għal kwalunkwe wieћed mill-eċċipjenti elenkati fissezzjoni 6.1 jew għal sulfonamides.
English: Unit Dose Blisters: 14 x 1 hard capsules
Maltese: Folji b'Doża Waħda: 14 × 1 kapsula iebsa
English: 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-farmakokinetiċi bejn persuni żgħażagħ (minn 21 - 40 sena) u anzjani (65 - 75 sena).
English: 1 mg/kg/day (once a day)
Maltese: 1 mg/kg/jum (darba kuljum).
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: Rash Pruritus Alopecia
Maltese: Raxx Ħakk Alopeċja
English: Pregnancy, breast-feeding and fertility
Maltese: Tqala,treddigħ u fertilità
English: very common ≥ 1/10 common
Maltese: komuni hafna ≥ 1/10 komuni
English: Printing ink Shellac
Maltese: Linka tal-istampar Shellac
English: Unit Dose Blisters: 56 x 1 hard capsules
Maltese: Folji b'Doża Waħda: 56 × 1 kapsula iebsa
English: PVC-PVdC/Aluminium foil blisters in cardboard cartons containing 28, 56, 98 and 196 capsules.
Maltese: Folji b'fojl tal-PVC-PVdC/Aluminju f'kaxxi tal-kartun li fihom 28, 56, 98 u 196 kapsula.
English: ES-08184 - Palau-solità i Plegamans Barcelona
Maltese: - Palau-solità i Plegamans Barcelona
English: Sulfonamide reactions
Maltese: Reazzjonijiet ta' sulfonamide
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, deidrazzjoni, tnaqqis fl-għaraq, testijiet tal-funzjoni tal-fwied b'riżultati anormali, infjammazzjoni talparti 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 mal-popolazzjoni adulta (partikularment f'individwi li kellhom inqas minn 12-il sena) u, f'inċidenza baxxa, amnesija, żieda fil-livell tal-krejatinina, limfadenopatija, u tromboċitopenija.
English: The other ingredients are: - capsule contents: microcrystalline cellulose, hydrogenated vegetable oil and sodium laurilsulfate - capsule shell: gelatin and titanium dioxide (E171) - printing ink: shellac and iron oxide red (E172)
Maltese: Is-sustanzi l-oħra huma: - kontenut tal-kapsula: microcrystalline cellulose, hydrogenated vegetable oil u sodium laurilsulfate - qoxra tal-kapsula: ġelatina u titanium dioxide (E171) - linka tal-istampar: shellac u iron oxide red (E172)
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'pazjenti bi tneħħija tal-kreatinina ta' < 20 mL/min (ara wkoll Sezzjoni 4.2).
English: Coma
Maltese: Koma
English: The other ingredients are: - capsule contents: microcrystalline cellulose, hydrogenated vegetable oil and sodium laurilsulfate - capsule shell: gelatin and titanium dioxide (E171) - printing ink: shellac, black iron oxide (E172) and potassium hydroxide.
Maltese: Is-sustanzi l-oħra huma: - kontenut tal-kapsula: microcrystalline cellulose, hydrogenated vegetable oil u sodium laurilsulfate - qoxra tal-kapsula: ġelatina u titanium dioxide (E171) - linka tal-istampar: shellac, black iron oxide (E172) u potassium hydroxide.
English: In epileptic patients, steady-state dosing with zonisamide resulted in no clinically relevant pharmacokinetic effects on carbamazepine, lamotrigine, phenytoin, or sodium valproate.
Maltese: F'pazjenti epilettiċi, id-dożaġġ fl-istat fiss b'zonisamide ma rriżulta fl-ebda effetti farmakokinetiċi li kienu klinikament rilevanti fuq carbamazepine, lamotrigine, phenytoin, jew sodium valproate.
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: • 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 m'għandhomx jieħdu 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 is metabolised primarily through reductive cleavage of the benzisoxazole ring of the parent drug by CYP3A4 to form 2-sulfamoylacetylphenol (SMAP) and also by N-acetylation.
Maltese: Zonisamide hu metabolat primarjament minn ġor-reductive cleavage taċ-ċirku ta' benzisoxazole talmediċina prinċipali minn CYP3A4 biex jifforma 2-sulfamoylacetylphenol (SMAP) u wkoll minn N-acetylation.
English: A pooled analysis of safety data on 95 elderly subjects has shown a relatively higher reporting frequency of oedema peripheral and pruritus compared to the adult population.
Maltese: Analiżi miġbura ta' dejta dwar is-sigurtà fuq 95 persuna anzjana wriet frekwenza relattivament ogħla ta' rappurtaġġ ta' edema periferali u ħakk meta mqabbla mal-popolazzjoni adulta.
English: Investigations Decreased bicarbonate
Maltese: Investigazzjonijiet Tnaqqis filbikarbonat
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-farmakokinetiċi ta' doża waħda ta' zonisamide mogħtija lil persuni b'saħħithom.
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 ilperjodu ta' 12-il ġimgħa ta' doża stabbli ġie osservat f'50% tal-individwi kkurati b'zonisamide u f'31% tal-pazjenti fuq il-plaċebo.
English: Drug-induced hypersensitivity syndrome Drug rash with eosinophilia and systemic symptoms
Maltese: Raxx minħabba l­mediċina b'eosinofilija u sintomi sistemiċi
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: There are limited data from clinical studies in patients with a body weight of less than 20 kg.
Maltese: Hemm dejta limitata minn studji kliniċi f'pazjenti b'piż tal-ġisem ta' inqas minn 20 kg.
English: Grand mal seizure Myasthenic syndrome Neuroleptic malignant syndrome
Maltese: Puplesija grand mal Sindrome mjasteniku Sindrome malinn newroleptiku Status epilepticus
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-espożizzjoni għal zonisamide hi iktar baxxa f'pazjenti epilettiċi li jkunu qed jirċievu sustanzi li huma CYP3A4 inducing agents bħal phenytoin, carbamazepine, u phenobarbitone.
English: Rash
Maltese: Rabja
English: Pneumonia aspiration Respiratory disorder Hypersensitivity-type Pneumonitis
Maltese: Aspirazzjoni pnewmonja Mard respiratorju Pnewmonite tat-tip ta' sensittività eċċessiva
English: Blood creatine phosphokinase increased
Maltese: Żieda fil-creatine phosphokinase fiddemm
English: Agitation Irritability Confusional state
Maltese: • aġitazzjoni, irrikwitezza, konfużjoni, dipressjoni
English: The incidence of marked decreases in weight of 20% or more was 0.7%.
Maltese: L-inċidenza ta' tnaqqis notevoli fil-piż ta' 20% jew iktar kienet ta' 0.7%.
English: Confusional state Acute psychosis Aggression Suicidal ideation Hallucination
Maltese: Stat ta' konfużjoni Psikożi akuta Aggressjoni Formazzjoni ta' ħsieb biex jitwettaq suwiċidju Alluċinazzjoni
English: Appropriate evaluation and monitoring of serum bicarbonate levels should be carried out in this population (see section 4.4 - Metabolic acidosis for full warning; see section 4.8 for incidence of low bicarbonate).
Maltese: Evalwazzjoni adattata u monitoraġġ tal-livelli ta' bicarbonate fisserum għandhom jitwettqu f'din il-popolazzjoni (ara sezzjoni 4.4 - Aċidożi metabolika għal twissija sħiħa; ara sezzjoni 4.8 għal inċidenza ta' bicarbonate baxx).