FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis West Nile suspension for injection for horses
Maltese: VETERINARJU Equilis West Nile suspensjoni għall-injezzjoni għaż-żwiemel
English: Type I glass pre-filled syringes of 1ml (1 dose), containing a plunger with a halogenobutyl end and closed with a halogenobutyl stopper.
Maltese: Siringa tal- ħġieġ tip I ta' 1ml (doża) mimlija għall-lest, li fiha planġer b'tarf tal-gomma halogenbutyl u magħluq b'tapp tal-gomma halogenbutyl.
English: Opalescent suspension.
Maltese: Mhux applikabbli.
English: Pharmacotherapeutic group: Immunologicals for Equidae, inactivated viral vaccines.
Maltese: Immunoloġiċi għaż-żwiemel, vaċċin virali inattivat.
English: PHARMACEUTICAL FORM Suspension for injection.
Maltese: GĦAMLA FARMAĊEWTIKA Suspensjoni għall-injezzjoni Suspensjoni opalaxxenti.
English: Potassium chloride
Maltese: Fosfatidilkolajn
English: Following the administration of a double dose of vaccine, no side-effects other than those described under section 4.6 have been observed.
Maltese: Wara injezzjoni doppja ta' vaċċin, l-ebda effett mhux mixtieq , apparti dawk deskritti f'sezzjoni 4.6, ma ġie osservat.
English: For the full list of excipients, see section 6.1.
Maltese: 1 Partijiet antiġeniċi iddeterminati bl' ELISA Għal-lista sħiħa ta' l-ingredjenti (mhux attivi), ara s-sezzjoni 6.1.
English: MANUFACTURER'S BATCH NUMBER Lot {number}
Maltese: NUMRU TAL-LOTT TAL-MANIFATTUR
English: Cardboard box or plastic box with 10 vials of 1 ml, or 5 or 10 pre-filled syringes of 1 ml
Maltese: Kaxxa tal-kartun jew plastik b`10 kunjetti ta` 1ml, jew 5 jew 10 sirinġi mimlija għall-lest ta` 1ml
English: Plastic box with 5 or 10 pre-filled syringes of 1 ml (1 dose).
Maltese: Kaxxa tal-plastik b'5 jew 10 siringi mimlijin għall-lest ta`1ml (1 doża)..
English: A mild body temperature increase (max. 1.5 °C) may very commonly occur for 1 to 2 days.
Maltese: Temperatura tal-ġisem tista' togħla ftit (mass. 1.5°C) tista sseħħ komuni ħafna għall-1 jew 2 ġranet.
English: Cardboard box with 10 glass vials of 1 ml (1 dose).
Maltese: Kaxxa tal-kartun b' 10 kunjetti tal-ħġieġ ta`1ml (1 doża).
English: BATCH NUMBER Lot {number}
Maltese: NUMRU TAL-LOTT
English: Antigenic units Opalescent suspension.
Maltese: Partijiet antiġeniċi iddeterminati bl' ELISA Suspensjoni opalaxxenti.
English: Cardboard box with 5 or 10 pre-filled syringes of 1 ml (1 dose).
Maltese: Kaxxa tal-kartun b'5 jew 10 siringi mimlijin għall-lest ta`1ml (1 doża)..
English: Capsule, hard blister (alu/PVC) 42 capsules
Maltese: Daqs tal-pakkett folja (alu/PVC) 42 kapsula flixkun (HDPE) 30 pillola
English: EU Number
Maltese: Numru ta' l-UE Isem ivvintat
English: Packaging
Maltese: Mnejn jingħata Il-pakkett
English: Table of ADRs
Maltese: Tabella ta' ADRs
English: Summary of product characteristics 4.7.
Maltese: Sommarju tal-Karatteristiċi tal-Prodott 4.7.
English: Varenicline - Loss of consciousness (EPITT no 19146)
Maltese: Varenicline - Telf mis-sensi (EPITT nru 19146)
English: Undesirable effects Nervous system disorders
Maltese: .8. Effetti mhux mixtieqa Disturbi fis-sistema nervuża
English: Nabumetone - Drug reaction with eosinophilia and systemic symptoms (DRESS)(EPITT no 19241)
Maltese: Nabumetone - Reazzjoni medika b'esinofilja u sintomi sistemiċi (DRESS)(EPITT nru 19241)
English: Very rare: Bullous reactions including toxic epidermal necrolysis, Stevens Johnson syndrome, drug reaction with eosinophilia and systemic symptoms, erythema multiforme, angioedema, pseudoporphyria, alopecia
Maltese: Rari ħafna: Reazzjonijiet bullużi li jinkludu nekroliżi epidermali tossika, sindrome Stevens Johnson, reazzjoni medika b'esonifilja u sintomi sistemiċi, erythema multiforme, anġjoedema, psewdoporfirja, alopeċja
English: Adopted at the 11-14 June 2018 PRAC
Maltese: Adottati fil-PRAC ta' bejn il-11 ul-14 ta' Ġunju 2018
English: Widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement (drug reaction with eosinophilia and systemic symptoms which is also known as DRESS or drug hypersensitivity syndrome).
Maltese: Raxx mifrux, temperatura għolja tal-ġisem, żidiet fl-enzimi tal-fwied, anormalitajiet tad-demm (esonifilja), limfonodi mkabbra u involviment ta' organi oħra tal-ġisem (reazzjoni medika b'esonifilja u sintomi sistemiċi li hija magħrufa wkoll bħala DRESS jew sindrome ta' sensittività eċċessiva għal mediċina).
English: Severe cutaneous adverse reactions (SCARs), including exfoliative dermatitis, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in association with nabumetone treatment (see section 4.4).
Maltese: Reazzjonijiet avversi severi tal-ġilda (SCARs) li jinkludu dermatite esfoljattiva, sindrome ta' StevensJohnson (SJS), nekroliżi epidermali tossika (TEN), reazzjoni medika b'esonifilja u sintomi sistemiċi (DRESS) ġew irrappurtati b'rabta ma' kura b'nabumetone (ara s-sezzjoni 4.4).
English: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported very rarely in association with the use of NSAIDs, including nabumetone (see section 4.8).
Maltese: Reazzjonijiet serji fil-ġilda, xi wħud minnhom fatali, li jinkludu dermatite esfoljattiva, sindrome ta' Stevens-Johnson (SJS), nekroliżi epidermali tossika (TEN), u reazzjoni medika b'esonifilja u sintomi sistemiċi (DRESS), li jistgħu jkunu ta' periklu għall-ħajja jew fatali, ġew irrappurtati b'mod rari ħafna b'rabta mal-użu ta' NSAIDs, inkluż nabumetone (ara sezzjoni 4.8).
English: CHAMPIX may be linked with produce dizziness, sleepiness and transient loss of consciousness.
Maltese: CHAMPIX jista' jkun assoċjat ma' jipproduċi sturdament, ngħas u telfien temporanju mis-sensi.
English: What you need to know before you take CHAMPIX
Maltese: X'għandek tkun taf qabel ma tieħu CHAMPIX
English: Skin and subcutaneous tissue disorders
Maltese: Mhux magħruf Telf temporanju mis-sensi
English: Possible side effects - Not known o Transient loss of consciousness
Maltese: - Mhux magħruf o Telfien temporanju mis-sensi
English: 29 November 2010
Maltese: 29 ta' Novembru 2010
English: Outcome of a procedure under Article 107 of Directive 2001/83/EC
Maltese: Riżultat ta' proċedura skont l-Artikolu 107 tad-Direttiva 2001/83/KE
English: Procedure start date:
Maltese: Data tal-opinjoni:
English: Ketoprofen is a non-steroidal anti-inflammatory drug (NSAID).
Maltese: Ketoprofen hija sustanza anti-infjammatorja mhux sterojdi (NSAID).
English: What is ketoprofen?
Maltese: X'inhu ketoprofen?
English: Company responses provided on: 5 January 2010, 26 February 2010 and 7 June 2010 Opinion date:
Maltese: 5 ta' Jannar 2010, 26 ta' Frar 2010 u 7 ta' Ġunju 2010
English: 17 December 2009
Maltese: 17 ta' Diċembru 2009
English: Topical formulations of ketoprofen are used to treat the symptoms of pain and inflammation in conditions such as minor trauma (sprains, bruising), tendonitis (inflammation of a tendon), small-joint osteoarthritis (swelling and pain in the small joints), acute low-back pain and phlebitis (inflammation of a vein).
Maltese: Formulazzjonijiet topiċi tal-ketoprofen jintużaw fil-kura tas-sintomi tal-uġigħ u tal-infjammazzjoni f'kundizzjonijiet bħal trawma minuri (tfekkik, tbenġil), tendonite (infjammazzjoni ta' għerq), osteoartrite tal-ġogi ż-żgħar (nefħa u uġigħ fil-ġogi ż-żgħar), uġigħ akut fil-parti t'isfel tad-dahar u flebite (infjammazzjoni ta' vina).
English: NSAIDs work by blocking an enzyme called cyclo-oxygenase, which is involved in the production of prostaglandins.
Maltese: NSAIDs jaħdmu billi jimblukkaw enzima msejħa cyclo-oxygenase, li hija nvoluta fil-produzzjoni ta' prostaglandini.
English: Octocrylene is a chemical sunscreen found in several cosmetics and care products such as shampoo, skin creams, anti-ageing creams, make-up removers and hair sprays.
Maltese: L-oktokrilin huwa protezzjoni kimika mix-xemx li jinsab f'diversi kożmetiċi u prodotti ta' kura bħal xampus, kremi tal-ġilda, kremi kontra x-xjuħija, make-up removers u sprejs tax-xagħar.
English: The CHMP looked into all the available safety data, including data from member states' databases and data provided by the companies marketing topical ketoprofen in the EU.
Maltese: Is-CHMP eżamina d-dejta kollha disponibbli dwar is-sigurtà, inkluż dejta mid-databases tal-Istati Membri u dejta pprovduta minn kumpaniji li jpoġġu l-ketoprofen applikata topikament fis-suq tal-UE.
English: The CHMP noted that the number of reports of adverse skin reactions including photoallergy is low throughout the EU and that the risk of these side effects could potentially be reduced using appropriate minimisation measures.
Maltese: Is-CHMP innota li n-numru ta' rapporti ta' reazzjonijiet avversi fuq il-ġilda, inkluż fotoallerġija huwa baxx fl-UE kollha u li r-riskju ta' dawn l-effetti sekondarji jista' potenzjalment jitnaqqas bl-użu ta' miżuri ta' minimizzazzjoni xierqa.
English: Since their marketing authorisation, the French medicines regulatory agency (Afssaps) has reviewed the safety of topical ketoprofen-containing medicines several times because of reports of photoallergy (allergic reactions to a medicine following exposure to sunlight) in patients using these medicines.
Maltese: Sa mill-awtorizzazzjoni għat-tqegħid fis-suq tagħhom, l-aġenzija regolatorja tal-mediċini Franċiża (Afssaps) irrevediet is-sigurtà ta' mediċini topiċi li fihom il-ketoprofen diversi drabi minħabba rapporti ta' fotoallerġija (reazzjonijiet allerġiċi għal mediċina wara esponiment għad-dawl tax-xemx) f'pazjenti li kienu qegħdin jużaw dawn il-mediċini.
English: Topical ketoprofen-containing medicines have been available in all Member States except for the Netherlands since 1978.
Maltese: Mediċini li fihom il-ketoprofen użati topikament ilhom disponibblifl-Istati Membri kollha minbarra filPajjiżi l-Baxxi mill-1978.
English: As a result, measures to reduce harm were implemented in France, such as the inclusion of warnings and precautions in the French product information, a pictogram on the packaging and dissemination of letters to healthcare professionals.
Maltese: B'riżultat ta' dan, fi Franza ġew implimentati miżuri biex inaqqsu l-ħsara, bħaż-żieda ta' twissijiet u prekawzjonijiet fl-informazzjoni Franċiża dwar il-prodott, piktogramma fuq l-ippakkjar u t-tqassim ta' ittri lill-professjonisti tal-kura tas-saħħa.
English: • Doctors, pharmacists and patients should be aware of the risk of photoallergy with topical ketoprofen.
Maltese: • It-tobba, l-ispiżjara u l-pazjenti għandhom ikunu konxji mir-riskju ta' fotoallerġija bil-ketoprofen applikata topikament.
English: The European Commission issued a decision on this opinion on 29 November 2010.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni dwar din l-opinjoni fid-29 ta' Novembru 2010.
English: Prostaglandins are messengers in the development of inflammation.
Maltese: Il-prostaglandini huma messaġġiera fl-iżvilupp ta' infjammazzjoni.
English: • strengthened warnings on sun exposure should be included in the product information, as well as advice to stop using topical ketoprofen if any skin reactions develop, including when using ketoprofen together with octocrylene;
Maltese: • twissijiet imsaħħa dwar l-esponiment għax-xemx għandhom jiġu nklużi fl-informazzjoni dwar il prodott, kif ukoll parir biex jieqaf l-użu tal-ketoprofen applikata topikament jekk jiżviluppaw reazzjonijiet fuq il-ġilda, inkluż l-użu tal-ketoprofen applikata flimkien mal-oktokrilin;
English: They may be available as creams, gels, solutions, sprays and plasters under various trade names and as generics.
Maltese: Jistgħu jkunu disponibbli bħala kremi, ġels, soluzzjonijiet, sprejs u ġibs taħt diversi ismijiet kummerċjali u bħala ġeneriċi.
English: The CHMP concluded that the benefits of topical ketoprofen-containing medicines continue to outweigh their risks but recommended the following risk minimisation measures:
Maltese: Is-CHMP ikkonkluda li l-benefiċċji ta' mediċini applikati topikament li fihom il-ketoprofen ikomplu jegħlbu r-riskji tagħhom iżda rrakkomanda l-miżuri li ġejjin għall-minimizzazzjoni tar-riskju:
English: In December 2009, after re-assessing these medicines, the French agency considered that their benefit-risk balance was no longer positive and decided to suspend the marketing authorisations of all topical medicines containing ketoprofen in France.
Maltese: F'Diċembru 2009, wara li vvalutat dawn il-mediċini mill-ġdid, l-aġenzija Franċiża kkunsidrat li l-bilanċ tal-benefiċċju-riskju tagħhom ma kienx għadu pożittiv u ddeċidiet li tissospendi l-awtorizzazzjonijiet għat-tqegħid fis-suq tal-mediċini kollha applikati topikament li fihom il-ketoprofen fi Franza.
English: EMA/CHMP/485343/2011 rev.1 EMEA/H/A-31/1275
Maltese: EMA/773287/2011 rev.1 EMEA/H/A-31/1275
English: 13 September 2011
Maltese: 13 ta' Settembru 2011
English: Medicines containing dexrazoxane are authorised for the prevention of cardiotoxic effects in Austria, Czech Republic, Germany, Denmark, Finland, France, Greece, Hungary, Ireland, Italy, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Slovakia Spain and the United Kingdom under the following invented names: Cardioxane, Cyrdanax, Dexrazoxane Cyathus, Enaxozar and Procard.
Maltese: Il-mediċini li fihom dexrazoxane huma awtorizzati għall-prevenzjoni ta' effetti kardjotossiċi fl-Awstrija, fir-Repubblika Ċeka, fil-Ġermanja, fid-Danimarka, fil-Finlandja, fi Franza, fil-Greċja, fl-Ungerija, flIrlanda, fl-Italja, fil-Litwanja, fil-Lussemburgu, fil-Pajjiżi l-Baxxi, fin-Norveġja, fil-Polonja, fil-Portugall, fir-Rumanija, fis-Slovakkja, fi Spanja u fir-Renju Unit taħt l-ismijiet ivvintati li ġejjin: Cardioxane, Cyrdanax, Dexrazoxane Cyathus, Enaxozar u Procard.
English: What is dexrazoxane?
Maltese: X'inhu dexrazoxane?
English: • Dexrazoxane should only be used in adult patients who have already received a minimum cumulative anthracycline dose of 300 mg/m2 of doxorubicin, or 540 mg/m2 of epirubicin.
Maltese: • Dexrazoxane għandu jintuża biss fuq pazjenti adulti li diġà rċevew doża minima kumulattiva ta' anthracycline ta' 300 mg/m2 ta' doxorubicin, jew 540 mg/m2 ta' epirubicin.
English: The European Medicines Agency has completed a review of the safety and effectiveness of dexrazoxane.
Maltese: L-Aġenzija Ewropea tal-Mediċini temmet reviżjoni tas-sigurtà u l-effikaċja ta' dexrazoxane.
English: The French medicines regulatory agency raised concerns that dexrazoxane could be linked to an increased risk of two cancers: acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS).
Maltese: L-aġenzija regolatorja tal-mediċini Franċiża qajmet tħassib li dexrazoxane seta' kien relatat ma' żieda fir-riskju ta' żewġ kanċers: il-lewkimja majelojde akuta (AML) u s-sindrome majelodisplastiku (MDS).
English: Dexrazoxane is used in patients with cancer to prevent long-tem toxic effects on the heart caused by treatment with the anticancer medicines doxorubicin and epirubicin.
Maltese: Dexrazoxane jintuża fil-pazjenti bil-kanċer għall-prevenzjoni tal-effetti tossiċi fit-tul fuq il-qalb ikkawżati mill-kura bil-mediċini kontra l-kanċer doxorubicin u epirubicin.
English: The CHMP reviewed reports on AML and MDS in patients receiving dexrazoxane.
Maltese: Is-CHMP irreveda rapporti dwar AML u MDS f'pazjenti li kienu qegħdin jirċievu dexrazoxane.
English: • Information on recommended dosing and additional information on the risks associated with dexrazoxane can be found in the updated prescribing information.
Maltese: • L-informazzjoni dwar id-dożaġġ irrakkomandat u informazzjoni addizzjonali dwar ir-riskji assoċjati ma' dexrazoxane jistgħu jinstabu fl-informazzjoni aġġornata dwar il-preskrizzjoni.
English: In addition to the restriction in the medicine's use, the CHMP has recommended a reduced dose ratio of 10:1 with doxorubicin (the dose ratio remains 10:1 for epirubicin) in adults and has included in the SmPCs more information on what is currently known about the risks of dexrazoxane-containing medicine.
Maltese: 1 għal epirubicin) fl-adulti u żied aktar informazzjoni dwar dak li huwa attwalment magħruf dwar ir-riskji ta' mediċini li fihom dexrazoxane fl-SmPCs.
English: The Committee also noted that in one study in breast cancer patients, dexrazoxane was associated with worsened response to cancer therapy while other studies showed an increased risk of dying in the first few months of treatment with dexrazoxane at a dose ratio of 20: 1 (20 parts dexrazoxane for 1 part of doxorubicin).
Maltese: Il-Kumitat innota wkoll li fi studju wieħed fuq pazjenti bil-kanċer tas-sider, dexrazoxane kien assoċjat ma' rispons agħar għat-terapija tal-kanċer filwaqt li studji oħra wrew żieda fir-riskju ta' mewt fl-ewwel ftit xhur ta' kura bi dexrazoxane f'doża fil-proporzjon ta' 20:
English: • Dexrazoxane should only be used in adult patients with advanced or metastatic breast cancer.
Maltese: • Dexrazoxane għandu jintuża biss fuq pazjenti adulti bil-kanċer tas-sider avvanzat jew metastatiku.
English: These concerns were based on studies in the United States reporting cases of AML and MDS in children with Hodgkin's disease as well as cases of AML reported in breast cancer patients receiving dexrazoxane.
Maltese: Dan it-tħassib kien ibbażat fuq studji li saru fl-Istati Uniti li rrapportaw każijiet ta' AML u MDS fi tfal bilmarda ta' Hodgkin kif ukoll każijiet ta' AML irrapportati f'pazjenti bil-kanċer tas-sider li kienu qegħdin jirċievu dexrazoxane.
English: • When deciding whether to use dexrazoxane prescribers should consider the short- and long-term risks associated with this product (e.g. myelosuppression and the potential for AML), alongside possible benefits in relation to protection of the heart.
Maltese: • Meta jkunu qegħdin jiddeċiedu jekk jużawx dexrazoxane dawk li qegħdin jippreskrivu għandhom jikkunsidraw ir-riskji fuq medda twila u qasira ta' żmien assoċjati ma' dan il-prodott (eż. majelosoppressjoni u l-potenzjal għal AML), flimkien mal-benefiċċji possibbli fir-rigward talprotezzjoni tal-qalb.
English: Studies showed a three-fold increase in the risk of new cancers such as AML and MDS.
Maltese: Listudji wrew żieda ta' tliet darbiet fir-riskju ta' kanċers ġodda bħall-AML u l-MDS.
English: The Committee noted that there was evidence of serious harm in children receiving dexrazoxane.
Maltese: Il-Kumitat innota li kien hemm evidenza ta' ħsara serja fit-tfal li kienu qegħdin jirċievu dexrazoxane.
English: The way in which dexrazoxane protects the heart is not entirely clear, but may be linked to the way the medicine attaches to charged iron particles that are involved in the processes that make anthracyclines toxic to the heart muscle.
Maltese: Il-Kumitat irreveda wkoll id-dejta kollha disponibbli dwar is-sigurtà u l-effikaċja ta' dexrazoxane, inklużi studji ppubblikati u dejta sottomessa mill-kumpaniji li jqiegħdu l-mediċini fis-suq.
English: The CHMP concluded that the benefits of dexrazoxanecontaining medicines do not outweigh its risk in children and adolescents, and the medicine should not be used in these age-groups.
Maltese: Is-CHMP ikkonkluda li l-benefiċċji tal-prodotti mediċinali li fihom dexrazoxane ma jegħlbux ir-riskji tiegħu fit-tfal u l-adoloxxenti, u l-mediċina ma għandhiex tintuża f'dawn il-gruppi ta' età.
English: Posology - Adults
Maltese: Pożoloġija - Adulti
English: • agitation, irritability, confusion, depression
Maltese: • aġitazzjoni, irrikwitezza, konfużjoni, depressjoni
English: Eisai Manufacturing Ltd, European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom.
Maltese: Eisai Manufacturing Ltd, European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, Ir-Renju Unit.
English: - 25 mg: 14, 28, 56 and 84 capsules - 50 mg: 14, 28, 56 and 84 capsules - 100 mg: 28, 56, 84, 98 and 196 capsules.
Maltese: - 25 mg: 14, 28, 56 u 84 kapsula - 50 mg: 14, 28, 56 u 84 kapsula - 100 mg: 28, 56, 84, 98 u 196 kapsula.
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: Paediatric population).
Maltese: Popolazzjoni pedjatrika).
English: Week 3 to 5
Maltese: Ġimgħa 3 sa 5
English: Hatfield, Hertfordshire, AL10 9SN United Kingdom
Maltese: Hatfield, Hertfordshire, AL10
English: • The capsule shell contains: gelatin, titanium dioxide (E171), shellac, propylene glycol, potassium hydroxide, black iron oxide (E172).
Maltese: • Il-qoxra tal-kapsula fiha: gelatin, titanium dioxide (E171), shellac, propylene glycol, potassium hydroxide, black iron oxide (E172).
English: PVC/PVDC/aluminium blisters, packs of 14, 28, 56 and 84 hard capsules.
Maltese: Folji tal-PVC/PVDC/aluminju, pakketti ta' 14, 28, 56 u 84 kapsula iebsa.
English: PVC/PVDC/aluminium blisters, packs of 28, 56, 84, 98 and 196 hard capsules.
Maltese: Folji tal-PVC/PVDC/aluminju, pakketti ta' 28, 56, 84, 98 u 196 kapsula iebsa.
English: Week 1 Weeks 2 to 8 Patients of weight 20 to 55 kg
Maltese: Ġimgħa 1 Ġimgħat 2 sa 8 Pazjenti li jiżnu 20 sa 55 kg
English: Agitation Irritability Confusional state
Maltese: Aġitazzjoni Irritabilità Stat ta' konfużjoni Depressjoni
English: Week 1 + 2 Week 3 + 4 Week 5 + 6
Maltese: Ġimgħa 1 + 2 Ġimgħa 3 + 4 Ġimgħa 5 + 6
English: • low blood potassium levels, convulsions/seizures.
Maltese: • livelli baxxi ta' potassium fid-demm, konvulżjonijiet/puplesiji.
English: Effect of Zonegran on cytochrome P450 enzymes
Maltese: L-effett ta' Zonegran fuq l-enzimi ta' cytochrome P450
English: Hydrogenated vegetable oil (from soyabean)
Maltese: Hydrogenated vegetable oil (mis-soyabean)
English: 14 hard capsules 28 hard capsules 56 hard capsules 84 hard capsules
Maltese: 14-il kapsula iebsa 28 kapsula iebsa 56 kapsula iebsa 84 kapsula iebsa
English: 28 hard capsules 56 hard capsules 84 hard capsules 98 hard capsules 196 hard capsules
Maltese: 28 kapsula iebsa 56 kapsula iebsa 84 kapsula iebsa 98 kapsula iebsa 196 kapsula iebsa
English: Leukopenia Thrombocytopenia
Maltese: Lewkopenija Tromboċitopenija
English: Capsule shells Gelatin
Maltese: Il-qoxra tal-kapsula Gelatin
English: • lung infection / inflammation, urinary tract infections.
Maltese: • infezzjoni/infjammazzjoni tal-pulmun, infezzjonijiet tal-apparat urinarju.
English: Diplopia
Maltese: Diplopija
English: 60528 Frankfurt am Main Germany
Maltese: 60528 Frankfurt am Main Il-Ġermanja
English: 6 to 8 mg/kg/day (once a day)
Maltese: 6 sa 8 mg/kg/jum (darba kuljum)
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 twofold or greater than clinically relevant unbound serum concentrations.
Maltese: Studji in vitro bl-użu ta' mikrożomi 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: Zonegran 25 mg, 50 mg, and 100 mg hard capsules zonisamide
Maltese: Zonegran 25 mg, 50 mg, u 100 mg kapsuli ibsin zonisamide
English: Zonegran is indicated as:
Maltese: Zonegran huwa indikat bħala:
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 tal-età ta' 6 snin jew aktar.
English: Excipients: 0.002 mg of sunset yellow FCF (E110) and 0.147 mg of allura red AC (E129).
Maltese: Eċċipjenti: 0.002 mg ta' sunset yellow FCF (E110) u 0.147 mg ta' allura red AC (E129).
English: • anger, aggression, thoughts of suicide, suicide attempt.
Maltese: • rabja, aggressjoni, ħsibijiet ta' suwiċidju, attentat ta' suwiċidju.
English: • The recommended daily dose is between 300 mg and 500 mg.
Maltese: • Id-doża rakkomandata ta' kuljum hi bejn 300 mg u 500 mg.