FrancophonIA/ELRC3.0 huggingface dataset:
English: For the full list of all side effects reported with Rezolsta, see the package leaflet.
Maltese: Għal-lista sħiħa taleffetti sekondarji kollha rrappurtati bi Rezolsta, ara l-fuljett ta' tagħrif.
English: Rezolsta, taken in combination with other HIV medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Maltese: Rezolsta, li jittieħed f'kombinazzjoni ma' mediċini oħrajn tal-HIV, inaqqas l-ammont ta' HIV fid-demm u jżommu f'livell baxx.
English: A risk management plan has been developed to ensure that Rezolsta is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Rezolsta jintuża bl-aktar mod sigur possibbli.
English: MA (EU) Number (Invented) Name
Maltese: Numru tal MA Isem ( Ivvintat)
English: Further information on Zebinix can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It is available as tablets (200 mg, 400 mg, 600 mg and 800 mg) and as a suspension to be taken by mouth.
Maltese: Jiġi bħala kapsuli (200 mg, 400 mg, 600 mg u 800 mg) u bħala sospensjoni li tittieħed mill-ħalq.
English: Zebinix was effective, although slightly less than carbamazepine, at reducing seizures after 6 months of treatment: 71% of patients who took Zebinix and did not prematurely withdraw from the study (276 out of 388 patients) were seizure-free after 6 months compared with 76% of patients taking carbamazepine (300 out of 397 patients).
Maltese: Zebinix kien effettiv, għalkemm ftit inqas minn carbamazepine, għat-tnaqqis tal-a ċċessjonijiet wara 6 xhur ta kura: 71% tal-pazjenti li ħadu Zebinix (276 minn 388 pazjent) u ma rtirawx mill-istudju qabel iż-żmien ma kellhom l-ebda aċċessjoni wara 6 xhur meta mqabbla ma' 76% tal-pazjenti li ħadu carbamazepine (300 minn 397 pazjent).
English: Other information about Zebinix
Maltese: Informazzjoni oħra dwar Zebinix
English: Zebinix must not be used in people who are hypersensitive (allergic) to eslicarbazepine acetate, any of the other ingredients or other carboxamide derivatives (medicines with a similar structure to eslicarbazepine acetate, such as carbamazepine or oxcarbazepine).
Maltese: Zebinix ma għandux jintuża f' nies li jkunu ipersensittivi (allerġiċi) għall-aċetat tal-eslikarbażipina, kwalunkwe sustanza oħra jew derivattivi oħra tal-karbossamid (mediċini bi struttura simili għall-aċetat tal-eslikarbazipina, bħal carbamazepine jew oxcarbazepine).
English: This summary was last updated in 06-2018.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f' 04-2017.
English: This compared with 25% of patients (10 out of 40) on placebo.
Maltese: Dan tqabbel ma' 25% tal-pazjenti (10 minn 40) li ngħataw plaċebo.
English: Over the 12 weeks of treatment, this fell to 9.8 and 9.0 seizures per month in patients taking Zebinix 800 mg and Zebinix 1,200 mg respectively, compared with 11.7 per month in those taking placebo.
Maltese: Fuq il-perjodu ta' 12-il ġimgħa ta kura, dan niżel għal 9.8 u 9.0 aċċessjonijet fix-xahar f' pazjenti li kienu qed jieħdu Zebinix 800 mg u Zebinix 1,200 mg rispettivament, meta mqabbla ma' 11.7 fix-xahar għal dawk li kienu qed jieħdu plaċebo.
English: For adults who take Zebinix on its own, a dose up to 1,600 mg may be used.
Maltese: Għall-adulti li jieħdu Zebinix waħdu, tista' tintuża doża sa 1,600 mg.
English: Why is Zebinix authorised?
Maltese: Għaliex ġie approvat Zebinix?
English: In one study involving 123 children aged 6 to 16 years, Zebinix over 12 weeks halved the number of seizures in 51% of patients (42 out of 83).
Maltese: Fi studju wieħed li kien jinvolvi 123 tifel u tifla ta' bejn is-6 snin u s-16-il sena, Zebinix fuq 12-il ġimgħa naqqas in-numru ta' aċċessjonijiet bin-nofs f' 51% tal-pazjenti (42 minn 83).
English: Another study compared Zebinix taken on its own with another epilepsy medicine, carbamazepine, in 815 newly diagnosed adults.
Maltese: Studju ieħor qabbel Zebinix meħud waħdu ma' mediċina oħra kontra l-epilessija, carbamazepine, fi 815-il adult li kienu għadhom kemm ġew dijanjostikati.
English: The active substance in Zebinix, eslicarbazepine acetate, is converted into eslicarbazepine in the body.
Maltese: Is-sustanza attiva f' Zebinix, l-aċetat tal-eslikarbażepina, ti ġi konvertita f eslikarbażepina fil-ġisem.
English: Zebinix should not be used in patients with severe kidney problems and the dose should be adjusted in moderately impaired kidney function.
Maltese: għandux jintuża f pazjenti bi problemi severi tal-kliewi u d-doża għandha tiġi aġġustata dawk b indeboliment moderat tal-funzjoni tal-kliewi.
English: What are the risks associated with Zebinix?
Maltese: X' inhuma r-riskji asso ċjati ma Zebinix?
English: Zebinix received a marketing authorisation valid throughout the EU on 21 April 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Zebinix fil-21 ta' April 2009.
English: Zebinix (eslicarbazepine acetate)
Maltese: jinkiseb biss b riċetta ta tabib.
English: In children weighing less than 60 kg, the starting dose is 10 mg per kg body weight once a day.
Maltese: Fi tfal li jiżnu inqas minn 60 kg, id-doża tal-bidu hija 10 mg għal kull kg ta' piż tal-ġisem darba kuljum.
English: Zebinix can be taken on its own, in newly diagnosed epilepsy, or can be added to existing antiepileptic medicines.
Maltese: aċċessjonijiet, meta użati bħala żieda ma mediċini oħra kontra l-epilessija.
English: Zebinix is an epilepsy medicine used to treat adults with partial-onset seizures (epileptic fits) with or without secondary generalisation.
Maltese: Zebinix huwa mediċina kontra l-epilessija użata fil-kura ta' adulti li jbatu minn aċċessjonijiet parzjali tal-bidu (attakki epiletti ċi) b ġeneralizzazzjoni sekondarja jew mingħajrha.
English: This is a type of epilepsy where too much electrical activity in one side of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted hearing, sense of smell or vision, numbness or a sudden sense of fear.
Maltese: Din hija tip ta epilessija fejn ħafna attività elettrika f' naħa waħda tal-moħħ tikkawża sintomi bħalma huma movimenti għallgħarrieda, mimlija skossi ta' parti waħda tal-ġisem, sens ta' smigħ, xamm jew viżta mhux ċari, tirżiħ jew sens ta'
English: Eslicarbazepine is thought to work by blocking ‘voltage-gated sodium channels', which stops sodium entering the nerve cells.
Maltese: Leslikarbazepina hija maħsuba li taħdem billi timblokka l-‘kanali tas-sodju mimlija vultaġġ', li jwaqqaf is-sodju milli jidħol fiċ-ċelloli tan-nervituri.
English: A second study in children aged 2 to 18 years did not find a difference between Zebinix and placebo, this was explained by the fact that lower doses were used.
Maltese: It-tieni studju fit-tfal ta' bejn is-sentejn sa 18-il sena ma sabx differenza bejn Zebinix u plaċebo, dan kien spjegat mill-fatt li ntużaw dożi iktar baxxi.
English: Three main studies compared Zebinix with placebo (a dummy treatment) in 1,050 adults with partialonset seizures that were not controlled by other medicines.
Maltese: Zebinix ma dawk ta plaċebo (kura finta) f 1,050 adult li kienu jbatu minn aċċessjonijiet parzjali tal-bidu li ma kinux ikkontrollati b' mediċini oħra.