FrancophonIA/ELRC3.0 huggingface dataset:
English: Excipient(s) with known effect Each gastro-resistant tablet contains 28 mg sucrose.
Maltese: Eċċipjent(i) b'effett magħruf Kull pillola gastro-reżistenti fiha 28 mg ta' sukrosju.
English: A moderate amount of data on pregnant women (between 300-1,000 pregnancy outcomes) indicate no malformative or feto/ neonatal toxicity of esomeprazole.
Maltese: Ammont moderat ta' tagħrif fuq nisa tqal (bejn 300-1,000 riżultat ta' tqala) ma jindika l-ebda malformazzjoni jew tossiċità fil-fetu/neonatali ta' esomeprazole.
English: - If you are allergic to medicines containing other proton pump inhibitors (e.g. pantoprazole,
Maltese: - Jekk inti allerġiku għal mediċini li fihom inibituri oħra tal-pompa tal-proton (eż. pantoprazole,
English: The use of esomeprazole with clopidogrel should be discouraged (see section 4.5).
Maltese: L-għoti flimkien ta' esomeprazole ma' atazanavir mhuwiex rakkomandat (ara sezzjoni 4.5).
English: Concomitant administration of esomeprazole has been reported to increase the serum levels of tacrolimus.
Maltese: L-għoti konkomitanti ta' esomeprazole ġie rrapportat li jżid il-livelli ta' tacrolimus fis-serum.
English: • Rash, possibly with pain in the joints.
Maltese: • Raxx, possibbilment b'uġigħ fil-ġogi
English: Time to sustained resolution of heartburn, defined as when 7 consecutive days of no heartburn was first recorded, was significantly shorter in the esomeprazole 20 mg group (39.7% - 48.7% by day 14 vs placebo 11.0% - 20.2%).
Maltese: Il-ħin għal solliev sostnut ta' ħruq ta' stonku, definit bħala meta perjodu ta' 7 t'ijiem konsekuttivi ta' ħruq ta' stonku ġie rreġistrat għall-ewwel darba, kien ferm iqsar fil-grupp ta' esomeprazole 20 mg (39.7%48.7% sa jum 14 vs plaċebo 11.0% - 20.2%).
English: Time to sustained resolution of heartburn, defined as when 7 consecutive days of no heartburn was first recorded, was significantly shorter in the esomeprazole 20 mg group (39.7% - 48.7% by day 14 vs. placebo 11.0% - 20.2%).
Maltese: Il-ħin għal solliev sostnut ta' ħruq ta' stonku, definit bħala meta perjodu ta' 7 t'ijiem konsekuttivi ta' ħruq ta' stonku ġie rreġistrat għall-ewwel darba, kien ferm iqsar fil-grupp ta' esomeprazole 20 mg (39.7%48.7% sa jum 14 vs. plaċebo 11.0% - 20.2%).
English: Esomeprazole has been shown to have no clinically relevant effects on the pharmacokinetics of amoxicillin and quinidine.
Maltese: Esomeprazole intwera li ma għandu l-ebda effett klinikament rilevanti fuq il-farmakokinetika ta' amoxicillin u quinidine.
English: Concomitant administration of esomeprazole and a combined inhibitor of CYP2C19 and CYP 3A4 may result in more than doubling of the esomeprazole exposure.
Maltese: L-għoti konkomitanti ta' esomeprazole u inibitur kombinat ta' CYP2C19 u CYP 3A4 jista' jwassal għal aktar minn irduppjar tal-espożizzjoni għal esomeprazole.
English: Omeprazole as well as esomeprazole act as inhibitors of CYP2C19.
Maltese: Omeprazole kif ukoll esomeprazole jaġixxu bħala inibituri ta' CYP2C19.
English: Treatment with PPIs may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and in hospitalised patients, also possibly Clostridium difficile.
Maltese: Il-kura bil-PPIs tista' twassal għal żieda żgħira fir-riskju ta' infezzjonijiet gastro-intestinali bħal Salmonella u Campylobacter u fil-pazjenti li jkollhom jiddaħħlu l-isptar, possibbilment ukoll Clostridium difficile.
English: Treatment with omeprazole 20 mg once a day had no effect on the exposure of darunavir (with concomitant ritonavir) and amprenavir (with concomitant ritonavir).
Maltese: Kura b'omeprazole 20 mg darba kuljum ma kellha l-ebda effett fuq l-espożizzjoni ta' darunavir (b'ritonavir konkomitanti) u amprenavir (b'ritonavir konkomitanti).
English: No gender difference is seen after repeated once-daily administration.
Maltese: Ma tidhirx differenza bejn is-sessi wara għoti ripetut darba kuljum.
English: If the combination of atazanavir with a PPI is judged unavoidable, close clinical monitoring is recommended in combination with an increase in the dose of atazanavir to 400 mg with 100 mg of ritonavir.
Maltese: Jekk jiġi ġġudikat li l-kombinazzjoni ta' atazanavir ma' PPI ma tistax tiġi evitata, huwa rrakkomandat li jkun hemm monitoraġġ kliniku mill-qrib f'kombinazzjoni ma' żieda fid-doża ta' atazanavir għal 400 mg b'100 mg ta' ritonavir.
English: • Skin rash, lumpy rash (hives) and itchy skin.
Maltese: • Raxx fil-ġilda, raxx imqabbeż (ħorriqija) u ġilda tieklok.
English: When starting or ending treatment with esomeprazole, the potential for interactions with medicinal products metabolised through CYP2C19 should be considered.
Maltese: Meta tinbeda jew tintemm kura b'esomeprazole, għandu jiġi kkunsidrat il-potenzjal għal interazzjonijiet ma' prodotti mediċinali metabolizzati permezz ta' CYP2C19.
English: Nexium Control 20 mg gastro-resistant capsules esomeprazole
Maltese: Nexium Control 20 mg kapsuli gastro-reżistenti esomeprazole
English: Concomitant administration of esomeprazole and a combined inhibitor of CYP2C19 and CYP3A4 may result in more than doubling of the esomeprazole exposure.
Maltese: L-għoti konkomitanti ta' esomeprazole u inibitur kombinat ta' CYP2C19 u CYP3A4 jista' jwassal għal aktar minn irduppjar tal-espożizzjoni għal esomeprazole.
English: • Muscle weakness
Maltese: • Tpejjipx aktar
English: • You have severe or persistent diarrhoea; esomeprazole has been associated with a small increased risk of infectious diarrhoea.
Maltese: • Ikollok dijarea severa jew persistenti: esomeprazole kien assoċjat ma' żieda żgħira fir-riskju ta' dijarea infettiva.
English: Renal and urinary disorders
Maltese: Disturbi filkliewi u fissistema urinarja nefrite interstizjali
English: After oral dosing with esomeprazole 20 mg and 40 mg the onset of effect occurs within one hour.
Maltese: Wara dożaġġ orali b'esomeprazole 20 mg u 40 mg, l-effett jibda fi żmien siegħa.
English: • You have severe kidney problems.
Maltese: • Għandek problemi severi fil-kliewi.
English: Combination with other medicinal products
Maltese: Kombinazzjoni ma' prodotti mediċinali oħra
English: An increased number of ECL cells possibly related to the increased serum gastrin levels, have been observed in some patients during long-term treatment with esomeprazole.
Maltese: Żieda fin-numru ta' ċelloli ECL possibbilment relatata maż-żieda fil-livelli ta' gastrina fis-serum, kienet osservata f'xi pazjenti waqt kura fit-tul b'esomeprazole.
English: • You should seek urgent medical advice if you experience chest pain with light-headedness, sweating, dizziness or shoulder pain with shortness of breath.
Maltese: • Biex tkun ċert li xrobt il-mediċina kollha, laħlaħ sewwa t-tazza b'nofs tazza ilma u ixrobha.
English: SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.
Maltese: SCLE wara kura preċedenti b'inibitur tal-pompa talprotoni jista' jżid ir-riskju ta' SCLE b'inibituri tal-protoni oħrajn.
English: Metabolism and nutrition disorders peripheral oedema hyponatraemia hypomagnesaemia; severe hypomagnesaemia can correlate with hypocalcaemia; hypomagnesaemia may also result in hypokalaemia
Maltese: Disturbi filmetaboliżmu u nnutrizzjoni edema periferali iponatrimja ipomagnesimj a; ipomagnesimj a severa tista' tkun korrelata ma' ipokalċimja; ipomanjesimij a tista' twassal ukoll għal ipokalemija
English: May take 2-3 days for full effect.
Maltese: Jista' jkollok bżonn tieħu l-kapsuli għal 2-3 ijiem wara xulxin qabel ma tħossok aħjar.
English: Capsule approximately 11 x 5 mm, with a clear body, and an amethyst cap imprinted with “NEXIUM 20 MG” in white.
Maltese: Kapsula ta' madwar 11 x 5 mm b'korp ċar, u b'għatu ta' kulur amethyst b'kitba' “NEXIUM 20
English: Esomeprazole must not be used concomitantly with nelfinavir (see section 4.5).
Maltese: Esomeprazole ma għandux jintuża b'mod konkomitanti ma' nelfinavir (ara sezzjoni 4.5).
English: Gastro-resistant hard capsule.
Maltese: Qoxra tal-kapsula Ġelatina
English: Esomeprazole is the S-isomer of omeprazole and reduces gastric acid secretion through a specific targeted mechanism of action.
Maltese: Il-metaboliti prinċipali ta' esomeprazole ma għandhom lebda effett fuq is-sekrezzjoni tal-aċidu gastriku.
English: Effects of esomeprazole on the pharmacokinetics of other medicinal products As esomeprazole is one enantiomer of omeprazole it is reasonable to advise about interactions reported with omeprazole.
Maltese: Effetti ta' esomeprazole fuq il-farmakokinetika ta' prodotti mediċinali oħra Peress li esomeprazole huwa enantiomer wieħed ta' omeprazole huwa raġonevoli li jingħata parir dwar interazzjonijiet rapportati b'omeprazole.
English: 14 gastro-resistant hard capsules
Maltese: 14-il kapsula iebsa gastro-reżistenti
English: Each gastro-resistant capsule contains 20 mg esomeprazole (as magnesium trihydrate).
Maltese: Kull kapsula gastro-reżistenti fiha 20 mg esomeprazole (bħala magnesium trihydrate).
English: Pfizer Ελλάς Α.Ε.
Maltese: Il-pilloli ma għandhomx jintmagħdu jew jitfarrku.
English: Poor metabolisers
Maltese: Metabolizzaturi ħżiena
English: The median time to first resolution of night-time heartburn was 1 day, statistically significant compared to placebo in one study (p=0.048) and approaching significance in the other (p=0.069).
Maltese: Iż-żmien medjan sal-ewwel fejqan tal-ħruq ta' stonku bil-lejl kien ġurnata, statistikament sinifikanti meta mqabbel ma' plaċebo fi studju wieħed (p=0.048) u jqarreb is-sinifikanza fl-ieħor (p=0.069).
English: • Diazepam (used to treat anxiety, relax muscles or in epilepsy).
Maltese: • Diazepam (użat għall-kura tal-ansjetà, għar-rilassament tal-muskoli jew f'epilessija).
English: Reddish-brown iron oxide (E172)
Maltese: Iron oxide aħmar fil-kannella (E 172) Iron oxide isfar (E 172)
English: +K+-ATPase
Maltese: MG” bl-abjad.
English: Single doses of 80 mg esomeprazole were uneventful.
Maltese: Dożi uniċi ta' 80 mg ta' esomeprazole kienu mingħajr inċidenza.
English: The apparent volume of distribution at steady state in healthy subjects is approximately 0.22 l/kg body weight.
Maltese: Il-volum apparenti fiss tad-distribuzzjoni f'individwi b'saħħithom huwa madwar 0.22 l/kg tal-piż tal-ġisem.
English: Each gastro-resistant tablet contains 20 mg esomeprazole (as magnesium trihydrate).
Maltese: Kull pillola gastro-reżistenti fiha 20 mg esomeprazole (bħala magnesium trihydrate).
English: Medicinal products known to induce CYP2C19 or CYP3A4 or both (such as rifampicin and St. John's wort (Hypericum perforatum)) may lead to decreased esomeprazole serum levels by increasing the esomeprazole metabolism.
Maltese: Prodotti mediċinali magħrufa li jinduċu CYP2C19 jew CYP3A4 jew it-tnejn (bħal rifampicin u St.
English: • Hair loss (alopecia).
Maltese: • Twaqqigħ tax-xagħar (alopeċja).
English: The following adverse reactions have been identified or suspected in the clinical studies programme for esomeprazole and post-marketing.
Maltese: Ir-reazzjonijiet avversi li ġejjin ġew identifikati jew suspettati fil-programm ta' studji kliniċi għal esomeprazole u wara t-tqegħid fis-suq.
English: • Diazepam (used to treat anxiety, relax muscles or in epilepsy)
Maltese: • Diazepam (użat għall-kura tal-ansjetà, għar-rilassament tal-muskoli jew f'epilessija)
English: Blood and lymphatic system disorders leukopenia, thrombocytopenia agranulocytosis, pancytopenia
Maltese: • Għadd baxx ta' ċelloli tad-demm ħomor, ċelloli tad-demm bojod, u plejtlits (kundizzjoni msejħa panċitopenija)
English: Each gastro-resistant tablet contains 20 mg esomeprazole (as magnesium trihydrate)
Maltese: Kull pillola gastro-reżistenti fih 20 mg esomeprazole (bħala magnesium trihydrate).
English: For atazanavir and nelfinavir, decreased serum levels have been reported when given together with omeprazole and concomitant administration is not recommended.
Maltese: Għal atazanavir u nelfinavir, ġie rrapportat tnaqqis fil-livelli fis-serum meta jingħataw flimkien ma' omeprazole u l-għoti konkomitanti mhuwiex rakkomandat.
English: • They have been on continuous symptomatic treatment of indigestion or heartburn for 4 or more weeks.
Maltese: • Ilhom fuq kura sintomatika kontinwa għal indiġestjoni jew ħruq ta' stonku għal aktar minn 4 ġimgħat.
English: Do not store above 30°C Store in the original package in order to protect from moisture.
Maltese: Taħżinx f'temperatura 'l fuq minn 30°C Aħżen fil-pakkett oriġinali sabiex tilqa' mill-umdità.
English: Posology The recommended dose is 20 mg esomeprazole (one capsule) per day.
Maltese: Id-doża rakkomandata hija ta' 20 mg ta' esomeprazole (kapsula waħda) kuljum.
English: • You have problems or pain when swallowing.
Maltese: • Ikollok problemi jew uġigħ meta tibla'.
English: Other secondary endpoints were supportive of the primary endpoint, including relief of heartburn at week 1 and week 2, percentage of 24 hour days without heartburn at week 1 and week 2, mean heartburn severity at week 1 and week 2, and time to initial and sustained resolution of heartburn over a 24 hour period and during the night compared to placebo.
Maltese: Punti ta' tmiem sekondarji oħrajn appoġġaw il-punt ta' tmiem primarju, inkluż serħan mill-ħruq ta' stonku f'ġimgħa 1 u f'ġimgħa 2, perċentwal ta' jiem ta' 24 siegħa mingħajr ħruq ta' stonku f'ġimgħa 1 u ġimgħa 2, severità medja ta' ħruq ta' stonku f'ġimgħa 1 u f'ġimgħa 2, u ħin għal solliev inizjali jew sostnut ta' ħruq ta' stonku fuq perjodu ta' 24 siegħa u matul il-lejl meta mqabbel ma' plaċebo.
English: (Gasto-resistant capsule).
Maltese: Kapsula iebsa gastro-reżistenti (Kapsula iebsa gastro-reżistenti).
English: The full EPAR for MiPet Easecto can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: MiPet Easecto was as effective as moxidectin/imidacloprid and the percentage of MiPet Easecto-treated dogs with no live mites was 15%, 69%, 93%, 94%, 100% and 100% on days 30, 60, 90, 120, 150 and 180, respectively.
Maltese: MiPet Easecto kien effettiv daqs moxidectin/imidacloprid u l-perċentwal ta' klieb ikkurati b'MiPet Easecto mingħajr dud ħaj kien 15 %, 69 %, 93 %, 94 %, 100 % u 100 % f'jiem 30, 60, 90, 120, 150 u 180, rispettivament.
English: It contains the active substance sarolaner.
Maltese: Dan fih is-sustanza attiva sarolaner.
English: MiPet Easecto was as effective as moxidectin/imidacloprid.
Maltese: MiPet Easecto kien effettiv daqs moxidectin/imidacloprid.
English: MiPet Easecto is available as chewable tablets (5, 10, 20, 40, 80 and 120 mg) and can only be obtained with a prescription.
Maltese: MiPet Easecto jiġi bħala pilloli li jintmagħdu (5, 10, 20, 40, 80 u 120 mg) u jista' jinkiseb biss b'riċetta ta' tabib.
English: In a study involving dogs with ear mite infestation, 283 dogs were treated with MiPet Easecto and 131 dogs received moxidectin/imidacloprid (a spot-on mite treatment).
Maltese: Fi studju li involva klieb b'infestazzjonijiet ta' dud tal-widna, 283 kelb ġew ikkurati b'Simaprica u 131 kelb irċevew moxidectin/imidacloprid (kura tad-dud li tiġi applikata dak il-ħin fuq il-post).
English: The European Commission granted a marketing authorisation valid throughout the EU for MiPet Easecto on 31 January 2018.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal MiPet Easecto fil-31/01/2018.
English: For MiPet Easecto the percentage of dogs with no live ear mites present was 91% at day 30 increasing to 99% on day 60, following two treatments.
Maltese: Għal MiPet Easecto, il-perċentwal ta' klieb li ma kellhomx dud ħaj preżenti f'widnejhom kien ta' 91 % f'jum 30 u żdied għal 99 % f'jum 60, wara żewġ kuri.
English: This is a summary of the European public assessment report (EPAR) for MiPet Easecto.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal MiPet Easecto.
English: The active substance in MiPet Easecto, sarolaner acts as an ‘ectoparasiticide'.
Maltese: Is-sustanza attiva f'MiPet Easecto, sarolaner taġixxi bħala ‘ektoparassitiċida'.
English: Why is MiPet Easecto approved?
Maltese: Għaliex ġiet approvat MiPet Easecto?
English: It blocks the normal movement of charged chloride particles (ions) in and out of nerve cells, especially those associated with gamma-aminobutyric acid (GABA) and glutamate, two substances that convey messages between nerves (neurotransmitters).
Maltese: Dan jimblokka l-moviment normali tal-partikoli ċċarġjati tal-klorur (joni) ġewwa u barra ċ-ċelloli tan-nervituri, speċjalment dawk assoċjati ma' aċidu gamma-aminobutirriku (GABA) u glutamat, żewġ sustanzi li jgħaddu l-messaġġi bejn in-nervituri (newrotrażmettituri).
English: Other information about MiPet Easecto
Maltese: Informazzjoni oħra dwar MiPet Easecto
English: What are the risks associated with MiPet Easecto?
Maltese: X'inhuma r-riskji assoċjati ma' MiPet Easecto?
English: MiPet Easecto is a veterinary medicine used to treat infestations with ticks and fleas, demodectic and sarcoptic mange (skin infestations caused by two different types of mites) and ear mite infestations in dogs.
Maltese: MiPet Easecto huwa mediċina veterinarja li jintuża biex jikkura infestazzjonijiet ta' qurdien u briegħed, ġarab demodektiku u sarkoptiku (infestazzjonijiet tal-ġilda kkawżati minn żewġ tipi differenti ta' dud) u infestazzjonijiet ta' dud tal-widna fil-klieb.
English: MiPet Easecto can be used as part of the management of flea allergy dermatitis (an allergic reaction to flea bites).
Maltese: MiPet Easecto jista' jintuża bħala parti mill-ġestjoni ta' dermatite allerġika mill-briegħed (reazzjoni allerġika għall-gdim tal-briegħed).
English: However, the following side effects are seen in less than 1 dog in 10,000: mild and short-lived vomiting and diarrhoea as well as tremor (shaking), ataxia (inability to coordinate body movements) or convulsions.
Maltese: Madankollu, l-effetti sekondarji li ġejjin jidhru f'inqas minn kelb 1 minn kull 10,000: rimettar u dijarea ħfief u li ma jdumux kif ukoll rogħda (tertir), atassija (nuqqas ta' ħila fil-koordinazzjoni tal-movimenti tal-ġisem) jew konvulżjonijiet.
English: This authorisation was based on the authorisation granted to Simparica in 2015 (‘informed consent').
Maltese: Din l-awtorizzazzjoni kienet ibbażata fuq l-awtorizzazzjoni mogħtija għal Simparica fl-2015 (‘kunsens infurmat').
English: 189 dogs were treated with MiPet Easecto for three months whilst 96 dogs were given another medicine, spinosad.
Maltese: 189 kelb ġew ikkurati b'MiPet Easecto għal tliet xhur filwaqt li 96 kelb ingħataw mediċina oħra, spinosad. MiPet Easecto kien effettiv daqs spinosad fit-tnaqqis tal-għadd ta' briegħed sa mhux aktar minn 90 jum wara l-kura.
English: The company that makes Simparica has agreed that its scientific data can be used for MiPet Easecto (‘informed consent').
Maltese: Il-kumpanija li tipproduċi Simparica qablet li d-data xjentifika tagħha tista' tintuża għal MiPet Easecto (‘kunsens infurmat').
English: In a study with 98 dogs with demodectic mange, 63 dogs were treated with MiPet Easecto monthly for up to six months and 35 dogs received moxidectin/imidacloprid.
Maltese: Fi studju fuq 98 kelb b'ġarab demodektiku, 63 kelb ġew ikkurati b'MiPet Easecto kull xahar sa massimu ta' sitt xhur u 35 kelb irċevew moxidectin/imidacloprid.
English: For treatment of tick and flea infestations MiPet Easecto should be given once every month throughout the flea and/or tick season for optimal control.
Maltese: Għall-kura ta' infestazzjonijiet tal-qurdien u l-briegħed, MiPet Easecto għandu jingħata darba fix-xahar matul l-istaġun tal-briegħed u/jew tal-qurdien għal kontroll ottimali.
English: 53 dogs were treated with MiPet Easecto for two months whilst 26 dogs were given a medicine containing moxidectin and imidacloprid.
Maltese: Studju ieħor involva klieb infestati bil-ġarab sarkoptiku. 53 kelb ġew ikkurati b'MiPet Easecto għal xahrejn filwaqt li 26 kelb ġew ikkurati b'mediċina li fiha moxidectin u imidacloprid.
English: Side effects with MiPet Easecto are not common.
Maltese: L-effetti sekondarji b'MiPet Easecto mhumiex komuni.
English: How is MiPet Easecto used?
Maltese: Kif jaħdem MiPet Easecto?
English: After MiPet Easecto is given its activity against ticks and fleas lasts for at least 5 weeks.
Maltese: Wara li jingħata MiPet Easecto, l-attività tiegħu kontra l-qurdien u briegħed iddum tal-inqas 5 ġimgħat.
English: MiPet Easecto was as effective as moxidectin and imidacloprid in eliminating live mites in skin scrapings.
Maltese: MiPet Easecto kien effettiv daqs moxidectin u imidacloprid fl-eliminazzjoni ta' dud ħaj fil-biċċiet tal-ġilda.
English: 122 dogs were treated with MiPet Easecto for three months whilst 59 dogs were treated with another medicine, fipronil, against ticks.
Maltese: Sar studju fuq il-post fi klieb infettati b'tal-inqas tliet briegħed ħajjin imwaħħlin. 122 kelb ġew ikkurati b'MiPet Easecto għal tliet xhur filwaqt li 59 kelb ġew ikkurati b'mediċina oħra, fipronil, kontra l-qurdien. MiPet Easecto kien effettiv daqs fipronil fit-tnaqqis tal-għadd ta' qurdien sa mhux aktar minn 90 jum wara l-kura.
English: Dogs with live mites on day 30 after initial treatment received a second treatment.
Maltese: Il-klieb b'dud ħaj f'jum 30 wara l-kura inizjali rċevew it-tieni kura.
English: Polska Ranbaxy (Poland) Sp. Z o. o.
Maltese: Ranbaxy (Poland) Sp. Z o. o.
English: Date of latest renewal: 14 November 2016
Maltese: Data tal-aħħar tiġdid: 14 Novembru 2016
English: NL-2132 JH Hoofddorp The Netherlands
Maltese: NL-2132 JH Hoofddorp L-Olanda
English: Adults and adolescents
Maltese: Adulti u addoloxxenti
English: Nederland/Pays-Bas/Niederlande/Нидерландия/Nizozemsko/ Nederlandene/Holland/Ολλανδία/Nizozemska/The Netherlands/Holland/ Ολλανδία/Nīderlande/Nyderlandai/Pays-Bas/Niederlande/Hollandia/ L-Olanda/Nederland/Nederland/Niederlande/Países Baixos/ Nizozemska/Holandsko/Alankomaat/Nederländerna/Nederländerna Tel./тел./tlf./τηλ./Sími/τηλ./Tlf./Puh./
Maltese: Nederland/Pays-Bas/Niederlande/Нидерландия/Nizozemsko/ Nederlandene/Holland/Ολλανδία/Nizozemska/The Netherlands/Holland/ Ολλανδία/Nīderlande/Nyderlandai/Pays-Bas/Niederlande/Hollandia/
English: Table 1.
Maltese: Skeda 1.
English: BSA subject (m2)
Maltese: BSA pazjent (m2)
English: Gastrointestinal disorders
Maltese: Mard gastrointestinali
English: Dose and frequency
Maltese: Doża u frekuenza
English: necrolysis, Stevens-Johnson syndrome, erythema multiforme
Maltese: Nekroliżi epidermali tossiku, sindromu ta' StevensJohnson, eritema multiforme
English: From 50 kg(2)
Maltese: Minn 50 kg (2)
English: Children (4 to 12 years)
Maltese: Tfal ( 4 sa 12-il sena)
English: 72 x serum creatinine (mg/dl)
Maltese: 72 x livell ta' krejatinina fis-serum (mg/dl)
English: Six-month seizure freedom was achieved in 73.0% of levetiracetam-treated patients and 72.8% of carbamazepine-CR treated patients; the adjusted absolute difference between treatments was 0.2% (95% CI: -7.8 8.2).
Maltese: Kien hemm 73.0 % tal-pazjenti li ġew trattati b' levetiracetam u 72.8 % ta' pazjenti li ġew trattati b' carbamazepine-CR li damu sitt xhur mingħajr aċċessjonijiet; id-differenza assoluta aġġustata bejn ittrattamenti kienet ta' 0.2 %(95 % CI:-7.8 8.2).
English: CLcr (ml/min) = -------------------------------------- (x 0.85 for women)
Maltese: Clcr (ml/min)= ------------------------------------------------ (x 0.85 għan-nisa)
English: [140-age (years)] x weight (kg)
Maltese: [140 -eta` (snin)] x piż (kg)
English: 500 to 1,000 mg once daily (2)
Maltese: 500 to 1,000 mg darba kuljum (2)
English: Levetiracetam SUN contains sodium
Maltese: Levetiracetam SUN fih sodium
English: The pharmacokinetic and safety profiles did not identify any safety concerns.
Maltese: Il-profil farmakokinetiku u ta' sigurta` ma wrew ebda problemi ta' sigurta`.
English: More than half of the subjects remained seizure free for 12 months (56.6% and 58.5% of subjects on levetiracetam and on carbamazepine CR respectively).
Maltese: Iżjed minn nofs il-pazjenti baqaw mingħajr aċċessjonijet għal 12 il-xahar ( 56.6 % u 58.5 % tal-pazjenti fuq levetiracetam u fuq carbamazepine CR rispettivament).
English: PHARMACEUTICAL FORM AND CONTENTS 500 mg/5 ml
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 500 mg/ 5 ml