FrancophonIA/ELRC3.0 huggingface dataset:
English: • skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (StevensJohnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis).
Maltese: • raxx fil-ġilda, li jista' jifforma bżieżaq u li jidher qisu targi żgħar (tikek ċentrali skuri mdawwra b'erja iżjed pallida, b'ċirku skur mat-tarf) (erythema multiforme), raxx diffuz bil-bżieżaq u ġilda li titqaxxar, partikolarrment madwar il-ħalq, mnieħer, għajnejn u l-ġenitali (sindrome ta' Stevens-Johnson), u forma iżjed severa li tikkawża ġilda li titqaxxar f'iżjed minn 30% tal-wiċċ tal-ġilda (nekroliżi tossiku epidermali).
English: The adverse reaction profile presented below is based on the analysis of pooled placebo-controlled clinical trials with all indications studied, with a total of 3,416 patients treated with levetiracetam.
Maltese: Il-profil tar-reazzjonijiet avversi ppreżentati hawn taħt huwa bbażat fuq lanaliżi ta' ġabra ta' provi kliniċi kkontrollati bil-plaċebo fejn ġew studjati l-indikazzjonijiet kollha, b'total ta' 3,416 pazjent trattati b'levetiracetam.
English: Levetiracetam Accord 750 mg film-coated tablets contains sunset yellow (E110) which may cause allergic reactions.
Maltese: Levetiracetam Accord 750 mg pilloli fihom Sunset Yellow FCF (E110).
English: No tissue distribution data are available in humans.
Maltese: M'hemmx dejta fuq id-distribuzzjoni fit-tessut tal-bniedem.
English: The dose level of 1800 mg/kg/day induced a marked maternal toxicity and a decrease in foetal weight associated with increased incidence of foetuses with cardiovascular/skeletal anomalies.
Maltese: Il-livell tad-doża ta' 1800 mg/kg/ġurnata indotta tossiċita` materna sostanzjali u tnaqqis fil-piz tal-fetu assoċjat ma' tnaqqis fl-inċidenza ta' feti b'abnormalitajiet cardjovaskolari/skeltrali.
English: If you stop taking Levetiracetam Accord
Maltese: Mediċini oħra u Levetiracetam Accord
English: Two embryo-foetal development (EFD) studies were performed in rats at 400, 1200 and 3600 mg /kg/day.
Maltese: Żewġt studji fuq l-iżvillup ta' l-embriju u l-fetu (EFD) saru fil-far b'400, 1200 u 3600 mg/kg/ġurnata.
English: INFORMATION IN BRAILLE Levetiracetam Accord 500 mg
Maltese: Levetiracetam Accord 500 mg
English: For 250mg:
Maltese: 250 mg:
English: In both population pharmacokinetic analyses, there was about a 20% increase of apparent clearance of levetiracetam when it was co-administered with an enzyme-inducing antiepileptic medicinal product.
Maltese: Fiż-żewġt analiżi tal-farmakokinetika fil-popolazzjoni, kien hemm żieda ta' madwar 20 % filclearance li tidher ta' levetiracetam meta ngħatat flimkien mal-prodott mediċinali ta' kontra lepilessija li jindotta l-enżimi.
English: 7 to 14 mg /kg (0.07 to 0.14 ml/kg) twice daily
Maltese: 7 sa 14 mg/kg (0.07 sa 0.14 ml/kg) darba kuljum
English: The blisters are further packed in to carton with leaflet in pack size of 10, 20, 30, 50, 60, 100 and 200 tablets per pack.
Maltese: Il-folji huma ppakkjati ulterjorment f'kartuna b'fuljett b'daqs tal pakkett ta' 10, 20, 30, 50, 60, 100 u 200 pillola kull pakkett.
English: Example: if your daily dose is 1,000 mg, you might take 2 tablets of 250 mg in the morning and 2 tablets of 250 mg in the evening.
Maltese: Jekk id-doża tiegħek hija 1,000 mg kuljum, tista' tieħu 2 pilloli ta 250 mg filgħodu u 2 pilloli ta' 250 mg filgħaxija.
English: (2) Following dialysis, a 250 to 500 mg supplemental dose is recommended.
Maltese: Wara id-dijaliżi, hija rrikkmandata doża supplimentari ta' bejn 250 u 500 mg.
English: 3.5 to 7 mg /kg (0.035 to 0.07 ml/kg) twice daily
Maltese: 3.5 sa 7 mg/kg (0.035 sa 0.07 ml/kg) (0.105 ml/kg)darbtejn kuljum
English: • on its own in adults and adolescents from 16 years of age with newly diagnosed epilepsy, to treat a certain form of epilepsy.
Maltese: • waħdu f'adulti u adoloxxenti minn 16 il-sena b'epilessija li għadha kif ġiet iddijanjostikata, fittrattament ta' ċertu forma ta' epilessija.
English: PVC/Alu blister pack:
Maltese: Pakkett ta' folji tal-PVC-Alu:
English: Box of 10, 20, 30, 50, 60, 100, 200 tablets
Maltese: TAGĦRIF LI GĦANDU JIDHER FUQ IL-PAKKETT TA' BARRA Kaxxa ta' 10, 20, 30, 50, 60, 100, 200 pillola
English: Accord Healthcare Limited Sage House
Maltese: Accord Healthcare Ltd.
English: Choreoathetosis,d yskinesia, hyperkinesia, gait disturbance,
Maltese: diskinesija, iperkinesja, diffikultà filmixi, enċefalopatija
English: Unit dose pack (perforated unit dose blister) containing 30x1, 60x1 and 100x1 tablets.
Maltese: Pakkett ta' doża waħda (folja ta' doża waħda perforata) li fiha 30x1, 60x1 u 100x1 pillola Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.
English: In paediatric patients (1 month to less than 4 years of age), levetiracetam efficacy was established in a double-blind, placebo-controlled study, which included 116 patients and had a treatment duration of 5days.
Maltese: F'pazjenti pedjatriċi (t'eta` ta' xahar sa inqas minn 4 snin), l-effikaċja ta' levetiracetam kienet stabbilita f'studju kkontrollat mill-plaċebo u double-blind li inkludew 116-il pazjent u kellu tul ta' trattament ta' 5 tijiem.
English: 5 to 10 mg /kg (0.05 to 0.10 ml/kg) twice daily
Maltese: 5 sa 10 mg/kg (0.05 sa 0.10 ml/kg) darbtejn kuljum
English: If you take more Levetiracetam Accord than you should The possible side effects of an overdose of Levetiracetam are sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing and coma.
Maltese: Effetti mhux mixtieqa li possibilment ikun hemm wara li jitteiħed iżjed Levetiracetam Accord milli suppost huma: ngħas, aġitazzjoni, aggressjoni, nuqqas ta' viġilanza, inhibizzjoni ta' nifs u koma.
English: Levetiracetam Accord 1000 mg film-coated tablet Levetiracetam
Maltese: Levetiracetam Accord 1000 mg pillola miksija b'rita Levetiracetam
English: Amnesia, memory impairment, coordination abnormal/ataxia, paraesthesia,disturbance in attention
Maltese: Amneżija, impediment tal memorja, ko ordinazzjoni abnormali/ataxja,
English: Iron oxide red (E172) Sunset yellow FCF (E110) 6.2 Incompatibilities Not applicable.
Maltese: Talc 500 mg Iron oxide yellow (E172) 750 mg Iron oxide red (E172) Sunset yellow FCF (E110) 6
English: • suicide attempt and suicidal ideation, mental disorder, abnormal behaviour, hallucination,
Maltese: • attentat ta' suwiċidju u ħsibijiet ta' suwiċidju, mġieba abnormali, alluċinazzjonijiet, rabja,
English: • as an add-on to other antiepileptic medicines to treat: - partial onset seizures with or without generalisation in adults, adolescents, children and infants from one month of age; - myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy - primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in adults and adolescents from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).
Maltese: - aċċessjonijiet tat-tip mijokloniċi (skossi qosra, bħal xokk f'muskolu jew grupp ta' muskoli) f'adulti u adoloxxenti minn 12 snin b'epilessija tat-tip mijoklonika li tibda fiż-żgħożija - aċċessjonijiet primarji u ġeneralizzati tat-tip tonic-clonic (aċċessjonijiet maġġuri, inkluż telf ta' koxjenza) f'adulti u adoloxxenti minn 12 il-sena b'epilessija idjopatika.ġeneralizzata (it-tip ta' epilessija li hi maħsuba li għandha kawża ġenetika).
English: Following single dose administration (20 mg /kg) of a 100 mg /ml oral solution to epileptic children (1 month to 4 years), levetiracetam was rapidly absorbed and peak plasma concentrations were observed approximately 1 hour after dosing.
Maltese: Wara li ngħatat doża waħda (20 mg/kg) ta' 100 mg/ml soluzzjoni orali lil tfal epilettiċi (xahar sa 4 snin), levetiracetam kien assorbit malajr u l-konċentrazzjonijiet massimi fil-plażma kienu osservati bejn wieħed u ieħor siegħa wara d-doża.
English: Monotherapy for adults and adolescents from 16 years of age
Maltese: Monoterapija għal adulti u adoloxxenti minn 16-il sena ‘l fuq
English: PVC-Alu blister
Maltese: Għal użu orali
English: • in the treatment of partial onset seizures with or without secondary generalisation in adults,adolescents, children and infants from 1 month of age with epilepsy.
Maltese: • fit-trattament ta' aċċessjonijiet tat-tip parzjali kemm meta jkun hemm, kif ukoll meta ma jkunx hemm ġeneralizzazzjoni sekondarja f'adulti, adolexxenti, tfal u trabi minn eta` ta' xahar b'epilessija.
English: Neonatal and juvenile animal studies in rats and dogs demonstrated that there were no adverse effects seen in any of the standard developmental or maturation endpoints at doses up to 1800 mg/kg/day (x6-17 the MRHD on a mg/m2 basis).
Maltese: Studji fl-annimali tat-twelid u ġovanili fil-firien u l-klieb wrew li ma kienx hemm effetti avversi filpunti tat-tmiem standard tal-iżvillup jew maturazzjoni b'dożi sa 1800 mg/kg/ġurnata ( x6 - 17 ilMRHD fuq bażi ta' mg/m2).
English: Levetiracetam Accord 750 mg film-coated tablet Levetiracetam
Maltese: Levetiracetam Accord 750 mg pillola miksija b'rita Levetiracetam
English: 3.5 to 10.5 mg /kg (0.035 to 0.105 ml/kg) twice daily
Maltese: 5 mg/kg (0.035 sa 0.105 ml/kg)darbtejn kuljum
English: Marketing authorization holder and manufacturer Marketing authorization holder Accord Healthcare S.L.U.
Maltese: Detentur tal-awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur Detentur tal-awtorizzazzjoni għat-Tqegħid fis-Suq Accord Healthcare S.L.U.
English: 0.20 ml/kg) once daily (3) (5) (1) Levetiracetam oral solution should be used for doses under 250 mg, for doses not multiple of 250 mg when dosing recommendation is not achievable by taking multiple tablets and for patients unable to swallow tablets.
Maltese: 10 sa 20 mg/kg (0.10 sa 0.20 ml/kg) darba kuljum (3) (5) (1) Levetiracetam soluzzjoni orali għandha tintuża għal dożi taħt il-250 mg, għal dożi mhux multipli ta' 250 mg meta r-rikomandazzjoni tad-dożaġġ ma jistax jintlaħaq billi jittieħdu pilloli multipli u għal pazjenti li ma jistgħux jibilgħu l-pilloli.
English: Suicide, suicide attempt, suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents including levetiracetam.
Maltese: Suwiċidju, attentat ta' suwiċidju, ħsibijiet u mġieba suwiċidali kienu rrappurtati f'pazjenti trattati b' mediċini ta' kontra l-epilessija (inkluż levetiracetam).
English: • suicide, personality disorders (behavioural problems), thinking abnormal (slow thinking,
Maltese: • suwiċidju, mard tal-personalita` (problemi ta' mġieba), ħsibijiet abnormali (ħsieb bil-mod, ma tistax tikkonċentra);
English: Levetiracetam Accord 750 mg film-coated tablets Levetiracetam
Maltese: Levetiracetam Accord 750 mg pilloli miksija b'rita Levetiracetam
English: Levetiracetam oral solution is the preferred formulation for use in infants and children under the age of 6 years.
Maltese: Levetiracetam soluzzjoni orali hija l-formulazzjoni preferita għall-użu fit-trabi u tfal taħt is-6 snin.
English: 5 to 15 mg /kg (0.05 to 0.15 ml/kg) twice daily
Maltese: 5 sa 15 mg/kg (0.05 sa
English: In this study, patients were prescribed 20 mg /kg, 25 mg /kg, 40 mg /kg or 50 mg /kg daily dose of oral solution based on their age titration schedule.
Maltese: F'dan l-istudju, il-pazjenti ġew mogħtija dożi ta' kuljum ta' 20 mg/kg, 25 mg/kg, 40 mg/kg jew 50 mg/kg ta' soluzzjoni orali bbażati fuq l-iskeda tat-titrazzjoni skond l-eta`.
English: [140-age (years)] x weight (kg) CLcr (ml/min) = ----------------------------------------- (x 0.85 for women) 72 x serum creatinine (mg/dl)
Maltese: għal adulti u addoloxenti ta' 50 kg jew aktar, billi tuża din il-formula: [140 -eta` (snin)] x piż (kg)
English: For 1000mg:
Maltese: Għal 1000mg:
English: The NOAEL was ≥ 1800 mg/kg/day for the F0 females, and for the survival, growth and development of the F1 offspring up to weaning (x 6 the MRHD on a mg/m2 basis).
Maltese: In- NOAEL kien ta' ≥ 1800 mg/kg/ġurnat għal firien feminili F0, u għassopravivenza, kobor u l-iżvillup taż-żrameġ F1 sa kemm jibdew jieklu weħedhom ( x6 il-MRHD fuq bażi ta' mg/m2).
English: With continued long-term treatment, 28.6% of the patients were free of myoclonic seizures for at least 6 months and 21.0% were free of myoclonic seizures for at least 1 year.
Maltese: tal-pazjenti ma kellhomx aċċessjonjiet mijokloniċi għal mill-inqas 6 xhur u 21.0 % ma kellhomx aċċessjonjiet mijokloniċi għal mill-inqas sena.
English: Levetiracetam Accord 250 mg film-coated tablets Levetiracetam
Maltese: Levetiracetam Accord 250 mg pillola miksija b'rita Levetiracetam
English: Each film-coated tablet contains 250 mg levetiracetam.
Maltese: Kull pillola miksija b'rita fiha 500 mg levetiracetam.
English: 10 to 30 mg /kg (0.10 to 0.30 ml/kg) twice daily
Maltese: 10 sa 30 mg/kg (0.10 sa
English: Levetiracetam Accord 500 mg film-coated tablet Levetiracetam
Maltese: Levetiracetam Accord 500 mg pillola miksija b'rita Levetiracetam
English: (2) A 10.5 mg /kg (0.105 ml/kg) loading dose is recommended on the first day of treatment with levetiracetam.
Maltese: 5 mg/kg (0.105 ml/kg) hija rrikkmandata fl-ewwel ġurnata tat-trattament b'levetiracetam.
English: Renal and Urinary Disorders
Maltese: Disturbi fil-kliewi u fis-sistema urinarja
English: There is no specific antidote for levetiracetam.
Maltese: Nekroliżi epidermali tossiku,
English: EU/1/11/712/001-007 (10/20/30/50/60/100/200 tablets in PVC/alu Blister) EU/1/11/712/029-031(30/60/100 tablets in Unit dose Blister)
Maltese: EU/1/11/712/001-007 (10/20/30/50/60/100/200 pillola f'Folja tal-PVC/alu)
English: Levetiracetam Accord 500 mg film-coated tablets Each film-coated tablet contains 500 mg levetiracetam
Maltese: Levetiracetam Accord 500 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha 500 mg ta' levetiracetam
English: The starting dose for a child or adolescent of 25 kg should be 250 mg twice daily with a maximum dose of 750 mg twice daily.
Maltese: Id-doża tal-bidu għal tifel jew tifla jew adolexxent ta' 25 kg għandha tkun 250 mg darbtejn kuljum b'doża massima ta' 750 mg darbtejn kuljum.
English: Acute Kidney injury
Maltese: Rappurtar tal-effetti sekondarji
English: EU/1/11/712/015-021 (10/20/30/50/60/100/200 tablets in PVC/alu Blister) EU/1/11/712/035-037 (30/60/100tablets in Unit dose Blister)
Maltese: EU/1/11/712/015-021 (10/20/30/50/60/100/200 pillola f'Folja tal-PVC/alu)
English: At 3600 mg /kg/day, in only one of the 2 EFD studies, there was a slight decrease in foetal weight associated with a marginal increase in skeletal variations/minor anomalies.
Maltese: B' 3600 mg/kg/ġurnata, f'studju wieħed miż-żewġt studji EFD,kien hemm tnaqqis żgħir fil-piz talfetu marbut ma' żieda marġinali f'varjazzjonijiet skeletali/ abnormalitajiet minuri.
English: EU/1/11/712/022-028 (10/20/30/50/60/100/200 tablets in PVC/alu Blister) EU/1/11/712/038-040(30/60/100tablets in Unit dose Blister)
Maltese: EU/1/11/712/022-028 (10/20/30/50/60/100/200 pillola f'Folja tal-PVC/alu)
English: The maximum dose is 1500 mg twice daily.
Maltese: Doża normali: bejn 1,000 mg u 3,000 mg kuljum.
English: NAME OF THE MEDICINAL PRODUCT Levetiracetam Accord 1000 mg film-coated tablets Levetiracetam STATEMENT OF ACTIVE SUBSTANCE (S) Each film-coated tablet contains 1000 mg levetiracetam.
Maltese: Meta l-ewwel tibda tieħu Levetiracetam Accord, it-tabib tiegħek ser jiktiblek doża aktar baxxa (500 mg kull jum) matul il-ġimagħtejn qabel ma jibdik fuq l-iżjed doża ġenerali baxxa ta' 1000 mg.
English: Levetiracetam and related analogs show a rank order of affinity for binding to the synaptic vesicle protein 2A which correlates with the potency of their anti-seizure protection in the mouse audiogenic model of epilepsy.
Maltese: Dan it-tagħrif jissuġġerixxi li l-interazzjoni bejn levtiracetam u l-proteina tal-bużżieqa tas-sinapsi 2A donnhom jikkontribwixxu għall-mekkaniżmu t'azzjoni kontra l-epilessija tal-prodott mediċinali.
English: EU/1/11/712/008-014 (10/20/30/50/60/100/200 tablets in PVC/alu Blister) EU/1/11/712/032-034 (30/60/100tablets in Unit dose Blister)
Maltese: (10/20/30/50/60/100/200 pillola f'Folja tal-PVC/alu) EU/1/11/712/032-034 (30/60/100 pillola f'Folja ta' doża Waħda)
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/712/022-028 (10/20/30/50/60/100/200 tablets in PVC/alu Blister) EU/1/11/712/038-040 (30/60/100tablets in Unit dose Blister)
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/11/712/022-028 (10/20/30/50/60/100/200 pillola f'Folja tal-PVC/alu)
English: Muscular weakness, myalgia Rhabdomyolysis and blood creatine tissue disorders phosphokinase increased*
Maltese: Disturbi muskolu-skeletriċi u tat-tessuti konnettivi
English: A risk of birth defects for your unborn child cannot be completely excluded.
Maltese: Riskju li jista' jkun hemm xi difetti għat-tarbija ġol-guf ma jistax jiġi kompletament eskluż.
English: Levetiracetam Accord 750 mg film-coated tablets Pink coloured, oval, biconvex, debossed ‘L 66' and break line on one side and plain on the other side.
Maltese: F'dan l-istudju, ilpazjenti ħadu levetiracetam bħala doża fissa ta' 60 mg/kg/ġurnata (maqsuma f'darbtejn kuljum). 44.6 % ta' pazjenti fuq levetiracetam u 19.6 % ta' pazjenti fuq il-plaċebo kellhom tnaqqis ta' 50 % jew iżjed mill-linja bażi fil-frekwenza fil-ġimgħa ta' aċċessjonijiet tat-tip parzjali.
English: Levetiracetam Accord 250 mg film-coated tablets Each film-coated tablet contains 250 mg levetiracetam
Maltese: Levetiracetam Accord 250 mg pilloli miksija b'rita Kull pillola miksija b'rita fiha 250 mg ta' levetiracetam
English: Pink coloured, oval, biconvex, film coated tablet, debossed ‘L 66' and break line on one side and plain on the other side.
Maltese: Lewn roża, ovali, ġejja għat-tond miż-żewġ naħat, imnaqqxa b''L 66' u b'linja minn fejn tinqasam fuq naħa u lixxa min-naħa l-oħra.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/712/001-007 (10/20/30/50/60/100/200 tablets in PVC/alu Blister) EU/1/11/712/029-031(30/60/100tablets in Unit dose Blister)
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/11/712/001-007 (10/20/30/50/60/100/200 pillola f'Folja tal-PVC/alu)
English: Efficacy of levetiracetam as monotherapy was established in a double-blind, parallel group, non-inferiority comparison to carbamazepine controlled release (CR) in 576 patients 16 years of age or older with newly or recently diagnosed epilepsy.
Maltese: L-effikaċja ta' levetitacetam bħala monoterapija ġiet stabbilita f'studju li qabblu b'mod double-blind, parallel group, non-inferiority ma' carbamazepine f' għamla li jintreħa b' mod kontrollat (CR) f'576 pazjenti ta' 16 il-sena jew iżjed li għadhom kif ġew dijanjostikati b' epilessija.
English: The CLcr in ml/min may be estimated from serum creatinine (mg/dl) determination, for adults and adolescents weighting 50 kg or more, the following formula:
Maltese: BSA pazjent (m2) Regolar tad-doża f'pazjenti adulti u addoloxxenti li jiżnu iżjed minn 50kg b' indeboliment fil-kliewi:
English: In this study, levetiracetam dose was 3000 mg /day for adults and adolescents or 60 mg /kg/day for children, given in 2 divided doses.
Maltese: F'dan l-istudju, id-doża ta' levetiracetam kienet ta' 3000 mg/ġurnata fl-adulti u l-addoloxxenti jew 60 mg/kg/ġurnata fit-tfal, li ingħataw f'2 dożi separati.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/712/015-021 (10/20/30/50/60/100/200 tablets in PVC/alu Blister) EU/1/11/712/035-037 (30/60/100tablets in Unit dose Blister)
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/11/712/015-021 (10/20/30/50/60/100/200 pillola f'Folja tal-PVC/alu)
English: No adverse reactions on male or female fertility or reproduction performance were observed in rats at doses up to 1800 mg/kg/day (x 6 the MRHD on a mg/m2 or exposure basis) in parents and F1 generation.
Maltese: riproduttiva ma kienu osservati fil-firien f'dożi sa 1800 mg/kg/day (x 6 l-MRHD fuq bażi ta'
English: If stopping treatment, Levetiracetam Accord should be discontinued gradually to avoid an increase of seizures.
Maltese: Jekk tkun ser twaqqaf it-trattament, għandek tnaqqas Levetiracetam Accord bil-mod biex ma jkunx hemm żieda fl-aċċessjonijiet.
English: Complete blood cell counts are advised in patients experiencing important weakness, pyrexia, recurrent infections or coagulation disorders (section 4.8).
Maltese: Għadd ta' ċelloli tad-demm kompleti huma rrikkmandati f'pazjenti li jħossu debbolezza importanti, deni, infezzjonijiet rikorrenti jew mard ta' koagulazzjoni (sezzjoni 4.8).
English: --1 Live attenuated avian infectious bronchitis virus (IBV), variant strain 4-91: ≥3.6 log10 EID50* per dose * EID50: 50% embryo infective dose - the virus titre required to produce infection in 50% of the embryos inoculated.
Maltese: --1 Virus ħaj imma modifikat tal-bronkite infettiva (IBV) variant strain 4-91: > 3.6 log10 EID50* kull doża.
English: Annex A
Maltese: Annex A EU (MA) numru Isem ivvintat
English: 3 Bottles
Maltese: 3 Fliexken
English: Capsicum annuum L. var. minimum (Miller) Heiser and small fruited varieties of Capsicum frutescens L., fructus
Maltese: Capsicum annuum L. var. minimum (Miller) Heiser u varjetajiet bi frott żgħir ta' Capsicum frutescens L. , fructus
English: Capsaicin is a selective agonist of the ‘transientreceptor-potential-vanilloid-1' (TRPV1) receptor.
Maltese: Il-bżar fih sustanza magħrufa bħala capsaicin. Capsaicin hija agonista selettiva għar-‘riċettur temporanju potenzjali vanilloid -1' (transient receptor potential vanilloid 1 - TRPV1).
English: What are the risks associated with capsicum medicines?
Maltese: X'inhuma r-riskji assoċjati mal-mediċini bil-bżar?
English: Further information on the HMPC assessment of capsicum medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Maltese: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Capsicum medicines must not be used in patients allergic to other sources of capsaicin and capsaicinlike compounds (e.g. paprika or chilli) and must not be applied onto broken skin, wounds and eczema.
Maltese: Mediċini bil-bżar ma għandhomx jintużaw f'pazjenti allerġiċi għal sorsi oħrajn ta' capsaicin u ta' komposti simili għal capsaicin (eż. paprika jew ċili) u ma għandhomx jiġu applikati fuq ġilda maqsuma, feriti u ekżema.
English: Other information about capsicum medicines
Maltese: Aktar informazzjoni dwar il-mediċini bil-bżar
English: Capsicum is the common name for the fruits of the plant Capsicum annuum L. var. minimum (Miller) Heiser and Capsicum frutescens L. These are types of peppers that are cultivated or gathered to obtain the plant parts for medicinal use.
Maltese: Il-bżar huwa l-isem komuni għall-frott tal-pjanta Capsicum annuum L. var. minimum (Miller) Heiser u Capsicum frutescens L.
English: How are capsicum medicines approved in the EU?
Maltese: Kif jiġu approvati fl-UE l-mediċini bil-bżar?
English: Herbal medicine: summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku
English: Herbal medicines containing capsicum are usually available in a medicated plaster or in semi-solid forms to be applied to the skin (such as creams).
Maltese: Mediċini erbali li fihom il-bżar normalment huma disponibbli f'ġibs medikat jew f'għamliet semi-solidi li għandhom jiġu applikati fuq il-ġilda (bħal kremi).
English: In its assessment, the HMPC considered a number of clinical studies which showed improvements in pain relief following treatment with capsicum medicated plaster and skin preparations compared with placebo (a dummy treatment).
Maltese: Fil-valutazzjoni tiegħu, l-HMPC qies numru ta' studji kliniċi li wrew titjib fis-serħan mill-uġigħ wara kura b'ġibs u preparazzjonijiet tal-ġilda medikati bil-bżar meta mqabbla ma' plaċebo (kura finta).
English: Capsicum should only be used in adults over the age of 18 years and should not be used continuously for more than 3 weeks.
Maltese: Il-bżar għandu jintuża biss fl-adulti li għandhom aktar minn 18-il sena u ma għandux jintuża kontinwament għal aktar minn 3 ġimgħat.