FrancophonIA/ELRC3.0 huggingface dataset:
English: Triumeq does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Maltese: Triumeq ma jfejjaqx infezzjonijiet tal-HIV jew AIDS, imma jista' jittardja l-ħsara lis-sistema immunitarja u l-iżvilupp ta' infezzjonijiet u mard assoċjati ma' AIDS.
English: Before starting treatment with Triumeq, all patients should have a test to find out if they have a gene called ‘HLA-B (type 5701)'.
Maltese: Qabel tinbeda l-kura b'Triumeq, il-pazjenti kollha għandhom jagħmlu test biex isiru jafu għandhomx ġene msejjaħ ‘HLA-B (tip 5701)'.
English: EMA/671614/2010 EMEA/H/C/000620
Maltese: EMEA/H/C/000620
English: The full EPAR for Macugen can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ ta' Macugen jinsab fis-sit tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: EPAR summary for the public pegaptanib
Maltese: Sommarju tal-EPAR għall-pubbliku pegaptanib
English: The active substance in Macugen, pegaptanib, is an ‘aptamer'.
Maltese: Is-sustanza attiva f'Macugen, il-pegaptanib, hija ‘aptamer'.
English: Macugen is used to treat adults with the ‘wet' form of age-related macular degeneration (AMD).
Maltese: Macugen jintuża fit-trattament ta' adulti li jsofru mill-forma ‘umda' tad-deġenerazzjoni makulari relatata mal-età (AMD).
English: The patients were given either Macugen (0.3 mg, 1 mg or 3 mg) or a ‘sham' injection.
Maltese: Il-pazjenti ngħataw Macugen (0.3 mg, 1 mg jew 3 mg) jew injezzjoni finta.
English: Macugen has been studied in two main clinical studies involving a total of 1,190 patients and lasting up to two years.
Maltese: Macugen ġie studjat f'żewġ studji kliniċi ewlenin u tul sentejn fuq total 1,190 pazjent.
English: After one year of treatment, about 70% of the patients treated with Macugen 0.3 and 1 mg lost less than 15 letters in the eye test compared with about 55% of those who received the sham injection.
Maltese: Wara sena trattament, madwar 70% tal-pazjenti ttrattati b'Macugen (0.3 mg u 1 mg) tilfu anqas minn 15-il ittra fit-test tal-għajnejn apparagun ma' madwar 55% ta' dawk li ngħatatilhom l-injezzjoni finta.
English: An aptamer is a single strand of molecules called nucleotides that has been designed to attach to a specific molecule in the body.
Maltese: Aptamer huwa faxxa waħda ta' molekuli msejħa nukleotidi li tfasslet apposta biex teħel ma' molekula speċifika fil-ġisem.
English: This is a summary of the European public assessment report (EPAR) for Macugen.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Macugen.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Macugen on 31 January 2006.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Macugen valida fl-Unjoni Ewropea kollha fil-31 ta' Jannar 2006.
English: The most common side effects with Macugen (seen in more than 1 patient in 10) are anterior chamber inflammation (inflammation of the front part of the eye), pain in the eye, raised intraocular pressure (increased pressure inside the eye), punctate keratitis (small marks on the eye surface) and vitreous floaters or opacities (small particles or spots in the vision).
Maltese: L-effetti sekondarji l-aktar komuni bl-użu ta' Macugen (li dehru f'iktar minn pazjent 1 minn kull 10) kienu infjammazzjoni tal-parti ta' quddiem tal-għajn, uġigħ fl-għajn, żieda fil-pressjoni intraokulari (żieda fil-pressjoni ta' ġewwa tal-għajn), punctuate keratitis (marki żgħar fuq l-għajn) u flowters vitrużi u opaċitajiet (partiċelli jew tikek żgħar fil-vista).
English: The CHMP noted that in patients with wet AMD Macugen 0.3 mg had similar effects on vision loss as Macugen 1 mg, therefore the lower dose was selected for approval.
Maltese: Is-CHMP innota li f'pazjenti b'AMD umduża it-trattament b'Macugen 0.3 mg kellu effetti simili fit-telf tal-vista bħat-trattament b'Macugen 1 mg.
English: Pegaptanib has been designed to attach to and block a protein called vascular endothelial growth factor (VEGF).
Maltese: Il-pegaptanib tfasslet biex teħel u timblokka proteina msejħa l-fattur tat-tkabbir tal-endotelju vaskolari (VEGF).
English: What is Macugen?
Maltese: X'inhu Macugen?
English: Why has Macugen been approved?
Maltese: Għaliex ġie approvat Macugen?
English: What is the risk associated with Macugen?
Maltese: X'inhu r-riskju assoċjat ma' Macugen?
English: How has Macugen been studied?
Maltese: Kif ġie studjat Macugen?
English: Sometimes, endophthalmitis (an infection inside the eye), vitreous haemorrhage (bleeding into the eye) and retinal damage can occur after Macugen treatment.
Maltese: Wara t-trattament b'Macugen xi drabi jistgħu jiżviluppaw endoftalmite (infezzjoni ġewwa l-għajn), emoraġija vitruża (fsada fl-għajn), u tista' ssir ukoll ħsara fir-retina.
English: Macugen should only be given by an ophthalmologist (eye specialist) who is experienced in giving intravitreal injections (injections into the vitreous humour, the jelly-like fluid in the eye).
Maltese: Macugen għandu jingħata biss minn oftalmologu (speċjalista tal-għajnejn) li jkollu l-esperjenza fl-għoti ta' injezzjonijiet intravitreali (injezzjonijiet fil-fluwidu trasparenti bejn ir-retina u l-kornea, il-fluwidu li jixbah il-ġeli fl-għajn).
English: Other information about Macugen
Maltese: Kif jintuża Macugen?
English: Pegaptanib injected into the eye blocks VEGF.
Maltese: Meta jingħata b'injezzjoni fl-għajn il-pegaptanib timblokka l-VEGF.
English: The company that makes Macugen will provide educational material for doctors (to minimise the risks associated with the injection in the eye) and for patients (so they can recognise any serious side effects, and know when to seek urgent attention from their doctor).
Maltese: Il-kumpanija li tipproduċi Macugen ser tqassam materjal edukattiv lit-tobba (biex tnaqqas ir-riskji assoċjati mal-injezzjonijiet fil-għajn) u lill-pazjenti (biex ikunu jistgħu jagħrfu kwalunkwe effett sekondarju serju u jkunu jafu meta għandhom jieħdu parir urġenti mingħand it-tabib tagħhom).
English: The 3 mg dose did not bring any additional benefit.
Maltese: Id-doża ta' 3 mg ma pproduċietx xi benefiċċji ulterjuri.
English: The CHMP decided that Macugen's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Macugen huma akbar mir-riskji tiegħu u għaldaqstant irrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Neocolipor contains inactivated strains of E. coli expressing the adhesins F4ab (K88ab), F4ac (K88ac), F4ad (|K88 ad) F5 (K99) F6 (987P) and F41.
Maltese: Neocolipor fih strains inattivati ta' E. coli li jesprimu l-adeżini (adhesins) F4ab (K88ab), F4ac (K88ac), F4ad (|K88 ad) F5 (K99) F6 (987P) u F41.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) NEOCOLIPOR EPAR summary for the public
Maltese: RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEW (EPAR) NEOCOLIPOR Sommarju tal-EPAR għall-pubbliku
English: Vaccination of the mother animal (sows and gilts) enables the offspring to receive a passive immunity during their first days of life against neonatal enterotoxicosis caused by E. coli strains carrying the adhesins F4, F5, F6 and F41.
Maltese: Il-vaċċinazzjoni tal-omm (ħanżira jew ħanżira ta' età żgħira) tittrasmetti lid-driefeġ immunizzazzjoni passiva matul l-ewwel jiem ta' ħajja kontra l-enterotossikożi neonatali kkawżata minn E. coli li ġġorr l-adeżini F4, F5, F6 u F41.
English: What are the side-effects of Neocolipor?
Maltese: X'inhuma l-effetti sekondarji ta' Neocolipor?
English: Vaccination may cause a slight rise in the animal's body temperature (less than 1.5°C during a maximum period of 24 hours).
Maltese: Il-vaċċinazzjoni tista' tikkawża żieda ċkejkna fit-temperatura tal-ġisem tal-annimal (inqas minn 1.5°C matul perjodu massimu ta' 24 siegħa).
English: The vaccine is given by intramuscular injection.
Maltese: Il-vaċċin jingħata b'injezzjoni intramuskolari.
English: Why has Neocolipor been approved?
Maltese: Għaliex ġie approvat Neocolipor?
English: The European Commission granted a marketing authorisation, valid throughout the European Union, for Neocolipor to Mérial on 9 August 2002.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Neocolipor lil Mérial fid-9 ta' Awwissu 2002.
English: Re-vaccination was shown to be effective at the intervals recommended.
Maltese: Is-sigurtà tal-prodott intweriet b'mod sodisfaċenti.
English: Other information about Neocolipor:
Maltese: Aktar tagħrif dwar Neocolipor:
English: What is Neocolipor?
Maltese: Kif jaħdem Neocolipor?
English: Neocolipor is an inactivated vaccine intended to be used to reduce neonatal enterotoxicosis (a bacterial infection caused by strains of E.coli) in very young piglets.
Maltese: Neocolipor huwa vaċċin inattivat biex jintuża għat-tnaqqis tal-enterotossikożi neonatali (infezzjoni batterika kkawżata minn strains ta' E. coli) fi driefeġ ta' età ċkejkna.
English: Zero days (the vaccine does not contain any ingredients that are likely to pose a risk for consumers of vaccinated animals at the recommended dose).
Maltese: Ebda ġurnata (il-vaċċin ma fihx ingredjenti li jistgħu jirrappreżentaw riskju għall-konsumaturi ta' annimali vaċċinati bid-doża rakkomandata).
English: How has Neocolipor been studied?
Maltese: Kif ġie studjat Neocolipor?
English: The Committee for Medicinal Products for Veterinary Use (CVMP) considered that, in accordance with European Union requirements, Neocolipor had been shown to be effective in the reduction of neonatal enterotoxicosis in piglets.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkunsidra li, skont ir-rekwiżiti tal-Unjoni Ewropea, Neocolipor wera ruħu effikaċi fit-tnaqqis tal-enterotossikożi neonatali tad-driefeġ.
English: 4ml (25mg/ml)
Maltese: Isem (ivvintat) Qawwa
English: 100mg/4ml
Maltese: Il-pakkett li jmiss malprodott
English: <EMA procedure number> <MA (EU) number> (Invented) name Strength Pharmaceutical form Route of administration Immediate Packaging <Content (concentration)> Pack size
Maltese: <Numru tal-proċedura ta' l-EMA> <Numru ta' l-EU> <Numru tal-MA> Isem (ivvintat) Qawwa Għamla farmaċewtika
English: Translations of Annex A must be in line and consistent with the adopted English product information annexes of the product concerned.
Maltese: Il-pakkett li jmiss mal-prodott <Kontenut (konċentrazzjoni)> Daqs tal-pakkett
English: Add-on therapy
Maltese: Terapija add-on
English: Metronidazole - Severe hepatic and neurologic toxicity in patients with Cockayne syndrome (EPITT no 18663)
Maltese: 2. Metronidazole - Tossiċità severa fil-kliewi u newroloġika f'pazjenti bis-sindrome ta' Cockayne (EPITT nru 18663)
English: • Stomach pain, anorexia, nausea, vomiting, fever, malaise, fatigue, jaundice, dark urine, putty or mastic coloured stools or itching.
Maltese: • Uġigħ fl-istonku, anoressija, dardir, rimettar, deni, tħossok ma tiflaħx, għejja, suffejra, awrina skura, ippurgar qisu stokk jew mastiċi kkulurit jew ħakk.
English: Adopted at the 26-29 September 2016 PRAC
Maltese: Adottata fil-PRAC ta' bejn is-26 u d-29 ta' Settembru 2016
English: Levetiracetam(oral solution) - Medication errors associated with accidental overdose (EPITT no 10519)
Maltese: 1. Levetiracetam (soluzzjoni orali) - Żbalji tal-mediċina assoċjati ma' doża eċċessiva aċċidentali (EPITT nru 10519)
English: (see table below for dose examples).
Maltese: (ara t-tabella hawn taħt għal eżempji tad-doża).
English: Dose in adults and adolescents from (16 years of age):
Maltese: Doża fl-adulti u fl-adolexxenti minn (16-il sena):
English: Keppra is taken twice daily, in two equally divided doses, each individual dose being measured between 5 ml (500mg) and 15 ml (1500mg).
Maltese: Keppra jittieħed darbtejn kuljum, f'żewġ dożi maqsumin indaqs, kull doża individwali titkejjel bejn 5 ml (500mg) u 15-il ml (1500mg).
English: Method of administration:
Maltese: Doża ġenerali:
English: 3 - How to take Keppra
Maltese: 3 - Kif għandek tieħu Keppra
English: General dose: Keppra is taken twice daily, in two equally divided doses, each individual dose being measured between 0.07 ml (7mg) and 0.21 ml (21mg), per kg bodyweight of the infant.
Maltese: Keppra jittieħed darbtejn kuljum, f'żewġ dożi maqsumin indaqs, kull doża individwali titkejjel bejn 0.07 ml (7mg) u 0.21 ml (21mg), għal kull kg ta' piż tal-ġisem tat-tarbija.
English: General dose: between 0.2 ml (20 mg) and 0.6 ml (60 mg) per kg bodyweight each day, divided in 2 intakes per day.
Maltese: Doża ġenerali: bejn 0.2 ml (20 mg) u 0.6 ml (60 mg) għal kull kg ta' piż tal-ġisem kuljum, maqsuma f'darbtejn kuljum.
English: Cases of severe liver toxicity/acute liver failure, including cases with a fatal outcome, in patients with Cockayne syndrome have been reported with product containing metronidazole.
Maltese: Każijiet ta' tossiċità severa tal-fwied/insuffiċjenza akuta tal-fwied, inkluż każijiet b'riżultat fatali, f'pazjenti bis-sindrome ta' Cockayne ġew irrapportati bi prodotti li fihom metronidazole.
English: Dose in children 6 months and older weighing less than 50 Kg Dose in infants (6 to 23 months), children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg:
Maltese: Doża fl-adulti u fl-adolexxenti (12 sa 17-il sena) li jiżnu 50 kg jew aktar:
English: General dose: between 10 ml (1000 mg) and 30 ml (3,000 mg) each day, divided in 2 intakes per day.
Maltese: Doża ġenerali: bejn 10 ml (1000 mg) u 30 ml (3,000 mg) kuljum, maqsuma f'darbtejn kuljum.
English: General dose: between 10 ml (1,000 mg) and 30 ml (3,000 mg) each day, divided in 2 intakes per day.
Maltese: Doża ġenerali: bejn 10 ml (1,000 mg) u 30 ml (3,000 mg) kuljum, maqsuma f'żewġ teħid tad-doża kuljum.
English: Cases of severe hepatotoxicity/acute hepatic failure, including cases with a fatal outcome with very rapid onset after treatment initiation in patients with Cockayne syndrome have been reported with products containing metronidazole for systemic use.
Maltese: Każijiet ta' tossiċità severa tal-fwied/insuffiċjenza akuta tal-fwied, inkluż każijiet b'riżultat fatali b'bidu rapidu ħafna wara l-inizjazzjoni tal-kura f'pazjenti bis-sindrome ta' Cockayne ġew irrapportati bi prodotti li fihom metronidazole għall-użu sistemiku.
English: General dose: Keppra is taken twice daily, in two equally divided doses, each individual dose being measured between 0.1 ml (10mg) and 0.3 ml (30mg), per kg bodyweight of the child. (see table below for dose examples).
Maltese: Keppra jittieħed darbtejn kuljum, f'żewġ dożi maqsumin indaqs, kull doża individwali titkejjel bejn 0.1 ml (10 mg) u 0.3 ml (30 mg), għal kull kg ta' piż tal-ġisem tat-tifel/tifla.
English: General dose: between 0.14 ml (14 mg) and 0.42 ml (42 mg) per kg bodyweight each day, divided in 2 intakes per day.
Maltese: Doża ġenerali: bejn 0.14 ml (14 mg) u 0.
English: If the liver function tests become markedly elevated during treatment, the drug should be discontinued.
Maltese: Jekk it-testijiet tal-funzjoni tal-fwied isiru elevati b'mod ċar waqt il-kura, il-mediċina għandha titwaqqaf.
English: For children 6 months to 4 years, measure the appropriate dosage using the 3 ml syringe included in the package.
Maltese: Għal tfal li għandhom minn 6 xhur sa 4 snin, kejjel id-dożaġġ xieraq bl-użu ta' siringa ta' 3 ml inkluża fil-pakkett.
English: Patients with Cockayne syndrome should be advised to immediately report any symptoms of potential liver injury to their physician and stop taking metronidazole.
Maltese: Pazjenti bis-sindrome ta' Cockayne għandhom jingħataw il-parir sabiex jirrapportaw minnufih kwalunkwe sintomu ta' ħsara potenzjali lill-fwied lit-tabib tagħhom u jieqfu jieħdu metronidazole.
English: For children above 4 years, measure the appropriate dosage using the 10 ml syringe included in the package.
Maltese: Għal tfal li għandhom aktar minn 4 snin, kejjel id-dożaġġ xieraq bl-użu ta' siringa ta' 10 ml inkluża fil-pakkett.
English: For infants 1 month to less than 6 months, measure the appropriate dosage using the 1 ml syringe included in the package.
Maltese: Għal trabi ta' xahar sa anqas minn 6 xhur, kejjel id-dożaġġ xieraq bl-użu ta' siringa ta' 1 ml inkluża fil-pakkett.
English: Summary of product characteristics (except for products for external use on the skin)
Maltese: Sommarju tal-karatteristiċi tal-prodott (ħlief għal prodotti ta' użu estern fuq il-ġilda)
English: Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/130)
Maltese: Eżitu ta' proċedura ta' referenza skont l-Artikolu 35 tad-Direttiva 2001/82/KE (EMEA/V/A/130)
English: The full changes made to the product information are detailed in Annex III of the CVMP opinion under 'All documents'.
Maltese: III tal-opinjoni tas-CVMP taħt ‘Id-dokumenti kollha' (‘All documents').
English: 20 September 2019
Maltese: EMA/602828/2019
English: What is tylosin?
Maltese: X'inhu tilosina?
English: Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CVMP concluded that, for 49 out of 50 products, those containing benzyl alcohol and propylene glycol as a non-active ingredient, the withdrawal periods for meat and offal from treated sheep should be 42 days, while the withdrawal periods for milk from treated sheep should be 108 hours.
Maltese: Abbażi tal-evalwazzjoni tad-data disponibbli bħalissa u d-diskussjoni xjentifika fi ħdan il-Kumitat, isCVMP ikkonkluda li, għal 49 minn 50 prodott, dawk li fihom l-alkoħol benżiliku u l-glikol tal-propilen bħala ingredjent mhux attiv, il-perjodi tal-irtirar għal-laħam u l-ġewwieni minn nagħaġ ikkurati għandhom ikunu 42 jum, filwaqt li l-perjodi ta' rtirar għall-ħalib minn nagħaġ ikkurati għandhom ikunu 108 siegħa.
English: Tylosin is a macrolide antibiotic used mainly to treat infections caused by bacteria known as Grampositive bacteria.
Maltese: Tilosina huwa antibijotiku makrolidu użat prinċipalment għall-kura ta' infezzjonijiet ikkawżati minn batterji magħrufa bħala batterji Gram-pożittivi.
English: Veterinary medicines containing tylosin are used in adult cattle, calves, pigs, sheep and goats and are given by injection into the muscle.
Maltese: Il-mediċini veterinarji li fihom tilosina jintużaw f'bhejjem tal-ifrat adulti, għoġġiela, ħnieżer, nagħaġ u mogħoż u jingħataw b'injezzjoni fil-muskolu.
English: The CVMP reviewed available data on residue depletion, which indicates how long a medicine takes to fall below maximum residue limits (MRLs) in the animal's body.
Maltese: Is-CVMP irrieżamina data disponibbli dwar it-tnaqqis ta' residwu, li jindika kemm iddum mediċina li taqa' taħt il-limiti massimi ta' residwi (MRLs) fil-ġisem tal-annimal.
English: The Dutch authority considered that the withdrawal periods for sheep in the EU might not be adequate to ensure consumer safety, noting that withdrawal periods differed across the EU: from 8 to 42 days for sheep meat and offal and from 4 to 7 days for sheep milk.
Maltese: L-awtorità Olandiża kkunsidrat li l-perjodi ta' tiżmim għan-nagħaġ fl-UE jistgħu ma jkunux adegwati biex tiġi żgurata s-sigurtà tal-konsumatur, filwaqt li nnotat li l-perjodi ta' rtirar ivarjaw madwar l-UE: minn 8 ijiem sa 42 jum għal-laħam u l-ġewwieni tan-nagħaġ u minn 4 sa 7 ijiem għall-ħalib tannagħaġ.
English: Why were veterinary medicines containing tylosin reviewed?
Maltese: Għaliex ġew rieżaminati mediċini veterinarji li fihom tilosina?
English: The Committee concluded that the injection should be divided over two injection sites (maximum 2.5 ml injection volume per injection site).
Maltese: Il-Kumitat ikkonkluda li l-injezzjoni għandha tinqasam f'żewġ siti ta' injezzjoni (volum massimu ta' injezzjoni ta' 2.5 ml għal kull sit ta' injezzjoni).
English: On 28 September 2018, the Dutch medicines authority requested that the CVMP review all available data and recommend withdrawal periods for milk, meat and offal from sheep treated with injectable veterinary medicines containing tylosin.
Maltese: Fit-28 ta' Settembru 2018, l-awtorità Olandiża tal-mediċini talbet li s-CVMP jirrieżamina d-data kollha disponibbli u jirrakkomanda perjodi ta' rtirar għal ħalib, laħam u ġewwieni minn nagħaġ ikkurati b'mediċini veterinarji injettabbli li fihom tilosina .
English: On 20 June 2019, the European Medicines Agency completed a review of the withdrawal periods for injectable veterinary medicines containing tylosin when used in sheep.
Maltese: Fl-20 ta' Ġunju 2019, l-Aġenzija Ewropea għall-Mediċini temmet rieżami tal-perjodi ta' rtirar għal mediċini veterinarji injettabbli li fihom tilosina meta jintużaw fin-nagħaġ.
English: For one medicine, Tilocen, which contains the non-active ingredient polyethylene glycol 400, there were no data available that could be used to set adequate withdrawal periods in sheep.
Maltese: Għal mediċina waħda, Tilocen, li fiha l-ingredjent mhux attiv ta' polietilenglikol 400, ma kien hemm lebda data disponibbli li setgħet tintuża biex jiġu stabbiliti perjodi ta' rtirar adegwati fin-nagħaġ.
English: Therefore, the CVMP concluded that the benefit-risk balance for the veterinary medicine Tilocen is not favourable for sheep and recommended a change to its marketing authorisation to remove any reference to use in sheep.
Maltese: Għalhekk, is-CVMP ikkonkluda li l-bilanċ bejn il-benefiċċju u r-riskju għall-mediċina veterinarja Tilocen mhuwiex favorevoli għan-nagħaġ u rrakkomanda bidla fl-awtorizzazzjoni għat-tqegħid fis-suq tiegħu biex titneħħa kwalunkwe referenza għall-użu fin-nagħaġ.
English: The European Commission issued a decision on 20 September 2019.
Maltese: Il-Kummissjoni Ewropea ħarġet deċiżjoni fl-20 ta' Settembru 2019.
English: The withdrawal period is the minimum time that has to elapse before an animal treated with a medicine can be slaughtered and its meat or other animal derived products may be used for human consumption.
Maltese: Mistoqsijiet u tweġibiet dwar il-perjodi ta' rtirar għal mediċini veterinarji injettabbli li fihom tilosina meta jingħataw lin-nagħaġ
English: EMA/696962/2014 EMEA/H/C/002785
Maltese: EMEA/H/C/002785
English: The full EPAR for Corbilta 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: All of the tablets contain 200 mg entacapone.
Maltese: Il-pilloli kollha fihom 200 mg entacapone.
English: Other information about Corbilta
Maltese: Informazzjoni oħra dwar Corbilta
English: Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5520
Maltese: Telephone +44 (0)20
English: The maximum daily dose of Corbilta is 10 tablets, except for the tablets containing 175 mg levodopa and 43.75 mg carbidopa, for which the maximum daily dose is eight tablets, and those containing 200 mg levodopa and 50 mg carbidopa, for which the maximum daily dose is seven tablets.
Maltese: Id-doża massima ta' kuljum ta' Corbilta hija 10 pilloli, għajr għall-pilloli li fihom 175 mg levodopa u 43.75 mg carbidopa, li għalihom id-doża massima hija tmien pilloli kuljum u dawk li fihom 200 mg levodopa u 50 mg carbidopa li għalihom id-doża massima ta' kuljum hija seba' pilloli kuljum.
English: Corbilta is available as a range of tablets in seven strengths, containing 50 to 200 mg levodopa and 12.5 to 50 mg carbidopa.
Maltese: Corbilta jiġi f'diversi pilloli b'seba' qawwiet differenti, li fihom minn 50 sa 200 mg levodopa u 12.5 sa 50 mg carbidopa.
English: Corbilta is a medicine that contains three active substances: levodopa, carbidopa and entacapone.
Maltese: Corbilta huwa mediċina li fiha tliet sustanzi attivi: levodopa, carbidopa u entacapone.
English: Why is Corbilta approved?
Maltese: Għal xiex ġie approvat Corbilta?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Corbilta on 11 November 2013.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Corbilta fil-11 ta' Novembru 2013.
English: • severely reduced liver function;
Maltese: • funzjoni tal-fwied imnaqqsa b'mod sever;