FrancophonIA/ELRC3.0 huggingface dataset:
English: Metformin Hydrochloride 850mg Tablet, Linagliptin 2.5mg Tablet
Maltese: Metformin Hydrochloride 850 mg Pillola, Linagliptin 2.5 mg Pillola
English: Metformin Lindopharm Metformin Hydrochloride 850mg Tablet
Maltese: Metformin Lindopharm Metformin Hydrochloride 850 mg Pillola
English: Austria 1a Pharma Gmbh
Maltese: 1a Pharma Gmbh
English: Metformin Hcl Plus Pharmacie Metformin Hydrochloride 500mg Tablet
Maltese: Metformin Hcl Plus Pharmacie Metformin Hydrochloride 500 mg Pillola
English: Metformin Lindopharm Metformin Hydrochloride 500mg Tablet
Maltese: Metformin Lindopharm Metformin Hydrochloride 500 mg Pillola
English: Metformin Hydrochloride 1000mg Tablet, Sitagliptin 50mg Tablet
Maltese: Metformin Hydrochloride 1000 mg Pillola, Sitagliptin 50 mg Pillola
English: Metformin Crescent Pharma Metformin Hydrochloride 850mg Tablet
Maltese: Metformin Crescent Pharma Metformin Hydrochloride 850 mg Pillola
English: Metformin Hydrochloride 1000mg Tablet, Empagliflozin 12.5mg Tablet
Maltese: Metformin Hydrochloride 1000 mg Pillola, Empagliflozin 12.5 mg Pillola
English: Metformin Crescent Pharma Metformin Hydrochloride 500mg Tablet
Maltese: Metformin Crescent Pharma Metformin Hydrochloride 500 mg Pillola
English: Denmark Rosemont Pharmaceuticals Limited Metformin Rosemont
Maltese: Id-Danimarka Rosemont Pharmaceuticals Limited Metformin Rosemont
English: Metformin Hydrochloride 850mg Tablet, Alogliptin 12.5mg Tablet
Maltese: Metformin Hydrochloride 850 mg Pillola, Alogliptin 12.5 mg Pillola
English: Greece Rosemont Pharmaceuticals Limited Metformin Hydrochloride Rosemont
Maltese: Rosemont Pharmaceuticals Limited Metformin Hydrochloride Rosemont
English: Metformin Chelonia Healthcare Metformin Hydrochloride Bp 500mg
Maltese: Metformin Chelonia Healthcare Metformin Hydrochloride Bp 500 mg Pillola Miksija b'Rita
English: Metformin Hydrochloride 850mg Tablet, Dapagliflozin 5mg Tablet
Maltese: Metformin Hydrochloride 850 mg Pillola, Dapagliflozin 5 mg Pillola
English: Metformin Hydrochloride 1000mg
Maltese: Metformin Hydrochloride 1000 mg Sachet
English: Metformin Hydrochloride 1000mg Tablet, Dapagliflozin 5mg Tablet
Maltese: Metformin Hydrochloride 1000 mg Pillola, Dapagliflozin 5 mg Pillola
English: Metformin Hydrochloride 850mg Tablet, Pioglitazone 15mg Tablet
Maltese: Metformin Hydrochloride 850 mg Pillola, Pioglitazone 15 mg Pillola
English: Tolife - Produtos Farmacêuticos, S.A.
Maltese: Tolife - Produtos Farmacêuticos, S.A. Metformina Tolife
English: Metformin Hydrochloride 850mg Tablet, Sitagliptin 50mg Tablet
Maltese: Metformin Hydrochloride 850 mg Pillola, Sitagliptin 50 mg Pillola
English: Metformin Hydrochloride 850mg Tablet, Empagliflozin 12.5mg Tablet
Maltese: Metformin Hydrochloride 850 mg Pillola, Empagliflozin 12.5 mg Pillola
English: Metformin Hydrochloride 1000mg Tablet, Glibenclamide 5mg Tablet
Maltese: Metformin Hydrochloride 1000 mg Pillola, Glibenclamide 5 mg Pillola
English: Norway Rosemont Pharmaceuticals Limited Metformin Rosemont
Maltese: Rosemont Pharmaceuticals Limited Metformin Rosemont
English: Germany Juta Pharma Gmbh
Maltese: Juta Pharma Gmbh
English: Germany Tad Pharma Gmbh
Maltese: Tad Pharma Gmbh
English: Metformin Hcl Plus Pharmacie Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Maltese: Metformin Hcl Plus Pharmacie Metformin Hydrochloride 1000 mg Pillola
English: Metformin Hydrochloride 1000mg Tablet, Canagliflozin 50mg Tablet
Maltese: Metformin Hydrochloride 1000 mg Pillola, Canagliflozin 50 mg Pillola
English: Metformin Hydrochloride 1000mg Film Film-Coated Tablet
Maltese: Metformin Hydrochloride 1000 mg Film
English: Metformin Hydrochloride 850mg Tablet, Canagliflozin 50mg Tablet
Maltese: Metformin Hydrochloride 850 mg Pillola, Canagliflozin 50 mg Pillola
English: Metformin Hydrochloride 1000mg Tablet, Empagliflozin 5mg Tablet
Maltese: Metformin Hydrochloride 1000 mg Pillola, Empagliflozin 5 mg Pillola
English: Metformin Hydrochloride 850mg Tablet, Empagliflozin 5mg Tablet
Maltese: Metformin Hydrochloride 850 mg Pillola, Empagliflozin 5 mg Pillola
English: Metformin Hydrochloride 1000mg Tablet Tablet
Maltese: Metformin Hydrochloride 1000 µg Pillola
English: Metformin Hydrochloride 1000mg Tablet, Canagliflozin 150mg Tablet
Maltese: Metformin Hydrochloride 1000 mg Pillola, Canagliflozin 150 mg Pillola
English: Metformin/Glibenklamid Lek Metformin Hydrochloride 500mg Tablet, Glibenclamide 5mg Tablet
Maltese: Lek Pharmaceuticals D.D. Ljubljana Metformin/Glibenklamid Lek Metformin Hydrochloride 500 mg Pillola, Glibenclamide 5 mg Pillola
English: Metformin/Glibenklamid Lek Metformin Hydrochloride 500mg Tablet, Glibenclamide 2.5mg Tablet
Maltese: Lek Pharmaceuticals D.D. Ljubljana Metformin/Glibenklamid Lek Metformin Hydrochloride 500 mg Pillola, Glibenclamide 2.5 mg Pillola
English: Metformin Hydrochloride 850mg Tablet, Canagliflozin 150mg Tablet
Maltese: Metformin Hydrochloride 850 mg Pillola, Canagliflozin 150 mg Pillola
English: Metformin Hydrochloride 400mg Tablet, Glibenclamide 2.5mg Tablet
Maltese: Metformin Hydrochloride 400 mg Pillola, Glibenclamide 2.5 mg Pillola
English: Metformin Hydrochloride 2.5mg Tablet, Glibenclamide 500mg Tablet
Maltese: Metformin Hydrochloride 2.5 mg Pillola, Glibenclamide 500 mg Pillola
English: Germany Sandoz Pharmaceuticals Gmbh Metformin Sandoz
Maltese: Sandoz Pharmaceuticals Gmbh
English: Luxembo urg
Maltese: L-Awstrija
English: Metformin Hydrochloride 500mg Tablet, Glibenclamide 2.5mg Tablet
Maltese: Metformin Hydrochloride 500 mg Pillola, Glibenclamide 2.5 mg Pillola
English: Focus Pharmaceuticals Limited Metformin Focus Pharmaceuticals
Maltese: Metformin Focus Pharmaceuticals
English: Metformin Hcl Ratiopharm Metformin Hydrochloride 500mg Tablet
Maltese: Metformin Hcl Ratiopharm Metformin Hydrochloride 500 mg Pillola
English: Metformin Hcl Ratiopharm Metformin Hydrochloride 850mg Tablet
Maltese: Metformin Hcl Ratiopharm Metformin Hydrochloride 850 mg Pillola
English: Metformin Hydrochloride 400mg Tablet, Glibenclamide 5mg Tablet
Maltese: Metformin Hydrochloride 400 mg Pillola, Glibenclamide 5 mg Pillola
English: Metformin-Ratiopharm Metformin Hydrochloride 500mg Tablet
Maltese: Metformin-Ratiopharm Metformin Hydrochloride 500 mg Pillola
English: Metformin Hydrochloride 500mg Tablet, Glibenclamide 5mg Tablet
Maltese: Metformin Hydrochloride 500 mg Pillola, Glibenclamide 5 mg Pillola
English: Metformin-Ratiopharm Metformin Hydrochloride 850mg Tablet
Maltese: Metformin-Ratiopharm Metformin Hydrochloride 850 mg Pillola
English: Metformine Hcl Ratiopharm Metformin Hydrochloride 500mg Tablet
Maltese: Metformine Hcl Ratiopharm Metformin Hydrochloride 500 mg Pillola
English: Metformine Hcl Ratiopharm Metformin Hydrochloride 850mg Tablet
Maltese: Metformine Hcl Ratiopharm Metformin Hydrochloride 850 mg Pillola
English: Germany Denk Pharma Gmbh & Co. Kg Metfo
Maltese: Denk Pharma Gmbh & Co.
English: Czech Republic
Maltese: ls-Slovakkja
English: Metformin Ratiopharm Metformin Hydrochloride 850mg Tablet
Maltese: Metformin Ratiopharm Metformin Hydrochloride 850 mg Pillola
English: Metformin Hydrochloride 500mg G
Maltese: Metformin Hydrochloride 500 mg Sachet
English: Metformin Ratiopharm Metformin Hydrochloride 500mg Tablet
Maltese: Metformin Ratiopharm Metformin Hydrochloride 500 mg Pillola
English: Metformine Ratiopharm Metformin Hydrochloride 500mg Tablet
Maltese: Metformine Ratiopharm Metformin Hydrochloride 500 mg Pillola
English: Metformin Hydrochloride 500mg/5 Ml
Maltese: Metformin Hydrochloride 500 mg/5 Ml Soluzzjoni Orali
English: Wörwag Pharma Gmbh & Co. Kg Metfogamma
Maltese: Wörwag Pharma Gmbh & Co.
English: Metformine Ratiopharm Metformin Hydrochloride 850mg Tablet
Maltese: Metformine Ratiopharm Metformin Hydrochloride 850 mg Pillola
English: Metformina Ratiopharm Metformin Hydrochloride 500mg Tablet
Maltese: Metformina Ratiopharm Metformin Hydrochloride 500 mg Pillola
English: Metformina Ratiopharm Metformin Hydrochloride 850mg Tablet
Maltese: Metformina Ratiopharm Metformin Hydrochloride 850 mg Pillola
English: Metformin Hcl Ratiopharm Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Maltese: Metformin Hcl Ratiopharm Metformin Hydrochloride 1000 mg Pillola
English: Metformine Hcl Ratiopharm Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Maltese: Metformine Hcl Ratiopharm Metformin Hydrochloride 1000 mg Pillola
English: Metformin Hydrochloride 500mg Film Film-Coated Tablet
Maltese: Metformin Hydrochloride 500 mg Film Pillola Miksija b'Rita
English: Metformin Hydrochloride 500mgg
Maltese: Metformin Hydrochloride 500 mg Soluzzjoni Orali
English: It is available as capsules (100 mg).
Maltese: Jiġi bħala kapsuli (100 mg).
English: • Niemann-Pick type C disease.
Maltese: • il-marda Niemann-Pick tip C .
English: Other information about Zavesca:
Maltese: Informazzjoni oħra dwar Zavesca:
English: • Gaucher disease;
Maltese: • il-marda Gaucher;
English: EPAR summary for the public miglustat
Maltese: Sommarju tal-EPAR għall-pubbliku miglustat
English: The full EPAR for Zavesca 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: The summaries of the opinions of the Committee for Orphan Medicinal Products for Zavesca on the Agency's website ema.europa.eu/Find medicine/Human medicines/Rare disease designations:
Maltese: Is-sommarji tal-opinjonijiet tal-Kumitat għall-Prodotti Mediċinali Orfni għal Zavesca jinsabu fis-sit elettroniku tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/Rare disease designations:
English: In the study of type 1 Gaucher disease, there were moderate reductions in the size of the liver (12% reduction) and the spleen (19% reduction) after a year.
Maltese: Fl-istudju tal-marda Gaucher tat-tip 1, kien hemm tnaqqis moderat fid-daqs tal-fwied (12 % tnaqqis) u tal-milsa (19 % tnaqqis) wara sena.
English: Zavesca is a medicine that contains the active substance miglustat.
Maltese: Zavesca huwa mediċina li fiha s-sustanza attiva miglustat.
English: • adults (aged 18 years and above) with mild to moderate type 1 Gaucher disease.
Maltese: • adulti (minn 18-il sena ‘l fuq) bil-marda Gaucher tat-tip 1 bejn ħafifa u moderata.
English: This document is a summary of the European Public Assessment Report (EPAR) for Zavesca.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Zavesca.
English: For Niemann-Pick type C disease, Zavesca was studied in one main study involving 31 patients, 12 of whom were less than 12 years old.
Maltese: Għall-marda Niemann-Pick tat-tip C, Zavesca ġie studjat fi studju ewlieni li involva 31 pazjent, 12 minnhom kellhom anqas minn 12-il sena.
English: There were also small improvements in blood counts: on average, the levels of haemoglobin increased by 0.26 g per decilitre and platelet counts increased by 8.29 million per millilitre.
Maltese: Kien hemm ukoll titjib żgħir fl-għadd komplut tad-demm: bħala medja, il-livelli tal-emoglobina żdiedu minn 0.26 g kull deċilitru u l-għadd ta' pjastrini żdied bi 8.29 miljun kull millilitru.
English: What is the risk associated with Zavesca?
Maltese: X'inhu r-riskju assoċjat ma' Zavesca?
English: Zavesca is used in patients who cannot receive the standard treatment of enzyme replacement therapy (ERT);
Maltese: Zavesca jintuża fuq pazjenti li ma jistgħux jieħdu t-trattament standard ta' terapija enzimatika sostituttiva (ERT) ;
English: The active substance in Zavesca, miglustat, prevents an enzyme called glucosylceramide synthase from working.
Maltese: Is-sustanza attiva f'Zavesca, il-miglustast, tipprevjeni enzima msejjħa sintażi tal-glukosilċeramide ) milli taħdem.
English: Why has Zavesca been approved?
Maltese: Għaliex ġie approvat Zavesca?
English: The most common side effects with Zavesca (seen in more than 1 patient in 10) are weight loss, decreased appetite, tremor (shaking), diarrhoea, flatulence (gas) and abdominal pain (stomach ache).
Maltese: L-effetti sekondarji l-aktar komuni b'Zavesca (li ntwerew f'iktar minn pazjent wieħed minn kull 10) huma telf fil-piż, nuqqas ta' aptit, rogħda, dijarrea, flatulanza (gass) u wġigħ addominali (uġigħ ta' stonku).
English: Because the number of patients with these diseases is low, they are considered ‘rare', and Zavesca was designated an ‘orphan medicine' (a medicine used in rare diseases) on 18 October 2000 for type 1 Gaucher disease and on 16 February 2006 for Niemann-Pick type C disease.
Maltese: Billi l-għadd ta' pazjenti b'dan il-mard huwa baxx, huma kkunsidrati ‘rari', u Zavesca kien ikklassifikat bħala ‘mediċina orfni' (mediċina użata għal mard rari) fit-18 ta' Ottubru 2000 għall-marda Gaucher tattip 1 u fis-16 ta' Frar 2006 għall-marda Niemann Pick tat-tip Ċ.
English: These include loss of co-ordination, problems with ‘saccadic' (rapid) eye movements that can lead to impaired vision, delayed development, difficulty swallowing, decreased muscle tone, fits and learning difficulties.
Maltese: Dawn jinkludu nuqqas ta' koordinazzjoni, problemi b'movimenti mgħaġġla tal-għajnejn tat-tip ‘saccadic' li jistgħu jwasslu għat-telf tal-vista, żvilupp ritardat, problemi biex wieħed jibla', tnaqqis fit-ton talmuskulatura, attakki ta' konvulżjoni u problemi fit-tagħlim.
English: What is Zavesca?
Maltese: X'inhu Zavesca?
English: As the company had supplied the additional information requested, the exceptional circumstances ended on 23 August 2012.
Maltese: Billi l-kumpanija pprovdiet it-tagħrif addizzjonali mitlub, iċ-ċirkostanzi eċċezzjonali ntemmu fit-23 ta' Awwissu 2012.
English: Patients with this disease lack an enzyme called glucocerebrosidase, which results in a glycosphingolipid called glucosylceramide building up in different parts of the body, such as the spleen, liver and bones.
Maltese: Pazjenti b'din ilmarda għandhom nuqqas ta' enzimi msejħa glukoċerebrosidażi, li jwassal għal żieda fil-livell ta' sustanza glukosilċeramide f'partijiet differenti tal-ġisem, bħall-milsa, il-fwied u l-għadam.
English: For type 1 Gaucher disease, Zavesca was investigated in one main study involving 28 adults with mild to moderate disease who were unable or unwilling to receive ERT.
Maltese: Għall-marda Gaucher tat-tip 1, Zavesca ġie investigat fi istudju ewlieni li involva 28 adult bil-marda bejn ħafifa u moderata li ma setgħux jew ma ridux jingħataw ERT. Il-parti prinċipali tal-istudju damet sena, iżda 13-il pazjent baqgħu jirċievu l-mediċina għal sentejn oħra.
English: This is expected to slow down or prevent the development of the symptoms of type 1 Gaucher disease and to reduce the symptoms of Niemann-Pick type C disease.
Maltese: Dan huwa mistenni li jnaqqas jew jipprevjeni l-iżvilupp tas-sintomi tal-marda Gaucher tat-tip 1 u jitnaqqsu s-sintomi tal-marda Niemann Pick tat-tip Ċ.
English: Zavesca is used to treat the neurological symptoms of the disease (symptoms affecting the brain and nerves).
Maltese: Zavesca jintuża sabiex jittratta s-sintomi newroloġiċi tal-marda (sintomi li jaffettwaw il-moħħ u n-nervituri).
English: The survey showed that Zavesca led to a stabilisation or a decrease in the rate at which symptoms got worse in about three-quarters of the patients.
Maltese: L-istħarriġ wera li Zavesca wassal għal stabilizzazzjoni jew għal tnaqqis fir-rata li biha s-sintomi marru għall-agħar f'madwar tliet kwarti talpazjenti.
English: The recommended starting dose for type 1 Gaucher disease is one capsule three times a day.
Maltese: Id-doża inizjali rakkomandata għall-marda Gaucher tat-tip 1 hija kapsula orali tliet darbiet kuljum.
English: The company also presented the results of a survey of 66 patients treated with Zavesca.
Maltese: Il-kumpannija ppreżentat ukoll ir-riżultati ta' stħarriġ ta' 66 pazjent ikkurati b'Zavesca.
English: How is Zavesca used?
Maltese: Kif jintuża Zavesca?
English: This enzyme is involved in the first step of the production of glycosphingolipids.
Maltese: Din l-enzima hija involuta fl-ewwel pass fil-produzzjoni tal-glikosfingolipidi.
English: However, there were signs of improvement in swallowing ability and intellectual function in the patients treated with Zavesca.
Maltese: Madankollu, kien hemm sinjali ta' titjib fil-kapaċitajiet li wieħed jibla' u fil-funzjoni intellettwali fil-pazjenti ttrattati b'Zavesca.
English: • patients of all ages with Niemann-Pick type C disease, a potentially fatal disease in which glycosphingolipids build up within cells in the brain and elsewhere in the body.
Maltese: • pazjenti ta' kull età bil-marda Niemann-Pick tat-tip Ċ, marda potenzjalment fatali li fiha jakkumulaw il-glikosfingolipidi fiċ-ċelloli fil-moħħ u f'partijiet oħra tal-ġisem.
English: The CHMP decided that Zavesca's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Zavesca huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: In the study of Niemann-Pick type C disease, the improvement in eye movements was similar in patients treated with and without Zavesca.
Maltese: Fl-istudju tal-marda Niemann-Pick tat-tip Ċ, it-titjib fil-movimenti tal-għajnejn kien simili fil-pazjenti ttrattati b'Zavesca u mingħajru.
English: What benefit has Zavesca shown during the studies?
Maltese: Liema benefiċċju wera Zavesca matul l-istudji?
English: For further information, see the summary of product characteristics (also part of the EPAR).
Maltese: Għal aktar informazzjoni, ara s-sommarju talkaratteristiċi tal-prodott (parti wkoll mill-EPAR).
English: Zavesca was originally authorised under ‘exceptional circumstances' because, as the diseases are rare, limited information was available at the time of approval.
Maltese: Zavesca kien oriġinarjament awtorizzat f'‘ċirkostanzi eċċezzjonali', għaliex, minħabba li l-marda hija rari, fi żmien l-approvazzjoni t-tagħrif disponibbli kien limitat.
English: The main measure of effectiveness was the change in the speed at which the patients made saccadic horizontal eye movements after a year, but the study also looked at other neurological symptoms such as the patients' ability to swallow and their intellectual function.
Maltese: Il-kejl prinċipali tal-effikaċja kien il-bidla fl-għaġla fil-movimenti talgħajnejn b'mod orizzontali tat-tip ‘saccadic' wara sena, iżda l-istudju ħares ukoll lejn sintomi newroloġiċi oħrajn bħalma huma l-kapaċitajiet tal-pazjenti sabiex jibilgħu u l-funzjoni intellettwali tagħhom.
English: The study looked at the effect of Zavesca on the size of the liver and spleen, and at blood counts, such as the levels of haemoglobin (a protein found in red blood cells that carries oxygen around the body) and platelets (components that help the blood to clot).
Maltese: L-istudju ħares lejn l-effett ta' Zavesca fuq id-daqs tal-fwied u l-milsa, u fuq il-parametri tad-demm, bħal-livelli tal-emoglobina (proteina fiċ-ċelloli ħomor tad-demm li ġġorr l-ossiġnu mal-ġisem) u l-pjastrini (komponenti li jgħinu ddemm jagħqad).
English: For the full list of all side effects reported with Zavesca, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Zavesca, ara l-fuljett ta' tagħrif.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22 August 2016
Maltese: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22 ta' Awwissu 2016
English: Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/110)
Maltese: Riżultat ta' proċedura ta' riferiment skont l-Artikolu 35 tadDirettiva 2001/82/KE (EMEA/V/A/110)
English: Which data has the CVMP reviewed?
Maltese: Liema data rreveda s-CVMP?
English: Lincomycin is active against gram-positive bacteria, some anaerobic gram-negative bacteria and Mycoplasma spp.
Maltese: Il-linkomiċina hija attiva kontra batterji gram-pożittivi, xi batterji anaerobiċi gram-negattivi u Mycoplasma spp.
English: What are lincomycin and spectinomycin?
Maltese: X'inhuma linkomiċina u spektinomiċina?
English: Commission Decision concerning, in the framework of Article 34 of Directive 2001/82/EC of the European Parliament and of the Council, the marketing authorisations for “Linco-Spectin 100 and its associated names”, veterinary medicinal products which contain the active substances “Lincomycin and spectinomycin” ((2014)5053 of 11/07/2014) http://ec.europa.eu/health/documents/community-register/html/vo25233.htm
Maltese: Deċiżjoni tal-Kummissjoni li tikkonċerna, fil-qafas tal-Artikolu 34 tad-Direttiva 2001/82/KE tal-Parlament Ewropew u talKunsill, l-awtorizzazzjonijiet għall-kummerċjalizzazzjoni għal “LincoSpectin 100 u ismijiet assoċjati tiegħu", prodotti mediċinali veterinarji li fihom issustanzi attivi “Lincomycin u spectinomycin” ((2014) 5053 tal-11/07/2014) http://ec.europa.eu/health/documents/community-register/html/vo25233.htm
English: Lincomycin is a lincosamide antibiotic derived from Streptomyces lincolnensis which inhibits protein synthesis.
Maltese: Il-linkomiċina hija antibijotiku linkosamidi derivat minn Streptomyces lincolnensis li jinibixxi s-sinteżi tal-proteini.
English: Spectinomycin is an aminocyclitol antibiotic derived from Streptomyces spectabilis; it has bacteriostatic activity and is active against some aerobic gram-negative bacteria, gram-positive cocci and Mycoplasma spp.
Maltese: Is-spektinomiċina hija antibijotiku aminocyclitol derivat minn Streptomyces spectabilis; għandu attività batterjostatika u huwa attiv kontra xi batterji aerobiċi gram-negattivi, kokki gram-pożittivi u Mycoplasma spp.
English: In September 2012 Belgium initiated a referral procedure under Article 34 of Directive 2001/82/EC for Linco-Spectin 100, powder for use in the drinking water for pigs and chickens (EMEA/V/A/088).
Maltese: F'Settembru 2012 il-Belġju ta bidu għal proċedura ta' riferiment skont l-Artikolu 34 tadDirettiva 2001/82/KE għal Linco-Spectin 100, trab għall-użu fl-ilma tax-xorb għall-ħnieżer u għat-tiġieġ (EMEA/V/A/088).
English: On 19 May 2016, the European Medicines Agency (the Agency) completed a review of the safety and effectiveness of, and antimicrobial resistance to, veterinary medicinal products containing a combination of lincomycin and spectinomycin to be administered orally to pigs and/or poultry.
Maltese: Fid-19 ta' Mejju 2016, l-Aġenzija Ewropea għall-Mediċini (l-Aġenzija) temmet reviżjoni tas-sigurtà u leffikaċja ta', u tar-reżistenza antimikrobika għal, prodotti mediċinali veterinarji li fihom kombinazzjoni ta' linkomiċina u spektinomiċina għall-għoti b'mod orali lill-ħnieżer u/jew lit-tjur.
English: Therefore, on 5 May 2015, Belgium initiated a procedure under Article 35 of Directive 2001/82/EC for veterinary medicinal products containing a combination of lincomycin and spectinomycin to be administered orally to pigs and/or poultry.
Maltese: Għalhekk, fil-5 ta' Mejju 2015, il-Belġju beda proċedura skont l-Artikolu 35 tad-Direttiva 2001/82/KE għall-prodotti mediċinali veterinarji li fihom kombinazzjoni ta' linkomiċina u spektinomiċina biex jingħataw b'mod orali lill-ħnieżer u/jew lit-tjur.
English: The lincosamides are considered to be bacteriostatic agents.
Maltese: Il-linkosamidi huma meqjusa bħala sustanzi batterjostatiċi.
English: The full changes made to the product information for powders for use in the drinking water are detailed in Annex III of the CVMP opinion on the 'All documents' tab.
Maltese: III tal-opinjoni tas-CVMP taħt it-tab "Id-dokumenti kollha" ("All documents").
English: Why were veterinary medicinal products containing a combination of lincomycin and spectinomycin reviewed?
Maltese: Għaliex ġew riveduti l-prodotti mediċinali veterinarji li fihom kombinazzjoni ta' linkomiċina u spektinomiċina?