FrancophonIA/ELRC3.0 huggingface dataset:
English: In this study, a specific subgroup of patients who had symptomatic angina had a small but significant increase in the combined risk of cardiovascular death or non-fatal heart attack with Corlentor compared with placebo (3.4% vs 2.9% yearly incidence rates).
Maltese: F'dan l-istudju, sottogrupp speċifiku ta' pazjenti li kellhom anġina sintomatika kellhom żieda żgħira iżda sinifikanti fir-riskju kkombinat ta' mewt kardjovaskulari jew attakk tal-qalb mhux fatali b'Corlentor meta mqabbel ma' plaċebo (rati ta' inċidenza ta' 3.4 % fis-sena meta mqabbla ma' 2.9 %).
English: Corlentor therefore reduces or prevents the symptoms of angina.
Maltese: Għaldaqstant Corlentor inaqqas jew jipprevjeni s-sintomi tal-anġina.
English: For the treatment of angina, Corlentor was originally authorised for patients whose heart rate is at least 60 beats per minute.
Maltese: Għall-kura tal-anġina, Corlentor oriġinarjament ġie awtorizzat għal pazjenti li r-rata tat-taħbit tal-qalb tagħhom hija tal-inqas 60 taħbita fil-minuta.
English: In patients over 75 years old, a lower starting dose of 2.5 mg twice a day can be used.
Maltese: F'pazjenti li għandhom 'il fuq minn 75 sena, tista' tintuża doża tal-bidu iżjed baxxa ta' 2.5 mg darbtejn kuljum.
English: The main measure of effectiveness was a reduction in the risk of death due to heart problems and non-fatal heart attack.
Maltese: Il-kejl ewlieni tal-effikaċja kien tnaqqis fir-riskju tal-mewt minħabba problemi kardijaċi u infart kardijaku mhux fatali.
English: However, the use was later restricted to patients whose heart rate is at least 70 beats per minute.1
Maltese: Madankollu, aktar tard l-użu ġie ristrett għal pazjenti li rrata tat-taħbit tal-qalb tagħhom hija tal-inqas 70 taħbita fil-minuta.1
English: The most common side effect with Corlentor ( which may affect more than 1 in 10 people) is luminous phenomena or ‘phosphenes' (a temporary brightness in the field of vision).
Maltese: L-effett sekondarju l-aktar komuni b'Corlentor (li jista' jaffettwa aktar minn 1 minn 10) huwa fenomeni mdawla jew “fosfeni” (dawl qawwi temporanju fil-vista).
English: What measures are being taken to ensure the safe and effective use of Corlentor?
Maltese: X'miżuri qegħdin jitteħdu biex jiġi żgurat l-użu sigur u effettiv ta' Corlentor?
English: It is used in combination with standard therapy including beta blockers, or in patients who cannot be treated with beta blockers.
Maltese: Jintuża flimkien ma' terapija standard li tinkludi l imblokkaturi tar-riċetturi Beta, jew f'pazjenti li ma jistgħux jiġu kkurati b'imblokkaturi tar-riċetturi Beta.
English: Corlentor was compared with placebo (a dummy treatment) and other treatments in five main studies involving over 4,000 adults with long-term stable angina.
Maltese: Corlentor tqabbel ma' plaċebo (kura finta) u kuri oħra f'ħames studji ewlenin li jinvolvu aktar minn 4,000 adult b'anġina stabbli fit-tul.
English: In stable angina, these symptoms appear during physical effort.
Maltese: Fl-anġina stabbli, dawn is-sintomi jidhru waqt sforzi fiżiċi.
English: In a fourth study in 889 patients, Corlentor was more effective than placebo, when both were added to atenolol.
Maltese: Fir-raba' studju f'889 pazjent, Corlentor kien aktar effikaċji minn plaċebo, meta t-tnejn li huma ġew miżjuda ma' atenolol.
English: For the full list of restrictions with Corlentor, see the package leaflet.
Maltese: Għal-lista sħiħa ta' restrizzjonijiet b'Corlentor, ara l-fuljett ta' tagħrif.
English: It is used in those who cannot be treated with beta blockers (another type of medicine to treat angina) or in combination with a beta blocker in patients whose disease is not controlled by beta blockers alone.
Maltese: Tintuża f'dawk li ma jistgħux jiġu kkurati bl -imblokkaturi tarriċetturi Beta (tip ta' mediċina oħra għall-kura tal-anġina), jew flimkien ma' imblokkaturi tar -riċetturi Beta f'pazjenti li l-marda tagħhom ma tkunx ikkontrollata bihom biss.
English: Corlentor must not be taken with a number of other medicines.
Maltese: Corlentor m'għandux jittieħed ma' għadd ta' mediċini oħra.
English: For the full list of all side effects reported with Corlentor, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Corlentor, ara l-fuljett ta' tagħrif.
English: 25 May 2012
Maltese: 25 ta' Mejju 2012
English: International non-proprietary name (inn): doramectin
Maltese: Denominazzjoni Komuni Internazzjonali (inn): id-doramektin
English: The application was submitted to Ireland as reference Member State and Austria, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Greece, Spain, Finland, France, Hungary, Latvia, Lithuania, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia and Sweden as concerned Member States, as well as Iceland and Norway.
Maltese: L-applikazzjoni ġiet ippreżentata lill-Irlanda bħala l-Istat Membru ta' referenza u lill-Awstrija, il-Bulgarija, iċ-Ċipru, ir-Repubblika Ċeka, id-Danimarka, l-Estonja, il-Greċja, Spanja, il-Finlandja, Franza, l-Ungerija, il-Latvja, il-Litwanja, il-Pajjiżi l-Baxxi, il-Polonja, il-Portugall, ir-Rumanija, isSlovakkja, is-Slovenja u l-Isvezja, bħala Stati Membri kkonċernati, kif ukoll lill-Islanda u lin-Norveġja.
English: Article 33(4) of Directive 2001/82/EC, as amended
Maltese: 1 L-Artikolu 33(4) tad-Direttiva 2001/82/KE, kif emendata
English: The Committee appointed Dr Michael Holzhauser-Alberti as rapporteur and Dr David Murphy as co-rapporteur.
Maltese: Il-Kumitat ħatar lil Dr Michael Holzhauser-Alberti bħala relatur u lil Dr David Murphy bħala korelatur.
English: Opinion following an Article 33(4)
Maltese: Opinjoni wara referenza skont l-Artikolu 33(4)
English: Both compounds share a wide spectrum of antiparasitic activity and produce a similar paralysis in nematodes and parasitic arthropods.
Maltese: Iż-żewġ komposti jaqsmu spettru wiesa' ta' attività kontra l-parassiti u jipproduċu paraliżi simili fin-nematodi u l-antropodi parassitiċi.
English: The applicant, Pfizer Limited, submitted an application for a decentralised procedure for the above mentioned veterinary medicinal product in the framework of Article 32 of Directive 2001/82/EC, as amended.
Maltese: L-applikant, Pfizer Limited, ippreżenta applikazzjoni għal proċedura deċentralizzata għall-prodott mediċinali veterinarju msemmi hawn fuq fil-qafas tal-Artikolu 32 tad-Direttiva 2001/82/KE, kif emendat.
English: On 26 April 2011 the reference Member State, Ireland, referred the matter to the CVMP pursuant to Article 33(4) of Directive 2001/82/EC.
Maltese: Fis-26 ta' April 2011, l-Istat Membru ta' referenza, l-Irlanda, irrefera l-kwistjoni lis-CVMP skont lArtikolu 33(4) tad-Direttiva 2001/82/KE.
English: Written explanations were provided by the applicant on 13 September 2011 and 11 January 2012.
Maltese: L-applikant ipprovda spjegazzjonijiet bil-miktub fit-13 ta' Settembru 2011 u fil-11 ta' Jannar 2012.
English: Veterinary Medicines and Product Data Management
Maltese: Mediċini għall-Użu Veterinarju u Ġestjoni tad-Dejta tal-Prodotti
English: Therefore, CVMP adopted a positive opinion on 8 February 2012 recommending the granting of a Marketing Authorisation for Prontax 10 mg/ml solution for injection for cattle, sheep and pigs and associated names.
Maltese: Għaldaqstant, is-CVMP adotta opinjoni pożittiva fit-8 ta' Frar 2012 u rrakkomanda l-għoti ta' Awtorizzazzjoni għat-Tqegħid fis-Suq għassoluzzjoni Prontax 10 mg/ml għal tilqim ta' baqar, nagħaġ u ħnieżer u ismijiet assoċjati.
English: Opinion following an Article 33(4)F F referral for Prontax 10 mg/ml solution for injection for cattle, sheep and pigs and associated names EMA/281970/2012
Maltese: Opinjoni wara referenza skont l-Artikolu 33(4)F F għas-soluzzjoni Prontax 10 mg/ml għal tilqim ta' baqar, nagħaġ u ħnieżer u ismijiet assoċjati
English: Prontax 10 mg/ml solution for injection for cattle, sheep and pigs (and associated names) contains doramectin.
Maltese: Is-soluzzjoni Prontax 10mg/ml għal tilqim ta' baqar, nagħaġ u ħnieżer (u ismijiet assoċjati) fiha ddoramektin.
English: Potential serious risks were identified during the decentralised procedure by two concerned Member States regarding the environmental risk assessment (the Netherlands and France) and regarding the proposed withdrawal period for cattle (the Netherlands).
Maltese: Waqt il-proċedura deċentralizzata ġew identifikati riskji serji potenzjali rigward il-valutazzjoni tar-riskju ambjentali minn żewġ Stati Membri kkonċernati (il-Pajjiżi l-Baxxi u Franza) u rigward il-perjodu ta' rtirar propost għall-baqar (il-Pajjiżi lBaxxi).
English: Doramectin is a macrocyclic lactone and is closely related to ivermectin.
Maltese: Id-Doramektin huwa lattone makroċikliku u huwa marbut ħafna mal-ivermektin.
English: Based on evaluation of the currently available data, the CVMP considered that the benefit-risk profile of Prontax 10 mg/ml solution for injection for cattle, sheep and pigs and associated names is deemed to be positive provided that the recommended risk mitigation measures are added to the product information regarding risk to aquatic organisms and dung fauna and the withdrawal period for meat and offal in cattle is set at 70 days.
Maltese: Abbażi tal-valutazzjoni tad-dejta disponibbli attwalment, is-CVMP qies li l-profil tal-benefiċċju u r-riskju tas-soluzzjoni Prontax 10 mg/ml għal tilqim ta' baqar, nagħaġ u ħnieżer u ismijiet assoċjati huwa kkunsidrat pożittiv sakemm il-miżuri rrakkomandati ta' mitigazzjoni tar-riskju jiddaħħlu malinformazzjoni dwar il-prodott rigward ir-riskju għall-organiżmi u l-fawna tad-demel u l-perjodu ta' rtirar għal-laħam u l-ġewwieni tal-baqar huwa stabbilit għal 70 jum.
English: The referral procedure started on 5 May 2011.
Maltese: Il-proċedura ta' referenza bdiet fil-5 ta' Mejju 2011.
English: The decentralised procedure started on 26 February 2010.
Maltese: Il-proċedura deċentralizzata bdiet fis-26 ta' Frar 2010.
English: The final opinion was converted into a Decision by the European Commission on 25 May 2012.
Maltese: L-opinjoni finali inbidlet f'Deċiżjoni mill-Kummissjoni Ewropea fil-25 ta' Mejju 2012.
English: EU (MA) Number
Maltese: Numru ta' l-EU Numru tal-MA
English: MA (EU) number
Maltese: Numru tal-MA (EU)
English: Immediate packaging
Maltese: Daqs tal-pakkett
English: This summary was last updated in 08-2010.
Maltese: Dan is-sommarju kien aġġornat l-aħħar fi 08-2010.
English: • anaemia;
Maltese: • anemija;
English: It contains the active substance imiglucerase.
Maltese: Fih is-sustanza attiva imiglucerase.
English: • thrombocytopenia (low blood platelet counts);
Maltese: • tromboċitopenija (għadd baxx ta' pjastrini fid-demm);
English: The European Commission granted a marketing authorisation valid throughout the European Union for Cerezyme to Genzyme Europe B.V. on 17 November 1997.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Cerezyme lil Genzyme Europe B.V. fis-17 ta' Novembru 1997.
English: This document is a summary of the European public assessment report (EPAR) for Cerezyme.
Maltese: Dan id-dokument huwa sommarju tar-Rapport ta' Valutazzjoni Pubblika Ewropew (EPAR) għal Cerezyme.
English: The most common side effects with Cerezyme (seen in between 1 and 10 patients in 100) are dyspnoea (difficulty breathing), coughing, urticaria (hives) or angioedema (swelling beneath the skin), pruritus (itching), rash and hypersensitivity (allergic) reactions.
Maltese: L-effetti sekondarji l-iktar komuni b'Cerezyme (li dehru f'bejn pazjent wieħed u 10 minn 100) huma dispneja (diffikultà fit-teħid tan-nifs), sogħla, urtikarija (ħorriqija) jew anġjoedema (nefħa taħt ilġilda), prurite (ħakk), raxx, u reazzjonijiet ta' sensittività eċċessiva (allerġiċi).
English: Imiglucerase, the active substance in Cerezyme, is a copy of this enzyme, which is produced by a method known as ‘recombinant DNA technology': the enzyme is made by a cell that has received a gene (DNA), which enables it to produce the enzyme.
Maltese: Imiglucerase, is-sustanza attiva f'Cerezyme, hija kopja ta' din l-enzima, li tiġi prodotta permezz ta' metodu magħruf bħala ‘teknoloġija tad-DNA rikombinanti': l-enzima tiġi prodotta minn ċellola li tkun irċeviet ġene (DNA), li tippermettilha tipproduċi l-enzima.
English: Gaucher disease has previously been treated using an enzyme called alglucerase, which was prepared from human placentas.
Maltese: Il-marda Gaucher ġiet ittrattata bl-użu ta' enzima msejħa alglucerase, li ġiet prodotta mill-plaċenta umana.
English: The studies have shown that Cerezyme is as safe and effective as alglucerase in controlling the symptoms of Gaucher disease.
Maltese: L-istudji wrew li Cerezyme huwa sikur u effikaċi daqs alglucerase fil-kontroll tas-sintomi tal-marda Gaucher.
English: What is Cerezyme?
Maltese: X'inhu Cerezyme?
English: • an enlarged liver or spleen.
Maltese: • fwied u milsa mkabbrin.
English: Why has Cerezyme been approved?
Maltese: Għaliex ġie approvat Cerezyme?
English: Without the enzyme, glucosylceramide builds up in the body, typically in the liver, spleen and bone marrow, which produces the symptoms of the disease: anaemia (low red blood cell counts), tiredness, easy bruising and a tendency to bleed, an enlarged spleen and liver, and bone pain and breaks.
Maltese: Mingħajr lenzima, il-glucosylceramide jakkumula fil-ġisem, normalment fil-fwied, fil-milsa u l-mudullun talgħadam, u b'hekk jipproduċi s-sintomi tal-marda: anemia (għadd baxx ta' ċelloli ħomor tad-demm), għeja, tendenza ta' tbenġil u ta' tnixxija ta' demm, milsa u fwied imkabbra, uġigħ u ksur tal-għadam. Cerezyme jintuża f'pazjenti li jbatu mill-marda Gaucher tat-tip 1, li ma taffettwax iċ-ċelloli tannervituri, jew il-marda Gaucher tat-tip 3, li tavvanza bil-mod u taffettwa liċ-ċelloli tan-nervituri.
English: Cerezyme is usually given by infusion every two weeks.
Maltese: Cerezyme normalment jingħata bħala infużjoni kull ġimagħtejn.
English: Patients can develop antibodies (proteins that are produced in response to Cerezyme and can affect treatment) and they should be monitored for any allergic reactions to Cerezyme.
Maltese: Pazjenti jistgħu jiżviluppaw antikorpi (proteina prodotti bħala risponse għal Cerezyme u jistgħu jaffettwaw it-trattament) u għandhom ikunu monitorjati għal kwalunkwe reazzjoni allerġika għal Cerezyme.
English: Cerezyme is a powder that is made up into a solution for infusion (a drip into a vein).
Maltese: Cerezyme huwa trab li jsir soluzzjoni għall-infużjoni (dripp fil-vina).
English: Gaucher disease is a rare inherited disorder, in which people do not have enough of an enzyme called acid beta-glucosidase, which normally breaks down a fatty waste product called glucosylceramide.
Maltese: Il-marda Gaucher hija disturb rari li tintiret, li fiha persuna ma jkollhiex biżżejjed mill-enzima msejħa acid betaglucosidase, li normalment tkisser prodott ta' xaħam żejjed imsejjaħ glucosylceramide.
English: What is the risk associated with Cerezyme?
Maltese: X'inhu r-riskju assoċjat ma' Cerezyme?
English: For type 3 Gaucher disease, which is extremely rare, the company presented data from published articles and from a special register of Gaucher disease patients.
Maltese: Għall-marda Gaucher tat-tip 3, li hija rari ħafna, il-kumpanija ppreżentat dejta minn artikli ppubblikati u min reġistru speċjali ta' pazjenti bil-marda Gaucher.
English: For type 1 Gaucher disease, Cerezyme has been studied in three studies involving a total of 40 patients.
Maltese: Għall-marda Gaucher tat-tip 1, Cerezyme ġie studjat fi tliet studji li kienu jinvolvu 40 pazjent.
English: How has Cerezyme been studied?
Maltese: Kif ġie studjat Cerezyme?
English: EU/1/11/692/001 Yellox
Maltese: EU/1/11/692/001
English: Ocular use bottle (PE) 5 ml
Maltese: Użu okulari flixkun (PE) 5 ml
English: 0.9 mg/ml
Maltese: Yellox mg/ml
English: Strength Pharmaceutical Form Route of Administration
Maltese: Isem (inventat) Qawwa Għamla farmaċewtika
English: Eye drops, solution
Maltese: Flixkun wieħed
English: EU Number
Maltese: soluzzjoni
English: Packaging Content (concentration)
Maltese: Mnejn jingħata Il-pakkett Kontenut (konċentrazzjoni
English: (Invented) name
Maltese: Numru ta' Proċedura ta' lEU
English: EMA/572586/2014 EMEA/H/C/000428
Maltese: EMEA/H/C/000428
English: The full EPAR for Mixtard 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: Mixtard human insulin
Maltese: Mixtard insulina umana
English: The usual dose is between 0.3 and 1.0 international units (IU) per kilogram body weight per day.
Maltese: Id-doża normali hija bejn 0.3 u 1.0 f'unitajiet internazzjonali (IU) għal kull kilogramm ta' piż tal-ġisem kuljum.
English: Mixtard is a suspension for injection that contains the active substance human insulin.
Maltese: Mixtard huwa sospensjoni għall-injezzjoni li fiha s-sustanza attiva insulina umana.
English: The active substance in Mixtard, human insulin, is produced by a method known as ‘recombinant technology': the insulin is made by a yeast cells into which a gene (DNA) has been introduced, which makes them able to produce insulin.
Maltese: Is-sustanza attiva f'Mixtard, l-insulina umana, hi prodotta b'metodu magħruf bħala ‘teknoloġija rekombinanti': dan isir minn ċelloli tal-ħmira li fihom tkun ġiet introdotta ġene (DNA) li tagħmilhom kapaċi jipproduċu l-insulina.
English: This is a summary of the European public assessment report (EPAR) for Mixtard.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Mixtard.
English: Why has Mixtard been approved?
Maltese: Għaliex ġie approvat Mixtard?
English: The study compared Mixtard 30 to a similar mix, but made up using an insulin analogue (insulin aspart).
Maltese: L-istudju qabbel il-Mixtard 30 ma' taħlita simili, iżda magħmula permezz tal-użu tal-insulina analoga (insulina aspart).
English: Mixtard is a replacement insulin which is very similar to the insulin made by the pancreas.
Maltese: Mixtard huwa insulina ta' sostituzzjoni simili ħafna għall-insulina prodotta mill-frixa.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Mixtard on 7 October 2002.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Mixtard valida fl-Unjoni Ewropea kollha fis-7 ta' Ottubru 2002.
English: Mixtard is given by injection under the skin, in the thigh, the abdominal wall (at the front of the waist), the gluteal region (buttocks) or the deltoid region (shoulder).
Maltese: Mixtard jingħata bħala injezzjoni taħt il-ġilda, normalment fil-koxxa, fl-addome (fil-parti ta' quddiem tal-qadd), fil-parti tal-glutei (il-warrani), jew fil-parti deltojde (l-ispalla).
English: What is Mixtard?
Maltese: X'inhu Mixtard?
English: Mixtard contains insulin in two forms: a soluble form, which acts quickly (within 30 minutes of injection) and an ‘isophane', form which is absorbed much more slowly during the day.
Maltese: Mixtard fih l-insulina f'żewġ forom: fil-forma li tinħall, li taġixxi malajr (fi żmien 30 minuta mill-injezzjoni) u fil-forma ‘isophane' li tiġi assorbita b'mod inqas mgħaġġel matul iljum.
English: A risk management plan has been developed to ensure that Mixtard is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Mixtard jintuża bl-aktar mod sigur possibbli.
English: Mixtard is given 30 minutes before a meal.
Maltese: Mixtard jingħata 30 minuta qabel l-ikel.
English: What is the risk associated with Mixtard?
Maltese: X'inhu r-riskju assoċjat ma' Mixtard?
English: It is available as vials, cartridges (Penfill) or pre-filled pens (InnoLet or FlexPen).
Maltese: Jiġi fi vjali, stoċċijiet (Penfill) jew pinnen mimlija minn qabel (InnoLet jew FlexPen).
English: Mixtard led to a decrease in the level of HbA1c, indicating that blood glucose levels had been controlled to a similar level to that seen with other human insulin.
Maltese: Mixtard wassal għal tnaqqis fil-livell ta' HbA1c, u dan jindika li l-livelli tal-glukożju fid-demm ġew ikkontrolati għal livell simili bħal b'insulina umana oħra.
English: Mixtard has been studied in a total of 294 patients with type 1 diabetes, when the pancreas cannot produce insulin, and type 2 diabetes, when the body is unable to use insulin effectively.
Maltese: Mixtard ġie studjat f'total ta' 294 pazjent bid-dijabete tat-tip1, fejn il-frixa ma tistax tipproduċi linsulina, u tad-dijabete tat-tip 2, fejn il-ġisem mhuwiex kapaċi juża l-insulina b'mod effettiv.
English: The most common side effect with Mixtard (seen in more than 1 patient in 10) is hypoglycaemia (low blood glucose levels).
Maltese: L-effett sekondarju l-aktar komuni b'Mixtard (li deher f'iktar minn pazjent 1 minn kull 10) huwa ipogliċemija (livelli baxxi ta' glukożju fid-demm).
English: What measures are being taken to ensure the safe and effective use of Mixtard?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Mixtard?
English: Mixtard contains both fast-acting (soluble) and long-acting (isophane) insulin:
Maltese: Mixtard fih kemm l-insulina li taħdem malajr (li tinħall) kif ukoll l-insulina li taħdem għal żmien twil (isophane):
English: Other information about Mixtard
Maltese: Kif ġie studjat Mixtard?
English: The study measured the level of glycosylated haemoglobin (HbA1c) after 12 weeks, which is the percentage of haemoglobin in the blood that has glucose attached.
Maltese: L-istudju kejjel il-livell tal-emoglobina glikosilata (HbA1c) wara 12-il ġimgħa, li huwa l-perċentwal ta' emoglobina fid-demm li magħha jeħel il-glukożju.
English: The replacement insulin acts in same way as naturally produced insulin and helps glucose enter cells from the blood.
Maltese: L-insulina ta' sostituzzjoni taġixxi bl-istess mod bħall-insulina prodotta b'mod naturali u tgħin lill-glukożju jidħol fiċ-ċelloli mid-demm.
English: 10 July 2017
Maltese: 10 ta' Lulju 2017
English: Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/121)
Maltese: Riżultat ta' proċedura ta' riferiment skont l-Artikolu 35 tadDirettiva 2001/82/KE (EMEA/V/A/121)
English: What is tylosin?
Maltese: X' inhu tylosin?
English: Which data has the CVMP reviewed?
Maltese: Liema data eżamina s-CVMP?
English: On 22 June 2016, Finland initiated a referral procedure under Article 35 of Directive 2001/82/EC for the aforementioned veterinary medicinal products.
Maltese: Fit-22 ta' Ġunju 2016, il-Finlandja nediet proċedura ta' riferiment skont l-Artikolu 35 tadDirettiva 2001/82/KE għall-prodotti mediċinali veterinarji msemmija qabel.
English: Tylosin is a macrolide antibiotic and is active mostly against Gram-positive bacteria and mycoplasmas.
Maltese: Tylosin huwa antibijotiku makrolid u huwa attiv l-aktar kontra batterji Gram pożittivi u mikroplażmi.
English: or ‘bovine mastitis caused by Mycoplasma bovis' from the product information.
Maltese: jew "mastite bovina kkawżata minn Mycoplasma bovis" mill-informazzjoni tal-prodott.
English: On 16 March 2017, the European Medicines Agency (the Agency) completed a review of the effectiveness of veterinary medicinal products containing tylosin that are administered parenterally and intended for the treatment of bovine mastitis caused by Mycoplasma spp.
Maltese: Fis-16 ta' Marzu 2017, l-Aġenzija Ewropea għall-Mediċini (l-Aġenzija) lestiet reviżjoni tal-effettività ta' prodotti mediċinali veterinarji li fihom tylosin li jingħataw b'mod parenterali u li huma intiżi għall-kura ta' mastite bovina kkawżata minn Mycoplasma spp.
English: Tylosin and its phosphate and tartrate salts are used in veterinary medicines for treatment of conditions caused by sensitive organisms.
Maltese: Tylosin u l-imluħa fosfati u tartratiċi tiegħu jintużaw f' mediċini veterinarji għall-kura ta' kondizzjonijiet ikkawżati minn organiżmi sensittivi.