FrancophonIA/ELRC3.0 huggingface dataset:
English: Posterior reversible encephalopathy syndrome
Maltese: Sindromu tal-enċefalopatija riversibbli posterjuri
English: In addition to the co-primary endpoints, benefit was also assessed using time to initiation of cytotoxic chemotherapy, best overall soft tissue response, time to first skeletal-related event, PSA response (≥ 50% decrease from baseline), time to PSA progression, and time to FACT-P total score degradation.
Maltese: Minbarra l-punti aħħarin koprimarji, il-benefiċċju ġie evalwat ukoll billi ntuża ż-żmien sal-bidu tal-kimoterapija ċitotossika, l-aħjar rispons globali tat-tessut artab, żmien għall ewwel avveniment relatat mal-iskeletru, rispons tal-PSA (tnaqqis ta' ≥50% mil-linja bażi), iż-żmien għall-progressjoni PSA, u ż-żmien għal degradazzjoni tal-punteġġ totali FACT-P.
English: The ECOG performance score was 0 - 1 in 91.5% of patients and 2 in 8.5% of patients; 28% had a mean Brief Pain Inventory score of ≥ 4 (mean of patient's reported worst pain over the previous 24 hours calculated for seven days prior to randomisation).
Maltese: 5% tal-pazjenti u 2 fi 8.5% tal-pazjenti; 28% kellhom punteġġ medjan fuq l-Inventarju Qasir tal-Uġigħ (Brief Pain Inventory) ta' ≥ 4 (medjan tal-agħar uġigħ irrappurtat mill-pazjent fuq l-24 siegħa preċedenti kkalkulat fuq sebat ijiem qabel saret l-għażla b'mod każwali).
English: - This medicine could possibly have an effect on male fertility.
Maltese: - Din il-mediċina jista' possibbilment ikollha effett fuq il-fertilità tal-irġiel.
English: Androgen deprivation therapy may prolong the QT interval In patients with a history of or risk factors for QT prolongation and in patients receiving concomitant medicinal products that might prolong the QT interval (see section 4.5) physicians should assess the benefit risk ratio including the potential for Torsade de pointes prior to initiating Xtandi.
Maltese: Terapija bi privazzjoni tal-androġen tista' ttawwal l-intervall tal-QT F'pazjenti bi storja ta' jew fatturi ta' riskju għal titwil tal-QT u f'pazjenti li qed jirċievu prodotti mediċinali konkomitanti li jistgħu jtawlu l-intervall tal-QT (ara sezzjoni 4.5), it-tobba għandhom jevalwaw il-proporzjon ta' riskju-benefiċċju, inkluż il-potenzjal għal Torsade de pointes qabel ma jinbeda Xtandi.
English: EMA/859285/2015 EMEA/H/C/003982
Maltese: EMA/859285/2015 EMA/H/C/003982
English: The full EPAR and risk management plan summary for Vaxelis 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: • pertussis (whooping cough);
Maltese: • pertussi (sogħla konvulżiva);
English: Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus type b conjugate vaccine (adsorbed)
Maltese: Difterite, tetnu, pertussi (aċellulari, komponent), epatite B (rDNA), poljomelite (inattivata) u tilqima konjugata tal-Haemophilus tip b (assorbit)
English: This is a summary of the European public assessment report (EPAR) for Vaxelis.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Vaxelis.
English: Vaxelis is a vaccine.
Maltese: Vaxelis huwa tilqima.
English: • tetanus (lockjaw, usually caused by infection of a wound);
Maltese: • tetnu (xedaq maqful, normalment ikkaġunat minn infezzjoni ta' ferita);
English: Why is Vaxelis approved?
Maltese: Għal xiex ġiet approvat Vaxelis?
English: • hepatitis B (a viral liver infection);
Maltese: • epatite B (infezzjoni virali fil-fwied);
English: Other information about Vaxelis
Maltese: Informazzjoni oħra dwar Vaxelis
English: • invasive diseases (such as pneumonia and meningitis) caused by H. influenzae type-b bacteria
Maltese: • mard invażiv (bħall-pulmonite u l-meninġite) ikkaġunat minn batterji H. influenzae tip b (Hib).
English: Both studies showed that Vaxelis produces satisfactory levels of antibodies to protect against all of these six diseases in between 90 and 100% of children who completed the course of vaccination with Vaxelis.
Maltese: Iż-żewġ studji wrew li Vaxelis jipproduċi livelli sodisfaċenti ta' antikorpi sabiex jipproteġu kontra dawn is-sitt mardiet kollha f'bejn 90 u 100% tat-tfal li komplew il-kors ta' tilqim b'Vaxelis.
English: The Committee considered that Vaxelis has been shown to produce satisfactory antibody levels against diphtheria, tetanus, pertussis, hepatitis B virus, polioviruses and Hib.
Maltese: Il-Kumitat qies li ntwera li Vaxelis jipproduċi livelli ta' antikorpi protettivi kontra difterite, tetnu, pertussi, il-virus talepatite B, poljovirusijiet u Hib.
English: Vaxelis is a vaccine containing active substances derived from diphtheria, tetanus, pertussis and Haemophilus influenzae type-b bacteria, the hepatitis B virus, and inactivated polioviruses.
Maltese: Vaxelis huwa tilqima li fiha s-sustanzi attivi li ġejjin minn difterite, tetnu, pertussi u batterji talHaemophilus influenzae tip b, il-virus tal-epatite B, u polivirusijiet inattivati.
English: The vaccine is ‘adsorbed' on aluminium compounds.
Maltese: It-tilqima hija 'assorbita' f'komposti tal-aluminju.
English: Vaxelis has been studied in two main studies involving more than 2,500 infants and toddlers over six weeks of age who were given either two or three doses of the vaccine during their first six months of life.
Maltese: Vaxelis ġie studjat f'żewġ studji ewlenin li involvew aktar minn 2,500 tarbija u tfal żgħar li għandhom aktar minn sitt ġimgħat li ngħataw jew żewġ dożi jew tlieta tat-tilqima waqt l-ewwel sitt xhur ta' ħajja.
English: The most common side effects with Vaxelis include pain, swelling and redness at the site of injection, irritability, crying, sleepiness, fever, reduced appetite and vomiting.
Maltese: L-effetti sekondarji l-aktar komuni b'Vaxelis jinkludu uġigħ, nefħa u ħmura fis-sit tal-injezzjoni, irritabilità, biki, ħedla, deni, nuqqas ta' aptit u rimettar.
English: A risk management plan has been developed to ensure that Vaxelis is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Vaxelis jintuża bl-aktar mod sigur possibbli.
English: • poliomyelitis (polio, a disease that affects the nerves and can lead to muscle weakness or paralysis);
Maltese: • poljomelite (poljo, marda li taffettwa n-nervituri u tista' twassal għal dgħjufija fil-muskoli jew paraliżi);
English: What are the risks associated with Vaxelis?
Maltese: X'inhuma r-riskji assoċjati ma' Vaxelis?
English: The main measure of effectiveness was the production of antibody levels known to be protective against diphtheria, tetanus, poliomyelitis, hepatitis B and H. influenzae type b infections and expected to protect against pertussis.
Maltese: Il-kejl ewlieni tal-effikaċja kien il-produzzjoni ta' livelli tal-antikorpi magħrufa li huma protettivi kontra difterite, tetnu, poljomelite, epatite B u infezzjonijiet ta' H. influenzae tip b u mistennija li jipproteġu kontra l-pertussi.
English: How does Vaxelis work?
Maltese: X'inhu Vaxelis u għal xiex jintuża?
English: For the full list of all side effects reported with Vaxelis, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Vaxelis, ara l-fuljett ta' tagħrif.
English: Vaxelis contains small amounts of materials derived from the viruses and bacteria it protects against.
Maltese: Vaxelis fih ammonti żgħar ta' materjali meħudin millvirusijiet u l-batterji li hu jipproteġi kontrihom.
English: Vaxelis must not be used in children who have ever had an allergic reaction to Vaxelis or a vaccine containing the same components, including substances used during the manufacture of the vaccine and which may be found at extremely low levels (such as the antibiotics neomycin or streptomycin).
Maltese: Vaxelis ma għandux jintuża fi tfal li ġieli kellhom reazzjoni allerġika għal Vaxelis jew għal tilqima li fiha l-istess komponenti, inkluż sustanzi użati waqt il-manifattura tat-tilqima u li jistgħu jinstabu f'livelli baxxi ħafna (bħall-antibijotiċi neomycin jew streptomycin).
English: They then received a booster dose shortly after their first birthday.
Maltese: Doża booster għandha tingħata tal-inqas sitt xhur wara l-aħħar waħda minn dawn id-dożi inizjali.
English: The effects of Vaxelis were compared with those of another vaccine, Infanrix hexa, designed to protect against the same six diseases as Vaxelis.
Maltese: L-effetti ta' Vaxelis tqabblu ma' dawk ta' tilqima oħra, Infanrix hexa, imfassla sabiex tipproteġi kont l-istess sitt mardiet bħal Vaxelis.
English: Co-rapporteur(s):
Maltese: Korapporteur(s):
English: 14 June 2010
Maltese: 14 ta' Ġunju 2010
English: Prof. Cristina Sampaio (Portugal)
Maltese: Cristina Sampaio (Portugall)
English: Prof. Philippe Lechat (France)
Maltese: Philippe Lechat (Franza)
English: 1 Article 107 of Directive 2001/83/EC as amended.
Maltese: 1 Artikolu 107 tad-Direttiva 2001/83/KE kif emendata.
English: EMA/811097/2009 Rev. 1 EMEA/H/A-107/1257
Maltese: 1 EMEA/H/A-107/1257
English: What is benfluorex?
Maltese: X'inhu l-benfluorex?
English: At the time of this review,they were available as tablets containing 150 mg benfluorex hydrochloride in France and Portugal2 under the following invented names, Mediator, Benfluorex Mylan and Benfluorex Qualimed.
Maltese: Fi żmien ilvalutazzjoni, dawn kienu disponibbli f'pilloli li jikkontienu 150 mg benfluorex kloridrat fi Franza u filPortugall2 b'dawn l-ismijiet ivvintati: Mediator, Benfluorex Mylan u Benfluorex Qualimed.
English: Questions and answers on the withdrawal of medicines containing benfluorex EMA/811097/2009 Rev. 1
Maltese: EMA/811097/2009 Rev.
English: 2 Benfluorex-containing products are also authorised but not marketed in Cyprus and Luxemburg.
Maltese: 2 Prodotti li fihom il-benfluorex huwa wkoll awtorizzati iżda mhux mqiegħda fis-suq f'Ċipru u fil-Lussemburgu.
English: In November 2009, following several reports of cardiac valvulopathy (thickening of the heart valves) and pulmonary arterial hypertension (high blood pressure in the artery that leads from the heart to the lungs), the French medicines regulatory authority carried out a review of the safety of benfluorex and decided to suspend its marketing authorisation.
Maltese: F'Novembru 2009, wara li daħlu bosta rapporti ta' valvulopatija kardijaka (tħaxxin tal-valvi tal-qalb) u ipertensjoni arterjali pulmonarja (pressjoni għolja tad-demm fl-arterja li twassal mill-qalb għall
English: Referral start date:
Maltese: Data tal-bidu tar-riferiment:
English: The review was carried out under an ‘Article 107' procedure1.
Maltese: Ir-reviżjoni saret skont il-proċedura tal-‘Artikolu 107'1.
English: Medicines containing benfluorex were first authorised in 1974.
Maltese: Il-mediċini li fihom il-benfluorex kienu ngħataw l-ewwel awtorizzazzjoni fl-1974.
English: Why was benfluorex reviewed?
Maltese: Għaliex saret reviżjoni oħra tal-benfluorex?
English: The review included information provided by the market leader from clinical trials, information published in scientific journals, and ‘spontaneous reports' of side effects from patients to the companies that make the medicines or health authorities.
Maltese: Ir-reviżjoni inkludiet informazzjoni li ġiet ipprovduta mill-istudji kliniċi tad-ditta prinċipali tas-suq, minn informazzjoni ppubblikata f'ġurnali xjentifiċi u minn ”rapporti spontanji” ta' effetti sekondarji li saru minn pazjenti lill-kumpaniji li jipproduċu l-mediċini jew lill-awtoritajiet tassaħħa.
English: The CHMP has reviewed available information on the safety and efficacy of benfluorex-containing medicines, particularly data on the associated risk of heart valve diseases and pulmonary arterial hypertension.
Maltese: Is-CHMP irreveda l-informazzjoni disponibbli dwar is-sikurezza u l-effikaċja ta' mediċini li fihom ilbenfluorex, b'mod partikolari d-dejta dwar ir-riskju assoċjat ta' mard fil-valvi tal-qalb u ta' ipertensjoni arterjali pulmonari.
English: Since its marketing authorisation, the safety of benfluorex has been reviewed several times.
Maltese: Sa mill-awtorizzazzjoni għat-tqegħid fis-suq tiegħu, is-sikurezza tal-benfluorex ġiet riveduta bosta drabi.
English: In addition, there is risk of valve diseases with the use of benfluorex, which was confirmed in a new study conducted in October 2009.
Maltese: Barra dan, bl-użu tal-benfluorex hemm riskju ta' mard fil-valvi, u dan ġie kkonfermat minn studju ġdid li sar f'Ottubru 2009.
English: Benfluorex was used as an add-on treatment in patients with diabetes who are overweight.
Maltese: Il-benfluorex kien jintuża bħala kura addizzjonali f'pazjenti bid-dijabete li jkollhom piż eċċessiv.
English: • Doctors should stop prescribing benfluorex.
Maltese: Mistoqsijiet u tweġibiet dwar l-irtirar ta' mediċini li fihom il-benfluorex
English: Therefore, on the basis of the evaluation of these data and the scientific discussion within the Committee, the CHMP concluded that the benefits of benfluorex-containing medicines do not outweigh their risks, and therefore recommended that the marketing authorisation of these medicines be revoked.
Maltese: Għaldaqstant, abbażi tal-valutazzjoni ta' din id-dejta u tad-diskussjoni xjentifika li saret fil-Kumitat, is-CHMP ikkonkluda li l-benefiċċji ta' mediċini li fihom il-benfluorex ma jisbqux ir-riskji tagħhom, u għalhekk irrakkomanda li tiġi revokata l-awtorizzazzjoni għat-tqegħid fis-suq ta' dawn ilmediċini.
English: Benfluorex works by making the cells more sensitive to insulin, which means that the body makes better use of the insulin it produces and the blood glucose is reduced.
Maltese: Il-benfluorex jaħdem billi jagħmel liċ-ċelloli aktar sensittivi għall-insulina, li jfisser li l-ġisem jagħmel użu aħjar mill-insulina li jipproduċi u jitnaqqas l-glukosju fid-demm.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of benfluorex no longer outweigh its risks, and that all marketing authorisations for medicines containing benfluorex should be revoked throughout the European Union (EU).
Maltese: IlKumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li l-benefiċċji tal-benfluorex ma għadhomx jisbqu lir-riskji tiegħu, u li għaldaqstant l-awtorizzazzjonijiet għat-tqegħid fis-suq tiegħu għal mediċini li fihom il-benfluorex għandhom jiġu revokati fl-Unjoni Ewropea (UE) kollha.
English: What are the recommendations for patients and prescribers?
Maltese: X'inhuma r-rakkomandazzjonijiet għall-pazjenti u għallprofessjonisti mediċi?
English: The CHMP noted that the available data show that the effect of benfluorex in the treatment of diabetes is only limited.
Maltese: Is-CHMP innota li d-dejta disponibbli tixhed li l-effett tal-benfluorex fil-kura tad-dijabete huwa limitat.
English: In 2007, a re-assessment of the benefit-risk balance led to the withdrawal of the indication for the use in patients with high blood levels of triglycerides, a type of fat.
Maltese: Fl-2007 saret valutazzjoni mill-ġdid tal-bilanċ bejn il-benefiċċji u r-riskji li wasslet għall-irtirar tal-indikazzjoni għall-użu f'pazjenti li jkollhom livelli għoljin ta' trigliċeridi (tip ta' xaħam) fid-demm.
English: EMA/254341/2010 EMEA/H/C/000710
Maltese: EMEA/681665/2009 EMEA/H/C/710
English: It contains a flu strain called A/California/7/2009 (H1N1)-derived strain NYMC X-181.
Maltese: Fih razza ta' influwenza msejħa A/California/7/2009 (H1N1)v tip li tixbah lil (X-181).
English: This document is a summary of the European Public Assessment Report (EPAR) for Focetria.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR).
English: Focetria should not be given to patients who have had an anaphylactic reaction (severe allergic reaction) to any of the components of the vaccine, or to any substances found at trace (very low) levels in the vaccine, such as egg or chicken protein, ovalbumin (a protein in egg white), kanamycin or neomycin sulphate (antibiotics), formaldehyde and cetyltrimethylammonium bromide.
Maltese: Focetria ma għandux jingħata lil pazjenti li kellhom reazzjoni anafilattika (reazzjoni allerġika qawwija) għal xi wieħed mill-komponenti tal-vaċċin, jew għal kwalunkwe sustanza li tinsab f'livelli ta' traċċi, bħal bajd jew proteina tat-tiġieġ, ovalbumina (proteina fl-abjad tal-bajd), formaldeħajd (formaldehyde), sulfat tal-ġentamiċina (gentamicin sulphate - antibijotiku) u sodju deoksikolat (sodium deoxycholate).
English: Focetria is a vaccine.
Maltese: Focetria huwa vaċċin.
English: Why has Focetria been approved?
Maltese: Għaliex ġie approvat Focetria?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Focetria to Novartis Vaccines and Diagnostics S.r.l.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għall-H5N1 vaċċin finta għal Focetria lil Novartis Vaccines and Diagnostics S.r.l. fit-2 ta' Mejju 2007.
English: It is a suspension for injection that contains parts (‘surface antigens') of the influenza (flu) virus.
Maltese: Huwa sospensjoni għall-injezzjoni li fiha xi partijiet (‘antiġeni tal-wiċċ') talvajrus tal-influwenza (flu).
English: The most common side effects with Focetria (seen in more than 1 patient in 10) are headache, myalgia (muscle pain), reactions at the site of the injection (pain, hardening and redness), malaise (feeling unwell), sweating and fatigue (tiredness).
Maltese: L-effetti sekondarji l-aktar komuni b'Cervarix (li dehru f'aktar minn pazjent 1 minn 10) huma wġigħ ta' ras, mijalġija (uġigħ fil-muskoli), reazzjonijiet fil-punt tal-injezzjoni fosthom uġigħ, ħmura u nefħa, u għeja.
English: What is the risk associated with Focetria?
Maltese: X'inhu r-riskju assoċjat ma' Focetria?
English: Focetria influenza vaccine (H1N1)v (surface antigen, inactivated, adjuvanted)
Maltese: Focetriavaċċin għall-influwenza pandemika (H1N1) (virjun maqsum (split virion), diżattivat, adjuvat) A/California/7/2009 (H1N1)
English: What is Focetria?
Maltese: X'inhu Focetria?
English: When a person is given the vaccine, the immune system recognises the virus parts as ‘foreign' and makes antibodies against it.
Maltese: Meta persuna tingħata l-vaċċin, is-sistema immunitarja tagħraf lill-virus bħala “barrani” u tipproduċi antikorpi kontrih.
English: Two main studies have been carried out that looked at the ability of a two-dose schedule of the vaccine to trigger an immune response, one study in 661 healthy adults (including 251 elderly subjects over 60 years of age), and one study in 720 healthy children and adolescents (aged between six months and 17 years).
Maltese: Għaddej studju simili fuq 720 tfal u adoloxxenti b'saħħithom (eta' bejn 6 xhur u 17 -il sena).
English: How has Focetria been studied?
Maltese: Kif ġie studjat Focetria?
English: The vaccine also contains an ‘adjuvant' (a compound containing oil) to enhance the immune response.
Maltese: Is-solvent fih ‘adjuvant' (taħlita li fiha ż-żejt) biex itejjeb irrispons immuni.
English: For the full list of all side effects reported with Focetria, see the Package Leaflet.
Maltese: Għal-lista sħiħa ta' l-effetti sekondarji kollha rrapportati b'Focetria, ara l-Fuljett tat-Tagħrif.
English: Focetria was originally developed as a pandemic vaccine, to be used during the influenza A (H1N1) pandemic declared in June 2009.
Maltese: Focetria huwa vaċċin li jipprevjeni l-influwenza ‘pandemika'.
English: Focetria is a vaccine to protect against flu caused by the A (H1N1)v 2009 virus.
Maltese: L-opinjoni pożittiva għal vaċċin H1N1 ġiet ippubblikata fl-24 ta' Settembru 2009.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Focetria.
Maltese: Is-CHMP ddeċieda li, skont l-informazzjoni miksuba mill-vaċċin finta u l-informazzjoni provduta fuq it-tip ta' bidla, il-benefiċċji ta' Focetria huma ikbar mir-riskji għal profilassi tal-influwenza fissitawazzjoni pandemika tal-H1N1 iddikjarata uffiċjali.
English: Other information about Focetria:
Maltese: Tagħrif ieħor dwar Focetria:
English: How does Focetria work?
Maltese: Għalxiex jintuża Focetria?
English: Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against a disease.
Maltese: Il-kumpanija studjat l-abilità ta' dan il-vaċċin finta li jqanqal ilproduzzjoni ta' antikorpi (immunoġeniċità) kontra t-tip ta' virus tal-influwenza qabel il-pandemija.
English: Draxxin tulathromycin
Maltese: Draxxin tulatromiċsin
English: The full EPAR for Draxxin can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/ European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Veterinary medicines/ European public assessment reports.
English: Draxxin is available as a solution for injection (25 mg/ml and 100 mg/ml).
Maltese: Draxxin jiġi f'soluzzjoni għall-injezzjoni (25 mg/ml u 100 mg/ml).
English: SRD with Bordetella bronchiseptica present.
Maltese: Bordetella bronchiseptica.
English: Other information about Draxxin:
Maltese: Informazzjoni oħra dwar Draxxin:
English: This summary was last updated in September 2016.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'Settembru 2016.
English: Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis and Bordetella bronchiseptica.
Maltese: il-Pasteurella multocida, il-Mycoplasma hyopneumoniae, il-Haemophilus parasuis u l
English: This is a summary of the European Public Assessment Report (EPAR) for Draxxin.
Maltese: Dan huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Draxxin.
English: Why is Draxxin approved?
Maltese: Għal xiex ġie approvat Draxxin?
English: • swine respiratory disease (SRD) in pigs caused by Actinobacillus pleuropneumoniae,
Maltese: • mard respiratorju tal-majjali (SRD) f'majjali kkawżat mill-Actinobacillus pleuropneumoniae,
English: Draxxin is given as a single injection of 2.5 mg per kilogram bodyweight.
Maltese: Draxxin jingħata bħala injezzjoni waħda ta' 2.5 mg għal kull kilogramm tal-piż tal-ġisem.
English: • bovine respiratory disease (BRD) in cattle caused by Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis;
Maltese: • mard respiratorju bovin (BRD) fi frat ikkawżat mill-Mannheimia haemolytica, il-Pasteurella multocida, il-Histophilus somni jew il-Mycoplasma bovis;
English: Draxxin is an antibiotic medicine that contains the active substance tulathromycin.
Maltese: Draxxin huwa mediċina antibijotika li fiha s-sustanza attiva tulatromiċin.
English: A single 2.5 mg/kg dose of Draxxin was effective in treating and preventing further outbreak of BRD in cattle and SRD in pigs.
Maltese: Doża singola ta' 2.5 mg/kg ta' Draxxin kienet effettiva fil-kura u l-prevenzjoni ta' tifqigħat futuri ta' BRD fil-frat u SRD fil-majjali.
English: Two weeks after treatment 84% of Draxxin-treated sheep were successfully treated compared to 82% of tilmicosin-treated sheep.
Maltese: Ġimagħtejn wara l-kura 84 % tan-nagħaġ ikkurati bi Draxxin kienu kkurati b'suċċess meta mqabbla ma' 82% tan-nagħaġ ikkurati b'tilmikosin.
English: The active substance in Draxxin, tulathromycin, is an antibiotic that belongs to the class ‘macrolides'.
Maltese: Is-sustanza attiva fi Draxxin, it-tulatromiċin, hija antibijotiku li jappartjeni għall-klassi ‘makrolidi'.
English: What are the risks associated with Draxxin?
Maltese: X'inhuma r-riskji assoċjati ma' Draxxin?
English: Draxxin is effective against the bacteria that most commonly cause BRD, SRD, IBK and foot rot.
Maltese: Draxxin huwa effettiv kontra l-batterji li l-aktar jikkawżaw BRD, SRD,IBK u n-nekrobaċillożi.
English: The European Commission granted a marketing authorisation valid throughout the EU for Draxxin on 23 July 2003.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Draxxin fit-23 ta' Lulju 2003.
English: Draxxin may also cause sensitisation (redness, itching and swelling) if it comes into contact with the skin.
Maltese: Draxxin jista' jikkawża wkoll sensitizzazzjoni (ħmura, ħakk u nefħa) jekk jiġi f'kuntatt mal-ġilda.