FrancophonIA/ELRC3.0 huggingface dataset:
English: Concerns were raised by the Netherlands regarding the efficacious and safe use of valproic acid/valproate containing medicinal products in the acute treatment of manic episodes and the prevention of recurrence of mood episodes in patients with bipolar disorder.
Maltese: Tqajjem tħassib mill-Olanda rigward l-użu effikaċi u sikur ta' valproic acid/prodotti mediċinali li fihom valproate fit-trattament akut ta' episodji ta' manija u l-prevenzjoni tar-rikorrenza ta' episodji tal-burdata f'pazjenti li għandhom disturb bipolari.
English: For theoretical reasons slow-release formulations could be advantageous for compliance reasons and also for avoiding high plasma peaks which may be accompanied by frequent adverse effects.
Maltese: rilaxx bil-mod jistgħu jkunu ta' vantaġġ għal raġunijiet ta' konformità u wkoll għall-evitar ta' livelli massimi ta' plażma li jistgħu jiġu akkumpanjati minn effetti avversi frekwenti.
English: These studies included nearly 2,500 patients, of whom over 1,400 received valproate.
Maltese: Dawn l-istudji kienu jinkludu kważi 2,500 pazjent, li minnhom aktar minn 1,400 irċevew valproate.
English: In addition, the CHMP considered the safety profile of valproic acid/valproate in this indication and recommended some amendments to the Product Information in relation to the risk of suicidal ideation and behaviour, to the use in pregnancy and to the inclusion of nausea, sedation and extrapyramidal effects as undesirable effects.
Maltese: Informazzjoni dwar il-Prodott fir-rigward tar-riskju ta' ideat u mġiba ta' suwiċidju, tal-użu fit tqala u tal-inklużjoni ta' nawżea, sedazzjoni u disturbi ekstrapiramidali bħala effetti mhux mixtieqa.
English: The MAHs should look into their respective safety databases and add the approapriate frequence of occurrence to the above additional adverse events.
Maltese: Il-MAHs għandhom jeżaminaw id-databases tassikurezza rispettivi tagħhom u jżidu l-frekwenza tal-okkorrenza xierqa mal-avvenimenti avversi addizzjonali msemmijin hawn fuq.
English: Based on the already well known safety profile for valproate, the MAHs are not in agreement with the submission of the Risk Management Plan.
Maltese: Fuq il-bażi tal-profil ta' sigurtà diġà magħruf sewwa ta' valproate, il-MAHs ma jaqblux mas-sottomissjoni tal-Pjan tal-Ġestjoni tar-Riskju.
English: Whereas the Bowden study which was lithium- and placebo- controlled failed to show a statistically significant difference with respect to the primary outcome criterium (time to recurrence of any mood episode), patients treated with valproate had better outcomes on several secondary outcome measures than those treated with lithium or placebo.
Maltese: Filwaqt li l-istudju ta' Bowden li kien ikkontrollat b'litju u plaċebo ma rnexxilux juri differenza statistikament sinifikanti fir-rigward tal-kriterju tal-eżitu primarju (ħin sar-rikorrenza ta' kwalunkwe episodju tal-burdata), il-pazjenti li ġew trattati b'valproate kellhom eżiti aħjar fuq bosta miżuri ta' eżitu sekondarju milli dawk li ġew trattati b'litju jew plaċebo.
English: According to the CHMP recommendation for valproate containing medicinal products the indication should be adapted as follows due to the limitations and shortcomings of the data from clinical trials as the analysis was based in relatively old clinical studies.
Maltese: Skont ir-rakkomandazzjoni tas-CHMP għall-prodotti mediċinali li fihom valproate, l-indikazzjoni għandha tiġi addattata kif ġej minħabba l-limitazzjonijiet u n-nuqqasijiet tad-dejta minn provi kliniċi għaliex l-analiżi kienet ibbażata fuq studji kliniċi relattivament antiki:
English: Furthermore, the MAHs refer to the fact that syrups and oral solutions are also approved for bipolar disorder in some Member States.
Maltese: Barra minn hekk, il-MAHs jirreferu għall-fatt li xiroppi u soluzzjonijiet orali huma approvati wkoll għal disturb bipolari f'xi Stati Membri.
English: Member State EU/EEA
Maltese: Membru EU/EEA
English: 49071 Beaucouzé France
Maltese: 49071 Beaucouzé Franza
English: D-85716 Unterschleißheim Germany
Maltese: D-85716 Unterschleißheim Germanja
English: Polígono Industrial El Montalvo I c/Zeppelín n° 6, parcela 38 37008 Carbajosa de la Sagrada - Salamanca Spain
Maltese: Polígono Industrial El Montalvo I c/Zeppelín n° 6, parcela 38 37008 Carbajosa de la Sagrada - Salamanca Spanja
English: Germany Intervet Deutschland GmbH Feldstraße 1a
Maltese: Germanja Intervet Deutschland GmbH Feldstraße 1a
English: Intervet GesmbH Siemensstrasse 107 1210 Wien Austria
Maltese: Intervet GesmbH Siemensstrasse 107 1210 Wien Austrija
English: Walton Manor, Walton Milton Keynes MK7 7AJ United Kingdom
Maltese: Walton Manor, Walton Milton Keynes MK7 7AJ Renju Unit
English: The application was submitted to France as reference Member State and to Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and the United Kingdom as concerned Member States.
Maltese: L-applikazzjoni ġiet ippreżentata lil Franza bħala l-Istat Membru ta' referenza u lill-Awstrija, lill-Belġju, lill-Bulgarija, lil Ċipru, lir-Repubblika Ċeka, lid-Danimarka, lill-Estonja, lill-Finlandja, lill-Ġermanja, lill-Greċja, lillUngerija, lill-Irlanda, lill-Italja, lil-Latvja, lil-Litwanja, lil-Lussemburgu, lill-Pajjiżi l-Baxxi, lin-Norveġja, lill-Polonja, lill-Portugall, lir-Rumanija, lis-Slovakkja, lis-Slovenja, lil Spanja u lir-Renju Unit bħala l-Istati Membri kkonċernati.
English: for avoiding bias.
Maltese: biex jiġi evitat il-preġudizzju.
English: Intervet Ireland Ltd. Magna Drive Magna Business Park Citywest Rd.
Maltese: Magna Drive Magna Business Park Citywest Rd.
English: The variation procedure (FR/V/0167/01/II/017) started on 28 January 2013.
Maltese: Il-proċedura ta' varjazzjoni (FR/V/0167/01/II/017) bdiet fit-28 ta' Jannar 2013.
English: The MIC90 of the total population of M. bovis was 4 µg/ml.
Maltese: Il-MIC90 talpopolazzjoni totali ta' M. bovis kienet ta' 4 µg/ml.
English: Schering-Plough S.A. 63, Agiou Dimitriou street 17456 Alimos Greece
Maltese: Schering-Plough S.A. 63, Agiou Dimitriou street 17456 Alimos Greċja
English: Intervet Nederland B.V. Wim de Koerverstraat 35 5831 AN Boxmeer The Netherlands
Maltese: Wim de Koerverstraat 35 5831 AN Boxmeer Olanda
English: Intervet Hellas S.A. 63, Agiou Dimitriou street 17456 Alimos Greece
Maltese: Intervet Hellas S.A. 63, Agiou Dimitriou street 17456 Alimos Greċja
English: The differences in daily failure rates from Day 5 to Day 18 between the two treatment groups were not statistically significant at any of these days nor was the overall difference in cumulative failure rates from Day 5 to Day 18 (29.9% vs. 23.6%; p = 0.3682).
Maltese: Id-differenzi fir-rati ta' falliment ta' kuljum minn Jum 5 sa Jum 18 bejn iż-żewġ gruppi ta' kura ma kinux statistikament sinifikanti f'ebda waħda minn dawn il-ġranet u lanqas ma kienet statistikament sinifikanti d-differenza globali fir-rati kumulattivi ta' falliment mill-Jum 5 sa Jum 18 (29.9% kontra 23.6%; p = 0.3682).
English: CVMP guideline on statistical principles for clinical trials for veterinary medicinal products (pharmaceuticals) (EMA/CVMP/EWP/81976/2010)
Maltese: CVMP guideline on statistical principles for clinical trials for veterinary medicinal products (pharmaceuticals) (EMA/CVMP/EWP/81976/2010) http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/01/WC500120834.pdf
English: It is indicated for the treatment of respiratory infections caused by Mannheimia haemolytica, Pasteurella multocida and Histophilus somni associated with pyrexia.
Maltese: Huwa indikat għall-kura ta' infezzjonijiet respiratorji kkawżati minn Mannheimia haemolytica, Pasteurella multocida u Histophilus somni assoċjati mad-deni.
English: Mannheimia haemolytica was the most prevalent pathogen pre-treatment (142 isolates).
Maltese: Mannheimia haemolytica kien il-patoġenu l-aktar prevalenti qabel il-kura (142 iżolat).
English: The success rate on Day 4 and Day 7 (primary endpoints) were significantly higher in the Resflor than in the saline group (Day 4: Resflor 96.9% versus saline 61.9%; Day 7: Resflor 92.2% versus saline 47.6%; p<0.0001 - Fischer exact test).
Maltese: Ir-rata ta' suċċess fil-Jum 4 u l-Jum 7 (punti ta' tmiem primarji) kienet ferm ogħla fil-grupp ta' Resflor milli fil-grupp tas-salina (Jum 4: Resflor 96.9% kontra salina 61.9%; Jum 7: Resflor 92.2% kontra salina 47.
English: Austria
Maltese: Austrija
English: The clinical cure rate in the florfenicol group (88.5%) was compared to the tulathromycin group (82%) and significant non-inferiority on Day 7 was confirmed.
Maltese: Ir-rata ta' kura klinika fil-grupp ta' florfenicol (88.5%) tqabblet malgrupp ta' tulathromycin (82%) u kien ikkonfermat nuqqas ta' inferjorità sinifikanti fil-Jum 7.
English: Intervet UK Ltd.
Maltese: Intervet Ireland Ltd.
English: Mycoplasma bovis was next with 63 isolates followed by Pasteurella multocida (50 isolates).
Maltese: Dan kien segwit minn Mycoplasma bovis b'63 iżolat segwit minn Pasteurella multocida (50 iżolat).
English: The tested group was compared to two control groups, one negative control (saline) and a positive control.
Maltese: Il-grupp ittestjat tqabbel ma' żewġ gruppi ta' kontroll, wieħed ta' kontroll negattiv (salina) u ieħor ta' kontroll pożittiv.
English: Currently there is no standardised method to determine the minimum inhibitory concentration (MIC) of florfenicol against M. bovis.
Maltese: Attwalment ma hemm l-ebda metodu standardizzat biex tiġi ddeterminata l-konċentrazzjoni inibitorja minima (MIC) ta' florfenicol kontra M. bovis.
English: Nevertheless, based on the pre-clinical data provided by the marketing authorisation holder, MICs of florfenicol against M. bovis strains isolated in several EU Member States between 2007 and 2013 ranged between 0.5 and >64 µg/ml.
Maltese: Madankollu, abbażi tad-dejta pre-klinika pprovduta middetentur tal-awtorizzazzjoni għat-tqegħid fis-suq, il-MICs ta' florfenicol kontra razez ta' M. bovis iżolati f'diversi Stati Membri tal-UE bejn l-2007 u l-2013 kienu jvarjaw bejn 0.5 u >64 µg/ml.
English: During the variation procedure at the veterinary coordination group for mutual recognition and decentralised procedure (CMDv) a potential serious risk to animal health was identified by Denmark and Germany regarding the demonstration of efficacy in the clinical trials and the justification of the recommended treatment dose of Resflor in the treatment of respiratory infections caused by Mycoplasma bovis, which may be associated with an increased risk of development of antimicrobial resistance.
Maltese: Matul il-proċedura ta' varjazzjoni fil-grupp veterinarju ta' koordinazzjoni għar-rikonoxximent reċiproku u l-proċeduri deċentralizzati (CMDv) id-Danimarka u l-Ġermanja identifikaw riskju potenzjali serju għas-saħħa tal-annimali fir-rigward tat-turija tal-effikaċja fil-provi kliniċi u l-ġustifikazzjoni għad-doża ta' kura ta' Resflor irrakkomandata fil-kura ta' infezzjonijiet respiratorji kkawżati minn Mycoplasma bovis, li jista' jkun marbut ma' riskju akbar għall-iżvilupp ta' reżistenza antimikrobika.
English: A single subcutaneous injection of 40 mg florfenicol and 2.2 mg flunixin per kg body weight (bw) is recommended (2 ml/15 kg bw).
Maltese: Hija rrakkomandata injezzjoni unika taħt il-ġilda ta' 40 mg ta' florfenicol u 2.2 mg ta' flunixin għal kull kg tal-piż tal-ġisem (2 ml/15 kg tal-piż tal-ġisem).
English: No significant difference could be shown in the cumulative success rate 4 to 10 days after treatment (79.4% with florfenicol alone versus 83.5% with Resflor).
Maltese: L-ebda differenza sinifikanti ma setgħet tintwera firrata kumulattiva ta' suċċess 4 sa 10 ijiem wara l-kura (79.4% bi florfenicol waħdu kontra 83.5% b'Resflor).
English: MIC data and evolution of resistance of M. bovis towards florfenicol
Maltese: Dejta dwar il-MIC u l-evoluzzjoni ta' reżistenza ta' M. bovis għal florfenicol
English: The pivotal challenge model performed in 2012 was randomised, blinded and GCP compliant.
Maltese: Il-mudell pivotali ta' sfida li sar fl-2012 kien b'mod każwali, blindat u konformi mal-GCP.
English: Based on the absence of standardised method to determine MIC, it is difficult to follow resistance evolution in the different publications.
Maltese: Abbażi tan-nuqqas ta' metodu standardizzat biex tiġi determinata l-MIC, huwa diffiċli li tiġi segwita levoluzzjoni tar-reżistenza fil-pubblikazzjonijiet differenti.
English: INN Pharmaceutical form Strength Animal species
Maltese: INN Għamla farmaċewtika
English: Based on the absence of standardised method to determine the MIC, it is difficult to follow resistance evolution of M. bovis toward florfenicol.
Maltese: Abbażi tan-nuqqas ta' metodu standardizzat biex tiġi ddeterminata l-MIC, huwa diffiċli li tiġi segwita levoluzzjoni tar-reżistenza ta' M. bovis għal florfenicol.
English: The final outcome and the risk for relapse was assessed when the antimicrobial effect of Resflor has ceased.
Maltese: Ir-riżultat finali u r-riskju ta' rikaduta ġew ivvalutati meta l-effett antimikrobiku ta' Resflor kien intemm.
English: The non-inferiority in success rate of Resflor to tulathromycin was demonstrated on Day 4 and Day 7 since the lower boundary of the 97.5% confidence interval was less than 15%.
Maltese: In-nuqqas ta' inferjorità fir-rata ta' suċċess ta' Resflor fuq tulathromycin intwera fil-Jum 4 u l-Jum 7 peress li l-konfini t'isfel tal-intervall ta' fiduċja ta' 97.5% kien inqas minn 15%.
English: This issue remained unsolved and therefore a CMDv procedure under Article 13(1) of Commission Regulation (EC) No 1234/2008 has started on 6 November 2013.
Maltese: Din il-kwistjoni baqgħet mhux solvuta u għalhekk fis-6 ta' Novembru 2013 inbdiet proċedura tas-CMDv skont l-Artikolu 13(1) tar-Regolament tal-Kummissjoni (KE) Nru 1234/2008.
English: An additional statistical analysis has been carried out to demonstrate non-inferiority of florfenicol in comparison to the positive control with regards to the clinical cure rate on Day 7.
Maltese: Saret analiżi statistika addizzjonali biex turi n-nuqqas ta' inferjorità ta' florfenicol meta mqabbel malkontroll pożittiv fir-rigward tar-rata ta' kura klinika fil-Jum 7.
English: There is little information on how pharmacokinetic and pharmacodynamic data should be applied in the treatment of M. bovis infections.
Maltese: Ftit hemm informazzjoni dwar kif id-dejta farmakokinetika u farmakodinamika għandha tiġi applikata filkura ta' infezzjonijiet b'M. bovis.
English: The authorisation of florfenicol for the treatment of respiratory disease caused by M. bovis would avoid the use of Critically Important Antimicrobials and consequently could decrease the selection pressure for emergence of resistant strains from the usage of other classes of antibiotics such as macrolides and fluoroquinolones.
Maltese: L-awtorizzazzjoni ta' florfenicol għall-kura ta' mard respiratorju kkawżat minn M. bovis għandha tevita l-użu ta' Antimikrobiċi Kritikament Importanti u konsegwentement tista' tnaqqas il-pressjoni tal-għażla għall-feġġ ta' razez reżistenti mill-użu ta' klassijiet oħra ta' antibijotiċi bħal makrolidi u fluworokwinoloni.
English: The efficacy of Resflor against respiratory infection caused by M. bovis was demonstrated in two experimental models (performed in 2008 and 2012) and two clinical field trials (performed in 2004 and
Maltese: L-effikaċja ta' Resflor kontra infezzjoni respiratorja kkawżata minn M. bovis intweriet f'żewġ mudelli sperimentali (li saru fl-2008 u l-2012) u f'żewġ provi kliniċi fuq il-post (li saru fl-2004 u l-2005).
English: Flunixin is one of the most potent anti-inflammatory substances on the market and exerts important effects on the pathophysiology of M. bovis pneumonia, as well as clinical parameters (quicker decrease in rectal temperature and demeanour score over the first 9 hours compared to florfenicol alone).
Maltese: Flunixin huwa wieħed mis-sustanzi anti-infjammatorji l-aktar qawwijin fuq is-suq u jeżerċita effetti importanti fuq il-patofiżjoloġija ta' pnewmonja b'M. bovis, kif ukoll il-parametri kliniċi (tnaqqis aktar mgħaġġel fit-temperatura tar-rektum u fil-punteġġ tal-imġiba matul l-ewwel 9 sigħat meta mqabbel ma' florfenicol waħdu).
English: Even if the florfenicol monoproduct which was used as a comparator is not approved for M. bovis infections, it had been shown effective in the M. bovis experimental model performed in 2008.
Maltese: Anke jekk il-monoprodott ta' florfenicol li ntuża bħala komparatur mhuwiex approvat għal infezzjonijiet b'M. bovis, fil-mudell sperimentali ta' M. bovis li sar fl-2008 kien intwera li kien effettiv.
English: This is in line with the recommendations of the CVMP guideline on statistical principles (EMA/CVMP/EWP/81976/2010)
Maltese: Dan huwa konformi mar-rakkomandazzjonijiet tal-linja gwida tas-CVMP dwar il-prinċipji statistiċi (EMA/CVMP/EWP/81976/2010)
English: The marketing authorisation holder Intervet International BV, submitted an application for a type II variation to add Mycoplasma bovis as a target pathogen.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq, Intervet International BV, ippreżenta applikazzjoni għal varjazzjoni tat-tip II biex iżid Mycoplasma bovis bħala patoġenu fil-mira.
English: The study confirmed the superiority of Resflor to placebo (saline) for the treatment of M. bovis-induced bovine respiratory disease (BRD).
Maltese: L-istudju kkonferma s-superjorità ta' Resflor fuq plaċebo (salina) għall-kura ta' mard respiratorju tal-bovini (BRD) ikkawżat minn M. bovis.
English: The results show that the success rate in both treated groups of this subset (84%) was close to the success rate of the overall population (83.5% in the Resflor group and 79.4% in the florfenicol monoproduct group).
Maltese: Irriżultati juru li r-rata ta' suċċess fiż-żewġ gruppi ta' dan is-sottogrupp li rċieva kura (84%) kienet qrib ir-rata ta' suċċess tal-popolazzjoni globali (83.5% fil-grupp ta' Resflor u 79.4% fil-grupp talmonoprodott ta' florfenicol).
English: Route of administration
Maltese: Mod talamministrazzjoni
English: Resflor solution injectable (thereafter called ‘Resflor') is a solution for injection for use in cattle containing florfenicol and flunixin as active substances.
Maltese: Resflor soluzzjoni injettabbli (minn hawn 'il quddiem imsejjaħ ‘Resflor') huwa soluzzjoni għall-injezzjoni għall-użu fil-frat li fih florfenicol u flunixin bħala sustanzi attivi.
English: Resistance
Maltese: INYECTABLE
English: The multicentre trial performed in 2005 compared the efficacy of the florfenicol monoproduct to tulathromycin in naturally occurring outbreaks of BRD.
Maltese: Il-prova multiċentrika li saret fl-2005 qabblet l-effikaċja tal-monoprodott ta' florfenicol ma' tulathromycin f'tifqigħat ta' BRD li seħħew b'mod naturali.
English: The field trial study performed in 2004 was a GCP study comparing a florfenicol monoproduct (40 mg/kg) and Resflor administered as a single subcutaneous dose for the treatment of bovine respiratory disease.
Maltese: L-istudju tal-prova fuq il-post li sar fl-2004 kien studju tal-GCP li qabbel monoprodott ta' florfenicol (40 mg/kg) u Resflor mogħti bħala doża unika taħt il-ġilda għall-kura ta' mard respiratorju tal-bovini.
English: Therefore, the trial also showed the therapeutic benefit of using a fixed combination of 40 mg florfenicol and 2.2 mg flunixin per kg bw (Resflor) compared to 40 mg florfenicol per kg bw alone.
Maltese: Għalhekk, il-prova uriet ukoll il-benefiċċju terapewtiku tal-użu ta' taħlita fissa ta' 40 mg ta' florfenicol u 2.2 mg ta' flunixin għal kull kg tal-piż tal-ġisem (Resflor) meta mqabbla ma' 40 mg ta' florfenicol għal kull kg tal-piż tal-ġisem waħdu.
English: Quality, target animal safety, user safety, environmental risk and residues were not assessed in this referral procedure.
Maltese: Il-kwalità, is-sigurtà tal-annimal fil-mira, is-sigurtà tal-utent, ir-riskju ambjentali u r-residwi ma ġewx ivvalutati f'din il-proċedura ta' riferiment.
English: Resflor was shown to be significantly superior over florfenicol alone with higher reduction in pyrexia, lower incidence of depression, and better respiratory score at 6 hours post-treatment.
Maltese: Resflor kien intwera li huwa ferm superjuri fuq florfenicol waħdu bi tnaqqis ogħla fid-deni, inċidenza aktar baxxa ta' dipressjoni, u punteġġ respiratorju aħjar 6 sigħat wara l-kura.
English: In order to address the concerns raised by Denmark and Germany, the marketing authorisation holder was requested to provide all available efficacy data for Resflor, together with a justification for the recommended treatment dose and the appropriateness of the study design for the pivotal challenge study performed in 2012.
Maltese: Sabiex jindirizza t-tħassib imqajjem mid-Danimarka u l-Ġermanja, id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq intalab jipprovdi d-dejta kollha disponibbli dwar l-effikaċja għal Resflor, flimkien ma' ġustifikazzjoni tad-doża ta' kura rrakkomandata u l-adegwatezza tad-disinn tal-istudju għallistudju pivotali ta' sfida li sar fl-2012.
English: • the CVMP considered that no specific risk of antimicrobial resistance has been identified with the use of this product at the recommended dose;
Maltese: • is-CVMP qies li fid-doża rrakkomandata ma ġie identifikat l-ebda riskju speċifiku ta' reżistenza antimikrobika bl-użu ta' dan il-prodott;
English: As the reference and concerned Member States were not able to reach an agreement in respect of the variation, on 24 January 2014, France referred the matter to the CVMP under Article 13(2) of Commission Regulation (EC) No
Maltese: Peress li l-Istati Membri ta' referenza u kkonċernati ma setgħux jaslu għal qbil fir-rigward tal-varjazzjoni, fl-24 ta' Jannar 2014, Franza rreferiet il-kwistjoni lis-CVMP skont l-Artikolu 13(2) tar-Regolament tal-Kummissjoni (KE) Nru 1234/2008.
English: By the end of the study (Day 18), 61 of 87 cases (70.1%) were successfully treated with florfenicol compared to 68 out of 89 cases (76.4%) treated with tulathromycin.
Maltese: 1%) kellhom suċċess bil-kura b'florfenicol meta mqabbla ma' 68 minn 89 każ (76.4%) li ngħataw kura b'tulathromycin.
English: Therefore, the justification of the recommended treatment dose of a single injection of 40 mg florfenicol and 2.2 mg flunixin per kg bw for the treatment of BRD associated with M. bovis is based on the clinical data.
Maltese: Għalhekk, il-ġustifikazzjoni tad-doża ta' kura rrakkomandata ta' injezzjoni unika ta' 40 mg ta' florfenicol u ta' 2.2 mg ta' flunixin għal kull kg tal-piż tal-ġisem għall-kura ta' BRD assoċjat ma' M. bovis hija bbażata fuq id-dejta klinika.
English: The benefit-risk ratio for the addition of M. bovis as a fourth BRD pathogen to the indication of Resflor is considered favourable.
Maltese: Il-proporzjon tal-benefiċċju-riskju għaż-żieda ta' M. bovis bħala r-raba' patoġenu ta' BRD malindikazzjoni ta' Resflor huwa meqjus favorevoli.
English: • the CVMP considered that based on clinical results of the data package (two experimental study and two field trials), the dose and duration of treatment of Resflor in the treatment of BRD associated with M. bovis are appropriate;
Maltese: • is-CVMP qies li abbażi tar-riżultati kliniċi tal-pakkett tad-dejta (żewġ studji sperimentali u żewġ provi fuq il-post), id-doża u t-tul tal-kura ta' Resflor fil-kura ta' BRD assoċjat ma' M. bovis huma xierqa;
English: Belgium Intervet International B.V. Wim de Koerverstraat 35
Maltese: Belgium Intervet International B.V.
English: There are too many uncertainties in the PK/PD analysis to justify the dose.
Maltese: Hemm wisq inċertezzi fl-analiżi PK/PD biex tiġi ġġustifikata d-doża.
English: The clinical benefit of Resflor in the treatment of BRD associated with M. bovis has been demonstrated and no specific risk of antimicrobial resistance or any other kind have been identified with the use of this product.
Maltese: Il-benefiċċju kliniku ta' Resflor fil-kura ta' BRD assoċjat ma' M. bovis intwera u ma ġie identifikat l-ebda riskju speċifiku ta' reżistenza antimikrobika jew ta' kwalunkwe tip ieħor bl-użu ta' dan il-prodott.
English: Lithuania Intervet International B.V. Wim de Koerverstraat 35
Maltese: Wim de Koerverstraat 35
English: Luxembourg Intervet International B.V. Wim de Koerverstraat 35
Maltese: Lussemburgu Intervet International B.V.