FrancophonIA/ELRC3.0 huggingface dataset:
English: The full EPAR and risk management plan summary for Entyvio 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 active substance in Entyvio, vedolizumab, is a monoclonal antibody.
Maltese: Is-sustanza attiva f'Entyvio, vedolizumab, hija antikorp monoklonali.
English: In one main study in adult patients with moderate to severe active Crohn's disease in whom conventional therapy or TNF-alfa antagonists were ineffective or could not be tolerated, 15% (32 out of 220) of patients receiving Entyvio showed improved symptoms after 6 weeks of treatment, compared with 7% (10 out of 148) of patients on placebo.
Maltese: Fi studju ewlieni wieħed f'pazjenti adulti b'marda ta' Crohn attiva moderata għal severa li fihom, terapija konvenzjonali jew antagonisti ta' TNF-alfa ma kinux effettivi jew ma setgħux jiġu ttollerati, 15% (32 minn 220) tal-pazjenti li rċevew Entyvio wrew sintomi mtejbin wara 6 ġimgħat ta' kura, meta mqabbel ma' 7% (10 minn 148) tal-pazjenti fuq plaċebo.
English: This is a summary of the European public assessment report (EPAR) for Entyvio.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Entyvio.
English: Other information about Entyvio
Maltese: Informazzjoni oħra dwar Entyvio
English: Entyvio must not be used in people with active serious infections such as tuberculosis, sepsis (infection in the blood), listeriosis (infection with bacteria called Listeria) or opportunistic infections (those seen in patients with a weakened immune system) such as progressive multifocal leukoencephalopathy (PML, a rare brain infection that usually leads to severe disability or death).
Maltese: Entyvio ma għandux jintuża f'nies li għandhom infezzjonijiet serji attivi bħal tuberkolożi, sepsis (infezzjoni fid-demm), listerjożi (infezzjoni b'batterji msejħin Listeria) jew infezzjonijiet opportunistiċi (dawk li jidhru f'pazjenti b'sistema immunitarja mdgħajfa) bħal lewkoenċefalopatija multifokali progressiva (PML, jew infezzjoni rari fil-moħħ li normalment twassal għal diżabilità severa jew mewt).
English: Why is Entyvio approved?
Maltese: Għaliex ġie approvat Entyvio?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Entyvio on 22 May 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq fl-Unjoni Ewropea kollha għal Entyvio fit-22 ta' Mejju 2014.
English: Entyvio is produced by a method known as ‘recombinant DNA technology'; it is made by cells into which a gene (DNA) has been introduced that makes them able to produce vedolizumab.
Maltese: Entyvio jiġi prodott b'metodu magħruf bħala 'teknoloġija tad-DNA rikombinanti'; huwa magħmul minn ċelloli li fihom ikun ġie introdott ġene (DNA) li jagħmilhom kapaċi jipproduċu vedolizumab.
English: Entyvio is a medicine that contains the active substance vedolizumab.
Maltese: Entyvio hija mediċina li fiha s-sustanza attiva vedolizumab.
English: Entyvio was shown to be more effective than placebo: 47% (106 out of 225) of patients who received Entyvio showed an improvement in symptoms, compared with 26% (38 out of 149) of patients who received placebo.
Maltese: Entyvio intwera li huwa aktar effettiv minn plaċebo: 47% (106 minn 225) tal-pazjenti li rċevew Entyvio wrew titjib fis-sintomi, meta mqabbel ma' 26% (38 minn 149) tal-pazjenti li rċevew plaċebo.
English: By blocking alfa-4-beta-7 integrin, vedolizumab reduces the inflammation in the gut and the symptoms of these diseases.
Maltese: Billi jimblokka alfa-4beta-7 integrin, vedolizumab inaqqas l-infjammazzjoni fl-imsaren u s-sintomi ta' dan il-mard.
English: What are the risks associated with Entyvio?
Maltese: X'inhuma r-riskji assoċjati ma' Entyvio?
English: Vedolizumab has been designed to attach to ‘alfa-4-beta-7 integrin', a protein mostly found on the surface of certain white blood cells in the gut.
Maltese: Vedolizumab ġie ddisinjat sabiex jeħel ma' ‘alfa-4-beta-7 integrin', proteina li tinstab l-aktar fuq il-wiċċ ta' ċerti ċelloli tad-demm bojod fl-imsaren.
English: In ulcerative colitis, the Committee considered that the benefit of Entyvio has been clearly demonstrated, which is relevant for patients who do not respond to TNF-alfa therapy.
Maltese: F'kolite ulċerattiva, ilKumitat qies li l-benefiċċju ta' Entyvio ntwera b'mod ċar, li huwa relevanti għal pazjenti li ma jwieġbux għal terapija b'TNF-alfa.
English: In ulcerative colitis, Entyvio has been investigated in a main study in patients with moderate to severe active disease in whom conventional therapy or TNF-alfa antagonists were ineffective or could not be tolerated.
Maltese: F'kolite ulċerattiva, Entyvio ġie investigat fi studju ewlieni f'pazjenti b'marda attiva severa li fihom, terapija konvenzjonali jew antagonisiti ta' TNF-alfa ma kinux effettivi jew ma setgħux jiġu ttollerati.
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) in the body.
Maltese: Antikorp monoklonali huwa antikorp (tip ta' proteina) li ġie ddisinjat sabiex jagħraf u jeħel ma' struttura speċifika (imsejħa antiġen) fil-ġisem.
English: In addition, the study also showed that Entyvio maintained the effect up to 52 weeks more effectively than placebo.
Maltese: Barra minn hekk, l-istudju wera li Entyvio żamm l-effett sa 52 ġimgħa b'mod aktar effettiv minn plaċebo.
English: Entyvio is available as a powder to be made up into a solution for infusion (drip) into a vein.
Maltese: Entyvio huwa disponibbli bħala trab sabiex ikun magħmul soluzzjoni għal infużjoni (dripp) fil-vina.
English: How is Entyvio used?
Maltese: Kif jaħdem Entyvio?
English: In Crohn's disease, the CHMP considered that although the time required for improvement of symptoms may be longer and the size of the effect limited when compared with anti-TNF-alfa therapy, Entyvio still offers a benefit for patients because of its different mechanism of action and safety profile.
Maltese: Fil-marda ta' Crohn, is-CHMP qies li għalkemm il-ħin meħtieġ għat-titjib tas-sintomi jista' jkun itwal u d-daqs tal-effett limitat meta mqabbel ma' terapija anti-TNF-alfa, Entyvio xorta joffri benefiċċju għallpazjenti minħabba l-mekkaniżmu ta' azzjoni differenti tiegħu u l-profil tas-sigurtà tiegħu.
English: In ulcerative colitis and Crohn's disease these cells are involved in causing inflammation in the gut.
Maltese: F'kolite ulċerattiva u fil-marda ta' Crohn, dawn iċ-ċelloli huma involuti fl-ikkawżar ta' infjammazzjoni fl-imsaren.
English: The most common side effects with Entyvio (which may affect more than 1 in 10 people) are nasopharyngitis (inflammation of the nose and throat such as a cold), headache and arthralgia (joint pain).
Maltese: L-effetti sekondarji l-aktar komuni b'Entyvio (li jistgħu jaffettwaw aktar minn 1 minn kull 10) huma nasofarinġite (infjammazzjoni tal-imnieħer u tal-gerżuma bħal riħ), uġigħ ta' ras u artralġija (uġigħ filġogi).
English: Entyvio was also shown to be more effective than placebo at improving symptoms of Crohn's disease.
Maltese: Entyvio ntwera li huwa aktar effettiv minn plaċebo fit-titjib tas-sintomi tal-marda ta' Crohn.
English: It is used to treat adult patients with ulcerative colitis (a disease causing inflammation and ulcers in the lining of the gut) or Crohn's disease (a disease causing inflammation of the digestive tract).
Maltese: Jintuża biex jikkura pazjenti adulti b'kolite ulċerattiva (marda li tikkawża infjammazzjoni u ulċeri fir-rita tal-imsaren) jew il-marda ta' Crohn (marda li tikkawża infjammazzjoni tal-passaġġ diġestiv).
English: The company will also provide educational material to all healthcare professionals expected to prescribe Entyvio to remind them of the need to monitor patients for signs of neurological disease or PML, in particular those treated with certain biological medicines which may potentially cause PML.
Maltese: Il-kumpanija sejra tipprovdi wkoll materjal edukattiv lill-professjonisti tal-kura tas-saħħa kollha li huma mistennija li jippreskrivu Entyvio sabiex tfakkarhom li hemm bżonn li jimmonitorjaw lill-pazjenti għal sinjali ta' mard newroloġiku jew PML, b'mod partikolari dawk ikkurati b'ċerti mediċini bijoloġiċi li potenzjalment jistgħu jikkawżaw PML.
English: 2 September 2011
Maltese: 2 ta' Settemrbu 2011
English: It contains the active substance fluconazole.
Maltese: Fiha s-sustanza attiva flukonażolu.
English: EMA/65764/2012
Maltese: EMA/CHMP/478970/2011
English: Diflucan is also available in the EU under other trade names: Fluconazole, Fungustatin, Fungata, Triflucan.
Maltese: Diflucan huwa disponibbli wkoll fl-UE b'ismijiet kummerċjali oħrajn: Fluconazole, Fungustatin, Fungata, Triflucan.
English: Medicines known to prolong the QT interval and which are metabolised via the cytochrome P450 (CYP) 3A4 such as cisapride, astemizole, pimozide, quinidine and erythromycin should also not be given to patients receiving Diflucan.
Maltese: Mediċini magħrufin li jtawwlu l-intervall QT u li jiġu metabolizzati permezz taċ-ċitokroma P450 (CYP) 3A4 bħal ċisaprid, astemiżolu, pimożid, kinidina u eritromiċina wkoll ma għandhomx jingħataw lil pazjenti li jirċievu Diflucan.
English: The European Medicines Agency has completed a review of Diflucan.
Maltese: L-Aġenzija Ewropea tal-Mediċini temmet reviżjoni ta' Diflucan.
English: Diflucan is authorised in the EU via national procedures.
Maltese: Diflucan huwa awtorizzat fl-UE permezz ta' proċeduri nazzjonali.
English: The CHMP agreed that Diflucan can be used for the following conditions: mucosal and invasive candidiasis, genital candidiasis (trush), crypotococcal meningitis, dermatomycosis, coccidiodomycosis and onychomycosis.
Maltese: Is-CHMP qabel li Diflucan jista' jintuża għall-kundizzjonijiet li ġejjin: kandidjażi tal-mukuża u invażiva, kandidjażi ġenitali (trush), meninġite kriptokokkali, dermatomikożi, kokkidjodomikożi u onikomikożi.
English: Other sections harmonised by the CHMP include sections on special warnings, side effects, interactions, pharmacological properties and quality.
Maltese: Sezzjonijiet oħrajn li ġew armonizzati mis-CHMP jinkludu sezzjonijiet dwar twissijiet speċjali, effetti sekondarji, interazzjonijiet, karatteristiċi farmakoloġiċi u l-kwalità farmakoloġika.
English: Diflucan is used to treat various fungal infections, including candidiasis (thrush) and fungus in the nails.
Maltese: Diflucan jintuża biex jittratta diversi infezzjonijiet fungali, inklużi l-kandidjażi (thrush) u l-fungi fid-dwiefer.
English: On 18 February 2010, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Diflucan in the EU.
Maltese: Fit-18 ta' Frar 2010, il-Kummissjoni rriferiet il-kwistjoni lis-CHMP sabiex jarmonizza lawtorizzazzjonijiet għat-tqegħid fis-suq għal Diflucan fl-UE.
English: Terfenadine must also not be used in patients receiving Diflucan at multiple doses of 400 mg per day or higher.
Maltese: Lanqas it-terfenadina ma għandha tintuża f'pazjenti li jingħataw Diflucan f'dożi multipli ta' 400 mg kuljum jew iktar.
English: Diflucan is an antifungal medicine that belongs to the triazoles group.
Maltese: Diflucan huwa mediċina antifungali li tappartieni lill-grupp tat-trijażoli.
English: Why was Diflucan reviewed?
Maltese: X'inhu Diflucan?
English: Diflucan was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Maltese: Il-Grupp ta' Koordinament dwar il-Proċeduri Reċiproċi u Deċentralizzati - Bnedmin (CMD(h)) identifika l-ħtieġa li Diflucan jiġi armonizzat.
English: The CHMP harmonised the dosing recommendations for the various indications to be in line with international guidelines.
Maltese: Is-CHMP armonizza r-rakkomandazzjonijiet tad-dożaġġ għall-indikazzjonijiet varji sabiex ikunu konformi mal-linji gwida internazzjonali.
English: The company that markets these medicines is Pfizer.
Maltese: Il-kumpanija li tqiegħed dawn il-mediċini fis-suq jisimha Pfizer.
English: Diflucan works by preventing the formation of ergosterol, which is an important part of fungal cell walls.
Maltese: Diflucan jaħdem billi jimpedixxi l-formazzjoni tal-ergosterolu, li huwa parti importanti mill-ħitan taċċelloli fungali.
English: The CHMP agreed that Diflucan should not be used in patients who are hypersensitive (allergic) to the active substance, to related azole substances, or to any of other ingredient of the medicine.
Maltese: Is-CHMP qabel li Diflucan ma għandux jintuża fuq pazjenti li huma ipersensittivi (allerġiċi) għassustanza attiva, għas-sustanzi ażoli relatati, jew għal xi sustanza oħra tal-mediċina.
English: The Committee harmonised the wording on the use of the medicine for these conditions, specifying when it is to be used for treatment and prophylaxis (prevention) and introducing restrictions for certain indications.
Maltese: Ilformolazzjoni tispeċfika meta għandha tintuża għall-kura u l-profilassi (prevenzjoni) u tintroduċi restrizzjonijiet għal ċerti indikazzjonijiet.
English: United Kingdom Gosmore Ltd 9 Pitch and Pay Lane Sneyd Park,
Maltese: Gosmore Ltd 9 Pitch and Pay Lane Sneyd Park,
English: Epidemiological studies of calf respiratory disease in a large commercial veal unit.
Maltese: MS, Pritchard DG. Epidemiological studies of calf respiratory disease in a large commercial veal unit.
English: 2 Miller WM, Harkness JW, Richards MS, Pritchard DG.
Maltese: 2 Miller WM, Harkness JW, Richards
English: = Daily dose of the active ingredient [mg.kgbw
Maltese: = Doża ta' kuljum tas-sustanza attiva [mg.kgbw
English: Svensson C., Hultgren J. and Oltenacu P. (2006) Morbidity in 3-7 month old dairy calves in south-western Sweden, and risk factors for diarrhoea and respiratory disease.
Maltese: (2006) Morbidity in 3-7 month old dairy calves in south-western Sweden, and risk factors for diarrhoea and respiratory disease.
English: Member State Applicant/Marketing Authorisation Holder
Maltese: Stat Membru Applikant/Detentur talAwtorizzazzjoni għatTqegħid fis-Suq
English: PEC initial soil
Maltese: PECħamrija inizjali
English: • Veal calves: The Netherlands - 19.8%, Belgium - 13.3% (Catry et al, 20091).
Maltese: • għoġiela tal-laħam tal-vitella: l-Olanda - 19.8%, il-Belġju - 13.3% (Catry et al, 20091).
English: • Commercial veal unit: UK - 75% (Miller et al, 19802).
Maltese: • unità kummerċjali tal-vitella: ir-Renju Unit - 75% (Miller et al, 19802).
English: 2.1 Incidence of BRD (Bovine Respiratory Disease)
Maltese: 2.1 Inċidenza ta' BRD (Mard Respiratorju Bovin)
English: • Dairy farm calves: Italy - 28.9% (Makoshey et al, 20086).
Maltese: • għoġiela tal-irziezet tal-prodotti tal-ħalib: l-Italja - 28.9% (Makoshey et al, 20086).
English: 6 Makoschey B., Munoz Bielsa J., Oliviero L., Roy O., Pillet F., Dufe D., Valla G. and Cavirani S. (2008) Field Efficacy of Combination Vaccines Against Bovine Respiratory Pathogens in Calves.
Maltese: 6 Makoschey B., Munoz Bielsa J., Oliviero L., Roy O., Pillet F., Dufe D., Valla G. and Cavirani S.
English: • Dairy calves: Sweden - 2.2-53.3% (Svensson et al 20064).
Maltese: • għoġiela fil-fażi tat-treddigħ: l-Iżvezja - 2.2-53.3% (Svensson et al 20064).
English: Florfenicol concentrations were below the limit of quantification (LOQ) (0.4 mg/kg) by day 2 and below the limit of detection (LOD) (0.1 mg/kg) by day 27.
Maltese: Il-konċentrazzjonijiet ta' Florfenicol kienu taħt il-limitu ta' kwantifikazzjoni (LOQ) (0.4 mg/kg) sattieni jum u taħt il-limitu ta' kxif (LOD) (0.1 mg/kg) sas-27 jum.
English: • Beef calves: Spain - 31.5%, UK - 13-15% (Martin et al, 20073).
Maltese: Spanja - 31.5%, ir-Renju Unit - 13-15% (Martin et al, 20073).
English: 1 Catry .B, Duchateau L, Van de Ven J, Laevens H, Opsomer, G., Haesebrouck F, DE Kruif, A. Efficacy of metaphylactic florfenicol therapy during natural outbreaks of bovine respiratory disease.
Maltese: 1 Catry .B, Duchateau L, Van de Ven J, Laevens H, Opsomer, G., Haesebrouck F, DE
English: The incidence rate observed by Martin et al, 2007 was refined to include the animals presenting clinical signs of BRD before the study, with the result that the incidence was increased to 37.7%.
Maltese: Ir-rata ta' inċidenza osservata minn Martin et al, 2007 ġiet irfinuta sabiex tinkludi l-annimali li wrew sinjali kliniċi ta' BRD qabel l-istudju, bir-riżultat li l-inċidenza żdiedet għal 37.7%.
English: 3 Martin G., Partida E., Villalobos P., López C., López-Guerrero C. and Blanco A. (2007) Evaluation of Mass and Selective Metaphylaxis Medication with Florfenicol at Feedlot entry as a tool against Bovine Respiratory Disease Under Commercial Conditions in Spain.
Maltese: (2007) Evaluation of Mass and Selective Metaphylaxis Medication with Florfenicol at Feedlot entry as a tool against Bovine Respiratory Disease Under Commercial Conditions in Spain.
English: = Depth of penetration into soil [m]
Maltese: = Fond tal-penetrazzjoni fil-ħamrija [m]
English: Section 4.2 of the SPC and Section 4 of the Package Leaflet:
Maltese: Sezzjoni 4.2 tal-SPC u Sezzjoni 4 tal-Fuljett ta' Tagħrif:
English: The dossier as submitted in the referral procedure is considered to fulfil the necessary requirements with regards to the environmental risk assessment (as established in Article 12(3)(j) of Directive 2001/82/EC, as amended by Directive 2004/28/EC) provided that the product is used only for therapeutic treatment of respiratory tract infections in cattle due to Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
Maltese: Id-dossier kif ippreżentat filproċedura ta' referenza huwa meqjus li jissodisfa r-rekwiżiti meħtieġa fir-rigward tal-valutazzjoni tarriskju ambjentali (kif stabbilita fl-Artikolu 12(3)(j) tad-Direttiva 2001/82/KE, kif emendata midDirettiva 2004/28/KE) sakemm il-prodott jintuża biss għall-kura terapewtika tal-infezzjonijiet talapparat respiratorju fil-frat ikkawżati minn Mannheimia haemolytica, Pasteurella multocida u Histophilus somni.
English: This overall process is described in VICH Phase I and Phase II guidelines (VICH Topic GL6 (Ecotoxicity Phase I; Guideline on environmental impact assessment (EIAS) for veterinary medicinal products - Phase I (CVMP/VICH/592/98-FINAL) and VICH GL 38 (Environmental impact assessment for veterinary medicinal products - Phase II (CVMP/VICH/790/03-FINAL)).
Maltese: Dan il-proċess kollu huwa deskritt fil-linji gwida tal-Fażi I u tal-Fażi II tal-VICH (Suġġett VICH GL6 (Ekotossiċità Fażi I; Linja gwida dwar il-valutazzjoni tal-impatt ambjentali (EIAS) għal prodotti mediċinali veterinarji - Fażi I (CVMP/VICH/592/98-FINAL) u VICH GL 38 (Valutazzjoni tal-impatt ambjentali għal prodotti mediċinali veterinarji - Fażi
English: OVERALL SUMMARY OF THE SCIENTIFIC CONCLUSIONS 1.
Maltese: TAL-KONKLUŻJONIJIET XJENTIFIĊI 1.
English: The LOQ is equal to 11% of the dose added to manure (0.4/3.6) and the LOD is equal to 2.7% (0.1/3.6) of the dose added to manure.
Maltese: Il-valur LOQ huwa ugwali għal 11% tad-doża miżjuda mad-demel (0.4/3.6) u l-valur LOD huwa ugwali għal 2.7% (0.1/3.6) tad-doża miżjuda mad-demel.
English: PECsoil initial = Predicted Environmental Concentration in soil [μg.kg-1] D
Maltese: Mbassra fil-ħamrija [μg.kg-1]
English: Fenflor contains florfenicol, which is a broad-spectrum primarily bacteriostatic antibiotic with a range of activity, including many Gram-negative and Gram-positive organisms.
Maltese: Fenflor fih florfenicol, li huwa antibijotiku ta' spettru wiesa' b'azzjoni prinċipalment batterjostatika b'medda ta' attività li jinkludi bosta organiżmi Gram-negattivi u Gram-pożittivi.
English: The Marketing Authorisation Holder provided a study to demonstrate that florfenicol degrades rapidly, with a DT50 of 14 hours (calculated using the Arrhenius equation to extrapolate from a DT50 of 5 hours measured at 20°C rather than at 10°C, as recommended in the CVMP guideline).
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq ipprovda studju sabiex juri li florfenicol jiddegrada malajr, b'DT50 ta' 14-il siegħa (ikkalkulat permezz tal-ekwazzjoni Arrhenius sabiex ikun estrapolat minn DT50 ta' 5 sigħat imkejla f'20°C minflok f'10°C, kif irrakkomandat fil-linja gwida tasCVMP).
English: 2.2 PECsoil CALCULATION
Maltese: 2.2 KALKOLU TAL-PECħamrija
English: = Fraction of herd treated [value between 0 and 1] (see Table 2 of the guideline) = Bulk density of dry soil [kg.m-3]
Maltese: = Frazzjoni tal-merħla kkurata [valur bejn 0 u 1] (ara t-Tabella 2 tal-linja gwida) = Densità tal-volum tal-ħamrija niexfa [kg.m-3] = Erja ta' ettaru [m2 .ha-1]
English: Using the value of 38% for the proportion of treated animals in a herd, a maximum PECsoil value of 88.6 μg/kg was calculated.
Maltese: Bl-użu tal-valur ta' 38% għall-proporzjon ta' annimali kkurati f'merħla, ġie kkalkulat valur PECħamrija massimu ta' 88.6 μg/kg.
English: PECsoil = 40 x 1 x 140 x 1.8 x 170 x 0.38 x 1000 =
Maltese: PECħamrija = 40 x 1 x 140 x 1.8 x 170 x 0.38 x 1000 =
English: “Diseases caused by florfenicol susceptible bacteria: therapeutic treatment of respiratory tract infections in cattle due to Mannheimia haemolytica, Pasteurella multocida and Hisophilus somni”
Maltese: “Mard ikkawżat minn batterji suxxettibbli għal florfenicol: kura terapewtika ta' infezzjonijiet tal-apparat respiratorju fil-frat ikkawżati minn Mannheimia haemolytica, Pasteurella multocida u Hisophilus somni”
English: 74:162-179 5 Godinho K., Wolf R., Sherington J., Rowan T., Sunderland S. and Evans N. (2005) Efficacy of tulathromycin in the treatment and prevention of natural outbreaks of bovine respiratory disease in European cattle.
Maltese: 5 Godinho K., Wolf R., Sherington J., Rowan T., Sunderland S. and Evans N.
English: = Animal turnover rate per place per year [place-1.y-1] (see Table 3 of the guideline) = EU nitrogen spreading limit [kg N.ha-1]
Maltese: Tabella 3 tal-linja gwida) = limitu tal-UE tal-firxa tan-nitroġenu [kg N.ha-1]
English: The CVMP concluded that adequate evidence had been provided to demonstrate that the proportion of treated animals in a herd would not be higher than 38% for therapeutic treatment of respiratory tract infections in cattle due to Mannheimia haemolytica, Pasteurella multocida and Histophilus somni and that the data justified the use of this figure of 38% as the value for the proportion of treated animals in a herd, for use in calculating the PECsoil.
Maltese: Is-CVMP kkonkluda li kienet ġiet ipprovduta prova adegwata li turi li l-proporzjon ta' annimali kkurati f'merħla ma jkunx ogħla minn 38% għal kura terapewtika ta' infezzjonijiet tal-apparat respiratorju fil-frat ikkawżati minn Mannheimia haemolytica, Pasteurella multocida u Histophilus somni u li d-data ġġustifikat l-użu ta' din iċ-ċifra ta' 38% bħala l-valur għall-proporzjon ta' annimali ttrattati f'merħla, għall-użu fil-kalkolu tal-PECħamrija.
English: During the mutual recognition procedure concerns were raised that Fenflor 300 mg/ml solution for injection for cattle may present a potential serious risk to the environment.
Maltese: Fenflor 300 mg/ml solution for injection for
English: “Diseases caused by florfenicol susceptible bacteria: therapeutic treatment of respiratory tract infections in cattle due to Mannheimia haemolytica, Pasteurella multocida and Histophilus somni”.
Maltese: “Mard ikkawżat minn batterji suxxettibbli għal florfenicol: kura terapewtika ta' infezzjonijiet talapparat respiratorju fil-frat ikkawżati minn Mannheimia haemolytica, Pasteurella multocida u Hisophilus somni”.
English: 1500 x 10000 x 0.05 x 10 x 1 Cattle (0 - 1 year) PECsoil = 40 x 1 x 200 x 1 x 170 x 0.38 x 1000 =
Maltese: 1500 x 10000 x 0.05 x 10 x 1 Frat (0 - sena) PECħamrija = 40 x 1 x 200 x 1 x 170 x 0.38 x 1000 =
English: In the first phase the DT50 was calculated to be 4 hours, while it was 12 hours in the second phase.
Maltese: Fl-ewwel fażi, id-DT50 ġie kkalkulat li huwa 4 sigħat, filwaqt li fit-tieni fażi kien 12-il siegħa.