FrancophonIA/ELRC3.0 huggingface dataset:
English: Nanotop is a diagnostic radiopharmaceutical kit containing denatured human serum albumin (HSA), which after radiolabelling with Sodium Pertechnetate (99mTc) solution results in Technetium (99mTc) Nanocolloid.
Maltese: Nanotop huwa tagħmir radjufarmaċewtiku dijanjostiku li fih albumina tas-serum uman denaturata (HSA), li wara li tiġi radjutikkettata b'soluzzjoni ta' Sodium Pertechnetate (99mTc) twassal għal Technetium (99mTc) Nanocolloid.
English: The mutual recognition marketing authorisation application (MAA) for Nanotop 0.5 mg, kit for radiopharmaceutical preparation / lyophilisate for suspension for injection was submitted on the basis of the marketing authorisation granted by Germany on 8th December 2011.
Maltese: L-applikazzjoni għal awtorizzazzjoni għat-tqegħid fis-suq (MAA) b'rikonoxximent reċiproku għal Nanotop 0.5 mg, tagħmir għal preparazzjoni radjufarmaċewtika / lyophilisate għal sospensjoni għallinjezzjoni kienet ippreżentata abbażi tal-awtorizzazzjoni għat-tqegħid fis-suq mogħtija mill-Ġermanja fit-8 ta' Diċembru 2011.
English: The relevant quality attributes including upper particle size limits are defined in the European core summary of product characteristics (SmPC) for Tc-99m Albumin Microcolloid (nm), in the relevant European and national Treatment Guidelines1,2,3 and in the SmPC of the approved products (e.g. Nanocoll) and have been cited by the MAH.
Maltese: L-attributi ta' kwalità rilevanti fosthom il-limiti massimi tad-daqs tal-partikoli huma definiti fis-sommarju prinċipali Ewropew tal-karatteristiċi tal-prodott (SmPC) għal Albumin Microcolloid Tc-99m (nm), fil-Linji Gwida ta' Kura Ewropej u nazzjonali rilevanti1,2,3 u fl-SmPC tal-prodotti approvati (eż. Nanocoll) u ġew ikkwotati mill-MAH.
English: In response to the objection that there is a difference in the data fluctuation between Nanotop and Nanocoll, the MAH has provided data to show that the fluctuations observed are comparable and that particle size group distribution is comparable between Nanotop and Nanocoll.
Maltese: Bi tweġiba għall-oġġezzjoni li hemm differenza fil-varjazzjoni tad-dejta bejn Nanotop u Nanocoll, ilMAH ipprovda dejta biex juri li l-varjazzjonijiet osservati huma komparabbli u li d-distribuzzjoni talgrupp tad-daqs tal-partikoli hija komparabbli bejn Nanotop u Nanocoll.
English: Technetium (99mTc) Nanocolloid is used for characterisation of the properties of the lymphatic system and in particular sentinel lymph node (SLN) detection in breast cancer and malignant melanoma.
Maltese: Technetium (99mTc) Nanocolloid jintuża biex jikkaratterizza l-karatteristiċi tas-sistema limfatika u b'mod partikulari l-iskoperta ta' glandoli limfatiċi sentinella (SLN) fil-kanċer tas-sider u melanoma malinna.
English: The upper particle size limits for SLN detection procedures used in Europe has been established and the acceptance criterion of at least 95% of particles having a diameter ≤ 80 nm was shown to be met by all batches of Nanotop.
Maltese: Il-limiti massimi tad-daqs tal-partikoli għal proċeduri ta' skoperti ta' SLN użati fl-Ewropa ġew stabbiliti u l-kriterji ta' aċċettazzjoni li mill-inqas 95% tal-partikoli jkollhom dijametru ta' ≤ 80 nm intwerew li kienu ntlaħqu mil-lottijiet kollha ta' Nanotop. Matul l-iżvilupp, il-MAH investiga d-distribuzzjoni ta' daqs taħt 80 nm u ħoloq “gruppi ta' daqsijiet ta' partikoli”.
English: In addition the MAH has provided data on Nanocoll and Nanotop batches that were analysed on four days (six batches), and on the same day.
Maltese: Barra minn hekk il-MAH ipprovda dejta dwar lottijiet ta' Nanocoll u Nanotop li kienu analizzati fuq erbat ijiem (sitt lottijiet), u fl-istess jum.
English: There have been no studies so far investigating the clinical effects of variability occurring within the particle size range of HSA nanocolloid (of 0 to 80 nm).
Maltese: S'issa ma kien hemm l-ebda studji li investigaw l-effetti kliniċi ta' varjabbiltà li sseħħ fil-firxa tad-daqs tal-partikoli tan-nanocolloid HSA (ta' 0 sa 80 nm).
English: The MAH argued that the fluctuations per se are not clinically relevant and therefore differences between such fluctuations are not likely to pose a risk to public health.
Maltese: Il-MAH argumenta li lvarjazzjonijiet per se mhumiex klinikament rilevanti u għalhekk differenzi bejn dawn il-varjazzjonijiet mhux probabbli li joħolqu riskju għas-saħħa pubblika.
English: In addition the MAH's clinical expert states that any variability in particle size within the specified range of Nanotop (≤ 80 nm of at least 95% of the particles) is not relevant for the clinical outcome.
Maltese: Barra minn hekk l-espert kliniku tal-MAH jiddikjara li kull varjabbiltà fid-daqs tal-partikoli fil-firxa speċifikata ta' Nanotop (≤ 80 nm ta' mill-inqas 95% tal-partikoli) mhijiex rilevanti għar-riżultat kliniku.
English: The legal basis for the submitted marketing authorisation application (MAA) was Article 10a "well established use", relying on appropriate scientific literature data of another similar product, Nanocoll.
Maltese: Il-bażi legali għall-applikazzjoni għall-awtorizzazzjoni għat-tqegħid fissuq (MAA) ippreżentata kienet l-Artikolu 10a "użu stabbilit sew", li tibbaża fuq dejta mil-letteratura xjentifika adegwata ta' prodott ieħor simili, Nanocoll.
English: Due to different views in the interpretation of the data related to particle size distribution within the defined limits relevant for efficacy, this referral was triggered to assess the importance of the batch to batch variability for the distribution and uptake of Nanotop in lymph nodes, and whether this could have an impact on efficacy.
Maltese: Minħabba fehmiet differenti fl-interpretazzjoni tad-dejta relatata mad-distribuzzjoni tad-daqs talpartikoli fil-limiti definiti rilevanti għall-effikaċja, dan ir-riferiment ingħata bidu biex jevalwa limportanza tal-lott għall-varjabbiltà tal-lott għad-distribuzzjoni u t-teħid ta' Nanotop fin-nodi limfatiċi, u jekk dan jistax ikollu impatt fuq l-effikaċja.
English: The efficacy of a Tc-99m albumin colloid is the ability to identify the first draining SLN. Once the Tc99m albumin colloid is administered, the passage of the tracer through the lymphatic system is recorded by imaging.
Maltese: Ladarba jingħata l-kollojde tal-albumina Tc-99m, il-passaġġ tat-tracer minn ġos-sistema limfatika jiġi reġistrat permezz ta' immaġini.
English: Considering the particle size and the particle size ranges range discussed above, the CHMP was of the view that Nanotop is comparable to Nanocoll - the product referred to in the submitted literature, and that therefore an impact on clinical efficacy is not expected.
Maltese: Wara li qies id-daqs tal-partikoli u l-firxa tad-daqs tal-partikoli diskussi hawn fuq, is-CHMP kien talfehma li Nanotop huwa komparabbli għal Nanocoll - il-prodott imsemmi fil-letteratura ppreżentata, u li għalhekk mhuwiex mistenni li jkun hemm impatt fuq l-effikaċja klinika.
English: • The Committee therefore concluded that the MAH has satisfactorily demonstrated that Nanotop is comparable to Nanocoll, and that therefore an impact on clinical efficacy is not expected.
Maltese: • Għalhekk il-Kumitat ikkonkluda li l-MAH wera b'mod sodisfaċenti li Nanotop huwa komparabbli ma' Nanocoll, u li għalhekk mhuwiex mistenni li jkun hemm impatt fuq l-effikaċja klinika.
English: Subcutaneous use
Maltese: Konklużjonijiet xjentifiċi
English: The MAH has discussed particle size ranges and its implication for clinical practice in general, with reference to clinical guidelines.
Maltese: Il-MAH iddiskuta l-firxiet tad-daqsijiet tal-partikoli u l-implikazzjoni tagħha għall-prattika klinika inġenerali, b'referenza għal linji gwida kliniċi.
English: The CMDh therefore referred the matter to the CHMP through an Art 29(4) referral procedure.
Maltese: Għalhekk is-CMDh irrefera l-kwistjoni lis-CHMP permezz ta' proċedura ta' riferiment skont l-Art 29(4).
English: The particle size range is in this respect the crucial parameter that characterises the particular compound since small-sized colloids allow identification of a greater number of sentinel lymph nodes with a high statistical significance4.
Maltese: F'dan ir-rigward il-firxa tad-daqs tal-partikoli hija l-parametru kruċjali li jikkaratterizza l-kompost partikulari peress li kollojdi ta' daqs żgħir jippermettu l-identifikazzjoni ta' għadd akbar ta' nodi limfatiċi sentinella b'sinifikat statistiku għoli4.
English: The particle range of Nanotop corresponds to that of Nanocoll.
Maltese: Il-firxa tal-partikoli ta' Nanotop tikkorrispondi għal dik ta' Nanocoll.
English: Bravničarjeva 13 Ljubljana SLOVENIA
Maltese: Bravničarjeva 13 Ljubljana IS-SLOVENJA
English: Viale Certosa 130 I-20156 Milan ITALY
Maltese: Viale Certosa 130 I-20156 Milan L-ITALJA
English: Bayer Sante 220 Avenue De La Recherche 59120 Loos FRANCE
Maltese: Bayer Sante 220 Avenue De La Recherche 59120 Loos FRANZA
English: BAYER PORTUGAL, SA Rua Quinta do Pinheiro, 5 2794-003 Carnaxide PORTUGAL
Maltese: BAYER PORTUGAL, SA Rua Quinta do Pinheiro, 5 2794-003 Carnaxide IL-PORTUGALL
English: 1123 Budapest HUNGARY
Maltese: 1123 Budapest L-UNGERIJA
English: ATCvet code: QJ01MA90.
Maltese: QJ01MA90.
English: EFSA Journal 2012; 10(3):2598 [233 pp.] doi:10.2903/j.efsa.2012.2598.
Maltese: EFSA Journal 2012; 10(3):2598 [233 pp.] doi:10.
English: <Date of last renewal:> <{DD/MM/YYYY}><{DD month YYYY}>.
Maltese: <Data tal-aħħar tiġdid:> <{DD/MM/YYYY}><{DD month YYYY}>.
English: Potassium hydroxide Purified water.
Maltese: Benzyl alcohol Potassium hydroxide Ilma purifikat.
English: Turkeys: 8 days
Maltese: Dundjani: 8 ijiem
English: CVMP guideline on user safety for pharmaceutical veterinary medicinal products (EMA/CVMP/543/03-Rev.1)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/03/WC500077971.pdf
Maltese: Il-linja gwida tas-CVMP dwar is-sigurtà ta' min juża l-prodott għall-prodotti mediċinali veterinarji farmaċewtiċi (EMA/CVMP/543/03-Rev.1)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/03/WC500077971.pdf
English: Pharmacotherapeutic group: quinolone and quinoxaline antibacterials, fluoroquinolones.
Maltese: Antibatteriċi quinolone u quinoxaline, fluoroquinolones.
English: 51368 Leverkusen GERMANY
Maltese: 51368 Leverkusen
English: Antimicrobial resistance
Maltese: Reżistenza antimikrobjali
English: Available online at www.efsa.europa.eu/efsajournal de Jong A, Stephan B, Silley P.(2012).Fluoroquinolone resistance in E coli and Salmonella from healthy livestock and poultry in the EU.
Maltese: Disponibbli online fuq www.efsa.europa.eu/efsajournal de Jong A, Stephan B, Silley P.(2012).
English: Enrofloxacin is active against many Gram-negative bacteria, against Gram-positive bacteria and Mycoplasma spp.
Maltese: Enrofloxacin huwa attiv kontra bosta batterji Gram-negattivi, kontra batterji Gram-pożittivi u Mycoplasma spp.
English: Protein binding in poultry is approximately 25 %.
Maltese: Ittwaħħil mal-proteini fit-tjur huwa madwar 25 %.
English: Bayer Vital GmbH 51368 Leverkusen GERMANY
Maltese: Il-Ġermanja Bayer Vital GmbH 51368 Leverkusen
English: Animal Health Division Bayer House Strawberry Hill Newbury
Maltese: Strawberry Hill Newbury
English: Clinical resistance of E. coli in chickens to ciprofloxacin was 1.9% in 1999-2000 and increased through 2002-3 to 5.9% in 2005-6.
Maltese: Ir-reżistenza klinika ta' E. coli fit-tiġieġ għal ciprofloxacin kienet 1.9% fl-1999-2000 u żdiedet matul l-2002-3 għal 5.9% fl-2005-6.
English: CVMP Reflection paper on the use of fluoroquinolones in food- producing animals - Precautions for use in the SPC regarding prudent use guidance (EMEA/CVMP/416168/2006)http://www.ema.europa.eu/docs/en_GB/document_library/Other/2009/10/WC500005173.pdf
Maltese: Id-dokument ta' riflessjoni tas-CVMP dwar l-użu ta' fluoroquinolones fl-annimali li jipproduċu l-ikel - Prekawzjonijiet għallużu fl-SPC rigward il-gwida tal-użu prudenti (EMEA/CVMP/416168/2006)http://www.ema.europa.eu/docs/en_GB/document_library/Other/2009/10/WC500005173.pdf is-CVMP irrakkomanda l-emenda tal-awtorizzazzjonijiet għat-tqegħid fis-suq li għalihom is-sommarju tal-karatteristiċi tal-prodott, it-tikkettar u l-fuljett ta' tagħrif huwa stabbilit fl-Anness
English: Rates of decreased susceptibility of E. coli to ciprofloxacin based on an epidemiological cut-off of 0.06 mg/l were 19.3% in 1999-2000 and 33.5% in 2005-6.
Maltese: Ir-rati ta' suxxettibbiltà mnaqqsa ta' E. coli għal ciprofloxacin ibbażati fuq valur ta' limitu epidemjoloġiku ta' 0.06 mg/l kienu 19.3% fl-1999-2000 u 33.5% fl-2005-6.
English: Do not use for prophylaxis.
Maltese: Tużax għal profilassi.
English: 1, 2006) and from commercial poultry in the Netherlands (Landman
Maltese: 1, 2006) kif ukoll minn tjur kummerċjali fil-Pajjiżi l-Baxxi (Landman
English: Treatment for 3-5 consecutive days; for 5 consecutive days in mixed infections and chronic progressive forms.
Maltese: Trattament għal 3-5 ijiem wara xulxin; għal 5 ijiem wara xulxin f'infezzjonijiet imħallta u forom kroniċi progressivi.
English: Baytril 10% oral solution at a dose rate of 100 ppm (approximately 10 mg/kg) for 6 days and repeating after a 3 day interval was shown to be safe to use in rabbits aged 30 days, in does at mating and 15 days after mating and when does were lactating.
Maltese: Baytril 10% soluzzjoni orali f'rata ta' doża ta' 100 ppm (madwar 10 mg/kg) għal 6 ijiem u ripetut wara waqfa ta' 3 ijiem intwera li huwa sigur biex jintuża fil-fniek ta' 30 jum, fil-fniek nisa fit-tgħammir u 15il jum wara t-tgħammir u meta l-fniek nisa jkunu qegħdin ireddgħu.
English: 4 days
Maltese: 4 ijiem
English: Chickens: 3 days Turkeys: 4 days
Maltese: Tiġieġ: 3 ijiem Dundjani: 4 ijiem
English: Maximum plasma concentrations of 2 mg/L are reached within 1.5 hours after a single bolus dose rate of 10 mg/kg body weight with a total systemic availability of 14.4 mg·hr/L.
Maltese: Konċentrazzjonijeit massimi fil-plażma ta' 2 mg/L jintlaħqu fi żmien 1.5 sigħat wara rata ta' doża bolus waħda ta' 10 mg/kg ta' piż tal-ġisem b'disponibbiltà sistemika totali ta' 14.4 mg·hr/L.
English: BAYER HEALTH CARE AG 51368 Leverkusen GERMANY
Maltese: CARE AG 51368 Leverkusen
English: Chickens: 3 days Turkeys: 3 days
Maltese: Tiġieġ: 3 ijiem Dundjani: 3 ijiem
English: The marketing authorisation holders agreed to delete the following indications from the product information either due to paucity of supporting data and/or because the indications were not consistent with responsible use on fluoroquinolones: Salmonella, Streptococcus spp, Staphylococcus spp, Klebsiella, Erysipelothrix rhusiopathae.
Maltese: Id-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq qablu li jħassru dawn l-indikazzjonijiet millinformazzjoni dwar il-prodott kemm minħabba l-insuffiċjenza tad-dejta ta' appoġġ kif ukoll/jew peress li l-indikazzjonijiet ma kinux konsistenti mal-użu responsabbli tal-fluoroquinolones: Salmonella, Streptococcus spp, Staphylococcus spp, Klebsiella, Erysipelothrix rhusiopathae.
English: In vitro, an antagonism was shown, when combining fluoroquinolones with bacteriostatic antimicrobial agents such as macrolides or tetracyclines and phenicols.
Maltese: In vitro, intwera antagoniżmu meta l-fluoroquinolones ġew kombinati ma' sustanzi antimikrobiċi batterjostatiċi bħal makrolidi jew tetracyclines u phenicols.
English: 100 ml, 500 ml and 1,000 ml high density polyethylene (HDPE) bottles with an HDPE insert and a polypropylene screw closure.
Maltese: Fliexken tal-polyethylene ta' densità għolja (HDPE) ta' 100 ml, 500 ml u 1,000 ml b'inserzjoni tal-HDPE u għeluq bil-kamin tal-polypropylene.
English: Therefore, and taking account of the scope of this Article 34 referral, the indication can be retained in the harmonised SPC.
Maltese: Għaldaqstant, u b'kunsiderazzjoni tal-ambitu ta' din ir-referenza tal-Artikolu 34, l-indikazzjoni tista' tinżamm fl-SPC armonizzat.
English: For chickens and turkeys, please refer to section 8.
Maltese: Għat-tiġieġ u d-dundjani, jekk jogħġbok irreferi għal sezzjoni 8.
English: Bottles of 100, 500 and 1,000 ml or canister of 5,000 ml.
Maltese: Fliexken ta' 100, 500, 1,000 u 5,000 ml.
English: Enrofloxacin 100 mg/ml oral solution Poultry
Maltese: Enrofloxacin 100 mg/ml soluzzjoni orali
English: 3641 RT Mijdrecht THE NETHERLANDS
Maltese: 3641 RT Mijdrecht IL-PAJJIŻI L-BAXXI
English: In vitro susceptibility has been shown in strains of (i) Gram-negative species such as Escherichia coli, Pasteurella multocida and Avibacterium (Haemophilus) paragallinarum and (ii) Mycoplasma gallisepticum and Mycoplasma synoviae.
Maltese: Intweriet suxxettibilità in vitro f'razez ta' (i) speċi Gram-negattivi bħal Escherichia coli, Pasteurella multocida u Avibacterium (Haemophilus) paragallinarum u (ii) Mycoplasma gallisepticum u Mycoplasma synoviae.
English: Total number of rabbits x Average body weight in kg x 0.1 = Total volume (ml) per day
Maltese: Numru totali ta' tjur x Piż medju tal-ġisem f'kg x 0.1 = Volum totali (ml) kull ġurnata
English: In poultry enrofloxacin is poorly metabolized to its active metabolite ciprofloxacin (approximately 5 %).
Maltese: Fit-tjur, enrofloxacin jiġi metabolizzat b'mod fqir għall-metabolit attiv tiegħu ciprofloxacin (madwar 5 %).
English: • Those with known hypersensitivity to (fluoro)quinolones should avoid contact with this product.
Maltese: • Nies li huma sensittivi għal (fluoro)quinolones għandhom jevitaw li jmissu ma' dan il-prodott.
English: Mommaertslaan 14
Maltese: Tiġieġ:
English: Resistance to fluoroquinolones has been reported to arise from five sources, (i) point mutations in the genes encoding for DNA gyrase and/or topoisomerase IV leading to alterations of the respective enzyme, (ii) alterations of drug permeability in Gram-negative bacteria, (iii) efflux mechanisms, (iv) plasmid mediated resistance and (v) gyrase protecting proteins.
Maltese: Ir-reżistenza għall-fluoroquinoles ġiet irrappurtata li tirriżulta minn ħames sorsi, (i) mutazzjonijiet tal-punt fil-ġeni li jikkodifikaw għall-gyrase tad-DNA u/jew għat-topoisomerase IV li jwasslu għal bidliet flenzima rispettiva, (ii) bidliet fil-permeabilità tal-mediċina f'batterji Gram-negattivi, (iii) mekkaniżmi ta' effluss, (iv) reżistenza medjata mill-plasmid u (v) proteini li jipproteġu l-gyrase.
English: Resistance has also been reported in Mycoplasma synoviae in the EU.
Maltese: Kienet irrappurtata wkoll reżistenza fil-Mycoplasma synoviae fl-UE.
English: If dosed as continuous drinking water medication (multiple dosing) steady-state concentrations of 0.5 mg (turkeys) to 0.8 mg (chicken) enrofloxacin per litre are achieved.
Maltese: Jekk jingħata bħala medikazzjoni kontinwa mal-ilma tax-xorb (dożaġġ multiplu), jinkisbu konċentrazzjonijiet stabbli ta' 0.5 mg (dundjani) sa 0.8 mg (tiġieġ) ta' enrofloxacin għal kull litru.
English: Baytril 10% oral solution and associated names are veterinary medicinal products authorised for use the target species chickens, turkeys and rabbits for treatment of the respiratory tract and of the digestive tract infections caused by identified bacteria susceptible to enrofloxacin.
Maltese: Baytril 10% soluzzjoni orali u ismijiet assoċjati huma prodotti mediċinali veterinarji awtorizzati għall-użu fl-ispeċijiet fil-mira ta' tiġieġ, dundjani u fniek għattrattament ta' infezzjonijiet tal-apparat respiratorju u infezzjonijiet tal-apparat diġestiv ikkawżati minn batterji identifikati suxxettibbli għal enrofloxacin.
English: The exposure of the environment from the use of the product in chickens (PECsoil 887 µg/kg) is greater than the exposure from the treatment of rabbits at the new proposed dose rate of 10 mg/kg during 5 days (PECsoil 361 µg/kg).
Maltese: esponimentmit-trattament tal-fniek fir-rata ta' doża proposta ġdida ta' 10 mg/kg għal 5 ijiem (PECsoil 361 µg/kg).
English: 10 mg enrofloxacin/kg bodyweight per day for 3-5 consecutive days.
Maltese: 10 mg enrofloxacin/kg ta' piż tal-ġisem kuljum għal 3-5 ijiem wara xulxin.
English: Enrofloxacin is eliminated from the body at a half-life of 6 hours.
Maltese: Enrofloxacin jiġi eliminat mill-ġisem b'half-life ta' 6 sigħat.
English: Baytril 10% Enrofloxacin 100 mg/ml oral solution Chickens and turkeys
Maltese: Baytril 10% Enrofloxacin 100 mg/ml soluzzjoni orali
English: At doses ≥ 50 mg/kg bodyweight/day administered for 5 days there was histological evidence of a detrimental effect on articular cartilage in broilers, but leg lesions were only clinically apparent in chickens and turkeys at doses > 100 mg/kg administered for ≥ 5 days.
Maltese: F'dożi ≥ 50 mg/kg piż tal-ġisem/kuljum mogħtija għal 5 ijiem kien hemm evidenza istoloġika ta' effett detrimentali fuq il-qarquċa artikolari fil-brojlers, iżda feriti fir-riġel kienu klinikament apparenti biss fit-tiġieġ u d-dundjani f'dożi > 100 mg/kg mogħtija għal ≥ 5 ijiem.
English: 5,000 ml HDPE canister with an aluminium/HDPE seal and an HDPE screw closure.
Maltese: Canister tal-HDPE ta' 5,000 ml b'siġill tal-aluminju/HDPE u għeluq bil-kamin tal-HDPE.
English: Card box (100 ml bottle)
Maltese: Kaxxa tal-kartun (għall-flixkun tal-PE ta' 100 ml)
English: However, it has to be considered that as E coli from poultry are often resistant to first line antimicrobials, fluoroquinolones are recognised as veterinary critically important antimicrobials in the treatment of colibacillosis septicaemia and chronic respiratory disease in this species and it is important to maintain this indication on the SPC.
Maltese: Madankollu, wieħed għandu jikkunsidra li minħabba li l-E coli mit-tjur huma spiss reżistenti għall-antimikrobjali ppreferuti, il-fluoroquinolones huma rikonoxxuti bħala antimikrobjali veterinarji kritikament importanti fittrattament ta' colibacillosis septicaemia u mard respiratorju kroniku f'din l-ispeċji u huwa importanti li tinżamm din l-indikazzjoni fl-SPC.
English: On 15 October 2010, the United Kingdom sent a referral notification under Article 34(1) of Directive 2001/82/EC, as amended, to the CVMP/European Medicines Agency for Baytril 10% oral solution and associated names.
Maltese: Fil-15 ta' Ottubru 2010, ir-Renju Unit bagħat notifika ta' referenza taħt l-Artikolu 34(1) tad-Direttiva 2001/82/KE, kif emendat, lis-CVMP/Aġenzija Ewropea għall-Mediċini għal Baytril 10% soluzzjoni orali u ismijiet assoċjati.
English: No adverse clinical symptoms were observed in chickens and turkeys treated respectively with doses up to 10 and 6 times higher than the therapy dose.
Maltese: Ma kienu osservati l-ebda sintomi kliniċi avversi f'tiġieġ u dundjani ttrattati rispettivament b'dożi sa 10 u 6 darbiet ogħla mid-doża terapewtika.
English: The marketing authorisation holders have provided a user risk assessment which, although not fully compliant with the current guideline on user safety for pharmaceutical veterinary medicinal products (EMA/CVMP/543/03-Rev.1)
Maltese: Id-detenturi tal-awtorizzazzjoni għat-tqegħid fis-suq ipprovdew valutazzjoni tar-riskju għal min juża lprodott li, għalkemm mhux għal kollox konformi mal-linja gwida attwali dwar is-sigurtà ta' min juża lprodott għall-prodotti mediċinali veterinarji farmaċewtiċi (EMA/CVMP/543/03-Rev.1)
English: Persistence of Mycoplasma synoviae in hens after two enrofloxacin treatments and detection of mutations in the parC gene.
Maltese: Il-persistenza ta' Mycoplasma synoviae fit-tiġieġ wara żewġ trattamenti b'enrofloxacin u rrilevamenti ta' mutazzjonijiet fil-ġene parC.
English: Rabbits: Meat and offal: 15 days.
Maltese: Laħam u ġewwieni tal-annimali: 15-il jum.
English: Lot: {number}
Maltese: {xahar/sena}
English: • Withdrawal period;
Maltese: • Il-perjodu tal-irtirar;
English: Excipient(s):
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I)
English: Concentration (MIC) of E. coli was significantly lower than the MIC of E. coli today.
Maltese: Konċentrazzjoni Inibitorja Minima (MIC) ta' E. coli kienet konsiderevolment aktar baxxa mill-MIC ta'E. coli illum.
English: Treatment of the respiratory tract and of the digestive tract infections caused by the following bacteria susceptible to enrofloxacin:
Maltese: Trattament tal-infezzjonijiet tal-apparat respiratorju u tal-apparat diġestiv ikkawżati mill-batterji li ġejjin suxxettibbli għal enrofloxacin:
English: Strength Pharmaceutical form
Maltese: GĦAMLA FARMAĊEWTIKA
English: 1831 Diegem (Machelen) BELGIUM
Maltese: BAYER SA-NV J.E. Mommaertslaan 14 1831 Diegem (Machelen) IL-BELĠJU
English: INN
Maltese: OĦRA