FrancophonIA/ELRC3.0 huggingface dataset:
English: At the recommended dosing regimen, the reduction in annual rate of exacerbations observed in the placebo-controlled predecessor Trials 1 and 2 (in patients with baseline blood eosinophil counts ≥300 cells/μL who were taking high-dose ICS) was maintained over the second year of treatment (Table 6).
Maltese: Bir-reġimen tad-dożaġġ rakkomandat, it-tnaqqis fir-rata annwali ta' taħrix osservata fil-Provi 1 u 2 ta' qabel ikkontrollati bil-plaċebo (f'pazjenti b'għadd ta' eosinofili fid-demm fil-linja bażi ≥300 ċellula/μL li kienu qed jieħdu ICS ta' doża għolja) inżamm matul it-tieni sena ta' kura (Tabella 6).
English: * Pharyngitis was defined by the following grouped preferred terms: ‘Pharyngitis', ‘Pharyngitis bacterial', ‘Viral pharyngitis', ‘Pharyngitis streptococcal'.
Maltese: Tista' wkoll tirrapporta effetti sekondarji direttament permezz tas-sistema ta' rappurtar nazzjonali mniżżla f'Appendiċi V.
English: Placebo patients in Trials 1 and 2 are included up to the end of the predecessor trial (Week 48 in Trial 1, Week 56 in Trial 2).
Maltese: Pazjenti tal-plaċebo fi Provi 1 u 2 huma inklużi sal-aħħar tal-prova ta' qabel (Ġimgħa 48 fi Prova 1, Ġimgħa 56 fi Prova c.
English: In the event of a hypersensitivity reaction, Fasenra should be discontinued permanently and appropriate therapy initiated.
Maltese: Fil-każ ta' reazzjoni ta' sensittività eċċessiva, Fasenra għandu jitwaqqaf b'mod permanenti u għandha tinbeda terapija xierqa.
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, other systemic drugs for obstructive airway diseases, ATC code: R03DX10
Maltese: Mediċini għal mard ostruttiv fil-pajp tan-nifs, mediċini sistemiċi oħrajn għal mard ostruttiv fil-pajp tan-nifs, kodiċi ATC;
English: SD = standard deviation a. Baseline blood eosinophil counts ≥300 cells/μL and taking high-dose ICS: Fasenra administered at the recommended dosage regimen.
Maltese: Aħżen is-siringa mimlija għal-lest/il-pinna mimlija għal-lest (Fasenra Pen) fil-pakkett oriġinali sabiex tilqa' mid-dawl.
English: Anaphylactic reactions have been reported.
Maltese: Ġew irrappurtati reazzjonijiet anafilattiċi.
English: Patients that entered Trial 4 from predecessor Trials 1 and 2 with baseline blood eosinophil counts ≥300 cells/μL who were taking high-dose ICS.
Maltese: Riżultati tar-rata tat-taħrix annwali u l-funzjoni tal-pulmun fi tmiem il-kura ta' Prova 1 u 2 permezz tal-għadd tal-eosinofili.
English: OUTER CARTON- PRE-FILLED SYRINGE
Maltese: L-effett tal-esinoflili fil-mukoża tal-pajp tan-nifs
English: Each film-coated tablet contains 300 mg of abacavir as abacavir sulphate, 150 mg lamivudine and 300 mg zidovudine
Maltese: Kull pillola miksija b'rita fiha300mg ta'abacavir břDODabacavir sulphate, 150mg lamivudineu300mg zidovudine
English: Blister (PVC/PCTFE/PVCAl/Paper
Maltese: Folja (PVC/PCTFE/PVCAl/Karta
English: Bottle (HDPE)
Maltese: Flixkun (HDPE)
English: Strength
Maltese: jingřDWD
English: Blister (opaque white PCTFE/PVCAl
Maltese: Folja (/PVC-Al opaka bajdanija
English: Str. Stadionului nr. 1
Maltese: Stadionului nr. 1
English: Member State/EEA
Maltese: Stat Membru/EEA
English: de Europa 20 B 28108 Alcobendas SPAIN
Maltese: Avda. de Europa 20 B 28108 Alcobendas SPAIN
English: Agroseed-Candilidis Parapleuros Attikis Road Exodos 1,Thesi Xiro Pigadi 19600 Mandra Attikis GREECE
Maltese: Il-Greċja Agroseed-Candilidis Parapleuros Attikis Road Exodos 1,Thesi Xiro Pigadi 19600 Mandra Attikis GREECE
English: Denmark Vetrepharm A/S Øgelundvej 7
Maltese: Id-Danimarka Vetrepharm A/S Øgelundvej 7
English: Romania CEVASA Cervantes 1543/45
Maltese: Ir-Rumanija CEVASA Cervantes 1543/45
English: Hungary Bayer Hungária Kft. Alkotás u. 50.
Maltese: L-Ungerija Bayer Hungária Kft. Alkotás u. 50.
English: 4400 Nyíregyháza HUNGARY
Maltese: 4400 Nyíregyháza
English: Romania Golashpharma Ltd. 33, Pobeda Str.
Maltese: Ir-Rumanija Golashpharma Ltd. 33, Pobeda Str.
English: New Vet Hellas AE Fleming 15
Maltese: Il-Greċja New Vet Hellas AE Fleming 15
English: 4002 Stavanger NORWAY
Maltese: 4002 Stavanger
English: 05-651 Drwalew POLAND
Maltese: 05-651 Drwalew
English: Romania Kepro B.V. Maagdenburgstraat 38 7421 ZE Deventer NETHERLANDS
Maltese: Ir-Rumanija Kepro B.V. Maagdenburgstraat 38 7421 ZE Deventer NETHERLANDS
English: Chickens (excluding laying hens) Turkey
Maltese: Tiġieġ (excluding laying hens) Turkey
English: Romania Ceva Santé Animale Romania SRL
Maltese: Ir-Rumanija Ceva Santé Animale Romania SRL
English: Dali Industrial Estate; P.O.
Maltese: Dali Industrial Estate;
English: Romania Pharmateka BT Szíjgyártó str. 10
Maltese: Ir-Rumanija Pharmateka BT Szíjgyártó str. 10
English: Schippers Europe B.V. Bleijenhoek 17
Maltese: L-Olanda Schippers Europe B.V. Bleijenhoek 17
English: Group
Maltese: Grupp
English: Av. Baix Llobregat, 3-5 08970 Sant Joan Despi (Barcelona)
Maltese: Baix Llobregat, 3-5 08970 Sant Joan Despi (Barcelona)
English: 00330 Helsinki FINLAND
Maltese: 00330 Helsinki
English: Przedsiębiorstwo Wielobranżowe "Vet Agro" Sp. zo.o.
Maltese: Il-Polonja Przedsiębiorstwo Wielobranżowe "Vet Agro" Sp. zo.o.
English: 08520 Les Franqueses del Valles
Maltese: 08520 Les Franqueses del Valles SPAIN
English: Germany Calluna Pharma bvba Lindendreef 16 box 4
Maltese: Il-Ġermanja Calluna Pharma bvba Lindendreef 16 box 4
English: Eurovet Animal Health B.V. Handelsweg 25
Maltese: L-Olanda Eurovet Animal Health B.V. Handelsweg 25
English: 10 rue Clement Ader ZA le Patis 78120 Rambouillet FRANCE
Maltese: 10 rue Clement Ader ZA le Patis 78120
English: Tetoros Bros ABE 10 Km National road AthensLamia
Maltese: Il-Greċja Tetoros Bros ABE 10 Km National road AthensLamia
English: Belgium Bayer N.V. Louizalaan 143
Maltese: Il-Belġju Bayer N.V. Louizalaan 143
English: Salmon Trout
Maltese: Salamun Trout
English: Belgium Ceva Santé Animale N.V. Metrologielaan 6
Maltese: Il-Belġju Ceva Santé Animale N.V. Metrologielaan 6
English: Przedsiębiorstwo Farmaceutyczne Okoniewscy "VETOS-FARMA" Sp. z o.o.
Maltese: Il-Polonja Przedsiębiorstwo Farmaceutyczne Okoniewscy "VETOS-FARMA" Sp. z o.o. ul.
English: 08228 Tarrasa SPAIN
Maltese: 08228 Tarrasa
English: 28031 Madrid SPAIN
Maltese: 28031 Madrid
English: Bovine
Maltese: Bovini
English: Salmonids
Maltese: Salmonidi
English: Romania DELOS IMPEX' 96 SRL Str. Horia
Maltese: Ir-Rumanija DELOS IMPEX' 96 SRL Str.
English: Scan Vet Poland Sp. z o.o.
Maltese: Il-Polonja Scan Vet Poland Sp. z o.o. ul.
English: Animal Health Division Bayer House Strawberry Hill Newbury
Maltese: L-Irlanda Bayer plc Animal Health Division Bayer House Strawberry Hill Newbury
English: Ceva Animal Health Ltd 90 The Broadway Chesham
Maltese: L-Irlanda Ceva Animal Health Ltd 90 The Broadway
English: Germany Albrecht GmbH Hauptstr.
Maltese: Il-Ġermanja Albrecht GmbH Hauptstr.
English: Germany Medistar Arzneimittel-Vertrieb GmbH
Maltese: Il-Ġermanja Medistar Arzneimittel-Vertrieb GmbH
English: 228.4 mg/ml (equivalent to 180 mg/ml Danofloxacin)
Maltese: 228.4 mg/ml (ekwivalenti għal 180 mg/ml Danofloxacin)
English: Active substance(s)
Maltese: Sustanza(i) attiva
English: Virbac S.A. via dei Gracchi, 30 20146 Milano (MI) ITALY
Maltese: Virbac S.A. via dei Gracchi, 30 20146
English: Box 40261 6302 Larnaca
Maltese: 6302 Larnaca
English: Danofloxacin mesilate per ml: danofloxacin mesylate 31,73 mg equivalent to danofloxacin 25 mg
Maltese: Danofloxacin mesilate per ml: danofloxacin mesylate 31,73 mg ekwivalenti għal danofloxacin 25 mg
English: Pfizer Trading Polska Sp. z o.o.
Maltese: Il-Polonja Pfizer Trading Polska Sp. z o.o.
English: Quinolone products1 (e.g. flumequine, oxolinic acid)
Maltese: Prodotti li fihom kwinoloni 1 (eż. flumequine, oxolinic acid)
English: Andreotti Farmaceutical Srl Via Eridania Ovest 65 45030 Guarda Veneta (RO) ITALY
Maltese: Andreotti Farmaceutical Srl Via Eridania Ovest 65 45030
English: Rzymowskiego 34 02-697 Warszawa POLAND
Maltese: 02-697 Warszawa
English: Flumeq 50-S 500 mg/g Powder for use in drinking water /milk for cattle and chicken
Maltese: Flumeq 50-S 500 mg/g Trab for use in drinking water /milk for cattle and chicken
English: Vetoquinol UK Ltd Great Slade, Buckingham Industrial Estate Buckingham
Maltese: L-Irlanda Vetoquinol UK Ltd Great Slade, Buckingham Industrial Estate
English: Pfizer Oy, Animal Health Tietokuja 4
Maltese: Il-Finlandja Pfizer Oy, Animal Health Tietokuja 4
English: Hungary Dunavet-B Zrt.
Maltese: L-Ungerija Dunavet-B Zrt.
English: Romania Orion Corporation Orionintie 1A
Maltese: Ir-Rumanija Orion Corporation Orionintie 1A
English: Premix for medicated feeding stuff
Maltese: MP Premix For Medicated Feeding Stuff
English: Romania Pasteur - Filiala Filipesti Srl Str. Principala nr. 944
Maltese: Ir-Rumanija Pasteur - Filiala Filipesti Srl Str.
English: 1 Not for decoquinate.
Maltese: 1 Mhux għal decoquinate.
English: Belgium Pfizer Animal Health Benelux Division
Maltese: Il-Belġju Pfizer Animal Health Benelux Division
English: Rabbits Fur animals
Maltese: Fur animals
English: 11.5 g/100 g Oral powder
Maltese: 11.5 g/100 g Trab orali
English: Concentrate for oral solution
Maltese: Concentrate for Soluzzjoni orali
English: 5531 BK Bladel NETHERLAND
Maltese: 5531 BK Bladel
English: Hungary Orion Corporation Orionintie 1A
Maltese: L-Ungerija Orion Corporation Orionintie 1A
English: Bruistensingel 310 5232 AE Den Bosch THE NETHRLANDS
Maltese: 5232 AE Den Bosch THE NETHRLANDS
English: Euro-Quin 10 % Powder for Oral Solution
Maltese: Euro-Quin 10 % Trab for Oral Solution
English: A. For products listed in Annex I containing fluoroquinolones (enrofloxacin, marbofloxacin, danofloxacin and difloxacin):
Maltese: Għall-prodotti elenkati fl-Anness I li fihom il-fluworokwinoloni (enrofloxacin, marbofloxacin, danofloxacin u difloxacin):
English: Naquilene 500 MP
Maltese: Naquilene 500
English: Industrial Area Aradippou 7100; P.O.
Maltese: Industrial Area Aradippou 7100; P.O. Box 40261
English: Romania Veterina Ltd. Svetonedeljska 2, Kalinovica 10436 Rakov Potok CROATIA
Maltese: Svetonedeljska 2, Kalinovica 10436
English: Oral suspension
Maltese: Sospensjoni orali
English: Fish (trout)
Maltese: Ħut (trota)
English: 3 43206 Reus
Maltese: Reus-Cambrils, Km. 3 43206 Reus
English: Pharmaqua-D. Kokkoris and Bros
Maltese: Kokkoris and Bros
English: Hoge Mauw 900 2370 Arendonk BELGIUM
Maltese: 2370 Arendonk BELGIUM
English: Lithuania Chemifarma S.p.A. 16, Via Don Eugenio Servadei 47100 Forli
Maltese: Il-Litwanja Chemifarma S.p.A. 16, Via Don Eugenio Servadei 47100 Forli
English: Germany Pfizer GmbH Linkstr.
Maltese: Il-Ġermanja Pfizer GmbH Linkstr. 10
English: Romania Chemifarma S.p.A. 16, Via Don Eugenio Servadei 47100 Forli
Maltese: Ir-Rumanija Chemifarma S.p.A. 16, Via Don Eugenio Servadei 47100 Forli
English: Fatro Uriach Veterinaria, S.L.
Maltese: Fatro Uriach Veterinaria, S.L. Constitucion, 1
English: Laboratorios Ovejero, S. A. Ctra.
Maltese: Laboratorios Ovejero, S. A.
English: Chinogel 50 Mix
Maltese: Chinogel 50
English: Pfizer Ltd Ramsgate Road Sandwich Kent
Maltese: Il-Bulgarija Pfizer Ltd Ramsgate Road Sandwich
English: Bayer Austria GmbH Herbststraße 6-10 1160 Wien AUSTRIA
Maltese: L-Awstrija Bayer Austria GmbH Herbststraße 6-10
English: Via Diaz 147/149
Maltese: Laboratorio Vaccinogeno Pagnini Via Diaz 147/149
English: 13 - piso 1 escritorio 3 Quinta da Beloura 2710-444 Sintra PORTUGAL
Maltese: Quinta da Beloura 2710-444
English: Biovet AD 39 Petar Rakov Str. 4550 Peshtera BULGARIA
Maltese: Il-Bulgarija Biovet AD 39 Petar Rakov Str.
English: Germany Vétoquinol Verwaltungs GmbH Parkstr.
Maltese: Il-Ġermanja Vétoquinol Verwaltungs GmbH Parkstr. 10
English: 5531 AE Bladel THE NETHERLANDS
Maltese: 5531 AE Bladel
English: 100 g/1000 g Oral powder
Maltese: 100 g/1000 g Trab orali
English: S.P.A. via della Libertà 1
Maltese: Azienda Terapeutica Italiana A.T.I. S.P.A. via della Libertà 1
English: Romania CENAVISA, S.A. Camí Pedra Estela S/N 43205 Reus
Maltese: Ir-Rumanija CENAVISA, S.A. Camí Pedra Estela S/N 43205 Reus
English: Lithuania CENAVISA, S.A. Camí Pedra Estela S/N 43205 Reus
Maltese: Il-Litwanja CENAVISA, S.A. Camí Pedra Estela S/N 43205 Reus
English: Industrial Area Aradippou 7100 P.O.
Maltese: Industrial Area Aradippou 7100 P.O. Box 40261
English: Flumesyva Oral paste Flumequine
Maltese: Oral paste Flumequine
English: Esteve Farma, Lda Av. Do Forte, 3 - Edifício Suécia II, Piso 4A 2794-044 Carnaxide PORTUGAL
Maltese: Do Forte, 3 - Edifício Suécia II, Piso 4A
English: Broilers
Maltese: Brojlers
English: S.P. Veterinaria S.A. Ctra.
Maltese: S.P. Veterinaria S.A.
English: The fluoroquinolone products concerned contain the active substances enrofloxacin, marbofloxacin, danofloxacin and difloxacin, and the quinolone products contain flumequine and oxolinic acid.
Maltese: Il-prodotti kkonċernati tal-fluworokwinoloni fihom issustanzi attivi enrofloxacin, marbofloxacin, danofloxacin u difloxacin, u l-prodotti tal-kwinoloni fihom flumequine u oxolinic acid.
English: Germany Virbac S.A. 1ere Avenue 2065 M LID B.P.
Maltese: Il-Greċja Virbac S.A. 1ere Avenue 2065 M LID B.P. 27
English: T. Skretting A/S P.O.
Maltese: In-Norveġja T. Skretting A/S P.O. Box 319
English: Romania Divasa-Farmavic S.A. Ctra San Hipolito km 71
Maltese: Ir-Rumanija Divasa-Farmavic S.A. Ctra San Hipolito km 71
English: 100 kg bw
Maltese: Frat : preruminanti sa 100 kg bw
English: Dolgos u. 2.
Maltese: Grupp 2.
English: Leijsendwarsstraat 26 4901 PG Oosterhout THE NETHRLANDS
Maltese: 4901 PG Oosterhout THE NETHRLANDS
English: The referral procedure involved 696 veterinary products containing (fluoro)quinolones as identified by the Member States (see Annex I).
Maltese: Il-proċedura ta' referenza kienet tinvolvi 696 prodott veterinarju li fihom (fluworo)kwinoloni kif identifikati mill-Istati Membri (ara Anness I).
English: Chanelle Pharmaceuticals Manufacturing Limited IDA Business & Technology Park
Maltese: Chanelle Pharmaceuticals Manufacturing Limited IDA Business & Technology Park Loughrea
English: Buckinghamshire HP5 1EG
Maltese: HP5 1EG
English: 40064 Ozzano dell' Emilia (BO)
Maltese: Ozzano dell' Emilia (BO) ITALY
English: Hungary VMD Állatgyógyászati Kft. Közraktár u. 22/b.
Maltese: Közraktár u. 22/b.
English: Romania Universal Farma, S.L Gran Via Carlos III 98-7a 08028 Barcelona
Maltese: Ir-Rumanija Universal Farma, S.L Gran Via Carlos III 98-7a 08028 Barcelona
English: Romania S.C. ROMVAC COMPANY S.A. Şos.
Maltese: ROMVAC COMPANY S.A. Şos. Centurii, nr. 7
English: Baytril 5 mg/mlLösung zum Eingeben für Schweine
Maltese: Baytril 5 mg/ml - Lösung zum Eingeben für Schweine
English: Vétoquinol B.V.
Maltese: Vétoquinol N.V.
English: Romania S.C. CRIDA PHARM S.R.L.
Maltese: Ir-Rumanija S.C. CRIDA PHARM
English: Following a focus group meeting of the CVMP with Interested Parties and Member States, the CVMP adopted a 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) detailing the precautionary phrases to be included in the Summary of the Product Characteristics, as follows:
Maltese: Wara laqgħa tal-grupp fokali tas-CVMP mal-Partijiet Interessati u l-Istati Membri, is-CVMP adotta dokument ta' Riflessjoni dwar l-użu tal-Fluworokwinoloni fl-annimali li jipproduċu l-ikel - Prekawzjonijiet għall-użu flSPC rigward il-gwida għall-użu prudenti (EMEA/CVMP/416168/2006) li jagħti dettalji dwar il-frażijiet ta' prekawzjoni li għandhom ikunu inklużi fis-Sommarju tal-Karatteristiċi tal-Prodott, kif ġej:
English: Pfizer Animal Health B.V. Rivium Westlaan 142
Maltese: L-Olanda Pfizer Animal Health B.V. Rivium
English: VETHELLAS 31 Augoustou 51 41221 Larissa GREECE
Maltese: 41221 Larissa GREECE
English: 105b 06406 Bernburg
Maltese: Il-Ġermanja Serumwerk Bernburg AG Hallesche Landstr. 105b 06406 Bernburg
English: Amoxicillin Flumequine per 100 g:
Maltese: Amoxicillin Flumequine għal kull 100 g: 25.
English: Overall summary of the scientific evaluation of veterinary medicinal products containing (fluoro)quinolones (see annex I)
Maltese: Sommarju globali tal-evalwazzjoni xjentifika ta' prodotti mediċinali veterinarji li fihom (fluoro)kwinoloni (ara anness I)
English: Hungary Divasa-Farmavic S.A. Ctra San Hipolito km 71
Maltese: L-Ungerija Divasa-Farmavic S.A. Ctra San Hipolito km 71
English: Biofaktor Sp. z o.o.
Maltese: Il-Polonja Biofaktor Sp. z o.o. ul.
English: VetPharma Animal Health S.L.
Maltese: VetPharma Animal Health S.L. Les Corts, 23
English: Veterinary medicinal products containing all the correct prudent use warnings in section 4 o f the SPC, exactly as the CVMP recommendation and Veterinary medicinal products containing all the prudent use warnings in section 4 of the SPC, which are however not exactly the text recommended by the CVMP, but conveys the same key messages Veterinary medicinal products that contain prudent use warnings in section 4 of the SPC but which do not adequately reflect the CVMP recommendations Veterinary medicinal products that do not contain the prudent use warnings in of section 4 of the SPC Veterinary medicinal products for which no information was submitted by the Applicants/Marketing Authorisation Holders or competent national authorities and for which no assessment of the existing SPC warnings was therefore possible Total The (fluoro)quinolone SPC warnings were satisfactory for 318 products, and therefore no further action needs to be taken for these products.
Maltese: Prodotti mediċinali veterinarji li fihom it-twissijiet kollha tajbin ta' użu prudenti fis-sezzjoni 4 tal-SPC (Prekawzjonijiet speċjali għall-użu), eżatt bħarrakkomandazzjoni tas-CVMP u prodotti mediċinali Veterinarji li fihom it-twissijiet kollha ta' użu prudenti fis-sezzjoni 4 tal-SPC, li madankollu m'humiex eżattament il-kitba rrakkomandata mis-CVMP, iżda li jgħaddu l-istess messaġġi ewlenin Prodotti mediċinali veterinarji li fihom twissijiet ta' użu prudenti fis-sezzjoni 4 talSPC iżda li ma jirriflettux b'mod adegwat ir-rakkomandazzjonijiet tas-CVMP Prodotti mediċinali veterinarji li ma fihomx twissijiet ta' użu prudenti fis-sezzjoni 4 tal-SPC Prodotti li għalihom ma ġiet sottomessa l-ebda informazzjoni millApplikanti/Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq jew awtoritajiet nazzjonali kompetenti u li għaldaqstant għalihom ma setgħetx issir evalwazzjoni tat-twissijiet eżistenti fl-SPC Total It-twissijiet fl-SPC tal-(fluworo)kwinoloni kienu sodisfaċenti għal 318-il prodott, u għaldaqstant m'hemmx ħtieġa ta' aktar azzjoni għal dawn il-prodotti.
English: Lda.Beloura Oficial Parque Edif.
Maltese: VIRBAC - Portugal Laboratórios Lda.Beloura Oficial Parque Edif. 13 - piso 1 escritorio 3
English: de Castellvell nº 24 43206 Reus (Tarragona) SPAIN
Maltese: Laboratorios Serra Pamies, S.A. Ctra. de Castellvell nº 24 43206 Reus (Tarragona)
English: Hungary Ceva-Phylaxia Co. Ltd. Szállás u. 5.
Maltese: L-Ungerija Ceva-Phylaxia Co.
English: Hungary Chanelle Pharmaceuticals Manufacturing Limited IDA Business & Technology Park
Maltese: L-Ungerija Chanelle Pharmaceuticals Manufacturing Limited IDA Business & Technology Park Loughrea
English: 1854 47020 Longiano (FC) ITALY
Maltese: Neofarma Srl Via Emilia Km 18n. 1854 47020 Longiano (FC) ITALY
English: Lithuania Laboratorios Calier, S.A. Barcelonés, 26
Maltese: Il-Litwanja Laboratorios Calier, S.A. Barcelonés, 26
English: Quinolones including fluoroquinolones are very potent antimicrobials used in human and veterinary medicine which have a unique mechanism of action not related to conventional antimicrobials.
Maltese: Il-kwinoloni inklużi l-fluworokwinoloni huma antimikrobjali qawwijin ħafna użati fil-mediċina talbniedem u dik veterinarja li għandhom mekkaniżmu ta' azzjoni uniku li mhuwiex relatat ma' antimikrobjali konvenzjonali.
English: Romania Pfizer Animal Health Ramsgate Road
Maltese: Ir-Rumanija Pfizer Animal Health Ramsgate Road
English: Calves, Lambs, Kids, Foals, Pigs
Maltese: Ħrief, Gidien, Qżieqeż, Fniek, Klieb
English: Powerflox 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats
Maltese: Powerflox 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Qtates
English: Farmavet OOD 40 Otec Paisij Str. 9700 Shumen BULGARIA
Maltese: Il-Bulgarija Farmavet OOD 40 Otec Paisij Str.
English: • for 132 the products identified by the Member States no or insufficient information was made available to the CVMP by the Applicants/Marketing Authorisation Holders or national authorities and therefore no conclusion on the availability or assessment the adequacy of precautionary phrases in the Summary of the Product Characteristics was possible; the Committee recommends the variation of the terms of the marketing authorisations of products containing quinolones including fluoroquinolones intended for food producing species as referred in Annex I in order to amend the Summary of the Product Characteristics and Package Leaflets in those cases where there are not in line with the CVMP Reflection Paper (EMEA/CVMP/416168/2006).
Maltese: • għall-132 prodott identifikati mill-Istati Membri ma kien hemm l-ebda informazzjoni disponibbli jew l-informazzjoni ma kinitx biżżejjed għas-CVMP mingħand l-Applikanti/id-Detenturi talAwtorizzazzjoni għat-Tqegħid fis-Suq jew awtoritajiet nazzjonali u għaldaqstant ma setgħet issir lebda konklużjoni dwar id-disponibbiltà jew evalwazzjoni dwar l-adegwatezza ta' frażijiet ta' prekawzjoni fis-Sommarju tal-Karatteristiċi tal-Prodott; il-Kumitat jirrakkomanda l-varjazzjoni tat-termini tal-awtorizzazzjonijiet għat-tqegħid fis-suq ta' prodotti li fihom il-kwinoloni inklużi fluworokwinoloni maħsuba għall-ispeċijiet li jipproduċu l-ikel kif imsemmija fl-Anness I sabiex jiġu emendati s-Sommarju tal-Karatteristiċi tal-Prodott u l-Fuljetti ta' Tagħrif f'dawk il-każijiet fejn m'hemmx konformità mad-Dokument ta' Riflessjoni tas-CVMP (EMEA/CVMP/416168/2006).
English: Applicant/ Marketing Authorisation Holder
Maltese: Applikant/ Detentur talAwtorizzazzjoni għatTqegħid fis-Suq
English: No information available
Maltese: Ebda informazzjoni disponibbli
English: Oral liquid
Maltese: Likwidu orali
English: Group 4 Products for which no information was submitted by the Applicants/Marketing
Maltese: Grupp 4 Prodotti li għalihom ma ġiet sottomessa l-ebda informazzjoni mill-Applikanti/Detenturi tal
English: Lithuania Pfizer Animal Health Ramsgate Road
Maltese: Il-Litwanja Pfizer Animal Health Ramsgate Road
English: Danofloxacin 31.73 mg/ml (equivalent to
Maltese: Danofloxacin 31.73 mg/ml (ekwivalenti għal 25 mg/ml
English: 1MUI/g Colistin sulphate 200mg/g oxolinic acid
Maltese: 200mg/g oxolinic acid
English: Mayflus Suspension Oral
Maltese: Mayflus Suspension Oral Flumequine
English: 43330 Riudoms (Tarragona) SPAIN
Maltese: Ctra. de Reus a Vignols km 4.1 43330 Riudoms (Tarragona)
English: • quinolones including fluoroquinolones are critical, efficient and valuable antimicrobials for animals and for some serious animal indications, fluoroquinolones are the only effective treatment available;
Maltese: • il-kwinoloni inkluż il-fluworokwinoloni huma antimikrobjali kritiċi, effiċjenti u ta' valur għallannimali u għal ċerti indikazzjonijiet serji tal-annimali, il-fluorokwinoloni huma l-uniku trattament disponibbli effettiv;
English: Romania Dar al Dawa Veterinary & Agricultural Industrial Co. Ltd. Jordan Na`ur 11710
Maltese: Ir-Rumanija Dar al Dawa Veterinary & Agricultural Industrial Co.
English: Pfizer Corporation Austria GmbH
Maltese: L-Awstrija Pfizer Corporation Austria GmbH Floridsdorfer Hauptstaße 1
English: Ceva Hellas S.A. Ag. Nikolaou 15
Maltese: Il-Greċja Ceva Hellas S.A. Ag.
English: • the use of (fluoro)quinolones in animals has selected for antimicrobial resistance in animal pathogens and food borne zoonotic pathogens;
Maltese: • l-użu ta' (fluworo)kwinoloni fl-annimali għażel għal reżistenza antimikrobjali f'patoġeni tal-annimali u patoġeni żoonotiċi li jinġarru mill-ikel;
English: Lithuania Codifar N.V. Lt. Caluwaertstraat 1
Maltese: Caluwaertstraat 1
English: FLUMIQUIL 50% plv.
Maltese: FLUMIQUIL 50% plv. sol.
English: Enrofloxacin No information available
Maltese: Enrofloxacin Ebda informazzjoni disponibbli
English: Animal Health Division Energieweg 1
Maltese: L-Olanda Bayer B.V. Animal Health Division Energieweg 1
English: Oxolinic acid 100% Medicated premix Fish
Maltese: Oxolinic acid 100% Taħlita lesta medikata Ħut
English: Pre-ruminant Cattle
Maltese: Majjali Bovini