FrancophonIA/ELRC3.0 huggingface dataset:
English: The Committee for Medicinal Products for Veterinary Use (CVMP) was requested to give its opinion on the measures that need to be taken in order to ensure the prudent use of colistin in food-producing animals across the EU and to minimise potential risks with the use of the identified products; inter alia whether there is a need to include adequate indications and warnings on prudent use in the product information and/or restrict indications for the identified products taking into account the CVMP revised guideline on the SPC for antimicrobial products (EMEA/CVMP/SAGAM/383441/2005)3.
Maltese: IlKumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) intalab jagħti l-opinjoni tiegħu dwar ilmiżuri li jeħtieġ jittieħdu sabiex jiġi żgurat l-użu prudenti ta' colistin f'annimali li jipproduċu l-ikel madwar l-UE u biex jiġu minimizzati r-riskji potenzjali bl-użu tal-prodotti identifikati; fost oħrajn jekk hemmx il-ħtieġa li fl-informazzjoni dwar il-prodott jiġu inklużi indikazzjonijiet u twissijiet adegwati dwar l-użu prudenti u/jew l-indikazzjonijiet jiġu ristretti għall-prodotti identifikati b'kont meħud tal-linja gwida riveduta tas-CVMP dwar l-SPC għal prodotti antimikrobiċi (EMEA/CVMP/SAGAM/383441/2005)3.
English: Netherlands Bela-pharm GmbH & Co.KG.
Maltese: Bela-pharm GmbH & Co.KG.
English: Poland AniMedica España, S.L.U.
Maltese: Il-Polonja AniMedica España, S.L.U.
English: 53000 Laval, France
Maltese: 53000 Laval, Franza
English: B-2370 Arendonk Belgium
Maltese: B-2370 Arendonk Il-Belġju
English: Pigs, cattle
Maltese: Majjali, tjur, bovini
English: ARNIKA VETERINA d.o.o., Vidikovac 20, 1000 Zagreb, Croatia
Maltese: Il-Kroazja ARNIKA VETERINA d.o.o., Vidikovac 20,
English: 100 mg/ml (equivalent to 3 000 000 IU/ml)
Maltese: 100 mg/ml (equivalent to 3 000 000
English: Novo mesto Šmarješka cesta 6 8501 Novo mesto Slovenia
Maltese: Novo mesto Šmarješka cesta 6 8501 Novo mesto Is-Slovenja
English: Kaplanstraße 10, 4600 Wels,
Maltese: Kaplanstraße 10,
English: Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Maltese: Šmarješka cesta 6, 8501 Novo mesto, Is-Slovenja
English: COLIVET 5,000,000 UI/G POLVO PARA ADMINISTRACIÓN EN AGUA DE BEBIDA PARA CERDOS, AVES Y TERNEROS
Maltese: UI/G POLVO PARA ADMINISTRACIÓN EN AGUA DE BEBIDA PARA CERDOS, AVES Y TERNEROS
English: IU/kg
Maltese: IU/mg
English: CEVA SANTE ANIMALE Z.I.
Maltese: Ceva Salute Animale S.p.A.
English: 2370 Arendonk Belgium
Maltese: 2370 Arendonk Il-Belġju
English: Poland SOGEVAL 200 Avenue De Mayenne Zi Des Touches 53000 - Laval France
Maltese: Avenue De Mayenne Zi Des Touches 53000 - Laval Franza
English: Hungary Vim Spectrum Hungary Kft. 1029 Budapest,
Maltese: L-Ungerija Ceva-Phylaxia Zrt. 1107 Budapest,
English: Data from the last report of the EMA European Surveillance of Veterinary Antimicrobial Consumption (ESVAC)2 shows that polymixins (colistin) are used mostly in oral forms.
Maltese: Data mill-aħħar rapport tas-Sorveljanza Ewropea tal-Konsum tal-Antimikrobiċi għal Użu Veterinarju (ESVAC)2 tal-EMA turi li polimiksini (colistin) jintużaw l-aktar fil-forom orali.
English: Oral suspension Pigs (piglets)
Maltese: Sospensjoni orali Ħnieżer (qżieqeż)
English: Belgium aniMedica Espana S.L.U.
Maltese: Il-Belġju aniMedica Espana S.L.U.
English: via della libertà, 1
Maltese: Ternova S.r.l. via della libertà, 1
English: Opinion following an Article 35 referral for veterinary medicinal formulations containing colistin at 2 000 000 IU per ml and intended for administration in drinking water to food producing species.
Maltese: Opinion following an Article 35 referral for veterinary medicinal formulations containing colistin at 2 000 000 IU per ml and intended for administration in drinking water to food producing species. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/veterinary/referrals/Colistin/vet_referral_000038.jsp&mi d=WC0b01ac05805c5170
English: Netherlands Eurovet Animal Health BV Postbus 179,
Maltese: Eurovet Animal Health BV Postbus 179, 5530 AD Bladel, Il-Pajjiżi l-Baxxi
English: Sant Hipòlit, km 71 08503 GURB - VIC Barcelona (Espanha) Spain
Maltese: Sant Hipòlit, km 71 08503 GURB - VIC Barcelona (Espanha) Spanja
English: 53000 - Laval France
Maltese: 53000 - Laval Franza
English: 1 200 000 IU/g Oral powder
Maltese: 1 200 000 IU/g Trab orali
English: Add, to all products and amend where applicable:
Maltese: Żid, għall-prodotti kollha u emenda fejn applikabbli:
English: Sweden Bio Vet Aps, Kongevejen 66 3480 Fredensborg, Denmark
Maltese: L-Isvezja Bio Vet Aps, Kongevejen 66 3480
English: According to the CVMP revised guideline on the SPC for antimicrobial products (EMEA/CVMP/SAGAM/383441/2005)3 indications should be for the treatment of named pathogens and
Maltese: Skont il-linja gwida riveduta tas-CVMP dwar l-SPC għall-prodotti antimikrobiċi (EMEA/CVMP/SAGAM/383441/2005)3 l-indikazzjonijiet għandhom ikunu għall-kura ta' patoġeni msemmija u għandhom jiġu evitati indikazzjonijiet ġenerali.
English: 4 800 000 IU/g Oral powder
Maltese: 4 800 000 IU/g Trab orali
English: Industrieterrein "Hoge Mauw" 900
Maltese: L-Estonja V.M.D. n.v. Industrieterrein "Hoge Mauw" 900
English: nv/sa Hoge Mauw 900, B-2370 Arendonk, Belgium
Maltese: L-Ungerija VMD. nv/sa Hoge Mauw 900, B-2370
English: “Colistin is of therapeutic importance in veterinary medicine for the treatment of enteric diseases in certain food-producing species for which there are few effective alternatives available for certain indications.
Maltese: “Colistin huwa ta' importanza terapewtika fil-mediċina veterinarja għall-kura ta' mard enteriku f'ċerti speċi li jipproduċu l-ikel li għalihom hemm ftit alternattivi effettivi disponibbli għal ċerti indikazzjonijiet.
English: Oral colistin products are regarded as effective medicines against enteric infectious diseases caused by non-invasive E. coli susceptible to colistin in certain food-producing species.
Maltese: Prodotti orali ta' colistin huma meqjusa mediċini effettivi kontra mard enteriku infettiv ikkawżat minn E. coli mhux invażiv suxxettibbli għal colistin f'ċerti speċi li jipproduċu l-ikel.
English: 50 M IU/100 g Oral powder for administration in drinking water
Maltese: 50 M IU/100 g Trab orali biex jingħata fl-ilma tax-xorb
English: In addition, orally administered colistin would not be appropriate for systemic therapy due to poor absorption from the gastrointestinal tract.
Maltese: Barra minn hekk, colistin li jingħata oralment ma jkunx xieraq għal terapija sistemika minħabba l-assorbiment fqir mis-sistema gastrointestinali.
English: Oral suspension Piglets
Maltese: Sospensjoni orali Qżieqeż
English: In order to strengthen the importance of an adequate treatment period, the Committee considered it useful for the veterinarian to add relevant information on the pharmacological properties of colistin in the SPC (“Colistin exerts concentration-dependent activity against Gram-negative bacteria.
Maltese: Sabiex tissaħħaħ limportanza ta' perjodu adegwat ta' kura, il-Kumitat qies li jkun utli għall-veterinarju biex fl-SPC tiżdied informazzjoni rilevanti dwar il-proprjetajiet farmakoloġiċi ta' colistin (“Colistin jeżerċita attività dipendenti fuq il-konċentrazzjoni kontra batterji Gram-negattivi.
English: ul.
Maltese: U.
English: Belgium Sogeval 200 Avenue de Mayenne Zone Industrielle des Touches
Maltese: Il-Belġju Sogeval 200 Avenue de Mayenne Zone Industrielle des Touches
English: 4.8 million IU/g Powder for oral solution
Maltese: 4.8 million IU/g Trab għal soluzzjoni orali
English: 2 000 000 IU Powder for oral solution
Maltese: 2 000 000 IU Soluzzjoni orali
English: 5 million IU/g Powder for oral solution
Maltese: 5 million IU/g Trab għal soluzzjoni orali
English: Pigs, domestic fowl, turkeys
Maltese: Ħnieżer, tjur domestiċi, dundjani
English: DK-7100 Vejle,
Maltese: QA07AA10
English: n.v. Hoge Mauw 900
Maltese: Il-Bulgarija V.M.D. n.v. Hoge Mauw 900
English: Germany Sogeval 200, Av. De Mayenne, ZI de Touches F-53000 Laval France
Maltese: De Mayenne, ZI de Touches F-53000
English: Most of the colistin formulations concerned (approximately 90%) are for administration in feed or water for group or flock treatment and, consequently, most of the indications are for “treatment and prevention”, meaning a situation where clinically diseased animals and in-contact animals presumably in the incubation phase but not yet showing clinical signs are treated at the same time.
Maltese: Ħafna mill-formulazzjonijiet ikkonċernati ta' colistin (madwar 90%) huma għall-għoti fl-għalf jew malilma għall-kura ta' grupp jew ta' qatgħa u, konsegwentement, ħafna mill-indikazzjonijiet huma għall“kura u prevenzjoni”, li jfisser sitwazzjoni fejn annimali klinikament morda u annimali f'kuntatt preżumibbilment fil-fażi ta' inkubazzjoni, iżda li għadhom ma bdewx juru sinjali kliniċi jiġu trattati flistess ħin.
English: 2.4 million IU/g Powder for oral use
Maltese: 2.4 million IU/g Trab għall-użu orali
English: NIPOXYME 200 mg/g ОРАЛНА СУСПЕНЗИЯ
Maltese: NIPOXYME 200 mg/g ОРАЛНА
English: Bulgaria DIVASA - FARMAVIC, S.A. Ctra.
Maltese: Il-Bulgarija DIVASA - FARMAVIC, S.A. Ctra.
English: Poland Bela-Pharm GmBH & Co.KG Lohner Straße 19,
Maltese: Il-Polonja Bela-Pharm GmBH & Co.KG Lohner Straße 19,
English: Murgašova 5,
Maltese: Via Togliatti 5,
English: Oral suspension Pigs
Maltese: Sospensjoni orali Ħnieżer
English: And concludes that: “Based on current evidence it is considered appropriate to maintain the use of colistin in veterinary medicine but to restrict indications to therapy or metaphylaxis and to remove all indications for prophylactic use in order to minimise any potential risk associated with a broader use.” and that “The SPCs of veterinary products containing colistin should be revised to take fully into account responsible use considerations.”
Maltese: U jikkonkludi li: “Abbażi ta' evidenza attwali huwa meqjus xieraq li l-użu ta' colistin jinżamm filmediċina veterinarja iżda l-indikazzjonijiet għandhom jiġu ristretti għal terapija jew għal metafilassi u li jitneħħew l-indikazzjonijiet kollha għall-użu profilattiku sabiex jiġi minimizzat kwalunkwe riskju potenzjali assoċjat ma' użu usa'.” u li “L-SPCs ta' prodotti veterinarji li fihom colistin għandhom jiġu riveduti biex jingħata kas bis-sħiħ tal-kunsiderazzjonijiet ta' użu responsabbli.
English: The use of colistin for prophylaxis does not comply with responsible use principles.
Maltese: L-użu ta' colistin għal profilassi mhuwiex konformi mal-prinċipji ta' użu responsabbli.
English: Germany Kon-Pharma GmbH Alter Flugplatz 38
Maltese: Kon-Pharma GmbH Alter Flugplatz 38 D-49377 Vechta
English: Broilers, turkeys, hens, rabbits, piglets up to 35 kg live weight
Maltese: Brojlers, dundjani, tiġieġ, fniek, qżieqeż sa 35 kg piż ħaj
English: 53000 Laval France
Maltese: 53000 Laval Franza
English: Emulsion for oral use
Maltese: Emulsjoni għallużu orali
English: In the previous CVMP assessment (EMA/CVMP, 2010) 4 the Committee concluded that the benefit-risk balance regarding the use of colistin for treatment of gastrointestinal infections caused by Salmonella spp.
Maltese: Fil-valutazzjoni preċedenti tasCVMP (EMA/CVMP, 2010) 4 il-Kumitat ikkonkluda li l-bilanċ tal-benefiċċju-riskju dwar l-użu ta' colistin għall-kura ta' infezzjonijiet gastrointestinali kkawżati minn Salmonella spp. kien meqjus negattiv filwaqt li baqa' pożittiv għall-użu ta' colistin għall-kura ta' infezzjonijiet enteriċi kkawżati minn E. coli mhux invażiv suxxettibbli għal colistin.
English: CEVA SANTE ANIMALE Zone Industrielle, La Ballastiere, 33500 Libourne, France
Maltese: CEVA SANTE ANIMALE, Z.I. La Ballastiere 33500 Libourne Franza
English: Poststr.
Maltese: Ltd.
English: Pigs (up to 40 kg bw)
Maltese: Ħnieżer (qżieqeż u ħnieżer <40 kg)
English: The advice also indicates for combinations of colistin with other antimicrobials that “The marketing authorisations for these products should be reviewed and unless sound justification can be provided that the combination is in line with responsible use principles, combination products should be withdrawn.”
Maltese: Għal kombinazzjonijiet ta' colistin ma' antimikrobiċi oħra, il-parir jindika wkoll li “L-awtorizzazzjonijiet għat-tqegħid fis-suq għal dawn il-prodotti għandhom jiġu riveduti u sakemm ma tkunx tista' tiġi pprovduta ġustifikazzjoni soda li l-kombinazzjoni hija konformi mal-prinċipji ta' użu responsabbli, ilprodotti ta' kombinazzjoni għandhom jiġu rtirati.”
English: COLIVET 2.000.000 IU/ml
Maltese: COLIVET 2.000.000
English: Responsible use principles
Maltese: Prinċipji ta' użu responsabbli
English: Poland Divasa - Farmavic S.A. Ctra.
Maltese: Il-Polonja Divasa - Farmavic S.A. Ctra.
English: Lithuania Divasa-Farmavic, S.A. Ctra.
Maltese: Il-Litwanja Divasa-Farmavic, S.A. Ctra.
English: Therefore, on 12 May 2014, the European Commission presented to the European Medicines Agency (‘the Agency') a referral notification under Article 35 of Directive 2001/82/EC for all veterinary medicinal products containing colistin as a sole active substance to be administered orally.
Maltese: Għalhekk, fit-12 ta' Mejju 2014, il-Kummissjoni Ewropea ppreżentat lill-Aġenzija Ewropea għallMediċini (‘l-Aġenzija') notifika ta' riferiment skont l-Artikolu 35 tad-Direttiva 2001/82/KE għall-prodotti mediċinali veterinarji kollha li fihom colistin bħala l-unika sustanza attiva biex jingħataw oralment.
English: Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
Maltese: KRKA, d.d. Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Is-Slovenja
English: sol.
Maltese: Pol.
English: Lithuania Bela-pharm GmbH & Co.KG Lohner Str.19,
Maltese: Il-Litwanja Bela-pharm GmbH & Co.KG Lohner Str.19,
English: Ceva Santé Animale 10, av. de la Ballastiére 33500 Libourne, France
Maltese: L-Estonja Ceva Santé Animale 10, av. de la Ballastiére 33500 Libourne
English: The indication is restricted to enteric infections caused by non-invasive E. coli susceptible to colistin.
Maltese: L-indikazzjoni hija ristretta għal infezzjonijiet enteriċi kkawżati minn E. coli mhux invażiv suxxettibbli għal colistin.
English: 100 g/100 g Powder for administration in drinking water
Maltese: 100 g/100 g Trab biex jingħata fl-ilma tax-xorb
English: Oral solution Cattle (calves), sheep (lambs), pigs, poultry (chickens, geese, turkeys, ducks, pheasants, partridges, quails and guinea fowl)
Maltese: Frat (għoġġiela), nagħaġ (ħrief), ħnieżer, tjur (tiġieġ, wiżż, dundjani, papri, faġani, perniċi, summien u farawni)
English: Lithuania Chemifarma S.p.A Via Don E. Servadei, 16-47100 Forlí,
Maltese: Servadei, 16-47100 Forlí,
English: Calves, piglets, chicken (broilers)
Maltese: Ħnieżer, tiġieġ (tiġieġ, brojlers), fniek
English: Lithuania Bela-Pharm GmbH & Co.KG Lohner Strase 19,
Maltese: Il-Litwanja Bela-Pharm GmbH & Co.KG Lohner Strase 19,
English: Strength
Maltese: NIPOXYME
English: The target species “horse” and any indication for horses should be taken out of the SPC and information should be added in the SPC that the use of colistin in horses, particularly in foals, is contraindicated due to the shift in gastrointestinal microflora balance and the development of antimicrobial associated colitis, typically associated with Clostridium difficile, which may be fatal.
Maltese: Il-letteratura xjentifika attwali ma tappoġġjax lużu ta' colistin fil-moħor peress li l-użu tiegħu jista' jfixkel il-bilanċ tal-mikroflora fis-sistema gastrointestinali, li jwassal għal kolite assoċjata mal-antimikrobiċi li hija rikonoxxuta sew u fatali, tipikament assoċjata ma' Clostridium difficile.
English: Calves, broilers, turkeys, laying hens, rabbits, piglets up to 35 kg live weight
Maltese: Għoġġiela, brojlers, dundjani, tiġieġ talbajd, fniek, qżieqeż sa 35 kg piż ħaj
English: These factors indicate that a longer duration of treatment than the one indicated in section 4.9, leading to unnecessary exposure, is not recommended.
Maltese: Dawn il-fatturi jindikaw li perjodu ta' kura itwal minn dak indikat fitsezzjoni 4.9, li jwassal għal esponiment mhux neċessarju, mhuwiex rakkomandat.
English: Pigs, chickens
Maltese: Ħnieżer, fniek
English: Pigs, poultry (hens, turkeys)
Maltese: Ħnieżer, tjur (tiġieġ, dundjani)
English: Calves, lambs, kid (goat), pigs, rabbits, poultry, turkeys, ducks, guinea hens, pheasants, partridges, geese, quails
Maltese: Għoġġiela, ħrief, gidien (mogħoż), ħnieżer, fniek, tjur, dundjani, papri, tiġieġ tal-Indi, faġani, perniċi, wiżż, summien
English: Do not use in horses, particularly in foals, since colistin, due to a shift in the gastrointestinal microflora balance could lead to the development of antimicrobial associated colitis (Colitis X), typically associated with Clostridium difficile, which may be fatal.
Maltese: Tużax fiż-żwiemel, b'mod partikolari fil-moħor, peress li colistin, minħabba bidla fil-bilanċ tal-mikroflora fis-sistema gastrointestinali jista' jwassal għall-iżvilupp ta' kolite assoċjata mal-antimikrobiċi (Colitis X), tipikament assoċjata ma' Clostridium difficile, li tista' tkun fatali.
English: La Ballastiere 33500 Libourne France
Maltese: 33500 Libourne
English: DK-3480 Fredensborg, Denmark
Maltese: ScanVet Animal Health A/S Kongevejen 66, DK-3480 Fredensborg, Id-Danimarka
English: 5 000 000 IU/g Powder for oral use
Maltese: 5 000 000 IU/g Trab għall-użu orali
English: Calves, piglets and weaners, domestic fowl - broilers
Maltese: Ħnieżer, brojlers, dundjani, tiġieġ talbajd
English: • the CVMP considered that the overall benefit-risk balance is positive for the veterinary medicinal products (see Annex I), subject to amendments in the product information; the CVMP recommended variations of the marketing authorisations for veterinary medicinal products containing colistin to be administered orally, in order to amend the summaries of product characteristics, labelling and package leaflets as set out in Annex III.
Maltese: • is-CVMP qies li l-bilanċ ġenerali tal-benefiċċju-riskju huwa pożittiv għall-prodotti mediċinali veterinarji (ara Anness I), soġġett għall-emendi fl-informazzjoni dwar il-prodott;
English: Calves, pigs (up to 35 kg), broilers, turkeys, guinea fowl, ducks, hens and rabbits
Maltese: Għoġġiela, ħnieżer (sa 35 kg), brojlers, dundjani, farawni, papri, tiġieġ u fniek
English: Belgium Divasa-Farmavic, S.A. Ctra.
Maltese: Il-Belġju Divasa-Farmavic, S.A. Ctra.
English: 4 000 000 IU/g Powder for oral solution
Maltese: 4 000 000 IU/g Trab għal soluzzjoni orali
English: APSASOL COLISTINA 3.000.000 UI/ml
Maltese: APSASOL COLISTINA 3.000.000
English: 1 000 000 IU/g Powder for oral solution
Maltese: 1 000 000 IU/g Trab għal soluzzjoni orali
English: Calves, piglets
Maltese: Ħnieżer, tiġieġ
English: 08150 Parets del Valles Spain
Maltese: Parets del Valles Spanja
English: Powder
Maltese: POLICHEM
English: 1 200 000 IU/g Powder for oral solution
Maltese: 1 200 000 IU/g Trab għal soluzzjoni orali
English: Oral solution Lambs, pigs, calves, poultry
Maltese: IU/ml oral solution for calves, pigs and poultry
English: From a pharmacological point of view, colistin exerts concentration-dependent activity and high concentrations of colistin are achieved in the gut following oral administration due to the poor absorption of the substance.
Maltese: Minn perspettiva farmakoloġika, colistin jeżerċita attività dipendenti fuq il-konċentrazzjoni u wara l-għoti orali jinkisbu konċentrazzjonijiet għoljin ta' colistin fil-musrana minħabba l-assorbiment fqir tassustanza.
English: 4 800 000 IU/g Powder for oral solution
Maltese: 4 800 000 IU/g Trab għal soluzzjoni orali
English: Ducks, turkeys, pheasants, rabbits, partidges, guinea hens, pigs, poultry
Maltese: Papri, dundjani, faġani, fniek, perniċi, tiġieġ tal-Indi, ħnieżer, tjur
English: Sant Hipòlit km 71, 08503, Gurb-Vic,
Maltese: Sant Hipòlit km 71, 08503, Gurb-Vic, Barcelona,
English: COLIVALL 2.000.000 UI/ml SOLUCIÓN ORAL
Maltese: 2 000 000 IU/mg Soluzzjoni orali
English: Denmark ScanVet Animal Health A/S Kongevejen 66,
Maltese: ScanVet Animal Health A/S Kongevejen 66, DK-3480 Fredensborg Id-Danimarka
English: Novo mesto, Smarjeska cesta 6, 8501 Novo Mesto Slovenia
Maltese: Il-Polonja KRKA, d.d. Novo mesto, Smarjeska cesta 6, 8501 Novo Mesto Is-Slovenja
English: The CVMP agreed that the treatment period should not exceed 7 days based on the following grounds: The most commonly recommended treatment duration for the products concerned is 3 to 7 days for both mammalians and poultry species, indicating that this has been concluded in many cases to be a
Maltese: L-aktar tul ta' kura komunement rakkomandat għall-prodotti kkonċernati huwa ta' 3 sa 7 ijiem kemm għallmammiferi u għall-ispeċi tat-tjur, li f'ħafna każijiet dan jindika li ġie konkluż li huwa perjodu ta' kura suffiċjenti.
English: Lithuania Divasa - Farmavic, S.A. Ctra.
Maltese: L-Ungerija Divasa - Farmavic, S.A. Ctra.
English: Cattle (calves), pigs (piglets), chicken (broilers)
Maltese: Frat (għoġġiela), ħnieżer (qżieqeż), tiġieġ (tal-brojlers)
English: 2 000 000 IU/g (95.65 mg/g)
Maltese: 2 000 000 IU/g (95.
English: Applicant/Marketing authorisation holder
Maltese: Applikant/Detentur talAwtorizzazzjoni għattqegħid fis-Suq
English: CEVA SANTE ANIMALE, Z.I.
Maltese: Il-Greċja CEVA SANTE ANIMALE Z.I. La Ballastiere
English: Lambs, quails, ducks, kid (goat), turkeys, pheasants, rabbits, geese, partidges, guinea hens, pigs, poultry
Maltese: Ħrief, summien, papri, gidien (mogħoż), dundjani, faġani, fniek, wiżż, perniċi, tiġieġ talIndi, ħnieżer, tjur
English: Calves, pigs, chickens
Maltese: Ħnieżer, tjur, fniek
English: COLISTINE 200 TOPDRESSING Colistin sulphate
Maltese: TOPDRESSING Colistin sulphate
English: The current scientific literature does not support the use of colistin in foals as its use could disrupt the gastrointestinal microflora balance, leading to a well-recognised fatal antimicrobial associated colitis, typically associated with Clostridium difficile.
Maltese: Barra minn hekk, fil-letteratura tal-prodott għandha tiżdied informazzjoni ulterjuri f'konformità malprinċipji ta' użu prudenti għall-antimikrobiċi.
English: GANAMIX COLISTINA 15.000.000 UI/ml PREMEZCLA MEDICAMENTOSA
Maltese: UI/ml PREMEZCLA MEDICAMENTOSA
English: Piglets, calves, chicken (broilers)
Maltese: Għoġġiela, qżieqeż, tiġieġ (tal-brojlers)
English: Lithuania Bela-Pharm GmbH & Co KG Lohner Str. 19,
Maltese: Bela-pharm GmbH & Co.KG Lohner Str. 19,
English: Pigs (up to 35 kg), broilers, turkeys, laying hens, rabbits
Maltese: Ħnieżer (sa 35 kg), brojlers, dundjani, tiġieġ tal-bajd, fniek
English: Calves, buffalo calves, lambs, goats, foal, pigs, chickens, turkeys, rabbits
Maltese: Ħrief, summien, papri, gidien (mogħoż), dundjani, fniek, wiżż, tiġieġ talIndi, ħnieżer, tjur
English: Germany Divasa-Farmavic S.A. Ctra.
Maltese: Il-Greċja Divasa-Farmavic S.A. Ctra.
English: KOLIFARM 1,2 mil. IU/g prášok na perorálny roztok
Maltese: KOLIFARM 1,2 mil.
English: BIOVETA COLISTIN 1 200 000 IU/mg prášek pro přípravu perorálního roztoku
Maltese: BIOVETA COLISTIN 1 200 000
English: de la Llana, 123 08191 Rubí
Maltese: L-Ungerija Andersen, S.A. Avda. de la Llana, 123 08191 Rubí
English: 200 000 IU/g Powder for oral use
Maltese: 200 000 IU/g Trab għall-użu orali
English: Calves, pigs (up to 35 kg), broilers, turkeys, laying hens, rabbits
Maltese: Għoġġiela, ħnieżer (sa 35 kg), brojlers, dundjani, tiġieġ talbajd, fniek
English: Following a request from the European Commission (EC), in July 2013 the CVMP and CHMP adopted scientific advice and detailed considerations on colistin1.
Maltese: Wara talba mill-Kummissjoni Ewropea (KE), f'Lulju 2013, is-CVMP u s-CHMP adottaw parir xjentifiku u kunsiderazzjonijiet dettaljati dwar colistin1.
English: 2 400 000 IU/g Powder for administration in drinking water
Maltese: 2 400 000 IU/g Trab biex jingħata fl-ilma tax-xorb
English: These factors indicate that a longer duration of treatment than the one indicated, leading to unnecessary exposure is not recommended”.)
Maltese: Dawn il-fatturi jindikaw li perjodu ta' kura itwal minn dak indikat, li jwassal għal esponiment mhux neċessarju mhuwiex rakkomandat”.)
English: Piglets, poultry
Maltese: Tiġieġ, ħnieżer
English: Cattle, rabbits, poultry (laying hens, turkeys), pigs
Maltese: Frat, fniek, tjur (tiġieġ tal-bajd, dundjani), ħnieżer
English: Lithuania ANDERSEN S.A. Avda.
Maltese: Il-Litwanja ANDERSEN S.A.
English: Romania ANDERSEN S.A. Avda.
Maltese: Ir-Rumanija ANDERSEN S.A.