FrancophonIA/ELRC3.0 huggingface dataset:
English: 58-260 Bielawa
Slovenian: Dzierżoniowska 21 58-260 Bielawa Poljska
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.
Slovenian: „Kolistin je terapevtsko pomemben v veterinarski medicini za zdravljenje enteričnih bolezni pri določenih živalskih vrstah za prehrano ljudi, za katere je za določene indikacije na voljo le malo drugih možnosti zdravljenja, ki bi bile učinkovite.
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can be provided that the combination is in line with responsible use principles, combination products should be withdrawn.”
Slovenian: V nasvetu je glede kombinacij kolistina z drugimi protimikrobnimi snovmi navedeno, da bi morali pregledati dovoljenja za promet s temi zdravili in jih, če ne obstaja trdna utemeljitev, da je zadevna kombinacija v skladu z načeli preudarne uporabe, umakniti.
English: Oral solution (directly into animal mouth, drinking water)
Slovenian: Peroralna raztopina (za dajanje neposredno v usta živali in uporabo v pitni vodi)
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
Slovenian: V skladu s spremenjenimi smernicami CVMP o povzetku glavnih značilnosti zdravila za protimikrobna zdravila (EMEA/CVMP/SAGAM/383441/2005)3 bi se indikacije morale nanašati na zdravljenje točno opredeljenih patogenov, splošnim indikacijam pa bi se bilo treba izogibati.
English: Delete, where applicable, any specific dosing recommendation related to target species horses.
Slovenian: Črtati, kjer je ustrezno, vsakršno posebno priporočilo glede odmerjanja, povezano s ciljno živalsko vrsto konji.
English: Poland Biofaktor Sp. z o.o.
Slovenian: Biofaktor Sp. z o.o.
English: ANIMEDICA ESPANA C/ Esmeralda, 19
Slovenian: Francija ANIMEDICA ESPANA C/ Esmeralda, 19
English: Colistin is a last resort antimicrobial for the treatment of infections due to highly resistant bacteria in humans, for which mortality can be very high.
Slovenian: Kolistin je protimikrobno zdravilo, ki pomeni zadnjo možnost za zdravljenje okužb, ki jih povzročijo visoko odporne bakterije, pri ljudeh, pri katerih je smrtnost lahko zelo visoka.
English: La Ballastiere 33500 Libourne France
Slovenian: La Ballastiere 33500 Libourne Francija
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.
Slovenian: V okviru predhodne ocene CVMP (EMA/CVMP, 2010)4 je odbor zaključil, da je razmerje med koristmi in tveganji za uporabo kolistina za zdravljenje okužb prebavil, ki jih povzroča Salmonella spp., negativno, za uporabo kolistina za zdravljenje enteričnih okužb, ki jih povzroča neinvazivna bakterija E. coli, občutljiva na kolistin, pa ostaja pozitivno.
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.
Slovenian: Trenutna znanstvena literatura ne podpira uporabe kolistina pri žrebetih, saj lahko zdravilo poruši ravnovesje mikroflore v prebavilih in povzroči dobro znan, s protimikrobnimi zdravili povezan smrtni kolitis, ki je običajno povezan z bakterijo Clostridium difficile.
English: The combinations of colistin with another antimicrobial substance and the non-oral administration of products containing colistin may be addressed as a next step following the completion of this referral procedure.
Slovenian: Kombinacije kolistina z drugimi protimikrobnimi snovmi in zdravila, ki vsebujejo kolistin in se ne uporabljajo peroralno, bodo morda obravnavani na naslednji stopnji po koncu tega napotitvenega postopka.
English: Belgium Prodivet pharmaceuticals sa/nv
Slovenian: Prodivet pharmaceuticals sa/nv
English: Oral suspension Pigs (after weaning, also for fattening pigs)
Slovenian: Prašiči (po odstavitvi, tudi za prašiče pitance)
English: Some of the products included in the scope of this referral procedure are indicated for use in horses and, although not stated explicitly in the product literature, it is assumed that these products are used predominantly in foals.
Slovenian: Nekatera zdravila, zajeta v tem napotitvenem postopku, so indicirana za uporabo pri konjih, zato se predvideva, da se ta zdravila uporabljajo predvsem za zdravljenje žrebet, čeprav to v informacijah o zdravilih ni izrecno navedeno.
English: • on the basis of the available data, the CVMP considered that the duration of treatment should be amended as described in Annex III;
Slovenian: • odbor CVMP je na podlagi razpoložljivih podatkov menil, da bi bilo treba trajanje zdravljenja spremeniti, kot je navedeno v Prilogi III;
English: Add, to all products:
Slovenian: Pri vseh zdravilih dodati:
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.”
Slovenian: V sklepu je navedeno, „da se na podlagi trenutnih dokazov zdi primerno, da se uporaba kolistina v veterinarski medicini ohrani, vendar da se indikacije omejijo na zdravljenje ali metafilakso in da se črtajo vse indikacije za profilaktično uporabo, da bi čim bolj zmanjšali morebitno tveganje, povezano s
English: 1 million IU/g Powder
Slovenian: 1 million IU/g Prašek
English: In addition, advice should be included in the SPC that the presence of the disease should be established in the group or herd before metaphylactic treatment.
Slovenian: Poleg tega bi morali v povzetek glavnih značilnosti zdravila vključiti nasvet, da bi bilo treba pred metafilaktičnim zdravljenjem potrditi prisotnost bolezni v skupini ali čredi.
English: Replace, where applicable, treatment recommendations which are extended beyond 7 days, or where no treatment duration recommendation is given, with the following statement:
Slovenian: Kjer je ustrezno, priporočila o trajanju zdravljenja, ki presegajo 7 dni, nadomestiti z naslednjim oziroma v primeru, da priporočila glede trajanja zdravljenja niso podana, navesti:
English: Lithuania Chemifarma S.p.A Via Don E. Servadei, 16-47100 Forlí,
Slovenian: Chemifarma S.p.A Via Don E. Servadei, 16-47100 Forlí, Italija
English: Germany Pharmawerk Weinböhla GmbH
Slovenian: Nemčija Pharmawerk Weinböhla GmbH
English: Liquid color from yellow to brown
Slovenian: Rumene do rjave barve.
English: MILICOLI 2000000 TV/ml geriamasis tirpalas galvijams,avims,kiaulėms,paukšč iams
Slovenian: MILICOLI 2000000 TV/ml geriamasis tirpalas galvijams,avims,kiaulėms,pauk ščiams
English: Thus, any pathogens other than non-invasive E. coli that are typically not associated with non-invasive gastrointestinal infections, and/or associated with general infections should be taken out of the SPC.
Slovenian: Zato bi bilo treba iz povzetka glavnih značilnosti zdravila odstraniti vse patogene razen neinvazivne bakterije E. coli, ki običajno niso povezani z neinvazivnimi okužbami prebavil in/ali so povezani s splošnimi okužbami.
English: Powder for oral use may be administered mixed in the feed.
Slovenian: Prašek za peroralno uporabo se lahko uporablja pomešan s krmo.
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.
Slovenian: S farmakološkega vidika je delovanje kolistina odvisno od koncentracije, zaradi slabe absorbcije snovi pa se s peroralno uporabo doseže visoka koncentracija kolistina v črevesju.
English: Replace, where applicable, treatment recommendations which are extended beyond 7 days, or where no treatment duration recommendation is given, with the following statement: Duration of treatment should be limited to the minimum time necessary for the treatment of the disease.
Slovenian: Kjer je ustrezno, priporočila o trajanju zdravljenja, ki presegajo 7 dni, nadomestiti z naslednjim oziroma v primeru, da priporočila glede trajanja zdravljenja niso podana, navesti: Trajanje zdravljenja je treba omejiti na najkrajši možni čas, potreben za ozdravitev.
English: The indication is restricted to enteric infections caused by non-invasive E. coli susceptible to colistin.
Slovenian: Indikacija je omejena na enterične okužbe, ki jih povzroča neinvazivna bakterija E. coli, občutljiva na kolistin.
English: C/Prudenci Bertrana n 5, 43206 REUS (Tarragona) Spain
Slovenian: C/Prudenci Bertrana n 5, 43206 REUS (Tarragona) Španija
English: Use of the product deviating from the instructions given in the SPC may lead to treatment failures and increase the prevalence of bacteria resistant to colistin.”
Slovenian: Uporaba zdravila na način, ki odstopa od navodil, podanih v povzetku glavnih značilnosti zdravila, lahko vodi k neuspešnemu zdravljenju in poveča razširjenost bakterij, odpornih proti kolistinu.“
English: COLIKERN 500 mg/g pré-mistura medicamentosa para alimento medicamentoso para suínos
Slovenian: COLIKERN 500 mg/g prémistura medicamentosa para alimento medicamentoso para suínos
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.
Slovenian: Iz povzetka glavnih značilnosti zdravila bi morali odstraniti ciljno živalsko vrsto „konj“ in vsakršno indikacijo za konje, poleg tega pa bi v povzetek glavnih značilnosti zdravila morali dodati informacijo, da je uporaba kolistina pri konjih, zlasti žrebetih, kontraindicirana zaradi spremembe ravnovesja mikroflore v prebavilih in razvoja s protimikrobnimi zdravili povezanega kolitisa, ki je običajno povezan z bakterijo Clostridium difficile in je lahko smrten.
English: Poland MEDIVET S.A. ul.
Slovenian: MEDIVET S.A. ul.
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.
Slovenian: Zdravila ne uporabljajte za zdravljenje konj, zlasti žrebet, saj lahko kolistin zaradi spremembe ravnovesja mikroflore v prebavilih povzroči s protimikrobnimi zdravili povezani kolitis (Colitis X), ki je običajno povezan z bakterijo Clostridium difficile in je lahko smrten.
English: 4941 VX Raamsdonksveer, Netherlands
Slovenian: 4941 VX Raamsdonksveer, Nizozemska
English: For products to be administered in feed or water (for group/herd treatment), it should be stated “treatment and metaphylaxis”, and the following advice should be added: The presence of the disease in the herd should be established before metaphylactic treatment.
Slovenian: Za zdravila, ki se uporabljajo v krmi ali vodi (za zdravljenje skupin/čred), je kot indikacijo treba navesti „zdravljenje in metafilakso“ ter dodati naslednji nasvet:
English: 4941 VX Raamsdonkveer, Netherlands
Slovenian: 4941 VX Raamsdonkveer, Nizozemska
English: Granular powder to be mixed with solid feed.
Slovenian: Zrnat prašek za mešanje s trdno krmo.
English: 08017 Barcelona, Spain
Slovenian: 08017 Barcelona, Španija
English: nv/sa Hoge Mauw 900, B-2370 Arendonk, Belgium
Slovenian: nv/sa Hoge Mauw 900, B-2370 Arendonk, Belgija
English: Emulsion for oral use
Slovenian: Emulzija za peroralno uporabo
English: Prudenci Bertrana, 5 E-43206 Reus Spain
Slovenian: Prudenci Bertrana, 5 E-43206 Reus Španija
English: 25 500 IU/g Powder for oral suspension
Slovenian: 25 500 IU/g Prašek za peroralno suspenzijo
English: 08950 Esplugues de Liobregat (Barcelona) Spain
Slovenian: 08950 Esplugues de Liobregat (Barcelona) Španija
English: Netherlands Aesculaap B.V. Mijlstraat 35, 5281 LJ Boxtel,
Slovenian: Mijlstraat 35, 5281 LJ Boxtel,
English: was recommended since none, very limited or non-conclusive clinical data was presented to support this indication.
Slovenian: Priporočen je bil izbris bakterije Salmonella spp., saj niso bili podani nikakršni dokazi v podporo tej indikaciji ali pa so bili ti dokazi zelo omejeni ali neprepričljivi.
English: Bulgaria V.M.D.
Slovenian: Bolgarija V.M.D.
English: 08150 Parets del Valles Spain
Slovenian: 08150 Parets del Valles Španija
English: The oral colistin products within the scope of this referral are effective medicines for the treatment and metaphylaxis of enteric diseases caused by non-invasive E. coli susceptible to colistin in certain foodproducing animal species for which there are few effective alternatives available due to increasing resistance development.
Slovenian: Peroralna zdravila, ki vsebujejo kolistin, zajeta v tem napotitvenem postopku, so učinkovita zdravila za zdravljenje in metafilakso enteričnih bolezni, ki jih povzroča neinvazivna bakterija E. coli, občutljiva na kolistin, pri določenih živalskih vrstah za prehrano ljudi, za katere je zaradi razvoja odpornosti v vse večjem obsegu na voljo le malo drugih možnosti zdravljenja, ki bi bile učinkovite.
English: was justified;
Slovenian: Prilogi III, utemeljene;
English: Hungary Andrés Pintaluba S.A. Pol.Ind.Agro-Reus C/ Prudenci Bertrana n°5
Slovenian: Madžarska Andrés Pintaluba S.A. Pol.Ind.Agro-Reus C/ Prudenci Bertrana n°5
English: 08017 Barcelona Spain
Slovenian: 08017 Barcelona Španija
English: Germany Sogeval 200, Av. De Mayenne, ZI de Touches F-53000 Laval France
Slovenian: Nemčija Sogeval 200, Av. De Mayenne, ZI de Touches F-53000 Laval Francija
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.
Slovenian: Peroralna zdravila, ki vsebujejo kolistin, se štejejo za učinkovita zdravila za zdravljenje enteričnih nalezljivih bolezni, ki jih povzroča neinvazivna bakterija E. coli, občutljiva na kolistin, pri nekaterih živalskih vrstah za prehrano ljudi.
English: Netherlands Bela-pharm GmbH & Co.KG.
Slovenian: Nizozemska Bela-pharm GmbH & Co.KG.
English: TARGET SPECIES Delete, where applicable, “horses”.
Slovenian: CILJNE ŽIVALSKE VRSTE Črtati, kjer je ustrezno, konje.
English: Via Togliatti 5, 42016 Guastalla (RE), Italy
Slovenian: Via Togliatti 5, 42016 Guastalla (RE), Italija
English: Poland Laboratorios Calier S.A. C/Barcelones, 26 (Pla del Ramassa);
Slovenian: Laboratorios Calier S.A. C/Barcelones, 26 (Pla del Ramassa);
English: Use of colistin products in animals within the European Union: development of resistance and possible impact on human and animal health (EMA/755938/2012) http://www.ema.europa.eu/docs/en_GB/document_library/Report/2013/07/WC500146813.pdf
Slovenian: Uporaba zdravil, ki vsebujejo kolistin, pri živalih v Evropski uniji: razvoj odpornosti in morebiten učinek na zdravje ljudi in živali (Use of colistin products in animals within the European Union: development of resistance and possible impact on human and animal health (EMA/755938/2012)),
English: Pigs aniMedica España, S.L.U.Esmeralda, 19 Esplugues de Llobregat (Barcelona) E-08950 Spain
Slovenian: Prašiči aniMedica España, S.L.U.Esmeralda, 19 Esplugues de Llobregat (Barcelona) E-08950 Španija
English: Delete, where applicable, any indication for horses.
Slovenian: Črtati, kjer je ustrezno, vsakršno indikacijo za konje.
English: Use of the product deviating from the instructions given in the SPC may lead to treatment failures and increase the prevalence of bacteria resistant to colistin.
Slovenian: Uporaba zdravila na način, ki odstopa od navodil, podanih v povzetku glavnih značilnosti zdravila, lahko vodi k neuspešnemu zdravljenju in poveča razširjenost bakterij, odpornih proti kolistinu.
English: “However, severe nosocomial infections due to multidrug-resistant (MDR) Gram-negative bacteria now account for high morbidity and mortality in man. Colistin is therefore nowadays a last resort drug in human medicine in the context of treatment of infections caused by MDR Pseudomonas aeruginosa, Acinetobacter baumannii and Enterobacteriaceae (Escherichia coli, Klebsiella pneumoniae), for which mortality can be extremely high.”
Slovenian: Kolistin zato danes pomeni zdravilo, ki se uporablja kot zadnja možnost v humani medicini za zdravljenje okužb, ki jih povzročijo bakterije Pseudomonas aeruginosa, Acinetobacter baumannii in Enterobacteriaceae (Escherichia coli, Klebsiella pneumoniae), odporne proti več zdravilom, pri katerih je lahko umrljivost izjemno visoka.“
English: United Kingdom aniMedica Espana, S.L.U, Esmeralda, 19, Esplugues de Llobregat, Barcelona, E-08950, Spain
Slovenian: Združeno kraljestvo aniMedica Espana, S.L.U, Esmeralda, 19, Esplugues de Llobregat, Barcelona, E-08950, Španija
English: de la Llana 123 P. I. La Llana 08191 Rubi Spain
Slovenian: de la Llana 123 P. I. La Llana 08191 Rubi Španija
English: 34 Rue Jean Monnet Zi D'etriche 49500 Segre France
Slovenian: Portugalska QALIAN 34 Rue Jean Monnet Zi D'etriche 49500 Segre Francija
English: 120 g/1000 g Oral powder for use in drinking water or liquid feed
Slovenian: 120 g/1000 g Peroralni prašek za uporabo v pitni vodi ali tekoči krmi
English: INDICATIONS
Slovenian: Indikacije
English: CALIER PORTUGAL S.A Centro Empresarial Sintra-Estoril II, Ed. C, R. Pé do Mouro, Estrada de Albarraque 2710-335 Sintra Portugal
Slovenian: Portugalska CALIER PORTUGAL S.A Centro Empresarial Sintra-Estoril II, Ed. C, R. Pé do Mouro,
English: MECANOVA Naves 27-28 25190 Lerida Spain
Slovenian: MECANOVA Naves 27-28
English: 08191 RUBI Barcelona Spain
Slovenian: 08191 RUBI Barcelona Španija
English: Kg Lohner Strasse 19, D-49377 Vechta Germany
Slovenian: Kg Lohner Strasse 19, D-49377 Vechta Nemčija
English: BE-B2610 Antwerp, Belgium
Slovenian: Alpharma BVBA Laarstraat 26, BE-B2610 Antwerp, Belgija
English: Powder for use in food, drinking water or milk
Slovenian: Prašek za uporabo v hrani, pitni vodi ali mleku
English: Germany Chevita Tierarzneimittel GmbH
Slovenian: Nemčija Chevita Tierarzneimittel GmbH
English: Poland Laboratorios Calier S.A. Barcelonès, 26 (Pla del Ramassà)
Slovenian: Laboratorios Calier S.A. Barcelonès, 26 (Pla del Ramassà)
English: In addition, orally administered colistin would not be appropriate for systemic therapy due to poor absorption from the gastrointestinal tract.
Slovenian: Poleg tega kolistin za peroralno uporabo zaradi slabe absorbcije iz prebavnega trakta ni primeren za sistemsko zdravljenje.
English: Via P. Togliatti, 5 42016 - Guastalla (RE) Italy
Slovenian: Via P. Togliatti, 5 42016 - Guastalla (RE) Italija
English: Hungary Coophavet 23 rue du Prieuré Saint Herblon, 44150 Ancenis,
Slovenian: Madžarska Coophavet 23 rue du Prieuré Saint Herblon, 44150 Ancenis,
English: Colistin exerts concentration-dependent activity against Gram-negative bacteria.
Slovenian: Kolistin deluje proti gramnegativnim bakterijam, pri čemer je njegovo delovanje odvisno od koncentracije.
English: Powder for use in feed
Slovenian: Prašek za uporabo v krmi
English: Netherlands Laboratoires Sogeval 200 Avenue de Mayenne, Zone Industrielle des Touches, 53000 Laval, France
Slovenian: Nizozemska Laboratoires Sogeval 200 Avenue de Mayenne, Zone Industrielle des Touches, 53000 Laval, Francija
English: Pigs, cattle
Slovenian: Prašiči, goveda
English: C/ Barcelona 411 Sant Vicents dels Horts 08620 Barcelona Spain
Slovenian: Sant Vicents dels Horts 08620 Barcelona Španija
English: Bioplex Colistin 25 mg/g - Pulver zum Eingeben für Rinder, Schweine, Hühner
Slovenian: Bioplex Colistin 25 mg/gPulver zum Eingeben für Rinder, Schweine, Hühner
English: Powder may be administered mixed with the solid feed
Slovenian: Prašek se lahko uporablja pomešan s trdno krmo.
English: Belgium aniMedica Espana S.L.U.
Slovenian: Belgija aniMedica Espana S.L.U.
English: • on the basis of the available data, the CVMP considered warning sentences in line with responsible use principles as provided in Annex III should be included in the product information;
Slovenian: • odbor CVMP je na podlagi razpoložljivih podatkov menil, da bi bilo treba v informacije o zdravilu vključiti opozorila v skladu z načeli preudarne uporabe, kot je navedeno v Prilogi III;
English: 200 Avenue de Mayenne zone industrielle des touches 53000 - Laval France
Slovenian: 200 Avenue de Mayenne zone industrielle des touches 53000 - Laval Francija
English: Pigs (piglets and fattening pigs)
Slovenian: Prašiči (pujski in prašiči pitanci)
English: Cattle, pigs, dogs
Slovenian: Goveda, prašiči, psi
English: Esplugues De Llobregat 08950 Barcelona Spain
Slovenian: Esplugues De Llobregat 08950 Barcelona
English: Ceva Sante Animale La Ballastière, 33501 Libourne, France
Slovenian: Ceva Sante Animale La Ballastière, 33501 Libourne, Francija
English: 100 g/100 g Powder for administration in drinking water
Slovenian: 100 g/100 g Prašek za uporabo v pitni vodi
English: E-08950 Esplugues de Llobregat (Barcelona) Spain
Slovenian: E-08950 Esplugues de Llobregat (Barcelona) Španija
English: Bulgaria Ceva Sante Animale 10 avenue de La Ballastiere 33500 Libourne Cedex France
Slovenian: Bolgarija Ceva Sante Animale 10 avenue de La Ballastiere 33500 Libourne Cedex Francija
English: B-2370 Arendonk, Belgium
Slovenian: B-2370 Arendonk, Belgija
English: 1200 x 106 IU/kg Powder for oral solution
Slovenian: 1200 x 106 IU/kg Prašek za peroralno raztopino
English: Netherlands Dopharma Research B.V. Zalmweg 24,
Slovenian: Nizozemska Dopharma Research B.V.
English: ARNIKA VETERINA d.o.o., Vidikovac 20, 1000 Zagreb, Croatia
Slovenian: Hrvaška ARNIKA VETERINA d.o.o., Vidikovac 20,
English: Romania CEVA SANTE ANIMALE 10 avenue de la Ballastiere, 33500 Libourne,
Slovenian: Romunija CEVA SANTE ANIMALE 10 avenue de la Ballastiere, 33500 Libourne,
English: Slovenia aniMedica España, S.L.U.
Slovenian: Slovenija aniMedica España, S.L.U.
English: B-2370 Arendonk Belgium
Slovenian: B-2370 Arendonk Belgija
English: Lithuania Sintofarm S. p. A. Via Togliatti 5-42016, Guastalla (RE),
Slovenian: Sintofarm S. p. A. Via Togliatti 5-42016, Guastalla (RE), Italija
English: • on the basis of the available data, the CVMP considered that the indication as provided in Annex III
Slovenian: • odbor CVMP je na podlagi razpoložljivih podatkov menil, da so indikacije, kot so navedene v
English: 2.4 million IU/g Powder for oral use
Slovenian: 2.4 million IU/g Prašek za peroralno uporabo
English: Delete, where applicable, any references to horses.
Slovenian: Črtati, kjer je ustrezno, vsakršno sklicevanje na konje.
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.
Slovenian: je odbor CVMP priporočil spremembo dovoljenj za promet za zdravila za uporabo v veterinarski medicini, ki vsebujejo kolistin in se uporabljajo peroralno, da bi spremenili povzetke glavnih značilnosti zdravila, označevanje in navodila za uporabo, kot je določeno v Prilogi III.
English: 71 08503 Gurb - Vic Spain
Slovenian: 71 08503 Gurb - Vic Španija
English: Les Franqueses del Valles 08520 Barcelona,
Slovenian: Les Franqueses del Valles 08520 Barcelona, Španija
English: COLISTINE 400 porc et agneauchevreau sevres
Slovenian: COLISTINE 400 porc et agneau-chevreau sevres