FrancophonIA/ELRC3.0 huggingface dataset:
English: Slovenia Lek Pharmaceuticals D.D.
Croatian: Lek Pharmaceuticals D.D.
English: Slovenia Medis, D.O.O.
Croatian: Medis, D.O.O.
English: Hungary Goodwill Pharma Ltd
Croatian: Goodwill Pharma Ltd
English: Germany Mylan Dura Gmbh
Croatian: Mylan Dura Gmbh
English: Spain Sandoz Farmacéutica, S.A.
Croatian: Sandoz Farmacéutica, S.A.
English: Finland Aurobindo Pharma (Malta) Limited Metformin Aurobindo
Croatian: Aurobindo Pharma (Malta) Limited Metformin Aurobindo
English: Croatia Sandoz D.O.O.
Croatian: Sandoz D.O.O.
English: Germany Rosemont Pharmaceuticals Limited Metfoliquid Geriasan
Croatian: Rosemont Pharmaceuticals Limited Metfoliquid Geriasan
English: France Biogaran
Croatian: Biogaran
English: Slovakia Pharmaswiss česká Republika S.R.O.
Croatian: Češka Republika Pharmaswiss česká Republika S.R.O.
English: Ireland Rowex Ltd
Croatian: Rowex Ltd
English: Laboratories
Croatian: Pharmaceuticals
English: Austria Genericon Pharma Gesellschaft M.B.H.
Croatian: Genericon Pharma Gesellschaft M.B.H.
English: Ireland Mcdermott Laboratories Ltd
Croatian: Mcdermott Laboratories Ltd
English: Bulgaria Berlin-Chemie Ag сиофор
Croatian: Berlin-Chemie Ag сиофор
English: Finland Hexal A-S
Croatian: Hexal A-S
English: Latvia Zaklady FarmaceutycznePolpharma- Spolka Akcyjna
Croatian: Zaklady FarmaceutycznePolpharma- Spolka Akcyjna
English: Metformin Hydrochloride 1g Tablet
Croatian: Metforminklorid 1 g tableta
English: Slovakia Sandoz Pharmaceuticals D.D.
Croatian: Sandoz Pharmaceuticals D.D.
English: Poland Zentiva, A.S.
Croatian: Češka Republika Zentiva, A.S.
English: Croatia Merck D.O.O
Croatian: Merck D.O.O
English: Belgium Merck N.V.-S.A.
Croatian: Luksemburg Merck N.V.-S.A.
English: 500mg Tablet
Croatian: 500 mg tableta
English: Sanofi - Produtos Farmaceuticos Lda
Croatian: Sanofi - Produtos Farmaceuticos Lda Metformina Zentiva
English: Belgium Sandoz N.V.
Croatian: Luksemburg Sandoz N.V.
English: Germany Stadapharm Gmbh
Croatian: Stadapharm Gmbh
English: Germany Winthrop Arzneimittel Gmbh
Croatian: Winthrop Arzneimittel Gmbh
English: Sweden Mylan Ab
Croatian: Mylan Ab
English: Germany T&d Pharma Gmbh
Croatian: T&d Pharma Gmbh
English: Pinewood Laboratories Limited Metformin Hydrochloride Pinewood Laboratories Ltd
Croatian: Metformin Hydrochloride Pinewood Laboratories Ltd
English: France Cristers
Croatian: Cristers
English: Germany Laboratori Guidotti S.P.A.
Croatian: Češka Republika Laboratori Guidotti S.P.A.
English: Metformin Hydrochloride Bp 500mg
Croatian: Metforminklorid Bp 500 mg
English: Poland Zaklady FarmaceutycznePolpharma- Spolka Akcyjna
Croatian: Zaklady FarmaceutycznePolpharma-Spolka Akcyjna
English: Romania Generics [uk] Limited
Croatian: Češka Republika Generics [uk] Limited
English: Germany Aurobindo Pharma Gmbh
Croatian: Aurobindo Pharma Gmbh
English: Finland Sandoz A-S
Croatian: Sandoz A-S
English: Slovakia Merck Santé S.A.S.
Croatian: Češka Republika Merck Santé S.A.S.
English: Metformin Hydrochloride 500ml/5 Ml
Croatian: Metforminklorid 500 ml/5
English: Germany Teva Gmbh
Croatian: Teva Gmbh
English: Metformin 850mg Tablet
Croatian: Metformin 850 mg tableta
English: Metformin Hydrochloride 400mg Capsule, Glibenclamide 2.5mg Capsule
Croatian: Metforminklorid 400 mg kapsula, glibenklamid 2,5 mg kapsula kapsula
English: Latvia Ratiopharm Gmbh
Croatian: Ratiopharm Gmbh
English: Slovakia Stada Arzneimittel Ag
Croatian: Češka Republika Stada Arzneimittel Ag
English: Austria Arcana Arzneimittel Gmbh
Croatian: Arcana Arzneimittel Gmbh
English: Poland Sandoz Gmbh
Croatian: Sandoz Gmbh
English: Metformin 1000mg Tablet
Croatian: Metformin 1000 mg tableta
English: Germany Abz-Pharma Gmbh
Croatian: Abz-Pharma Gmbh
English: Austria Stada Arzneimittel Gmbh
Croatian: Stada Arzneimittel Gmbh
English: Metformin Hydrochloride 850mg
Croatian: Metforminklorid 850 mg
English: Metformin Medley Pharma
Croatian: Metformin Crescent Pharma
English: Lithuania Vitabalans Oy
Croatian: Češka Republika Vitabalans Oy
English: Germany Glenmark Arzneimittel Gmbh
Croatian: Glenmark Arzneimittel Gmbh
English: Slovakia Medreg S.R.O.
Croatian: Češka Republika Medreg S.R.O.
English: Germany Aaa-Pharma Gmbh
Croatian: Aaa-Pharma Gmbh
English: Slovenia Merck D.O.O.
Croatian: Merck D.O.O.
English: Rosemont Pharmaceuticals Limited Metformin Hydrochloride Rosemont Pharmaceuticals
Croatian: Rosemont Pharmaceuticals Limited Metformin Hydrochloride Rosemont
English: Germany Hormosan Pharma Gmbh
Croatian: Hormosan Pharma Gmbh
English: Pinewood Laboratories Limited Metformin Hydrochloride Pinewood Laboratories
Croatian: Metformin Hydrochloride Pinewood Laboratories
English: France Ranbaxy Pharmacie Generiques Metformine Ranbaxy
Croatian: Ranbaxy Pharmacie Generiques
English: Germany Dexcel Pharma Gmbh
Croatian: Dexcel Pharma Gmbh
English: Slovakia Actavis Group Ptc Ehf.
Croatian: Češka Republika Actavis Group Ptc Ehf.
English: Norway Rosemont Pharmaceuticals Limited Metformin Rosemont
Croatian: Rosemont Pharmaceuticals Limited Metformin Rosemont
English: Portugal
Croatian: Grčka
English: Austria Bluefish Pharmaceuticals Ab
Croatian: Češka Republika Bluefish Pharmaceuticals Ab
English: Germany Biomo Pharma Gmbh
Croatian: Biomo Pharma Gmbh
English: Metformin 500mg Tablet
Croatian: Metformin 500 mg tableta
English: Greece Farmasyn S.A.
Croatian: Farmasyn S.A.
English: Metformin Wockhardt Uk
Croatian: Metformin Wockhardt Uk Ltd
English: Germany Aliud Pharma Gmbh
Croatian: Aliud Pharma Gmbh
English: Metformin Hydrochloride 100mg/ Ml
Croatian: Metforminklorid 100 mg/
English: France Sandoz
Croatian: Sandoz
English: Austria Hexal Pharma Gmbh
Croatian: Hexal Pharma Gmbh
English: Metformin Hydrochloride 850mg Tablet, Alogliptin 25mg Tablet
Croatian: Metforminklorid 850 mg tableta, alogliptin 25 mg tableta
English: Germany Heumann Pharma Gmbh & Co. Generica Kg
Croatian: Heumann Pharma Gmbh & Co.
English: Germany Berlin-Chemie Ag
Croatian: Češka Republika Berlin-Chemie Ag
English: Metformin Hydrochloride 170mg/Ml
Croatian: Metforminklorid 170 mg/Ml oralna otopina
English: Metformin Hydrochloride Glenmark Generics Europe
Croatian: Glenmark Generics (Europe) Limited Metformin Hydrochloride Glenmark Generics
English: Metformin Hydrochloride 850mg Tablet, Linagliptin 2.5mg Tablet
Croatian: Metforminklorid 850 mg tableta, linagliptin 2,5 mg tableta
English: Metformin Hydrochloride 850mg Tablet, Dapagliflozin 5mg Tablet
Croatian: Metforminklorid 850 mg tableta, dapagliflozin 5 mg tableta
English: Austria 1a Pharma Gmbh
Croatian: 1a Pharma Gmbh
English: Metformin Wockhardt Uk Ltd Metformin Hydrochloride 500mg Tablet
Croatian: Metformin Wockhardt Uk Metforminklorid 500 mg tableta filmom obložena tableta
English: Metformin Hydrochloride 1000mg Tablet, Sitagliptin 50mg Tablet
Croatian: Metforminklorid 1000 mg tableta, sitagliptin 50 mg tableta
English: Metformin Hydrochloride 850mg Tablet, Alogliptin 12.5mg Tablet
Croatian: Metforminklorid 850 mg tableta, alogliptin 12,5 mg tableta
English: Metformin Hydrochloride 1000mg Tablet, Empagliflozin 12.5mg Tablet
Croatian: Metforminklorid 1000 mg tableta, empagliflozin 12,5 mg tableta
English: Metformin Hydrochloride 1000mg Tablet, Linagliptin 2.5mg Tablet
Croatian: Metforminklorid 1000 mg tableta, linagliptin 2,5 mg tableta
English: Metformin Wockhardt Uk Ltd Metformin Hydrochloride 850mg Tablet
Croatian: Metformin Wockhardt Uk Metforminklorid 850 mg tableta filmom obložena tableta
English: Metformin Hydrochloride 500mg Film Film-Coated Tablet
Croatian: Metforminklorid 500 mg film filmom obložena tableta
English: Metformin Hydrochloride 1000µg Tablet Film-Coated Tablet
Croatian: Metforminklorid 1000µg tableta filmom obložena tableta
English: Germany Denk Pharma Gmbh & Co. Kg Metfo
Croatian: Denk Pharma Gmbh & Co.
English: Metformin Hydrochloride 1000mg Sachet Powder For Oral Solution
Croatian: Metforminklorid 1000 mg vrećica prašak za oralnu otopinu
English: Metformin Hydrochloride 1000mg Film Film-Coated Tablet
Croatian: Metforminklorid 1000 mg film filmom obložena tableta
English: Metformin Embonate 700mg Tablet
Croatian: Metforminembonat 700 mg tableta tableta
English: Metformin Hydrochloride 500mg G
Croatian: Metforminklorid 500 mg
English: Metformin Crescent Pharma Metformin Hydrochloride 850mg Tablet
Croatian: Metformin Medley Pharma Metforminklorid 850 mg tableta tableta
English: Metformin Hydrochloride 850mg Tablet, Sitagliptin 50mg Tablet
Croatian: Metforminklorid 850 mg tableta, sitagliptin 50 mg tableta
English: Germany Juta Pharma Gmbh
Croatian: Juta Pharma Gmbh
English: Germany Tad Pharma Gmbh
Croatian: Tad Pharma Gmbh
English: Metformin Crescent Pharma Metformin Hydrochloride 500mg Tablet
Croatian: Metformin Medley Pharma Metforminklorid 500 mg tableta tableta
English: Metformin Hydrochloride 850mg Tablet, Empagliflozin 12.5mg Tablet
Croatian: Metforminklorid 850 mg tableta, empagliflozin 12,5 mg tableta
English: Metformin Hydrochloride 850mg Tablet, Empagliflozin 5mg Tablet
Croatian: Metforminklorid 850 mg tableta, empagliflozin 5mg tableta
English: Metformin Hydrochloride 1000mg Tablet, Saxagliptin 2.5mg Tablet
Croatian: Metforminklorid 1000 mg tableta, saksagliptin 2,5 mg tableta
English: Metformin Lindopharm Metformin Hydrochloride 500mg Tablet
Croatian: Metformin Lindopharm Metforminklorid 500 mg tableta filmom obložena tableta
English: Wörwag Pharma Gmbh & Co. Kg Metfogamma
Croatian: Wörwag Pharma Gmbh & Co.
English: Metformin Lindopharm Metformin Hydrochloride 850mg Tablet
Croatian: Metformin Lindopharm Metforminklorid 850 mg tableta filmom obložena tableta
English: Metformin Relonchem Metformin Hydrochloride 850mg Tablet
Croatian: Metformin Relonchem Metforminklorid 850 mg tableta filmom obložena tableta
English: Metformin Hydrochloride 1000mg Tablet, Empagliflozin 5mg Tablet
Croatian: Metforminklorid 1000 mg tableta, empagliflozin 5mg tableta
English: Metformin Hydrochloride 850mg Sachet Powder For Oral Solution
Croatian: Metforminklorid 850 mg Vrećica prašak za oralnu otopinu
English: Metformin Hydrochloride 850mg Tablet, Saxagliptin 2.5mg Tablet
Croatian: Metforminklorid 850 mg tableta, saksagliptin 2,5 mg tableta
English: Metformin Hydrochloride 1000mg/1117 Mg
Croatian: Metforminklorid 1000 mg/1117 Mg filmom obložena tableta
English: Metformin Hydrochloride 1000mg Tablet, Dapagliflozin 5mg Tablet
Croatian: Metforminklorid 1000 mg tableta, dapagliflozin 5 mg tableta
English: Metformin Hydrochloride 850mg Tablet, Pioglitazone 15mg Tablet
Croatian: Metforminklorid 850 mg tableta, Pioglitazon 15mg tableta
English: Metformin Hcl Ratiopharm Metformin Hydrochloride 850mg Tablet
Croatian: Metformin Hcl Ratiopharm Metforminklorid 850 mg tableta filmom obložena tableta
English: Metformin Relonchem Metformin Hydrochloride 500mg Tablet
Croatian: Metformin Relonchem Metforminklorid 500 mg tableta filmom obložena tableta
English: Metformin Hydrochloride 1000mg Sachet Powder For Oral Solution In Sachet
Croatian: Metforminklorid 1000 mg vrećica prašak za oralnu otopinu u vrećici
English: United Kingdom
Croatian: Nizozemska
English: Metformin Hcl Ratiopharm Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Croatian: Metformin Hcl Ratiopharm Metforminklorid 1000 mg tableta filmom obložena tableta
English: Metformin Hydrochloride 1000mg Tablet Tablet
Croatian: Metforminklorid 1000 mg tableta Šumeća tableta
English: Metformin Hydrochloride 500mg Sachet Powder For Oral Solution
Croatian: Metforminklorid 500 mg vrećica prašak za oralnu otopinu
English: Metformin Hydrochloride 400mg Tablet, Glibenclamide 5mg Tablet
Croatian: Metforminklorid 400 mg tableta, glibenklamid 5 mg tableta
English: Metformin Hydrochloride 400mg Tablet, Glibenclamide 2.5mg Tablet
Croatian: Metforminklorid 400 mg tableta, glibenklamid 2,5 mg tableta
English: Metformin Hydrochloride 500mg Tablet, Glibenclamide 5mg Tablet
Croatian: Metforminklorid 500 mg tableta, glibenklamid 5 mg tableta
English: Metformin Hydrochloride 2.5mg Tablet, Glibenclamide 500mg Tablet
Croatian: Metforminklorid 2,5 mg, glibenklamid 500 mg tableta
English: Metformin Hydrochloride 500mg Tablet, Glibenclamide 2.5mg Tablet
Croatian: Metforminklorid 500 mg tableta, glibenklamid 2,5 mg tableta
English: Metformina Mylan Generics Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Croatian: Metformine Hcl Mylan Metforminklorid 1000 mg tableta filmom obložena tableta
English: Germany Sandoz Pharmaceuticals Gmbh Metformin Sandoz
Croatian: Sandoz Pharmaceuticals Gmbh
English: Focus Pharmaceuticals Limited Metformin Focus Pharmaceuticals
Croatian: Metformin Focus Pharmaceuticals
English: Metformin Hcl Ratiopharm Metformin Hydrochloride 500mg Tablet
Croatian: Metformin Hcl Ratiopharm Metforminklorid 500 mg tableta filmom obložena tableta
English: Slovenia Wörwag Pharma Gmbh & Co. Kg Metfogamma
Croatian: Češka Republika Wörwag Pharma Gmbh & Co.
English: Metformine Arrow Generiques Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Croatian: Metformine Arrow Lab Metforminklorid 1000 mg tableta filmom obložena tableta
English: Metformin Hydrochloride 500mg Sachet Powder For Oral Solution In Sachet
Croatian: Metforminklorid 500 mg vrećica prašak za oralnu otopinu u vrećici
English: Metformin Hydrochloride 1000mg Tablet, Glibenclamide 5mg Tablet
Croatian: Metforminklorid 1000 mg tableta, glibenklamid 5 mg tableta
English: Metformin Hydrochloride 850mg Tablet, Canagliflozin 50mg Tablet
Croatian: Metforminklorid 850 mg tableta, kanagliflozin 50 mg tableta
English: Metformin Hydrochloride 850mg Sachet Powder For Oral Solution In Sachet
Croatian: Metforminklorid 850 mg vrećica prašak za oralnu otopinu
English: Metformina Mylan Generics Metformin Hydrochloride 850mg Tablet
Croatian: Metformine Hcl Mylan Metforminklorid 850 mg tableta filmom obložena tableta
English: Metformin-Ratiopharm Metformin Hydrochloride 850mg Tablet
Croatian: Metformin-Ratiopharm Metforminklorid 850 mg tableta filmom obložena tableta
English: Metformin Hydrochloride 1000mg Tablet, Canagliflozin 50mg Tablet
Croatian: Metforminklorid 1000 mg tableta, kanagliflozin 50 mg tableta
English: Metformin-Ratiopharm Metformin Hydrochloride 500mg Tablet
Croatian: Metformin-Ratiopharm Metforminklorid 500 mg tableta filmom obložena tableta
English: Metformin Hydrochloride 1000mg Tablet, Canagliflozin 150mg Tablet
Croatian: Metforminklorid 1000 mg tableta, kanagliflozin 150 mg tableta
English: Metformin Hcl Plus Pharmacie Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Croatian: Metformin 1 A Pharma Metforminklorid 1000 mg tableta filmom obložena tableta
English: Metformina Mylan Generics Metformin Hydrochloride 500mg Tablet
Croatian: Metformine Hcl Mylan Metforminklorid 500 mg tableta filmom obložena tableta
English: Metformin Ratiopharm Metformin Hydrochloride 850mg Tablet
Croatian: Metformin Ratiopharm Metforminklorid 850 mg tableta filmom obložena tableta
English: Metformin Ratiopharm Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Croatian: Metformin Ratiopharm Metforminklorid 1000 mg tableta filmom obložena tableta
English: Metformina Ratiopharm Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Croatian: Metformina Ratiopharm Metforminklorid 1000 mg tableta filmom obložena tableta
English: Metformine Ratiopharm Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Croatian: Metformine Ratiopharm Metforminklorid 1000 mg tableta filmom obložena tableta
English: Metformin Ratiopharm Metformin Hydrochloride 500mg Tablet
Croatian: Metformin Ratiopharm Metforminklorid 500 mg tableta filmom obložena tableta
English: Metformin Hydrochloride 850mg Tablet, Canagliflozin 150mg Tablet
Croatian: Metforminklorid 850 mg tableta, kanagliflozin 150 mg tableta
English: Metformina Ratiopharm Metformin Hydrochloride 850mg Tablet
Croatian: Metformina Ratiopharm Metforminklorid 850 mg tableta filmom obložena tableta
English: Kingdom
Croatian: Španjolska
English: Metformine Ratiopharm Metformin Hydrochloride 850mg Tablet
Croatian: Metformine Ratiopharm Metforminklorid 850 mg tableta filmom obložena tableta
English: Metformina Ratiopharm Metformin Hydrochloride 500mg Tablet
Croatian: Metformina Ratiopharm Metforminklorid 500 mg tableta filmom obložena tableta
English: (Invented) name Strength
Croatian: (Zaštićeno) ime Doza
English: The European Commission issued a decision on 22 August 2016.
Croatian: Europska komisija objavila je odluku 22. kolovoza 2016.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22 August 2016
Croatian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom22. kolovoza 2016.
English: The procedure was concluded and on 11 July 2014 the European Commission adopted a Decision1.
Croatian: Postupak je završen i 11. srpnja 2014.
English: Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/110)
Croatian: Ishod postupka upućivanja u skladu s člankom 35. Direktive 2001/82/EZ (EMEA/V/A/110)
English: What are lincomycin and spectinomycin?
Croatian: Što su linkomicin i spektinomicin?
English: Which data has the CVMP reviewed?
Croatian: Koje je podatke CVMP ocijenio?
English: The full changes made to the product information for powders for use in the drinking water are detailed in Annex III of the CVMP opinion on the 'All documents' tab.
Croatian: Cjelovite izmjene informacija o proizvodu za praškove za uporabu u vodi za piće detaljno su navedene u prilogu III. mišljenju CVMP-a u kartici „Svi dokumenti”.
English: The lincosamides are considered to be bacteriostatic agents.
Croatian: Linkozamidi se smatraju bakteriostatskim agensima.
English: Commission Decision concerning, in the framework of Article 34 of Directive 2001/82/EC of the European Parliament and of the Council, the marketing authorisations for “Linco-Spectin 100 and its associated names”, veterinary medicinal products which contain the active substances “Lincomycin and spectinomycin” ((2014)5053 of 11/07/2014) http://ec.europa.eu/health/documents/community-register/html/vo25233.htm
Croatian: Direktive 2001/82/EZ Europskog parlamenta i Vijeća o odobrenjima za stavljanje u promet proizvoda „Linco-Spectin 100 i povezane nazive”, veterinarsko-medicinskih proizvoda koji sadrže djelatne tvari „linkomicin i spektinomicin” ((2014)5053 od 11. srpnja 2014.) http://ec.europa.eu/health/documents/community-register/html/vo25233.htm
English: Subsequent to the outcome of the aforementioned Article 34 referral procedure for Linco-Spectin 100, Belgium considered that it is in the interest of the EU to promote effective and rational use of the lincomycin-spectinomycin combination in orally administered veterinary medicinal products, and thereby limit the risk of the development of resistance.
Croatian: Nakon ishoda prethodno navedenog postupka upućivanja u skladu s člankom 34. za Linco-Spectin 100, Belgija je smatrala da je u interesu EU-a promicati učinkovitu i racionalnu uporabu kombinacije linkomicina i spektinomicina u veterinarsko-medicinskim proizvodima koji se oralno primjenjuju te da na taj način ograničiti rizik od razvoja otpornosti.
English: Questions and answers on veterinary medicinal products containing a combination of lincomycin and spectinomycin to be administered orally to pigs and/or poultry EMA/462762/2016
Croatian: Pitanja i odgovori o veterinarsko-medicinskim proizvodima koji sadrže kombinaciju linkomicina i spektinomicina za oralnu primjenu u svinja i/ili peradi EMA/462762/2016
English: Why were veterinary medicinal products containing a combination of lincomycin and spectinomycin reviewed?
Croatian: Zašto su veterinarsko-medicinski proizvodi koji sadrže kombinaciju linkomicina i spektinomicina ponovno ocjenjivani?
English: In September 2012 Belgium initiated a referral procedure under Article 34 of Directive 2001/82/EC for Linco-Spectin 100, powder for use in the drinking water for pigs and chickens (EMEA/V/A/088).
Croatian: Belgija je pokrenula postupak upućivanja u skladu s člankom 34. Direktive 2001/82/EZ za Linco-Spectin 100, prašak za uporabu u vodi za piće za svinje i perad (EMEA/V/A/088).
English: Therefore, on 5 May 2015, Belgium initiated a procedure under Article 35 of Directive 2001/82/EC for veterinary medicinal products containing a combination of lincomycin and spectinomycin to be administered orally to pigs and/or poultry.
Croatian: Belgija je stoga 5. svibnja 2015. pokrenula postupak u skladu s člankom 35. Direktive 2001/82/EZ za veterinarsko-medicinske proizvode koji sadrže kombinaciju linkomicina i spektinomicina za oralnu primjenu u svinja i/ili peradi.
English: Proprietary data and scientific references on efficacy and residue depletion were provided by the marketing authorisation holders in this Article 35 referral procedure.
Croatian: Nositelji odobrenja za stavljanje u promet pružili su podatke proizvođača i znanstvena upućivanja o učinkovitosti i smanjenju rezidua u okviru postupka upućivanja iz članka 35.
English: No amendments to the currently approved withdrawal periods for pigs and chicken for the aforementioned powders for use in the drinking water were considered necessary.
Croatian: Zaključeno je da postojeća razdoblja karencije za svinje i piliće za prethodno navedene praškove za uporabu u vodi za piće nije potrebno mijenjati.
English: Lincomycin is a lincosamide antibiotic derived from Streptomyces lincolnensis which inhibits protein synthesis.
Croatian: Linkomicin je linkozamidni antibiotik koji se dobiva iz bakterije Streptomyces lincolensis, koji onemogućuje sintezu bjelančevina.
English: Lincomycin is active against gram-positive bacteria, some anaerobic gram-negative bacteria and Mycoplasma spp.
Croatian: Linkomicin je djelotvoran protiv gram-pozitivnih bakterija, nekih anaerobnih gram-negativnih bakterija i bakterije Mycoplasma spp.
English: The CVMP was requested to assess the available data and to review the indications, dosage regimens and withdrawal periods for pigs and poultry in order to ensure consumer safety, efficacious treatment in pigs, chickens and other poultry species, as well as a lower risk of the development of antimicrobial resistance to lincomycin and spectinomycin.
Croatian: Od CVMP-a je zatraženo da procijeni dostupne podatke i ponovno ocijeni indikacije, režime doziranja i razdoblja karencije za svinje i perad radi osiguravanja sigurnosti potrošača, djelotvorne terapijske primjene u svinja, pilića i drugih vrsta peradi te manjeg rizika od razvoja antimikrobne otpornosti na linkomicin i spektinomicin.
English: On 19 May 2016, the European Medicines Agency (the Agency) completed a review of the safety and effectiveness of, and antimicrobial resistance to, veterinary medicinal products containing a combination of lincomycin and spectinomycin to be administered orally to pigs and/or poultry.
Croatian: Europska agencija za lijekove (Agencija) dovršila je 19. svibnja 2016. ocjenjivanje sigurnosti i učinkovitosti veterinarsko-medicinskih proizvoda koji sadrže kombinaciju linkomicina i spektinomicina za oralnu primjenu u svinja i/ili peradi te antimikrobnu otpornost na te proizvode.
English: Questions and answers on veterinary medicinal products containing a combination of lincomycin and spectinomycin to be administered orally to pigs and/or poultry
Croatian: Pitanja i odgovori o veterinarsko-medicinskim proizvodima koji sadrže kombinaciju linkomicina i spektinomicina za oralnu primjenu u svinja i/ili peradi
English: For pigs and poultry three pharmaceutical forms for oral administration exist with a combination of lincomycin and spectinomycin - premixes for medicated feeding stuff, powders to be administered with the feed and powders for use in the drinking water.
Croatian: Postoje tri farmaceutska oblika oralne primjene kombinacije linkomicina i spektinomicina u svinja i peradi, a to su premiksi za hranu za životinje s dodatkom lijeka, prašci za primjenu s hranom za životinje i prašci za uporabu u vodi za piće.
English: The CVMP recommended that all marketing authorisations for premixes for medicated feeding stuff and powders to be administered with the feed containing a combination of lincomycin and spectinomycin be withdrawn throughout the European Union (EU).
Croatian: CVMP je preporučio povlačenje svih odobrenja za stavljanje u promet premiksa za hranu za životinje s dodatkom lijekova i praškova za primjenu s hranom koji sadrže kombinaciju linkomicina i spektinomicina na prostoru Europske unije (EU-a).