FrancophonIA/ELRC3.0 huggingface dataset:
English: Emulsion for injection.
Slovenian: FARMACEVTSKA OBLIKA Emulzija za injiciranje.
English: Active immunisation of cattle, sheep and pigs from 2 weeks of age against foot-and-mouth disease to reduce clinical signs.
Slovenian: Aktivna imunizacija goveda, ovc in prašičev od 2 tednov starosti proti bolezni slinavke in parkljavke za zmanjšanje kliničnih znakov.
English: Pack sizes: - Cardboard box with 1 bottle of 10, 25, 50, 100 or 150 doses; - Cardboard box with 10 bottles of 10, 25, 50, 100 or 150 doses.
Slovenian: Velikosti pakiranj: - Kartonska škatla s stekleničko po 10, 25, 50, 100 ali 150 odmerkov; - Kartonska škatla z 10 stekleničkami po 10, 25, 50, 100 ali 150 odmerkov.
English: Vaccination of sheep with strain O1 Manisa resulted in a reduction of clinical signs in animals exposed to infection.
Slovenian: Cepljenje ovc s sevom O1 Manisa zmanjša pojavnost kliničnih znakov pri živalih, izpostavljenih okužbi.
English: Vaccination of pigs with strain Asia1 Shamir resulted in a reduction of clinical signs and virus shedding in animals exposed to infection.
Slovenian: Cepljenje prašičev s sevom Asia1 Shamir zmanjša pojavnost kliničnih znakov in izločanje virusa pri živalih, izpostavljenih okužbi.
English: one dose of 2 ml, by intramuscular route.
Slovenian: en odmerek po 2 ml, intramuskularno Priporočljiva je uporaba multiplega injektorja.
English: To stimulate active immunity of cattle, sheep and pigs against purified, inactivated foot-and-mouth disease virus strain antigens related to those contained in the vaccine.
Slovenian: Za stimulacijo aktivne imunosti proti prečiščenim, inaktiviranim antigenom sevov virusa slinavke in parkljevke pri govedu, ovcah in prašičih (sorodnim antigenom z antigeni v cepivu).
English: Sheep from 2 weeks of age:
Slovenian: Ovce od 2tednov starosti dalje:
English: Cattle and sheep: SC.
Slovenian: NAČIN IN POT(I) UPORABE Govedo in ovce: SC
English: This is best achieved by inverting the vial several times base over apex.
Slovenian: Najboljša homogenizacija je dosežena z večkratnim obračanjem stekleničke.
English: Cattle, sheep: SC. Pigs: IM.
Slovenian: POT(I) UPORABE ZDRAVILA Govedo, ovce: SC Prašiči: IM
English: Liquid paraffin ............................................................................................................................. 537 mg.
Slovenian: Dodatek: Tekoči parafin ............................................................................................................................... 537 mg
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottle of 50, 100 and 150 doses
Slovenian: PODATKI NA ZUNANJI OVOJNINI Steklenička s 50, 100 ali 150 odmerkov
English: PACKAGE LEAFLET: AFTOVAXPUR DOE emulsion for injection for cattle, sheep and pigs
Slovenian: NAVODILO ZA UPORABO: AFTOVAXPUR DOE emulzija za injiciranje za govedo, ovce in prašiče
English: Cardboard box with 1 bottle of 10, 25, 50, 100 or 150 doses Cardboard box with 10 bottles of 10, 25, 50, 100 or 150 doses
Slovenian: Kartonska škatla z 10 stekleničkami po 10, 25, 50, 100 ali 150 odmerkov.
English: Cattle and sheep: for subcutaneous use.
Slovenian: NAČIN IN POT(I) UPORABE Govedo in ovce: subkutano.
English: Special warnings for each target species:
Slovenian: Posebna opozorila za vsako ciljno živalsko vrsto: Cepite le zdrave živali.
English: Inactivated FMD antigen, ≥ 6 cattle PD50 per strain.
Slovenian: NAVEDBA UČINKOVIN(E) IN DRUGIH SNOVI Inaktivirani antigeni FMD, ≥6 ZO50 za govedo na sev
English: EXP {month/year} Once broached use immediately.
Slovenian: Po prvem odprtju stične ovojnine uporabite takoj.
English: Purified, inactivated foot-and-mouth disease virus strain antigens, at least 6 PD50* per strain.
Slovenian: Prečiščeni, inaktivirani antigeni virusa slinavke in parkljevke, vsaj 6 ZO50 * na sev *ZO50 - 50% zaščitnega odmerka pri govedu, pri govedu, kot določa Ph. Eur monografija 0063.
English: Paraffin, liquid
Slovenian: Z uporabo PrioCHECK
English: AFTOVAXPUR DOE emulsion for injection for cattle, sheep and pigs
Slovenian: Emulzija za injiciranje za govedo, ovce in prašiče
English: No adverse reactions except those mentioned in section “adverse reactions” were observed after the administration of a double dose to calves, lambs and piglets.
Slovenian: Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno): Po dajanju dvakratnega odmerka pri teletih, jagnjetih in pujskih niso bili opisani nobeni drugi neželeni učinki, razen omenjenih v poglavju Neželeni učinki.
English: Cattle, sheep and pigs
Slovenian: CILJNE ŽIVALSKE VRSTE Govedo, ovce in prašiči
English: No adverse reactions except those mentioned in section 4.6 were observed after the administration of a double dose to calves, lambs and piglets.
Slovenian: Po dajanju dvakratnega odmerka pri teletih, jagnjetih in pujskih niso bili opisani nobeni drugi neželeni učinki, razen omenjenih v poglavju 4.6.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Bottle of 10 or 25 doses
Slovenian: Steklenička z 10 ali 25 odmerki
English: (*) equivalent to titre prior to inactivation (log 10)
Slovenian: (*) enakovredno titru pred inaktivacijo (log 10)
English: PRO.MED.CS PRAHA a.s. Telčská 1
Slovenian: PRO.MED.CS PRAHA a.s.
English: S.C. TERAPIA S.A. Str. Fabricii nr. 124 Cluj Napoca România
Slovenian: Str. Fabricii nr. 124 Cluj Napoca România
English: TRIMETAZIDIN VIM SPECTRUM 20 mg, capsule 20 mg
Slovenian: TRIMETAZIDIN VIM SPECTRUM 20 mg, capsule 20 mg kapsula
English: DILATAN 20 mg, comprimate filmate, 20 mg 20mg
Slovenian: DILATAN 20 mg, comprimate filmate, 20 mg
English: PREDUCTAL MR 35 mg filmsko oblozene tablete s prirejenim sproscanjem
Slovenian: PREDUCTAL MR 35 mg filmsko oblozene tablete s prirejenim sproscanjem filmsko obložena tableta s prirejenim sproščanjem
English: Vastarel 35 mgFilmtabletten mit veränderter Wirkstofffreisetzung
Slovenian: Vastarel 35 mgFilmtabletten mit veränderter Wirkstofffreisetzung filmsko obložena tableta s prirejenim sproščanjem peroralna uporaba
English: TRIMETAZIDIN SERVIER 35 mg filmsko obložene tablete s prirejenim sproščanjem
Slovenian: TRIMETAZIDIN SERVIER 35 mg filmsko obložene tablete s prirejenim sproščanjem filmsko obložena tableta s prirejenim sproščanjem peroralna uporaba
English: Marketing authorisation holder
Slovenian: Imetnik dovoljenja za promet z zdravilom Ime zdravila
English: Trimetazidina Bluepharma 20 mg Comprimidos
Slovenian: Trimetazidina Bluepharma 20 mg Comprimidos obložena tableta
English: Teva Pharma B.V. Computerweg 10
Slovenian: Computerweg 10
English: 20 mg/ml
Slovenian: 20 mg/ml kapljice
English: Trimetazidina Jaba 20 mg Comprimidos revestidos
Slovenian: Trimetazidina Jaba 20 mg Comprimidos revestidos obložena tableta
English: TRIMETAZIDINA 20 mg, drajeuri
Slovenian: TRIMETAZIDINA 20 mg, drajeuri obložena tableta
English: Poland ratiopharm GmbH Graf-Arco-Strasse 3 Ulm, 89079
Slovenian: Poljska ratiopharm GmbH Graf-Arco-Strasse 3 Ulm, 89079
English: Trimetazidina Baldacci 20 mg Comprimidos
Slovenian: Trimetazidina Baldacci 20 mg Comprimidos obložena tableta
English: Trimetazidina Generis 20 mg Comprimidos Revestidos 20 mg
Slovenian: Trimetazidina Generis 20 mg Comprimidos Revestidos 20 mg obložena tableta
English: Coated tablets
Slovenian: Predozone obložena tableta
English: TRIMETAZIDINE ZYDUS 20 mg/ml
Slovenian: TRIMETAZIDINE ZYDUS 20 mg/ml peroralna raztopina
English: TRIMETAZIDINE SANDOZ 20 mg/ml
Slovenian: TRIMETAZIDINE SANDOZ 20 mg/ml peroralna raztopina
English: Controlled release tablet Oral use
Slovenian: filmsko obložena tableta s prirejenim sproščanjem peroralna uporaba
English: TRIMETAZIDINE WINTHROP 20 mg/ml
Slovenian: TRIMETAZIDINE WINTHROP 20 mg/ml peroralna raztopina
English: TRIMETAZIDINE BIOGARAN 20 mg/ml
Slovenian: TRIMETAZIDINE BIOGARAN 20 mg/ml peroralna raztopina
English: Hungary ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany
Slovenian: Madžarska ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany
English: Bulgaria ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany
Slovenian: Bolgarija ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany
English: Prolonged-release filmcoated tablet
Slovenian: Trimetazidine filmsko obložena tableta s podaljšanim sproščanjem
English: Trimetazidina Mepha 20 mg Comprimidos Revestidos 20 mg
Slovenian: Trimetazidina Mepha 20 mg Comprimidos Revestidos obložena tableta
English: Slovak Republic ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany
Slovenian: Slovaška ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany
English: Trimetazidina Labesfal 20 mg Comprimidos Revestidos 20 mg
Slovenian: Trimetazidina Labesfal 20 mg Comprimidos Revestidos obložena tableta
English: TRIMETAZIDINE MYLAN 20 mg/ml
Slovenian: TRIMETAZIDINE MYLAN 20 mg/ml peroralna raztopina
English: Modified-release film coated tablet
Slovenian: filmsko obložena tableta s prirejenim sproščanjem
English: TRIMETAZIDINE IGEN 20 mg/ml
Slovenian: TRIMETAZIDINE IGEN 20 mg/ml peroralne kapljice, raztopina
English: Very rarely, allergic reactions, sometimes severe, have been reported.
Slovenian: Zelo redko so poročali o alergičnih reakcijah, včasih tudi hudih.
English: 1 February 2016 EMA/492394/2015 Corr. 1
Slovenian: oktober 2015 EMA/828149/2015
English: Linseed should only be used in adults and adolescent aged over 12 years.
Slovenian: Seme navadnega lana se lahko uporablja samo pri odraslih in mladostnikih, starejših od 12 let.
English: This means that there are bibliographic data providing scientific evidence of linseed's effectiveness and safety when used in this way, covering a period of at least 10 years in the EU.
Slovenian: To pomeni, da obstajajo podatki iz literature z znanstvenimi dokazi o njegovi učinkovitosti in varnosti pri uporabi na navedeni način, ki zajemajo obdobje vsaj 10 let v EU.
English: This effect may reduce gastrointestinal discomfort.
Slovenian: Ta učinek lahko zmanjša nelagodje v prebavilih.
English: This summary is not intended to provide practical advice on how to use medicines containing linseed.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o uporabi zdravil, ki vsebujejo seme navadnega lana.
English: These include bulging of the belly.
Slovenian: Mednje sodi napihnjen trebuh.
English: Although an early clinical study on linseed for the treatment of gastrointestinal discomfort is available, it was too limited to be used them as evidence and the HMPC's conclusions for this indication are based on the medicines' long-standing use.
Slovenian: Čeprav je na voljo zgodnja klinična študija o semenu navadnega lana za zdravljenje nelagodja v prebavilih, je ta nezadostna, da bi se lahko uporabila kot dokaz učinkovitosti, zato zaključki odbora HMPC za to indikacijo temeljijo na dolgotrajni uporabi teh zdravil.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of linseed.
Slovenian: To je povzetek znanstvenih zaključkov Odbora za zdravila rastlinskega izvora (HMPC) v zvezi z medicinsko uporabo semena navadnega lana.
English: Linseed must not be used in patients who have difficulty swallowing or have any throat problems.
Slovenian: Seme navadnega lana se ne sme uporabljati pri bolnikih, ki imajo težave s požiranjem ali kakršne koli težave z grlom.
English: Linseed is the common name for the seeds of the plant Linum usitatissimum L. The dried, ripe seeds for medicinal use are obtained from plants that have been cultivated.
Slovenian: Seme navadnega lana je splošno ime za seme rastline Linum usitatissimum L. Posušena, zrela semena se za medicinsko uporabo pridobivajo iz rastlin, ki so bile gojene.
English: Further information on the risks associated with linseed medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Slovenian: Dodatne informacije o tveganjih, povezanih z zdravili, ki vsebujejo seme navadnega lana, vključno z ustreznimi previdnostnimi ukrepi za njihovo varno uporabo, so na voljo v monografiji na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: This helps to make the stool softer and pass through the gut more easily.
Slovenian: To prispeva k temu, da je blato mehkejše in se lažje izloči skozi črevo.
English: Linseed can also be found in combination with other herbal substances in some herbal medicines.
Slovenian: Seme navadnega lana je v nekaterih zdravilih rastlinskega izvora lahko na voljo tudi v kombinaciji z drugimi rastlinskimi snovmi.
English: Information on the use and licensing of linseed medicines in EU Member States should be obtained from the relevant national authorities.
Slovenian: Za informacije o uporabi in dovoljenjih za promet z zdravili, ki vsebujejo seme navadnega lana, v državah članicah EU se obrnite na pristojni nacionalni organ.
English: It should also not be used in patients with abnormal constriction or blockage of the digestive tract, paralysis in the gut, or abnormal widening of the large intestine, or with diseases of the oesophagus (the tube between mouth and stomach).
Slovenian: Prav tako se ne sme uporabljati pri bolnikih z nenormalnim zoženjem ali zaporo prebavil, paralizo črevesja, nenormalno razširitvijo debelega črevesa ali z boleznimi požiralnika (cevi, ki povezuje usta z želodcem).
English: How does linseed work as a medicine?
Slovenian: Kako seme navadnega lana deluje kot zdravilo?
English: In its assessment, the HMPC considered a number of clinical studies showing linseed's effect on constipation and hard stool.
Slovenian: V svoji oceni je odbor HMPC upošteval več kliničnih študij, ki so pokazale učinek semena navadnega lana na zaprtost in trdo blato.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing linseed.
Slovenian: Ugotovitve odbora HMPC države članice EU upoštevajo pri ocenjevanju vlog za izdajo dovoljenja za promet z zdravili rastlinskega izvora, ki vsebujejo seme navadnega lana.
English: Any applications for the licensing of medicines containing linseed have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Slovenian: Vlogo za izdajo dovoljenja za promet z zdravili, ki vsebujejo seme navadnega lana, je treba predložiti pristojnemu nacionalnemu organu za zdravila, ki bo to vlogo za izdajo dovoljenja za promet z zdravilom rastlinskega izvora ocenil in upošteval znanstvene zaključke odbora HMPC.
English: Common side effects (seen between 1 and 10 patients in 100) have been reported with linseed.
Slovenian: Pri uporabi semena navadnega lana so poročali o pogostih neželenih učinkih (opaženih pri 1 do 10 bolnikih od 100).
English: How are linseed medicines approved in the EU?
Slovenian: Kako so zdravila, ki vsebujejo seme navadnega lana, odobrena v EU?
English: What evidence supports the use of linseed medicines?
Slovenian: Kateri dokazi podpirajo uporabo zdravil, ki vsebujejo seme navadnega lana?
English: Further information on the HMPC assessment of linseed medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Slovenian: Dodatne informacije o oceni zdravil, ki vsebujejo seme navadnega lana, ki jo je opravil odbor HMPC, vključno z njegovimi znanstvenimi zaključki, so na voljo na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: For treating constipation, linseed must not be used in patients with a sudden change in bowel habit that persists for more than 2 weeks, or undiagnosed bleeding from the anus, or if constipation is not relieved despite the use of a laxative.
Slovenian: Seme navadnega lana se ne sme uporabljati za zdravljenje zaprtosti pri bolnikih z nenadnimi spremembami pri odvajanju blata, ki trajajo več kot dva tedna, pri bolnikih z nediagnosticiranimi krvavitvami iz anusa (zadnjika) ali v primeru, da se zaprtost kljub uporabi odvajala ne izboljša.
English: Other information about linseed medicines
Slovenian: Druge informacije o zdravilih, ki vsebujejo seme navadnega lana
English: The HMPC conclusions on the use of linseed for treating constipation are based on ‘well-established use'.
Slovenian: Zaključki odbora HMPC o uporabi semena navadnega lana za zdravljenje zaprtosti temeljijo na „dobro uveljavljeni medicinski uporabi“.
English: The HMPC concluded that linseed can be used to treat habitual constipation or in conditions requiring the stool to be softer so it can pass more easily.
Slovenian: Odbor HMPC je zaključil, da se seme navadnega lana lahko uporablja za zdravljenje habitualne (ponavljajoče) zaprtosti ali v primerih, ko je potrebno, da je blato mehkejše in se tako lažje izloči.
English: The HMPC conclusions on the use of linseed medicines for the relief of mild gastrointestinal discomfort are based on their ‘traditional use' in this condition.
Slovenian: Zaključki odbora HMPC v zvezi z uporabo zdravil, ki vsebujejo seme navadnega lana, za zdravljenje blagega nelagodja v prebavilih temeljijo na njihovi „tradicionalni uporabi“ pri tem stanju.
English: Detailed instructions on how to take linseed medicines and who can use them can be found in the package leaflet that comes with the medicine.
Slovenian: Podrobna navodila o jemanju zdravil, ki vsebujejo seme navadnega lana, in o tem, kdo sme ta zdravila jemati, so v navodilu za uporabo, ki je priloženo posameznemu zdravilu.
English: The studies demonstrated that linseed reduced habitual constipation.
Slovenian: Študije so dokazale, da seme navadnega lana zmanjšuje habitualno (ponavljajočo) zaprtost.
English: What are the risks associated with linseed medicines?
Slovenian: Kakšna tveganja so povezana z zdravili, ki vsebujejo seme navadnega lana?
English: It is likely that linseed mucilage coats the lining of the digestive tract and thus protects it from irritation.
Slovenian: Verjetno je, da sluz semena navadnega lana tvori sloj, ki prekrije sluznico prebavil in jih tako ščiti pred draženjem.
English: For practical information about using linseed medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o njihovi uporabi naj bolniki preberejo navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujejo z zdravnikom ali farmacevtom.
English: For more information about treatment with linseed medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravili, ki vsebujejo seme navadnega lana, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujte z zdravnikom ali farmacevtom.
English: Linseed swells with water in the gut to form a thick jelly-like substance (mucilage).
Slovenian: Seme navadnega lana nabrekne z vodo v črevesju in tvori gosto, želatini podobno snov (sluz).
English: The HMPC also concluded that, on the basis of its long-standing use, linseed can be used to relieve mild gastrointestinal (stomach and gut) discomfort.
Slovenian: Na podlagi njegove dobro uveljavljene uporabe je odbor HMPC prav tako zaključil, da se seme navadnega lana lahko uporablja za zmanjšanje blagega nelagodja v prebavilih (želodcu in črevesju).
English: Also, the swelling effect of linseed widens the gut and this stretching effect speeds up passage of the stool through the gut.
Slovenian: Zaradi nabrekanja seme navadnega lana prav tako povzroči raztezanje črevesa, ta učinek pa pospeši izločanje blata skozenj.
English: What is linseed?
Slovenian: Kaj je seme navadnega lana?
English: Herbal medicines containing linseed, also known as Lini semen, are to be taken by mouth.
Slovenian: Zdravila rastlinskega izvora, ki vsebujejo seme navadnega lana, se jemljejo peroralno (uživajo skozi usta).
English: Linseed
Slovenian: Seme navadnega lana
English: Advice should be taken from a doctor or a qualified healthcare professional if constipation persists after 3 days of using linseed or if mild gastrointestinal discomfort persists after 7 days of using linseed.
Slovenian: Če se po uporabi semena navadnega lana zaprtost ne izboljša v treh dneh, blago nelagodje v prebavilih pa ne po sedmih dneh, se je treba posvetovati z zdravnikom ali usposobljenim zdravstvenim delavcem.
English: Czech Republic BAXTER CZECH spol.
Slovenian: Češka Republika BAXTER CZECH spol.
English: Zona Industrial da Abrunheira Edifício 10 - Sintra Business Park 2710-089 Sintra Portugal
Slovenian: Zona Industrial da Abrunheira Edifício 10 - Sintra Business Park 2710-089 Sintra
English: Baxter MédicoFarmacêutica, Lda.
Slovenian: Baxter Médico-Farmacêutica, Lda.
English: Pouet de Camilo, 2 46394 Ribarroja del Turia (Valencia) Spain
Slovenian: 46394 Ribarroja del Turia (Valencia) Spain
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, marketing authorisation holders in the member states for Numeta G13%E and Numeta G16%E emulsions for infusion
Slovenian: Priloga I Seznam imen, farmacevtskih oblik, jakosti zdravila, poti uporabe zdravila, imetnikov dovoljenja za promet z zdravilom v državah članicah
English: Belgium BAXTER S.A. Bd. René Branquart 80 7860 Lessines
Slovenian: Bd. René Branquart 80 7860 Lessines Belgium
English: Baxter Deutschland GmbH
Slovenian: Baxter Deutschland GmbH Edisonstr.
English: Poligono Industrial Sector 14
Slovenian: Poligono Industrial Sector 14 Pouet de Camilo, 2
English: 00144 ROMA Italy
Slovenian: Piazzale dell' Industria, 20 00144 ROMA
English: Numeta G 16 % E Emulsion zur Infusio
Slovenian: Numeta G 16 % E Emulsion zur Infusion
English: MUMETA G16%E, emulsión para perfusión
Slovenian: NUMETA G16%E, emulsión para perfusión
English: MUMETA G13%E, emulsión para perfusión
Slovenian: NUMETA G13%E, emulsión para perfusión
English: 16 May 2013
Slovenian: 16. maj 2013
English: The decentralised procedure (DE/V/0122/002/DC) started on 12 November 2010.
Slovenian: Decentralizirani postopek (DE/V/0122/002/DC) se je začel 12. novembra 2010.
English: The reconsidered opinion was converted into a Decision by the European Commission on 16 May 2013.
Slovenian: Novo mnenje je bilo spremenjeno v Odločbo Evropske komisije z dne 16. maja 2013.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the condition to lift the suspension of the marketing authorisation in Annex III.
Slovenian: Seznam zadevnih imen zdravila je v Prilogi I. Znanstveni zaključki so podani v Prilogi II, skupaj s pogoj za preklic začasnega umika dovoljenj za promet z zdravilom v Prilogi III.
English: On 27 September 2012 a plenary meeting of the Standing Committee on Veterinary Medicinal Products took place and on 3 October 2012 the European Commission sent a letter to the CVMP requesting a reconsideration of the opinion adopted on 13 June 2012.
Slovenian: 27. septembra 2012 je potekalo plenarno zasedanje Stalnega odbora za zdravila za uporabo v veterinarski medicini, 3. oktobra 2012 pa je Evropska komisija v dopisu pozvala CVMP, naj ponovno preuči mnenje, ki ga je sprejel dne 13. junija 2012.
English: Therefore the CVMP recommended the refusal of the granting of the marketing authorisations and the suspension of the existing marketing authorisations.
Slovenian: Zato je CVMP priporočil zavrnitev vloge za pridobitev dovoljenja za promet z zdravilom in začasen umik obstoječih dovoljenj.
English: On 7 February 2013 the CVMP adopted a reconsidered opinion, concluding that the application does not comply with Article 13 of Directive 2001/82/EC, and consequently does not satisfy the criteria for authorisation in respect of efficacy.
Slovenian: CVMP je 7. februarja 2013 sprejel novo mnenje, v katerem je zaključil, da vloga ni v skladu s členom 13 Direktive 2001/82/ES in posledično ne izpolnjuje meril za odobritev na podlagi učinkovitosti.