FrancophonIA/ELRC3.0 huggingface dataset:
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.
Estonian: Polüpropüleenpudel nitriilelastomeersulguriga, kinnitatud alumiiniumkorgiga Pakendi suurused: - Pappkarbis 1 pudel 10, 25, 50, 100 või 150 doosiga; - Pappkarbis 10 pudelit 10, 25, 50, 100 või 150 doosiga.
English: Liquid paraffin ............................................................................................................................. 537 mg.
Estonian: Vedel parafiin ……………………………………………………………………………………537 mg
English: Cattle, sheep and pigs.
Estonian: Veis, lammas ja siga.
English: Pharmaceutical group: inactivated viral vaccine, foot-and-mouth disease virus.
Estonian: Farmakoterapeutiline rühm: Inaktiveeritud viirusvastased vaktsiinid - suu- ja sõrataudi viirus ATCvet kood: QI02AA04
English: Inactivated FMD antigen, ≥ 6 cattle PD50 per strain.
Estonian: Inaktiveeritud FMD antigeen, ≥ 6 veise PD50 tüve kohta
English: Trometamol
Estonian: RAVIMVORM
English: Swellings (diameter of up to 12 cm in ruminants and 4 cm in pigs) occurred very commonly in most animals after administration of a dose of vaccine.
Estonian: Pärast vaktsiinidoosi manustamist tekkis enamikul loomadest väga sageli süstekohas paistetus (mäletsejalistel diameetriga kuni 12 cm ja sigadel kuni 4 cm).
English: one dose of 2 ml, by intramuscular route.
Estonian: 1 doos 2 ml, intramuskulaarselt Soovituslik on kasutada mitmekordseks süstimiseks mõeldud seadet.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.
Estonian: Ärge kasutage seda ravimit pärast kõlblikkusaega, mis on märgitud sildil EXP. Kõlblikkusaeg pärast pakendi esmast avamist: kasutada koheselt.
English: Cattle, sheep, and pigs
Estonian: Veis, lammas ja siga
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottle of 50, 100 and 150 doses
Estonian: MINIMAALSED ANDMED, MIS PEAVAD OLEMA VÄIKESEL VAHETUL SISEPAKENDIL Pudel 50, 100 ja 150 doosi
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
Estonian: Pappkarbis 1 pudel 10, 25, 50, 100 või 150 doosiga.
English: PACKAGE LEAFLET: AFTOVAXPUR DOE emulsion for injection for cattle, sheep and pigs
Estonian: PAKENDI INFOLEHT AFTOVAXPUR DOE süsteemulsioon veistele, lammastele ja sigadele
English: AFTOVAXPUR DOE emulsion for injection for cattle, sheep and pigs
Estonian: AFTOVAXPUR DOE süsteemulsioon veistele, lammastele ja sigadele
English: rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Estonian: - väga sage (kõrvaltoime(d) ilmnes(id) rohkem kui 1-l loomal 10-st ravitud loomast) - sage (rohkem kui 1-l, kuid vähem kui 10-l loomal 100-st ravitud loomast) - aeg-ajalt (rohkem kui 1-l, kuid vähem kui 10-l loomal 1000-st ravitud loomast) - harv (rohkem kui 1-l, kuid vähem kui 10-l loomal 10,000-st ravitud loomast) - väga harv (vähem kui 1-l loomal 10,000-st ravitud loomast, kaasaarvatud üksikjuhud).
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.
Estonian: Kahekordse doosi manustamisel vasikatele, talledele ja põrsastele ei täheldatud muid kõrvaltoimeid kui need, mis on ära toodud punktis 4.6.
English: DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION
Estonian: ANNUSTAMINE LOOMALIIGITI, MANUSTAMISVIIS(ID) JA -MEETOD
English: Sheep from 2 weeks of age:
Estonian: Lammas alates 2 nädala vanusest: 1 doos 2 ml, subkutaanselt Siga alates 2 nädala vanusest:
English: Paraffin, liquid
Estonian: KK/AAAA
English: (*) equivalent to titre prior to inactivation (log 10)
Estonian: (*) vastab tiitrile enne aktiveerimist (log 10)
English: Strength
Estonian: B
English: Pharmaceutical Form
Estonian: Ravimvorm Loomaliigid Manustamisviis Pakendi iseloomustus
English: Packaging
Estonian: C
English: Invented Name
Estonian: Nimetus Toimeaine kogus
English: Annex I List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, marketing authorisation holder(s) in the member states
Estonian: Ravimi nimede, ravimvormide ja tugevuste nimekiri, manustamisteed ja müügiloa hoidjad liikmesriikides
English: Coated tablet
Estonian: Kaetud tablet
English: Teva Pharma B.V. Computerweg 10
Estonian: Computerweg 10
English: Poland ratiopharm GmbH Graf-Arco-Strasse 3 Ulm, 89079
Estonian: Poola ratiopharm GmbH Graf-Arco-Strasse 3 Ulm, 89079
English: Controlled release tablet Oral use
Estonian: Kontrollitud vabanemisega tablett
English: Modified-release filmcoated tablet tablet
Estonian: Toimeainet modifitseeritult vabastav õhukese polümeerikattega tablett Suukaudne
English: Hungary ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany
Estonian: Ungari ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany
English: Slovak Republic ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany
Estonian: Slovakkia ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany
English: Bulgaria ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany
Estonian: Bulgaaria ratiopharm GmbH Graf-Arco-Strasse 3 89079 Ulm Germany
English: Prolonged release tablet
Estonian: Toimeainet prolongeeritult vabastav õhukese polümeerikattega tablett
English: Oral drops
Estonian: Suukaudsed tilgad
English: Linseed
Estonian: Linaseeme
English: 1 February 2016 EMA/492394/2015 Corr. 1
Estonian: oktoober 2015 EMA/828135/2015
English: These include bulging of the belly.
Estonian: Nende hulka kuulub kõhu paisumine.
English: Linseed should only be used in adults and adolescent aged over 12 years.
Estonian: Linaseemet tohivad kasutada ainult täiskasvanud ja üle 12-aastased noored.
English: What is linseed?
Estonian: Mis on linaseeme?
English: Very rarely, allergic reactions, sometimes severe, have been reported.
Estonian: Väga harva on teatatud allergilistest reaktsioonidest, mis võiad olla rasked.
English: Other information about linseed medicines
Estonian: Muu teave linaseemet sisaldava ravimi kohta
English: This effect may reduce gastrointestinal discomfort.
Estonian: See toime võib vähendada ebamugavustunnet seedetraktis.
English: Common side effects (seen between 1 and 10 patients in 100) have been reported with linseed.
Estonian: Linaseemne kasutamisel on teatatud sagedatest kõrvalnähtudest (esinenud 1-10 patsiendil 100st).
English: It is likely that linseed mucilage coats the lining of the digestive tract and thus protects it from irritation.
Estonian: Tõenäoliselt katab linaseemnest tekkinud taimeliim seedetrakti limaskesta ja kaitseb seda ärrituse eest.
English: The studies demonstrated that linseed reduced habitual constipation.
Estonian: Uuringud tõendasid, et linaseeme vähendab harjumuslikku kõhukinnisust.
English: Linseed must not be used in patients who have difficulty swallowing or have any throat problems.
Estonian: Linaseemet ei tohi kasutada patsiendid, kellel on neelamisraskusi või kurguprobleeme.
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.
Estonian: Lisateave linaseemet sisaldava ravimiga kaasnevate riskide, sh selle ohutu kasutamise ettevaatusabinõude kohta, on ravimtaime monograafias Euroopa Ravimiameti veebilehe jaotises „All documents”: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: What evidence supports the use of linseed medicines?
Estonian: Millised tõendid toetavad linaseemet sisaldava ravimi kasutamist?
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.
Estonian: Kuigi on olemas varane kliiniline uuring linaseemne kasutamise kohta seedetrakti ebamugavustunde raviks, on see tõendina kasutamiseks liiga piiratud ning taimsete ravimite komitee järeldused selle näidustuse kohta tuginevad ravimi pikaajalisele kasutusele.
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.
Estonian: Lisateave linaseemet sisaldava ravimi hinnangu kohta, sh komitee kokkuvõtte detailne kirjeldus, on Euroopa Ravimiameti veebilehe jaotises „All documents”: 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.
Estonian: See aitab väljaheidet pehmendada ja seda soolest kergemini väljutada.
English: Linseed can also be found in combination with other herbal substances in some herbal medicines.
Estonian: Mõnes taimses ravimis esineb linaseemet ka kombinatsioonis teiste taimsete ainetega.
English: In its assessment, the HMPC considered a number of clinical studies showing linseed's effect on constipation and hard stool.
Estonian: Hindamisel vaatas taimsete ravimite komitee läbi mitu kliinilist uuringut, mis tõendavad linaseemne toimet kõhukinnisuse ja kõva väljaheite suhtes.
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.
Estonian: Kõhukinnisuse raviks ei tohi linaseemet kasutada patsiendid, kelle sooletegevus muutub järsku ja muudatus püsib üle 2 nädala, kellel esineb diagnoosimata veritsus pärakust või kui kõhukinnisus püsib ka lahtisti kasutamise korral.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing linseed.
Estonian: ELi liikmesriigid võtavad taimsete ravimite komitee järeldusi arvesse, kui nad hindavad linaseemet sisaldavate taimsete ravimite müügilubade taotlusi.
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.
Estonian: Linaseemet sisaldava ravimi müügiloa taotlus tuleb esitada riiklikule ravimiametile, mis hindab taimse ravimi müügiloa taotlust, võttes arvesse taimsete ravimite komitee teaduslike järelduste kokkuvõtet.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of linseed.
Estonian: See on taimsete ravimite komitee teaduslike järelduste kokkuvõte, mis käsitleb linaseemne meditsiinilisi kasutusviise.
English: What are the risks associated with linseed medicines?
Estonian: Mis riskid kaasnevad linaseemet sisaldava ravimiga?
English: How are linseed medicines approved in the EU?
Estonian: Kuidas antakse Euroopa Liidus linaseemet sisaldavale ravimile müügiluba?
English: Linseed swells with water in the gut to form a thick jelly-like substance (mucilage).
Estonian: Linaseeme paisub sooles oleva vee toimel ja tekib paks sültjas aine (taimeliim).
English: This summary is not intended to provide practical advice on how to use medicines containing linseed.
Estonian: Kokkuvõttes ei anta linaseemet sisaldava ravimi kasutamise kohta praktilisi nõuandeid.
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.
Estonian: Taimsete ravimite komitee järeldused linaseemet sisaldavate ravimite kasutamise kohta seedetrakti kerge ebamugavustunde leevendamiseks põhinevad nende traditsioonilisel kasutamisel selle seisundi korral.
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).
Estonian: Samuti ei tohi seda kasutada patsiendid, kellel on soolel ebanormaalne ahend või ummistus, soolehalvatus, jämesoole ebanormaalne laienemine või söögitoru haigused.
English: For more information about treatment with linseed medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Estonian: Kui vajate lisateavet linaseemet sisaldava ravimi kasutamise kohta, lugege palun pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: How does linseed work as a medicine?
Estonian: Kuidas linaseeme ravimina toimib?
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.
Estonian: Kui vajate linaseemet sisaldava ravimi kasutamise kohta praktilisi nõuandeid, lugege ravimi pakendi infolehte või pöörduge oma arsti või apteekri poole.
English: Information on the use and licensing of linseed medicines in EU Member States should be obtained from the relevant national authorities.
Estonian: ELi liikmesriikides saab teavet linaseemet sisaldava ravimi kasutamise ja müügiloa kohta riiklikult ravimiametilt.
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.
Estonian: Lisaks järeldas taimsete ravimite komitee, et pikaajalise kasutamiskogemuse alusel tohib linaseemet kasutada seedetrakti (mao ja soole) kerge ebamugavustunde korral.
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.
Estonian: See tähendab, et linaseemet sisaldavate ravimite sellel näidustusel kasutamise efektiivsuse ja ohutuse kohta on Euroopa Liidus avaldatud teaduskirjandusandmeid vähemalt 10 aastat.
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.
Estonian: Linaseemet sisaldavate ravimite võtmise ja näidustuse üksikasjalik teave on ravimi pakendi infolehel.
English: Herbal medicines containing linseed, also known as Lini semen, are to be taken by mouth.
Estonian: Linaseemet (Lini semen) sisaldavaid taimseid ravimeid manustatakse suu kaudu.
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.
Estonian: Taimsete ravimite komitee järeldas, et linaseemet tohib kasutada hariliku kõhukinnisuse raviks või kui väljaheidet on vaja sooletegevuse lihtsustamiseks pehmendada.
English: Also, the swelling effect of linseed widens the gut and this stretching effect speeds up passage of the stool through the gut.
Estonian: Ka linaseemne paisumine laiendab soolt, mis kiirendab väljaheite väljutamist.
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.
Estonian: Linaseeme on taime Linum usitatissimum L. seemnete üldnimetus.
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.
Estonian: Kui kõhukinnisus ei kao 3 päeva pärast linaseemne võtmist või kui kerge ebamugavustunne seedetraktis ei kao 7 päeva pärast linaseemne võtmist, tuleb pöörduda arsti või pädeva tervishoiutöötaja poole.
English: The HMPC conclusions on the use of linseed for treating constipation are based on ‘well-established use'.
Estonian: Taimsete ravimite komitee järeldused linaseemet sisaldavate ravimite kasutamise kohta kõhukinnisuse raviks põhinevad nende traditsioonilisel kasutamisel.
English: Zona Industrial da Abrunheira Edifício 10 - Sintra Business Park 2710-089 Sintra Portugal
Estonian: Zona Industrial da Abrunheira Edifício 10 - Sintra Business Park 2710-089 Sintra
English: Baxter MédicoFarmacêutica, Lda.
Estonian: Baxter Médico-Farmacêutica, Lda.
English: Czech Republic BAXTER CZECH spol.
Estonian: BAXTER CZECH spol.
English: Pouet de Camilo, 2 46394 Ribarroja del Turia (Valencia) Spain
Estonian: 46394 Ribarroja del Turia (Valencia)
English: United Kingdom Baxter Healthcare Limited
Estonian: Ühendkuningriik Baxter Healthcare Limited Caxton Way
English: Belgium BAXTER S.A. Bd. René Branquart 80 7860 Lessines
Estonian: Bd. René Branquart 80 7860 Lessines Belgium
English: Baxter Deutschland GmbH
Estonian: Baxter Deutschland GmbH Edisonstr.
English: Poligono Industrial Sector 14
Estonian: Poligono Industrial Sector 14 Pouet de Camilo, 2
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
Estonian: Lisa I Ravimi(te) nimetuste, ravimvormi(de), tugevus(t)e, manustamisviisi(de), müügiloa hoidja(te) loetelu liikmesriikides
English: 00144 ROMA Italy
Estonian: Piazzale dell' Industria, 20 00144 ROMA
English: Numeta G 16 % E Emulsion zur Infusio
Estonian: Numeta G 16 % E Emulsion zur Infusion
English: MUMETA G16%E, emulsión para perfusión
Estonian: NUMETA G16%E, emulsión para perfusión
English: Caxton Way, Thetford Norfolk IP24 3SE
Estonian: Norfolk IP24 3SE
English: MUMETA G13%E, emulsión para perfusión
Estonian: NUMETA G13%E, emulsión para perfusión
English: Baxter Healthcare GmbH
Estonian: Baxter Healthcare Limited Caxton Way
English: NUMETA (G16)
Estonian: NUMETZAH G16%E
English: 16 May 2013
Estonian: 16. mai 2013
English: The application was submitted to Germany as reference Member State and Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, France, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain and the United Kingdom as concerned Member States.
Estonian: Müügiloa taotlus esitati viiteliikmesriik Saksamaale ning asjaomastele liikmesriikidele Austriale, Belgiale, Bulgaariale, Eestile, Hispaaniale, Iirimaale, Itaaliale, Kreekale, Küprosele, Leedule, Luksemburgile, Lätile, Madalmaadele, Maltale, Poolale, Portugalile, Prantsusmaale, Rumeeniale, Slovakkiale, Sloveeniale, Taanile, Tšehhi Vabariigile, Ungarile ja Ühendkuningriigile.
English: The decentralised procedure (DE/V/0122/002/DC) started on 12 November 2010.
Estonian: Detsentraliseeritud menetlus (DE/V/0122/002/DC) algas 12. novembril 2010.
English: The reconsidered opinion was converted into a Decision by the European Commission on 16 May 2013.
Estonian: Lõplik arvamus vormistati Euroopa Komisjoni otsusena 16. mail 2013.
English: Therefore the CVMP recommended the refusal of the granting of the marketing authorisations and the suspension of the existing marketing authorisations.
Estonian: Seetõttu soovitas veterinaarravimite komitee keelduda müügiloa andmisest ja peatada juba olemasolevad müügiload.
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.
Estonian: 27. septembril 2012 toimus veterinaarravimite alalise komitee plenaaristung ja 3. oktoobril 2012 saatis Euroopa Komisjon veterinaarravimite komiteele kirja, milles nõudis, et komitee vaataks oma 13. Juuni 2012. aasta arvamuse veel kord üle.
English: The reconsideration procedure started on 10 October 2012.
Estonian: Arvamuse ülevaatamise menetlus algas 10. oktoobril 2012.
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.
Estonian: 7. veebruaril 2013 võttis veterinaarravimite komitee vastu ülevaadatud arvamuse ja järeldas, et taotlus ei ole vastavuses direktiivi 2001/82/EÜ artikli 13 kriteeriumidega, mistõttu taotlus ei vasta efektiivsuse osas müügiloa andmise kriteeriumidele.
English: Potential serious risks were identified during the decentralised procedure by Denmark regarding the cumulative failure rate observed in the pivotal clinical field trial and potential for development of antimicrobial resistance to florfenicol.
Estonian: Detsentraliseeritud menetluse ajal teatas Taani võimalikest tõsistest riskidest, mis olid seotud ravi ebaõnnestumise kumulatiivse määraga põhilises kliinilises väliuuringus ja võimaliku antimikroobse resistentsuse kujunemisega florfenikooli suhtes.
English: This was a ‘hybrid application' according to Article 13(3) Directive 2001/82/EC, as amended, referring to the reference product, Nuflor Swine 300 mg/ml solution for injection (FR/V/0118/001).
Estonian: See oli muudetud direktiivi 2001/82/EÜ artikli 13 lõike 3 kohane hübriidtaotlus, milles viidati võrdlusravimile Nuflor Swine 300 mg/ml süstelahusele (FR/V/0118/001).
English: The Committee appointed Prof. Christian Friis as rapporteur and Dr Cornelia Ibrahim as co-rapporteur.
Estonian: Veterinaarravimite komitee määras hindajaks professor Christian Friisi ja kaashindajaks dr Cornelia Ibrahimi.
English: On 31 August 2012, the Netherlands submitted an objection to the opinion adopted by CVMP on 13 June 2012 during the written phase of the Standing Committee procedure.
Estonian: 31. augustil 2012 esitasid Madalmaad alalise komitee kirjaliku menetluse etapis vastulause veterinaarravimite komitee 13. juuni 2012 arvamusele.
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.
Estonian: Teaduslikud järeldused on II lisas müügilubade peatamise lõpetamise tingimused III lisas.
English: The Committee re-appointed Prof Christian Friis as rapporteur and Dr Cornelia Ibrahim as co-rapporteur for the reconsideration procedure.
Estonian: Veterinaarravimite komitee määras arvamuse ülevaatamise menetluse hindajaks professor Christian Friisi ja kaashindajaks dr Cornelia Ibrahimi.
English: The referral procedure started on 10 January 2012.
Estonian: Esildismenetlust alustati 10. jaanuaril 2012.
English: On 19 December 2011, the reference Member State, Germany, notified to the European Medicines Agency that the CMD(v) had failed to reach an agreement regarding the product and referred the matter to the CVMP pursuant to Article 33(4) of Directive 2001/82/EC.
Estonian: 19. detsembril 2011 teatas viiteliikmesriik Saksamaa Euroopa Ravimiametile, et veterinaarravimite vastastikuse tunnustamise ja detsentraliseeritud menetluste kooskõlastusrühm ei jõudnud ravimi suhtes kokkuleppele ning suunas direktiivi 2001/82/EÜ artikli 33 lõike 4 alusel küsimuse edasi veterinaarravimite komiteele.
English: The proposed dose is 30 mg florfenicol per kg bodyweight given by intramuscular administration as a single injection.
Estonian: Florfenikooli soovitatav annus on 30 mg florfenikooli kg kehamassi kohta, mis manustatakse ühekordse intramuskulaarse süstina.
English: Day 60 of the CMD(v) procedure was on 15 December 2011, and since the Member States concerned failed to reach an agreement regarding the product the procedure was referred to the CVMP.
Estonian: Veterinaarravimite vastastikuse tunnustamise ja detsentraliseeritud menetluste kooskõlastusrühma menetluse 60. päev oli 15. detsembril 2011 ning et asjaomased liikmesriigid ei jõudnud ravimi suhtes kokkuleppele, suunati menetlus edasi veterinaarravimite komiteele.
English: Oral explanations were given by the applicant on 10 January 2013.
Estonian: Müügiloa taotleja esitas suulised selgitused 10. jaanuaril 2013.