FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Epivir, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: Epivir is used in combination with other antiviral medicines to treat patients infected with human immunodeficiency virus (HIV), the virus that causes acquired immune deficiency syndrome (AIDS).
Slovenian: Zdravilo Epivir se uporablja v kombinaciji z drugimi protivirusnimi zdravili za zdravljenje bolnikov, ki so okuženi z virusom humane imunske pomanjkljivosti (HIV), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
English: The fifth study compared the effects of adding Epivir or placebo (a dummy treatment) to existing treatment for HIV infection in 1,895 adults who had been taking antiviral medicines for at least four weeks.
Slovenian: V peti študiji so primerjali učinke dodajanja zdravila Epivir ali placeba (zdravila brez zdravilne učinkovine) obstoječemu zdravljenju okužbe z virusom HIV pri 1 895 odraslih, ki so vsaj štiri tedne jemali protivirusna zdravila.
English: For the full list of all side effects and restrictions with Epivir, see the package leaflet.
Slovenian: Za celoten seznam vseh neželenih učinkov in omejitev pri uporabi zdravila Epivir glejte navodilo za uporabo.
English: It does not cure HIV infection or AIDS, but it can hold off damage to the immune system and avoid the development of infections and diseases associated with AIDS.
Slovenian: Zdravilo Epivir ne ozdravi okužbe z virusom HIV ali aidsa, vendar pa lahko upočasni slabšanje imunskega sistema ter razvoj okužb in bolezni, povezanih z aidsom.
English: What is the risk associated with Epivir?
Slovenian: Kakšna tveganja so povezana z zdravilom Epivir?
English: Four of these studies compared Epivir in combination with zidovudine (another antiviral medicine) to either Epivir or zidovudine alone, or to the combination of Epivir and zalcitabine (another antiviral medicine).
Slovenian: V štirih od teh študij so zdravilo Epivir v kombinaciji z zidovudinom (drugim protivirusnim zdravilom) primerjali bodisi samo z zdravilom Epivir ali samo z zidovudinom oziroma s kombinacijo zdravila Epivir in zalcitabina (drugega protivirusnega zdravila).
English: The oral solution can be used to achieve the appropriate dose.
Slovenian: Ustrezen odmerek se lahko doseže z uporabo peroralne raztopine.
English: In the first four studies in adults, Epivir, taken in combination with zidovudine, increased CD4 cell counts more than the comparator medicines after 24 weeks of treatment.
Slovenian: V prvih štirih študijah z odraslimi je po 24 tednih zdravljenja zdravilo Epivir, dajano v kombinaciji z zidovudinom, bolj povečalo število celic CD4 kot primerjalna zdravila.
English: Why has Epivir been approved?
Slovenian: Zakaj je bilo zdravilo Epivir odobreno?
English: The study compared the effects of Epivir taken with zidovudine to didanosine (another antiviral medicine) taken alone.
Slovenian: V študiji so učinke zdravila Epivir, uporabljenega v kombinaciji z zidovudinom, primerjali z didanozinom (drugim protivirusnim zdravilom), vzetim samostojno.
English: The active substance in Epivir, lamivudine, is a nucleoside reverse transcriptase inhibitor (NRTI).It works by blocking the activity of reverse transcriptase, an enzyme needed by HIV to produce the genetic instructions for making more viruses once it has infected the cell.
Slovenian: Deluje tako, da zavira delovanje reverzne transkriptaze, tj. encima, ki ga virus HIV potrebuje za izdelavo genskih navodil za tvorbo še več virusov, potem ko je okužil celico.
English: What is Epivir used for?
Slovenian: Za kaj se zdravilo Epivir uporablja?
English: How has Epivir been studied?
Slovenian: Kako je bilo zdravilo Epivir raziskano?
English: How is Epivir used?
Slovenian: Kako se zdravilo Epivir uporablja?
English: What is Epivir?
Slovenian: Kaj je zdravilo Epivir?
English: The dose of Epivir needs to be adjusted in patients who have severe kidney problems.
Slovenian: Pri bolnikih, ki imajo resne težave z ledvicami, je treba odmerek zdravila Epivir prilagoditi.
English: How does Epivir work?
Slovenian: Kako zdravilo Epivir deluje?
English: 30 HU**
Slovenian: 30 HE**
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Slovenian: Učinkovina biološkega izvora namenjena vzbujanju aktivne imunosti, ni vključena v Uredbo(ES) št. 470/2009.
English: Annual.
Slovenian: Letno.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of the first authorisation: 17/12/2010
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 17/12/2010
English: a) the administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Slovenian: a) bi uporaba ovirala izvajanje nacionalnega programa za diagnozo, nadzor ali zatiranje živalskih bolezni ali da bi povzročila težave pri zagotavljanju odsotnosti okuženosti pri živih živalih ali živilih ali drugih proizvodih, pridobljenih iz zdravljenih živali.
English: (**) Haemolytic units For the full list of excipients, see section 6.1.
Slovenian: (**) Hemolizne enote Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Slovenian: Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
English: The use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of Bluetongue.
Slovenian: Uporaba tega zdravila za uporabo v veterinarski medicini je dovoljena samo pod posebnimi pogoji, ki jih za nadzor nad boleznijo modrega jezika predpisuje zakonodaja Evropske skupnosti.
English: MERIAL Animal Health Limited Biological Laboratory, Ash Road, Pirbright, Woking, Surrey GU24 0NQ United Kingdom
Slovenian: MERIAL Animal Health Limited Biological Laboratory, Ash Road, Pirbright, Woking, Surrey GU24 0NQ Združeno Kraljestvo
English: - Second injection: after 3-4 weeks
Slovenian: - Drugi odmerek: po 3-4 tednih
English: The duration of immunity for cattle and sheep is 1 year after the primary vaccination course.
Slovenian: Trajanje imunosti pri ovcah in govedu je 1 leto po osnovnem cepljenju.
English: b) the disease to which the product is intended to confer immunity is largely absent from the territory in question.
Slovenian: b) bolezen, za katero se pridobi imunost, na območju skoraj ni prisotna.
English: Onset of immunity has been demonstrated 3 weeks after the primary vaccination course.
Slovenian: Imunost nastopi 3 tedne po osnovnem cepljenju.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary Very rare and transient apathy can be observed after the administration of a double-dose of the vaccine.
Slovenian: 4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Zelo redko se lahko po dajanju dvakratnega odmerka cepiva pojavi prehodna apatija.
English: Incompatibilities: Do not mix with any other veterinary medicinal product.
Slovenian: Inkompatibilnosti: Ne mešajte z drugimi zdravili za uporabo v veterinarski medicini.
English: Pharmacotherapeutic group: bluetongue virus vaccine, ATCvet code QI04AA02 (sheep) and QI02AA08 (cattle).
Slovenian: Farmakoterapevtska skupina: cepivo proti virusu bolezni modrikastega jezika; Oznaka ATC vet QI04AA02 (ovce) in QI02AA08 (govedo).
English: PHARMACEUTICAL FORM Homogeneous milky white suspension for injection.
Slovenian: FARMACEVTSKA OBLIKA Homogena mlečno bela suspenzija za injiciranje.
English: 50 doses (50 ml)
Slovenian: 50 odmerkov (50 ml)
English: No other adverse reactions except those mentioned in section ‘Adverse Reactions' were observed.
Slovenian: Drugi neželeni učinki, razen tistih, ki so navedeni v ‘Neželeni učinki', niso bili opaženi.
English: Date of the last renewal:
Slovenian: Datum zadnjega podaljšanja dovoljenja za promet:
English: TARGET SPECIES Sheep and cattle
Slovenian: CILJNE ŽIVALSKE VRSTE Ovce in govedo
English: In this category of animals the vaccine should be used only according to the benefit/risk assessment by the responsible veterinarian and/or national Competent Authorities on the current vaccination policies against Bluetongue Virus (BTV).
Slovenian: Pri tej kategoriji živali je potrebno cepivo uporabljati glede na presojo razmerja korist/tveganje odgovornega veterinarja oziroma v skladu z veljavnimi smernicami pristojnih nacionalnih organov glede cepljenja proti bolezni modrikastega jezika (BT).
English: • Revaccination
Slovenian: • Ponovno cepljenje
English: In very rare cases it has been observed a transient increase in body temperature, normally not exceeding an average of 1.1 °C, may occur within 24 hours after vaccination.
Slovenian: V zelo redkih primerih se lahko do 24 ur po cepljenju prehodno poviša telesna temperatura, ki navadno ne preseže 1,1 °C.
English: *(below the level of detection by the validated RT-PCR method at 3.68 log10 RNA copies/ml, indicating no infectious virus transmission)
Slovenian: *(pod stopnjo detekcije z validirano metodo RT-PCR pri 3,68 log10 RNA kopijah/ml, ni prenosa virusa)
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 10 doses (10 ml)
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV 10 odmerkov (10 ml)
English: Name and address of the manufacturer of the biological active substance
Slovenian: Ime in naslov izdelovalcev biološke zdravilne učinkovine
English: A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be decided on a case by case basis.
Slovenian: Zato se je za uporabo tega cepiva pred ali po uporabi katerega koli drugega zdravila potrebno odločiti od primera od primera.
English: Do not mix with any other veterinary medicinal product.
Slovenian: Ne mešajte z drugimi zdravili za uporabo v veterinarski medicini.
English: Can be used during pregnancy and lactation in cows
Slovenian: Lahko se uporablja v obdobju brejosti in laktacije pri kravah.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 1 ml contains:
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Vsak odmerek (1 ml) cepiva vsebuje:
English: Any person intending to manufacture, import, possess, sell, supply and/or use BTVPUR AlSap 1 must consult the relevant Member State's competent authority on the current vaccination policies prior to the manufacture, import, possession, sale, supply and/or use.
Slovenian: Vsakdo, ki namerava proizvajati, uvažati, posedovati, prodajati, oskrbovati in/ali uporabljati BTVPUR AlSap 1, se mora posvetovati s pristojnimi organi posamezne države članice o veljavnih programih cepljenja še pred proizvodnjo, uvozom, posedovanjem, prodajo, oskrbo in/ali uporabo.
English: PACKAGE SIZE 100 doses (100 ml)
Slovenian: VELIKOST PAKIRANJA 100 odmerkov (100 ml)
English: MARKETING AUTHORISATION NUMBER(S) EU/2/10/112/001
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/10/112/001
English: Once broached, use immediately
Slovenian: Po odprtju uporabite takoj.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Subcutaneous use
Slovenian: NAČIN IN POT(I) UPORABE Subkutana uporaba.
English: Silicon antifoam Phosphate buffer Glycine buffer
Slovenian: Silikon (proti penjenju) Fosfatni pufer Glicerinski pufer
English: NAME OF THE VETERINARY MEDICINAL PRODUCT BTVPUR AlSap 1 suspension for injection for sheep and cattle
Slovenian: IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI BTVPUR AlSap 1 suspenzija za injiciranje za ovce in govedo
English: The vaccine contains inactivated Bluetongue Virus Serotype 1 with aluminium hydroxide and saponin adjuvants.
Slovenian: Cepivo vsebuje inaktiviran virus bolezni modrikastega jezika, serotip 1, z aluminijevim hidroksidom in saponini kot dodatkoma.
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required.
Slovenian: SPC, tabela 1 (dovoljene snovi) priloge Uredbe Komisije (EU) št.37/2010 določa, da MRL ni potreben ali pa, kot so uporabljene v tem zdravilu za uporabo v veterinarski medicini, niso vključene v Uredbo(ES) št. 470/2009.
English: Administer one dose of 1 ml subcutaneously according to the following vaccination scheme:
Slovenian: Injicirajte 1 ml odmerek v podkožje po naslednjem razporedu:
English: Al3+ (as hydroxide)
Slovenian: (kot hidroksid)
English: Can be used during pregnancy in ewes.
Slovenian: Lahko se uporablja v obdobju brejosti pri ovcah.
English: In very rare cases it has been observed a small local swelling at the injection site (at most 32 cm² in cattle and 24 cm² in sheep) which becomes residual 35 days later (≤ 1 cm2).
Slovenian: V zelo redkih primerih se po cepljenju lahko na mestu dajanja pojavi prehodna manjša lokalizirana oteklina (največ 32 cm pri govedu in 24 cm pri ovcah), ki se občutno zmanjša v največ 35 dneh
English: PACKAGE LEAFLET FOR: BTVPUR AlSap 1 suspension for injection for sheep and cattle
Slovenian: NAVODILO ZA UPORABO BTVPUR AlSap 1 suspenzija za injiciranje za ovce in govedo
English: Veterinary medicinal product subject to prescription.
Slovenian: Zdravilo za uporabo v veterinarski medicini na veterinarski recept.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALCI BIOLOŠKE ZDRAVILNE UČINKOVINE IN IMETNIKI DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVORNI ZA SPROŠČANJE SERIJE
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each dose of 1 ml contains Bluetongue Virus
Slovenian: NAVEDBA ZDRAVILNE(IH) UČINKOVIN(E) IN DRUGIH SNOVI Vsak odmerek (1 ml) cepiva vsebuje virus modrega jezika:
English: The manufacture, import, possession, sale, supply and/or use of BTVPUR AlSap 1 may be prohibited in a certain Member State on the whole or part of their territory pursuant to national legislation.
Slovenian: Proizvodnja, uvoz, posedovanje, prodaja, oskrba in/ali uporaba BTVPUR AlSap 1 je lahko prepovedana v določeni državi članici na njihovem celotnem ozemlju ali delu ozemlja v skladu z nacionalno zakonodajo.
English: Special precautions for use in animals: Vaccinate healthy animals only.
Slovenian: Posebni previdnostni ukrepi za uporabo pri živalih Cepite le zdrave živali.
English: The manufacture, import, possession sale, supply and/or use of BTVPUR AlSap 1 may be prohibited in a Member State on the whole or part of their territory pursuant to national legislation.
Slovenian: Proizvodnja, uvoz, posedovanje, prodaja, oskrba in/ali uporaba BTVPUR AlSap 1 je lahko prepovedana vdržavi članici na njihovem celotnem ozemlju ali delu ozemlja v skladu z nacionalno zakonodajo.
English: Shelf life after first opening the immediate packaging: immediately Do not use this veterinary medicinal product after the expiry date which is stated on the carton after EXP:
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini, po EXP.
English: Active immunisation of sheep and cattle to prevent viraemia* and to reduce clinical signs caused by Bluetongue Virus Serotype 1.
Slovenian: Aktivna imunizacija ovc in goveda proti virusu bolezni modrikastega jezika, serotip 1, za preprečitev viremije* in zmanjšanje kliničnih znakov.
English: 1 bottle of 10 doses (1x 10 ml) 1 bottle of 50 doses (1 x 50 ml) 10 bottles of 50 doses (10 x 50 ml) 1 bottle of 100 doses (1 x 100 ml) 10 bottles of 100 doses (10 x 100 ml)
Slovenian: 1 steklenička z 10 odmerki (1 x 10 ml) 1 plastenka s 50 odmerki (1 x 50 ml) 10 plastenk s 50 odmerki (10 x 50 ml) 1 plastenka s 100 odmerki (1 x 100 ml) 10 plastenka s 100 odmerki (10 x 100 ml)
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) Inactivated BTV 1 ...................................................................................................... ≥ 1.9 log10 pixels
Slovenian: KOLIČINA ZDRAVILNE(IH) UČINKOVIN(E) Inaktiviran BTV 1, inaktiviran ............................................................................... ≥ 1,9 log10 pikslov
English: Type I glass bottle of 10 ml with butyl elastomere closure Box of 1 bottle of 10 doses (1 x 10 ml)
Slovenian: 10 ml steklenička (steklo tipa I) z butil elastomerno zaporko Škatla z 1 stekleničko z 10 odmerki (1 x 10 ml).
English: The frequency of adverse reactions is defined using the following convention: - Very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment).
Slovenian: Pogostost neželenih učinkov je določena po naslednjem dogovoru: - Zelo pogosti (pojavijo se pri več kot 1 živali od 10 živali) - Pogosti (pojavijo se pri 1 od 10 živali od 100 živali) - Občasni (pojavijo se pri 1 od 10 živali od 1.000 živali) - Redki (pojavijo se pri 1 od 10 živali od 10.000 živali) - Zelo redki (pojavijo se pri manj kot 1 živali od 10.000 živali, vključujoč posamezne primere).
English: Inactivated BTV1 ..................................................................................................... ≥ 1.9 log10 pixels* Aluminium hydroxide, Saponin, qs 1 dose (*) (*) see package leaflet
Slovenian: Inaktiviran BTV 1, inaktiviran ............................................................................. ≥ 1,9 log10 pikslov* Aluminijev hidroksid, Saponin q.s.
English: In sheep - First injection: from 1 month of age in naive animals (or from 2.5 months of age in young animals born to immune sheep).
Slovenian: Ovce - Prvi odmerek: od 1 meseca starosti pri predhodno necepljenih živalih (ali od 2,5 meseca starosti pri mladičih imunih ovc).
English: In cattle - First injection: from 1 month of age in naive animals (or from 2.5 months of age in young animals born to immune cattle).
Slovenian: Govedo - Prvi odmerek: od 1 meseca starosti pri predhodno necepljenih živalih (ali od 2,5 meseca starosti pri mladičih imunih krav).
English: It induces an active and specific immunity against bluetongue virus serotype 1 in the vaccinated animal.
Slovenian: Pri cepljeni živali sproži nastanek aktivne in specifične imunosti proti virusu bolezni modrikastega jezika, serotip 1.
English: Polypropylene bottle of 50 or 100 ml with butyl elastomere closure Box of 1 bottle of 100 doses (1 x 100 ml) Box of 10 bottles of 100 doses (10 x 100 ml)
Slovenian: 50 ali 100 ml polipropilenska plastenka z butil elastomerno zaporko Škatla z 1 plastenko s 100 odmerki (1 x 100 ml).
English: It induces an active and specific immunity against Bluetongue Virus Serotype 1 in the vaccinated animal.
Slovenian: Pri cepljeni živali povzroči nastanek aktivne in specifične imunosti proti virusu bolezni modrikastega jezika, serotip 1.
English: EXPIRY DATE EXP {month/year} Once broached, use immediately.
Slovenian: Rok uporabnosti po prvem odpiranju stične ovojnine: uporabite takoj.
English: None
Slovenian: Al
English: Box of 1 bottle of 50 doses (1 x 50 ml) Box of 10 bottles of 50 doses (10 x 50 ml)
Slovenian: Škatla z 1 plastenko s 50 odmerki (1 x 50 ml).
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Each dose of 1 ml contains:
Slovenian: Vsak odmerek (1 ml) cepiva vsebuje:
English: Shelf life of the veterinary medicinal product as package for sale (100 ml bottle): 2 years Shelf life of the veterinary medicinal product as package for sale (50 ml bottle): 2 years Shelf life of the veterinary medicinal product as package for sale (10 ml bottle): 18 months Shelf life after first opening the immediate packaging: use immediately
Slovenian: Rok uporabnosti zdravila v pakiranju za prodajo (10 ml steklenička): 18 mesecev.
English: Active substances:
Slovenian: Seznam pomožnih snovi
English: Inactivated Bluetongue Virus Serotype 1 ................................................................. ≥ 1.9 log10 pixels* (*) Antigen content (VP2 protein) by immuno-assay Adjuvants: .
Slovenian: Virus bolezni modrikastega jezika, serotip 1, inaktiviran ................................... ≥ 1,9 log10 pikslov*
English: Not all pack sizes may be marketed Box of 1 bottle of 10 doses (1 x 10 ml) Box of 1 bottle of 50 doses (1 x 50 ml) Box of 10 bottles of 50 doses (10 x 50 ml) Box of 1 bottle of 100 doses (1 x 100 ml) Box of 10 bottles of 100 doses (10 x 100 ml)
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla z 1 stekleničko z 10 ml Škatla z 1 plastenko s 50 ml Škatla z 10 plastenkami s 50 ml Škatla z 1 plastenko s 100 ml Škatla z 10 plastenkami s 100 ml
English: Box of 10 bottles of 50 ml,
Slovenian: Plastenka z 10 in 50 ml
English: Inactivated BTV 1 ....................................................................................................... ≥ 1.9 log10 pixels
Slovenian: BTV 1, inaktiviran ................................................................................................. ≥ 1,9 log10 pikslov
English: Box of 1 bottle of 100 ml,
Slovenian: Škatla z 1 stekleničko z 10 odmerki (1 x 10 ml).
English: The other studies took place in the USA and Japan respectively.
Slovenian: Drugi študiji sta potekali v ZDA oziroma na Japonskem.
English: Treatment is repeated after one week, but the ears should not be cleaned for the second dose.
Slovenian: Zdravljenje se ponovi po enem tednu, vendar se ušes pri drugem odmerjanju ne sme očistiti.
English: They often lead to the ear(s) being inflamed (red, swollen and sore) or painful.
Slovenian: Pogosto povzročijo vnetje ušesa (ušes) (rdečico, otekanje in rano) ali bolečino.
English: Other information about Osurnia:
Slovenian: Druge informacije o zdravilu Osurnia:
English: What benefit has Osurnia shown during the studies?
Slovenian: Kakšne koristi je zdravilo Osurnia izkazalo med študijami?
English: The main measure of effectiveness in the EU and Japanese studies was the reduction in severity of otitis externa 28 days after initial treatment; in the US study clinical success was measured after 45 days.
Slovenian: Glavno merilo za učinkovitost v študijah v EU in na Japonskem je bilo zmanjšanje resnosti vnetja zunanjega ušesa 28 dni po prvotnem zdravljenju; v študiji v ZDA so klinično uspešnost merili po 45 dneh.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Osurnia on 31 July 2014.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Osurnia, veljavno po vsej Evropski uniji, izdala 31/07/2014.
English: Florfenicol is an antibiotic which works by blocking protein formation in bacterial cells.
Slovenian: Florfenikol je antibiotik, ki deluje tako, da zavira tvorbo beljakovin v bakterijskih celicah.
English: The inside of the ear should be cleaned and dry before treatment.
Slovenian: Pred zdravljenjem je treba notranjost ušesa očistiti in posušiti.
English: Terbinafine kills fungi by blocking the formation of ergosterol, an important part of fungal cell walls.
Slovenian: Terbinafin ubije glivice, tako da zavira tvorbo ergosterola, pomembne sestavine glivične celične stene.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Osurnia exceed the risks for the approved indications and recommended that Osurnia be given a marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Osurnia večje od z njim povezanih tveganj za odobrene indikacije, in priporočil, da se zanj izda dovoljenje za promet.
English: What is the risk associated with Osurnia?
Slovenian: Kakšna tveganja so povezana z zdravilom Osurnia?