FrancophonIA/ELRC3.0 huggingface dataset:
English: Very common (may affect more than 1 in 10 people): - nausea - pain in your muscles, joints or bones (musculoskeletal pain) - low white blood cell counts (including neutrophils and lymphocytes which may increase the
Slovenian: Zelo pogosti (lahko se pojavijo pri 1 bolniku od 10): - slabost (navzea);
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Slovenian: Povzetek podatkov o preživetju - populacija za zdravljenje
English: Alcobendas
Slovenian: Dojenje
English: Unopened vial 2 years.
Slovenian: 2 leti.
English: Add a sufficient quantity of sodium chloride 9 mg/mL (0.9 %) solution for injection to the container to make the total volume 250 mL.
Slovenian: V vsebnik dodajte zadostno količino 9 mg/ml (0,9 %) raztopine natrijevega klorida za injiciranje, da bo končna prostornina spet dosegla 250 ml. Vsebnik nežno obračajte, da se vsebina ustrezno premeša.
English: Toxicity in the elderly
Slovenian: Ženske v rodni dobi/kontracepcija pri ženskah
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING VIAL LABEL - 50 mL vial
Slovenian: NALEPKA VIALE - 50-mililitrska viala
English: Clinical efficacy and safety
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA
English: NAME OF THE MEDICINAL PRODUCT Lartruvo 10 mg/mL sterile concentrate olaratumab
Slovenian: Lartruvo 10 mg/ml sterilen koncentrat olaratumab
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING VIAL LABEL - 19 mL vial
Slovenian: NALEPKA VIALE - 19-mililitrska viala
English: Do not administer the solution if you notice any particulate matter or discoloration.
Slovenian: Če opazite delce ali obarvanje, raztopine ne uporabite.
English: Tell your doctor or nurse immediately if you feel unwell during infusion.
Slovenian: Če se med infuzijo slabo počutite, se o tem takoj posvetujte z zdravnikom ali medicinsko sestro.
English: Olaratumab is a human monoclonal antibody.
Slovenian: − Zdravilna učinkovina je olaratumab.
English: - Keep this leaflet.
Slovenian: Ne pretresajte.
English: Pack of 1 vial of 19 mL.
Slovenian: Pakiranje z 1 vialo z 19 ml. Pakiranje z 2 vialama z 19 ml. Pakiranje z 1 vialo s 50 ml.
English: Gastrointestinal disorders
Slovenian: PODATKI NA STIČNI OVOJNINI
English: Your doctor will check your platelet count prior to treatment with Lartruvo.
Slovenian: Pred zdravljenjem z zdravilom Lartruvo bo zdravnik pri vas preveril število trombocitov.
English: These resolved within a maximum of 25 days.
Slovenian: Trajale so do največ 25 dni.
English: ATCvet code: QI02AA.
Slovenian: Oznaka ATC vet: QI02AA.
English: The type of strain included in the final product will be adapted to the current epidemiological situation at the time of formulation of the final product and will be shown on the label.
Slovenian: Vrsta seva, vključenega v končnem zdravilu bo prilagojena trenutni epidemiološki situaciji v času formulacije končnega zdravila in bo prikazan na ovojnini.
English: Avoid multiple broaching.
Slovenian: Izogibajte se večkratnemu prebadanju viale.
English: If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Slovenian: Če opazite kakršne koli resne stranske učinke, tudi tiste, ki niso navedeni v tem navodilu za uporabo ali mislite, da zdravilo ni delovalo, obvestite svojega veterinarja.
English: Local reactions may increase slightly following the second dose, in this case lasting up to 15 days.
Slovenian: Po drugem odmerku se lahko rahlo poviša število lokalnih reakcij, ki v tem primeru trajajo do 15 dni.
English: The level of efficacy for other species may differ from that observed in sheep and cattle.
Slovenian: Stopnja učinkovitosti pri drugih vrstah se lahko razlikuje od tiste pri ovcah in govedu.
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 or considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Slovenian: SPC, so bodisi dovoljene snovi, za katere tabela 1 priloge Uredbe Komisije (EU) št.37/2010 določa, da MRL ni potreben, ali pa ne spadajo v področje uporabe Uredbe (ES) št. 470/2009, kadar so uporabljene tako kot v tem zdravilu za uporabo v veterinarski medicini.
English: Date of first authorisation: 25/04/2017.
Slovenian: Datum pridobitve dovoljenja za promet: 25.04.2017.
English: The target species will also be shown on the label.
Slovenian: Ciljni živalski vrsti bosta prikazani tudi na ovojnini.
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - 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).
Slovenian: Pogostost neželenih učinkov je določena po naslednjem dogovoru: - zelo pogosti (neželeni učinki se pokažejo pri več kot 1 od 10 zdravljenih živali) - pogosti (pri več kot 1 toda manj kot 10 živali od 100 zdravljenih živali) - občasni (pri več kot 1 toda manj kot 10 živali od 1.000 zdravljenih živali) - redki (pri več kot 1 toda manj kot 10 živali od 10.000 zdravljenih živali) - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri).
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 cepiva je dovoljena le pod posebnimi pogoji zakonodaje EU o kontroli bolezni modrikastega jezika.
English: There is evidence of BTV-1 seroneutralising antibodies indicative of protection for up to 21 months after primary vaccination.
Slovenian: Obstajajo dokazi o BTV-1 seroneutralizacijskih protitelesih, ki kažejo na zaščito do 21 mesecev po osnovnem cepljenju.
English: Any person intending to manufacture, import, possess, sell, supply and use this veterinary medicinal product must first consult the relevant Member State's competent authority on the current vaccination policies, as these activities may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Slovenian: Vsakdo, ki namerava izdelovati, uvažati oziroma vnašati, posedovati, prodajati, oskrbovati in/ali uporabljati to zdravilo, se mora najprej posvetovati s pristojnim organom posamezne države članice o veljavnih programih cepljenja, saj so lahko te dejavnosti prepovedane v državi članici na njenem celotnem ozemlju ali delu ozemlja v skladu z nacionalno zakonodajo.
English: Full stability data for three batches of monovalent BTV-4 vaccine within 39 months of the granting of the Marketing Authorisation shall be provided.
Slovenian: Celosta stabilnostna študija za tri serije monovalentnega cepiva BTV-4 mora biti zagotovljena v 39 mesecih po izdaji dovoljenja za promet z zdravilom.
English: Subcutaneous use (sheep) or intramuscular use (cattle).
Slovenian: Subkutana uporaba (ovce) ali intramuskularna uporaba (govedo).
English: If used in other domestic and wild ruminant species that are considered at risk of infection, its use in these species should be undertaken with care and it is advisable to test the vaccine on a small number of animals prior to mass vaccination.
Slovenian: Če ga uporabljamo pri drugih domačih in divjih vrstah prežvekovalcev, ki se smatrajo kot tvegane za okužbo, naj bo njegova uporaba pri teh vrstah previdna in priporočljivo je testiranje cepiva na manjšem številu živali pred masovnim cepljenjem.
English: Off-white or pink liquid.
Slovenian: Belkasta ali roza obarvana tekočina.
English: Pharmacotherapeutic group: Immunologicals for Bovidae, inactivated viral vaccines for cattle.
Slovenian: Farmakoterapevtska skupina: Imunološka zdravila za votloroge (Bovidae), inaktivirana virusna cepiva za govedo.
English: Primary vaccination
Slovenian: Osnovno cepljenje
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 uporabite cepivo le v skladu z oceno razmerja korist/tveganje odgovornega veterinarja in/ali v skladu s trenutnimi smernicami pristojnih državnih organov za cepljenje proti virusu bolezni modrikastega jezika (BTV).
English: Potassium dihydrogen phosphate Disodium phosphate dihydrate Sodium chloride
Slovenian: Kalijev dihidrogenfosfat Dinatrijev fosfat dihidrat Natrijev klorid
English: **Relative potency by a mice potency test compared to a reference vaccine efficacious in sheep.
Slovenian: ** Relativna potenca pri testu potence pri miših v primerjavi z učinkovitim referenčnim cepivom pri ovcah.
English: Zoetis Manufacturing & Research Spain, S.L.
Slovenian: Proizvajalec, odgovoren za sproščanje serij: Zoetis Manufacturing & Research Spain, S.L.
English: *Relative potency by a mice potency test compared to a reference vaccine efficacious in sheep and cattle.
Slovenian: * Relativna potenca pri testu potence pri miših v primerjavi z učinkovitim referenčnim cepivom pri ovcah in govedu.
English: A transient increase in rectal temperature, not exceeding 1.6 °C, may very commonly occur during the 48 hours following vaccination.
Slovenian: Prehodno povišanje rektalne temperature, ki ne presega 1,6 °C se lahko zelo pogosto pojavi v 48 urah po cepljenju.
English: To stimulate active immunity of sheep and cattle against bluetongue virus serotype(s) related to those contained in the vaccine.
Slovenian: Za stimulacijo aktivne imunosti ovac in goveda proti serotipu(om) virusa bolezni modrikastega jezika, povezanega(ih) s tistimi, ki jih vsebuje cepivo.
English: In order to avoid accidental contamination of the vaccine during use, it is recommended to use a multi injection type vaccination system when larger dose presentations are used.
Slovenian: Da bi se izognili naključni kontaminaciji cepiva med uporabo, je pri uporabi večjih pakiranjih priporočljivo uporabljati sistem multiinjekcijskega cepljenja.
English: 20 ml (10 doses)
Slovenian: 20 ml (10 odmerkov)
English: Al3+ (as hydroxide)
Slovenian: (Al3+) ( kot aluminijev hidroksid)
English: Detailed information on this veterinary medicinal product is available on the website of the European
Slovenian: Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) (http://www.ema.europa.eu/).
English: A local reaction at the injection site may occur very commonly after vaccination.
Slovenian: Zelo pogosto se lahko po cepljenju na mestu injiciranja pojavi lokalna reakcija.
English: Method of administration (sheep and cattle)
Slovenian: Način dajanja (ovce in govedo)
English: Overdose (symptoms, emergency procedures, antidotes):
Slovenian: Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi): Ovce:
English: Interaction with other medicinal products and other forms of interaction: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Slovenian: 4.8 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Ni podatkov o varnosti ter učinkovitosti ob uporabi tega cepiva s katerim koli drugim zdravilom za uporabo v veterinarski medicini.
English: SC (sheep) / IM (cattle)
Slovenian: s.c. (ovce) / i.m.
English: OTHER INFORMATION Pack sizes:
Slovenian: DRUGE INFORMACIJE Pakiranja:
English: It can be used during lactation in cattle.
Slovenian: Lahko se uporablja v obdobju laktacije pri govedu.
English: Each dose of 2 ml of vaccine contains:
Slovenian: Vsak odmerek (2 ml) vsebuje:
English: The safety of the vaccine has not been established during lactation in sheep.
Slovenian: Varnost zdravila v obdobju laktacije ni bila ugotovljena pri ovcah.
English: Camprodon s/n "la Riba" 17813 Vall de Bianya Girona
Slovenian: 17813 Vall de Bianya
English: Zero days.
Slovenian: dni).
English: Quil-A (Quillaja saponaria saponin extract)
Slovenian: Qil-A (Quillaja saponaria izvleček saponina)
English: Pregnancy: Can be used during pregnancy in sheep and cattle.
Slovenian: Brejost: Lahko se uporablja v obdobju brejosti pri ovcah in govedu.
English: Inactivated bluetongue virus, serotype 4, strain SPA-1/2004
Slovenian: inaktiviran virus bolezni modrikastega jezika, serotip 4, sev SPA-1/2004
English: 100 ml (50 doses) 240 ml (120 doses)
Slovenian: 100 ml (50 odmerkov) 240 ml (120 odmerkov)
English: A transient increase in rectal temperature, not exceeding 2 °C, may occur in 10% of the animals during the 24 hours following administration of a two-fold overdose.
Slovenian: Pri 10 % živali se lahko v 24 urah po dajanju 2-krat prevelikega odmerka pojavi prehodno povišanje rektalne temperature, ki ne presega 2 °C.
English: High density polyethylene (HDPE) bottles of 20, 100 or 240 ml with chlorobutyl elastomer stopper and aluminium seal.
Slovenian: 20 ml, 100 ml ali 240 ml plastenke iz polietilena visoke gostote (HDPE) z zamaškom iz klorobutilnega elastomera in aluminijsko zaporko.
English: 20 ml (10 doses) 100 ml (50 doses) 240 ml (120 doses)
Slovenian: 20 ml (10 odmerkov) 100 ml (50 odmerkov) 240 ml (120 odmerkov)
English: Zulvac BTV suspension for injection for sheep
Slovenian: Zulvac BTV suspenzija za injiciranje za ovce
English: Once broached, use immediately.
Slovenian: Načeto uporabite takoj.
English: After administration with a double dose (4 ml), reactions in sheep are similar to those seen after administration of a single dose, but injection site reactions may persist for a longer time (general swelling at the injection site persisting for not more than 9 days or subcutaneous granuloma possibly persisting for more than 63 days).
Slovenian: Po dajanju dvojnega odmerka (4 ml) so reakcije pri ovcah podobne tistim pri dajanju enojnega odmerka, le da reakcije na mestu injiciranja trajajo dalj časa (oteklina na mestu injiciranja običajno traja do 9 dni, subkutani granulomi pa lahko trajajo tudi več kot 63 dni .
English: Administer one dose of 2 ml according to the following vaccination scheme: 1st injection: from 12 weeks of age.
Slovenian: Dajte en odmerek (2 ml) v skladu z naslednjim programom cepljenja: 1. injekcija: od 12. tedna starosti.
English: These reactions take the form in most cases of a diffuse swelling of the injection site (persisting for not more than 7 days) or of palpable nodules up to a size of 60 cm2 (subcutaneous granuloma, decreasing in size over time but possibly persisting for more than 50 days).
Slovenian: Te reakcije so v večini primerov v obliki difuzne otekline na mestu injiciranja (ki ne traja več kot 7 dni) ali kot otipljivi noduli v velikosti do 60 cm2 (subkutani granulomi, ki se sčasoma zmanjšajo in lahko trajajo tudi več kot 50
English: Administer one dose of 2 ml according to the following vaccination scheme: 1st injection: from 6 weeks of age.
Slovenian: Dajte en odmerek (2 ml) v skladu z naslednjim programom cepljenja: 1. injekcija: od 6. tedna starosti.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE (BIOLOŠKIH) UČINKOVINE (UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI) ZDRAVILA, ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
English: Local reactions of < 2 cm diameter were very commonly observed while reactions of up to 5 cm diameter were commonly observed after administration of a single dose in field safety studies.
Slovenian: V terenskih študijah o varnosti zdravila so po dajanju enkratnega odmerka zelo pogosto opazili lokalne reakcije premera < 2 cm, ter pogosto reakcije premera do 5 cm po dajanju enkratnega odmerka.
English: Revaccination:
Slovenian: Ponovno cepljenje
English: Zulvac BTV suspension for injection for sheep and cattle
Slovenian: Zulvac BTV suspenzija za injiciranje za ovce in govedo
English: Per dose of 2 ml: Inactivated BTV, serotype 4
Slovenian: V odmerku 2 ml: Inaktiviran virus bolezni modrikastega jezika, serotip 4
English: Quil-A (Quillaja saponaria saponin extract) Thiomersal
Slovenian: Quil -A (Quillaja saponaria izvleček saponina) Tiomersal
English: Cardboard box with 1 bottle of 120 doses (240 ml).
Slovenian: Kartonska škatla z 1 plastenko s 120 odmerki (240 ml).
English: Cardboard box with 1 bottle of 10 doses (20 ml).
Slovenian: Kartonska škatla z 1 plastenko z 10 odmerki (20 ml).
English: Duration of immunity: 12 months after completion of the primary vaccination scheme.
Slovenian: Trajanje imunosti: 12 mesecev po končanem osnovnem programu cepljenja.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box 1 x 20 ml, 1 x 100 ml and 1 x 240 ml (BTV-4 for sheep)
Slovenian: PODATKI NA ZUNANJI OVOJNINI Kartonska škatla 1 x 20 ml, 1 x 100 ml in 1 x 240 ml (BTV-4 za ovce)
English: The safety and the efficacy of the vaccine have not been established in breeding males.
Slovenian: Varnost in učinkovitost zdravila ni bila ugotovljena pri plemenskih samcih.
English: Cardboard box with 1 bottle of 50 doses (100 ml).
Slovenian: Kartonska škatla z 1 plastenko s 50 odmerki (100 ml).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box 1 x 20 ml, 1 x 100 ml and 1 x 240 ml (BTV-1 for sheep and cattle; BTV-8 for sheep and cattle)
Slovenian: PODATKI NA ZUNANJI OVOJNINI Kartonska škatla 1 x 20 ml, 1 x 100 ml in 1 x 240 ml (BTV-1 za ovce in govedo; BTV-8 za ovce in govedo)
English: Local reactions of up to 5 cm diameter were very commonly observed and reactions > 5 cm diameter were commonly observed after repeated administration of a single dose in field safety studies.
Slovenian: V študijah o varnosti zdravila so po ponavljajočem dajanju enkratnega odmerka pogosto opazili reakcije > 5 cm.
English: One of the following inactivated bluetongue virus strains: Inactivated bluetongue virus, serotype 1, strain BTV-1/ALG2006/01 E1
Slovenian: En izmed naslednjih inaktiviranih sevov virusa bolezni modrikastega jezika: inaktiviran virus bolezni modrikastega jezika, serotip 1, sev BTV-1/ALG2006/01 E1 RP* ≥ 1 inaktiviran virus bolezni modrikastega jezika, serotip 8, sev BTV-8/BEL2006/02
English: PACKAGE LEAFLET: Zulvac BTV suspension for injection for sheep and cattle
Slovenian: NAVODILO ZA UPORABO Zulvac BTV suspenzija za injiciranje za ovce in govedo
English: Pack sizes:
Slovenian: Velikost pakiranj:
English: A transient increase in rectal temperature, not exceeding 2.7 °C, was commonly observed during the 48 hours following vaccination in field safety studies.
Slovenian: V terenskih študijah o varnosti zdravila so v 48 urah po cepljenju zelo pogosto opazili prehodno povišanje rektalne temperature, ki ne presega 2,7 °C.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottle of 100 ml and 240 ml (BTV-1 for sheep and cattle; BTV-8 for sheep and cattle)
Slovenian: Plastenka po 100 ml in 240 ml (BTV-1 za ovce in govedo; BTV-8 za ovce in govedo)
English: Al3+ (as hydroxide), Quil-A (Quillaja saponaria saponin extract), thiomersal.
Slovenian: aluminijev hidroksid, Quil-A (Quillaja saponaria izvleček saponina), tiomersal.
English: Onset of immunity: 21 days after completion of the primary vaccination scheme.
Slovenian: Nastop imunosti: 21 dni po končanem osnovnem programu cepljenja.
English: *Below the level of detection of < 3.9 log10 genome copies/ml by the validated RT-qPCR method, indicating no presence of viral genome.
Slovenian: * Pod nivojem detekcije < 3,9 log10 kopij genoma/ml, pri validirani metodi RT-qPCR, kar kaže, da virusni genom ni prisoten.
English: For protection against serotype 1 or serotype 8, administer one dose of 2 ml, every 12 months.
Slovenian: Za zaščito proti serotipu 1 ali serotipu 8, dajte en odmerek (2 ml), vsakih 12 mesecev.
English: **Below the level of detection of < 3.4 log10 genome copies/ml by a validated RT-qPCR method, indicating no presence of viral genome.
Slovenian: **Pod nivojem detekcije < 3,4 log10 kopij genoma/ml, pri validirani metodi RT-qPCR, kar kaže, da virusni genom ni prisoten.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottle of 100 ml and 240 ml (BTV-4 for sheep)
Slovenian: PODATKI NA ZUNANJI OVOJNINI Plastenka po 100 ml in 240 ml (BTV-4 za ovce)
English: For protection against serotype 4, administer two doses of 2 ml three weeks apart, every 12 months.
Slovenian: Za zaščito proti serotipu 4, dajte dva odmerka po 2 ml, v razmiku treh tednov, vsakih 12 mesecev.
English: Bluetongue virus, serotype 8: 25 days after completion of the primary vaccination scheme.
Slovenian: Virus bolezni modrikastega jezika, serotip 8: 25 dni po končanem osnovnem programu cepljenja.
English: For protection against serotype 8, administer two doses of 2 ml three weeks apart, every 12 months.
Slovenian: Za zaščito proti serotipu 8, dajte dva odmerka po 2 ml, v razmiku treh tednov, vsakih 12 mesecev.
English: Active immunisation of sheep from 6 weeks of age for the reduction* of viraemia caused by bluetongue virus, serotype 4.
Slovenian: Za aktivno imunizacijo ovac, starejših od 6 tednov, za zmanjšanje* viremije, ki jo povzroča virus bolezni modrikastega jezika, serotipa 4.
English: EU/2/17/207/002 (100 ml) BTV 1 EU/2/17/207/003 (240 ml) BTV 1 EU/2/17/207/008 (100 ml) BTV 8
Slovenian: EU/2/17/207/002 (100 ml) BTV 1 EU/2/17/207/003 (240 ml) BTV 1 EU/2/17/207/008 (100 ml) BTV 8 EU/2/17/207/009 (240 ml) BTV 8
English: For protection against serotype 1, administer one dose of 2 ml, every 12 months.
Slovenian: Za zaščito proti serotipu 1, dajte en odmerek (2 ml), vsakih 12 mesecev.
English: Bluetongue virus, serotype 8: 12 months after completion of the primary vaccination scheme.
Slovenian: Virus bolezni modrikastega jezika, serotip 8: 12 mesecev po končanem osnovnem programu cepljenja.
English: Inactivated BTV, serotype 1 Inactivated BTV, serotype 8
Slovenian: inaktiviran virus bolezni modrikastega jezika, serotip 1 inaktiviran virus bolezni modrikastega jezika, serotip 8
English: Inactivated BTV, serotype 1
Slovenian: Inaktiviran virus bolezni modrikastega jezika, serotip 1
English: Cattle: Active immunisation of cattle from 12 weeks of age for the prevention** of viraemia caused by bluetongue virus, serotype 1 or serotype 8.
Slovenian: Aktivna imunizacija goveda, starejšega od 12 tednov, za preprečitev** viremije, ki jo povzroča virus bolezni modrikastega jezika, serotip 1 ali serotip 8.
English: Bluetongue virus, serotype 1: 12 months after completion of the primary vaccination scheme.
Slovenian: Virus bolezni modrikastega jezika, serotip 1: 12 mesecev po končanem osnovnem programu cepljenja.
English: Bluetongue virus, serotype 1: 15 days after completion of the primary vaccination scheme.
Slovenian: Virus bolezni modrikastega jezika, serotip 1: 15 dni po končanem osnovnem programa cepljenja.
English: Excipient:
Slovenian: Brejost :
English: Active immunisation of sheep from 6 weeks of age for the prevention* of viraemia caused by bluetongue virus, serotype 1 or serotype 8.
Slovenian: Za aktivno imunizacijo ovac, starejših od 6 tednov, za preprečitev* viremije, ki jo povzroča virus bolezni modrikastega jezika, serotip 1 ali serotip 8.
English: Lot
Slovenian: Girona
English: EU/2/17/207/005 (100 ml) BTV 4 EU/2/17/207/006 (240 ml) BTV 4
Slovenian: EU/2/17/207/005 (100 ml) BTV 4
English: PROHIBITION OF SALE, SUPPLY AND/OR USE
Slovenian: POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE
English: or of palpable nodules up to a size of 60 cm2 (subcutaneous granuloma, decreasing in size over time but possibly persisting for more than 50 days).
Slovenian: Te reakcije so v večini primerov v obliki difuzne otekline na mestu injiciranja (ki ne traja več kot 7 dni) ali kot otipljivi noduli v velikosti 60 cm2 (subkutani granulomi, ki se sčasoma zmanjšajo in lahko trajajo tudi več kot 50 dni).
English: EU/2/17/207/001-009
Slovenian: ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/17/207/001-009