natgillin/translations-raw huggingface dataset:
Consequently the CVMP considered that the recommendations for prudent use in the SPC under section 4.5 Special precautions for use, should be amended as follows: “The product should be used for treatment of clinical mastitis only. 
Posledično je CVMP menil, da je treba priporočila o preudarni rabi v poglavju 4.5 povzetka glavnih značilnosti zdravila Posebni previdnostni ukrepi spremeniti, kot sledi:
Harmonisation of the withdrawal periods 
Uskladitev odmerjanja
3 syringes 12 syringes 24 syringes 300 syringes 350 syringes 
3 injektorji 12 injektorjev 24 injektorjev 300 injektorjev
When any other milking routine is followed milk may be taken for human consumption only after the same period from the last treatment (e.g. with 3 times a day milking, milk for human consumption may only be taken at the 8th milking). 
Če se uporablja drugačna shema molže, se sme mleko uporabiti za prehrano ljudi po preteku istega časovnega obdobja (npr. pri 3-krat dnevni molži, se sme mleko uporabiti za prehrano ljudi šele pri 8. molži).
Therefore the CVMP has recommended the variation of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Synulox Lactating Cow and associated names (see Annex I). 
Zato je CVMP priporočil spremembo dovoljenj za promet z zdravilom Synulox Lactating Cow in povezanimi imeni (glejte Dodatek I), katerih povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo so navedeni v Dodatku III.
Where any other milking routine is followed, milk may be taken for human consumption only after the same period from the last treatment (e.g. with 3 times a day milking, milk may be taken for human consumption at the 11th milking). 
Če se uporablja drugačna shema molže, se sme mleko uporabiti za prehrano ljudi šele po preteku enakega časnovnega obdobja (npr. pri trikrat dnevni molži se sme mleko uporabiti za prehrano ljudi pri 11. molži).
In a Staphylococcus aureus challenge, a reduction of udder induration, udder swelling and inflammation was observed at some time-points following the product administration. 
Pri izpostavitvi bakteriji Staphylococcus aureus so ugotovili zmanjšanje otrdline, otekanja in vnetja vimena v nekaterih časovnih točkah po dajanju zdravila.
The product is efficacious regarding the claimed indications, treatment of bovine clinical mastitis in lactating cows, including cases of infections associated with the following pathogens: 
Zdravilo je učinkovito pri opisanih indikacijah, zdravljenju bovinega kliničnega mastitisa pri kravah v obdobju laktacije, vključno s primeri okužb zaradi naslednjih povzročiteljev:
Milk: 80 hours. 
Mleko: 80 ur.
Therefore, while clinical cure and bacteriological cure have been demonstrated for the formulation it was considered that the marketing authorisation holders had not demonstrated the efficacy of prednisolone in the combination. 
Zato se šteje, da imetniki dovoljenja za promet z zdravilom kljub dokazu klinične in bakteriološke ozdravitve za formulacijo niso dokazali učinkovitosti prednizolona v kombinaciji.
QUANTITY OF THE ACTIVE SUBSTANCE(S) Amoxicillin 
KOLIČINA ZDRAVILNE(IH) UČINKOVIN(E)
PACKAGE LEAFLET “Product name” (to be completed nationally) intramammary suspension for lactating cattle NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT Marketing authorisation holder: To be completed nationally 
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA PROIZVODNJO ZDRAVILA, ODGOVORNEGA ZA SPROSTITEV SERIJ V EGP, ČE STA RAZLIČNA
Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations. 
Če ste preobčutljivi ali so vam svetovali, da ne smete rokovati s temi učinkovinami, ne smete priti v stik z zdravilom.
“In cases of infections caused by Staphylococcus aureus, a longer course of antibacterial therapy may be required. 
„V primerih okužb zaradi Staphylococcus aureus je morda potrebno daljše protimikrobno zdravljenje.
Staphylococcus aureus, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus uberis and Gram negative bacteria. 
Klinična in bakteriološka učinkovitost zdravila Synulox Lactating Cow proti Staphylococcus aureus, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus uberis in gramnegativnim bakterijam je bila enakovredna učinkovitosti primerjalnega zdravila.
Synulox Lactating Cow was non-inferior to the comparator. 
Zdravilo Synulox Lactating Cow je bilo enakovredno primerjalnemu zdravilu.
The product is intended for the treatment of bovine clinical mastitis in lactating cows, including cases of infections associated with the following pathogens: 
Zdravilo je namenjeno zdravljenju bovinega kliničnega mastitisa pri kravah v obdobju laktacije, vključno s primeri okužb zaradi naslednjih povzročiteljev:
Milk: 60 hours 
Mleko: 60 ur
Prednisolone is an anti-inflammatory corticosteroid. 
Prednizolon je kortikosteroid s protivnetnim delovanjem.
• the CVMP reviewed the summary of products characteristics, labelling and package leaflet proposed by the marketing authorisation holders and considered all the overall submitted data; the CVMP, concluded that the overall benefit/risk balance for this product remains positive subject to the recommended changes in the product information. 
• CVMP je pregledal povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo, ki so jih predlagali imetniki dovoljenj za promet z zdravilom, in obravnaval vse predložene podatke.
MARKETING AUTHORISATION NUMBER(S) To be completed nationally 
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET
Meat and offal: 7 days Milk: 84 hours 
Meso in organi: 7 dni Mleko: 84 ur
The product is presented in disposable intramammary syringes containing 200 mg amoxicillin as amoxicillin trihydrate, 50 mg clavulanic acid as potassium clavulanate and 10 mg prednisolone in 3 g suspension. 
Zdravilo je na voljo v intramamarnih brizgah za enkratno uporabo, ki v 3 g suspenzije vsebujejo 200 mg amoksicilina v obliki amoksicilin trihidrata, 50 mg klavulanske kisline v obliki kalijevega klavulanata in 10 mg prednizolona.
However, it is recognised that in cases of infections caused by Staphylococcus aureus, a longer course of antibacterial therapy may be required. 
Vendar je bilo ugotovljeno, da je v primerih okužb zaradi Staphylococcus aureus morda potrebno daljše protimikrobno zdravljenje.
Strengths Pharmaceutical form 
Farmacevtska oblika
Therefore overall treatment length must be at the veterinarian's discretion but should be long enough to ensure complete resolution of intramammary infection.” A longer duration of treatment would not impact the recommended withdrawal periods for meat and milk. 
Zato mora o skupnem trajanju zdravljenja presoditi veterinar, vendar mora biti dovolj dolgo, da se zagotovi popolna odprava intramamarne okužbe.“
Do not use in animals, which are known to be hypersensitive to ß-lactam antibiotics. 
Ne uporabite v primeru preobčutljivosti na betalaktamske antibiotike.
Clavulanic acid inactivates -lactamases. 
Klavulanska kislina inaktivira beta-laktamazo.
Milk: 60 hours. 
Milk: 60 ur.
THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only. 
BESEDILO “SAMO ZA ŽIVALI”
Romania Pfizer Animal Health MA EEIG 
Romunija Pfizer Animal Health MA EEIG
200 mg 50 mg 10 mg 
200,0 mg klavulanska kislina 50,0 mg prednizolon
SPECIAL WARNINGS 
Posebna opozorila
NAME OF THE VETERINARY MEDICINAL PRODUCT “Product name” (to be completed nationally) intramammary suspension for lactating cattle 
Ime proizvoda (izpolni država članica) intramamarna suspenzija za krave v laktaciji
It is presented in disposable intramammary syringes containing 50 mg clavulanic acid as potassium clavulanate; 200 mg amoxicillin as amoxicillin trihydrate and 10 mg prednisolone in 3 g suspension. 
Zdravilo je na voljo v intramamarnih brizgah za enkratno uporabo, ki v 3 g suspenzije vsebujejo 50 mg klavulanske kisline v obliki kalijevega klavulanata, 200 mg amoksicilina v obliki amoksicilin trihidrata in 10 mg prednizolona.
METHOD AND ROUTE(S) OF ADMINISTRATION Intramammary use. 
NAČIN IN POT(I) UPORABE
MARKETING AUTHORISATION NUMBER To be completed nationally 
ŠTEVILKA DOVOLJENJA ZA PROMET
Emulsifying Wax White Soft Paraffin Liquid Paraffin Light 
Vosek, emulgirajoči Vazelin, beli Parafin, redko tekoči
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER To be completed nationally 
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM
Escherichia coli (including -lactamase producing strains) 
Escherichia coli (vključno s sevi, ki proizvajajo β-laktamazo)
Summary of product characteristics, labelling and package leaflet 
Povzetek glavnih značilnosti zdravila, ovojnina in navodilo za uporabo
Milk: 84 hours, i.e. 7 milking times with 2 times a day milking or 11 milking times with 3 times a day milking. 
7 molž pri shemi molže 2-krat dnevno ali 11 molž pri 3-krat dnevni molži.
Meat and offal: 7 days 
Meso in organi: 7 dni
Based on the past and recent data, the incidence of pathogens producing β-lactamase, i.e. Staphylococcus aureus and Escherichia coli from cases of bovine mastitis can be considered as high in some regions. 
Staphylococcus aureus in Escherichia coli, v primerih bovinega mastitisa na določenih območjih štejemo za visoko.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES One dose (3 g) 
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ODMERKOV
Harmonisation of the posology 
Uskladitev karence
Cattle Meat: 7 days Milk: 60 hours In combination with SYNULOX RTU: 
Amoxicillin (as amoxicillin trihydrate) Clavulanic acid (as potassium clavulanate) Prednisolone intramamarna suspenzija govedo Meso: 7 dni Mleko: 60 ur V kombinaciji s SYNULOX RTU:
Lithuania Pfizer Animal Health MA EEIG 
Bolgarija Pfizer Animal Health MA EEIG
In cases of infections caused by Staphylococcus aureus, a longer course of antibacterial therapy may be required. 
Pri okužbah s Staphylococcus aureus bo morda potrebno daljše protimikrobno zdravljenje.
Prednisolone: 
Karenca:
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate 
6.6 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi
Synulox comp. vet Amoxicillin (as amoxicillin trihydrate) Clavulanic acid (as potassium clavulanate) Prednisolone 
Synulox comp. vet Amoxicillin (as amoxicillin trihydrate) Clavulanic acid (as potassium clavulanate) Prednisolone intramamarna emulzija govedo Meso: 6 dni Mleko: 5 dni
DATE OF RENEWAL OF THE AUTHORISATION To be completed nationally 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET
• Escherichia coli (including β-lactamase producing strains). 
• Escherichia coli (vključno s sevi, ki tvorijo laktamaze beta).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Polyethylene syringe 
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
• Escherichia coli (including β-lactamase producing strains) A review of the susceptibility of the mastitis pathogens against amoxicillin-clavulanic acid indicates that the major bacterial causes of bovine mastitis continue to be susceptible to clavulanate potentiated amoxicillin. 
Pregled občutljivosti povzročiteljev mastitisa za kombinacijo amoksicilina in klavulanske kisline kaže, da so poglavitni bakterijski povzročitelji bovinega mastitisa še vedno občutljivi za amoksicilin v kombinaciji s klavulanatom.
However it was noted that the self-cure effect was not considered regarding 
Vendar je bilo ugotovljeno, da v primerih okužb z Escherichia coli ni bil upoštevan učinek samoozdravitve.
Amoxicillin (as amoxicillin trihydrate) Clavulanic acid (as potassium clavulanate) Prednisolone 
Amoxicillin (as amoxicillin trihydrate) Clavulanic acid (as potassium clavulanate) Prednisolone intramamarna suspenzija govedo Užitna tkiva: 4 dni
Meat and offal: 7 days Milk: 84 hours. 
Meso in organi: 7 dni Mleko: 84 ur, t.j.
Potassium clavulanate equivalent to clavulanic acid 
Zdravilne učinkovine amoksicilin trihidrat, ekvivalenten amoksicilinu kalijev klavunalat, ekvivalenten klavulanski kislini prednizolon
4.4 Special warnings 
4.3 Kontraindikacije
Consequently the CVMP considered that since the added value of prednisolone in the product has not been demonstrated, the following statement in the SPC under section 5. 
Posledično je CVMP menil, da se zaradi nedokazane dodane vrednosti prednizolona v zdravilu naslednja izjava v poglavju 5 povzetka glavnih značilnosti zdravila Farmakološke lastnosti: „Prednizolon je glukokortikoid s protivnetnimi lastnostmi.
NAME OF THE VETERINARY MEDICINAL PRODUCT “Product name” (to be completed nationally 
IME ZDRAVILA ZA UPORABO V VETERINARSKI MEDICINI
10 mg 
odmerek (3 g)
Milk (cows milked twice daily): 60 hours (i.e. at the 5th milking) after the last treatment. 
Mleko (2-krat dnevna molža): 60 ur (t.j.
OTHER INFORMATION To be completed nationally 
Izpolni država članica
Staphylococci (including -lactamase producing strains) Streptococci (including S.agalactiae, S.dysgalactiae and S.uberis) Escherichia coli (including -lactamase producing strains) 
Za zdravljenje kliničnih primerov mastitisa, vključno s primeri, povezanimi z okužbo z naslednjimi povzročitelji: stafilokoki (vključno s sevi, ki proizvajajo β-laktamazo), streptokoki (vključno s Streptococcus agalactiae, S. dysgalactiae in S. uberis), Escherichia coli (vključno s sevi, ki proizvajajo β-laktamazo)
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED To be completed nationally 
DATUM ZADNJE ODOBRITVE NAVODIL ZA UPORABO
Synulox 
amoksicilin
Swab teat end with appropriate disinfectant before treatment. 
Posebni previdnostni ukrepi za uporabo pri živalih Pred zdravljenjem razkužite vrh seska s primernim razkužilom.
WITHDRAWAL PERIOD Withdrawal period: 
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA
Amoxicillin was the limiting active substance to determine the withdrawal period in milk. 
Omejitvena zdravilna učinkovina za določitev karence za mleko je bil amoksicilin.
Staphylococci (including -lactamase producing strains) Streptococci (including S. agalactiae, S. dysgalactiae and S. uberis) Arcanobacteria (including A. pyogenes) 
Kombinacija amoksicilina in klavulanske kisline deluje in vitro proti širokemu spektru klinično pomembnih bakterij, vključno z naslednjimi običajnimi povzročitelji mastitisa pri govedu: stafilokoki (vključno s sevi, ki proizvajajo β-laktamazo), streptokoki (vključno s S. agalactiae, S. dysgalactiae in S. uberis), Arcanobacteria (vključno z A. pyogenes)
- 2nd injection: after 3-4 weeks. 
- Drugi odmerek: po 3-4 tednih.
a) the administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control and 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. 
a) bi uporaba zdravila 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.
According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal product on the whole or part of their territory if it is established that: 
Skladno z 71. členom Direktive 2001/82/ES Evropskega parlamenta in Sveta, država članica v skladu z nacionalno zakonodajo prepove ali lahko prepove proizvodnjo, uvoz, posedovanje, prodajo, oskrbo in/ali uporabo imunološkega zdravila za uporabo v veterinarski medicini na svojem celotnem ozemlju ali delu ozemlja, če se ugotovi da:
MERIAL Animal Health Limited Biological Laboratory, Ash Road, Pirbright, Woking, Surrey GU24 0NQ United Kingdom 
MERIAL Animal Health Limited Biological Laboratory, Ash Road, Pirbright, Woking, Surrey GU24 0NQ Združeno kraljestvo
The import, sale, supply and/or use of BTVPUR AlSap 8 is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy. 
Uvoz, prodaja, oskrba in/ali uporaba BTVPUR AlSap 8 je ali je lahko prepovedana v nekaterih državah članicah na njihovem celotnem ozemlju ali delu ozemlja v skladu z nacionalnim programom zdravstvenega varstva živali.
Any person intending to import, sell, supply and/or use BTVPUR AlSap 8 must consult the relevant Member State's competent authority on the current vaccination policies prior to the import, sale, supply and/or use. 
Vsakdo, ki namerava uvažati, prodajati, oskrbovati in/ali uporabljati BTVPUR AlSap 8, se mora posvetovati s pristojnimi organi posamezne države članice o veljavnih programih cepljenja še pred vnosom/uvozom, prodajo, oskrbo in/ali uporabo.
Each dose of 1 ml of vaccine contains: 
Vsak odmerek (1 ml) cepiva vsebuje:
Vaccination may be followed by a small local swelling at the injection site (at most 32 cm²) for a short period (at most 14 days). 
Po cepljenju se lahko na mestu dajanja pojavi prehodna manjša lokalizirana oteklina (največ 32 cm²), ki hitro izgine (v največ 14 dneh).
Do not use this veterinary medicinal product after the expiry date which is stated on the carton after EXP. 
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na zunanji ovojnini po EXP.
In cattle and sheep - 1st injection: from 1 month of age in naive animals (or from 2.5 months of age in young cattle and sheep born to immune animals). 
Govedo in ovce - Prvi odmerek: od 1 meseca starosti pri predhodno necepljenih živalih (ali od 2,5 meseca starosti pri potomcih imunih krav in ovc).
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. 
C. NAVEDBA NAJVIŠJIH DOVOLJENIH KOLIČIN OSTANKOV ZDRAVILA (MRL) Učinkovina biološkega izvora namenjena vzbujanju aktivne imunosti, ni vključena v Uredbo(ES) št. 470/2009.
BATCH NUMBER Lot{number} 
ŠTEVILKA SERIJE Lot {številka}
The duration of immunity for cattle and sheep is 1 year after the primary vaccination course. 
Trajanje imunosti pri govedu in ovcah je eno leto po osnovnem cepljenju.
Aluminium hydroxide Purified saponin Silicon antifoam Phosphate buffer Glycine buffer Water for injection 
Aluminijev hidroksid Prečiščen saponin Silikon (proti penjenju) Fosfatni pufer Glicerinski pufer Voda za injiciranje
Sheep and cattle 
Ovce in govedo.
TARGET SPECIES Sheep and cattle. 
CILJNE ŽIVALSKE VRSTE Ovce in govedo.
No adverse reactions except those mentioned in section 4.6 were observed after the administration of a double- dose of the vaccine. 
Drugi učinki, razen tistih ki so navedeni v poglavju 4.6, niso bili opaženi po dajanju dvakratnega odmerka cepiva.
A transient increase in body temperature, normally not exceeding an average of 1.1 °C, may occur within 24 hours after vaccination. 
Do 24 ur po cepljenju je možen pojav prehodnega povišanja telesne temperature, ki navadno ne preseže 1.1 °C.
Pharmacotherapeutic group: bluetongue virus vaccine, ATCvet code: QI04AA02 (sheep) and QI02AA08 (cattle). 
Farmakoterapevtska skupina: cepivo proti virusu modrega jezika; oznaka ATCvet QI04AA02 (ovce) in QI02AA08 (govedo).
MARKETING AUTHORISATION NUMBER(S) EU/2/09/094/001 
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/09/094/001
Can be used during pregnancy and lactation in cows. 
Lahko se uporablja v obdobju brejosti in laktacije pri kravah.
4.11 Withdrawal period Zero days. 
4.11 Karenca Nič dni.
Shelf life after first opening the immediate packaging: immediately after broaching. 
Rok uporabnosti po prvem odpiranju stične ovojnine: takoj po prvem odpiranju.
The safety and the efficacy of the vaccine has not been established in breeding males. 
Varnost in učinkovitost cepiva nista bili ugotovljena pri plemenjakih.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. 
Ni podatkov o varnosti ter učinkovitosti cepiva ob istočasnem dajanju katerega koli drugega zdravila za uporabo v veterinarski medicini.
* (below the level of detection by the validated RT-PCR method at 3.14 log10 RNA copies/ml, indicating no infectious virus transmission) 
* (pod stopnjo detekcije z validirano metodo RT-PCR pri 3,14 log10 RNA kopijah/ml, ni prenosavirusa)
*below the level of detection by the validated RT-PCR method at 3.14 log10 RNA copies/ml, indicating no infectious virus transmission 
*pod stopnjo detekcije z validirano metodo RT-PCR pri 3,14 log10 RNA kopijah/ml, ni prenosa virusa
SPECIAL STORAGE CONDITIONS Store and transport refrigerated (2 °C-8 °C). 
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte in prevažajte v hladilniku (2 °C-8 °C).
Polypropylene bottle of 50 or 100 ml with butyl elastomere closure. 
50 ali 100 ml polipropilenska plastenka z butil elastomerno zaporko.
No adverse reactions except those mentioned in section ‘Adverse Reactions' were observed after the administration of a double-dose of vaccine. 
Drugi učinki, razen tistih, ki so navedeni v poglavju neželeni učinki, niso bili opaženi po dajanju dvojnega odmerka cepiva.
The excipients (including adjuvants) listed in section 6.1 of the SPC are allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required. 
Za pomožne snovi, navedene v poglavju 6.1 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.
1 bottle of 10 doses (1 x 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) 
1 steklenička z 10 odmerki (1 x 10 ml) 1 plastenka s 50 odmerki (1 x 50 ml) 10 plastenk s 50 odmerki (1 x 50 ml) 1 plastenka s 100 odmerki (1 x 100 ml) 10 plastenka s 100 odmerki (1 x 100 ml)
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). 
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 modrega jezika (BTV).
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). 
Pri tej kategoriji živali je potrebno cepivo uporabljati glede na presojo razmerja korist/tveganje odgovornega veterinarja oziroma v skladu z veljavnimi smernicami kompetentnih nacionalnih organov glede cepljenja proti bolezni modrega jezika (BTV).
Shelf life of the veterinary medicinal product as package for sale (50-ml and 100-ml bottles): 2 years. 
Rok uporabnosti zdravila v pakiranju za prodajo (50 ml in 100 ml stekleničke): 2 leti.
Type I glass bottle of 10 ml with butyl elastomere closure. 
10 ml steklenička (steklo tipa I) z butil elastomerno zaporko.
SC. Read the package leaflet before use. 
SC. Pred uporabo preberite navodilo za uporabo.
Bluetongue virus serotype 8 antigen ........................................................................... ≥ 2.1 log10 pixels* (*) Antigen content (VP2 protein) by immuno-assay Adjuvants: 
Virus modrega jezika, serotip 8, antigen .................................................................. ≥ 2,1 log10 pikslov* (*) Vsebnost antigena (VP2 protein) z imunološkim preskusom Dodatki:
Box of 1 bottle of 10 ml Box of 1 bottle of 50 ml, Box of 10 bottles of 50 ml, Box of 1 bottle of 100 ml, Box of 10 bottles of 100 ml 
Škatla z 1 stekleničko z 10 ml Škatla z 1 plastenko s 100 ml Škatla z 10 plastenkami po 100 ml Škatla z 1 plastenko s 50 ml Škatla z 10 plastenkami 50 ml