Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
EQUINE ARTERITIS VIRUS INACTIVATED, STRAIN BUCYRUS
Zoetis Ireland Limited
QI05AA07
EQUINE ARTERITIS VIRUS INACTIVATED, STRAIN BUCYRUS
Emulsion for Injection
POM: Prescription Only Medicine as defined in relevant national legislation
Equine - Food
equine arteritis virus
Immunological - Inactivated vaccine
Authorised
2013-06-21
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Equip Artervac emulsion for injection for horses and ponies. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Emulsion for injection. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Horses and ponies from the age of 9 months. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the active immunisation of horses and ponies against equine arteritis in order to reduce clinical signs and shedding of virus in nasal secretion after infection. Onset of immunity: 3 weeks post primary vaccination Duration of immunity: 6 months 4.3 CONTRAINDICATIONS Do not use in sick animals. Each dose of 1 ml contains : ACTIVE SUBSTANCE Inactivated Equine Arteritis Vaccine, Bucyrus strain RP*=1.0-1.8 * Relative Potency compared to a reference vaccine ADJUVANT Squalane* 1.61 mg *As component of MetaStim (that also contains Pluronic L-121 and Polysorbate 80) EXCIPIENT Eagles Hepes (0.05 % LAH) Medium qs to 1.0 ml For a full list of excipients, see section 6.1. I R I S H M E D I C I N E S B O A R D ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _2_ _4_ _/_ _0_ _6_ _/_ _2_ _0_ _1_ _3_ _C_ _R_ _N_ _ _ _7_ _0_ _1_ _5_ _1_ _0_ _3_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccination does not prevent infection. Vaccination does not have an effect on the shedding of EAV by previously infected carrier stallions. The effect of the vaccine on the fertility of breeding stallions has not been investigated. Under some national legisl Leggi il documento completo