Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Live attenuated bovine respiratory syncytial virus; strain rb94
Zoetis Belgium S.A.
QI02AD04
Live attenuated bovine respiratory syncytial virus; strain rb94
.
Powder for suspension for injection
POM (E): Prescription Only Exempt as defined in relevant national legislation
Cattle
bovine respiratory syncytial virus (BRSV)
Immunological - Live Vaccine
Authorised
2014-07-11
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT RISPOVAL RS 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of Rispoval RS contains the following : ACTIVE INGREDIENT(S) Live attenuated Bovine Respiratory Syncytial Virus, strain RB94 : minimum :10 CCID per dose. For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Powder for suspension for injection. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle and calves from 7 days of age. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES RISPOVAL RS is a live attenuated vaccine designed to reduce the respiratory symptoms caused by Bovine Respiratory Syncytial Virus in cattle. Use of the vaccine results in a reduction in viral shedding. Duration of immunity is 4 months. 4.3 CONTRAINDICATIONS None. 5.5 50 H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _1_ _0_ _/_ _0_ _3_ _/_ _2_ _0_ _1_ _7_ _C_ _R_ _N_ _ _ _7_ _0_ _2_ _5_ _3_ _9_ _6_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Do not vaccinate animals for at least one month after cessation of corticosteroid treatment. The presence of maternally derived antibodies may affect the efficacy of Rispoval RS. When vaccinating calves of less than 4 months of age, an extra injection is required (see Section 4.9). Unhealthy animals should not be vaccinated. Maximum protection occurs when the whole herd is vaccinated. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS None. Lestu allt skjalið