Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Inactivated bovine respiratory syncytial virus, strain bio-24, Inactivated bovine parainfluenza 3 virus, strain bio-23, Inactivated mannheimia (pasteurella) haemolyica, a1 strain dsm 5283
Merial Animal Health Limited
QI02AL
Inactivated bovine respiratory syncytial virus, strain bio-24, Inactivated bovine parainfluenza 3 virus, strain bio-23, Inactiva
.
Suspension for injection
POM (E): Prescription Only Exempt as defined in relevant national legislation
Cattle
Inactivated viral and inactivated bacterial vaccines
Immunological - Inactivated Vaccine
Authorised
2016-02-26
Health Products Regulatory Authority 27 February 2018 CRN000XS0 Page 1 of 5 1 NAME OF THE VETERINARY MEDICINAL PRODUCT BOVALTO Respi 3 suspension for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One dose (2 ml) contains: ACTIVE SUBSTANCES: Inactivated bovine respiratory syncytial virus, strain BiO-24 RP ≥1* Inactivated bovine parainfluenza 3 virus, strain Bio-23 RP ≥1* Inactivated _Mannheimia haemolytica_, serotype A1 strain DSM 5283 RP ≥1* * Relative potency (RP) in comparison with the reference serum obtained after vaccination of guinea pigs with a vaccine batch that has successfully passed the challenge test in the target animals. ADJUVANTS: Aluminium hydroxide 8.0 mg Quillaja saponin (Quil A) 0.4 mg EXCIPIENTS: Thiomersal 0.2 mg Formaldehyde 1.0 mg at most For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Suspension for injection. Appearance: Pinkish liquid with sediment. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of cattle in the absence of maternally derived antibodies against: - parainfluenza 3 virus, to reduce virus excretion due to infection - bovine respiratory syncytial virus, to reduce virus excretion due to infection - _Mannheimia haemolytica _serotype A1, to reduce clinical signs and lung lesions. Health Products Regulatory Authority 27 February 2018 CRN000XS0 Page 2 of 5 Onset of immunity: 3 weeks Duration of immunity: 6 months 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None. Vaccinate healthy animals only. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS Safety and efficacy studies were performed in sero-negative calves. The efficacy of the vaccination has not been demonstrated in presence of antibodies. The level of antibody response may be reduced by the presence of maternal antibodies. In the presence of maternal antibodies, timing of initial vaccination of calves should be planned accordi Read the complete document