Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
Inactivated bovine respiratory syncytial virus strain ev908; Inactivated Parainfluenza-3-virus, strain SF-4 Reisinger; Inactivated mannheimia (pasteurella) haemolyticaA1, strain M4/1
Intervet Ireland Limited
QI02AL04
Inactivated bovine respiratory syncytial virus strain ev908; Inactivated Parainfluenza-3-virus, strain SF-4 Reisinger; Inactivated mannheimia (pasteurella) haemolyticaA1, strain M4/1
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Suspension for injection
POM (E): Prescription Only Exempt as defined in relevant national legislation
Cattle
bovine parainfluenza virus + bovine respiratory syncytial virus + pasteurella
Immunological - Inactivated Vaccine
Authorised
2000-06-06
Registration file / April 2022 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Bovilis Bovipast RSP, suspension for injection for cattle. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose (5 ml) contains: ACTIVE SUBSTANCES: Inactivated Bovine Respiratory Syncytial virus, strain EV908 10 4.77 – 10 5.45 U/dose * Inactivated Parainfluenza-3Virus, strain SF-4 Reisinger 10 3.54 – 10 4.85 U/dose * Inactivated _Mannheimia haemolytica _ A1 _, _ strain M4/1 _ _ 10 4.24 – 10 5.00 U/dose * *Results obtained with AlphaLISA assays ADJUVANTS: Aluminium hydroxide 37.5 mg Quil A (Saponin) 0.189 – 0.791 mg EXCIPIENTS: Thiomersal 0.032 – 0.058 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Suspension for injection. The product is pale yellow to red-pink with whitish sediment. By shaking the sediment is easily suspended to an opaque, whitish to red/pink suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the active immunisation of cattle against: - Parainfluenza-3 virus, to reduce infection, - Bovine Respiratory Syncytial virus, to reduce infection and clinical signs, - _Mannheimia haemolytica _ serotype A1, to reduce infection, mortality, clinical signs, lung lesions and bacterial invasion of the lung caused by serotypes A1 and A6. Cross-reactive immunity to the A6 serotype of _Mannheimia haemolytica_ has been demonstrated in a challenge experiment under laboratory conditions after primary course of vaccination. Approximately two weeks after completion of the basic immunisation programme, the humoral immune response against Bovine Respiratory Syncytial virus and Parainfluenza-3 virus is at its highest level. The duration of protective immunity has not been established in challenge experiments. Onset of immunity: 2 weeks. Duration of immunity: not established. 4.3 CONTRAINDICATIONS Registration file / April 2022 Do not vaccinate animals that have intercurrent disease, heavy parasitic infestation or are in poor general condit Διαβάστε το πλήρες έγγραφο