Land: Storbritannia
Språk: engelsk
Kilde: VMD (Veterinary Medicines Directorate)
Bovine parainfluenza virus 3, Bovine respiratory syncytial virus, Bovine viral diarrhoea virus, Mannheimia haemolytica
Boehringer Ingelheim Animal Health UK Ltd
QI02AL
Bovine parainfluenza virus 3, Bovine respiratory syncytial virus, Bovine viral diarrhoea virus, Mannheimia haemolytica
Suspension for injection
POM-V - Prescription Only Medicine – Veterinarian
Cattle
Inactivated Viral and Bacterial Vaccine
Authorized
2016-02-17
Revised: August 2023 AN: 03123/2022 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT BOVALTO Respi 4 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 bovine viral diarrhoea virus, strain BIO-25 ..................................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 the 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 Revised: August 2023 AN: 03123/2022 Page 2 of 5 - bovine viral diarrhoea virus, to reduce virus excretion due to infection - _Mannheimia_ _haemolytica_ serotype A1, to reduce clinical signs and lung lesions. Onset of immunity_:_ 3 weeks Duration of immunity_:_ 6 months 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Vaccinate healthy animals only. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals: Safety and effic Les hele dokumentet