Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: 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
Unknown
Suspension for Injection
POM(E)
Bovine
Inactivated viral and inactivated bacterial vaccines
Immunological - Inactivated vaccine
Authorised
2016-02-26
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT BOVALTO Respi 3 suspension for injection for cattle 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) 0.4mg 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. _Onset of immunity (demonstrated by challenge):_ 3 weeks after primary vaccination _Duration of immunity (demonstrated by challenge):_ 6 months after primary vaccination 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_ _ Izlasiet visu dokumentu