국가: 영국
언어: 영어
출처: VMD (Veterinary Medicines Directorate)
Bovine parainfluenza virus 3, Bovine respiratory syncytial virus
Kernfarm B.V.
QI02AD07
Bovine parainfluenza virus 3, Bovine respiratory syncytial virus
Solution for injection
POM-V - Prescription Only Medicine – Veterinarian
Cattle
Live Viral Vaccine
Expired
2015-03-27
Revised: May 2020 AN: 02154/2019 Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Rispoval RS+PI3 IntraNasal 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Per dose of 2 ml: Powder ACTIVE SUBSTANCE: - Modified live Bovine Parainfluenza type 3 virus (PI3V), thermosensitive strain RLB103, ≥10 5.0 and ≤10 8.6 CCID 50 * - Modified live Bovine Respiratory Syncytial virus (BRSV) strain 375, ≥10 5.0 and ≤10 7.2 CCID 50 * *CCID 50 : Cell Culture Infective Dose 50% Diluent: - Sodium chloride 18 mg - Water for injection 2 ml EXCIPIENTS: For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and diluent for suspension for intranasal application. Slightly coloured powder and clear colourless diluent. The reconstituted, dissolved vaccine is a pinkish suspension. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of maternally derived antibody positive or negative calves from 9 days of age against BRSV and PI3V, to reduce the mean titre and duration of excretion of both viruses. Onset of protective immunity: 5 days for BRSV and 10 days for PI3V after a single vaccination. Duration of protective immunity: 12 weeks following a single dose. The duration of protective immunity against the PI3V fraction may be reduced in MDA positive calves vaccinated before 3 weeks of age. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS FOR CATTLE None. Revised: May 2020 AN: 02154/2019 Page 2 of 4 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Vaccinate only healthy animals. Vaccinal viruses can spread from vaccinated to non-vaccinated calves and may cause a serological response, but without causing clinical signs. In laboratory experiments based on the data using 3 week-old animals, shedding was observed for BRSV and PI3V up to 11 and 7 days respectively after vaccination with one dose containing the maximal virus content. Animals should preferably be vaccinated at least 10 da 전체 문서 읽기