Riik: Saksamaa
keel: inglise
Allikas: HMA (Heads of Medicines Agencies)
Bovine Parainfluenza 3 Virus (pi3), RLB103, attenuated 10 ml, Bovine Respiratory Syncytial Virus (BRSV), strain 375 attenuated 10 ml
Pfizer Animal Health
QI02AD07
Injection
Bovine respiratory syncytial virus vaccine + Bovine parainfluenza virus vaccine
Cattle
2011-07-21
Revised: October 2011 AN: 00050/2010 Page 1 of 3 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: October 2011 AN: 00050/2010 Page 2 of 3 4.5 SPECIAL PRECAUTIONS FOR USE Lugege kogu dokumenti