Rispoval RS+Pi3 Intranasal
Country: Germany
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
30-03-2013
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Active ingredient:
Bovine Parainfluenza 3 Virus (pi3), RLB103, attenuated 10 ml, Bovine Respiratory Syncytial Virus (BRSV), strain 375 attenuated 10 ml
Available from:
Pfizer Animal Health
ATC code:
QI02AD07
Pharmaceutical form:
Injection
Therapeutic group:
Bovine respiratory syncytial virus vaccine + Bovine parainfluenza virus vaccine
Therapeutic area:
Cattle
Authorization date:
2011-07-21
Summary of Product characteristics
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
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