RISPOVAL RS+PI3 INTRANASAL

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BOVINE PARAINFLUENZA 3 VIRUS (PI3), RLB103, ATTENUATED BOVINE RESPIRATORY SYNCYTIAL VIRUS (BRSV), STRAIN 375 ATTENUATED

Available from:

Pfizer Healthcare Ireland

ATC code:

QI02AD07

Pharmaceutical form:

pdr and diluent for intra-nasal soln

Therapeutic group:

Immunological - Live Vaccine

Therapeutic area:

Bovine

Authorization date:

2006-08-02

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Rispoval RS+PI3 IntraNasal.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
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.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 21/10/2011_
_CRN 7007831_
_page number: 1_
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
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,�