RISPOVAL 3 BRSV PI3 BVD LYOPHILISATE AND SUSPENSION FOR SUSPENSION FOR INJECTION FOR CATTLE

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PARAINFLUENZA 3 VIRUS, MODIFIED LIVE, STRAIN RLB103, BOVINE RESPIRATORY SYNCYTIAL VIRUS, MODIFIED LIVE, STRAIN 375, INACTIVATED BOVINE VIRAL DIARRHOEA VIRUS 1, STRAIN 5960 (CYTOPATHIC), INACTIVATED BOVINE VIRAL DIARRHOEA VIRUS TYPE 1 STRAIN 6309 (NON CYTOPATHIC), INACTIVATED BOVINE VIRAL DIARRHOEA VIRUS (BVDV) TYPE 1, STRAIN 5960 (CYTOPATHIC) INDUCE A GMT2 IN GUINEA PIGS

Available from:

Zoetis Ireland Limited

ATC code:

QI02AH

INN (International Name):

PARAINFLUENZA 3 VIRUS, MODIFIED LIVE, STRAIN RLB103, BOVINE RESPIRATORY SYNCYTIAL VIRUS, MODIFIED LIVE, STRAIN 375, INACTIVATED

Dosage:

Unknown

Pharmaceutical form:

Lyophilisate for suspension for injection

Prescription type:

POM(E)

Therapeutic group:

Bovine

Therapeutic area:

Live and inactivated viral vaccines

Therapeutic indications:

Immunological - Mixed vaccine (live and inactivated)

Authorization status:

Authorised

Authorization date:

2013-12-09

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Rispoval 3 BRSV Pi3 BVD
Lyophilisate and suspension for suspension for injection for cattle.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Lyophilisate and suspension for suspension for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle.
One dose (4 ml) contains:
ACTIVE INGREDIENT(S):
_LYOPHILISED FRACTION_
Parainfluenza 3 virus, modified live strain RLB 103
10
5.0
to 10
8.6
CCID
50
Bovine Respiratory Syncytial Virus, modified live strain 375
10
5.0
to 10
7.2
CCID
50
_LIQUID FRACTION_
Bovine Virus Diarrohea Virus Type 1, Inactivated strains 5960 (cytopathic) and 6309
(non-cytopathic), to induce a GMT seroneutralisation titre in guinea pigs of at least 3.0
log
2
ADJUVANT:
Alhydrogel 2%
0.8 ml (equivalent to 24.36 mg
of aluminium hydroxide)
CCID
50 =
Cell Culture Infectious Dose 50%
For a full list of excipients, see section 6.1
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 22/10/2015_
_CRN 7020228_
_page number: 1_
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of calves from 12 weeks of age to:
- reduce virus excretion and the clinical signs caused by bovine Pi3 virus,
- reduce virus excretion caused by BRSV infection,
- reduce virus excretion and the severity of the leucopenia induced by BVDV type 1 infection.
Onset of immunity: 3 weeks after vaccination
Duration of immunity: 6 months (demonstrated by challenge studies) after vaccination for BRSV and BVDV Type 1.
Duration of immunity has not been established for
bovine Pi3 virus.
Efficacy has not been demonstrated against BVDV Type 2 strains.
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SP