NOBIVAC DHP

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CANINE DISTEMPER VIRUS, STRAIN ONDERSTEPOORT, CANINE ADENO VIRUS TYPE 2 (CAV2) STRAIN MANHATTAN LPV3 LIVE, CANINE PARVOVIRUS STRAIN 154

Available from:

Intervet Ireland Limited

ATC code:

QI07AD02

INN (International Name):

CANINE DISTEMPER VIRUS, STRAIN ONDERSTEPOORT, CANINE ADENO VIRUS TYPE 2 (CAV2) STRAIN MANHATTAN LPV3 LIVE, CANINE PARVOVIRUS STR

Dosage:

Unknown

Pharmaceutical form:

Lyophilisate for suspension for injection

Prescription type:

POM

Therapeutic group:

Canine

Therapeutic area:

Canine distemper virus vaccine + Canine adenovirus vaccine + Canine parvovirus vaccine

Therapeutic indications:

Immunological - Live Vaccine

Authorization status:

Authorised

Authorization date:

2004-11-12

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobivac DHP.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of dogs to reduce clinical signs of disease caused by canine distemper virus infection; to
prevent clinical signs and viral excretion caused by canine parvovirus infection; to reduce clinical signs of canine
contagious hepatitis and viral excretion due to canine adenovirus 1 infection and to reduce clinical signs of respiratory
infection and viral excretion caused by adenovirus type 2 infection.
Specific claims:
Onset of immunity: one week.
Duration of immunity: three years.
4.3 CONTRAINDICATIONS
None.
_Active substances:_
Per dose of 1ml reconstituted vaccine:
Canine distemper virus, strain Onderstepoort not less than 10
4.0
TCID
50*
Canine adenovirus 2, strain Manhattan LPV3 not less than 10
4.0
TCID
50*
Canine parvovirus, strain 154
not less than 10
7.0
TCID
50*
*Tissue culture infective dose 50%
_Solvent (1ml per vial):_
Phosphate buffered saline
_Excipients:_
For a full list of excipients see Section 6.1
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 19/01/2015_
_CRN 7019566_
_page number: 1_
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The efficacy of the CDV, CAV2 and CPV components of the vaccine may be reduced due to maternal antibody
interference. However, the vaccine has been proven to be of benefit against virulent challenge in the presence of
maternal antibody levels to CDV, CAV2 and CPV that are likely to be encountered under field conditi