Nobivac DHPPi

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Canine distemper virus strain ondertespoort (live); Canine adenovirus type 2 strain manhattan lpv3 (live); Canine parvovirus strain 154 (live); Canine parainfluenza virus strain Cornell (Live)

Available from:

Intervet Ireland Limited

ATC code:

QI07AD04

INN (International Name):

Canine distemper virus strain ondertespoort (live); Canine adenovirus type 2 strain manhattan lpv3 (live); Canine parvovirus strain 154 (live); Canine parainfluenza virus strain Cornell (Live)

Dosage:

.

Pharmaceutical form:

Lyophilisate for solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Dogs

Therapeutic area:

canine distemper virus + canine adenovirus + canine parvovirus + canine parainfluenza virus

Therapeutic indications:

Immunological - Live Vaccine

Authorization status:

Authorised

Authorization date:

2005-06-03

Summary of Product characteristics

Health Products Regulatory Authority
14 October 2021
CRN00CCQ2
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobivac DHPPi
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Per 1 ml dose of reconstituted vaccine:
ACTIVE SUBSTANCE:
Canine distemper virus
not less than 10
4.0
TCID
50*
Canine adenovirus 2
not less than 10
4.0
TCID
50*
Canine parvovirus
not less than 10
7.0
TCID
50*
Canine parainfluenzavirus
not less than 10
5.5
TCID
50*
*TCID
50
: Tissue culture infective dose 50%
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Lyophilisate for reconstitution 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 reduce viral excretion caused by canine parvovirus
infection, to reduce clinical signs and/or virus excretion
caused by canine parainfluenza virus 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.
ONSET OF IMMUNITY
CDV and CPV one week, CAV2 two weeks, and CPi four weeks after
vaccination.
DURATION OF IMMUNITY
CDV, CAV2 and CPV: at least three years
CPi: has not been demonstrated, but an anamnestic response is produced
in dogs given a revaccination one year after basic
vaccination.
4.3 CONTRAINDICATIONS
None.
Health Products Regulatory Authority
14 October 2021
CRN00CCQ2
Page 2 of 5
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The CPV vaccine strain may be shed at very low levels for up to 8 days
after inoculation. However, there is no evidence of any
reversion to virulence of the vaccine strain and therefore no need to
separate unvaccinated dogs from contact with recently
vaccinated individuals.
A good immune response is reliant on the reaction of