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 STR

Dosage:

Unknown

Pharmaceutical form:

Lyophilisate for reconstitution for injection

Prescription type:

POM

Therapeutic group:

Canine

Therapeutic area:

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

Therapeutic indications:

Immunological - Live Vaccine

Authorization status:

Authorised

Authorization date:

2005-06-03

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobivac DHPPi
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
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.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 30/09/2016_
_CRN 7024887_
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4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The CPV vaccine strain may be shed at very low levels for�