Nobivac DHPPi, Lyophilisate for Suspension for Injection for Dogs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Canine adenovirus, Canine distemper virus, Canine parainfluenza virus, Canine parvovirus

Available from:

MSD Animal Health UK Limited

ATC code:

QI07AD04

INN (International Name):

Canine adenovirus, Canine distemper virus, Canine parainfluenza virus, Canine parvovirus

Pharmaceutical form:

Powder for suspension for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Dogs

Therapeutic area:

Live Viral Vaccine

Authorization status:

Authorized

Authorization date:

2005-10-20

Summary of Product characteristics

Revised: October 2022
AN: 03004/2021
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobivac DHPPi lyophilisate for suspension for injection for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml dose contains:
ACTIVE SUBSTANCES:
Live canine distemper virus (CDV), strain Onderstepoort

10
4.0
TCID
50
*
Live canine adenovirus type 2 (CAV
2
), strain Manhattan LPV3

10
4.0
TCID
50
*
Live canine parvovirus (CPV), strain 154

10
7.0
TCID
50
*
Live canine parainfluenza virus (CPi), strain Cornell

10
5.5
TCID
50
*
* TCID
50
= median Tissue Culture Infective Dose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate for suspension for injection.
Off-white or cream-coloured pellet.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of dogs to prevent mortality and clinical
signs caused by canine
distemper virus infection. To reduce clinical signs of infectious
hepatitis and viral
excretion due to canine adenovirus type 1 infection. To prevent
mortality, clinical signs
and viral excretion following canine parvovirus infection. To reduce
clinical signs and
viral excretion caused by canine parainfluenza virus infection and to
reduce clinical
signs of respiratory disease and viral excretion following adenovirus
type 2 infection.
Onset of immunity:
Canine distemper virus, canine adenovirus and canine parvovirus
vaccine components:
1 week.
Canine parainfluenza virus vaccine component: 4 weeks.
Revised: October 2022
AN: 03004/2021
Page 2 of 7
Duration of immunity:
Canine distemper virus, canine adenovirus and canine parvovirus
vaccine components:
3 years.
The duration of immunity for the canine parainfluenza virus component
has not been
demonstrated, but an anamnestic response is produced in dogs given a
revaccination
one year after basic vaccination. Annual revaccination with the canine
parainfluenza
virus vaccine component is recommended.
4.3
CONTRAINDICAT