Canigen DP Lyophilisate and Solvent for Suspension for Injection for Dogs (Puppies)

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Canine distemper virus, Canine parvovirus

Available from:

MSD Animal Health UK Limited

ATC code:

QI07AD03

INN (International Name):

Canine distemper virus, Canine parvovirus

Pharmaceutical form:

Lyophilisate and solvent for suspension for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Dogs

Therapeutic area:

Live and Inactivated Viral Vaccine

Authorization status:

Authorized

Authorization date:

2023-01-12

Summary of Product characteristics

Issued: January 2023
AN: 00979/2022
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Canigen DP lyophilisate and solvent for suspension for injection for
dogs (puppies)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (1 ml) of reconstituted vaccine contains:
ACTIVE SUBSTANCES:
Live attenuated canine distemper virus strain Onderstepoort: 10
5.1
– 10
6.5
TCID
50
*
Live recombinant canine parvovirus strain 630a: 10
5.1
– 10
6.7
TCID
50
*
*TCID
50
: Tissue culture infective dose 50%
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
Lyophilisate: off-white or cream-colour.
Solvent: clear colourless solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs (puppies)
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of puppies from 4 weeks of age onwards to
prevent
clinical signs and mortality of canine distemper virus infection and
canine parvovirus
infection and to prevent viral excretion following canine distemper
virus infection and
following canine parvovirus infection.
Onset of immunity:
canine distemper virus: 7 days;
canine parvovirus: 3 days.
Duration of immunity: 8 weeks.
4.3
CONTRAINDICATIONS
None.
Issued: January 2023
AN: 00979/2022
Page 2 of 5
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
Moderate to high levels of maternally derived antibodies against
canine distemper
virus can reduce the efficacy of the product against canine distemper.
It is typically advised that each pup is vaccinated with this product
at 6 weeks of age.
In cases where there is a high risk of canine parvovirus infection
and/or canine
distemper virus infection, it is advised that pups are vaccinated
earlier, but not before
4 weeks of age. The routine vaccinations with core vaccines against
canine
distemper, canine parvovirosis, canine contagious hepatitis and
respiratory disease
caused by adenovirus type 2 infection should be given as indicated i