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

Država: Velika Britanija

Jezik: angleščina

Source: VMD (Veterinary Medicines Directorate)

Aktivna sestavina:

Canine distemper virus, Canine parvovirus

Dostopno od:

MSD Animal Health UK Limited

Koda artikla:

QI07AD03

INN (mednarodno ime):

Canine distemper virus, Canine parvovirus

Farmacevtska oblika:

Lyophilisate and solvent for suspension for injection

Tip zastaranja:

POM-V - Prescription Only Medicine – Veterinarian

Terapevtska skupina:

Dogs

Terapevtsko območje:

Live and Inactivated Viral Vaccine

Status dovoljenje:

Authorized

Datum dovoljenje:

2023-01-12

Lastnosti izdelka

Revised: January 2024
AN: 03822/2022
Page 1 of 6
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
*
* 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:
for canine distemper virus: 7 days.
for canine parvovirus: 3 days.
Duration of immunity: 8 weeks.
4.3
CONTRAINDICATIONS
None.
Revised: January 2024
AN: 03822/2022
Page 2 of 6
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
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 dis