Duramune DAP

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Canine adenovirus, Canine distemper virus, Canine parvovirus

Available from:

Pfizer Ltd

ATC code:

QI07AD02

INN (International Name):

Canine adenovirus, Canine distemper virus, Canine parvovirus

Authorization status:

Expired

Summary of Product characteristics

Revised: August 2011
AN: 01052/2010
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE IMMUNOLOGICAL VETERINARY MEDICINAL
PRODUCT
Duramune DAP (UK, BG, RO, SE)
Duramune CHP (FR)
Galaxy DAP (DK, FI)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
QUALITATIVE COMPOSITION
Combined canine distemper virus vaccine (live), freeze dried; canine
adenovirus vaccine (live), freeze dried and canine parvovirosis
vaccine
(live), freeze dried.
QUANTITATIVE COMPOSITION
1. Freeze-dried fraction:
Active Substances
Per 1 ml dose
Canine Distemper virus, strain Onderstepoort
10
2.5
to 10
4.8
TCID
50
*
Canine Adenovirus type 2, strain V197
10
4.8
to 10
7.0
TCID
50
*
Canine Parvovirus, strain SAH
10
4.7
to 10
6.5
TCID
50
*
*TCID50 = tissue culture 50% infective dose
Excipients
None giving rise to safety concerns
For a full list of excipients, see section 6.1.
2. Liquid diluent fraction:
Sterilised water for injections (Ph.Eur.)
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
Page 1 of 5
Revised: August 2011
AN: 01052/2010
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of dogs to prevent mortality and disease
caused by canine distemper virus and canine parvovirus; to prevent
mortality and reduce clinical signs due to infectious canine
hepatitis;
and to reduce clinical
signs and infection caused by canine
adenovirus 2.
The onset of immunity is from two weeks after the second vaccination.
The duration of immunity is three years for the canine distemper
virus,
canine adenovirus, and canine parvovirus fractions.
4.3
CONTRAINDICATIONS
See section 4.6.
4.4
SPECIAL WARNINGS
The live vaccine strains of canine adenovirus type 2 (strain V197) and
canine parvovirus (strain SAH) may spread to unvaccinated animals,
but do not cause disease.
Animals
that
have
received
immunosuppressive
drugs
(e.g.
glucocorticoids) should not be vaccinated until an interval of at
least
4 weeks has elapsed.
4.5
SPECIAL PRECAUTIONS FOR USE
i. Special precautions