Galaxy DAP + L Lyophilisate and Solvent for Suspension for Injection for Dogs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Canine adenovirus, Canine distemper virus, Canine parvovirus, Leptospira canicola, Leptospira icterohaemorrhagiae

Available from:

Pfizer Ltd

ATC code:

QI07AI03

INN (International Name):

Canine adenovirus, Canine distemper virus, Canine parvovirus, Leptospira canicola, Leptospira icterohaemorrhagiae

Authorization status:

Expired

Summary of Product characteristics

Revised: January 2011
AN: 01278/2009
00908/2010
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Duramune DAP + L Lyophilisate and Solvent for Suspension for Injection
for Dogs.
Galaxy DAP + L Lyophilisate and Solvent for Suspension for Injection
for
Dogs (UK and PT only).
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENT PER DOSE:
1. LYOPHILISATE:
Live attenuated canine distemper virus, strain Onderstepoort: minimum
10
2.5
TCID
50
, maximum 10
4.8
TCID
50
(Tissue Culture Infective Dose 50%).
Live attenuated canine adenovirus type 2, strain V197: minimum 10
4.8
TCID
50
,maximum 10
7.0
TCID
50
.
Live attenuated canine parvovirus, strain SAH: minimum 10
4.7
TCID
50
,
maximum 10
6.5
TCID
50
.
2. SOLVENT:
Inactivated _Leptospira interrogans _bacteria (outer membrane coat)
Serogroup _Canicola_, serovar _canicola _Minimum 40 Hamster PD80*
Serogroup _Icterohaemorrhagiae_, serovar Minimum 40 Hamster PD80*
_icterhaemorrhagiae_
* Hamster-80% Protective Doses
ADJUVANT:
Ethylene/Maleic anhydride (EMA)
0.01 ml
Neocryl A640
0.03 ml
For a full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
Lyophilisate: cream coloured cake.
Solvent: opaque liquid.
Reconstituted vaccine: buff-coloured liquid.
4. CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
Page 1 of 6
Revised: January 2011
AN: 01278/2009
00908/2010
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of dogs to prevent mortality and reduce
disease caused by canine distemper virus and canine parvovirus; to
prevent mortality and reduce clinical signs due to infectious canine
hepatitis
and _Leptospira interrogans _serovars _icterohaemorrhagiae _and
_canicola_;
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 at least three years for the canine distemper,
canine
adenovirus and canine parvovirus components and at least one ye