DURAMUNE DAP + L
Country: France
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
14-02-2013
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Active ingredient:
canine adenovirus 10 IU, canine distemper virus 10 IU, canine parvovirus 10 IU, Leptosira Canicola, Leptosira Icterohaemorrhagiae 1 IU, leptospira interrogans serogroup canicola 1 IU
Available from:
Fort Dodge Animal Health
ATC code:
QI07AI03
Pharmaceutical form:
Suspension for injection
Therapeutic group:
live Canine distemper virus vaccine + live Canine adenovirus vaccine + live Canine parvovirus vaccine + inactivated Leptospira v
Therapeutic area:
Dogs
Authorization date:
2011-09-29
Summary of Product characteristics
Revised: November 2012
AN: 00961/2011
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE IMMUNOLOGICAL VETERINARY MEDICINAL
PRODUCT
Duramune DAP + L
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
QUALITATIVE COMPOSITION
Combined canine distemper virus vaccine (live), lyophilisate; canine
adenovirus vaccine (live), lyophilisate; canine parvovirosis vaccine
(live), lyophilisate and canine leptospirosis vaccine (inactivated).
QUANTITATIVE COMPOSITION
1. LYOPHILISATE 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 SOLVENT FRACTION:
Active Substances
Per 1 ml dose
Inactivated _Leptospira interrogans _bacteria
(outer membrane coat)
Serogroup _canicola_, Serovar _canicola_
Potency according to
Ph.Eur.*
Serogroup _icterohaemorrhagiae_, serovar
_icterohaemorrhagiae_
Potency according to
Ph.Eur.*
Adjuvants
Ethylene/Maleic anhydride (EMA)
0.01 ml
Neocryl A640
0.03 ml
Excipients
For a full list of excipients, see section 6.1.
*hamster 80% protective dose according to Ph.Eur.
Revised: November 2012
AN: 00961/2011
Page 2 of 6
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
Lyophilisate: Cream-yellow colour powder
Solvent: Opaque White liquid
Reconstituted vaccine: orange or yel
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