Duramune Puppy DP + C Lyophilisate and Solvent for Suspension for Injection for Dogs

Summary of Product characteristics

                                Revised: 01 December 2014
AN. 00723/2014
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Duramune Puppy DP + C
Lyophilisate and solvent for suspension for Injection for Dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1. LYOPHILISATE FRACTION:
Active Ingredients
Per 1 ml dose
Canine Distemper virus, strain Onderstepoort
10
1.1
to 10
3.4
TCID
50
*
Canine Parvovirus, strain SAH
10
4.7
to 10
6.5
TCID
50
*
*TCID
50
= tissue culture 50% infective dose
2. LIQUID SOLVENT FRACTION:
Active Ingredients
Per 1 ml dose
Canine Coronavirus, strain TN449
RP* 1.0-2.0
Adjuvant
Ethylene/Maleic anhydride (EMA-31)
0.1 mg
Neocryl
0.015 ml
*RP = Relative Potency
Excipients:
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
Lyophilisate: Cream-yellow colour powder
Solvent: opaque liquid.
4.
CLINICAL PARTICULARS 4.1
TARGET SPECIES
Dogs.
Revised: 01 December 2014
AN. 00723/2014
Page 2 of 5
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;
to
prevent
mortality
and
disease
and
reduce
virus
shedding caused by canine parvovirus infection; to reduce infection at
the intestinal
level caused by canine coronavirus.
The onset of immunity is from two weeks after the second vaccination.
The duration of immunity is at least three years for canine distemper
and at least 1
year for canine corona virus.
The
duration
of
immunity
for
the
canine
parvovirus
component
has
been
demonstrated to be at least three years following challenge with
CPV2b. A duration
of immunity of at least 1 year has been proven after CPV2a challenge.
Duration of
immunity against CPV2c has not been investigated. Demonstration of
onset of
immunity against canine parvovirus was conducted by challenge studies
using
virulent CPV2a and CPV2b following vaccination from 6 weeks of age and
CPV2c
following vaccination from 8 weeks of age.
4.3 CONTRAINDICATIONS
O
                                
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