Duramune DAPPi

Država: Velika Britanija

Jezik: engleski

Izvor: VMD (Veterinary Medicines Directorate)

Aktivni sastojci:

Canine adenovirus, Canine distemper virus, Canine parainfluenza virus, Canine parvovirus

Dostupno od:

Zoetis UK Limited

ATC koda:

QI07AD04

INN (International ime):

Canine adenovirus, Canine distemper virus, Canine parainfluenza virus, Canine parvovirus

Status autorizacije:

Expired

Svojstava lijeka

Revised: May 2014
AN: 00154/2014
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Duramune DAPPi
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substances:
Per 1 ml dose
FREEZE-DRIED FRACTION:
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 parainfluenza virus, Strain FDL
10
5.1
to 10
7.4
TCID
50
*
Canine parvovirus, strain SAH
10
4.7
to 10
6.5
TCID
50
*
*TCID
50
= tissue culture 50% infective dose
STERILE SOLVENT:
Water for injections (Ph.Eur.)
1 ml
Excipients:
Stabilising medium
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: clear and colourless liquid
4.
CLINICAL PARTICULARS
4.1.
TARGET SPECIES
Dogs
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; to prevent mortality and disease and reduce
virus
shedding caused by canine parvovirus infection ; to prevent mortality
and
reduce clinical signs caused by infectious canine hepatitis and to
reduce
clinical signs and infection caused by canine adenovirus 2 and to
reduce
clinical signs and shedding caused by infection with canine
parainfluenza virus.
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 and
canine adenovirus components and at least one year for canine
parainfluenza.
Page 1 of 6
Revised: May 2014
AN: 00154/2014
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 CP