Duramune DAPPi + L

Страна: Велика Британія

мова: англійська

Джерело: VMD (Veterinary Medicines Directorate)

Активний інгредієнт:

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

Доступна з:

Pfizer Ltd

Код атс:

QI07AI02

ІПН (Міжнародна Ім'я):

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

Статус Авторизація:

Expired

Характеристики продукта

Revised: May 2013
AN: 00959/2012
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Duramune CHPPi + L (FR only)
Duramune DAPPi + L (All other CMS)
Lyophilisate and Solvent for Suspension for Injection for Dogs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1. Lyophilisate:
ACTIVE INGREDIENTS
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 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
EXCIPIENTS
For a full list of excipients, see section 6.1.
2. Solvent:
ACTIVE INGREDIENTS
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.
*
ADJUVANT
Ethylene/Maleic anhydride (EMA)
0.01 ml
Neocryl A640
0.03 ml
EXCIPIENTS
For a full list of excipients, see section .
* hamster 80% protective dose according to Ph.Eur.
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
Lyophilisate: Cream-yellow colour powder
Solvent: opaque liquid.
Page 1 of 6
Revised: May 2013
AN: 00959/2012
4. CLINICAL PARTICULARS
TARGET SPECIES
Dogs.
4.1 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 _Leptospira interrogans_ serovars
_icterohaemorrhagiae_
and _canicola_; 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