Galaxy DAPPi + L, Lyophilisate and Solvent for Suspension for Injection for Dogs

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

AN: 00959/2013
Revised: May 2013
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Duramune DAPPi + L, Lyophilisate and Solvent for Suspension For
Injection for Dogs.
Galaxy DAPPi + L, Lyophilisate and Solvent for Suspension for
Injection
for Dogs. (UK and PT only)
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
Page 1 of 9
AN: 00959/2013
Revised: May 2013
Ethylene/Maleic anhydride (EMA)
0.01 ml
Neocryl A640
0.03 ml
EXCIPIENTS
For a full list of excipients, see section Error:
Reference source not found.
* 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.
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 reduce
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 respiratory
signs
due to infection with canine parainfluenza vir