Eurican DAPPi lyophilisate and solvent for suspension for injection

Country: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Attenuated canine distemper virus, strain ba5, Attenuated canine adenovirus type 2, strain dk13, Attenuated canine parvovirus, strain cag2, Attenuated canine parainfluenza virus type 2, strain cgf 2004/75

Доступно од:

Merial Animal Health Limited

АТЦ код:

QI07AD04

INN (Међународно име):

Attenuated canine distemper virus, strain ba5, Attenuated canine adenovirus type 2, strain dk13, Attenuated canine parvovirus, s

Дозирање:

.

Фармацеутски облик:

Lyophilisate and solvent for suspension for injection

Тип рецептора:

POM: Prescription Only Medicine as defined in relevant national legislation

Терапеутска група:

Dogs

Терапеутска област:

canine distemper virus + canine adenovirus + canine parvovirus + canine parainfluenza virus

Терапеутске индикације:

Immunological - Live Vaccine

Статус ауторизације:

Authorised

Датум одобрења:

2016-07-22

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Eurican DAPPi lyophilisate and solvent for suspension for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose of lyophilisate contains:
ACTIVE SUBSTANCES:
MINIMUM
MAXIMUM
Attenuated Canine Distemper virus, strain BA5
10
4.0
CCID
50
*
10
6.0
CCID
50
*
Attenuated Canine Adenovirus type 2, strain DK13
10
2.5
CCID
50
*
10
6.3
CCID
50
*
Attenuated Canine Parvovirus type 2, strain CAG2
10
4.9
CCID
50
*
10
7.1
CCID
50
*
Attenuated Canine Parainfluenza virus type 2, strain
10
4.7
CCID
50
*
10
7.1
CCID
50
*
CGF 2004/75
(* CCID
50
: 50 % cell culture infective dose)
SOLVENT:
Sterile water 1 ml
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection
Beige to pale yellow lyophilisate and colourless solution for
injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs
H
E
A
L
T
H
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D
U
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T
S
R
E
G
U
L
A
T
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R
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U
T
H
O
R
I
T
Y
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4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of dogs to:
-
prevent mortality and clinical signs caused by canine distemper virus
(CDV),
-
prevent mortality and clinical signs caused by infectious canine
hepatitis virus (CAV),
-
reduce viral excretion during respiratory disease caused by canine
adenovirus type 2 (CAV-2),
-
prevent mortality, clinical