Eurican DAPPi Lyophilisate and Solvent for Suspension for Injection

Land: Storbritannien

Sprog: engelsk

Kilde: VMD (Veterinary Medicines Directorate)

Aktiv bestanddel:

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

Tilgængelig fra:

Boehringer Ingelheim Animal Health UK Limited

ATC-kode:

QI07AD04

INN (International Name):

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

Lægemiddelform:

Lyophilisate and solvent for suspension for injection

Recept type:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutisk gruppe:

Dogs

Terapeutisk område:

Live Viral Vaccine

Autorisation status:

Authorized

Autorisation dato:

2016-05-26

Produktets egenskaber

Revised: May 2024
AN: 00735/2023 & 03445/2023
Page 1 of 6
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
Each 1 ml dose of vaccine 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
EXCIPIENTS:
QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS_ _
LYOPHILISATE:
Casein hydrolysate
Gelatin
Dextran 40
Dipotassium phosphate
Potassium dihydrogen phosphate
Potassium hydroxide
Sorbitol
Sucrose
Water for injections
SOLVENT:
Water for injections
Beige to pale yellow lyophilisate and colourless liquid.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Dogs
Revised: May 2024
AN: 00735/2023 & 03445/2023
Page 2 of 6
3.2
INDICATIONS FOR USE FOR EACH 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-1),
-
reduce viral excretion during respiratory disease caused by canine
adenovirus
type 2 (CAV-2),
-
prevent mortality, clinical signs and viral excretion caused by canine
parvovirus
(CPV)*,
-
reduce viral excretion caused by canine parainfluenza virus type 2
(CPiV),
Onset of immunity: 2 weeks after the second injection of the primary
vaccination
course.
Duration of immunity: at least one year after the second injection of
the primary
vaccination course.
Current available challenge and serological data show that protection
for distemper
virus, adenovirus and parvovirus* lasts for 2 years after primary
vaccination course
followed by a first annual bo