Eurican DAP Lyophilisate and Solvent for Suspension for Injection

Land: Storbritannien

Sprog: engelsk

Kilde: VMD (Veterinary Medicines Directorate)

Aktiv bestanddel:

Canine adenovirus, Canine distemper virus, Canine parvovirus

Tilgængelig fra:

Boehringer Ingelheim Animal Health UK Ltd

ATC-kode:

QI07AD02

INN (International Name):

Canine adenovirus, Canine distemper 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 & 03443/2023
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Eurican DAP 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
*
* 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 & 03443/2023
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)*.
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 and at least 2 years after the first annual
booster.
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 booster. Any decision to adapt the
vaccination schedule of
this veterinary medicinal product needs to be made on a case by case
bas