Eurican DAPPi Lyophilisate and Solvent for Suspension for Injection

Land: Storbritannien

Språk: engelska

Källa: VMD (Veterinary Medicines Directorate)

Aktiva substanser:

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

Tillgänglig från:

Boehringer Ingelheim Animal Health UK Ltd

ATC-kod:

QI07AD04

INN (International namn):

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

Läkemedelsform:

Lyophilisate and solvent for suspension for injection

Receptbelagda typ:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutisk grupp:

Dogs

Terapiområde:

Live Viral Vaccine

Bemyndigande status:

Authorized

Tillstånd datum:

2016-05-26

Produktens egenskaper

Revised: February 2021
AN: 00815/2020
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
One dose of vaccine (1 ml) contains:
Lyophilisate:
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:
Sterilised water for injections 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 liquid.
4. CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
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),
Revised: February 2021
AN: 00815/2020
Page 2 of 6
-
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 for all strains.
Duration of immunity: at least one year after the second injection of
the primary
vaccination course for all strains.
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 s