Eurican DAPPi lyophilisate and solvent for suspension for injection

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

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

Disponible depuis:

Boehringer Ingelheim Vetmedica GmbH

Code ATC:

QI07AD04

DCI (Dénomination commune internationale):

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

Dosage:

.

forme pharmaceutique:

Lyophilisate and solvent for suspension for injection

Type d'ordonnance:

POM: Prescription Only Medicine as defined in relevant national legislation

Groupe thérapeutique:

Dogs

Domaine thérapeutique:

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

indications thérapeutiques:

Immunological - Live Vaccine

Statut de autorisation:

Authorised

Date de l'autorisation:

2016-07-22

Résumé des caractéristiques du produit

Health Products Regulatory Authority
05 February 2021
CRN009XFD
Page 1 of 4
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, CGF 2004/75
​10
4.7
CCID
50
*
​
10
7.1
CCID
50
*
(* 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),
- 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 adap