Eurican DAP lyophilisate and solvent for suspension for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

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

Available from:

Boehringer Ingelheim Vetmedica GmbH

ATC code:

QI07AD02

INN (International Name):

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

Dosage:

.

Pharmaceutical form:

Lyophilisate and solvent for suspension for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Dogs

Therapeutic area:

canine distemper virus + canine adenovirus + canine parvovirus

Therapeutic indications:

Immunological - Live Vaccine

Authorization status:

Authorised

Authorization date:

2016-07-15

Summary of Product characteristics

Health Products Regulatory Authority
05 February 2021
CRN009XCQ
Page 1 of 4
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
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
*
​
* 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)*.
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 and at least 2 years after
the first annual booster 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 schedule of
this veterinary medicinal product needs to be made on a case by case
basis, taking into a