EURICAN DAP LYOPHILISATE AND SOLVENT FOR SUSPENSION FOR INJECTION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
06-12-2016
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Active ingredient:
ATTENUATED CANINE DISTEMPER VIRUS, STRAIN BA5, ATTENUATED CANINE ADENOVIRUS TYPE 2, STRAIN DK13, ATTENUATED CANINE PARVOVIRUS, STRAIN CGF
Available from:
Merial Animal Health Limited
ATC code:
QI07AD02
INN (International Name):
ATTENUATED CANINE DISTEMPER VIRUS, STRAIN BA5, ATTENUATED CANINE ADENOVIRUS TYPE 2, STRAIN DK13, ATTENUATED CANINE PARVOVIRUS, S
Dosage:
Unknown
Pharmaceutical form:
Lyophilisate and solvent for suspension for injection
Prescription type:
POM
Therapeutic group:
Canine
Therapeutic area:
Canine distemper virus vaccine + Canine adenovirus vaccine + Canine parvovirus vaccine
Therapeutic indications:
Immunological - Live Vaccine
Authorization status:
Authorised
Authorization date:
2016-07-15
Summary of Product characteristics
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 lyophilisate 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
SOLVENT:
Sterile water 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 solution for injection.
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 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, takin
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