Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Attenuated canine distemper virus, strain ba5, Attenuated canine adenovirus type 2, strain dk13, Attenuated canine parvovirus, strain cgf
Merial Animal Health Limited
QI07AD02
Attenuated canine distemper virus, strain ba5, Attenuated canine adenovirus type 2, strain dk13, Attenuated canine parvovirus, s
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Lyophilisate and solvent for suspension for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Dogs
canine distemper virus + canine adenovirus + canine parvovirus
Immunological - Live Vaccine
Authorised
2016-07-15
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, taking into account the vaccination history of the dog and the epidemiological context. *Protection has been demonstrated against canine parvovirus type 2a, 2b and 2c either by challenge (type 2b) or serology (type 2a and 2c) Read the complete document