País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
Attenuated canine distemper virus, strain ba5; Attenuated canine adenovirus type 2, strain dk13; Attenuated canine parvovirus, strain cgf
Boehringer Ingelheim Vetmedica GmbH
QI07AD02
Attenuated canine distemper virus, strain ba5; Attenuated canine adenovirus type 2, strain dk13; Attenuated canine parvovirus, strain cgf
.
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
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 Llegiu el document complet