Pays: Royaume-Uni
Langue: anglais
Source: VMD (Veterinary Medicines Directorate)
Canine adenovirus, Canine distemper virus, Canine parainfluenza virus, Canine parvovirus
Zoetis UK Limited
QI07AD04
Canine adenovirus, Canine distemper virus, Canine parainfluenza virus, Canine parvovirus
Lyophilisate for suspension for injection
POM-V - Prescription Only Medicine – Veterinarian
Dogs
Live Viral Vaccine
Authorized
2014-07-04
Unlimited Renewal March 2024 AN: 03023/2023 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Versican Plus DHPPi lyophilisate and solvent for suspension for injection for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 1 ml contains: ACTIVE SUBSTANCES: MINIMUM MAXIMUM LYOPHILISATE (LIVE ATTENUATED): Canine distemper virus, strain CDV Bio 11/A 10 3.1 TCID 50 * 10 5.1 TCID 50 * Canine adenovirus Type 2, strain CAV-2 Bio 13 10 3.6 TCID 50 * 10 5.3 TCID 50 * Canine parvovirus Type 2b, strain CPV-2b Bio 12/B 10 4.3 TCID 50 * 10 6.6 TCID 50 * Canine parainfluenza Type 2 virus, strain CPiV-2 Bio 15 10 3.1 TCID 50 * 10 5.1 TCID 50 * Solvent: Water for injections (_Aqua ad iniectabilia_) 1 ml * Tissue culture infectious dose 50%. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection. The visual appearance is as follows: Lyophilisate: spongy matter of white colour. Solvent: clear colourless liquid. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Active immunisation of dogs from 6 weeks of age: to prevent mortality and clinical signs caused by canine distemper virus, to prevent mortality and clinical signs caused by canine adenovirus type 1, Unlimited Renewal March 2024 AN: 03023/2023 Page 2 of 7 to prevent clinical signs and reduce viral excretion caused by canine adenovirus type 2, to prevent clinical signs, leucopoenia and viral excretion caused by canine parvovirus and to prevent clinical signs (nasal and ocular discharge) and reduce viral excretion caused by canine parainfluenza virus. Onset of immunity: 3 weeks after the first vaccination for CDV, CAV, CPV, and 3 weeks after completion of the primary course for CPiV. Duration of immunity: At least three years following the primary vaccination course for canine distemper virus, canine adenovirus type 1, canine adenovirus type 2 and canine parvovirus. The duration of immunity against CAV-2 Lire le document complet