Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
CANINE DISTEMPER VIRUS (LEDERLE STRAIN), CANINE PARVOVIRUS (CPV 780916 STRAIN), CANINE ADENOVIRUS TYPE 2 (MANHATTAN STRAIN), CANINE PARAINFLUENZA (MANHATTAN STRAIN)
Virbac S.A.
QI07AD04
CANINE DISTEMPER VIRUS (LEDERLE STRAIN), CANINE PARVOVIRUS (CPV 780916 STRAIN), CANINE ADENOVIRUS TYPE 2 (MANHATTAN STRAIN), CAN
Per Cent
Lyophilisate and solvent for suspension for injection
POM
Canine
Canine distemper virus vaccine + Canine adenovirus vaccine + Canine parvovirus vaccine + Canine para
Immunological - Live Vaccine
Authorised
2016-09-16
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT CANIXIN DHPPi lyophilisate and solvent for suspension for injection for dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 1 ml contains: ACTIVE SUBSTANCES: LYOPHILISATE : SOLVENT: 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. Lyophilisate: White pellet. Solvent: Colourless liquid. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dog Canine distemper virus (CDV) - Lederle strain 10 3.0 - 10 4.9 CCID 50 Canine adenovirus type 2 (CAV-2) - Manhattan strain 10 4.0 - 10 6.0 CCID 50 Canine parvovirus (CPV) - CPV780916 strain 10 5.0 - 10 6.8 CCID 50 Canine parainfluenza virus (CPIV) - Manhattan strain 10 5.0 - 10 6.9 CCID 50 Cell culture infectious dose 50 % * * * * * HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 16/09/2016_ _CRN 7021356_ _page number: 1_ 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of dogs from 8 weeks of age to: - prevent mortality and clinical signs caused by canine distemper virus; - prevent mortality and clinical signs caused by canine adenovirus type 1; - prevent clinical signs and mortality and reduce excretion caused by canine parvovirus in challenge studies performed with a CPV-2b strain; - prevent clinical signs and reduce excretion caused by canine parvovirus in a challenge study performed with a CPV-2c strain - reduce respiratory clinical signs and viral excretion caused by canine parainfluenza virus and canine adenovirus type 2; Onset of immunity: The onset of immunity has been demonstrated: • From 3 weeks after the primary vaccination for CDV Read the complete document