מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
CANINE DISTEMPER VIRUS STRAIN N-CDV (LIVE, ATTENUATED), CANINE ADENOVIRUS TYPE 2 VIRUS, STRAIN MANHATTAN (LIVE, ATTENUATED), CANINE PARAINFLUENZA TYPE 5 VIRUS, STRAIN NL-CPI-5 (LIVE, ATTENUATED), CANINE PARVOVIRUS, STRAIN NL-35-D, LIVE ATTENUATED, LEPTOSPIRA ICTEROHAEMORRHAGIAE INACTIVATED, LEPTOSPIRA CANICOLA INACTIVATED
Zoetis Ireland Limited
QI07AI02
CANINE DISTEMPER VIRUS STRAIN N-CDV (LIVE, ATTENUATED), CANINE ADENOVIRUS TYPE 2 VIRUS, STRAIN MANHATTAN (LIVE, ATTENUATED), CAN
%v/v
Lyophilisate and solvent for solution for injection
POM
Canine
Live Canine distemper virus vaccine + live Canine adenovirus vaccine + live Canine parainfluenza vi
Immunological - Mixed vaccine (live and inactivated)
Authorised
2014-09-12
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT VANGUARD 7 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Quantity per 1 ml dose ACTIVE SUBSTANCE(S): Freeze dried fraction: Vanguard DA 2 Pi Canine distemper virus, strain N-CDV (live attenuated) minimum titre: 10 3.0 CCID 50 * Canine adenovirus Type 2, strain Manhattan (live attenuated) minimum titre: 10 3.2 CCID 50 * Canine parainfluenza virus, strain NL-CPI-5 (live attenuated) minimum titre: 10 6.0 CCID 50 * Liquid fraction: Vanguard CPV-L Canine Parvovirus, strain NL-35-D, low passage (live attenuated) minimum titre : 10 7.0 CCID 50 * _Leptospira canicola _(inactivated) at least 40 hamster protective doses _Leptospira icterohaemorrhagiae _(inactivated) at least 40 hamster protective doses. *Cell culture infectious dose-50 For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Lyophilisate and solvent for solution for injection. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Canine from 6 weeks of age. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 29/09/2014_ _CRN 7019006_ _page number: 1_ 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Active immunisation of dogs to prevent clinical signs of disease and reduce infection caused by canine adenovirus Type 2, to prevent mortality and clinical signs including leucopenia and reduce viral shedding caused by canine parvovirus (types 2a, 2b and 2c), to prevent clinical signs of disease caused by canine distemper virus and canine adenovirus Type 1, to reduce pathological signs of disease caused by parainfluenzavirus and to reduce infection caused by _Leptospira canicola _and _Leptospira icterohaemorrhagiae_. Onset of immunity occurs by approximately 2 weeks afte קרא את המסמך השלם