Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
CANINE DISTEMPER VIRUS, STRAIN ONDERSTEPOORT, CANINE ADENOVIRUS TYPE 2, STRAIN V197, CANINE PARAINFLUENZA VIRUS, STRAIN FDL, CANINE PARVOVIRUS SAH 2B STRAIN, LEPTOSPIRA INTERROGANS BACTERIA: SEROGROUP CANICOLA, SEROVAR CANICOLA, LEPTOSPIRA INTERROGANS BACTERIA: SEROGROUP ICTEROHAEMORRHAGIAE, SEROVAR ICTEROHAEMORRHAGIAE, CANINE CORONAVIRUS STRAIN TN449
Zoetis Ireland Limited
QI07AJ10
CANINE DISTEMPER VIRUS, STRAIN ONDERSTEPOORT, CANINE ADENOVIRUS TYPE 2, STRAIN V197, CANINE PARAINFLUENZA VIRUS, STRAIN FDL, CAN
Unknown
Lyophilisate and solvent for suspension for injection
POM
Canine
Live Canine distemper virus vaccine + live Canine adenovirus vaccine + live parainfl.virus vaccine +
Immunological - Mixed vaccine (live and inactivated)
Authorised
2013-12-09
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Duramune DAPPi + LC Lyophilisate and solvent for suspension for injection for dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection. Lyophilisate: Cream-yellow colour powder Solvent: opaque liquid. 1. LYOPHILISATE FRACTION: ACTIVE SUBSTANCES PER 1 ML DOSE Canine distemper virus, strain Onderstepoort 10 1.1 to 10 3.4 TCID 50 * Canine adenovirus type 2, strain V197 10 4.0 to 10 6.2 TCID 50 * Canine parvovirus, Strain SAH 10 4.7 to 10 6.5 TCID 50 * Canine parainfluenza virus, strain FDL 10 4.5 to 10 6.8 TCID 50 * *TCID 50 = tissue culture 50% infective dose EXCIPIENTS For a full list of excipients, see section 6.1. 2. LIQUID SOLVENT FRACTION: ACTIVE SUBSTANCES PER 1 ML DOSE Inactivated _Leptospira interrogans _bacteria (outer membrane coat) Serogroup _canicola_, Serovar _canicola_ Potency according to Ph.Eur. * Serogroup _icterohaemorrhagiae_, serovar _icterohaemorrhagiae_ Potency according to Ph.Eur. * Canine coronavirus, strain TN449 (inactivated) RP* 1.0 - 2.0** AJUVANTS Ethylene/Maleic anhydride (EMA-31) 0.1 mg Neocryl 0.015 ml EXCIPIENTS For a full list of excipients, see section 6.1. *hamster 80% protective dose according to Ph. Eur. **Relative Potency HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 30/10/2015_ _CRN 7021631_ _page number: 1_ 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of dogs to prevent mortality and disease caused by canine distemper virus; to prevent mortality and disease and reduce virus shedding caused by canine parvovirus infection; to prevent mortality and reduce clinical Baca dokumen lengkap