Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
CANINE PARAINFLUENZA VIRUS (PHILIPS ROXANE STRAIN) CORONA VIRUS (STRAIN FEC-SAH) LEPTOSPIRA INTERROGANS SEROVAR ICTEROHAEMORRHAGIAE (STRAIN 115) LEPTOSPIRA INTERROGANS SEROVAR CANICOLA (STRAIN 117)
Intervet Ireland Limited
QI07AJ12
Lyophilisate and solvent for suspension for injection
Immunological - Mixed vaccine (live and inactivated)
Canine
2011-01-28
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Procyon Dog Pi/CvL Lyophilisate and solvent for suspension for injection for dogs. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION i. Pi – freeze dried fraction ii. CvL – liquid diluent fraction 1 Tissue culture infective dose 50% 2 Serum Neutralisation value in guinea pig potency test 3 Hamster protective dose 80% (Ph.Eur. monograph) EXCIPIENTS For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. ACTIVE SUBSTANCE (LIVE ATTENUATED) Quantity per dose (log 10 TCID 50 1 ) Canine parainfluenza virus (Philips Roxane strain) 4.8 – 6.1 ACTIVE SUBSTANCES (INACTIVATED) Quantity per 1 ml dose Feline coronavirus (strain FEC-SAH) > 6.3 log 2 SN units 2 _Leptospira interrogans _serovar _icterohaemorrhagiae_ (strain 115) > 40 Hamster PD 80 3 _Leptospira interrogans _serovar _canicola_ (strain 117) > 40 Hamster PD 80 3 ADJUVANT Aluminium Hydroxide 1.63 -2.21 mg IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 01/02/2011_ _CRN 7007581_ _page number: 1_ 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the active immunisation of dogs from 6 weeks of age: - to prevent mortality and reduce clinical signs of disease caused by _Leptospira interrogans _serovars _canicola _and _icterohaemorrhagiae_; - to reduce viral shedding of canine parainfluenza virus - to reduce intestinal infection caused by canine coronavirus Immunity has been demonstrated from: - 3 weeks after the primary vaccination course for parainfluenza (serological response only) and for coronavirus - 4 weeks after the primary vaccination course for _Leptospira interrogans _serovars Läs hela dokumentet