国家: 法国
语言: 英文
来源: HMA (Heads of Medicines Agencies)
canine adenovirus 4 log10 CCID50, canine distemper virus 3.15 log10 CCID50, canine parainfluenza virus 5 log10 CCID50, canine parvovirus 5 log10 CCID50, leptospira interrogans serogroup canicola 8.33 8log10 bact/mL, leptospira interrogans serogroup icterohaemorragiae 8.33 8log10 bact/mL
Virbac S.A.
QI07AI02
Powder and solvent for suspension for injection
live canine distemper virus + live canine adenovirus + live canine parainfluenza virus + live canine parvovirus + inactivated le
Dogs
2011-12-16
CANIGEN/CANIXIN DHPPI/L – FR/V/0/0237/001/MR The release requirements for the finished product are the following : _FREEZE-DRIED FRACTION _ TEST ACCEPTABILITY LIMITS aspect White pellet pH 7.2 +/- 0.5 Solubility Satisfactory Titres – in log 10 TCID 50 CDV CAV-2 CPiV CPV ≥ 4.1 ≥ 5.1 ≥ 5.9 ≥ 5.3 Sterility mycoplasma extraneous agents Sterile Absence absence Residual humidity 0.1 - 3 % _LIQUID FRACTION _ TEST ACCEPTABILITY LIMITS Aspect Translucid liquid pH 7.2 +/- 0.5 Volume 1.2 +/- 0.2 Mercurothiolate content <6.35 µg/ml potency Conform to EP test described in monograph 0447 Sterility Sterile Inactivation Absence of leptopsirae 阅读完整的文件
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT CANIGEN DHPPi/L (FR) CANIXIN DHPPi/L (UK) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Lyophilisate (before lyophilisation) Canine distemper virus (CDV) - Lederle strain 10 3.15 - 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 * Excipient QSF 1 dose * Cell culture infectious dose 50% Suspension Inactivated _Leptospira interrogans_ serogroup canicola serovar canicola minimum titre not less than 8,33 10 8 bact/ml before inactivation conferring > 80% protection* _ _ Inactivated _Leptospira interrogans_ serogroup icterohaemorrhagiae serovar icterohaemorrhagiae minimum titre not less than 8,33 10 8 bact/ml before inactivation conferring > 80% protection* Excipient QSF 1 dose of 1 ml *According to Eur. pharmacopeia monograph 447, Hamster potency test For full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Lyophilisate and suspension for suspension for injection. Lyophilisate: White pellet Suspension: Translucent liquid 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dog 4.2 INDICATIONS FOR USE For active immunisation of dogs from 8 weeks of age to: - prevent mortality and clinical signs of canine distemper and infectious canine hepatitis caused by canine adenovirus type 1; - prevent mortality and clinical signs and reduce excretion caused by canine parvovirus in a challenge s 阅读完整的文件