Страна: Франція
мова: англійська
Джерело: 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 Прочитайте повний документ
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 Прочитайте повний документ