Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Canine Parainfluenza, live; Leptospira interrogans serogroup canicola, inactivated; Leptospira interrogans serogroup icterohaemorragiae, inactivated
Virbac S.A.
QI07AI08
Canine Parainfluenza, live; Leptospira interrogans serogroup canicola, inactivated; Leptospira interrogans serogroup icterohaemorragiae, inactivated
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Lyophilisate and suspension for suspension for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Dogs
live canine parainfluenza virus + inactivated leptospira
Immunological
Authorised
2017-04-13
Health Products Regulatory Authority 31 January 2022 CRN00CHWY Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT CANIXIN Pi/L lyophilisate and suspension for suspension for injection for dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 1 ml contains: ACTIVE SUBSTANCES: Lyophilisate: Live attenuated canine parainfluenza virus (CPiV), Manhattan strain 10 4.8 - 10 6.9 CCID 50 * * Cell culture infectious dose 50% Suspension: Inactivated _Leptospira interrogans_: - serogroup Canicola serovar Canicola, strain 601903 4350 - 7330 U** - serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae, strain 601895 4250 - 6910 U** ** Antigenic mass ELISA units EXCIPIENTS For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Lyophilisate and suspension for suspension for injection. Lyophilisate: White lyophilisate. Suspension: Translucent liquid. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dog. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunisation of dogs from 8 weeks of age to: - reduce respiratory clinical signs and viral excretion caused by canine parainfluenza virus; - prevent mortality and reduce infection, clinical signs, kidney colonisation, renal lesions and urine shedding of _Leptospira _ Canicola; - reduce infection, clinical signs, kidney colonisation and urine shedding of _Leptospira_ Icterohaemorrhagiae; Onset of immunity: The onset of immunity has been demonstrated from 4 weeks after the primary vaccination for CPiV, 5 weeks for _Leptospira_ Canicola and 2 weeks for _Leptospira_ Icterohaemorrhagiae_._ Duration of immunity: The duration of immunity lasts for one year after the primary vaccination for all components. In the one-year duration of immunity studies there was no significant difference between vaccinated and control dogs in viral excretion for CPiV, in reduction of kidney colonisation for _Leptospira_ Canicola and _Leptospira_ Icterohaemorrhagiae, nor in renal lesions and urine shedding for _Leptospira_ Canicola. 4.3 read_full_document