Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
INACTIVATED SUB-UNIT ANTIGEN (GP70) OF FELINE LEUKAEMIA VIRUS (FELV) SUBTYPES A,B&C (KAWAKAMI-THEILEN STRAIN), QUIL A, CHOLESTEROL, DDA (DIMETHYL-DIOCTADECYL AMMONIUM BROMIDE), CARBOPOL
Zoetis Ireland Limited
QI06AA01
INACTIVATED SUB-UNIT ANTIGEN (GP70) OF FELINE LEUKAEMIA VIRUS (FELV) SUBTYPES A,B&C (KAWAKAMI-THEILEN STRAIN), QUIL A, CHOLESTER
Suspension for Injection
POM: Prescription Only Medicine as defined in relevant national legislation
Feline
feline leukaemia virus
Immunological - Inactivated vaccine
Authorised
2013-08-29
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Versifel FeLV, suspension for injection for cats 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose of 1 ml contains: ACTIVE SUBSTANCE: Inactivated feline leukaemia virus (FeLV) subtypes A, B and C (Kawakami-Theilen strain) including gp70 sub-unit antigen, inducing anti-gp70 antibodies GMT 8.1 log 2 * * As determined by mouse potency test (anti-gp70 antibodies, GMT denotes: geometric mean titre) ADJUVANTS: For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Suspension for injection. Slightly opaque suspension. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For active immunization of susceptible cats from 9 weeks of age to reduce the number of cats infected with FeLV and presenting clinical signs of the related disease. No data are available in the studies to demonstrate protection against related clinical disease but prevention of infection is associated with protection against related clinical disease. Onset of immunity occurs within four weeks of the completion of the primary vaccination course. The duration of immunity is at least one year after the primary course and three years after the booster. 4.3 CONTRAINDICATIONS None. Quil A 20 µg Cholesterol 20 µg DDA (Dimethyl-dioctadecyl ammonium bromide) 10 µg Carbomer 0.5 mg H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _2_ _9_ _/_ _0_ _1_ _/_ _2_ _0_ _1_ _6_ _C_ _R_ _N_ _ _ Leggi il documento completo