Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Feline leukemia virus
Zoetis UK Limited
QI06AA01
Feline leukemia virus
Suspension for injection
POM-V - Prescription Only Medicine – Veterinarian
Cats
Inactivated Viral Vaccine
Authorized
2012-12-20
Revised: October 2019 AN: 01048/2019 Page 1 of 6 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: Quil A 20 g Cholesterol 20 g DDA (Dimethyl-dioctadecyl ammonium bromide) 10 g Carbomer 0.5 mg. 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. Revised: October 2019 AN: 01048/2019 Page 2 of 6 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. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Only healthy animals should be vaccinated. Do not vaccinate FeLV antigen positive cats. Therefore a test for presence of FeLV before vaccination is recommended. No data are available for the efficacy of the product in presence of maternal derived antibodies. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Not applicable. Special precautions to be taken by the person administering the veterinary medicinal product to animals In case of accidental self-injection Read the complete document