País: Grécia
Língua: inglês
Origem: HMA (Heads of Medicines Agencies)
feline leukaemia virus 8.1 log2
Pfizer Limited
QI06AA01
Suspension for injection
Feline leukaemia virus
Cats Non Food
2012-07-25
Versifel FeLV 1 of 16 MRP VAR 1A/004/G – 04/07/2013 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Versifel FeLV 2 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Versifel FeLV Suspension for injection for cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml dose of Versifel FeLV contains the following: 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 Carbopol 0.5 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM 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. Versifel FeLV 3 of 16 Onset of immunity occurs within four weeks of the complet Leia o documento completo
Versifel FeLV 1 of 16 MRP D90 REVISION – 25/07/2012 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Versifel FeLV 2 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Versifel FeLV Suspension for injection for cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml dose of Versifel FeLV contains the following: 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 Carbopol 0.5 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM 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. Versifel FeLV 3 of 16 Onset of immunity occurs within four weeks of the completio Leia o documento completo