Versifel FeLV
Country: Գերմանիա
language: անգլերեն
source: HMA (Heads of Medicines Agencies)
PIL active_ingredient:
feline leukaemia virus 8.1 log2
MAH:
Pfizer Limited
ATC_code:
QI06AA01
pharmaceutical_form:
Suspension for injection
therapeutic_group:
Feline leukaemia virus
therapeutic_area:
Cats Non Food
authorization_date:
2012-07-25
PIL
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
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SPC
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
read_full_document
