Versifel FeLV
Ülke: Almanya
Dil: İngilizce
Kaynak: HMA (Heads of Medicines Agencies)
Bilgilendirme broşürü
(PIL)
09-07-2013
Ürün özellikleri
(SPC)
09-07-2013
Aktif bileşen:
feline leukaemia virus 8.1 log2
Mevcut itibaren:
Pfizer Limited
ATC kodu:
QI06AA01
Farmasötik formu:
Suspension for injection
Terapötik grubu:
Feline leukaemia virus
Terapötik alanı:
Cats Non Food
Yetkilendirme tarihi:
2012-07-25
Bilgilendirme broşürü
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
Belgenin tamamını okuyun
Ürün özellikleri
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
Belgenin tamamını okuyun
