Fevaxyn FeLV

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Feline leukemia virus

Available from:

Pfizer Ltd

ATC code:

QI06AA01

INN (International Name):

Feline leukemia virus

Authorization status:

Expired

Summary of Product characteristics

Revised: April 2010
AN: 02039/2009
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Fevaxyn FeLV
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
QUALITATIVE COMPOSITION
Feline leukaemia virus subgroups A and B inactivated vaccine for
veterinary use.
QUANTITATIVE COMPOSITION
Active Ingredients
Per 1ml dose
Inactivated Feline Leukaemia Virus
>1.0 RP*
*RP = Relative Potency unit of FeLV antigen gp70
Adjuvant
Carbopol
1 mg
Excipients:
Formaldehyde
3.
PHARMACEUTICAL FORM
A milky white suspension for injection.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cats
4.2
INDICATIONS FOR USE SPECIFYING THE TARGET SPECIES
The vaccine is used for the prevention of persistent viraemia
associated with feline leukaemia virus infection.
Onset of immunity is 2 weeks after primary vaccination and the
duration of immunity is one year.
4.3
CONTRAINDICATIONS
Do not vaccinate sick cats.
4.4
SPECIAL WARNINGS
Vaccination has no known beneficial effect in cats already infected
with
FeLV. Therefore, diagnostic testing of cats for the presence of feline
Revised: April 2010
AN: 02039/2009
leukaemia (FeLV) core protein p27 in serum prior to vaccination may
be advisable.
4.5
SPECIAL PRECAUTIONS FOR USE
i. Special precautions for use in animals
In the event of allergic reaction, immediate treatment should be
given using epinephrine (adrenaline) intramuscularly and/or a
short
acting
glucocorticoid
(e.g.
dexamethasone
sodium
phosphate) intravenously.
ii. Special precautions to be taken by the person administering
the veterinary medicinal product to animals
In case of accidental self-injection/ingestion/spillage onto skin,
seek medical advice immediately and show the package insert
or label to the physician.
Other precautions
Fevaxyn FeLV does not have any impact on the environment.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Local injection site reactions such as swelling, pain, pruritis or
hair loss
may occur post vaccination. A small percentage of vaccinated cats may
also develop post vaccination reactions such as fev