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 fever, vomiting,
anorexia and lethargy.
Hypersensitivity reactions such as urticaria or facial oedema,
sometimes accompanied by respiratory signs have been reported.
4.7
Use during pregnancy, lactation or lay
Do not vaccinate cats during pregnancy.
4.8
Interactions with other medicinal products and other forms
of interaction
Animals that have received immunosuppressive drugs should not be
vaccinated until an interval of at least four weeks has elapsed.
No information is available on the safety and efficacy from the
concurrent use of this vaccine with any other product except Katavac
CHP or Eclipse IV provided that these two vaccines are authorised. It is
therefore recommended that no other vaccines than these should be
administered within 14 days before or after vaccination with the product.
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4.9
Amounts to be administered and administration route
The vaccination of female cats prior to mating is recommended to
provide maternally derived antibody for the kittens.
One full dose of 1 ml of the vaccine is to be administered
subcutaneously to cats of 9 weeks of age or older.
Vaccination Schedule
Primary vaccination:
A single dose of Fevaxyn FeLV should be administered from 9 weeks
of age followed by a second injection after an interval of 3 weeks.
Booster vaccination:
Booster vaccinations are recommended every 12 months.
4.10
Overdose (symptoms, emergency procedures, antidotes), if
necessary
Administration of an overdose does not result in significantly worse
adverse reactions to those seen after administration of a single dose.
4.11
Withdrawal period(s)
Not Applicable.
5.
IMMUNOLOGICAL PROPERTIES
To stimulate active immunity against Feline Leukaemia virus antigen
gp70.
The antigen was selected on its immunogenic property. The FeLV
subgroup-A Rickard strain is known to cause the typical symptoms of
Feline Leukaemia. Subgroup-B and subgroup-C are recombinations of
subgroup-A with cat genome sequences. Subgroup-A and B are part
of Fevaxyn FeLV vaccine antigen and should also immunise against
subgroup-C.
After infection with FeLV, cats develop either a transient or persistent
viraemia. Persistent viraemia is strongly correlated with degenerative,
proliferative or neoplastic changes of cells of the haemopoietic system
resulting in immunosuppression, leukaemia or tumours. On the other
hand, transiently viraemic cats may develop a protective immunity
resulting in either the elimination of cells with integrated FeLV genome
or a persistent, non-productive latent infection.
ATC Vet Code: QI06AA01
Environmental properties
Please refer to section 4.5
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6.
PHARMACEUTICAL PARTICULARS
6.1
List of excipients
Phosphate buffer saline
6.2
Incompatibilities
Do not mix with any other vaccine/immunological product except
Katavac CHP or Eclipse IV provided that these two vaccines are
authorised.
6.3
Shelf life
12 months
6.4
Special precautions for storage
Store and transport refrigerated (2°C - 8°C).
Protect from light.
Do not freeze.
6.5
Nature and composition of immediate packaging
Vial:
Type I (Ph.Eur.) borosilicate glass. 2 ml capacity
Closure: Type I (Ph.Eur.) bromobutyl rubber stoppers sealed with
aluminium crimp caps
Pack Sizes
Packs with 10 x 1 ml doses.
6.6
Special precautions for the disposal of unused veterinary
medicinal product or waste materials derived from the use
of such products
Any unused vaccine or waste material should be disposed of in
accordance with local requirements.
7.
MARKETING AUTHORISATION HOLDER
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
8.
MARKETING AUTHORISATION NUMBERS
Vm 00057/4320
Revised: April 2010
AN: 02039/2009
9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
March 2001
10.
DATE OF REVISION OF THE TEXT
April 2010
PROHIBITION OF SUPPLY, SALE AND/OR USE
Not Applicable