Revised: April 2010
AN: 02039/2009
SUMMARY OF PRODUCT CHARACTERISTICS
- NAME OF THE VETERINARY MEDICINAL PRODUCT
Fevaxyn FeLV
- QUALITATIVE AND QUANTITATIVE COMPOSITION
Qualitative composition
Feline leukaemia virus subgroups A and B inactivated vaccine for veterinary use.
Quantitative composition
Active IngredientsPer 1ml dose
Inactivated Feline Leukaemia Virus >1.0 RP*
*RP = Relative Potency unit of FeLV antigen gp70
Adjuvant
Carbopol 1 mg
Excipients:
Formaldehyde
- PHARMACEUTICAL FORM
A milky white suspension for injection.
- CLINICAL PARTICULARS
4.1Target Species
Cats
4.2Indications 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.
4.3Contraindications
Do not vaccinate sick cats.
4.4Special warnings
Vaccination has no known beneficial effect in cats already infected with FeLV. Therefore, diagnostic testing of cats for the presence of feline leukaemia (FeLV) core protein p27 in serum prior to vaccination may be advisable.
4.5Special 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.
4.6Adverse 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.
4.7Use during pregnancy, lactation or lay
Do not vaccinate cats during pregnancy.
4.8Interactions 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.
4.9Amounts 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.
4.10Overdose (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.
4.11Withdrawal period(s)
Not Applicable.
- 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
- PHARMACEUTICAL PARTICULARS
6.1List of excipients
Phosphate buffer saline
6.2Incompatibilities
Do not mix with any other vaccine/immunological product except Katavac CHP or Eclipse IV provided that these two vaccines are authorised.
6.3Shelf life
12 months
6.4Special precautions for storage
Store and transport refrigerated (2°C - 8°C).
Protect from light.
Do not freeze.
6.5Nature 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.
6.6Special 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.
- MARKETING AUTHORISATION HOLDER
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
- MARKETING AUTHORISATION NUMBERS
Vm00057/4320
- DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
March 2001
- DATE OF REVISION OF THE TEXT
April 2010
PROHIBITION OF SUPPLY, SALE AND/OR USE
Not Applicable