Suspension for injection

Presentation

The inactivated vaccine contains 102 μg per ml of purified p45 FeLV-envelope antigen, obtained by genetic recombination of a strain of E. coli. The antigenic suspension is adjuvanted with

0.1 ml of a 3% aluminium hydroxide gel and with 10μg purified extract of Quillaja saponaria.

Uses

For active immunisation of healthy cats to prevent persistent feline leukaemia virus viraemia and any associated clinical signs. The onset of protection begins 2 weeks after immunisation and the duration of protection lasts one year after the primary vaccination course.

Dosage and administration

Shake the vial before use. Administer via the subcutaneous route 1 dose of Nobivac FeLV according to the following protocol.

Basic vaccination scheme

A first injection in cats from minimum 8 weeks of age.

A second injection in cats 3 to 4 weeks later.

Revaccination scheme

Annual revaccination.

Nobivac FeLV can be used to reconstitute 1 dose (1 vial) of Nobivac Tricat immediately prior to use by the addition of the contents of 1 vial (1 ml) Nobivac FeLV.

Contra-indications, warnings, etc.

Since no data have been generated, do not use to vaccinate females during pregnancy and lactation.

Transient mild skin thickening or nodule formation, approximately 5-10 mm in size, may be observed at the injection site and disappear within 2 to 6 weeks without treatment.

Where Nobivac FeLV has been used to reconstitute Nobivac Tricat prior to inoculation, a small, painless nodule at the site of vaccination is frequently observed. It can persist for up to 13 days post inoculation.

In the rare event of hypersensitivity reaction following vaccination, administer an antihistamine, corticosteroid or adrenaline without delay and by the most immediate route.

Occasionally, systemic reactions (hyperthermia, anorexia, lethargy) may occur within one to two days after vaccine administration.

No undesirable effects have been seen after the administration of an overdose of Nobivac FeLV except those indicated above.

The vaccine should be administered in accordance with the usual aseptic conditions for vaccination.

Vaccinate only healthy animals.

It is recommended that animals be treated for intestinal parasites at least 10 days prior to vaccination.

No information is available on the safety and efficacy from the concurrent use of this vaccine with any other except Nobivac Tricat. It is therefore recommended that no vaccine other than Nobivac Tricat should be administered within 14 days before or after vaccination with Nobivac FeLV.

Do not mix with other vaccine/immunological product except Nobivac Tricat.

Operator warnings:

In the case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

Withdrawal period:

Not applicable.

FOR ANIMAL TREATMENT ONLY.

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.

Pharmaceutical precautions

Store and transport in the original package at a temperature of 4°C ± 2°C and away from light.

Do not freeze.

Keep container in the outer carton.

Any unused product or waste material should be disposed of in accordance with national requirements.

Legal category

POM-V                                  To be supplied only on veterinary prescription.

Package quantities

Cardboard boxes containing 10 or 50 single dose vials of vaccine.

Not all presentations may be marketed.

Further information

Nobivac FeLV has been developed by genetic engineering technology which allows for the production of the single specific antigen responsible for the stimulation of full immunity to all components of FeLV disease.  This antigen is sub-group A FeLV p45 which is the specific fraction of the envelope glycoprotein gp70 involved in the immune process.  In field condi­tions, only sub-group A of FeLV is infective and once established in the cat’s body it leads to the production of sub-groups B, C and FOCMA.  By concentrating only sub-group A p45 in the vaccine, full protection is achieved with no danger of infection or immunosuppression re­sulting from the inclusion of other viral components in the vaccine.

Marketing Authorisation number

Vm 05653/4059

Distributor:

Intervet UK Ltd.

Walton Manor, Walton

Milton Keynes, Bucks MK7 7AJ

Date of text preparation:

February 2007.

Item code: 097702                                                                                                       61501^.Aug2007/MP/2K