SUMMARY OF THE PRODUCT CHARACTERISTICS

1. NAME OF THE IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCT

Nobivac FeLV, suspension for injection for cats

2. Qualitative and quantitative composition

Per dose of 1 ml:

Active substance

Minimum quantity of purified p45 FeLV-envelope antigen 102 µg

Adjuvants

3 % aluminium hydroxide gel expressed as mg Al 1 ml

Purified extract of Quillaja saponaria 10 µg

Excipient

Buffered isotonic solution to 1 ml

For a full list of excipients, see section 6.1

3. Pharmaceutical form

Suspension for injection.

Opalescent liquid.

4. Clinical particulars

4.1 Target species

Cat.

4.2 Indications for use, specifying the target species

• For active immunisation of healthy cats to prevent persistent feline leukaemia-virus viraemia and any associated clinical signs of the feline leucosis.

• The onset of protection begins 2 weeks after immunisation and the duration of protection lasts one year after the primo-vaccination.

4.3 Contra-indications

Since no data have been generated, it is recommended not to vaccinate females during pregnancy and lactation.

4.4 Special Warnings

None.

4.5 Special precautions for use

Special precautions for use in animals

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.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

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

4.6 Adverse reactions (frequency and seriousness)

Transient and small thickening or nodule, approximately 5 - 10 mm in size, may be observed at the injection site and disappear within 2 to 6 weeks without treatment. Occasionally, systemic reactions (hyperthermia, anorexia, lethargy) may occur within one or two days after vaccine administration.

Where Nobivac FeLV has been used to reconstitute cat vaccines in the Nobivac range containing feline calicivirus (F9 strain), feline rhinotracheitis virus (G2620A strain) and/or feline panleucopenia virus (MW-1 or Bristol strain) prior to inoculation, a small nodule at the site of vaccination is frequently observed. It can persist for up to 18 days post-inoculation. Occasionally, the nodule may be painful for up to 6 days after injection. A transient rise in body temperature or lameness may occur and last up to 3 days post vaccination. In some cases, a slight dullness or reduced appetite may be observed for up to 1 day post vaccination.

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

4.7 Use during pregnancy, lactation or lay

Do not use in pregnant or lactating cats.

4.8 Interaction with other medicinal products and other forms of interaction

Safety and/or efficacy data are available which demonstrate that this vaccine can be mixed with cat vaccines of the Nobivac range containing feline calicivirus (F9 strain), feline rhinotracheitis virus (G2620A strain) and/or feline panleucopenia virus (MW-1 or Bristol strain).

Do not mix with other medicinal products except cat vaccines of the Nobivac range containing feline calicivirus (F9 strain), feline rhinotracheitis virus (G2620A strain) and/or feline panleucopenia virus (MW-1 or Bristol strain).

4.9 Amounts to be administered and administration route

Shake the vial before use. Administer viathe subcutaneous route 1 dose of Nobivac FeLV according to the following regimen of vaccination.

Basic vaccination scheme

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

A second injection of cats 3 to 4 weeks later.

Re-vaccination scheme

Annual.

Nobivac FeLV can be used to reconstitute 1 dose (1 vial) of cat vaccines of the Nobivac range containing feline calicivirus (F9 strain), feline rhinotracheitis virus (G2620A strain) and/or feline panleucopenia virus (MW-1 or Bristol strain) immediately prior to use by the addition of the contents of one vial (1 ml) of Nobivac FeLV.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

No undesirable effects have been seen after the administration of an overdose of Nobivac FeLV except those indicated in section 4.6. Adverse reactions (frequency and seriousness)

4.11 Withdrawal period

Not applicable.

5. IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: inactivated viral vaccine.

ATCVet code: QI06AA01. Vaccine against feline leukaemia

The vaccine contains the purified p45 FeLV- envelope antigen, obtained by genetic recombination of the E. colistrain. The antigen suspension is adjuvanted with an aluminium hydroxide gel and with a purified extract of Quillaja saponaria.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sodium chloride

Disodium phosphate anhydrous

Potassium dihydrogen phosphate

Aluminium hydroxide

Quillaja saponaria

6.2 Incompatibilities

Do not mix with other medicinal products except cat vaccines of the Nobivac range containing feline calicivirus (F9 strain), feline rhinotracheitis virus (G2620A strain) and/or feline panleucopenia virus (MW-1 or Bristol strain).

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life after first opening the immediate packaging: use immediately.

6.4 Special precautions for storage

Store and transport refrigerated (2 °C - 8 °C).

Do not freeze.

Protect from sunlight.

6.5 Nature and composition of immediate packaging

A 3 ml-glass vial with a 13 mm-diameter butyl elastomer stopper and set with an aluminium capsule.

Cardboard or plastic box with 10 vials.

Cardboard or plastic box with 50 vials.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

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

7. MARKETING AUTHORISATION HOLDER

Virbac S.A.

1ère avenue - 2065m – L.I.D.

06516 Carros Cedex

France

8. MARKETING AUTHORISATION NUMBER

Vm05653/4059

9. DATE OF FIRST AUTHORISATION

Date:28 October 2005

10. DATE OF REVISION OF THE TEXT

Date:April 2015

Approved: 29 April 2015