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Oncept IL-2 (vCP1338 virus) – Package leaflet - QL03AX

PACKAGE LEAFLET FOR:

Oncept IL-2

lyophilisate and solvent for suspension for injection for cats

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

Marketing authorisation holder: MERIAL

29, avenue Tony Garnier 69007 Lyon

France

Manufacturer responsible for batch release: MERIAL

Laboratoire Porte des Alpes Rue de l'Aviation

69800 Saint Priest France

2.NAME OF THE VETERINARY MEDICINAL PRODUCT

Oncept IL-2 lyophilisate and solvent for suspension for injection for cats

3.STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

After reconstitution, each dose of 1 ml contains:

 

Feline interleukin-2 recombinant canarypox virus (vCP1338) .......................................

≥ 106.0 EAID*50

*ELISA infectious dose 50 %.

 

Lyophilisate: whitish homogeneous pellet.

 

Solvent: clear colourless liquid.

 

4.INDICATIONS

Immunotherapy to be used in addition to surgery and radiotherapy in cats with fibrosarcoma (2-5 cm diameter) without metastasis or lymph node involvement in order to reduce the risk of relapse and to increase the time to relapse (local recurrence or metastasis). This was demonstrated in a field trial over a period of 2 years.

5.CONTRAINDICATIONS

None.

6.ADVERSE REACTIONS

Transient apathy and fever (above 39.5 °C) may occur.

A moderate local reaction may occur (pain on palpation, swelling, scratching) that usually disappears spontaneously within 1 week at most.

If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.

7.TARGET SPECIES

Cats.

8.DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION

Subcutaneous use.

After reconstitution of the lyophilisate with the solvent, shake gently and administer five injections (each approximately 0.2 ml) around the tumour excision site: one injection at each corner and one injection at the centre of a 5 cm x 5 cm square centred on the middle of the surgical scar.

Treatment course: 4 administrations at 1-week intervals (day 0, day 7, day 14, day 21) followed by 2 administrations at 2-week intervals (day 35, day 49).

Start the treatment course the day before radiation therapy, preferably within one month after surgical excision.

9.ADVICE ON CORRECT ADMINISTRATION

Use immediately after reconstitution.

10.WITHDRAWAL PERIOD

Not applicable.

11.SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

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

Store in the original package in order to protect from light.

Do not freeze.

Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP.

12.SPECIAL WARNINGS

Special warnings for each target species:

Use of the recommended mode of administration in 5 injection points is important for achieving efficacy of the product; injection in 1 point may lead to reduced efficacy (see section “Dosage for each species, route and method of administration”).

Efficacy has only been tested in conjunction with surgery and radiotherapy; therefore the treatment should be conducted according to treatment course described in section “Dosage for each species, route and method of administration”.

Efficacy has not been tested in cats with metastasis or lymph node involvement.

As safety and efficacy of repetition of the treatment to treat fibrosarcoma recurrence have not been investigated, repetition of the treatment should be considered by the veterinarian taking into account the benefit-risk balance.

Efficacy of the treatment has not been investigated beyond 2 years following treatment.

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

Canarypox recombinants are known to be safe for humans. Mild local and/or systemic adverse reactions related to the injection itself may be observed transitorily. Moreover feline IL-2 has been shown to have very low biological activity on human leukocytes compared to human IL-2. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

Pregnancy and lactation:

The safety of the veterinary medicinal product has not been established during pregnancy and lactation.

Overdose (symptoms, emergency procedures, antidotes):

After the administration of an overdose (10 doses), transient moderate to marked hyperthermia, as well as local reactions (swelling, redness or slight pain, and in some cases, heat at the injection site) may occur.

Interaction with other medicinal products and other forms of interaction:

No information is available on the safety and efficacy of this immunological veterinary medicinal product when used with any other veterinary medicinal product. A decision to use this immunological veterinary medicinal product before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.

Incompatibilities:

Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the veterinary medicinal product.

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.

14.DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.

15.OTHER INFORMATION

The vaccine strain vCP1338 is a recombinant canarypox virus expressing feline interleukin-2 (IL-2). The virus expresses the IL-2 gene at the inoculation site, but does not replicate in the cat.

Oncept IL-2 injected into the tumour bed thus delivers in situ a low dose of feline interleukin-2, which stimulates antitumour immunity while avoiding toxicity associated with systemic treatment.

Specific mechanisms by which immunostimulation induces anti-tumoural activity is not known.

In a randomized clinical study, cats from different origins presenting a fibrosarcoma without metastasis or lymph node involvement were included in two groups, one receiving the reference treatment – surgery and radiotherapy – and the other receiving Oncept IL-2 in addition to surgery and radiotherapy. After two years of study follow-up, Oncept IL-2 treated cats showed a longer median time to relapse (above 730 days) compared to control cats (287 days). Oncept IL-2 treatment reduced the risk of relapse, from 6 months after the start of treatment, by approximately 56% after 1 year and 65% after 2 years, compared to the control group.

Cardboard box containing 6 vials of 1 dose of lyophilisate and 6 vials of 1 ml of solvent.

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