Oncept IL-2 (vCP1338 virus) – Package leaflet - QL03AX
Updated on site: 09-Feb-2018
|Medication name:||Oncept IL-2|
- 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
- 2. NAME OF THE VETERINARY MEDICINAL PRODUCT
- 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
- 4. INDICATIONS
- 5. CONTRAINDICATIONS
- 6. ADVERSE REACTIONS
- 7. TARGET SPECIES
- 8. DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
- 9. ADVICE ON CORRECT ADMINISTRATION
- 10. WITHDRAWAL PERIOD
- 11. SPECIAL STORAGE PRECAUTIONS
- 12. SPECIAL WARNINGS
- 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
- 14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
- 15. OTHER INFORMATION
PACKAGE LEAFLET FOR:
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
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
3.STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
After reconstitution, each dose of 1 ml contains:
≥ 106.0 EAID*50
*ELISA infectious dose 50 %.
Lyophilisate: whitish homogeneous pellet.
Solvent: clear colourless liquid.
Immunotherapy to be used in addition to surgery and radiotherapy in cats with fibrosarcoma
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.
8.DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
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
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.
11.SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
Store and transport refrigerated (2
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.
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
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
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.
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/.
The vaccine strain vCP1338 is a recombinant canarypox virus expressing feline
Specific mechanisms by which immunostimulation induces
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
Cardboard box containing 6 vials of 1 dose of lyophilisate and 6 vials of 1 ml of solvent.