Oncept IL-2 (vCP1338 virus) – Summary of product characteristics - QL03AX
Updated on site: 09-Feb-2018
|Medication name:||Oncept IL-2|
- 1. NAME OF THE VETERINARY MEDICINAL PRODUCT
- 2. QUALITATIVE AND QUANTITATIVE COMPOSITION
- 4. CLINICAL PARTICULARS
- 4.1 Target species
- 4.2 Indications for use, specifying the target species
- 4.4 Special warnings
- 4.5 Special precautions for use
- 4.6 Adverse reactions (frequency and seriousness)
- 4.7 Use during pregnancy, lactation or lay
- 4.8 Interaction with other medicinal products and other forms of interaction
- 4.9 Amounts to be administered and administration route
- 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
- 4.11 Withdrawal period
- 5. IMMUNOLOGICAL PROPERTIES
- 6. PHARMACEUTICAL PARTICULARS
- 7. MARKETING AUTHORISATION HOLDER
- 8. MARKETING AUTHORISATION NUMBERS
- 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
- 10. DATE OF REVISION OF THE TEXT
1.NAME OF THE VETERINARY MEDICINAL PRODUCT
2.QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, each dose of 1 ml contains:
≥ 106.0 EAID*50
*ELISA infectious dose 50%.
For the full list of excipients, see section 6.1.
Lyophilisate and solvent for suspension for injection.
Lyophilisate: whitish homogeneous pellet.
Solvent: clear colourless liquid.
4.2Indications for use, specifying the target species
Immunotherapy to be used in addition to surgery and radiotherapy in cats with fibrosarcoma
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 4.9). Efficacy has only been tested in conjunction with surgery and radiotherapy; therefore the treatment should be conducted according to treatment course described in section 4.9.
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.
4.5Special precautions for use
Special precautions for use in animals
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
4.6Adverse reactions (frequency and seriousness)
Transient apathy and hyperthermia (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.
4.7Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
4.8Interaction 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.
4.9Amounts to be administered and administration route
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.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
After the administration of an overdose (10 doses), transient moderate to marked hyperthermia, as well as local reactions (swelling, erythema or slight pain, and in some cases, heat at the injection site) may occur.
4.11 Withdrawal period
Pharmacotherapeutic group: Antineoplastic and immunomodulating agents, other immunostimulants. ATCvet code: QL03AX.
The vaccine strain vCP1338 is a recombinant canarypox virus expressing feline
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
6.1List of excipients
Disodium phosphate dihydrate
Potassium dihydrogen phosphate.
Water for injections.
Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the veterinary medicinal product.
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 after reconstitution.
6.4Special precautions for storage
Store and transport refrigerated (2
Store in the original package in order to protect from light.
Do not freeze.
6.5Nature and composition of immediate packaging
Type I glass vial with a butyl elastomer closure, sealed with an aluminium cap.
Cardboard box of 6 vials of 1 dose of lyophilisate and 6 vials of 1 ml of solvent.
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.
7.MARKETING AUTHORISATION HOLDER
29 Avenue Tony Garnier
8.MARKETING AUTHORISATION NUMBERS
9.DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10.DATE OF REVISION OF THE TEXT
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
PROHIBITION OF SALE, SUPPLY AND/OR USE