Страна: Європейський Союз
мова: англійська
Джерело: EMA (European Medicines Agency)
vCP1338 virus
Boehringer Ingelheim Vetmedica GmbH
QL03AX
feline interleukin-2 recombinant canarypox virus (vCP1338 virus)
Cats
Immunostimulants, ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS, Immunostimulants,
Immunotherapy to be used in association with surgery and radiotherapy in cats with fibrosarcoma (2-5 cm diameter) without metastasis or lymph node involvement, to reduce the risk of relapse and increase the time to relapse (local recurrence or metastasis).
Revision: 5
Authorised
2013-05-03
14 B. PACKAGE LEAFLET 15 PACKAGE LEAFLET: 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: Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein GERMANY Manufacturer responsible for batch release: Boehringer Ingelheim Animal Health France SCS 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) ....................................... ≥ 10 6.0 EAID* 50 *ELISA infectious dose 50%. Lyophilisate: whitish homogeneous pellet. Solvent: clear colourless liquid. 4. INDICATION(S) 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 A moderate local reaction (pain on palpation, swelling, scratching) occurred very commonly in safety studies. It usually disappeared spontaneously within 1 week at most. Transient apathy and fever (above 39.5 °C) occurred commonly in field studies. 16 The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reaction(s)) during the course of one treatment) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated ) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very Прочитайте повний документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Oncept IL-2 lyophilisate and solvent for suspension for injection for cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION After reconstitution, each dose of 1 ml contains: ACTIVE SUBSTANCE: Feline interleukin-2 recombinant canarypox virus (vCP1338) ......................................... ≥ 10 6.0 EAID * 50 * ELISA infectious dose 50%. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection. Lyophilisate: whitish homogeneous pellet. Solvent: clear colourless liquid. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES 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. 4.3 CONTRAINDICATIONS None. 4.4 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 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 benefit-risk balance. Efficacy of the treatment has not been investigated beyond 2 years following treatment. 3 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Not applicable. Special precautions to be taken by the person administerin Прочитайте повний документ