Oncept IL-2
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
20-08-2020
Valmisteyhteenveto
(SPC)
20-08-2020
Julkisesta arviointikertomuksesta
(PAR)
18-07-2013
Aktiivinen ainesosa:
vCP1338 virus
Saatavilla:
Boehringer Ingelheim Vetmedica GmbH
ATC-koodi:
QL03AX
INN (Kansainvälinen yleisnimi):
feline interleukin-2 recombinant canarypox virus (vCP1338 virus)
Terapeuttinen ryhmä:
Cats
Terapeuttinen alue:
Immunostimulants, ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS, Immunostimulants,
Käyttöaiheet:
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).
Tuoteyhteenveto:
Revision: 5
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2013-05-03
Pakkausseloste
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
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Valmisteyhteenveto
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
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