Masivet
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
26-09-2013
Produktets egenskaber
(SPC)
26-09-2013
Offentlige vurderingsrapport
(PAR)
15-05-2009
Aktiv bestanddel:
Masitinib mesilate
Tilgængelig fra:
AB Science S.A.
ATC-kode:
QL01XE90
INN (International Name):
masitinib mesilate
Terapeutisk gruppe:
Dogs
Terapeutisk område:
Antineoplastic agents
Terapeutiske indikationer:
Treatment of non-resectable dog mast-cell tumours (grade 2 or 3) with confirmed mutated c-KIT tyrosine-kinase receptor.
Produkt oversigt:
Revision: 6
Autorisation status:
Authorised
Autorisation dato:
2008-11-17
Indlægsseddel
20
B. PACKAGE LEAFLET
21
PACKAGE LEAFLET
MASIVET 50 MG FILM-COATED TABLETS FOR DOGS
MASIVET 150 MG FILM-COATED TABLETS FOR DOGS
1.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF
THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH
RELEASE, IF DIFFERENT
Marketing authorisation holder:
AB Science S.A.
3 avenue George V
FR-75008 Paris
France
Manufacturer for batch release:
Centre Spécialités Pharmaceutiques
Avenue du Midi
63800 Cournon d’Auvergne
France
The printed package leaflet of the medicinal product must state the
name and address of the
manufacturer responsible for the release of the concerned batch.
2.
NAME OF THE VETERINARY MEDICINAL PRODUCT
MASIVET 50 mg film-coated tablets for dogs
MASIVET 150 mg film-coated tablets for dogs
3.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
MASIVET is a light-orange, round, film-coated tablet.
Each tablet contains either 50 mg or 150 mg of masitinib, which is the
active substance. Each tablet
also contains Sunset yellow FCF (E 110) aluminium lake and Titanium
dioxide (E171) as colourants.
The tablets are market with “50” or “150” on one side, and
with the company logo on the other side.
4.
INDICATION(S)
Masivet is for the treatment of dogs with non-resectable mast cell
tumours (Grade 2 or 3) with a
confirmed mutated c-kit tyrosine kinase receptor.
5.
CONTRAINDICATIONS
Your dog should not be given Masivet if it:
•
is pregnant or nursing puppies,
•
is less 6 months of age or weights less than 4 kg,
•
is suffering from inadequate liver or renal function,
•
has an anaemia or low neutrophil count,
•
has an allergic reaction to masitinib, the active ingredient of
Masivet or an excipient used in
this medicine.
22
6.
ADVERSE REACTIONS
SHOULD I EXPECT SIDE EFFECTS FOR MY DOG DURING MASIVET THERAPY?
Masivet like any other medicine may cause adverse reactions. Your
veterinarian can best describe
these for you.
Very common effects:
Mild to moderate gastrointestinal reactions (diarrhoea and vomiting)
with a mean duration o
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
MASIVET 50 mg film-coated tablets for dogs
MASIVET 150 mg film-coated tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains:
ACTIVE SUBSTANCE:
Masitinib 50 mg (equivalent to masitinib mesylate 59.6 mg)
Masitinib 150 mg (equivalent to masitinib mesylate 178.9 mg)
EXCIPIENTS.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Light-orange, round shape, film-coated tablet embossed with “50”
or “150” on one side and the
company logo on the other side.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of non-resectable dog mast cell tumours (Grade 2 or 3) with
confirmed mutated c-kit
tyrosine kinase receptor.
4.3
CONTRAINDICATIONS
Do not use in pregnant or lactating bitches (see section 4.7).
Do not use in dogs less than 6 months of age or less than 4 kg body
weight.
Do not use in dogs suffering from liver impairment, defined as AST or
ALT > 3 x Upper Limit of
Normal (ULN). Do not use in dogs suffering from renal function
impairment, defined as Urinary
Protein Creatinine (UPC) ratio > 2 or albumin < 1 x Lower Limit of
Normal (LLN).
Do not use in dogs with anaemia (haemoglobin < 10 g/dl).
Do not use in dogs with neutropenia defined as absolute neutrophil
count < 2,000 /mm
3
.
Do not use in case of hypersensitivity to the active substance or to
any of the excipients.
4.4
SPECIAL WARNINGS
For any mast cell tumour treatable by surgery, surgery should be the
first choice of treatment.
Masitinib treatment should only be used in dogs with non-resectable
mast cell tumours and which
express the mutated c-kit tyrosine kinase receptor. The presence of a
mutated tyrosine kinase c-kit
receptor must be confirmed prior to treatment (see also section 5.1).
3
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Dogs should be carefully monitored and treatment might need to be
adj
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