Država: Evropska unija
Jezik: angleščina
Source: EMA (European Medicines Agency)
Masitinib mesilate
AB Science S.A.
QL01XE90
masitinib mesilate
Dogs
Antineoplastic agents
Treatment of non-resectable dog mast-cell tumours (grade 2 or 3) with confirmed mutated c-KIT tyrosine-kinase receptor.
Revision: 6
Authorised
2008-11-17
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 Preberite celoten dokument
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 Preberite celoten dokument