Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
toceranib
Zoetis Belgium SA
QL01EX90
toceranib
Dogs
Antineoplastic agents
Treatment of non-resectable Patnaik grade-II (intermediate-grade) or -III (high-grade), recurrent, cutaneous mast-cell tumours in dogs.
Revision: 10
Authorised
2009-09-23
17 B. PACKAGE LEAFLET 18 PACKAGE LEAFLET: PALLADIA 10 MG FILM-COATED TABLETS FOR DOGS. PALLADIA 15 MG FILM-COATED TABLETS FOR DOGS. PALLADIA 50 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: Zoetis Belgium SA Rue Laid Burniat 1 1348 Louvain-la-Neuve BELGIUM Manufacturer responsible for the batch release: Pfizer Italia s.r.l. Località Marino del Tronto 63100 Ascoli Piceno (AP) ITALY 2. NAME OF THE VETERINARY MEDICINAL PRODUCT Palladia 10 mg film-coated tablets for dogs. Palladia 15 mg film-coated tablets for dogs. Palladia 50 mg film-coated tablets for dogs. toceranib. 3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Each film-coated tablet contains toceranib phosphate equivalent to 10 mg, 15 mg or 50 mg of toceranib as active substance. Each tablet also contains lactose monohydrate, cellulose microcrystalline, magnesium stearate, silica colloidal anhydrous and Crospovidone. Palladia are round tablets and have a coloured film coat to minimise risk of exposure and to help identify the correct tablet strength. Palladia 10 mg: blue Palladia 15 mg: orange Palladia 50 mg: red 4. INDICATION(S) Treatment of non-resectable Patnaik grade II (intermediate grade) or III (high grade), recurrent, cutaneous mast cell tumours. 19 5. CONTRAINDICATIONS Do not use in pregnant or lactating bitches or in dogs intended for breeding. Do not use in cases of hypersensitivity to the active substance or to any of the excipients. Do not use in dogs less than 2 years of age or less than 3 kg bodyweight. Do not use in dogs with evidence of stomach bleeding. Your veterinarian will advise you if this is the case for your dog. 6. ADVERSE REACTIONS Results from the clinical field study involving 151 treated and placebo-treated dogs showed that the clinical signs of the disease (mast cell tumour) and treatment related adverse reactions are very similar in nature. Some Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Palladia 10 mg film-coated tablets for Dogs Palladia 15 mg film-coated tablets for Dogs Palladia 50 mg film-coated tablets for Dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Each film-coated tablet contains toceranib phosphate equivalent to 10 mg, 15 mg or 50 mg of toceranib. EXCIPIENTS: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets. Palladia 10 mg: Round shaped, blue coloured tablets Palladia 15 mg: Round shaped, orange coloured tablets Palladia 50 mg: Round shaped, red coloured tablets Each tablet is marked with the strength (10, 15 or 50) on one side, the reverse side is blank. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of non-resectable Patnaik grade II (intermediate grade) or III (high grade), recurrent, cutaneous mast cell tumours in dogs . 4.3 CONTRAINDICATIONS Do not use in pregnant or lactating bitches or in dogs intended for breeding. Do not use in cases of hypersensitivity to the active substance or to any of the excipients. Do not use in dogs less than 2 years of age or less than 3 kg body weight. Do not use in dogs with gastrointestinal bleeding. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES For any mast cell tumour treatable by surgery, surgery should be the first choice of treatment. 4.5 SPECIAL PRECAUTIONS FOR USE Special precautions for use in animals Dogs should be carefully monitored. Dose reductions and/or dose interruptions may be needed to manage adverse events. Treatment should be reviewed weekly for the first six weeks and every six 3 weeks thereafter or at intervals deemed appropriate by the veterinarian. Evaluations should include assessment of clinical signs reported by the pet owner. To appropriately use the dose adjustment table it is advised that a complete blood cell count, serum chemistry panel and urinalysis be conducted prior to initiation of treatment and Aqra d-dokument sħiħ