Země: Švédsko
Jazyk: švédština
Zdroj: Läkemedelsverket (Medical Products Agency)
everolimus
medac pharma s.r.l
L01EG02
everolimus
5 mg
Tablett
everolimus 5 mg Aktiv substans; laktos (vattenfri) Hjälpämne; laktosmonohydrat Hjälpämne; butylhydroxitoluen Hjälpämne
Receptbelagt
Avregistrerad
2019-03-29
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Everolimus medac 5 mg tablets Everolimus medac 10 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Everolimus medac 5 mg tablets Each tablet contains 5 mg everolimus. Excipient with known effect: Each tablet contains 149 mg lactose. Everolimus medac 10 mg tablets Each tablet contains 10 mg everolimus. Excipient with known effect: Each tablet contains 297 mg lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Everolimus medac 5 mg tablets White, oblong, flat, bevelled edge tablets, marked with “EV” on one side and “5” on the other. Everolimus medac 10 mg tablets White, oblong, flat, bevelled edge tablets, marked with “EV” on one side and “10” on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Hormone receptor-positive advanced breast cancer _ Everolimus medac is indicated for the treatment of hormone receptor-positive, HER2/neu negative advanced breast cancer, in combination with exemestane, in postmenopausal women without symptomatic visceral disease after recurrence or progression following a non-steroidal aromatase inhibitor. _Neuroendocrine tumours of pancreatic origin _ Everolimus medac is indicated for the treatment of unresectable or metastatic, well- or moderately- differentiated neuroendocrine tumours of pancreatic origin in adults with progressive disease. _Neuroendocrine tumours of gastrointestinal or lung origin _ Everolimus medac is indicated for the treatment of unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) non-functional neuroendocrine tumours of gastrointestinal or lung origin in adults with progressive disease (see sections 4.4 and 5.1). _Renal cell carcinoma _ Everolimus medac is indicated for the treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with VEGF-targeted therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Everolimus medac should be initiated and supe Přečtěte si celý dokument