מדינה: מלטה
שפה: אנגלית
מקור: Medicines Authority
BORTEZOMIB
Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
L01XX32
BORTEZOMIB 3.5 mg
POWDER FOR SOLUTION FOR INJECTION
BORTEZOMIB 3.5 mg
POM
ANTINEOPLASTIC AGENTS
Withdrawn
2015-06-05
1 PACKAGE LEAFLET: INFORMATION FOR THE USER BORTEZOMIB ACTAVIS 3.5 MG POWDER FOR SOLUTION FOR INJECTION bortezomib READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Bortezomib Actavis is and what it is used for 2. What you need to know before you use Bortezomib Actavis 3. How to use Bortezomib Actavis 4. Possible side effects 5. How to store Bortezomib Actavis 6. Contents of the pack and other information 1. WHAT BORTEZOMIB ACTAVIS IS AND WHAT IT IS USED FOR Bortezomib Actavis contains the active substance bortezomib, a so-called ‘proteasome inhibitor’. Proteasomes play an important role in controlling cell function and growth. By interfering with their function, bortezomib can kill cancer cells. Bortezomib Actavis is used for the treatment of multiple myeloma (a cancer of the bone marrow) in patients older than 18 years: - alone or together with the medicines pegylated liposomal doxorubicin or dexamethasone, for patients whose disease is worsening (progressive) after receiving at least one prior treatment and for whom blood stem cell transplantation was not successful or is unsuitable. - in combination with the medicines melphalan and prednisone, for patients whose disease has not been previously treated and are unsuitable for high-dose chemotherapy with blood stem cell transplantation. - in combination with the medicines dexamethasone or dexamethasone together with thalidomide, for patients whose disease has not been previously treated and before receiving high-dose chemotherapy with blood stem cell transplantation (induction treatment). Bortezomib Actavis is used for the treatment of mantle cell lymphoma (a type of cancer affecting the lym קרא את המסמך השלם
Page 1 of 37 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Bortezomib Actavis 3.5 mg powder for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 3.5 mg bortezomib (as a mannitol boronic ester). After reconstitution, 1 ml of solution for subcutaneous injection contains 2.5 mg bortezomib. After reconstitution, 1 ml of solution for intravenous injection contains 1 mg bortezomib. For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Powder for solution for injection. White to off-white cake or powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Bortezomib Actavis as monotherapy or in combination with pegylated liposomal doxorubicin or dexamethasone is indicated for the treatment of adult patients with progressive multiple myeloma who have received at least 1 prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation. Bortezomib Actavis in combination with melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for high-dose chemotherapy with haematopoietic stem cell transplantation. Bortezomib Actavis in combination with dexamethasone, or with dexamethasone and thalidomide, is indicated for the induction treatment of adult patients with previously untreated multiple myeloma who are eligible for high-dose chemotherapy with haematopoietic stem cell transplantation. Bortezomib Actavis in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation. Page 2 of 37 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment must be initiated and administered under the supervision of a physician qualified and experienced in the use of chemotherapeutic agents. Bortezomib Actavis must be reconstituted by a healthcare professional. Posology for treatment קרא את המסמך השלם