Negara: Malaysia
Bahasa: Inggris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LENALIDOMIDE
CAMBER LABORATORIES SDN. BHD.
LENALIDOMIDE
3x7s Capsules
Hetero Labs Limited
Consumer Medication Information Leaflet (RiMUP) LINADEX 5/10/15/25 Lenalidomide Capsules (5 mg, 10 mg, 15 mg & 25 mg) Page. 1 What is in this leaflet 1. What LINADEX is used for 2. How LINADEX works 3. Before you use LINADEX 4. How to use LINADEX 5. While you are using it 6. Side effects 7. Storage and disposal of LINADEX 8. Product description 9. Manufacturer and product registration holder 10. Date of revision 11. Serial Number What LINADEX is used for What is LINADEX LINADEX contains the active substance ‘lenalidomide’. This medicine belongs to a group of medicines which affect how your immune system works. What LINADEX is used for LINADEX is used in adults for multiple myeloma. What is multiple myeloma Multiple myeloma is a type of cancer which affects a certain kind of white blood cell, called the plasma cell. These cells collect in the bone marrow and divide, becoming out of control. This can damage the bones and kidneys. Multiple myeloma generally cannot be cured. However, the signs and symptoms can be greatly reduced or disappear for a period of time. This is called a ‘response’. Newly diagnosed multiple myeloma – in patients who have had a bone marrow transplant LINADEX is used on its own as maintenance therapy after patients have recovered enough following a bone marrow transplant. Newly diagnosed multiple myeloma – in patients who cannot have a bone marrow transplant LINADEX is taken with an anti- inflammatory medicine called ‘dexamethasone’. You will take this other medicine at the start of treatment and then continue to take LINADEX on its own. Multiple myeloma – in patients who have had treatment before LINADEX is taken together with an anti- inflammatory medicine called ‘dexamethasone’. How LINADEX works LINADEX works by affecting the body’s immune system and directly attacking the cancer. It works in a number of different ways: • by stopping the cancer cells developing • by stopping blood vessels growing in the cancer • by stimulating part of the immune system to atta Baca dokumen lengkapnya
LINADEX 5 (Lenalidomide Capsules 5 mg) LINADEX 10 (Lenalidomide Capsules 10 mg) LINADEX 15 (Lenalidomide Capsules 15 mg) LINADEX 25 (Lenalidomide Capsules 25 mg) Font size: 7 NAME AND STRENGTH OF ACTIVE INGREDIENT Each capsule of LINADEX 5 contains 5 mg Lenalidomide. Each capsule of LINADEX 10 contains 10 mg Lenalidomide. Each capsule of LINADEX 15 contains 15 mg Lenalidomide. Each capsule of LINADEX 25 contains 25 mg Lenalidomide. DOSAGE FORM Oral (Capsules) PRODUCT DESCRIPTION LINADEX 5 (Lenalidomide Capsules 5 mg): White opaque cap and white opaque body, size '2' hard gelatin capsules with 'H' on cap and 'L2' on body, imprinted in black, filled with off white to pale yellow color powder. LINADEX 10 (Lenalidomide Capsules 10 mg): Orange opaque cap and white opaque body, size '0' hard gelatin capsules with 'H' on cap and 'L4' on body, imprinted in black, filled with off white to pale yellow color powder. LINADEX 15 (Lenalidomide Capsules 15 mg): Red opaque cap and white opaque body, size '0' hard gelatin capsules with 'H' on cap and 'L5' on body, imprinted in black, filled with off white to pale yellow color powder. LINADEX 25 (Lenalidomide Capsules 25 mg): White opaque cap and white opaque body, size '0' hard gelatin capsules with 'H' on cap and 'L7' on body, imprinted in black, filled with off white to pale yellow color powder. PHARMACODYNAMICS Pharmacotherapeutic group: Other immunosuppressants. ATC code: L04AX04. Mechanism of action The lenalidomide mechanism of action includes anti-neoplastic, anti-angiogenic, pro-erythropoietic, and immunomodulatory properties. Specifically, lenalidomide inhibits proliferation of certain haematopoietic tumour cells (including MM plasma tumour cells and those with deletions of chromosome 5), enhances T cell- and Natural Killer (NK) cell-mediated immunity and increases the number of NK T cells, inhibits angiogenesis by blocking the migration and adhesion of endothelial cells and the formation of micro vessels, augments foetal haemoglobin production by CD34+ haematopoietic st Baca dokumen lengkapnya