Krajina: Malajzia
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
lenalidomide.
Celgene Sdn. Bhd.
lenalidomide.
21Capsule Capsules
Celgene International Sarl
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ REVLIMID _®_ CAPSULE _ _ Lenalidomide (5mg, 10mg, 15mg, 25mg) __________________________________________________________________________________________________ 1 WHAT IS IN THIS LEAFLET 1. What Revlimid ® is used for 2. How Revlimid ® works 3. Before you use Revlimid ® 4. How to use Revlimid ® 5. While you are using it 6. Side effects 7. Storage and disposal of Revlimid ® 8. Product description 9. Manufacturer and product registration holder 10. Date of revision WHAT REVLIMID ® IS USED FOR _What is Revlimid_ _®_ _ _ Revlimid ® contains the active substance ‘lenalidomide’. This medicine belongs to a group of medicines which affect how your immune system works. _What Revlimid_ _®_ _ is used for _ Revlimid ® 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 Revlimid ® 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 Revlimid ® 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 Revlimid ® on its own. Multiple myeloma – in patients who have had treatment before Revlimid ® is taken together with an anti- inflammatory medicine called ‘dexamethasone’. HOW REVLIMID ® WORKS Revlimid ® works by affecting the body’s immune system and directly attacking the cancer. It works in a number of differen Prečítajte si celý dokument
1 1. NAME OF THE MEDICINAL PRODUCT Revlimid ® 5 mg hard capsules Revlimid ® 10 mg hard capsules Revlimid ® 15 mg hard capsules Revlimid ® 25 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ Each Revlimid ® 5 mg hard capsule contains 5 mg of lenalidomide. Excipient: Each capsule contains 147 mg of anhydrous lactose. Each Revlimid ® 10 mg hard capsule contains 10 mg of lenalidomide. Excipient: Each capsule contains 294 mg of anhydrous lactose. Each Revlimid ® 15 mg hard capsule contains 15 mg of lenalidomide. Excipient: Each capsule contains 289 mg of anhydrous lactose. Each Revlimid ® 25 mg hard capsule contains 25 mg of lenalidomide. Excipient: Each capsule contains 200 mg of anhydrous lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. Revlimid ® 5 mg hard capsules: White to off-white, opaque size 2 hard gelatin capsule with a black imprint “REV 5mg”, contains white to off-white to pale-yellow powder. Revlimid ® 10 mg hard capsules: Pale yellow opaque body, blue green opaque cap, size 0, hard gelatin capsules with a black imprint “REV 10mg”, contains white to off-white to pale-yellow powder. Revlimid ® 15 mg hard capsules: White to off-white opaque body, powder blue opaque cap, size 0, hard gelatin capsule with a black imprint “REV 15mg”, contains white to off-white to pale-yellow powder. Revlimid ® 25 mg hard capsules: White to off-white, opaque size 0 hard gelatin capsule with a black imprint “REV 25mg”, contains white to off-white to pale-yellow powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Revlimid ® as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Revlimid ® in combination with dexamethasone is indicated for the treatment of previously untreated multiple myeloma patients who are not eligible for transplant. Revlimid ® in combination with dexamethasone is indicated for the treatment of Prečítajte si celý dokument