Država: Malezija
Jezik: angleščina
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
LENALIDOMIDE (POVIDONE)
Dr. Reddy`s Laboratories Malaysia Sdn. Bhd.
LENALIDOMIDE (POVIDONE)
1 x 7 Capsules; 2 x 7 Capsules; 3 x 7 Capsules; 4 x 7 Capsules; 3 x 10 Capsules
DR. REDDY'S LABORATORIES LIMITED
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ LENANGIO ® 5/10/15/25 Lenalidomide Hard Capsules (5mg, 10mg, 15mg, 25mg) 1 WHAT IS IN THIS LEAFLET 1. What Lenangio is used for 2. How Lenangio works 3. Before you use Lenangio 4. How to use Lenangio 5. While you are using it 6. Side effects 7. Storage and disposal of Lenangio 8. Product description 9. Manufacturer and product registration holder 10. Date of revision WHAT LENANGIO IS USED FOR _What is Lenangio _ Lenangio contains the active substance ‘lenalidomide’. This medicine belongs to a group of medicines which affect how your immune system works _. _ _ _ _What Lenangio_ _ _ _is used for _ Lenangio 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 Lenangio 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 Lenangio 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 Lenangio on its own. Multiple myeloma – in patients who have had treatment before Lenangio is taken together with an anti- inflammatory medicine called ‘dexamethasone’. HOW LENANGIO WORKS Lenangio 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 Preberite celoten dokument
1 PRESCRIBING INFORMATION LENANGIO ® 5 (LENALIDOMIDE HARD CAPSULES 5 MG) LENANGIO ® 10 (LENALIDOMIDE HARD CAPSULES 10 MG) LENANGIO ® 15 (LENALIDOMIDE HARD CAPSULES 15 MG) LENANGIO ® 25 (LENALIDOMIDE HARD CAPSULES 25 MG) COMPOSITION LENANGIO ® 25 (LENALIDOMIDE HARD CAPSULES 25 MG) Each hard capsule contains: Lenalidomide 25mg LENANGIO ® 15 (LENALIDOMIDE HARD CAPSULES 15 MG) Each hard capsule contains: Lenalidomide 15mg LENANGIO ® 10 (LENALIDOMIDE HARD CAPSULES 10 MG) Each hard capsule contains: Lenalidomide 10 mg LENANGIO ® 5 (LENALIDOMIDE HARD CAPSULES 5 MG) Each hard capsule contains: Lenalidomide 5mg For the full list of excipients, see section LIST OF EXCIPIENTS PHARMACEUTICAL FORM Hard capsule. _Lenangio_ ® _ 25 (Lenalidomide Hard Capsules 25 mg)_ : White to off white colored powder filled in size ‘0’ hard gelatin capsules with opaque white colored cap imprinted ‘RDY’ with black ink and opaque white colored body imprinted ‘25mg’ with black ink _Lenangio_ ® _ 15 (Lenalidomide Hard Capsules 15 mg)_ : White to off white colored powder filled in size ‘1’ hard gelatin capsules with blue colored cap imprinted ‘RDY’ with black ink and white colored body imprinted ‘15mg’ with black ink. _Lenangio_ ® _ 10 (Lenalidomide Hard Capsules 10 mg)_ : White to off white colored powder filled in size ‘2’ hard gelatin capsules with pale green colored cap imprinted ‘RDY’ with black ink and pale yellow colored body imprinted ‘10mg’ with black ink. WARNING: Lenalidomide should never be taken by pregnant women or women capable of becoming pregnant as even a single dose can cause severe birth defects or death to an unborn baby. 2 _Lenangio_ ® _ 5 (Lenalidomide Hard Capsules 5 mg)_ : White to off white colored powder filled in size ‘4’ hard gelatin capsules with White opaque colored cap imprinted ‘RDY’ with black ink and White opaque colored body imprinted ‘5mg’ with black ink CLINICAL INFORMATION THERAPEUTIC INDICATIONS Lenangio ® as monotherapy is indicated for the mainten Preberite celoten dokument