Ország: Hollandia
Nyelv: holland
Forrás: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
LENALIDOMIDEHYDROCHLORIDE 1-WATER SAMENSTELLING overeenkomend met ; LENALIDOMIDE
Medac Pharma s.r.l.
L04AX04
LENALIDOMIDEHYDROCHLORIDE 1-WATER COMPOSITION corresponding to ; LENALIDOMIDE
Capsule, hard
AMMONIA (E 527) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSCARMELLOSE NATRIUM (E 468) ; GELATINE (E 441) ; IJZEROXIDE ZWART (E 172) ; KALIUMHYDROXIDE (E 525) ; PROPYLEENGLYCOL (E 1520) ; SCHELLAK (E 904) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171) ; ZWARTE INKT
Oraal gebruik
Lenalidomide
2019-11-20
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LENALIDOMIDE MEDAC 5 MG HARDE CAPSULES LENALIDOMIDE MEDAC 10 MG HARDE CAPSULES LENALIDOMIDE MEDAC 15 MG HARDE CAPSULES LENALIDOMIDE MEDAC 25 MG HARDE CAPSULES lenalidomide READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - 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 [Product name] is and what it is used for 2. What you need to know before you take [Product name] 3. How to take [Product name] 4. Possible side effects 5. How to store [Product name] 6. Contents of the pack and other information 1. WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR WHAT [PRODUCT NAME] IS [Product name] contains the active substance ‘lenalidomide’. This medicine belongs to a group of medicines which affect how your immune system works. [Product name] is used in adults for Multiple myeloma. 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 [Product name] 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 [Product name] is taken w Olvassa el a teljes dokumentumot
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Lenalidomide Medac 5 mg harde capsules Lenalidomide Medac 10 mg harde capsules Lenalidomide Medac 15 mg harde capsules Lenalidomide Medac 25 mg harde capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION [Product name] 5 mg hard capsules Each capsule contains lenalidomide hydrochloride hydrate corresponding to 5 mg of lenalidomide. [Product name] 10 mg hard capsules Each capsule contains lenalidomide hydrochloride hydrate corresponding to 10 mg of lenalidomide. [Product name] 15 mg hard capsules Each capsule contains lenalidomide hydrochloride hydrate corresponding to 15 mg of lenalidomide. [Product name] 25 mg hard capsules Each capsule contains lenalidomide hydrochloride hydrate corresponding to 25 mg of lenalidomide. Excipients with known effect: [Product name] 5 mg hard capsules: Each capsule contains 0.5 mg of sodium. [Product name] 10 mg hard capsules: Each capsule contains 0.9 mg of sodium. [Product name] 15 mg hard capsules: Each capsule contains 1.35 mg of sodium. [Product name] 25 mg hard capsules: Each capsule contains 2.25 mg of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. [Product name] 5 mg hard capsules Hard, non-transparent capsules, size “4” (approximately 14.3 mm in length), imprinted in black with ‘5’ on white body and with white cap, containing off-white to pale yellow or beige powder or compressed powder. [Product name] 10 mg hard capsules Hard, non-transparent capsules, size “2” (approximately 18 mm in length), imprinted in black with ‘10’ on ivory body and with green cap, containing off-white to pale yellow or beige powder or compressed powder. 2 [Product name] 15 mg hard capsules Hard, non-transparent capsules, size “1” (approximately 19.4 mm in length), imprinted in black with ‘15’ on white body and with blue cap, containing off-white to pale yellow or beige powder or compressed powder. [Product name] 25 mg hard capsules Hard, non-transparent capsu Olvassa el a teljes dokumentumot