Land: Malta
Språk: engelska
Källa: Medicines Authority
LENALIDOMIDE
Fresenius Kabi Italia S.r.l Via Camagre 41, 37063 Isola della Scala (Vr) , Italy
L04AX04
LENALIDOMIDE 7.5 mg
HARD CAPSULE
LENALIDOMIDE 7.5 mg
POM
IMMUNOSUPPRESSANTS
Authorised
2018-11-06
Page 1 of 13 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LENALIDOMIDE FRESENIUS KABI 2.5 MG HARD CAPSULES LENALIDOMIDE FRESENIUS KABI 5 MG HARD CAPSULES LENALIDOMIDE FRESENIUS KABI 7.5 MG HARD CAPSULES LENALIDOMIDE FRESENIUS KABI 10 MG HARD CAPSULES LENALIDOMIDE FRESENIUS KABI 15 MG HARD CAPSULES LENALIDOMIDE FRESENIUS KABI 20 MG HARD CAPSULES LENALIDOMIDE FRESENIUS KABI 25 MG HARD 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 Lenalidomide Fresenius Kabi is and what it is used for 2. What you need to know before you take Lenalidomide Fresenius Kabi 3. How to take Lenalidomide Fresenius Kabi 4. Possible side effects 5. How to store Lenalidomide Fresenius Kabi 6. Contents of the pack and other information 1 WHAT LENALIDOMIDE FRESENIUS KABI IS AND WHAT IT IS USED FOR Lenalidomide Fresenius Kabi contains the active substance lenalidomide. This medicine belongs to a group of medicines which affect how your immune system works. Lenalidomide Fresenius Kabi is used in adults for • Multiple Myeloma • Myelodysplastic syndromes • Mantle cell lymphoma • Follicular lymphoma 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’. Läs hela dokumentet
1. NAME OF THE MEDICINAL PRODUCT Lenalidomide Fresenius Kabi 2.5 mg hard capsules Lenalidomide Fresenius Kabi 5 mg hard capsules Lenalidomide Fresenius Kabi 7.5 mg hard capsules Lenalidomide Fresenius Kabi 10 mg hard capsules Lenalidomide Fresenius Kabi 15 mg hard capsules Lenalidomide Fresenius Kabi 20 mg hard capsules Lenalidomide Fresenius Kabi 25 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 2.5 mg of lenalidomide. Each capsule contains 5 mg of lenalidomide. Each capsule contains 7.5 mg of lenalidomide. Each capsule contains 10 mg of lenalidomide. Each capsule contains 15 mg of lenalidomide. Each capsule contains 20 mg of lenalidomide. Each capsule contains 25 mg of lenalidomide. Excipient(s) with known effect: Each capsule contains 33.2 mg of lactose. Each capsule contains 66.4 mg of lactose. Each capsule contains 99.7 mg of lactose. Each capsule contains 132.9 mg of lactose. Each capsule contains 199.3 mg of lactose. Each capsule contains 265.8 mg of lactose. Each capsule contains 332.2 mg of lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. Opaque white body and opaque green to light green cap, with a length of approximately14.3 mm, marked “L9NL” and “2.5”. Opaque white body and opaque white cap, with a length of approximately 18.0 mm, marked “L9NL” and “5”. Opaque white body and opaque yellow cap, with a length of approximately 18.0 mm, marked “L9NL” and “7.5”. Opaque yellow body and opaque green to light green cap, with a length of approximately 21.7 mm, marked “L9NL” and “10”. Opaque white body and opaque blue to light blue cap, with a length of approximately 21.7 mm, marked “L9NL” and “15”. Opaque blue to light blue body and opaque green to light green cap, with a length of approximately 21.7 mm, marked “L9NL” and “20”. Opaque white body and opaque white cap, with a length of approximately 21.7 mm, marked “L9NL” and “25”. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDI Läs hela dokumentet