Land: Israel
Sprache: Englisch
Quelle: Ministry of Health
LENALIDOMIDE
NEOPHARM SCIENTIFIC LTD
L04AX04
HARD CAPSULE
LENALIDOMIDE 25 MG
PER OS
Required
CELGENE EUROPE LTD, UK
LENALIDOMIDE
LENALIDOMIDE
Multiple Myeloma (MM)Revlimid is indicated for the treatment of multiple myeloma.Myelodysplastic Syndromes REVLIMID is indicated for patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.Revlimid 7.5 mg is not indicated for treatment in MDS.Mantle Cell LymphomaREVLIMID is indicated for the treatment of adult patients with relapsed and/or refractory mantle cell lymphoma (MCL).Follicular lymphomaRevlimid in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma.
2014-04-30
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) 1986 This medicine is dispensed with a doctor's prescription only REVLIMID 2.5 MG, 5 MG, 7.5 MG, 10 MG, 15 MG, 20 MG, 25 MG HARD CAPSULES Each hard capsule contains: Lenalidomide 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg or 25 mg. INACTIVE INGREDIENTS AND ALLERGENS: see section ‘IMPORTANT INFORMATION ABOUT SOME OF THIS MEDICINE’S INGREDIENTS’, and section 6 ‘ADDITIONAL INFORMATION’. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. In addition to the leaflet, Revlimid has a Patient Information Brochure. This brochure contains important safety information that you need to know, before starting and during treatment with Revlimid and you should act according to it. The brochure focuses on the risk of birth defects to an unborn baby. Read the Patient Information Brochure and the Patient Information Leaflet before you begin taking the medicine. Keep the brochure for future reference if necessary. 1. WHAT IS THIS MEDICINE INTENDED FOR? Revlimid is used in adult patients for: • Multiple myeloma • Myelodysplastic syndromes (MDS) • Mantle cell lymphoma (MCL) • Follicular lymphoma Revlimid 7.5 mg is not indicated for treatment of myelodysplastic syndromes. THERAPEUTIC GROUP: The medicine belongs to a group of medicines which affect how your immune system works. How Revlimid works Revlimid 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 attack the cancer cells MULTIPLE MYELOMA Multiple mye Lesen Sie das vollständige Dokument
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Revlimid 2.5 mg, hard capsules Revlimid 5 mg, hard capsules Revlimid 7.5 mg, hard capsules Revlimid 10 mg, hard capsules Revlimid 15 mg, hard capsules Revlimid 20 mg, hard capsules Revlimid 25 mg, hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Revlimid 2.5 mg hard capsules Each capsule contains 2.5 mg of lenalidomide. Excipient(s) with known effect Each capsule contains 73.5 mg of lactose (as anhydrous lactose). Revlimid 5 mg hard capsules Each capsule contains 5 mg of lenalidomide. Excipient(s) with known effect Each capsule contains 147 mg of lactose (as anhydrous lactose). Revlimid 7.5 mg hard capsules Each capsule contains 7.5 mg of lenalidomide. Excipient(s) with known effect Each capsule contains 144.5 mg of lactose (as anhydrous lactose). Revlimid 10 mg hard capsules Each capsule contains 10 mg of lenalidomide. Excipient(s) with known effect Each capsule contains 294 mg of lactose (as anhydrous lactose). Revlimid 15 mg hard capsules Each capsule contains 15 mg of lenalidomide. Excipient(s) with known effect Each capsule contains 289 mg of lactose (as anhydrous lactose). Revlimid 20 mg hard capsules Each capsule contains 20 mg of lenalidomide. Excipient(s) with known effect Each capsule contains 244.5 mg of lactose (as anhydrous lactose). Revlimid 25 mg hard capsules Each capsule contains 25 mg of lenalidomide. Excipient(s) with known effect Each capsule contains 200 mg of lactose (as anhydrous lactose). 2 For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. Revlimid 2.5 mg hard capsules Blue-green/white capsules, size 4, 14.3 mm, marked “REV 2.5 mg”. Revlimid 5 mg hard capsules White capsules, size 2, 18.0 mm, marked “REV 5 mg”. Revlimid 7.5 mg hard capsules Pale yellow/white capsules, size 2, 18.0 mm, marked “REV 7.5 mg”. Revlimid 10 mg hard capsules Blue-green/pale yellow capsules, size 0, 21.7 mm, marked “REV 10 mg”. Revlimid 15 mg hard capsules Pale blue/white capsules, siz Lesen Sie das vollständige Dokument