Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Pomalidomide
Bristol-Myers Squibb Pharma EEIG
L04AX06
pomalidomide
Immunosuppressants
Multiple Myeloma
Imnovid in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide.Imnovid in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.
Revision: 24
Authorised
2013-08-05
56 B. PACKAGE LEAFLET 57 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT IMNOVID 1 MG HARD CAPSULES IMNOVID 2 MG HARD CAPSULES IMNOVID 3 MG HARD CAPSULES IMNOVID 4 MG HARD CAPSULES pomalidomide This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. IMNOVID IS EXPECTED TO CAUSE SEVERE BIRTH DEFECTS AND MAY LEAD TO THE DEATH OF AN UNBORN BABY. • Do not take this medicine if you are pregnant or could become pregnant. • You must follow the contraception advice described in this leaflet. 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, pharmacist or nurse. • 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, pharmacist or nurse. • This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Imnovid is and what it is used for 2. What you need to know before you take Imnovid 3. How to take Imnovid 4. Possible side effects 5. How to store Imnovid 6. Contents of the pack and other information 1. WHAT IMNOVID IS AND WHAT IT IS USED FOR WHAT IMNOVID IS Imnovid contains the active substance ‘pomalidomide’. This medicine is related to thalidomide and belongs to a group of medicines which affect the immune system (the body’s natural defences). WHAT IMNOVID IS USED FOR Imnovid is used to treat adults with a type of cancer called ‘multiple myeloma’. Imnovid is either used with: • TWO OTHER MEDICINES - called ‘bortezomib’ (a type of chemotherapy medicine) and ‘dexamethasone’ (an anti-inflammatory medicine) in people who have had at least one other trea Przeczytaj cały dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. NAME OF THE MEDICINAL PRODUCT Imnovid 1 mg hard capsules Imnovid 2 mg hard capsules Imnovid 3 mg hard capsules Imnovid 4 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Imnovid 1 mg hard capsules Each hard capsule contains 1 mg of pomalidomide. Imnovid 2 mg hard capsules Each hard capsule contains 2 mg of pomalidomide. Imnovid 3 mg hard capsules Each hard capsule contains 3 mg of pomalidomide. Imnovid 4 mg hard capsules Each hard capsule contains 4 mg of pomalidomide. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule Imnovid 1 mg hard capsules Dark blue opaque cap and yellow opaque body, imprinted “POML” in white ink and “1 mg” in black ink, size 3 gelatin hard capsule. Imnovid 2 mg hard capsules Dark blue opaque cap and orange opaque body, imprinted “POML 2 mg” in white ink, size 1 gelatin hard capsule. Imnovid 3 mg hard capsules Dark blue opaque cap and green opaque body, imprinted “POML 3 mg” in white ink, size 1 gelatin hard capsule. Imnovid 4 mg hard capsules Dark blue opaque cap and blue opaque body, imprinted “POML 4 mg” in white ink, size 1 gelatin hard capsule. 3 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Imnovid in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide. Imnovid in combination with dexamethasone is indicated in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy. 4.2 POSOLOGY AND METHOD OF Przeczytaj cały dokument