Krajina: Malajzia
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Pomalidomide
Dr. Reddy`s Laboratories Malaysia Sdn. Bhd.
Pomalidomide
3 x 7 Capsules
DR. REDDY'S LABORATORIES LIMITED
1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ POMARZA 1 (POMALIDOMIDE CAPSULES 1MG) POMARZA 2 (POMALIDOMIDE CAPSULES 2MG) POMARZA 3 (POMALIDOMIDE CAPSULES 3MG) POMARZA 4 (POMALIDOMIDE CAPSULES 4MG) Pomalidomide (1mg, 2mg, 3mg, 4mg) WHAT IS IN THIS LEAFLET 1. What POMARZA is used for 2. How POMARZA works 3. Before you use POMARZA 4. How to use POMARZA 5. While you are using it 6. Side effects 7. Storage and Disposal of POMARZA 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial Number WHAT POMARZA IS USED FOR POMARZA is used to treat adults with a type of cancer called ‘multiple myeloma’. Multiple myeloma is a type of cancer which affects a certain type of white blood cell (called the ‘plasma cell’). These cells grow out of control and accumulate in the bone marrow. This results in damage to the bones and kidneys. Multiple myeloma generally cannot be cured. However, treatment can reduce the signs and symptoms of the disease or make them disappear for a period of time. When this happens, it is called ‘response’. POMARZA 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). POMARZA 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 treatment - including lenalidomide. Or • one other medicine – called ‘dexamethasone’ in people whose myeloma has become worse, despite having at least two other treatments - including lenalidomide and bortezomib. HOW POMARZA WORKS POMARZA works in several different ways: by stopping the myeloma cells developing. • by stimulating the immune system to attack the cancer cells. • by stopping the formation of blood vessels supplying the cancer cells. The benefit of using POMARZA with bortezomib and dexamethasone When POMARZA is u Prečítajte si celý dokument
PRESCRIBING INFORMATION 1 1. NAME OF THE MEDICINAL PRODUCT POMARZA 1 (POMALIDOMIDE CAPSULES 1mg) POMARZA 2 (POMALIDOMIDE CAPSULES 2mg) POMARZA 3 (POMALIDOMIDE CAPSULES 3mg) POMARZA 4 (POMALIDOMIDE CAPSULES 4mg) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 1 mg of pomalidomide. Each hard capsule contains 2 mg of pomalidomide. Each hard capsule contains 3 mg of pomalidomide. Each hard capsule contains 4 mg of pomalidomide. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsules. _POMARZA 1 (POMALIDOMIDE CAPSULES 1mg): _ Light yellow to yellow colored powder filled into hard gelatin capsule shells with purple colored cap and dark pink colored body imprinted and ‘1mg’ on cap & ‘520’ on body with white ink _POMARZA 2 (POMALIDOMIDE CAPSULES 2mg):_ Light yellow to yellow colored powder filled into hard gelatin capsule shells with purple colored cap and pink opaque colored body imprinted and ‘2mg’ on cap & ‘519’ on body with white ink _POMARZA 3 (POMALIDOMIDE CAPSULES 3mg):_ Light yellow to yellow colored powder filled into hard gelatin capsule shells with purple colored cap and violet opaque colored body imprinted and ‘3mg’ on cap & ‘518’ on body with white ink _POMARZA 4 (POMALIDOMIDE CAPSULES 4mg):_ Light yellow to yellow colored powder filled into hard gelatin capsule shells with purple colored cap and purple opaque colored body imprinted and ‘4mg’ on cap & ‘517’ on body with white ink 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS POMARZA in combination with bortezomib and dexamethasone is indicated in the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior treatment regimen including lenalidomide. POMARZA 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 progre Prečítajte si celý dokument