Pajjiż: Iżrael
Lingwa: Ingliż
Sors: Ministry of Health
POMALIDOMIDE
NEOPHARM SCIENTIFIC LTD
L04AX06
HARD CAPSULE
POMALIDOMIDE 4 MG
PER OS
Required
CELGENE INTERNATIONAL SARL, SWITZERLAND
POMALIDOMIDE
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.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
2019-05-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor's prescription only IMNOVID 1 MG IMNOVID 2 MG IMNOVID 3 MG IMNOVID 4 MG ACTIVE INGREDIENTS: IMNOVID 1 MG: Each hard capsule contains pomalidomide 1 mg IMNOVID 2 MG: Each hard capsule contains pomalidomide 2 mg IMNOVID 3 MG: Each hard capsule contains pomalidomide 3 mg IMNOVID 4 MG: Each hard capsule contains pomalidomide 4 mg Inactive ingredients and allergens: See chapter 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 illness is similar to yours. Imnovid is expected to cause severe harm to an unborn baby and may lead to death. Do not take this medicine if you are pregnant or anticipate becoming pregnant. You must follow the contraception advice described in this leaflet. 1. WHAT IS THIS MEDICINE INTENDED FOR? Imnovid is used to treat adults with a type of cancer called ‘multiple myeloma’. Imnovid is used with: • two other medicines - one called “bortezomib” (a type of chemotherapy medicine) and “dexamethasone” (an anti-inflammatory medicine) in adults who have had at least one other treatment - including lenalidomide. Or • one other medicine called “dexamethasone” (in adults whose multiple myeloma has recurred or become worse, despite having received at least two other treatments, including lenalidomide and bortezomib) and presented progression of the disease during the last treatment. THERAPEUTIC GROUP: The medicine belongs to a group of medicines which suppress the immune system. WHAT IS MULTIPLE MYELOMA Multiple myeloma is a type of cancer which affects a certain type of white blood cell (called ‘plasma cells’). These cells grow out of Aqra d-dokument sħiħ
1 1. NAME OF THE MEDICINAL PRODUCT Imnovid 1 mg Imnovid 2 mg Imnovid 3 mg Imnovid 4 mg 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 Hard gelatin capsule, size 3, with dark blue opaque cap and yellow opaque body, imprinted “POML” in white ink and “ 1 mg ” in black ink. Imnovid 2 mg hard capsules Hard gelatin capsule, size 1, with d ark blue opaque cap and orange opaque body, imprinted “POML 2 mg” in white ink. Imnovid 3 mg hard capsules Hard gelatin capsule, size 1, with d ark blue opaque cap and green opaque body, imprinted, “POML 3 mg” in white ink . Imnovid 4 mg hard capsules Hard gelatin capsule, size 1, with dark blue opaque cap and blue opaque body, imprinted “POML 4 mg” in white ink. 2 IMNOVID IS CONTRAINDICATED IN PREGNANCY. IMNOVID IS A THALIDOMIDE ANALOGUE. THALIDOMIDE IS A KNOWN HUMAN TERATOGEN THAT CAN CAUSE SEVERE BIRTH DEFECTS OR FETAL DEATH. IN WOMEN OF CHILD BEARING POTENTIAL, OBTAIN A NEGATIVE PREGNANCY TEXT BEFORE STARTING IMNOVID TREATMENT. WARN PATIENTS TO FOLLOW THE CONTRACEPTION ADVICE IN THIS LEAFLET. 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 A Aqra d-dokument sħiħ