Ország: Izrael
Nyelv: angol
Forrás: Ministry of Health
THALIDOMIDE
NEOPHARM LTD
L04AX02
HARD CAPSULE
THALIDOMIDE 50 MG
PER OS
Required
BRISTOL-MYERS SQUIBB PHARMA EEIG, IRELAND
THALIDOMIDE
Multiple myeloma : * For the treatment of multiple myeloma after failure of standard therapies. * Thalidomide BMS 50 mg hard capsules in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma. * Thalidomide BMS in combination with melphalan and prednisone is indicated for the treatment of patients with untreated multiple myeloma > or = 65 years or ineligible for high dose chemotherapy. Erythema Nodosum Leprosum: For the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL). Thalidomide is not indicated as monotherapy for such ENL treatment in the presence of moderate to severe neuritis. It is also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence.
2015-02-12
1 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed only by a physician’s prescription THALIDOMIDE BMS ® 50MG HARD CAPSULES COMPOSITION: NAME AND QUANTITY OF ACTIVE INGREDIENT: EACH CAPSULE CONTAINS: Thalidomide 50mg Inactive ingredients - See section “Additional information”. READ THIS PACKAGE INSERT CAREFULLY IN ITS ENTIRETY BEFORE USING THIS MEDICINE AND EVERY TIME THIS MEDICINE IS PRESCRIBED TO YOU, AS IT MAY CONTAIN NEWER INFORMATION. IT IS RECOMMENDED TO READ THIS INSERT WITH ANOTHER FAMILY MEMBER. This leaflet contains summary information about this medicine. If you have any further questions, refer to the physician or the pharmacist. This medicine has been prescribed for treating 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. DO NOT GIVE THIS MEDICINE TO A CHILD UNDER THE AGE OF 12 YEARS. SAFETY AND EFFECTIVENESS IN CHILDREN YOUNGER THAN 12 YEARS HAVE NOT BEEN ESTABLISHED. THALIDOMIDE HAS CAUSED SEVERE BIRTH DEFECTS WHEN TAKEN DURING PREGNANCY. THALIDOMIDE SHOULD NEVER BE USED BY WOMEN WHO ARE PREGNANT OR WHO COULD BECOME PREGNANT WHILST TAKING THE MEDICINE OR COULD BECOME PREGNANT WITHIN 4 WEEKS AFTER STOPPING THE MEDICINE. EVEN A SINGLE DOSE CAN CAUSE BIRTH DEFECTS. 1. WHAT IS THIS MEDICINE INTENDED FOR? This medicine is indicated for the treatment of multiple myeloma and certain symptoms of leprosy. THERAPEUTIC GROUP: Immunosuppressive agent 2. BEFORE USING THIS MEDICINE 2 DO NOT USE THIS MEDICINE IF: Women: ! Do not use this medicine IF YOU ARE PREGNANT, THINK YOU MAY BE PREGNANT OR ARE PLANNING TO BECOME PREGNANT OR ARE BREASTFEEDING. If you take it during pregnancy, Thalidomide BMS 50mg Hard Capsules causes birth defects (deformed babies) and death to an foetus and may affect your developing foetus. Thalidomide BMS 50mg Hard Capsules should never be used by women who are pregnant, and women of childbearing potential who are not using, Olvassa el a teljes dokumentumot
1 PRODUCT INFORMATION I) NAME OF THE MEDICINAL PRODUCT THALIDOMIDE BMS 50 MG HARD ® CAPSULES QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains thalidomide 50mg PHARMACEUTICAL FORM Hard Capsule TERATOGENIC EFFECTS: THALIDOMIDE HAS CAUSED SEVERE BIRTH DEFECTS WHEN TAKEN DURING PREGNANCY. THALIDOMIDE SHOULD NEVER BE USED BY WOMEN WHO ARE PREGNANT OR WHO COULD BECOME PREGNANT WHILST TAKING THE MEDICINE OR COULD BECOME PREGNANT WITHIN 4 WEEKS AFTER STOPPING THE MEDICINE (SEE SECTION 2). EVEN A SINGLE DOSE CAN CAUSE BIRTH DEFECTS . PATIENT SAFETY INFORMATION CARD THE MARKETING OF THALIDOMIDE IS SUBJECT TO A RISK MANAGEMENT PLAN (RMP) INCLUDING ' PATIENT SAFETY INFORMATION CARD '. THE ' PATIENT SAFETY INFORMATION CARD ' EMPHASIZES IMPORTANT SAFETY INFORMATION THAT THE PATIENT SHOULD BE AWARE OF BEFORE AND DURING TREATMENT. PLEASE EXPLAIN TO THE PATIENT THE NEED TO REVIEW THE CARD BEFORE STATING TREATMENT. II) THERAPEUTIC INDICATIONS MULTIPLE MYELOMA • For the treatment of multiple myeloma after failure of standard therapies. • Thalidomide BMS 50mg Hard Capsules in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma. • Thalidomide BMS in combination with melphalan and prednisone is indicated for the treatment of patients with untreated multiple myeloma > or = 65 years or ineligible for high dose chemotherapy. ERYTHEMA NODOSUM LEPROSUM (ENL) • For the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL). Thalidomide is not indicated as monotherapy for such ENL treatment in the presence of moderate to severe neuritis. It is also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence. 2 Thalidomide BMS 50mg Hard Capsules contain thalidomide, 2-(2,6-dioxo-3- piperidinyl)-1H-iso-indole-1,3(2H)-dione. The Chemical Abstract Service (CAS) registry number for thalidomide is 50-35-1 and the structural formula is: III) DESCRIPTION Thalidomi Olvassa el a teljes dokumentumot