국가: 이스라엘
언어: 영어
출처: Ministry of Health
BELIMUMAB
GLAXO SMITH KLINE (ISRAEL) LTD
L04AA26
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
BELIMUMAB 120 MG
I.V
Required
GLAXO GROUP LTD, UK
BELIMUMAB
BELIMUMAB
Benlysta is indicated as add-on therapy in patients aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti-dsDNA and low complement) despite standard therapy.Benlysta is indicated in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis.
2017-01-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed according to a physician’s prescription only Benlysta I.V. 120 mg Powder for concentrate for solution for infusion Each vial contains: 120 mg of belimumab (80 mg/ml after reconstitution) Benlysta I.V. 400 mg Powder for concentrate for solution for infusion Each vial contains: 400 mg of belimumab (80 mg/ml after reconstitution) For the list of the inactive and allergenic ingredients in the medicine, see section 2 – “Important information about some of the ingredients in the medicine” and section 6 – “Additional information”. Read the leaflet carefully in its entirety before using the medicine. This leaflet contains concise information about the medicine. If you have further questions, refer to the physician or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? Benlysta is indicated as an add-on therapy in patients from the age of 5 years and up with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g., positive anti-dsDNA and low complement) despite standard therapy. Benlysta, in combination with immunosuppressive therapies, is intended for the treatment of adult patients with active lupus nephritis. Therapeutic group: selective immunosuppressant. Lupus is a disease in which the immune system (the system that fights infection) attacks your own cells and tissues, causing inflammation and organ damage. The disease can affect almost any organ in the body, and is thought to involve a type of white blood cells called B cells. Benlysta contains belimumab (a human monoclonal antibody). It reduces the number of B cells in your blood by blocking the action of BLyS, a protein that helps B cells to live longer and is found in high levels in people with lupus. You will be given Benlysta 전체 문서 읽기
Page 1 of 24 Benlysta I.V. 120 mg Benlysta I.V. 400 mg 1. NAME OF THE MEDICINAL PRODUCT Benlysta I.V. 120 mg Benlysta I.V. 400 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Benlysta I.V. 120 mg: Each vial contains 120 mg of belimumab. After reconstitution, the solution contains 80 mg belimumab per mL. Benlysta I.V. 400 mg: Each vial contains 400 mg of belimumab. After reconstitution, the solution contains 80 mg belimumab per mL. Belimumab is a human, IgG1λ monoclonal antibody, produced in a mammalian cell line (NS0) by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion. White to off-white powder. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Benlysta is indicated as add-on therapy in patients aged 5 years and older with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g. positive anti-dsDNA and low complement) despite standard therapy (see section 5.1). Benlysta is indicated in combination with background immunosuppressive therapies for the treatment of adult patients with active lupus nephritis (see sections 4.2 and 5.1). Limitations of Use: The efficacy of Benlysta has not been evaluated in patients with severe active central nervous system lupus. Benlysta has not been studied in combination with other biologics. Use of Benlysta is not recommended in these situations. 4.2 Posology and method of administration Page 2 of 24 Benlysta treatment should be initiated and supervised by a qualified physician experienced in the diagnosis and treatment of SLE. Benlysta infusions should be administered by a qualified healthcare professional trained to give infusion therapy. Administration of Benlysta may result in severe or life-threatening hypersensitivity reactions and infusion reactions. Patients have been reported to develop symptoms of acute hypersensitivity several hours after the infusion has been administered. Recurrence of clinically significant reacti 전체 문서 읽기