Երկիր: Սինգապուր
Լեզու: անգլերեն
Աղբյուրը: HSA (Health Sciences Authority)
Denosumab
AMGEN BIOTECHNOLOGY SINGAPORE PTE LTD
M05BX04
60 mg/ml
INJECTION, SOLUTION
Denosumab 60 mg/ml
SUBCUTANEOUS
Prescription Only
Amgen Manufacturing Limited
ACTIVE
2011-09-27
Page 1 of 15 PROLIA TM DENOSUMAB QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 60 mg of denosumab in 1.0 mL solution (60 mg/mL). PHARMACEUTICAL FORM Solution for subcutaneous injection. Clear, colourless to slightly yellow solution, pH 5.2 and may contain trace amounts of translucent to white proteinaceous particles. CLINICAL PARTICULARS INDICATIONS _TREATMENT OF POSTMENOPAUSAL WOMEN WITH OSTEOPOROSIS AT HIGH RISK FOR FRACTURE_ _PROLIA _is indicated for the treatment of postmenopausal women with osteoporosis at high risk of fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other osteoporosis therapy. In postmenopausal women with osteoporosis, _PROLIA _reduces the incidence of vertebral, nonvertebral, and hip fractures. _TREATMENT OF MEN WITH OSTEOPOROSIS AT HIGH RISK OF FRACTURE_ _PROLIA _is indicated for the treatment of men with osteoporosis at high risk of fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other osteoporosis therapy. DOSAGE AND ADMINISTRATION ADMINISTRATION Administration should be performed by an individual who has been adequately trained in injection techniques. 2B DOSAGE The recommended dose of _PROLIA _is 60 mg administered as a single subcutaneous injection once every 6 months. All patients should receive calcium 1000 mg daily and at least 400 IU vitamin D daily whilst undergoing treatment. If a dose of _PROLIA _is missed, administer the injection as soon as the patient is available. Thereafter, schedule injections every 6 months from the date of the last injection. Page 2 of 15 POPULATIONS CHILDREN _PROLIA _is not recommended in paediatric patients as the safety and effectivene Կարդացեք ամբողջական փաստաթուղթը
1 PROLIA ® DENOSUMAB NAME OF THE MEDICINAL PRODUCT Prolia 60 mg solution for injection in pre-filled syringe QUALITATIVE AND QUANTITATIVE COMPOSITION Each pre-filled syringe contains 60 mg of denosumab in 1.0 mL solution (60 mg/mL). Denosumab has an approximate molecular weight of 147 kDa. Denosumab is produced in genetically engineered mammalian (Chinese hamster ovary) cells. PHARMACEUTICAL FORM Solution for subcutaneous injection. Clear, colourless to slightly yellow solution, pH 5.2 and may contain trace amounts of translucent to white proteinaceous particles. CLINICAL PARTICULARS INDICATIONS _TREATMENT OF POSTMENOPAUSAL WOMEN WITH OSTEOPOROSIS AT HIGH RISK FOR FRACTURE _ Prolia is indicated for the treatment of postmenopausal women with osteoporosis at high risk of fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other osteoporosis therapy. In postmenopausal women with osteoporosis, Prolia reduces the incidence of vertebral, nonvertebral, and hip fractures. _TREATMENT OF MEN WITH OSTEOPOROSIS AT HIGH RISK OF FRACTURE _ Prolia_ _is indicated for the treatment of men with osteoporosis at high risk of fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other osteoporosis therapy. _TREATMENT OF BONE LOSS IN MEN RECEIVING ANDROGEN DEPRIVATION THERAPY FOR PROSTATE CANCER _ Prolia is indicated as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer. In these patients Prolia also reduced the incidence of vertebral fractures. _TREATMENT OF BONE LOSS IN WOMEN RECEIVING ADJUVANT AROMATASE INHIBITOR THERAPY FOR BREAST CANCER _ Prolia is indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for nonmetastatic breast cancer. 2 _TREATMENT OF BONE LOSS ASSOCIATED WITH LONG-TERM SY Կարդացեք ամբողջական փաստաթուղթը