Indications : התוויות

1      INDICATIONS AND USAGE
1.1 Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture Teriparatide Kamada is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, Teriparatide Kamada increases BMD reduces the risk of vertebral and nonvertebral fractures [see Clinical Studies (14.1)].
1.2 Increase of Bone Mass in Men with Primary or Hypogonadal Osteoporosis at High Risk for Fracture Teriparatide Kamada is indicated to increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy [see Clinical Studies (14.2)].
1.3 Treatment of Men and Women with Glucocorticoid-Induced Osteoporosis at High Risk for Fracture Teriparatide Kamada is indicated for the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy (daily dosage equivalent to 5 mg or greater of prednisone) at high risk for fracture, defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy [see Clinical Studies (14.3)].