מדינה: ישראל
שפה: אנגלית
מקור: Ministry of Health
TERIPARATIDE
ELI LILLY ISRAEL LTD, ISRAEL
H05AA02
SOLUTION FOR INJECTION
TERIPARATIDE 250 MCG/ML
S.C
Required
LILLY FRANCE S.A.S., FRANCE
TERIPARATIDE
TERIPARATIDE
Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture:Forteo 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, Forteo increases BMD reduces the risk of vertebral and nonvertebral fractures . Increase of Bone Mass in Men with Primary or Hypogonadal Osteoporosis at High Risk for Fracture :Forteo 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 . Treatment of Men and Women with Glucocorticoid-Induced Osteoporosis at High Risk for Fracture:Forteo 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 .
2013-10-31
I FORTPN F 09 Page 1 of 6 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 This medicine is dispensed with a physician’s prescription only FORTEO Solution for subcutaneous injection ACTIVE INGREDIENT AND ITS QUANTITY: teriparatide 250 mcg/ml Each injected dose contains: teriparatide 20 mcg INACTIVE INGREDIENTS: see Section 6 “Additional information”. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, contact your doctor or pharmacist. Also read the User Manual of the FORTEO pen. This medicine has been prescribed for the treatment of your illness. Do not pass it on to others. It may harm them even if their illness seems to be the same as yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? • Treatment of men and postmenopausal women who are suffering from osteoporosis and are at high risk of developing fractures. • Treatment of osteoporosis associated with corticosteroid therapy in men and women at increased risk for fractures. • FORTEO increases bone mineral density (BMD), strengthens the bone and reduces the risk for fractures. THERAPEUTIC GROUP : Parathyroid hormones. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS PREPARATION IF: • you are sensitive (allergic) to the active ingredient or to any of the other ingredients of this medicine (see section 6). Reactions include angioedema and anaphylactic reaction. SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE: • Bone cancer (osteosarcoma) has been reported rarely in patients who had been taking FORTEO. In people, osteosarcoma is a serious but rare cancer. It is not known if people who take FORTEO have a higher chance of getting osteosarcoma. • The duration of treatment is limited to two years over your lifetime. BEFORE STARTING TREATMENT WITH FORTEO, TELL YOUR DOCTOR IF: • you are sensitive (allergic) to the active ingredient or to any of the other ingredients of this medicine. • y suffer ou or have s קרא את המסמך השלם
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