Šalis: Singapūras
kalba: anglų
Šaltinis: HSA (Health Sciences Authority)
zoledronic acid
SANDOZ SINGAPORE PTE. LTD.
M05BA08
5mg
INFUSION, SOLUTION
zoledronic acid 5mg
INTRAVENOUS
Prescription Only
Fresenius Kabi Austria GmbH
ACTIVE
2006-03-30
1 1. NAME OF THE MEDICINAL PRODUCT Aclasta 5 mg solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each bottle with 100 ml of solution contains 5 mg zoledronic acid anhydrous, corresponding to 5.330 mg zoledronic acid monohydrate. One ml solution contains 0.05 mg zoledronic acid anhydrous, corresponding to 0.0533 mg zoledronic acid monohydrate. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for infusion The solution is sterile, clear and colorless. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of osteoporosis in post-menopausal women in men at increased risk of fracture, including those with a recent low-trauma hip fracture. To prevent glucocorticoid-induced bone mineral density loss and to increase bone mineral density in post-menopausal women and men on long-term glucocorticoid use, who are at increased risk of fracture Prevention of osteoporosis in post-menopausal women with increased risk of osteoporosis. Treatment of Paget’s disease of the bone. The optimal duration of use of bisphosphates for the treatment of osteoporosis has not been determined. All patients on bisphosphonate therapy should have the need for continued therapy re- evaluated on a periodic basis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For the treatment of post-menopausal osteoporosis, osteoporosis in men and the prevention and treatment of osteoporosis associated with long-term systemic glucocorticoid therapy, the recommended dose is a single intravenous infusion of 5 mg Aclasta administered once a year. In patients with a recent low-trauma hip fracture, it is recommended to give the Aclasta infusion two or more weeks after hip fracture repair (see section 5.1). Novartis Page 2 Country Specific Perskaitykite visą dokumentą
Page 1 of 14 1. NAME OF THE MEDICINAL PRODUCT Aclasta 5 mg solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each bottle with 100 ml of solution contains 5 mg zoledronic acid anhydrous, corresponding to 5.330 mg zoledronic acid monohydrate. One ml solution contains 0.05 mg zoledronic acid anhydrous, corresponding to 0.0533 mg zoledronic acid monohydrate. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for infusion The solution is sterile, clear and colorless. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of osteoporosis • in post-menopausal women • in men at increased risk of fracture, including those with a recent low-trauma hip fracture. To prevent glucocorticoid-induced bone mineral density loss and to increase bone mineral density in post-menopausal women and men on long-term glucocorticoid use, who are at increased risk of fracture. Prevention of osteoporosis in post-menopausal women with increased risk of osteoporosis. Treatment of Paget’s disease of the bone. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For the treatment of post-menopausal osteoporosis, osteoporosis in men and the prevention and treatment of osteoporosis associated with long-term systemic glucocorticoid therapy, the recommended dose is a single intravenous infusion of 5 mg Aclasta administered once a year. In patients with a recent low-trauma hip fracture, it is recommended to give the Aclasta infusion two or more weeks after hip fracture repair (see section 5.1). For the prevention of postmenopausal osteoporosis, the recommended regimen is a single intravenous infusion of 5 mg Aclasta. An annual assessment of the patient's risk of fracture and clinical response to treatment should guide the decision of when re-treatment should occur. For the prevention of postmenopausal osteoporosis it is important that patients be adequately supplemented with calcium and vitamin D if dietary intake is inadequate (see section 4.4). Page 2 of 14 For the treatment of Paget’s disease, Aclas Perskaitykite visą dokumentą