Transcription of New Zealand Data Sheet - Medsafe
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New Zealand Data Sheet - Medsafe
New Zealand data Sheet ACLASTA zoledronic acid 5 mg/100 mL solution for infusion DESCRIPTION AND COMPOSITION Pharmaceutical Form(s) Solution for infusion. The solution is sterile, clear and colourless. Active Substance(s) One bottle with 100 mL solution contains 5 mg zoledronic acid (anhydrous), corresponding to mg zoledronic acid monohydrate. Active Moiety Zoledronic acid (anhydrous). Excipients Mannitol, sodium citrate, water for injections. INDICATIONS Treatment of osteoporosis in postmenopausal women to reduce the incidence of hip, vertebral and non-vertebral fractures and to increase bone mineral density. Treatment of osteoporosis in men. Treatment of Paget s disease of bone. Treatment and prevention of glucocorticoid-induced osteoporosis. Prevention of clinical fractures in patients after hip fracture. Prevention of postmenopausal osteoporosis. DOSAGE AND ADMINISTRATION General The incidence of post-dose symptoms occurring within the first three days after administration of Aclasta can be reduced with the administration of paracetamol or ibuprofen shortly following Aclasta administration.
after Aclasta administration. Renal impairment has been observed in patients after a single administration. Renal failure requiring dialysis or with a fatal outcome has rarely occurred in
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