Страна: Нова Зеландія
мова: англійська
Джерело: Medsafe (Medicines Safety Authority)
Zoledronic acid monohydrate 0.0533 mg/mL equivalent to zoledronic acid 0.05 mg/mL
Sandoz New Zealand Limited
Zoledronic acid monohydrate 0.0533 mg/mL (= zoledronic acid 0.05 mg/mL)
5 mg/100mL
Solution for infusion
Active: Zoledronic acid monohydrate 0.0533 mg/mL equivalent to zoledronic acid 0.05 mg/mL Excipient: Mannitol Sodium citrate dihydrate Water for injection
Bottle, plastic, 100 mL
Prescription
Prescription
Novartis Pharma AG
· Treatment of osteoporosis in postmenopausal women to reduce the incidence of hip, vertebral and non-vertebral fractures and to increase bone mineral density. · Prevention of postmenopausal osteoporosis.
Package - Contents - Shelf Life: Bottle, plastic, - 100 mL - 36 months from date of manufacture stored at or below 30°C 24 hours opened stored at 2° to 8°C (Refrigerate, do not freeze)
2004-10-11
Aclasta 1 ACLASTA _Zoledronic acid _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Aclasta. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available. YOU SHOULD ENSURE THAT YOU SPEAK TO YOUR PHARMACIST OR DOCTOR TO OBTAIN THE MOST UP-TO-DATE INFORMATION ON THE MEDICINE. YOU CAN ALSO DOWNLOAD THE MOST UP-TO- DATE LEAFLET FROM WWW.MEDSAFE.GOVT.NZ Those updates may contain important information about the medicine and its use of which you should be aware. All medicines have risks and benefits. Your doctor has weighed the risks of you having Aclasta against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT HAVING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. You may need to read it again. WHAT ACLASTA IS USED FOR The active ingredient in Aclasta is zoledronic acid, which belongs to a group of medicines called bisphosphonates. Aclasta is used to treat osteoporosis in postmenopausal women and in men, to prevent additional fractures in men or women who have recently had a hip fracture, or to treat or prevent osteoporosis in men and women caused by treatment with steroid medicines such as prednisone. Aclasta is also used to treat Paget’s disease of bone. Osteoporosis is a disease which causes bones to become less dense, gradually making them weaker, more brittle and likely to break. This is common in women after menopause, when a woman’s ovaries stop producing the female hormone, oestrogen, which keeps bones healthy. It also occurs in men and women with increasing age. Broken bones may result from injury or simple falls. Breaks may occur during normal everyday activity, such as lifting, or from minor injury that would not ordinarily fracture normal bone. Fractures in people with osteoporosis usually occur Прочитайте повний документ
NEW ZEALAND DATA SHEET 1 PRODUCT NAME ACLASTA ® zoledronic acid 5 mg/100 mL solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Single-use sterile solution containing 5 mg/100 mL zoledronic acid (anhydrous), corresponding to 5.330 mg/100 mL zoledronic acid monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion. The solution is sterile, clear and colourless. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC 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. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE 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. Patients must be appropriately hydrated prior to administration of Aclasta. This is especially important in the elderly and for patients receiving diuretic therapy (see Section 4.4 Special warnings and precautions for use). TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS For the treatment of postmenopausal osteoporosis, the recommended dose is a single intravenous infusion of 5 mg infusion of Aclasta administered once a year. Adequate supplemental calcium and vitamin D intake is important in women with osteoporosis if dietary intake is inadequate (see Section 4.4 Special warnings and precautions for use). PREVENTION OF CLINICAL FRACTURES AFTER A HIP FRACTURE For the prevention of clinical fractures after a low-trauma hip fracture, 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, Прочитайте повний документ