Ország: Ausztrália
Nyelv: angol
Forrás: Department of Health (Therapeutic Goods Administration)
zoledronic acid monohydrate, Quantity: 5.33 mg (Equivalent: zoledronic acid, Qty 5 mg)
Sandoz Pty Ltd
zoledronic acid monohydrate
Injection, solution
Excipient Ingredients: mannitol; sodium citrate dihydrate; water for injections
Intravenous
3 Vials, 6 Vials, 1 Vial
(S4) Prescription Only Medicine
- Treatment of osteoporosis in postmenopausal women to reduce the incidence of hip, vertebral and non-vertebral fractures. - Treatment of osteoporosis in patients over 50 years of age with a history of at least one low trauma hip fracture, to reduce the incidence of further fractures. - To increase bone mineral density in men with osteoporosis. - To increase bone mineral density in patients with osteoporosis associated with long term glucocorticoid use. - To prevent glucocorticiod-induced bone mineral density loss. - Treatment of Paget's disease of bone.
Visual Identification: Clear colourless solution; Container Type: Vial; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius
Registered
2008-06-23
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.NOVARTIS.COM.AU 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 at the hip, spine or Olvassa el a teljes dokumentumot
1 AUSTRALIAN PRODUCT INFORMATION - ACLASTA (ZOLEDRONIC ACID) SOLUTION FOR INJECTION 1. NAME OF THE MEDICINE Zoledronic acid 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Aclasta 5 mg/100 mL solution for infusion contains 5 mg zoledronic acid (anhydrous), corresponding to 5.330 mg zoledronic acid monohydrate. Contains sodium and sulfites. For the full list of excipients, section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Solution for intravenous infusion. Aclasta 5 mg/100 mL solution for infusion 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. • Treatment of osteoporosis in patients over 50 years of age with a history of at least one low trauma hip fracture, to reduce the incidence of further fractures. • To increase bone mineral density in men with osteoporosis. • To increase bone mineral density in patients with osteoporosis associated with long term glucocorticoid use. • To prevent glucocorticoid-induced bone mineral density loss. • Treatment of Paget’s disease of bone. 4.2 DOSE AND METHOD OF 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 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). Adequate hydration can be achieved by the patient drinking two glasses of fluid (such as water) before and after the infusion. The inclusion and exclusion criteria of the clinical trials should be used as a basis for patient selection (see section 5.1 Pharmacodynamic properties, Clinical trials). Treatment of Postmenopausal Osteoporosis For the treatment of postmenopausal osteoporosis the recommended dose Olvassa el a teljes dokumentumot