Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
zoledronic acid monohydrate
Teva Generics B.V
M05BA08
zoledronic acid
Bisphosphonates
Osteoporosis; Osteitis Deformans
Treatment of osteoporosisin post-menopausal womenin adult menat increased risk of fracture, including those with recent low-trauma hip fracture.Treatment of osteoporosis associated with long-term systemic glucocorticoid therapyin post-menopausal womenin adult menat increased risk of fracture.Treatment of Paget's disease of the bone in adults.
Revision: 2
Withdrawn
2014-03-27
51 B. PACKAGE LEAFLET Medicinal product no longer authorised 52 PACKAGE LEAFLET: INFORMATION FOR THE USER _ _ ZOLEDRONIC ACID TEVA GENERICS 5 MG SOLUTION FOR INFUSION IN BOTTLES zoledronic acid READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Zoledronic acid Teva Generics is and what it is used for 2. What you need to know before you are given Zoledronic acid Teva Generics 3. How Zoledronic acid Teva Generics is given 4. Possible side effects 5. How to store Zoledronic acid Teva Generics 6. Contents of the pack and other information 1. WHAT ZOLEDRONIC ACID TEVA GENERICS IS AND WHAT IT IS USED FOR Zoledronic acid Teva Generics contains the active substance zoledronic acid. It belongs to a group of medicines called bisphosphonates and is used to treat post-menopausal women and adult men with osteoporosis or osteoporosis caused by treatment with steroids, and Paget’s disease of the bone in adults. OSTEOPOROSIS Osteoporosis is a disease that involves the thinning and weakening of the bones and is common in women after the menopause, but can also occur in men. At the menopause, a woman’s ovaries stop producing the female hormone oestrogen, which helps keep bones healthy. Following the menopause bone loss occurs, bones become weaker and break more easily. Osteoporosis could also occur in men and women because of the long term use of steroids, which can affect the strength of bones. Many patients with osteoporosis have no symptoms but they are still at risk of breaking bones because osteoporosis has made their bones weaker. Decreased circulating levels of sex hormones, mainly oestrogens converted from androgens, also play a role in the m Læs hele dokumentet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Zoledronic acid Teva Generics 5 mg solution for infusion in bottles 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each bottle contains 5 mg zoledronic acid (as monohydrate). Each ml of the solution contains 0.05 mg zoledronic acid (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for infusion. Clear and colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of osteoporosis • in post-menopausal women • in adult men at increased risk of fracture, including those with a recent low-trauma hip fracture. Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy • in post-menopausal women • in adult men at increased risk of fracture. Treatment of Paget’s disease of the bone in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Patients must be appropriately hydrated prior to administration of zoledronic acid. This is especially important for the elderly and for patients receiving diuretic therapy. Adequate calcium and vitamin D intake are recommended in association with zoledronic acid administration. _Osteoporosis _ For the treatment of post-menopausal osteoporosis, osteoporosis in men and the treatment of osteoporosis associated with long-term systemic glucocorticoid therapy, the recommended dose is a single intravenous infusion of 5 mg zoledronic acid administered once a year. The optimal duration of bisphosphonate treatment for osteoporosis has not been established. The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of zoledronic acid on an individual patient basis, particularly after 5 or more years of use. In patients with a recent low-trauma hip fracture, it is recommended to give the zoledronic acid infusion at least two weeks after hip fracture repair (see section 5.1). In patients with a recent low-trauma hip fractur Læs hele dokumentet