国: マルタ
言語: 英語
ソース: Malta Medicines Authority
ZOLEDRONIC ACID, MONOHYDRATE
FAIR-MED HEALTHCARE GmbH Planckstr. 13, 22765 Hamburg, Germany
M05BA08
ZOLEDRONIC ACID MONOHYDRATE 5 mg
SOLUTION FOR INFUSION
ZOLEDRONIC ACID MONOHYDRATE 5 mg
POM
DRUGS FOR TREATMENT OF BONE DISEASES
Withdrawn
2014-04-15
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER ZOLEDRONIC ACID FAIR-MED 5MG/100ML SOLUTION FOR INFUSION Zoledronic acid READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE, BECAUSE IT CONTAINS INPORTANT 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 Fair-Med is and what it is used for 2. What you need to know before you are given Zoledronic acid Fair-Med 3. How Zoledronic acid Fair-Med is given 4. Possible side effects 5. How to store Zoledronic acid Fair-Med 6. Contents of the pack and other information 1. WHAT ZOLEDRONIC ACID FAIR-MED IS AND WHAT IT IS USED FOR Zoledronic acid Fair-Med 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 th 完全なドキュメントを読む
Page 1 of 19 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Zoledronic acid Fair-Med 5 mg/100ml solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial with 100 ml of solution contains 5 mg zoledronic acid (as monohydrate). Each ml of the solution contains 0.05 mg zoledronic acid anhydrous (as monohydrate). This medicinal product contains less than 1 mmol sodium (23 mg) per infusion, i.e. essentially ‘sodium free’. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for infusion Clear and colourless solution. pH: 5.50-7.00 Osmolality (Osmol / kg): 0.23-0.33 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 Osteoporosis Page 2 of 19 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 Fair-Med 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 Fair-Med on an individual patient basis, particularly after 5 or more years of use. In p 完全なドキュメントを読む