Krajina: Malta
Jazyk: angličtina
Zdroj: Medicines Authority
ZOLEDRONIC ACID, MONOHYDRATE
Wockhardt UK Limited Ash Road North, Wrexham, LL13 9UF, United Kingdom
M05BA08
ZOLEDRONIC ACID MONOHYDRATE 5 mg
SOLUTION FOR INFUSION
ZOLEDRONIC ACID MONOHYDRATE 5 mg
POM
DRUGS FOR TREATMENT OF BONE DISEASES
Withdrawn
2012-12-14
PACKAGE LEAFLET: INFORMATION FOR THE USER ZOLEDRONIC ACID 5MG/100ML SOLUTION FOR INFUSION (Referred to as Zoledronic Acid Infusion in the remainder of this leaflet) 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 Infusion is and what it is used for 2. What you need to know before you are given Zoledronic Acid Infusion 3. How Zoledronic Acid Infusion is given 4. Possible side effects 5. How to store Zoledronic Acid Infusion 6. Contents of the pack and other information 1. WHAT ZOLEDRONIC ACID INFUSION IS AND WHAT IT IS USED FOR Zoledronic Acid Infusion contains the active substance zoledronic acid. It belongs to a group of medicines called bisphosphonates and is used to treat Paget’s disease of the bone in adults. PAGET’S DISEASE OF THE BONE It is normal that old bone is removed and is replaced with new bone material. This process is called remodelling. In Paget’s disease, bone remodelling is too rapid and new bone is formed in a disordered fashion, which makes it weaker than normal. If the disease is not treated, bones may become deformed and painful, and may break. Zoledronic Acid Infusion works by returning the bone remodelling process to normal, securing formation of normal bone, thus restoring strength to the bone. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ZOLEDRONIC ACID INFUSION Follow carefully all instructions given to you by your doctor or nurse carefully before you are given Zoledronic Acid Infusion. YOU SHOULD NOT BE GIVEN ZOLEDRONIC ACID INFUSION: • if you are allergic to zoledronic acid, other bisphosphonates or any of the other ingredients of this medicine (listed in section 6). - if you hav Prečítajte si celý dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zoledronic Acid 5mg/100ml Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each bottle 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 (23mg) per dose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion Clear, colourless solution; free from visible foreign matter. The pH of the solution is 6.0 – 7.0 and the osmolarity is 260 – 340 mOsm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of Paget's disease of the bone in adults. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology For the treatment of Paget's disease, zoledronic acid infusion should be prescribed only by physicians with experience in the treatment of Paget's disease of the bone. The recommended dose is a single intravenous infusion of 5 mg zoledronic acid. Re-treatment of Paget's disease: After initial treatment with zoledronic acid infusion in Paget's disease an extended remission period is observed in responding patients. Re-treatment consists of an additional intravenous infusion of 5mg zoledronic acid after an interval of one year or longer from initial treatment in patients who have relapsed. Limited data on re-treatment of Paget’s disease are available (see section 5.1). Patients must be appropriately hydrated prior to administration of zoledronic acid infusion. This is especially important for the elderly and for patients receiving diuretic therapy. Adequate calcium and vitamin D intake are recommended in association with administration of zoledronic acid infusion. In addition, in patients with Paget's disease, it is strongly advised that adequate supplemental calcium corresponding to at least 500 mg elemental calcium twice daily is ensured for at least 10 days following administration of zoledronic acid infusion (see section 4.4). _Special Prečítajte si celý dokument