Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Zoledronic acid
Wockhardt UK Limited
M05BA; M05BA08
Zoledronic acid
4mg/100 millilitre(s)
Solution for infusion
Product subject to prescription which may not be renewed (A)
Bisphosphonates; zoledronic acid
Not marketed
2013-05-17
PACKAGE LEAFLET: INFORMATION FOR THE USER ZOLEDRONIC ACID 4MG/100ML SOLUTION FOR INFUSION (Referred to as Zoledronic Acid Solution for 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 Solution for Infusion is and what it is used for 2. What you need to know before you are given Zoledronic Acid Solution for Infusion 3. How Zoledronic Acid Solution for Infusion is used 4. Possible side effects 5. How to store Zoledronic Acid Solution for Infusion 6. Contents of the pack and other information 1. WHAT ZOLEDRONIC ACID SOLUTION FOR INFUSION IS AND WHAT IT IS USED FOR The active substance in Zoledronic Acid Solution for Infusion is zoledronic acid, which belongs to a group of substances called bisphosphonates. Zoledronic acid works by attaching itself to the bone and slowing down the rate of bone change. It is used: • TO PREVENT BONE COMPLICATIONS, e.g. fractures, in adult patients with bone metastases (spread of cancer from primary site to the bone). • TO REDUCE THE AMOUNT OF CALCIUM in the blood in adult patients where it is too high due to the presence of a tumour. Tumours can accelerate normal bone change in such a way that the release of calcium from bone is increased. This condition is known as tumour-induced hypercalcaemia (TIH). 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ZOLEDRONIC ACID SOLUTION FOR INFUSION Follow carefully all instructions given to you by your doctor. Your doctor will carry out blood tests before you start treatment with Zoledronic Acid Solution for Infusion and will check your response to treatment at regular intervals. YOU SHOULD NOT BE GIVEN ZOL Прочитать полный документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zoledronic Acid 4mg/100ml Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One bottle contains 4 mg zoledronic acid, corresponding to 4.264 mg zoledronic acid monohydrate. Each ml of the solution contains 0.04 mg zoledronic acid anhydrous, corresponding to 0.04264 mg zoledronic acid 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 between 6.0 – 7.0 and the osmolality is between 260 – 340 mOsm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in adult patients with advanced malignancies involving bone. Treatment of adult patients with tumour-induced hypercalcaemia (TIH). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Zoledronic acid solution for infusion must only be prescribed and administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates. Patients treated with zoledronic acid should be given the package leaflet and patient reminder card. Posology _Prevention of skeletal related events in patients with advanced malignancies involving bone_ _Adults and older people_ The recommended dose in the prevention of skeletal related events in patients with advanced malignancies involving bone is 4 mg zoledronic acid every 3 to 4 weeks. Patients should also be administered an oral calcium supplement of 500 mg and 400 IU vitamin D daily. The decision to treat patients with bone metastases for the prevention of skeletal related events should consider that the onset of treatment effect is 2-3 months. _Treatment of TIH_ _Adults and older people_ H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ __ Прочитать полный документ