Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Zoledronic acid monohydrate
Wockhardt UK Limited
M05BA; M05BA08
Zoledronic acid monohydrate
4 mg/5ml
Concentrate for solution for infusion
Product subject to prescription which may not be renewed (A)
Bisphosphonates; zoledronic acid
Not marketed
2013-03-01
PACKAGE LEAFLET: INFORMATION FOR THE USER ZOLEDRONIC ACID 4MG/5ML CONCENTRATE FOR SOLUTION FOR INFUSION (Referred to as Zoledronic Acid Concentrate 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 Concentrate is and what it is used for 2. What you need to know before you are given Zoledronic Acid Concentrate 3. How Zoledronic Acid Concentrate is used 4. Possible side effects 5. How to store Zoledronic Acid Concentrate 6. Contents of the pack and other information 1. WHAT ZOLEDRONIC ACID CONCENTRATE IS AND WHAT IT IS USED FOR The active substance in Zoledronic Acid Concentrate 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 CONCENTRATE Follow carefully all instructions given to you by your doctor. Your doctor will carry out blood tests before you start treatment with Zoledronic Acid Concentrate and will check your response to treatment at regular intervals. YOU SHOULD NOT BE GIVEN ZOLEDRONIC ACID CONCENTRATE: - if you are breast-feeding. - if you are allergic Preberite celoten dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zoledronic Acid 4mg/5ml Concentrate for Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One vial with 5 ml concentrate contains 4 mg zoledronic acid (anhydrous). One ml concentrate contains zoledronic acid (as monohydrate) corresponding to 0.8 mg zoledronic acid (anhydrous). This medicinal product contains less than 1 mmol sodium (23mg) per dose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion Clear, colourless solution; free from visible foreign matter. The pH of the concentrate is 6.0 – 7.0 and the osmolarity is 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 concentrate for 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 the 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_ The recommended dose in hypercalcaemia (albumin-corrected serum calcium > 12.0 mg/d Preberite celoten dokument