Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Zoledronic acid
Rowex Ltd
M05BA; M05BA08
Zoledronic acid
4 mg/5 millilitre(s)
Concentrate for solution for infusion
Product subject to prescription which may not be renewed (A)
Bisphosphonates; zoledronic acid
Marketed
2012-08-03
PACKAGE LEAFLET: INFORMATION FOR THE USER ZOLEDRONIC ACID SANDOZ 4 MG/5 ML CONCENTRATE FOR SOLUTION FOR INFUSION 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, nurse or pharmacist. If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Zoledronic acid Sandoz is and what it is used for 2. What you need to know before you are given Zoledronic acid Sandoz 3. How Zoledronic acid Sandoz is used 4. Possible side effects 5. How to store Zoledronic acid Sandoz 6. Contents of the pack and other information 1. WHAT ZOLEDRONIC ACID SANDOZ IS AND WHAT IT IS USED FOR The active substance in Zoledronic acid Sandoz 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 SANDOZ Follow carefully all instructions given to you by your doctor. Your doctor will carry out blood tests before you start treatment with Zoledronic acid Sandoz and will check your response to treatment at regular intervals. YOU SHOULD NOT BE GIVEN ZOLEDRONIC ACID SANDOZ_ _ if you are breast-feeding if you are allergic to zoledronic acid, another bisphosphonate (the group of substances to which Zoledronic Lestu allt skjalið
Health Products Regulatory Authority 20 May 2020 CRN008HGL Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zoledronic acid Sandoz 4mg/5ml Concentrate for Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One vial of 5 ml concentrate for solution for infusion contains 4 mg zoledronic acid, corresponding to 4.264 mg zoledronic acid monohydrate. 1 ml concentrate for solution for infusion contains 0.8 mg zoledronic acid. Excipients with known effect: This medicinal product contains 0.245 mmol sodium (5.63 mg) per 5 ml concentrate for solution for infusion. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion Clear and colourless solution. 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 Sandoz must only be prescribed and administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates. Patients treated with Zoledronic acid Sandoz 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 (al Lestu allt skjalið