Страна: Европейски съюз
Език: английски
Източник: myHealthbox
zoledronic acid monohydrate
Accord Healthcare Limited
M05BA08
zoledronic acid
4 mg/5 ml concentrate
Concentrate for solution for infusion
Intravenous use
1, 4 or 10 vials 4 mg/5 ml concentrate for solution for infusion
Medicinal product subject to medical prescription
Accord Healthcare Limited
Drug affecting bone structure and mineralization, bisphosphonates
Hypercalcemia cancer, bone fractures
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).
Authorized
2014-01-16
PACKAGE LEAFLET: INFORMATION FOR THE USER ZOLEDRONIC ACID ACCORD 4 MG/5 ML CONCENTRATE FOR SOLUTION FOR INFUSION Zoledronic acid READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 Accord is and what it is used for 2. What you need to know before you are given Zoledronic Acid Accord 3. How Zoledronic Acid Accord is used 4. Possible side effects 5. How to store Zoledronic Acid Accord 6. Contents of the pack and other information 1. WHAT ZOLEDRONIC ACID ACCORD IS AND WHAT IT IS USED FOR The active substance in Zoledronic Acid Accord 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 ACCORD Follow carefully all instructions given to you by your doctor. Your doctor w Прочетете целия документ
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Zoledronic Acid Accord 4 mg/5 ml concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial with 5 ml concentrate contains 4 mg zoledronic acid (as monohydrate) One ml concentrate contains 0.8 mg zoledronic acid (as monohydrate). 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 Accord must only be prescribed and administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates. Posology _Prevention of skeletal related events in patients with advanced malignancies involving bone_ _Adults and elderly_ 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 elderl Прочетете целия документ