Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Pamidronic acid
Pinewood Laboratories Ltd,
M05BA; M05BA03
Pamidronic acid
15 milligram(s)/millilitre
Concentrate for solution for infusion
Bisphosphonates; pamidronic acid
Not marketed
2005-08-26
PACKAGE LEAFLET: INFORMATION FOR THE USER DISODIUM PAMIDRONATE 15MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have further questions, please ask your doctor or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4. The name of your medicine is Disodium Pamidronate 15mg/ml Concentrate for Solution for Infusion. In the rest of this leaflet it is called Disodium Pamidronate. WHAT IS IN THIS LEAFLET: 1. What Disodium Pamidronate is and what it is used for 2. What you need to know before you are given Disodium Pamidronate 3. How Disodium Pamidronate should be given 4. Possible side effects 5. How to store Disodium Pamidronate 6. Contents of the pack and other information 1. WHAT DISODIUM PAMIDRONATE IS AND WHAT IT IS USED FOR The active ingredient is called Disodium Pamidronate. Disodium pamidronate belongs to a group of medicines called bisphosphonates, which prevent bones from weakening and breaking. Disodium Pamidronate is used to treat: • high blood calcium levels (hypercalcaemia) due to tumours • holes in the bone and bone pain due to the spread of breast cancer or bone marrow cancer (myeloma) • Paget’s disease of the bone (a chronic bone disorder) 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN DISODIUM PAMIDRONATE YOU SHOULD NOT BE GIVEN DISODIUM PAMIDRONATE: • if you are allergic to Disodium Pamidronate, any other bisphosphonate, or any of the other ingredients of this medicine (listed in section 6.) • if you are pregnant • if you are breast feeding WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR OR NURSE BEFORE BEING GIVEN DISODIUM PAMIDRONATE IF YOU: • are receiving dental tr Læs hele dokumentet
Health Products Regulatory Authority 04 January 2021 CRN009YTH Page 1 of 11 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Disodium Pamidronate 15mg/ml Concentrate for Solution for Infusion, 6ml 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1ml of concentrate contains 15mg disodium pamidronate. One ampoule of 6ml contains 90mg of disodium pamidronate. Excipient with known effect: Each 6 ml ampoule contains 36 mg sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Concentrate for solution for infusion Colourless solution, free from particles. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of conditions associated with increased osteoclast activity: Tumour-induced hypercalcaemia Osteolytic lesions and bone pain in patients with bone metastases associated with breast cancer or multiple myeloma Paget's disease of bone. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Method of administration Disodium pamidronate concentrate must never be given as a bolus injection (see Warnings). The concentrate of disodium pamidronate concentrate in ampoules should be diluted in a calcium-free infusion solution (0.9 % Sodium Chloride Intravenous Infusion B.P. is recommended) and infused slowly. The infusion rate should never exceed 60mg/hour (1mg/min), and the concentration of disodium pamidronate concentrate in the infusion solution should not exceed 90mg/250mL. A dose of 90mg should normally be administered as a 2-hour infusion in 250mL infusion solution. However, in patients with multiple myeloma and in patients with tumour-induced hypercalcaemia, it is recommended not to exceed 90mg in 500mL over 4 hours. In patients with established or suspected renal impairment (e.g. those with tumour-induced hypercalcaemia or multiple myeloma) it is recommended that the infusion rate does not exceed 20mg/h (see also Renal Impairment). In order to minimise local reactions at the infusion site, the cannula should be inserted carefully into a relatively large vein. Until further exp Læs hele dokumentet