Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
Pamidronic acid
Wockhardt UK Limited
M05BA; M05BA03
Pamidronic acid
15 milligram(s)/millilitre
Concentrate for solution for infusion
Product subject to prescription which may not be renewed (A)
Bisphosphonates; pamidronic acid
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. ‘Contents of the pack and other information’) • are pregnant • are breast feeding WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR OR NURSE BEFORE BEING GIVEN DISODIUM PAMIDRONATE Leggi il documento completo
HealthProductsRegulatoryAuthority 19March2019 CRN008J4D Page1of10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT DisodiumPamidronate15mg/mlConcentrateforSolutionforInfusion,2ml. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1mlofconcentratecontains15mgdisodiumpamidronate.Oneampouleof2mlcontains30mgofdisodiumpamidronate. Excipientwithknowneffect Each2mlampoulecontains12mgsodium. Forthefulllistofexcipients,seesection6.1. 3 PHARMACEUTICAL FORM Concentrateforsolutionforinfusion. Colourlesssolution,freefromparticles. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatmentofconditionsassociatedwithincreasedosteoclastactivity: Tumour-inducedhypercalcaemia Osteolyticlesionsandbonepaininpatientswithbonemetastasesassociatedwithbreastcancerormultiplemyeloma Paget'sdiseaseofbone. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Methodofadministration Disodiumpamidronateconcentratemustneverbegivenasabolusinjection(seeWarnings).Theconcentrateofdisodium pamidronateconcentrateinampoulesshouldbedilutedinacalcium-freeinfusionsolution(0.9%SodiumChlorideIntravenous InfusionB.P.isrecommended)andinfusedslowly. Theinfusionrateshouldneverexceed60mg/hour(1mg/min),andtheconcentrationofdisodiumpamidronateconcentratein theinfusionsolutionshouldnotexceed90mg/250mL.Adoseof 90mgshouldnormallybeadministeredasa2-hourinfusion in250mLinfusionsolution.However,inpatientswithmultiplemyelomaandinpatientswithtumour-inducedhypercalcaemia, itisrecommendednottoexceed90mgin Leggi il documento completo