Country: European Union
Language: English
Source: EMA (European Medicines Agency)
ibandronic acid
Accord Healthcare S.L.U.
M05BA06
ibandronic acid
Drugs for treatment of bone diseases
Wounds and Injuries; Breast Diseases; Neoplastic Processes; Calcium Metabolism Disorders; Water-Electrolyte Imbalance
Ibandronic acid is indicated in adults forPrevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.Treatment of tumour induced hypercalcaemia with or without metastases.Treatment of osteoporosis in postmenopausal women at increased risk of fracture (see section 5.1).A reduction in the risk of vertebral fractures has been demonstrated, efficacy on femoral neck fractures has not been established.
Revision: 14
Authorised
2012-11-18
42 B. PACKAGE LEAFLET 43 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT IBANDRONIC ACID ACCORD 2 MG CONCENTRATE FOR SOLUTION FOR INFUSION IBANDRONIC ACID ACCORD 6 MG CONCENTRATE FOR SOLUTION FOR INFUSION ibandronic acid 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 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 Ibandronic acid Accord is and what it is used for 2. What you need to know before you receive Ibandronic acid Accord 3. How to receive Ibandronic acid Accord 4. Possible side effects 5. How to store Ibandronic acid Accord 6. Contents of the pack and other information 1. WHAT IBANDRONIC ACID ACCORD IS AND WHAT IT IS USED FOR Ibandronic acid Accord contains the active substance ibandronic acid. This belongs to a group of medicines called bisphosphonates. Ibandronic acid Accord is used in adults and prescribed to you if you have breast cancer that has spread to your bones (called ‘bone metastases’). • It helps to prevent your bones from breaking (fractures). • It helps to prevent other bone problems that may need surgery or radiotherapy. Ibandronic acid Accord can also be prescribed if you have a raised calcium level in your blood due to a tumour. Ibandronic acid Accord works by reducing the amount of calcium that is lost from your bones. This helps to stop your bones from getting weaker. 2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE IBANDRONIC ACID ACCORD _ _ DO NOT RECEIVE IBANDRONIC ACID ACCORD • if you are allergic to ibandronic acid or any of the other ingredients of this medicine (listed in section 6) • if you have, or have ever had low levels of calcium in your blood Do not receive this medicine if any of the above apply to you. If you are not sure, t Read the complete document
1 _ _ _ _ ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Ibandronic acid Accord 2 mg concentrate for solution for infusion Ibandronic acid Accord 6 mg concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial with 2 ml concentrate for solution for infusion contains 2 mg ibandronic acid (as sodium monohydrate). One vial with 6 ml concentrate for solution for infusion contains 6 mg ibandronic acid (as sodium monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion (sterile concentrate). Clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ibandronic acid is indicated in adults for − Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases. − Treatment of tumour-induced hypercalcaemia with or without metastases. _ _ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ Patients treated with ibandronic acid should be given the package leaflet and the patient reminder card. Ibandronic acid therapy should only be initiated by physicians experienced in the treatment of cancer. Posology _Prevention of skeletal events in patients with breast cancer and bone metastases_ The recommended dose for prevention of skeletal events in patients with breast cancer and bone metastases is 6 mg intravenous injection given every 3-4 weeks. The dose should be infused over at least 15 minutes. A shorter (i.e. 15 min) infusion time should only be used for patients with normal renal function or mild renal impairment. There are no data available characterising the use of a shorter infusion time in patients with creatinine clearance below 50 ml/min. Prescribers should consult the section _Patients with _ _Renal Impairment _ below for recommendations on dosing and administration in this patient group. _Treatment of tumour-induced hypercalcaemia_ Prior to treatment with ibandronic acid the p Read the complete document