Země: Evropská unie
Jazyk: angličtina
Zdroj: EMA (European Medicines Agency)
ibandronic acid
Pharmathen S.A.
M05BA06
ibandronic acid
Drugs for treatment of bone diseases
Hypercalcemia; Fractures, Bone; Neoplasm Metastasis; Breast Neoplasms
Concentrate for solution for infusion 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. Film-coated Tablets Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in patients with breast cancer and bone metastases.,
Revision: 11
Authorised
2011-01-21
72 B. PACKAGE LEAFLET 73 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT IASIBON 1 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 Iasibon is and what it is used for 2. What you need to know before you receive Iasibon 3. How to receive Iasibon 4. Possible side effects 5. How to store Iasibon 6. Contents of the pack and other information 1. WHAT IASIBON IS AND WHAT IT IS USED FOR Iasibon contains the active substance ibandronic acid. This belongs to a group of medicines called bisphosphonates. Iasibon 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 Iasibon can also be prescribed if you have a raised calcium level in your blood due to a tumour. Iasibon 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 IASIBON DO NOT RECEIVE IASIBON • if you are allergic to ibandronic acid or any of the other ingredients of this medicine that are 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, talk to your doctor or pharmacist before having Iasibon. WARNINGS AND PRECAUTIONS A side effect called osteonecrosis of the jaw (ONJ) (bone damage in the jaw) has been reported very rarely in the post marketing setting in patients receiving ib Přečtěte si celý dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Iasibon 1 mg concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One ampoule with 1 mL concentrate for solution for infusion contains 1 mg ibandronic acid (as sodium monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Concentrate for solution for infusion. Clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Iasibon 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 Iasibon 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 _ (see section 4.2) for recommendations on dosing and administration in this patient group. _Treatment of tumour-induced hypercalcaemia_ Prior to treatment with Iasibon the patient should be adequately rehydrated with 9 mg/mL (0.9%) sodium chloride solution. Consideration should be given to the severity of the hypercalcaemia as well as the tumour type. In general patients with osteolytic bone metastases require lower doses than patients with the humoral type of hypercalcaemia. In most patients with severe hypercalcaemia Přečtěte si celý dokument