Država: Evropska unija
Jezik: angleščina
Source: EMA (European Medicines Agency)
zoledronic acid monohydrate
Actavis Group PTC ehf
M05BA08
zoledronic acid
Drugs for treatment of bone diseases
Fractures, Bone
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.
Revision: 15
Authorised
2012-04-20
27 B. PACKAGE LEAFLET 28 PACKAGE LEAFLET: INFORMATION FOR THE USER _ _ ZOLEDRONIC ACID ACTAVIS 4 MG/5 ML CONCENTRATE FOR SOLUTION FOR INFUSION zoledronic acid READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 Actavis is and what it is used for 2. What you need to know before you are given Zoledronic acid Actavis 3. How Zoledronic acid Actavis is used 4. Possible side effects 5. How to store Zoledronic acid Actavis 6. Contents of the pack and other information 1. WHAT ZOLEDRONIC ACID ACTAVIS IS AND WHAT IT IS USED FOR The active substance in Zoledronic acid Actavis 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 ACTAVIS _ _ Follow carefully all instructions given to you by your doctor. Your doctor will carry out blood tests before you start treatment with Zoledronic acid Actavis and will check your response to treatment at regular intervals. YOU SHOULD NOT BE GIVEN ZOLEDRONIC ACID ACTAVIS - if you are allergic to zoledronic acid, another bisphosphonate (the group of substances to which Zoledr Preberite celoten dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Zoledronic acid Actavis 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 (sterile concentrate). Clear and colourless concentrate for solution for infusion. 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 Actavis must only be prescribed and administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates. Patients treated with Zoledronic acid Actavis should be given the package leaflet and the patient reminder card. Posology _Prevention of skeletal related events in patients with advanced malignancies involving bone _ _Adults and older people _ 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 older people _ The recommended dose in hypercalcaemia (albumin-corrected serum calcium ≥ 12.0 mg/dl or 3.0 mmol/l) is a single dose of 4 mg zoledronic acid. 3 _Renal impairment _ _TIH: _ Zoledronic acid Actavis treatment in TIH patients who also have Preberite celoten dokument