Properties
What is it?
Aclasta solution for infusion 5mg/100ml vial Composition: Active substance: zoledronic acid; 100 ml of solution contains 5 mg of zoledronic acid (anhydrous), equivalent to 5.33 mg of zoledronic acid monohydrate; Excipients: Mannitol (E 421), sodium citrate, water for injections. Indications: Treatment of osteoporosis in postmenopausal women and in men to reduce the incidence of hip, vertebral and other fractures, increase bone mineral density. Prevention of recurrent fractures after hip fracture in men and women. Treatment and prevention of glucocorticoid-induced osteoporosis. Paget's disease of bone (osteitis deformans). Contraindications: Hypersensitivity to the active substance of the drug or to any of the excipients, or hypersensitivity to bisphosphonates. Severe renal impairment with creatinine clearance < 35 ml/min. Hypocalcemia. Pregnancy and lactation. Dosage and administration: Treatment of postmenopausal osteoporosis, osteoporosis in men, treatment and prevention of glucocorticoid-induced osteoporosis, prevention of recurrent fractures after hip fracture: Recommended dose - one intravenous infusion of Aclasta 5 mg per year. Treatment of Paget's disease of bone: Recommended dose - one intravenous infusion of Aclasta 5 mg. The drug is prescribed only by physicians experienced in the treatment of Paget's disease of bone. Data on repeated treatment with the drug are not available. A long period of remission is observed after a single treatment of Paget's disease of bone with Aclasta. However, repeated treatment with Aclasta may be prescribed for patients with disease relapse caused by elevated serum alkaline phosphatase levels, in whom normalization of serum alkaline phosphatase levels was not achieved, or in patients with persistent symptoms 12 months after the start of treatment. Aclasta (5 mg per 100 ml of ready-to-use infusion solution) is administered intravenously through a system assembled at a stable infusion rate. The infusion time should be at least 15 minutes. Aclasta infusion is carried out under conditions of adequate hydration of the patient. This is especially important for elderly patients and patients taking diuretics. For osteoporosis in women and men, glucocorticoid-induced osteoporosis, it is necessary to prescribe calcium and vitamin D if the diet cannot compensate for their required amount. For patients with Paget's disease of bone, adequate intake of vitamin D and calcium in daily doses for 10 days after administration of Aclasta must be ensured. Patients with renal insufficiency. Administration of Aclasta to patients with renal insufficiency with creatinine clearance < 35 ml/min is not recommended due to insufficient clinical experience in the treatment of such patients. Dose adjustment is not required for patients with creatinine clearance ≥ 35 ml/min. Patients with hepatic insufficiency. Dose adjustment is not required. Elderly patients (≥ 65 years). Dose adjustment is not required, as the bioavailability, distribution, and excretion of the drug were similar in elderly patients and younger subjects. Instructions for use of the drug. Aclasta must not be mixed or administered intravenously with any other medicinal product. The drug should be administered via a separate intravenous infusion system at a constant rate. If the solution is refrigerated, it must be allowed to reach room temperature before use. Aseptic technique must be followed when preparing the solution for intravenous infusion. The drug is for single use only. Unused solution must be disposed of after infusion. From a microbiological point of view, the prepared infusion solution must be used immediately. Otherwise, the user is responsible for the storage time and conditions before use. Unused solution can be stored for no more than 24 hours at a temperature of 2-8°C. Storage conditions: Unopened vial does not require special storage conditions. Store for 24 hours after opening the vial at a temperature of 2-8°C. Keep out of reach of children.