REZOCLASTIN FS CONCENTRATE FOR A SOLUTION FOR INFUSION 4MG/5ML

International non-proprietary name: zoledronic acid
Dosage Form: concentrate for solution for infusion 1 bottle contains 5 ml (4 mg zoledronic acid) or 6.25 ml (5 mg zoledronic acid) concentrate

Pharmacological properties:

The drug "Rezoklastin FS" refers to a new class of highly effective bisphosphonates, which have a selective effect on bone tissue. The selective effect is based on the high affinity of zoledronic acid to mineralized bone tissue. Zoledronic acid inhibits the activity of osteoclasts, does not have an undesirable effect on the formation, mineralization and mechanical properties of bone tissue. In addition to the inhibitory effect on bone resorption, zoledronic acid has direct antitumor properties that provide efficacy in bone metastases.

Indications for use:

• Hypercalcemia (serum Calcium adjusted albumin ≥ 12 mg / dL or 3 mmol / L) induced by malignant tumors
• Metastatic bone lesions in malignant solid tumors
• Myeloma (to reduce the risk of pathological fractures, compression of the spinal cord, hypercalcemia caused by the tumor, and reduce the need for radiotherapy)
• Postmenopausal primary osteoporosis
• Senile form of primary osteoporosis
• Secondary osteoporosis
• Pedzhet's bone disease

Contraindications:

• Hypersensitivity to zoledronic acid, other bisphosphonates or any other components that make up the preparation
• Severe renal failure (creatinine clearance ≤ 30 ml / min)
• Pregnancy and lactation period
• Children and adolescents

Carefully:

with impaired renal function, with severe liver failure (no data on the use), in patients with bronchial asthma sensitive to Acetylsalicylic acid.

Instructions for the preparation of the solution

The solution is prepared under aseptic conditions. Before the introduction of the drug is diluted (the contents of 1 bottle - 4 mg / 5 ml or 5 mg / 6.25 ml, depending on the recommended dose) in 100 ml of solution for infusions that do not contain calcium (0.9% solution of sodium chloride or 5% dextrose solution). The prepared solution of Resoclastine FS should be used immediately after preparation. Unused solution can be stored in a refrigerator at a temperature of from 2 to 8 ° C for no more than 24 hours.

Prior to administration, the solution should be kept indoors until it reaches room temperature 4.When prepared, the solution of zoledronic acid must be administered using a separate system for IV infusion.