Zometa concentrate 4mg, No. 1 5ml
Expiration Date: 05/2027
Russian Pharmacy name:
Зомета концентрат 4мг, №1 5мл
bone metastases of common malignant tumors (prostate cancer, breast cancer) and myeloma, incl. to reduce the risk of pathological fractures, spinal cord compression, tumor-related hypercalcemia, and reduce the need for radiation therapy or bone surgery;
hypercalcemia due to malignant tumor.
IV, drip; the duration of the infusion is at least 15 minutes. Multiplicity of appointment - every 3-4 weeks. In case of bone metastases of common malignant tumors and myeloma in adults and elderly patients, the recommended dose of the drug is 4 mg. Before the administration of the drug, the concentrate (contents of 1 vial) is diluted in 100 ml of an infusion solution that does not contain calcium (0.9% sodium chloride solution or 5% dextrose solution).
Patients should also be additionally prescribed calcium by mouth at a dose of 500 mg / day and vitamin D by mouth at a dose of 400 IU / day.
In case of hypercalcemia caused by a malignant tumor (calcium concentration with correction for albumin levels is 12 mg / dL or 3 mmol / L), in adults and elderly patients, the recommended dose of the drug is 4 mg. To ensure adequate hydration of the patient, it is recommended to administer saline before, in parallel or after the infusion of Zometa.
The decision on the treatment of hypercalcemia caused by a malignant tumor with Zometa in patients with severe renal impairment should be made only after a thorough assessment of the risk of using the drug and the expected benefits of therapy. Patients whose serum creatinine concentration is <400 ?mol / L or <4.5 mg / dL does not require dosage adjustment.
In bone metastases of common malignant tumors and myeloma, the dose of Zometa depends on the initial level of creatinine clearance, calculated using the Cockcroft-Gault formula. It is not recommended to use Zometa in patients with severely impaired renal function (creatinine Cl values ???30 ml / min).
Recommended doses in patients with mild to moderate renal impairment (Cl creatinine values ??30-60 ml / min) are given below.
| Initial value of Cl creatinine, ml / min | Recommended dose of Zometa |
| > 60 | 4 mg (5 ml concentrate) |
| 50-60 | 3.5 mg (4.4 ml concentrate) |
| 40Ц49 | 3.3 mg (4.1 ml of concentrate) |
| 30Ц39 | 3.0 mg (3.8 ml concentrate) |
After the start of therapy with Zometa, the concentration of serum creatinine should be determined before the introduction of each dose of the drug. If renal dysfunction is detected, the next administration of Zometa should be postponed. Renal dysfunction is defined by the following parameters:
- for patients with normal baseline creatinine values ??(<1.4 mg / dl) - an increase in serum creatinine concentration by 0.5 mg / dl.
- for patients with abnormalities of the baseline creatinine level (> 1.4 mg / dl) - an increase in serum creatinine concentration by 1 mg / dl.
Zometa therapy is resumed only after the creatinine level reaches values ??within 10% of the initial value, in the same dose that was used before the interruption of treatment.
Rules for the preparation of solution for infusion
A solution for infusion is prepared from a concentrate of 4 mg / 5 ml (contents of 1 vial). The solution should be prepared under aseptic conditions. Before the administration of the drug, dilute the concentrate (contents of 1 vial. Or a smaller volume, if required) in 100 ml of a solution for infusion that does not contain calcium (0.9% sodium chloride solution or 5% dextrose solution). It is advisable to use the prepared Zometa solution immediately after preparation. The solution unused immediately can be stored in the refrigerator at a temperature of 2Ц8 ? C for no more than 24 hours. Before administration, the solution should be kept indoors until it reaches room temperature.
The total time between dilution of the concentrate, storage of the prepared solution in the refrigerator at a temperature of 2-8 ? C and the end of the drug administration should not exceed 24 hours.
Zometa solution should not be mixed with any other medicinal products. Zometa should not be mixed with any solutions containing calcium or any other divalent cations, such as Ringer's lactate solution. The prepared zoledronic acid solution must be administered using a separate IV infusion system.
| Concentrate for solution for infusion | 5 ml (1 fl.) |
| zoledronic acid monohydrate | 4,264 mg |
| (corresponds to 4 mg of anhydrous zoledronic acid) | |
| excipients: mannitol, sodium citrate, water for injection, nitrogen |
in vials of 5 ml; in a cardboard box 1 bottle.
hypersensitivity to zoledronic acid, other bisphosphonates and other components of the drug;
pregnancy;
lactation period (breastfeeding).