Acido Zoledrónico Servycal

Zoledronic Acid 4 mg

INJECTION FOR I.V. USE ONLY STERILE LYOPHILIZED POWDER

SALE UNDER PRESCRIPTION

MADE IN ARGENTINA

QUALI-QUANTITATIVE COMPOSITION:

Each vial contains:

Zoledronic Acid Monohydrate

(corresponding to 4.00mg zoledronic acid,

anhydrous) ..........................................................4.264mg

Mannitol .......................................................... 220.000mg

Sodium citrate ................................................... 24.000mg

Each ampoule diluent contains:

Sterile distilled water.................................................5.0ml

THERAPEUTIC ACTION:

Inhibitor of osteoclastic bone resorption.

ATC Classification: M05BA 08.

INDICATIONS:

Zoledronic acid is indicated for the treatment of tumor-induced hypercalcemia. A strong saline hydration and a therapy for hypercalcemia should be initiated without delay, and 2 liters/day of liquid should be administered to replace the excreted urine. Slight or asymptomatic hypercalcemia may be managed with traditional support measures (saline hydration, with or without Diuretics). Patients should be adequately hydrated during therapy; however, overhydration should be avoided in patients with cardiac failure. Diuretic therapy should only be initiated once hypovolemia is corrected.

Safety and efficacy of zoledronic acid for hypercalcaemia associated with hyperparathyroidism or other condition unrelated to tumors have not been established.

PRESENTATION:

Packed containing 1 vial with lyophilized powder and 1 ampoule with diluent.

Keep between 15 °C and 30 °C