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DESCRIPTION:

Zoledoma® is a bisphosphonate derivative which inhibits bone resorption via actions on osteoclasts or on osteoclast precursors; inhibits osteoclastic activity and skeletal calcium release induced by tumors.

Zoledoma® is supplied in one vial containing 4 mg zoledronic acid (as mono hydrate).

Zoledoma® API is manufactured in MAPRIMED S.A.Co. Argentina and developed by Homa pharmed Co.

Indication:

Special Warning and precautions:

Adequately rehydrate patients with hypercalcemia of malignancy prior to administration of Zoledoma and monitor electrolytes during treatment. Deterioration in renal function recommended. Monitor serum creatinine before each dose. The use of Zoledoma is not recommended in patients with severe renal impairment Osteonecrosis of the jaw (ONJ) has been reported. Preventive dental exams should be performed before starting Zoledoma. Avoid invasive dental procedures. Atypical subtrochanteric and diaphyseal femoral fractures have been reported in patients receiving bisphosphonate therapy. These fractures may occur after minimal or no trauma. Evaluate patients with thigh or groin pain to rule out a femoral fracture. Consider drug discontinuation in patients suspected to have an atypical femur fracture. Advise females of reproductive potential of potential risk to a fetus and to use effective contraception.

Administration

Zoledoma® should be administrated intravenous infusion over no less than 15 minutes.

Dilute solution with 100 ml of sodium chloride 0.9% or with decstrose serum 5%.

Infuse in a line separate from other medications.

Patients must be appropriately hydrated prior to treatment.

Acetaminophen after administration may reduce the incidence of acute reaction (eg, arthralgia, fever, flu-like symptoms, myalgia)

Side effects:

The most common adverse events were nausea, fatigue, anemia, Ostealgia, Renal insufficiency, constipation, fever, vomiting, and dyspnea.

Contraindication:

Hypersensitivity to zoledronic acid or any component of the formulation

Evidence of acute renal impairment(CrCl < 35 mL/minute)

Uncorrected hypocalcemia at the time of infusion

Pregnancy and breast-feeding women

Storage:

Zoledoma® should be stored at 30-15 ˚C and protect from light.

Keep away from children.

It is our honor to help patients who are suffering from the disease. We always hope to have a greater share in resolving diseases in the hope of getting rid of any suffering.

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Address :No.26 . Nader Alley . Parvin St . West Fatemi St . Tehran . Iran Tel : +982162769000 Fax: +982166908071 Mail: info@homapharmed.com