Zoledronic acid-Pharmex concentrate for solution for infusion 0.8 mg/ml bottle 5 ml No. 1

Concentrate for solution for infusion Zoledronic acid-Pharmex is indicated for the prevention of symptoms associated with bone tissue damage (pathological fractures, spinal column compression, complications after surgical interventions and radiotherapy or hypercalcemia due to malignant tumors) in patients with malignant neoplasms in the late stages.

Composition

Active ingredient: zoledronic acid;

1 ml of concentrate contains 0.8 mg of zoledronic acid;

Excipients: mannitol (E 421), sodium, water for injections.

Contraindication

Hypersensitivity to the active substance (zoledronic acid), other bisphosphonates or any of the excipients included in the medicinal product.

Pregnancy or breastfeeding

Method of application

The drug can only be administered by doctors who have experience in administering bisphosphonates.

Before administration, 4 mg of the concentrate should be diluted in 100 ml of 0.9% sodium chloride solution or 5% glucose solution. The prepared solution for infusion should be administered as a single infusion over at least 15 minutes.

The concentrate must not be mixed with infusion solutions containing calcium or other divalent cations, such as lactated Ringer's solution, and must be administered as a single infusion using a separate infusion system.

Application features

Pregnant women

Contraindicated.

Children

Contraindicated.

Drivers

With caution.

Overdose

Clinical experience in the treatment of acute overdose is limited. There have been reports of accidental administration of zoledronic acid at a dose of 48 mg. Patients who have received a dose exceeding the recommended dose should be monitored closely for possible renal impairment (including renal failure) and changes in serum electrolytes (including calcium, phosphate and magnesium concentrations). In the event of hypocalcemia, calcium gluconate infusion is indicated as clinically indicated. Treatment is symptomatic.

Side effects

General disorders and administration site conditions: often - fever, influenza-like illness (including fatigue, chills, malaise and flushing); sometimes - injection site reactions (including pain, irritation, swelling, induration), asthenia, peripheral edema, chest pain, weight gain, anaphylactic reactions/shock, urticaria; rarely - arthritis and joint edema as symptoms of an acute phase reaction.

Interaction

No clinically significant interactions have been observed with the concomitant use of zoledronic acid and other medicinal products, such as antineoplastic agents, diuretics, antibiotics, analgesics.

Storage conditions

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Shelf life - 2 years.