Zolacid concentrate for solution for infusion 4 mg/5 ml bottle No. 1

Zolacid concentrate for solution for infusion is indicated for the prevention of symptoms associated with bone lesions (pathological fractures, spinal column compression, complications after surgery and radiotherapy or hypercalcemia due to malignant tumors) in patients with advanced malignant tumors.

Composition

Active ingredient: zoledronic acid;

5 ml of concentrate (1 vial) contains 4 mg of zoledronic acid anhydrous, corresponding to 4.264 mg of zoledronic acid monohydrate;

1 ml of concentrate contains 0.8 mg of zoledronic acid anhydrous;

Excipients: mannitol (E 421), sodium (E 331), 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

Zolacid should only be administered by physicians experienced in the administration of bisphosphonates.

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

Zolacid 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 out of the reach of children in the original packaging at a temperature not exceeding 30 °C.

After dilution in sterile 0.9% sodium chloride solution or 5% glucose solution, the drug is stable for 24 hours at a storage temperature of 2-8 °C.

After aseptic dilution, the finished product must be used immediately.

Shelf life - 3 years.