Instructions for Resorba (Zoledronic acid) Lyophilisate solution of 4 mg
English Product Name
Rezorba
Release Form
d/prigot. r. d/inf liophilisate 4 mg: FL 1 w/ solvent
Description Resorba:
Liophilisate for preparation of solution for infusions of white or almost white color; Applied solvent - transparent colorless liquid, odorless.
FL 1
monohydrate Zoledronic acid 4.26 mg,
which corresponds to the content of Zoledronic acid with no water 4 mg
Auxiliaries: D-mannitol - 220 mg, sodium citrate - 24 mg.
Solvent: Water D/i - 5 ml, sodium chloride solution for infusion 0.9% - 100 ml.
Dark glass bottles (1) complete with water solvent (amp.) - cell contour (1) package - cardboard packages.
Dark glass bottles (1) complete with solvent water f/w (ap) - cell contour (1) packaging, container in bag with sodium chloride solvent solution for infusion 0.9% (1) - packs cardboard .
ATX codes
M05BA08 Zoledronic acid
Clinical and pharmacological groups / Group affiliation
Inhibitor of bone tissue resorption. Bisphosphonate
Active substance
Zoledronic acid
Pharmacotherapeutic group:
Bone cutoff inhibitor bisphosphonate
Storage conditions:
The drug Resorba should be stored in a dry place, protected from light and away from children at a temperature not exceeding 25°C.
Expiry Date
Shelf life - 3 years,
solvent - 5 years.
Restored mud can be stored at a temperature of 5° to 25°C for 24 hours
Indications Resorba:
hypercalciemia (concentration of albumine serum ≥ 12 mg/dl or 3 mmol/l) induced by malignant tumors;
Metastatic bone damage in malignant solid tumors and myeloma disease (to reduce the risk of pathological fractures, spinal cord compression, tumor-induced hypercalciemia and the need for radiation therapy).
Method of application, course and dosage Resorba:
Drip for at least 15 minutes.
For bone metastases and osteolitic centers with multiple myeloma, the recommended dose is 4 mg every 3-4 weeks.
Additionally, it is recommended to inject calcium at 500 mg/day and vitamin D at 400 ME/day.
In hypercalciemia (calcium concentration corrected to albumin level ≥12 mg/dl or 3 mmol/l) due to malignant tumors, the recommended dose is 4 mg, once. Infusion is carried out under condition of adequate hydration of the patient.
Patients with kidney disorders
Hypercalciemia caused by malignant tumors: The decision to treat patients with severe kidney function disorders with Zoledronic acid should be made only after careful assessment of the risk/benefit ratio. No dosing correction is required for creatinine concentration < 400 ummol/l or < 4.5 mg/dl.
Bone metastases of common malignant tumors and myeloma disease: the Zoledronic acid dose depends on the initial HC level calculated using the Cocroft-Gault formula.
Zoledronic acid is not recommended for severe kidney disorders (AC < 30 mL/min).
Recommended doses for mild or moderate kidney function disorders (KC values of 30-60 ml/min) are given below.
Kidney disorders
Care should be taken to prescribe the drug Resorba in case of kidney failure.
Application for liver function disorders
Care should be taken when liver failure is reported (no application data available).
Terms of sale
The drug Resorba is prescription.
Child use
Contradiction: Children and adolescents (safety and effectiveness of use are not established).
- Nosology (ICD codes)
- C40
- Malignant neoplasm of bones and joint cartilage
- C79.5
- Secondary malignant neoplasm of bone and bone marrow
- C90.0
- Multiple myeloma
Pharmacological effect:
Zoledronic acid belongs to highly effective bisphosphonates, selectively acting on bone tissue. The drug Resorba suppresses the resorption of bone tissue, affecting osteoclasts. Selective effect of bisphosphonates on bone tissue is based on high affinity to mineralized bone tissue. The exact molecular mechanism for inhibition of osteoclast activity is still unclear.
Zoledronic acid has no unwanted effect on the formation, mineralization and mechanical properties of bone.
In addition to inhibiting effect on bone resorption, Zoledronic acid has anti-tumor properties that provide effectiveness of the drug Resorba at metastases in bones. In vivo: inhibits osteoclastes from bone tissue re-sorption, alters bone marrow microenvironment, and reduces tumor cell growth; exhibits antiangiogenic activity. Oppression of bone resorption is clinically accompanied, including, expressed reduction of pain sensations.
