Gallium citrate 67Ga (Solution) Instructions for Use

Instructions
Dosage forms

ATC Code

V09HX01 (Gallium (67Ga) citrate)

Active Substance

Gallium (67 Ga) citrate (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Diagnostic agent. Radioisotope for scintigraphy

Pharmacotherapeutic Group

Radioisotope diagnostic agent

Pharmacological Action

Radioisotope agent. It is a chemical compound of sodium citrate with the radionuclide Ga-67 in the form of a sterile solution with a pH of 5-6.

The isotope 67 Ga with a half-life of 78.26 hours emits gamma quanta with energies of 0.091 (3%) MeV, 0.093 (37%) MeV, 0.185 (20.7%) MeV, 0.209 (2.3%) MeV, 0.300 (16.6%) MeV, 0.393 (4.6%) MeV upon decay.

It actively accumulates in primary and metastatic malignant neoplasms, as well as in foci of nonspecific inflammatory processes, which allows it to be used for diagnostic purposes.

Indications

For the diagnosis of systemic malignant lymphoproliferative diseases (Hodgkin’s lymphoma, Boeck’s sarcoidosis), primary and metastatic lung tumors, soft tissue sarcomas.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
Z03	Medical observation and evaluation for suspected disease or pathological condition

ICD-11 code	Indication
QA02	Medical observation or examination for suspected diseases or conditions that were ruled out

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Solution

It is administered intravenously at a dose of 1.5-2.0 MBq/kg of body weight.

Scintigraphic examination is performed 24-48 hours after the administration of gallium citrate.

The criterion for a positive conclusion about the pathological hyperfixation of the drug in certain areas of the examined organs and tissues is a differential accumulation coefficient of more than 1.3 relative to areas with normal accumulation within one or a paired organ.

Radiation exposure to organs and the whole body of the patient (mSv/MBq): red bone marrow – 0.12, ovaries – 0.09, testes – 0.05, liver – 0.11, kidneys – 0.11, urinary bladder – 0.06, skeleton – 0.32, whole body (effective equivalent dose) – 0.1.

The critical organ is the red bone marrow.

Adverse Reactions

No adverse effects have been identified.

Contraindications

General clinical contraindications to the use of radionuclide studies.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Special Precautions

Gallium (67 Ga) citrate should be stored in accordance with the “Basic Sanitary Rules for Ensuring Radiation Safety”.

Gallium (67 Ga) citrate is dispensed only to specialized radioisotope medical and diagnostic institutions.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer