Composition, form of production and packaging
Lyophilizate for the preparation of a solution for intravenous administration in white.
sodium diphosphate decahydrate 27.35 mg
Excipients: tin dichloride dihydrate - 2.09 mg.
The finished product is a colorless, clear liquid.
technetium 99mTc 185-1480 MBq
Excipients: tin dichloride dihydrate 0.21-0.42 mg, sodium diphosphate decahydrate 2.73-5.47 mg, sodium chloride 9 mg, water q / q qs
Vials (5) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
Pirfoteh, 99m Tc - radiopharmaceutical preparation is prepared from lyophilizate and sodium pertechnetate solution, 99m Tc from the technetium-99m generator.
The isotope 99m Tc has a half-life of 6.04 hours. In decay 99m, Tc emits gamma rays with an energy of 140 KeV and a 90% yield.
Pirfoteh, 99m Tc is excreted from the blood and accumulates in the skeleton. After 1 hour, more than 30% of the administered amount accumulates in the skeleton. 3 hours after the injection, 10-15% of the drug is contained in the blood. Excreted from the body by the urinary system. 1 hour after the administration, 30% is excreted in the urine, 45% of the preparation for 3 hours.
Pirfoteh, 99m Tc after intravenous injection is actively absorbed in the zone of myocardial infarction disturbances in case of infarction, foci of pathological skeletal changes and in malignant neoplasms of the ovaries, which allows using it in the diagnosis of the above pathological conditions. With the separate administration of lyophilizate and sodium pertechnetate, 99m Tc with an interval of 20 min, in vivo labeling of erythrocytes occurs for a period of up to 3-4 hours.
- scintigraphy of the skeleton in order to determine the pathological changes of different etiology (primary and metastatic tumors, osteomyelitis, osteoarticular tuberculosis, etc.);
- scintigraphic detection of acute myocardial infarction;
- scintigraphy for differential diagnosis of ovarian tumors;
- for labeling erythrocytes in vivo for radionuclide ventriculography;
- to determine the volume of circulating and deposited blood (BCC and UDC) and in the emission computerized tomography (ECG) of the liver with labeled erythrocytes.
The drug Pirfoteh, 99m Tc is prepared in a medical facility immediately before consumption.
The finished preparation Pirfoteh, 99m Tc is a technetium-99m complex with sodium diphosphate.
Preparation of the preparation Pirfoteh, 99m Tc:
- 5- 10 ml eluate from the technetium-99m generator with volumetric activity of 185 -1480 MBq / ml under aseptic conditions are injected into the vial with lyophilizate by means of a syringe, digging the rubber stopper with a needle;
- If necessary, dilute the eluate with an isotonic solution of sodium chloride before the required volume activity;
- the contents of the vial are mixed by shaking until the lyophilizate is completely dissolved;
- the preparation is ready for use immediately after complete dissolution of the lyophilizate;
- A ready-made preparation prepared on the basis of a lyophilizate contained in one bottle can be used to study 5 patients.
For scintigraphy of the skeleton, detection of acute myocardial infarction and ovarian tumors, the drug is administered intravenously in an amount of 3-6 MBq per 1 kg of body weight of the patient. Scintigraphy is carried out 3 hours after the administration of the drug.
In radionuclide ventricyclocography, determination of bcc and in liver ECT with labeled erythrocytes, the labeling of erythrocytes in vivo is carried out by separate administration of dissolved lyophilizate in 5 ml of isotonic sodium chloride solution and after 20-30 min of sodium pertechnetate solution, 99m Tc. The patient is injected intravenously with a lyophilizate solution at a rate of 0.016-0.032 mg tin dichloride per kg body weight of the patient and 4-12 MBq (in determining the bcc) or 555-740 MBq (with radionuclide ventriculography, liver EBC with labeled erythrocytes) sodium pertechnetate, 99m Tc .
Radiation loads on the organs and the whole body of the patient with the use of the preparation "Pirfoteh, 99m Tc"
Organs and systems Absorbed dose, mGy / MBq
Red bone marrow 0.0058
Total body (effective dose), mSv / MBq 0.0020
Side effects with the use of the drug for diagnostic purposes are not revealed.
- during pregnancy and lactation;
- hypersensitivity to the drug or its components.
PREGNANCY AND LACTATION
Contraindicated in pregnancy and lactation.
Work with the drug should be carried out in accordance with the "Basic Sanitary Rules for Ensuring Radiation Safety" (OSPORB-99), the "Norms of Radiation Safety" (NRB-99) and the guidelines "Hygienic Requirements for Radiation Safety in Radionuclide Diagnostics by Radiopharmaceuticals" (MU 22.214.171.1242-04).
With a single administration, an overdose is unlikely, due to the lack of pharmacodynamic properties in the preparation.
When conducting diagnostic studies, interaction with other drugs was not detected.
TERMS OF RELEASE FROM PHARMACY
Implementation through the pharmacy network is not. It is only released on request-applications to specialized radioisotope laboratories of medical diagnostic facilities.
TERMS AND CONDITIONS OF STORAGE
The lyophilizate is stored at a temperature of 2 В° C to 10 В° C. It is allowed to deviate from the temperature regime (18-25 В° C) during transportation for 1 month. The finished product is stored in accordance with OSPORB-99 and MU 126.96.36.1992-04. Shelf life of the lyophilizate is 1 year from the date of manufacture, the preparation Pirfoteh, 99m Tc -3 h from the time of preparation.