Pirfoteh 99mTc (Pirfotechum, 99MTC)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Lyophilizate for the preparation of a solution for intravenous administration

Composition:

Lyophilizate:

Active substances:

-

Excipients:

Tin dichloride dihydrate 2.09 mg

Sodium diphosphate decahydrate 27.35 mg

- 1 bottle

Ready product:

Active substances:

Technetium-99m 185-1480 MBq

Excipients:

tin dihydrate dihydrate 0.21-0.42 mg

sodium diphosphate decahydrate 2.73-5.47 mg

sodium chloride 9.0 mg

water for injection q.s.

- 1 ml

Description:

Lyophilizate is white.

The finished product is a colorless, clear liquid.

Physicochemical characteristics

"Pirfoteh, 99m Tc "- radiopharmaceutical preparation is prepared from lyophilizate and sodium pertechnetate solution, 99mTc from the technetium-99t generator.

Isotope 99mTc has a half-life of 6.04 hours. Upon decay 99m Tc emits gamma quanta with an energy of 140 KeV and a yield of 90%.


Pharmacotherapeutic group:Radiopharmaceutical diagnostic tool
ATX: & nbsp
  • 99m Tc-Technetium-pyrophosphate
    • Pharmacodynamics:


    Pharmacokinetics:

    "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.After 3 hours after injection, 10-15% of the drug is excreted from the body by the urinary system.It is excreted in the urine within 1 hour after administration 30%, for 3h - 45% of the drug.

    "Pirfoteh, 99mTc "after intravenous administration is actively absorbed in the zone of myocardial infarction disturbance atinfarction, foci of pathological changes in the skeleton 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 occurs in vivolabeling of erythrocytes for up to 3-4 hours.

    Indications:

    The drug "Pirfoteh, 99m Tc "are used for scintigraphy of the skeleton in order to determine the pathological changes of different etiology (primary and metastatic tumors, osteomyelitis, osteoarticular tuberculosis, etc.), for scintigraphic detection of acute myocardial infarction, in differential diagnosis of ovarian tumors, for erythrocyte labeling in vivo in radionuclide ventriculography, to determine the volume of circulating and deposited blood (BCC and UDC) and in the emission of computed tomography (ECT) of the liver with labeled erythrocytes.

    Contraindications:

    The use of the drug is contraindicated if the patient has a hypersensitivity to the drug or its components, during pregnancy and lactation.

    Dosing and Administration:

    The drug "Pirfoteh, 99mTc "is prepared in a medical institution immediately before consumption.

    Ready-made preparation "Pirfoteh, 99mTc "is a technetium-99m complex with sodium diphosphate.

    Preparation of the preparation "Pirfoteh, 99mTc ":

    • 5-10 ml of the eluate from the technetium-99m generator with volumetric activity of 185 -1480 MBq / ml under aseptic conditions are injected with a syringe into a vial of lyophilizate, piercing the rubber stopper with a needle;
    • if necessary in advance dilute the eluate with an isotonic solution of sodium chloride to the required volume activity;
    • the contents of the vial are stirred 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 a single vial can be used to study 5 patients.

    Enter intravenously.

    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.

    With radionuclide ventricococlography, determination of bcc and in liver ECT with labeled erythrocytes, labeling of erythrocytes in vivo separate injection of dissolved lyophilizate in 5 ml of isotonic sodium chloride solution and after 20-30 minutes of sodium pertechnetate solution, 99mTc. The patient is intravenously injected with lyophilizate solution at the rate of 0.016-0.032 mg of tin dichloride per 1 kg of the body weight of the patient and 4-12 MBq (in determining the bcc) or 555-740 MBq (with radionuclide ventriculography, liver ECT with labeled erythrocytes) of sodium pertechnetate, 99mTc.

    Table 1

    Radiation loads
    on the organs and entire body of the patient when used
    preparation "Pirfoteh, 99tTc "

    Organs and Systems

    Absorbed dose, mGy / MBq

    Skeleton

    0,037

    Bladder

    0,074

    Kidneys

    0,019

    Red marrow

    0,0058

    Ovaries

    0,0044

    Testes

    0,0029

    Whole body (effective dose), mSv / MBq

    0,0020

    Side effects:Side effects with the use of the drug for diagnostic purposes are not revealed.
    Overdose:

    With a single administration, an overdose is unlikely, due to the lack of pharmacodynamic properties in the preparation.

    Interaction:

    When conducting diagnostic studies, interaction with other drugs was not detected.

    Special instructions:

    Work with the drug should be carried out in accordance with the "Basic Sanitary Rules for Ensuring Radiation Safety" (OSPORB-99),"Norms of radiation safety" (NRB-99) and guidelines "Hygienic requirements for ensuring radiation safety during radionuclide diagnostics by means of radiopharmaceuticals "(MU 2.6.1.1892-04).

    Form release / dosage:

    Lyophilizate for the preparation of a solution for intravenous administration.

    Packaging:

    For 5 bottles together with a passport and instructions for medical use of the drug in a box of cardboard.

    Storage conditions:

    Lyophilizate stored at a temperature of 2 ° C to 10 ° C. It is allowed to deviate from the temperature regime (18-25 ° C) during transportation for 1 month.

    Ready product stored in accordance with OSPORB-99 and MU 2.6.1.1892-04.

    Shelf life:

    Lyophilizate - 1 year from the date of manufacture.

    The drug "Pirfoteh" , 99mTc " - 3 hours from the time of preparation.

    Terms of leave from pharmacies:For hospitals
    Registration number:P N000494 / 01
    Date of registration:14.03.2008
    The owner of the registration certificate:DIAMED, LLC DIAMED, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp14.03.16
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