MacroTech 99mTc (Macrotech 99mTc)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbsplyophilizate for the preparation of a solution for intravenous administration
Composition:

Lyophilizate:

Albumin 2.0 mg

Number of macroaggregates 3.0-106 PC.

Tin dihydrate dihydrate 0.2 mg

Dextrose (glucose) monohydrate 20.0 mg

Ascorbic acid 5.0 mg

Sodium chloride 4.5 mg

1 bottle

Ready product:

Active substances:

Technetium-99m 37- 148 MBq

Excipients:

Albumin 0.25-1.0 mg

Number of macroaggregates 0.37 ∙ 106 - 1,5∙106 PC.

Tin dihydrate dihydrate 0.025-0.100 mg

Dextrose (glucose) monohydrate 2.5 - 10.0 mg

Ascorbic acid 0.6 - 2.5 mg

Sodium chloride 9.6-11.3 mg

Water for injection up to 1.0 ml

Description:

Lyophilizate is white.

The finished preparation is a suspension of white color. When standing, a precipitate falls out. The liquid above the precipitate is colorless. When the vial is shaken after standing, a suspension is again formed.

Pharmacotherapeutic group:Radiopharmaceutical diagnostic tool
ATX: & nbsp
  • Technetium 99m colloid for injection
    • Pharmacodynamics:

    Physicochemical characteristics

    Macrotech, 99m Tc - radiopharmaceutical preparation, which is prepared from lyophilizate and sodium pertechnetate solution, 99m Tc from the technetium-99m generator. At least 95% of the macroaggregates have a size of 10 to 90 μm.

    Isotope Macrotech, 99m Tc has a half-life of 6.04 hours. Upon decay 99m Tc emits gamma rays with an energy of 140 keV and a yield of 90%.

    Pharmacokinetics:

    After intravenous administration of 95% of the drug Macrotech, 99m Tc enters the capillary bed of the lungs and remains there for 2-3 hours. The remaining amount is distributed in approximately equal proportions between the kidneys, the liver, the brain and the thyroid gland.

    At 5 hours after administration, the accumulation of the drug in the lung decreased to 61-64% in the case of its use within 1 hour after preparation, and from 35 to 45% when administered within 5 hours after production. After 24 hours, 19-24% and 15-18%, respectively, remain in the lungs.

    There is an accumulation of sodium pertechnetate, 99m Tc in the thyroid gland, gastrointestinal tract and urinary tract.

    After 2 -3 hours in the lungs, the destruction of particles and the release of pertechnetate sodium, 99m Tc, which is accompanied by an increase in the radioactive background of the blood.

    Indications:

    For perfusion lung scintigraphy with:

    - pulmonary thromboembolism, pulmonary infarction;

    - chronic obstructive pulmonary diseases;

    - regional violations of ventilation;

    - emphysema of the lungs

    To conduct a radioisotope phlebography with:

    - deep vein thrombosis of the lower extremities and pelvis;

    - Obstruction (occlusion) of the inferior vena cava.

    Contraindications:Pregnancy, hypersensitivity to protein, age to 18 years.
    Pregnancy and lactation:If it is necessary to administer the drug during lactation, breastfeeding should be discontinued within 24 hours after the study.
    Dosing and Administration:

    Preparing the preparation

    - 2 - 8 ml of the eluate from the technetium-99m generator are introduced into the vial with lyophilizate by puncturing a rubber plug with a syringe needle;

    - It is forbidden to use an air needle;

    - if necessary, dilute the eluate with 0.9% Sodium chloride solution to the required volume activity value;

    - vial vigorously shaken 2-4 times, placed in a lead container and kept in a container for 15-20 minutes, periodically shaking;

    - under these conditions, the labeled 99m Tc albuminal macroaggregates intended for lung scintigraphy. The drug is ready for use.

    The injected dose is 1.7 MBq / kg of body weight of the patient. One bottle of the finished product can be used to study 5 patients.

    The patient is examined in prone position. The gamma camera detector is placed as close to the body surface as possible so that both light in the front and rear projections are included in the field of view of the sensor.The collection of information for planar studies is carried out in a static mode before dialing from 300,000 to 500,000 pulses. In the case of performing emission tomography, studies are performed in a dynamic mode with a set of 100,000 - 150,000 pulses per projection.

    Evaluation of the results of the study is carried out on the basis of qualitative and quantitative analysis of scintigrams (location, size, shape, homogeneity of the distribution of the drug in the pulmonary artery system, the ratio of the affected and intact parts of the lung tissue). It is also advisable to compare the results obtained with the functional parameters of external respiration and a radioisotope study of pulmonary ventilation.

    The drug is administered intravenously in an amount of 37-148 MBq, depending on the equipment used.

    The amount of particles in the administered dose should be 250-300 thousand.

    Table

    Radiation loads on the organs and entire body of the patient when using the drug Macrotech, 99m Tc

    Organs and Systems

    Absorbed dose, mGy / MBq

    Ovaries

    0,005

    Bladder

    0,021

    Kidneys

    0,051

    Red marrow

    0,005

    Uterus

    0,005

    Thyroid

    0,038

    Lungs

    0,078

    Liver

    0,019

    Testes

    0,001

    Total body (effective equivalent dose), mSv / MBq

    0,005
    Side effects:Side effects with the use of the drug for diagnostic purposes are not revealed. Allergic reactions are possible.
    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 must be in accordance with the "basic sanitary rules of radiation safety" (OSPORB-99), "Norms of Radiation Safety" (NRB -99) and methodological guidelines "Hygienic requirements for radiation safety during radionuclide diagnosis using radiopharmaceuticals" (MU 2.6.1.1892-04).
    Form release / dosage:Lyophilizate for preparation of solution for intravenous use (vials).
    Packaging:5 vials together with a passport and instructions for preparation and use of the drug in a box made of cardboard.
    Storage conditions:

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

    The finished product is 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 Macrotech, 99m Tc - 5 hours from the time of preparation.

    Terms of leave from pharmacies:For hospitals
    Registration number:LS-002157
    Date of registration:24.06.2010
    Expiration Date:Unlimited
    The owner of the registration certificate:DIAMED, LLC DIAMED, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp30.03.2018
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