Active substanceTechnetium [99mTc] sextibiTechnetium [99mTc] sextibi
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  • Technetril, 99mTc
    lyophilizate in / in 
    DIAMED, LLC     Russia
  • Dosage form: & nbspLiophilizate for the preparation of a solution for intravenous administration.
    Composition:

    Lyophilizate:

    Tin dichloride

    0.05 mg

    Copper tetramibium tetrafluoroborate

    0.80 mg

    L-cysteine ​​hydrochloride monohydrate

    1.2 mg

    Mannitol

    10.0 mg

    Sodium dihydrogen citrate

    11.0 mg

    - 1 bottle

    Ready product:

    Active substances:

    Technetium-99m

    37-1850 MBq

    Excipients:

    Tin dichloride

    0.017 mg

    Copper tetramibium tetrafluoroborate

    0.267 mg

    L-cysteine ​​hydrochloride monohydrate

    0.4 mg

    Mannitol

    3.33 mg

    Sodium dihydrogen citrate

    3.67 mg

    Sodium chloride

    9.0 mg

    Water for injections

    up to 1.0 ml

    Description:

    Lyophilizate - white color.

    Ready product - colorless, clear liquid.

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

    Physicochemical characteristics

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

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

    Pharmacokinetics:

    "Technetril, 99mTc "with intravenous administration quickly leaves the vascular bed, and after 3-5 minutes its content in the circulating blood is no more than 2% of the input quantity.

    The maximum accumulation of the drug in a healthy myocardium is observed at 5 minutes after the injection and averages (2.68 ± 0.1)% of the administered dose. This level of myocardial capture remains unchanged for 3 hours, which determines the optimal timing of a planar or single-photon emission tomography, which is 1-2 hours after intravenous administration of the drug. The content of the drug in the lungs is insignificant, and its excretion is significantly ahead of the clearance of "Technetril, 99mTc "from the myocardium.After 5 minutes after the introduction of the lungs contained no more (2.12 ± 0,8)% of the input quantity.

    "Technetril, 99mTs "leaves the body mainly through the hepatobilliary tract and small intestine (about 40% within two days) and partially by the kidneys - 15%.

    Indications:

    To assess the perfusion of the myocardium in various pathological processes leading to a violation of its blood supply (coronary atherosclerosis, acute myocardial infarction, postinfarction and postmyocarditis cardiosclerosis, ischemic heart disease), as well as for visualization of malignant neoplasms of the lungs and mammary gland.

    Contraindications:

    Pregnancy.

    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:

    - 3 ml of the eluate from the technetium-99m generator in aseptic conditions are injected with a syringe into a vial of lyophilizate, piercing the rubber stopper with a needle;

    - It is forbidden to use an air needle;

    - If necessary, dilute the eluate with an isotonic solution of sodium chloride before the required volume activity;

    - the vial with the drug is placed in a lead container and heated in a water bath for 15 minutes from the boiling point of the water. The water level in the water bath should be higher than the level of the drug solution in the vial;

    - the preparation is ready for use after cooling the contents of the vial to room temperature.

    Introduce intravenously.

    When examining patients to assess the blood supply of the myocardium at rest and under stress test conditions with an interval of about 24 hours, "Technetril, 99mTc "is administered in an amount of 259-370 MBq for each study on an empty stomach or at least 4 hours after ingestion.

    After intravenous administration of the drug, a light breakfast (eggs, milk, tea, coffee) is recommended to the patient.

    When visualizing malignant neoplasms, the drug is administered in an amount of 570-740 MBq for each study. After 20 minutes after the administration, planar (in three projections) or single-photon emission computed tomography is performed. When examining patients with suspected malignant neoplasm of the breast, they are placed lying on the stomach, with the breast mesh cut down, the detector is in the lateral position.

    A ready-made preparation prepared on the basis of a lyophilizate contained in one vial can be used to study 5 patients.

    Radiation loads Mr.but the organs and the whole body of the patient when using the drug "Technetril,99m Tc "

    Organs and Systems

    The absorbed dose,

    mGy / MBq

    Bladder

    0,019

    Stomach

    0,008

    Small intestine

    0,043

    The upper part of the large intestine

    0,083

    Lower part of large intestine

    0,046

    Kidneys

    0,028

    Liver

    0,008

    Lungs

    0,003

    Muscles

    0,005

    Spleen

    0,005

    Pancreas

    0,008

    A heart

    0,006

    Thyroid

    0,010

    Leather

    0,002

    Red marrow

    0,005

    Skeleton

    0,006

    Testes

    0,003

    Ovaries

    00,18

    Total body (effective equivalent dose), mSv / MBq

    0,009

    Side effects:

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

    In rare cases, after the administration of the drug appears a short metallic taste of the mouth.

    Allergic reactions are possible.
    Overdose:With a single injection, an overdose is unlikely in connection with 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-99/2010), "Radiation Safety Standards" (NRB-99) and guidelines "Hygienic-".

    Form release / dosage:Lyophilizate for the preparation of a solution for intravenous administration.
    Packaging:
    • 30 pcs., - In bottles for medicines with a capacity of 10 ml (5) / In bottles for medicines with a capacity of 10 ml. The vials are sealed with rubber stoppers and crimped with aluminum or aluminum-plastic caps. 5 bottles with lyophilizate are placed in a contour cell package from a polyvinylchloride film.One out-of-pocket cell pack together with the instruction for the use of the drug "Technetril, 99mTc" is placed in a pack of cardboard. / - a pack of cardboard
    Storage conditions:

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

    The finished product is stored in accordance with the "Basic Sanitary Rules for Ensuring Radiation Safety".
    Shelf life:

    Lyophilizate - 1 year from the date of manufacture.

    The drug is Technetril,99m Tc - 5 hours from the time of preparation.

    Terms of leave from pharmacies:For hospitals
    Registration number:LS-001887
    Date of registration:16.09.2011
    Expiration Date:Unlimited
    The owner of the registration certificate:DIAMED, LLC DIAMED, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp04.01.2017
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