Active substanceTechnetium [99mTc] succimerTechnetium [99mTc] succimer
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  • Technemek 99mTc
    lyophilizate in / in 
    DIAMED, LLC     Russia
  • Dosage form: & nbspLyophilizate for the preparation of a solution for intravenous administration
    Composition:

    Lyophilizate in one bottle contains:

    tin bivalent in view product acid interaction dimercaptosuccinic c tin bicarbonate anhydrous - 0,115 mg

    acids dimercaptosuccinic in the free state and in view product interaction with tin dichloride - 1,05 mg

    The finished product in 1 ml contains:

    Active substances:

    technetium-99m -- 37 - 222 MBq

    tin bivalent as a product interaction of tin dichloride and acid dimercaptosuccinic -- 0,023 mg

    acid dimercaptosuccinic acid dimercaptosuccinic -- 0,21 mg

    Excipients:

    sodium chloride -- 9,0 mg

    water for injection up to - 1.0 ml

    Description:

    Lyophilizate - white or white with a slightly pinkish tinge. The finished product is a colorless, clear liquid.

    Physicochemical characteristics

    Tehnemek, 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 99m Tc emits gamma quanta with an energy of 140 keV and a yield of 90%.

    Pharmacotherapeutic group:Radiopharmaceutical diagnostic tool
    ATX: & nbsp

    V.09.C.A   Compounds of technetium 99m

    Pharmacodynamics:

    The drug is absorbed by the cells of the epithelium of the proximal parts of the convoluted tubules of the kidneys.

    Pharmacokinetics:

    After intravenous administration is withdrawn from the blood according to the two-exponential dependence on time with T1Biol. = 8 min and T2 Biol = 9 hours and selectively absorbed in the kidneys by cells of proximal convoluted tubules. After 2 hours, the accumulation in the kidneys reaches 40% of the administered amount.

    The drug is excreted from the body by the urinary system. Within 3 h after injection with urine, 10-15% of the administered amount is excreted.

    Indications:For kidney scintigraphy to determine their shape, size, position, developmental abnormalities and the presence of organic and functional lesions.
    Contraindications:

    Pregnancy.

    Pregnancy and lactation:

    During breastfeeding, mothers should refrain from breastfeeding the baby within 24 hours after drug administration.

    Dosing and Administration:

    Preparation of the preparation:

    - 5 ml eluate from the technetium-99m generator is injected with a syringe under aseptic conditions 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 sodium chloride solution to the required volume activity value;

    - The preparation is ready for consumption 30 minutes after the addition of the generator eluate technetium-99m.

    Enter intravenously.

    Admission dose for adults: 1.5 MBq per 1 kg of body weight of the patient. One bottle of the finished product can be used to study 10 patients. Static or tomoscintigraphy (SPECT) is carried out 2-3 hours after the administration of the drug.

    Table

    Radiation loads

    on the organs and the whole body of the patient with the use of the drug Technemek,99m Tc

    Organs and Systems

    Absorbed dose, mG p / MBq

    Kidneys

    0,23

    Bladder

    0,015

    Liver

    0,023

    Lungs

    0,012

    Ovaries

    0,0034

    Testes

    0,0018



    Whole body (effective

    equivalent dose), mSv / MBq

    0,005

    Side effects:

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

    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) NRB-99 and MU 2.6.1. 1892-04.

    Form release / dosage:

    Lyophilizate for preparation of solution for intravenous use (vials). 5 bottles together with a passport and instructions for preparation and use in a cardboard box.

    Packaging:bottles (5) - packings, cellular, contour-packs, cardboard
    Storage conditions:

    Lyophilizate for the preparation of the drug Tehnemek, 99m Tc for intravenous administration is 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.

    The finished product is stored in accordance with the "Basic Sanitary Rules for Ensuring Radiation Safety" (OSPORB-99), MU 2.6.1. 1892-04.

    Shelf life:

    Lyophilisate -1 year from the date of manufacture.

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

    Terms of leave from pharmacies:For hospitals
    Registration number:LS-002364
    Date of registration:18.05.2012
    The owner of the registration certificate:DIAMED, LLC DIAMED, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp27.09.2015
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