Pentatech 99mTc (Pentatech 99mTc)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceCalcium trisodium pentateCalcium trisodium pentate
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  • Pentatech 99mTc
    lyophilizate in / in 
    DIAMED, LLC     Russia
  • Pentacin
    solution d / inhal. in / in 
    FARMZASCHITA NPC, FSUE     Russia
    • Dosage form: & nbsplyophilizate for the preparation of a solution for intravenous administration
    Composition:

    Lyophilizate:

    Active substances:

    Calcium trisodium pentetate (Calcium trisodium salt diethylenetriaminepentaacetic acid) 4.8 mg

    Excipients:

    Tin dichloride anhydrous 0.33 mg

    Acid ascorbic acid 0.16 mg

    1 bottle

    Ready product:

    Active substances:

    Technetium -99 75 - 1500 MBq

    Calcium trisodium pentetate (Calcium trisodium salt diethylenetriaminepentaacetic acid) 0.96 mg

    Excipients:

    Tin dichloride anhydrate 0.066 mg

    Acidified ascorbic acid 0.032 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.
    Pharmacotherapeutic group:Radiopharmaceutical diagnostic tool
    ATX: & nbsp

    V.03.A.B   Antidotes

    Pharmacodynamics:

    "Pentatech, 99mTc "- radiopharmaceutical preparation is prepared from lyophilizate and sodium pertechnetate solution,99mTc from the technetium-99 generatorm.

    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:

    "Pentatech, 99mTc "after intravenous administration is excreted from the blood due to glomerular filtration and exit into the extracellular space.In healthy individuals after 60 minutes a dynamic equilibrium occurs between the concentrations of the drug" Pentatech, 99mTc "in the blood plasma and extracellular fluid.At this time, the removal of the drug from the blood occurs only due to glomerular filtration.

    For 3 hours, the urinary system displays about 30% of the administered amount of the drug, in 24 hours - about 90%.

    The secretion and reabsorption of the drug in the tubules of the nephron does not occur.

    The aforementioned mechanism for removing the drug "Pentatech, 99mTc "by the kidneys makes it possible to use it to study the state of glomerular filtration of the kidneys.

    In the case of brain tumors, the drug is concentrated in the lesion due to the violation of the blood-brain barrier in them, which makes it possible to visualize tumors of the central nervous system.

    Indications:

    The drug "Pentatech, 99mTs "are used for dynamic kidney scintigraphy for various diseases of the urinary tract (glomerulonephritis, pyelonephritis, urolithiasis, etc.)if there is a suspicion of neoplasm of the brain, as well as in the pathology of the heart and large arteries, using the method of radionuclide angiocardiography.

    Contraindications:

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

    Pregnancy and lactation:

    During lactation should refrain from breastfeeding for 24 hours after the drug.

    Dosing and Administration:

    The drug "Pentatech, 99mTs "are prepared in a medical institution immediately before use. Ready-made preparation "Pentatech, 99mTc "is a technetium-99m complex with petacin (CaNa3 diethyl triaminopentoacetate, DTPA).

    Preparing the preparation

    -5 ml eluate from the technetium-99m generator with volumetric activity from 75 to 1500 MBq / ml in aseptic conditions are injected with a syringe into the vial with 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 mixed by shaking until the lyophilizate is completely dissolved;

    - the preparation is ready for use 30 minutes after the addition of the eluate to the vial with lyophilizate;

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

    "Pentatech, 99mTc "is administered intravenously in an amount of 110-370 MBq for scintigraphy of kidneys and brain tumors, 11.1-18.5 MBq for the glomerular filtration rate and 555-740 MBq for radionuclide angiocardiography.

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

    Table 1

    Radiation loads

    on the organs and the whole body of the patient when using Pentatech,99tTc

    Organs and Systems

    Absorbed dose, mGy / MBq

    Kidneys

    0,01

    The walls of the bladder (critical organ)

    0,06

    Red marrow

    0,002

    Testes

    0,003

    Ovaries

    0,006

    Whole body (effective dose), mSv / MBq

    0,002
    Side effects:

    Perhaps the development of an allergic reaction to the administration of the drug.

    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), "Radiation Safety Standards" (NRB-99) and guidelines "Hygienic Requirements for Radiation Safety in Radionuclide Diagnostics by Radiopharmaceuticals" (MU 2.6.1.1892-04).

    Implementation through the pharmacy network is not.

    It is only released on request-applications to specialized radioisotope laboratories of medical diagnostic facilities.


    Form release / dosage:Lyophilizate for the preparation of a solution for intravenous administration
    Packaging:

    Lyophilizate for the preparation of a solution for intravenous administration (vials).

    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.

    Preparation "Pentatech , 99mTc "-5 hours from the time of preparation.

    Terms of leave from pharmacies:For hospitals
    Registration number:P N000543 / 01
    Date of registration:04.04.2008
    The owner of the registration certificate:DIAMED, LLC DIAMED, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp11.09.2015
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