Phosphotech, 99mTc (Phosphotech, 99mTc)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceEthidronic acidEthidronic acid
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    lyophilizate in / in 
    DIAMED, LLC     Russia
    • Dosage form: & nbsplyophilizate for the preparation of a solution for intravenous administration
    Composition:

    Lyophilizate (1 bottle):

    Active substances:

    -

    Excipients:

    Tin dichloride dihydrate

    1.47 mg

    Potassium and sodium etidronate dihydrate

    11.75 mg

    Acid ascorbic acid

    0.50 mg

    Finished product (1 ml):

    Active substances:

    Technetium-99m

    185-740 MBq

    Excipients:

    Tin dichloride dihydrate

    0.29 mg

    Potassium and sodium etidronate dihydrate

    2.35 mg

    Acid ascorbic acid

    0.10 mg

    Sodium chloride

    9.0 mg

    Water for Injection

    q.s.
    Description:

    Lyophilizate: white color.

    Ready product: colorless, clear liquid.

    Pharmacotherapeutic group:radiopharmaceutical diagnostic tool
    ATX: & nbsp

    M.05.B.A.01   Ethidronic acid

    Pharmacodynamics:

    Physicochemical characteristics

    "Fosfoteh, 99mTc "- radiopharmaceutical preparation is prepared from lyophilizate and sodium pertechnetate solution,99mTc 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%.

    Pharmacological properties

    "Fosfoteh, 99mTc "has a high tropism to the bone tissue, accumulating, mainly in the organic component of the bone,binding to crystals of hydroxyapatite calcium. In the foci of increased metabolism of bone tissue, hyperfixation of the drug is noted.

    Pharmacokinetics:

    After intravenous administration of the drug "Phosphotech, 99mTc "in the human body, the pharmacokinetics are characterized by a high rate of redistribution, mainly between two systems: bone tissue and urinary excretion system." The maximum accumulation of "Phosphotech, 99mTc "in the skeleton is observed 1-3 hours after the injection and amounts to 30-40% of the administered amount.For the same periods, the content of the drug in the blood does not exceed 5%. The accumulation of the drug in the area of ​​bone pathology is 2,3-3,0 times exceeds the level of accumulation in healthy bone tissue.

    Removal of the drug occurs through the urinary system and is characterized by high speed. For 3 hours after administration, 60% of the administered amount is excreted. Pharmacokinetic parameters allow for high-quality visualization of the skeleton.

    Indications:

    The drug is used for scintigraphy of the skeleton in order to identify foci of pathological changes of various origin and prevalence: primary and metastatic malignant tumors, osteomyelitis, osteoarticular tuberculosis, arthritis of various origin.

    Contraindications:

    Pregnancy, hypersensitivity to the drug, 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:

    The drug is intended for intravenous administration.

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

    Ready-made preparation "Phosphotech, 99mTc "is a complex of technetium-99m with hydroxyethylidenediphosphonic acid.

    Preparation of the preparation "Phosphotech, 99tTc ":

    - 5 ml eluate from technetium-99 generatorm with a volume activity 185 -740 MBq / ml aseptically injected with a syringe into the vial with the lyophilisate, the needle piercing the rubber stopper;

    - if necessary, dilute the eluate with an isotonic sodium chloride solution to the required volume activity value;

    - the contents of the vial are stirred by shaking until the lyophilizate is completely dissolved;

    - the preparation is ready for use after 20 minutes;

    - 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.

    The administered dose: 5 MBq per 1 kg of body weight.

    The study is carried out using gamma cameras or a scanner 1-3 hours after the injection of the drug, after emptying the bladder. Scintigrams or scenograms are evaluated by the nature of the distribution of the drug in the skeleton. Zones of pathological changes in bone tissue are characterized by hyperfixation of the preparation "Phosphotech,99mTc. "For the semi-quantitative evaluation of hyperfixation of the drug, the coefficient of differential accumulation (CDN) in the field of pathological accumulation is used in comparison with the symmetrical skeletal department or a number of adjacent sections of bone tissue.The result of osteoscintigraphy is considered positive from the point of view of pathological changes in bone tissue, if CDN is 140% or higher, the accumulation of the drug is lowered with the lysis of the bone tissue.

    Table. Radiation loads on the organs and the entire body of the patient when using the drug "Phosphotech, 99mTc "

    Organs and Systems

    The absorbed dose,

    mGy / MBq

    Ovaries

    0,004

    Bladder

    0,048

    Kidneys

    0,007

    Red marrow

    0,009

    Skeleton

    0,063

    Testes

    0,002

    Total body (effective equivalent dose), mSv / MBq

    0,0057
    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 must be in accordance with the "basic sanitary rules of radiation safety" (OSPORB-99), "Norms of Radiation Safety" (SRS-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 the preparation of a solution for intravenous administration
    Packaging:In the bottles.

    For 5 vials with 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 (10-25 ° C) during transportation for 1 month.

    Ready product stored in accordance with OSPORB-99, MU 2.6.1. 1892-04.

    Shelf life:

    Lyophilizate: 1 year from the date of manufacture.

    The preparation of Phosphotech,99mTc: 5 hours from the time of preparation.

    Do not use after expiry date.

    Terms of leave from pharmacies:For hospitals
    Registration number:LSR-006032/09
    Date of registration:23.07.2009
    The owner of the registration certificate:DIAMED, LLC DIAMED, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp10.10.2015
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