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Dosage form: & nbsplyophilizate for the preparation of a solution for intravenous administration
Composition:

Lyophilizate in one bottle contains:

tin bivalent in the form of reaction products

tin dichloride anhydrous, oxabiboric acid and

sodium oxabiphore

0.10 mg

phosphorus in the form of oxabiboric acid, sodium oxabiphor and

products of their interaction with tin bicarbonate

1.25 mg


The finished product in 1 ml contains:

Active substances:


technetium-99m

85-740 MBq

tin bivalent in the form of products

interaction of tin dichlorous,

oxabiboric acid and sodium oxabiphore

0.02 mg

phosphorus in the form of sodium oxabiphor, oxabiboric acid and

products of their interaction with tin bicarbonate

0.25 mg

Excipients:


sodium chloride

9.0 mg

water for injection

up to 1.0 ml

Description:Lyophilizate - white color.
Ready product - colorless, clear liquid.
Pharmacotherapeutic group:radiopharmaceutical diagnostic tool
ATX: & nbsp
  • Compounds of technetium 99m
  • Pharmacodynamics:

    Tehnefor, 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 Technefor, 99mTc in the human body, pharmacokinetics is characterized by a high rate of redistribution, mainly between two systems: bone tissue and urinary system. The maximum accumulation of Technefor, 99mTc in the skeleton is observed 3 hours after the injection and is about 30% of the administered amount. At the same time, the content of the drug in the blood does not exceed 6%.

    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:

    Identification of foci of pathological changes in the skeleton of various origin and prevalence: primary and metastatic malignant tumors, osteomyelitis, osteoarticular tuberculosis, arthritis of various origin, etc.

    Contraindications:

    Pregnancy.

    Pregnancy and lactation:

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

    Dosing and Administration:

    Preparing the preparation:

    - 5 ml eluate from the technetium-99m generator with volumetric activity of 185-740 MBq / ml is injected with a syringe into the vial with lyophilizate, piercing the rubber stopper with a needle;

    - stir the contents of the vial by shaking until the reagent is completely dissolved;

    The drug is ready for use after complete dissolution of the lyophilizate.

    Enter intravenously.

    The administered dose: 5 MBq per 1 kg of body weight. One vial is recommended to be used for examination of not more than 3 patients.

    The study is carried out using gamma cameras or a scanner 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 Technefor, 99mTc. With the lysis of bone tissue, the accumulation of the drug is reduced.

    Table. Radiation loads on the organs and the entire body of the patient with the use of the drug Technefor,99m Tc

    Organs and Systems

    The absorbed dose, mG p / MBq

    Ovaries

    0,004

    Bladder

    0,039

    Kidneys

    0,024

    Red marrow

    0,008

    Skeleton

    0,071

    Testes

    0,0027

    Total body (effective equivalent dose), mSv / MBq

    0,0025

    Side effects:

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

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

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

    5 vials together with a passport and instructions for preparation and use of the drug in a box made of cardboard.

    Storage conditions:

    Lyophilizate 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.

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

    Shelf life:

    Lyophilizate - 1 year from the date of manufacture.

    The drug Technhefor,99mTc - 5 hours from the time of preparation.

    Terms of leave from pharmacies:For hospitals
    Registration number:LS-002366
    Date of registration:28.09.2011 / 21.04.2014
    The owner of the registration certificate:DIAMED, LLC DIAMED, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp01.03.2016
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