Sodium pertechnetate, 99mTs extraction - instructions for use, dose, side effects, contraindications

Active substanceSodium pertechnetate [99mTc]Sodium pertechnetate [99mTc]

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Radium Institute. VGKhlopina NGO, State Unitary Enterprise Russia

Dosage form: & nbspsolution for intravenous administration

Composition:

Active substance:

Technetium-99m (in the form of sodium pertechnetate) - 0,74-2,96 GBq.

Excipients:

Sodium chloride is 9.0 mg.

Water for injection - up to 1.0 ml.

Description:

Colorless transparent liquid.

Pharmacotherapeutic group:Radiopharmaceutical diagnostic tool

ATX: & nbsp

V.09.F.X Other radiopharmaceuticals for diagnosing thyroid diseases

Pharmacodynamics:

Physicochemical characteristics

"Sodium pertechnetat,^99mTc extraction "- a radiopharmaceutical prepared by extraction of technetium-99m with methyl ethyl ketone from solution ⁹⁹Mo-^99mTc, followed by evaporation of methyl ethyl ketone and dissolution of the dry residue in a 0.9% solution of sodium chloride.

The preparation is a colorless transparent solution of 0.9% sodium chloride, containing ^99mTc in the form of pertechnetate. The volume activity of the solution is 0.74 - 2.96 GBq / ml at the date and time of manufacture; pH 5.0 to 7.0; radiochemical purity - not less than 99.0%. Radionuclide impurities: ⁹⁹Mo - not more than 2 * 10^-3%, others - not more than 1 * 10^-4 % of radionuclide activity ^99mTc at the date and time of manufacture.

Radionuclide ^99mTc decays with the emission of gamma quanta with a half-life of 6.01 hours. The most intense gamma radiation has an energy of 0.1405 MeV with a quantum yield of 89.6%.

Pharmacological properties

Unlike sodium iodide, sodium pertechnetate,^99mTc, accumulating in the thyroid gland, does not participate in the synthesis of thyroid hormones. This circumstance makes it possible to use the drug for scintigraphic studies of the thyroid gland against the background of the use of antithyroid drugs that block the seizure of iodine by the thyroid gland. Slow removal of sodium pertechnetate,^99mTc from circulating blood allows it to be used to evaluate the dynamic characteristics of the blood flow of various organs of patients (brain, heart, etc.)

Pharmacokinetics:

Technetium-99m after intravenous administration is relatively slow (according to the multi-exponential time dependence) is derived from the circulating blood. After 60 minutes, circulating blood still contains 10-12 % of the input quantity. The half-life is about 1 hour. Sodium pertechnetate,^99mTc is distributed in the extracellular space of organs, and tissues in proportion to their blood supply, selectively the drug accumulates in the thyroid gland, in the salivary glands and in the mucous membrane of the stomach. Excretion drug occurs through the hepatobiliary system, the mucous membrane of the stomach and through the urinary system. About 70% of the drug is excreted through the urinary system.

Indications:

The drug is used in adults as a diagnostic tool for:

- scintigraphy (scanning) of the thyroid and salivary glands;

- scintigraphy of the brain;

- radionuclide angiocardiography and ventriculography;

- for the preparation of various radiopharmaceuticals based on reagent kits.

Contraindications:

Presence of hypersensitivity to the drug and / or its components. Contraindicated use of the drug during pregnancy.Breastfeeding mothers should refrain from breastfeeding the baby within 24 hours after drug administration.

Dosing and Administration:

At a scintigraphy (scanning) of a thyroid gland and salivary glands preparation "Sodium pertechnetat,^99mTc "is administered intravenously in an amount of 1 MBq per 1 kg of the patient's body weight, for brain scintigraphy - 5 MBq / kg and for radionuclide angiocardiography and ventriculography - 8-10 MBq / kg.

Scintigraphy (scanning) of the thyroid and salivary glands is carried out 30-60 minutes after the administration of the drug "Sodium pertechnetate,^99mTc. "Scintigrams are evaluated according to the standard criteria for the interpretation of the scintigraphic pattern of glands (shape and size, the distribution pattern of the drug, the presence and localization of foci of hyperfixation and hypofixation of RFP, etc.).

Scintigraphy of the brain is carried out in dynamic and static modes. Study of cerebral blood flow in the dynamic mode of scintigram recording for 40-60 sec with exposure of a single frame 1 sec. The drug is administered intravenously, bolus. The pathological processes in the brain, as a result of which the blood-brain barrier is broken,are detected according to the data of planar static scintigrams in 4 projections or tomographic scintigrams, as foci of increased content of the drug. Scintigraphy of the brain is performed in 10-15 minutes. and 3 hours after intravenous sodium pertechnetate,^99mTc.

Radionuclide angiocardiography and ventriculography are performed in a dynamic mode of recording scintigrams of the heart and large vessels for 40-60 sec with exposure of a single frame of 1 sec. The drug is administered intravenously, bolus.

To obtain radiopharmaceuticals based on a set of reagents of the preparation "Sodium pertechnetate,^99mTc "is used in accordance with the instructions for preparing these solutions.

Radiation loads on the organs and entire body of the patient when using the drug "Sodium pertechnetate,^99m,Tc extraction "

Organs and Systems	Absorbed dose, mGy / MBq
Thyroid	0,023
Stomach	0,013
Lower part of large intestine	0,067
Brain	0,0018
Liver	0,0030
Lungs	0,0023
Testes	0,0032
Ovaries	0,0086

Whole body (effective equivalent dose)	0,011 mSv / MBq

Side effects:

There were no any side effects when using the drug for diagnostic purposes.

Overdose:With a single injection, an overdose is unlikely, due to an extremely low concentration of active substance (less than 0.001 μg / ml).

Interaction:

Data on interactions with other drugs are not available.

Special instructions:

Work with the drug should be carried out in accordance with the "Basic Sanitary Rules for Ensuring Radiation Safety" ("OSPORB-99"), "Norms of Radiation Safety" (NRB-99) and "Hygienic Requirements for Ensuring Radiation Safety in Conducting Radionuclide Diagnosis Using Radiopharmaceuticals" . Methodical instructions (MU 2.6.1.1892-04).

Form release / dosage:

Solution for intravenous administration.

Packaging:Delivered for 0.5 GBq, 3.0 GBq, 7.0 GBq, 15.0 GBq for the set date and time of delivery in vials for medicinal products with a capacity of 10 ml or 20 ml, hermetically sealed with rubber medical closures and crimped aluminum caps (primary packaging ). Each passport is accompanied by a passport and instructions for use. The vial, passport and instructions for use are placed in a package transport packaging for radioactive substances (secondary packaging).

Storage conditions:

The drug is stored in accordance with the "Basic Sanitary Rules for Ensuring Radiation Safety" (OSPORB - 99).

Shelf life:

18 hours

Do not use after expiry date.

Terms of leave from pharmacies:For hospitals

Registration number:P N001867 / 01

Date of registration:15.12.2008 / 24.11.2014

Expiration Date:Unlimited

The owner of the registration certificate:Radium Institute. VGKhlopina NGO, State Unitary Enterprise Radium Institute. VGKhlopina NGO, State Unitary Enterprise Russia

Manufacturer: & nbsp

Radium Institute. VGKhlopina NGO, State Unitary Enterprise Russia

Information update date: & nbsp25.05.2018

Illustrated instructions

Instructions

Sodium pertechnetate, 99mTc extraction (Sodium pertechnetate 99mTc, extractional)