Sodium pertechnetate, 99mTc from the generator (Sodium pertechnetate 99mTc, from generator)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceSodium pertechnetate [99mTc]Sodium pertechnetate [99mTc]
Dosage form: & nbspsolution for intravenous administration
Composition:
Composition*:

Technetium-99m without carrier (TU 95-2305-99) (in the form of sodium pertechnetate) 74-3700 MBq;

sodium chloride 8.0-10.0 mg, water for injection up to 1.0 ml.

*) the preparation "Sodium pertechnetate, 99mTc" is received directly in medical institutions in accordance with the instruction manual of the technetium-99m generator in portions of not less than 5 ml with a volume activity of 74-3700 MBq / ml in bottles for medicinal products with a capacity of 15 ml, hermetically sealed with stoppers rubber medical and crimped aluminum caps.

Description:

Colorless transparent liquid.

Pharmacotherapeutic group:Radiopharmaceutical diagnostic tool
ATX: & nbsp

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

Pharmacodynamics:

Physicochemical characteristics. The drug "Sodium pertechnetate, 99mTc from the generator, "is a solution of pertechnetate, 99mTc in an isotonic NaCl medium, obtained from a technetium-99m generator. Sodium pertechnetate, 99mTc is obtained directly in medical institutions by passing through a generator a sterile 0.9% solution of sodium chloride.

Volumetric activity of sodium pertechnetate solution, 99mTc, obtained from the technetium-99m generator does not exceed 1.85 GBq / ml. The radiochemical purity is 99%. Sodium pertechnetate,99mTc decays through an isomeric transition with a half-life of 6.02 hours. Photon radiation, 99mTc are gamma quanta with an energy of 140.5 keV with a probability of reaching a decay rate of 88.9%.

Pharmacodynamics. 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 dynamic characteristics of blood flow of various organs of patients (brain, heart, etc.).
Pharmacokinetics:

After intravenous administration, the drug is relatively slow (according to the multiexponential time dependence) is derived from the pool of circulating blood. After 60 minutes, circulating blood still contains 10-12% of the administered amount, and the half-life during this period 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 the stomach mucosa. Removal of the drug occurs through the hepatobiliary system, the gastric mucosa and through the urinary system. About 70% of the drug is excreted through the urinary system.

Indications:

Sodium pertechnetate, 99mTc from the generator is used as a diagnostic preparation for:

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

- scintigraphy of the brain;

- radionuclide angiocardiography and ventriculography.

Sodium pertechnetate, 99mTc is widely used for the preparation of various radio-form preparations based on the sets of appropriate reagents.
Contraindications:

- Hypersensitivity to the drug.

- Pregnancy.

- Lactation period.

Pregnancy and lactation:

The drug is contraindicated in pregnancy.

If it is necessary to prescribe the drug during lactation, breastfeeding should be stopped.

Dosing and Administration:When scintigraphy (scoring) of the thyroid and salivary glands, the drug is administered intravenously or per os in amounts of 1 MBq per 1 kg of body weight of patients. For brain scintigraphy - 5 MBq / kg and for radionuclide angiocardiography and ventriculography - 8-10 MBq / kg.

Scintigraphy (scaling) of the thyroid and salivary glands is carried out 30-60 minutes after the administration of 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 preparation, 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.The study of cerebral blood flow is carried out in a dynamic mode of recording scintigrams for 40-60 seconds. with exposure of a single frame 1 sec. The drug is administered intravenously, bolus. Pathological processes in the brain, as a result of which the blood-brain barrier is broken, are detected according to planar static scintigrams in 4 projections or tomographic scintigrams, as foci of increased drug content. Scintigraphy of the brain is performed after 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 seconds, with exposure of a single frame of 1 second. The drug is administered intravenously, bolus.

To obtain radiopharmaceuticals based on reagent kits, the solution of sodium pertechnetate, 99mTc are used in accordance with the instructions for preparing these preparations.

Radiation loads on the organs and entire body of the patient when using the drug "Sodium pertechnetate, 99mTc from the "

BODIES AND SYSTEMS

Equivalent dose, mSv / MBq

1

2

Whole body

0,003

Red marrow

0,004

Ovaries

0,01

Testes

0,003

Thyroid

0,02

Stomach

0,03

Small intestine

0.02

The upper part of the large intestine

0,06

Lower part of large intestine

0,02

Bladder

0,02

The effective equivalent dose

0,01

The critical organ is the ovaries.
Side effects:

There may be allergic reactions.

Overdose:Overdose of the drug is unlikely in connection with the careful control of the injected activity in the conditions of a specialized hospital.
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), Methodological instructions "Hygienic requirements for ensuring radiation safety during radionuclide diagnostics using radiopharmaceuticals" (MU - 2.6.1.1892 - 04).

Form release / dosage:
Solution for intravenous administration, with a volume activity of 74-3700 MBq / ml at the date and time of manufacture.
Packaging:

The preparation is received directly in medical institutions in accordance with the instruction manual of the technetium-99m generator in portions of not less than 5 ml with a volume activity of 74-3700 MBq / ml in bottles for medicines with a capacity of 15 ml,sealed with rubber medical closures and crimped aluminum caps.

Storage conditions:

Generators of technetium-99m and solutions "Sodium pertechnetate, 99mTs from the generator "are stored in accordance with the current" Basic Sanitary Rules for Ensuring Radiation Safety "(OSPORB-99) and" Norms of Radiation Safety "(NRB-99).

Shelf life:

Not more than 24 hours from the date and time of manufacture.

Terms of leave from pharmacies:For hospitals
Registration number:P N001868 / 01-2002
Date of registration:05.07.2010
Expiration Date:Unlimited
The owner of the registration certificate:NIFHI them. LYKARPOVA NIFHI them. LYKARPOVA Russia
Manufacturer: & nbsp
Information update date: & nbsp25.05.2018
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