Sodium pertechnetate, 99mTc from the extraction generator (Sodium pertechnetate 99mTc, from extraction 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:

In 1 ml of the drug contains:

Active substance:

Technetium-99t 740-1480 MBq

Excipients:

Sodium chloride 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 pertechnetate,99mTc from the extraction generator "is 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. Volume activity of the solution is 740-1480 MBq / ml at the production date and time; 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.The slow excretion 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 the patients (brain, heart, etc.).

Pharmacokinetics:

Technetium-99m after intravenous administration is relatively slow (according to multiexponential time dependence) is derived from 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 in the gastric mucosa.The elimination 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:

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.

Pregnancy and lactation:

Breastfeeding mothers should refrain from breastfeeding the baby within 24 hours after drug administration.

Dosing and Administration:

With the scintigraphy (scanning) of the thyroid and salivary glands, the drug "Sodium pertechnetate,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 "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 "Sodium 99mTc pertechnetate "are used in accordance with the instructions for preparing these solutions.

Radiation loads on the organs and entire body of the patient when used preparation "Sodium pertechnetate,99mTc from the extraction generator "

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 may be allergic reactions when using the drug.Any side effects when using the drug for diagnostic purposes are not documented.

Interaction:

When conducting diagnostic studies, interaction with other drugs was not detected.

Form release / dosage:

Solution for intravenous administration.

Packaging:Supplied in hermetically ukuporennyh bottles for medicinal products with a capacity of 10 or 20 ml of 7500 MBq for the set date and time of delivery (primary packaging). One bottle with a passport and instruction for use is 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:

a) The expiration date of the drug used for the preparation of radiopharmaceuticals with 99tTc on the basis of specially prepared reagents with a volume activity of 740 MBq / ml -18 hours, with a volume activity of 1480 MBq / ml -24 hours;

b) The shelf life of the drug used for diagnostic purposes is dependent on the volume activity, taking into account that it should be at least 17 MBq / ml.

Do not use after expiry date.

Terms of leave from pharmacies:For hospitals
Registration number:P N001103 / 01
Date of registration:07.07.2008 / 18.06.2009
Expiration Date:Unlimited
The owner of the registration certificate:NII JF FGNU NII JF FGNU Russia
Manufacturer: & nbsp
Information update date: & nbsp25.05.2018
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