Universal reference book for medicines
Product name: SODIUM PERTEHNETAT, 99m Tc, FROM EXTRACTION GENERATOR (SODIUM PERTECHNETATE, 99m Tc, FROM EXTRACTION GENERATOR)

Active substance: nonappropriate

Type: Diagnostic drug.
Radioisotope for scintigraphy
Producer: SRI YF FGNU (Russia) manufactured by ORTAT (Russia)
Composition, form of production and packaging
The solution for intravenous administration is
clear, colorless, with activity at the date and time of delivery.

1 ml

technetium 99mTc 74-1480 MBq

Excipients: sodium chloride 9 mg, water d / and up to 1 ml.

7500 MBq - Vials with a capacity of 10 ml (1) - a packaging kit for radioactive substances.

7500 MBq - Vials with a capacity of 20 ml (1) - a packaging kit for radioactive substances.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2014.

PHARMACHOLOGIC EFFECT

"Sodium pertechnetate, 99m Tc from an extraction generator" is a radiopharmaceutical prepared by extraction of technetium-99m with methyl ethyl ketone from a solution of 99Mu- 99mTc , followed by evaporation of methyl ethyl ketone and dissolution of a dry residue in a 0.9% solution of sodium chloride.

The preparation is a colorless transparent solution of 0.9% sodium chloride, containing 99m Tc 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 - no more than 1-10 -4 % of the activity of the radionuclide 99m Tc at the date and time of manufacture.
The radionuclide 99m Tc 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%.

Unlike sodium iodide, "Sodium pertechnetate, 99m Tc", 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, 99m Tc 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, 99m Tc" 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. 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

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.

DOSING MODE

With the scintigraphy (scanning) of the thyroid and salivary glands, the drug "Sodium pertechnetate, 99m Tc" is administered intravenously in the amount of 1 MBq per 1 kg of the body weight of the patient, 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 introduction of "Sodium pertechnetate, 99m Tc".
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. Pathological processes in the brain, as a result of which the blood-brain barrier is broken, are identified by platinum static scintigrams in 4 projections or tomographic scintigrams, as foci of increased drug content. Scintigraphy of the brain is performed in 10-15 minutes. and 3 hours after intravenous sodium pertechnetate, 99m Tc.
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 on the basis of a set of reagents, "Sodium pertechnetate, 99m Tc" is used in accordance with the instructions for preparing these solutions.

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

The liver 0.0030

Lungs 0,0023

Testes 0,0032

Ovaries 0,0086

The whole body (effective equivalent dose) 0.011 mSv / MBq



SIDE EFFECT

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

- the presence of hypersensitivity to the drug and / or its components;

- Pregnancy.

PREGNANCY AND LACTATION

Contraindicated use of the drug during pregnancy.
Breastfeeding mothers should refrain from breastfeeding the baby within 24 hours after drug administration.
DRUG INTERACTION

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

TERMS OF RELEASE FROM PHARMACY

It is only released on request to specialized radioisotope laboratories of medical diagnostic facilities.

TERMS AND CONDITIONS OF STORAGE

The drug is stored in accordance with the "Basic Sanitary Rules for Ensuring Radiation Safety" (OSPORB - 99).
Shelf life
a) Shelf life of the preparation used for the preparation of radiopharmaceuticals with 99m Tc 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 h;

b) Shelf life of the drug used for diagnostic purposes, depending on the volume activity, taking into account that it should be at least 17 MBq / ml.
Do not use after expiry date.
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