Active substanceSodium iodide [131I]Sodium iodide [131I]
Dosage form: & nbsporal solution
Composition:

Composition per ml:

Active substance: iodine-131 (in the form of sodium iodide [131I]) 37.0-1110 MBq;

Auxiliary substances: sodium hydroxide, water for injection.
Description:

Colorless Transparent liquid.

Physicochemical characteristics.

Sodium iodide,131I is a solution of sodium iodide with iodine-131 with a pH of 7.0 - 12.0, the radiochemical purity of the preparation is 95.0%. Volumetric activity of 37.0 - 1110 MBq / ml at the date of manufacture of the preparation. Iodine-131 decays with a half-life of 8.05 days; The most intense component of gamma radiation has an energy of 364.0 keV (81.2%), and 3-radiation - 606.0 keV (89.7%).

Pharmacotherapeutic group:Radiopharmaceutical diagnostic tool.
ATX: & nbsp

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

Pharmacodynamics:

Selective accumulation 131 I in the thyroid gland allows the use of the drug for diagnostic purposes to determine the functional state and visualization of the thyroid gland by radiometry and scanning.

Pharmacokinetics:

The drug, administered on an empty stomach through the mouth with 25 to 30 ml of distilled water, is absorbed in the stomach and enters the blood with a half-life from the stomach cavity of 8 to 10 minutes. Subsequently, the radioactive isotope of iodine 131I, accumulates mainly in the thyroid gland or in metastases of the thyroid gland. Kinetics of iodine uptake 131I of the thyroid gland (relative to the administered amount) is on average: in an hour - 14%, after 4 hours - 19%, after 24 hours - 27%. During the day, about 60% of the drug is excreted in urine and feces.

The value of the accumulation and rate of removal of the drug from the organs and tissues depends on the functional state of the thyroid gland, as well as on the age and sex of the patient.




Indications:

For diagnostic purposes, the drug is used to assess the functional state of the thyroid gland,scanning and scintigraphy of the thyroid gland in various diseases, including the diagnosis of distearosis, as well as A-cell thyroid cancer and metastases.

Contraindications:

- Pregnancy.

- Lactation period.

- Hypersensitivity.

- The age limit is 18 years.

Carefully:not described
Pregnancy and lactation:contraindicated
Dosing and Administration:

The drug "Sodium iodide,131I "is administered orally.

Preparation of the patient. Research of the functional state of the thyroid gland should be carried out no earlier than 4-6 weeks after the withdrawal of preparations of stable iodine, iodine and iodinated foods and multivitamin preparations containing iodine, iodine-containing radiopaque agents, fluoride, bromine, triiodothyronine, thyroxine, thyroidin, 6-methylthiouracil and other similar antithyroid drugs, as well as glucocorticosteroids.

Radioiodine diagnostics. DTo study the function of the thyroid gland according to the accumulation value of 1-131, it is sufficient to introduce 0,037-0,074 MBq of the drug, when scanning the thyroid gland, determining protein-bound iodine, and studying the entire body by radiometry-0,111-0,185 MBq. Methods of research.

Functional state of the thyroid gland can be estimated by:

- the amount of iodine-131 accumulation in the gland after 2, 4, 24 hours and at a later time after taking the drug;

- the level of protein-bound plasma iodine;

- results of radiometry of the whole body.

The accumulation of iodine-131 in the thyroid gland is the total index of the state of the inorganic and organic phases of iodine metabolism in this organ. The determination is made using a radiometer, placing the end of the sensor at a distance of 30 cm from the front surface of the neck. Radiometry standard, which uses iodine-131 in an amount equal to the injected patient, is carried out under the same geometric conditions.

The percentage of radionuclide accumulation in the thyroid gland (A) is calculated by the formula:

A = (B - Nf) / (C - Nf) x 100%, where

AT - the content of iodine-131 in iron, imp / min, C-content of iodine-131 in the standard, imp / min, Nf - background, imp / min.

In healthy people, in the thyroid gland, after an average of 14 hours, an average of 14% of the added amount of isotope accumulates, after 4 hours - 19%, after 24 hours - 27%, and after 10 days 6-12% of the administered amount of iodine-131.

With the aim of determination of the level of protein-bound iodine in a patient after 48 hours a blood sample is taken from the ulnar vein (8-10 ml). After centrifugation, 4 to 5 ml of blood plasma is transferred to a test tube and the protein is separated by adding 3% of 10% trichloroacetic acid solution in a volume equal to the volume of the plasma to be analyzed, followed by centrifugation at 2000 rpm for 10 minutes. The resulting precipitate is dissolved in a 2M solution of caustic sodium or caustic potassium, leading to the original volume of blood plasma, and radiometric in the well counter in parallel with the standard. As the latter, a solution of iodine-131 diluted in a ratio of 1: 500 is used; the volume of the standard should be equal to the volume of plasma taken for radiometry.

The percentage of protein-bound iodine (A) is calculated by the formula:

A = (B - Nf) x 1000 x 100 / C x (D - Nf) x 500% / l, where

AT - content of iodine-131 in the sample, imp / min, FROM - volume of blood plasma taken for analysis, ml, D - iodine-131 content in the standard, imp / min, Nf - background, imp / min.

The normative level of protein-bound iodine is no more than 0.3% per liter. Radiometry of the whole body allows to evaluate the peripheral stage of the exchange of thyroid hormones and is carried out as follows. After 2 hours after taking 1.0 MBq of the drug, during which the patient is asked not to empty the bladder,is carried out with a scintillation sensor with a Diameter 10-20 cm the first measurement in geometry, providing the necessary accuracy. The results of this first radiometry are taken as 100%. Subsequently, the radiometry is repeated after 24, 72, 120 and 192 hours. The registration is carried out every time with both a shielding of the neck (thyroid) region with a lead plate 4-5 cm thick, and without screening. Based on radiometry, iodine-131 subsequent terms in the thyroid glandeze and throughout the body, except for thyroid gland, as a percentage of the amount administered.
The iodine-131 content is normal in the body (excluding the thyroid gland) 10-25% after a day, 9.7-15% after 3 days, and 2-12% after 8 days. The method of radionuclide diagnosis of A-cell cancer and thyroid metastases involves scanning or scintigraphy of the entire body 24 and 48 hours after intravenous injection of 111-165 MBq of the drug.
Radiation loads on the organs and tissues of the patient when using the drug "Sodium iodide, 131I".
BODIES ................................................. ......... ABSORBED DOSE, mG p / MBq

stomach................................................. ..................... .34
red bone marrow ............................................... ........... 0.035
lungs................................................. ...................................... .031
the bladder ................................................ ...................... 0.61
liver ................................................. ..................................... 0.033

pancreas ................................................ ............ 0.03
kidneys ................................................. ...................................... .0655
spleen ................................................. .................................. .0344
small intestine ................................................ ............................ .038

colon ................................................ ........................... .0
thyroid ................................................ ................ .029
testicles ................................................. ...................................... .042
ovaries ................................................. .................................. 0.037

Equivalent dose (mSv / MBq) ........................................... ... 0.037

Side effects:

Allergic reactions are possible.

Overdose:

Overdose of the drug is unlikely in connection with the careful control of the injected activity in the conditions of a specialized hospital.

Interaction:

In the dosages used, no interaction with other drugs was noted.

Special instructions:

Work with the drug should be carried out in accordance with the "Basic Sanitary Rules for Ensuring Radiation Safety" (OSPORB-99), MU 2.6.1.1892-04 "Hygienic requirements for ensuring radiation safety during radionuclide diagnostics using radiopharmaceuticals."
The study of the functional state of the thyroid gland should be administered no earlier than 4-6 weeks after the withdrawal of stable iodine preparations,iodine and iodinated food products and multivitamin preparations, iodine-containing radiopaque agents, fluoride, bromine, triiodothyronine, thyroxine, thyroidin and other similar antithyroid drugs, as well as glucocorticosteroids.

Effect on the ability to drive transp. cf. and fur:not described
Form release / dosage:

The preparation is released as a solution for oral administration in hermetically sealed bottles of 15 ml in portions of 120, 200, 400, 600, 1000, 1200, 2000, 4000 MBq for the set delivery date.

The bottle, passport and instructions for use are placed in a transport package for radioactive substances.

Packaging:bottles (1) -complete packaging transport for radioactive substances
Storage conditions:

In accordance with OSPORB-99 and NRB-99.

Shelf life:

Shelf life of the drug is 15 days from the date of manufacture.

Terms of leave from pharmacies:For hospitals
Registration number:P N002570 / 01
Date of registration:14.07.2009
The owner of the registration certificate:NIFHI them. LYKARPOVA NIFHI them. LYKARPOVA Russia
Manufacturer: & nbsp
Information update date: & nbsp09.09.2014
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