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

One capsule contains:

Active substances: iodine-131

(in the form of sodium iodide with 131I) 0.2; 0.4; 1; 4 MBq

Excipients:
sodium diphosphate (sodium phosphate pyrolyte) 237 mg capsule gelatinous; (gelatin 33.26%, methylparahydroxybenzoate (nipagin) 0.14%, glycerol (glycerol) 0.05%, propyl parahydroxybenzoate (nipazole) 0.036%, sodium lauryl sulfate 0.023%).

Description:

Capsule gelatinous, № 1, hard, with a lid - a case of white color, a lid of yellow color. The contents of the capsule are white powder.

Physicochemical characteristics

Sodium iodide, 1311 - the preparation is obtained by applying a solution of sodium iodide, 131I on the sodium diphosphate in the capsule.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%), p-radiation - 606.0 keV (89.7%).

Pharmacotherapeutic group:Radiopharmaceutical diagnostic tool
ATX: & nbsp

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

Pharmacodynamics:

The capsule, administered on an empty stomach through the mouth with 25-30 ml of distilled water, dissolves in the stomach, on average, for 15 min, sodium iodide, 131I enters the blood with a half-life from the cavity of the stomach for 8-10 minutes. Subsequently, radioactive iodine-131 accumulates mainly in the thyroid gland. The kinetics of absorption of iodine-131 by the thyroid gland (in relation to the amount administered) is, on average, 10% after 2 hours, 19% after 4 hours, and 27% after 24 hours. Within a day about 60 % the drug is excreted in the urine and feces. Values ​​of accumulation and removal rates of the drug from organs and tissues depend on the functional state of the thyroid gland, age and sex of the patient.

Indications:The drug is used in adults to assess the functional state of the thyroid gland,scanning and scintigraphy of the thyroid gland in various diseases, including for diagnosis of thyroid dysfunction.
Contraindications:

Pregnancy, breast-feeding, in patients with a violation of the act of swallowing.

Dosing and Administration:

The drug "Sodium iodide, -131I "is intended for oral administration.

To study the functions of the thyroid gland in terms of the accumulation of iodine-131, scintigraphy (scanning) of the thyroid gland, determination of protein-bound iodine, and the study of the peripheral stage of thyroid hormone metabolism, it is sufficient to introduce 0.06-0.60 MBq

Preparation of patient. The study of the functional state of the thyroid gland should be conducted no earlier than 2 weeks after the withdrawal of the use of stable iodine preparations, iodine and iodinated foods and multivitamin preparations (Centrum, Vitrum, Unicap, Multi-tabs , etc.), iodine-containing radiocontrast agents, fluoride, bromine, triiodothyronine, thyroxine, thyroidin, 6-methylthiouracil and other similar antithyroid drugs, as well as glucocorticosteroids

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 is used as a capsule containing 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

B - iodine-131 content in iron, imp / min, C - iodine-131 content in standard, imp / min, Nf - background, imp / min.

In healthy people, in the thyroid gland, after an average of 10 hours, an average of 10% of the administered amount of radionuclide 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 48 hours after the administration of the drug, a blood sample (8-10 ml) is taken from the ulnar vein.After centrifugation, 4-5 ml of plasma is transferred to a test tube and the protein is separated by adding triplicate 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 to the original volume of plasma in a 2M solution of sodium or potassium hydroxide and is metered in a 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. Preparation of the standard is carried out by dissolving the capsule in hot water.

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
B - content of iodine-131 in the sample, imp / min, C - volume of plasma taken for analysis, ml, D - content of iodine-131 in the standard, imp / min, Nf ) - background, imp / min.

The normal level of protein-bound iodine is no more than 0.3% / l.

The peripheral stage of the exchange of thyroid hormones is carried out by radiometry of the whole body and is carried out as follows. After 2 hours after taking 1 MBq of the drug, during which the patient is asked not to empty the bladder,Scintillation probe with a diameter of 10-20 cm is carried out with a first measurement in geometry that ensures the necessary accuracy. These results are taken as 100%. Subsequently, the radiometry is repeated after 24, 72 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 the results of radiometry, the iodine-131 content is calculated in subsequent terms in the thyroid gland and in the whole body, except for the thyroid gland, as a percentage of the amount administered. The iodine-131 content is normal in the body (excluding the thyroid gland) in a day -10-25%, after 3 days - 9.7-15%, after 8 days - 2-12%.

Radiation loads on the organs and tissues of the patient when using the drug "Sodium iodide, 131I "

Organs

Absorbed dose, mGy / MBq

Stomach

0,39

Red marrow

0,015

Lungs

0,02

Bladder

0,38

Liver

0,04

Pancreas

0,03

Kidneys

0,03

Spleen

0,03

Small intestine

0,05

Thyroid

25,0

Eggs

0,08

Ovaries

0,81

Equivalent dose, mSv / MBq

11,0

Side effects:

Side effect when using the drug is not revealed.

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 OSPORB - 99/2010, NRB-99/2009 and MU 2.6.1.1892-04.

Form release / dosage:

Capsules.

Packaging:

The preparation is delivered in hermetically ukuporennyh bottles in portions of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 capsules with an activity of 0.2; 0.4; 1; 4 MBq for the set delivery date. Admissible deviation of iodine-131 activity values ​​in each capsule from the nominal value is ± 10%.

A vial with a passport and instruction for medical use in a package transport packaging for radioactive substances.

Storage conditions:

The drug is stored in compliance with OSPORB-99/2010, NRB-99/2009 and MU 2.6.1. 1892-04.

Shelf life:

20 days from the date of manufacture. Do not use after expiry date.

Terms of leave from pharmacies:On prescription
Registration number:P N003388 / 01
Date of registration:01.10.2007 / 14.03.2016
Expiration Date:Unlimited
The owner of the registration certificate:Federal State Unitary Enterprise "Federal Center for Design and Development of Nuclear Medicine Facilities" FMBA of RussiaFederal State Unitary Enterprise "Federal Center for Design and Development of Nuclear Medicine Facilities" FMBA of Russia Russia
Manufacturer: & nbsp
Information update date: & nbsp26.05.2018
Illustrated instructions
    Instructions
    Up