Active substanceSodium iodide [123I] isotonicSodium iodide [123I] isotonic
Dosage form: & nbsp

solution for intravenous and oral administration

Composition:

In 1 ml of the drug contains:

iodine-123 -not less than 55,0 MBq

Sodium Chloride - 7.85mg

phosphorus in the form of sodium orthophosphate -0.75mg

sodium thiosulfate -1.90mg

water for injection -up to 1 ml

Description:

Colorless transparent liquid.

Pharmacotherapeutic group:Radiopharmaceutical diagnostic tool
Pharmacodynamics:

Physicochemical characteristics. Sodium iodide, 123I, isotonic - radiopharmaceutical diagnostic preparation is an isotonic solution of sodium iodide with iodine-123 in phosphate buffer solution, pH 7.0-7.5, the radiochemical purity of the preparation is not less than 97.0%. Radionuclide impurities: iodine-125 is 0.006% and tellurium-121 is 0.0001% of iodine-123 activity at the date and time of manufacture. Iodine-123 decomposes electron capture with a half-life of 13.3 hours and has the most intense gamma-ray component with an energy of 159.0 keV (83.4%).

Pharmacological action. Radioactive isotope of iodine 123I, like its other isotopes, when introduced into the body, accumulates mainly in the thyroid gland.The value of the accumulation and removal rates of the drug from organs and tissues depend on the functional state of the thyroid gland, as well as on the age and sex of the patient. Selective accumulation of iodine-123 in the thyroid gland allows the use of the drug for diagnostic purposes.

Pharmacokinetics:

The kinetics of absorption of iodine-123 by the thyroid gland (in relation to the administered amount) is normally: after 2 hours, 10%, after 4 hours - 20%, after 24 hours - 27%. During the day, 60% of the drug is excreted in urine and feces.

Indications:

Determination of the functional state and visualization of the thyroid gland by radiometry and scintigraphy.

Contraindications:

Pregnancy, the period of breastfeeding, as well as severe leukopenia and hypersensitivity. General clinical contraindications for radionuclide studies. The age limit is 18 years.

Dosing and Administration:

Intravenous or oral. The patient is given an empty stomach to take 0.185-0.370 MBq of the drug dissolved in 30-50 ml of water, supplementing the introduction with flushing from the walls of the used dishes. Thyroid radiometry is carried out after 2, 4 and 24 hours. Simultaneously, radiometry is subjected to a phantom of the thyroid gland with an equal number of indicators taken ill.The result is expressed as a percentage of the accumulation of the radionuclide from the administered amount and is calculated by the formula:

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

where A is the accumulation of a radionuclide in the thyroid gland,%,

B - the content of iodine-123 in iron, imp / min,

C - content of iodine-123 in the standard, imp / min,

Nf - background, imp / min

To conduct gammatographic examinations, a patient on an empty stomach is given or accepted intravenously 8.0 - 10.0 MBq of the drug. If necessary, the preparation is diluted with a certain amount of saline. The optimal time for a thyroid scan is from 2 to 6 hours after the administration of the drug. Research of the functional state and topography of the thyroid gland should be conducted no earlier than 1 month after the discontinuation of the ingestion of substances and medications containing iodine or affecting the iodine-accumulating function of the thyroid gland. These include: stable iodine (including contact with the skin or mucous membranes), iodine-containing and iodinated products, radiocontrast agents, iodine-containing multivitamin preparations (Centrum, Vitrum, Unicap, Multi-tabs and others), fluorine, bromine, triiodothyronine, thyroxine, thyroidin, 6-methylthiouracil and other similar antithyroid drugs, as well as pituitary, sex and steroid hormones.The degree and duration of the effect of organic iodine compounds is determined by the rate of their decay in the body and the amount of iodine liberated.

With the aim of determination of the level of protein-bound iodine in a patient after 48 hours a blood sample (8-10 ml) is taken from the ulnar vein. After centrifugation, 4-5 ml of plasma is transferred to a 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 to the original volume of the plasma in a 2 M solution of sodium or potassium hydroxide and the radiometry is run in a well counter in parallel with the standard. 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)% / l, where

The content of iodine-123 in the sample, imp / mip; C is the volume of plasma taken for analysis, ml; D - iodine-123 content in the standard, imp / min; Nf - background, imp / min.

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

Radiation loads on the organs and entire body of the patient when using the drug

"Sodium iodide, 123I, isotonic "

Organs

Absorbed dose, mGy / MBq

Stomach

0,0069

Red marrow

0,0094

Lungs

0,0061

Bladder

0,0094

Liver

0,0067

Pancreas

0,0076

Kidneys

0,011

Spleen

0,007

Small intestine

0,0085

Colon

0,0097

Thyroid

0,0051

Eggs

0,0069

Ovaries

0,0098

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

0,013

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 requirements of the "Basic Sanitary Rules for Ensuring Radiation Safety" (OSPORB-99/2010), "Radiation Safety Standards" (NRB-99/2009) and the Guidelines "Hygienic Requirements for Radiation Safety in Radionuclide diagnostics with the help of radiopharmaceuticals "(MU 2.6.1, 1892-04).

Form release / dosage:

Solution for intravenous administration and oral administrationOrders for 50, 100, 150, 200. 300 MBq for the set date and time of delivery.

Packaging:In hermetically ukuporennyh bottles for medicines with a capacity of 10 or 20 ml. 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 accordance with the requirements of OSPORB-99/2010.

Shelf life:60 hours from the date and time of manufacture. Do not use after expiry date.
Terms of leave from pharmacies:For hospitals
Registration number:LS-001624
Date of registration:22.09.2011
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
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