Sodium iodide, I131 – oral solution

Registration certificate #  P N002167/01

Therapeutic and diagnostic radiopharmaceutical agent.

  • Optimum treatment of high differentiated thyroid cancer.
  • Radioiodine therapy of thyroid cancer metastases. The main condition is thyroidectomy. Treatment shall be performed 3-4 weeks after thyroidectomy or L-thyroxine dechallenge for 20 days prior to the agent administration.
  • Treatment of thyrotoxicosis in case of diffuse and multinodular toxic goiter.
  • Scintigraphy and thyroid scanning for to various diseases diagnosis.
  • Due to its prolong half-life the agent can be delivered to distant regions of Russia.

PHYSICOCHEMICAL PROPERTIES:

Selective accumulation of iodine-131 in the thyroid gland allows using the agent for diagnostic purposes to determine the functional state of the thyroid gland and its visualization by means of radiometry and scanning; for therapeutic purposes – to treat of thyrotoxicosis and thyroid cancer metastases.

THERAPEUTIC CATEGORY:

Therapeutic and diagnostic radiopharmaceutical agent

PHARMACOKINETIC PROPERTIES:

The agent administered through the mouth in the fasted state with 25-30 ml of distilled water absorbs in the stomach and enters the blood with a half-life of 8-10 minutes in the gastric cavity. Then the radioactive isotope of iodine-131 accumulates mainly in the thyroid gland or thyroid cancer metastases. Kinetics of iodine-131 absorption by the thyroid (relative to the administered quantity) is, on average, in 2 hours - 14%, in 4 hours 19%, in 24 hours, 27%. During one day, about 60% of the agent is excreted from organs and tissues by the kidneys. The values ​​of accumulation and the rate of excretion of the agent from organs and tissues depend on inorganic iodine-131 metabolism and thyroid hormones in them, the functional state of the thyroid gland, age and sex of the patient.

THERAPEUTIC INDICATIONS:

The agent is used in adults to assess the functional state of the thyroid gland, thyroid scintigraphy scan in various diseases, including diagnosis of thyroid dysfunction in various diseases, as well as A-cell carcinoma of the thyroid gland and metastasis. The agent is used to treat thyrotoxicosis and thyroid cancer metastases.

COUNTERINDICATIONS:

Pregnancy, breast feeding, hypersensitivity, age limit – up to 18 years (for diagnosis), up to 20 years (for therapy).

Indication in case of pregnancy and breast feeding.

Patient’s organs and body radiation exposure if “Sodium iodide, 131I” is used

Organs

Absorbed dose, mGy/MBq

stomach

0.39

red bone marrow

0.015

lungs

0.02

bladder

0.38

liver

0.04

pancreatic gland

0.03

kidneys

0.03

lien

0.03

small intestine

0.05

thyroid

25.0

testicles

0.08

ovaries

0.81

Effective dose equivalent, mSv/MBq

11.0

Expiration date:  15 days of the production date.

 Delivery: on request.


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