Sodium iodide, 131I, caps

Registration certificate # ЛСР-003509/07

Description:

a white gelcap, # 1, solid, with a yellow top. Cap contents ─ white powder.

Activity of iodine -131 in a cap: 0.5; 1.0; 2.0; 0.4 GBq on the preset date of delivery.

Permissible tolerance of iodine-131 activity in a cap ± 10 % of rate.

Radionuclide impurities: relative quantity of tellurium impurities (121mTe, 121Te, 123mTe, 125mTe, 127mTe, 129mTe) and 75Se shall not exceed 0,01% of iodine-131 activity on the date of production.

Half-life Т: 8.02 days.

Filling: 

caps of the same nominal value with activity of 0.5; 1.0; 2.0; 4.0  GBq; one cap on the preset date of delivery.

Therapeutic indications:  

the agent is used for treatment of thyrotoxicosis, caused by overactive thyroid cells, differentiated thyroid cancer and its metastases.

Counterindications:

pregnancy, breast feeding, hypersensitivity, in patients with dysphagy, age under 20 years.  Blood diseases with hemogenesis suppression (with leucopoiesis and thrombocytopoiesis dysfunction), evident hemorrhagic syndrome; gastric and duodenal ulcers (acute stage); kidneys diffuse lesions.

Posology: for treatment of differential thyroid cancer, as well as distant metastases: 37-56 MBq per 1 kg of body weight; for treatment of thyrotoxicosis with diffuse toxic and multinodular goiter a fixed iodine-131 activity is used: 190 MBq ─ small glands, 380 MBq ─ medium-size glands, 570 MBq – large glands.

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:  20 days of the production date.

Delivery: on request.


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