Registration certificate # P N003388/01

Description:

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

Activity of iodine -131 in a cap: 0.2; 0.4; 1.0; 4.0 MBq on the 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 0.2; 0.4; 1.0; 4.0 MBq in number of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 pieces on the preset date of delivery.

Therapeutic indications:

for examination of thyroid functions according to iodine-131 accumulation rate, scintigraphy (scanning) of thyroid gland, determination of protein-bound iodine and examination of peripheral stage of thyroid hormones metabolism by means of radiometry

Counterindications: pregnancy, breast feeding, in patients with dysphagy.

Posology: from 0.06 to 0.60 MBq.

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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