Active substanceSodium iodopyrupate [131I]Sodium iodopyrupate [131I]
Dosage form: & nbspsolution for intravenous administration
Composition:

iodine-131 - 4.0-40.0 MBq

Sodium o-iodoppurate 9.0-12.0 mg

Benzyl alcohol 8.0 to 10.0 mg

sodium chloride - 8.0 - 10.0 mg

water for injection - 1.0 ml

Description:

Colorless or slightly yellowish transparent liquid.

Pharmacotherapeutic group:Radioisotope diagnostic tool
ATX: & nbsp

V.09.C.X   Other radiopharmaceuticals for the detection of kidney diseases

Pharmacodynamics:

Sodium o-iodophipate, labeled with iodine-131, an intravenous solution is a radiopharmaceutical in which a part of the "iodide-iodipurpuric acid sodium salt" is replaced by radioactive iodine-131 with sterile and non-pyrogenic.

Physicochemical characteristics. Isotope 131I has a half-life of 8.94 days. In the decay 131I photons with energy of 364 keV (81%), 284 keV (6.1%), 637 keV (7.3%), photons of bremsstrahlung with an average energy of 30 keV (4.0%) and photons of seven more energy lines decay with a total probability of not more than 2%.

The energy contribution of beta radiation, conversion electrons, and Auger electrons to the energy yield relative to radiation 131I leaves 33%. The main contribution to the intensity of the electron radiation is carried by β-electrons with an average energy of 191 keV with a probability of 89%, conversion electrons with an energy of 46 keV with a probability of 3.6% and 330 keV with a probability of 1.5%.

Pharmacokinetics:

The drug, administered intravenously, is rapidly excreted from the circulating blood by the kidneys with a periodhouse elimination half-life Teff = 12-14 min. The sodium content of o- yodhippurate,131I in the kidneys reaches 6-8% of the administered amount, with a half-life of 2-5 minutes.

Diagnostic properties. According to the rate of excretion of the drug from the body, the values ​​and time characteristics of the accumulation and excretion of the drug by the kidneys determine their functional state.

Indications:

The drug is used in adults to diagnose the functional state of the kidney in various diseases.

Contraindications:

The use of the drug is limited by general clinical contraindications to the use of radionuclide studies. Absolute contraindication for the use of the drug are: pregnancy, lactation.

Dosing and Administration:

Assessment of the functional state of the kidneys is made by: the data of renography; data of dynamic scintigraphy.

The drug is administered intravenously in an amount of 0.7-1.0 MBq with renography and 9-13 MBq with scintigraphy.

When carrying out renography, two scintillation radiation detectors are placed on the kidneys, the third - on the heart area.

Reno-graphic and dynamic scintigraphic studies are carried out within 15-20 minutes after administration of the drug to the patient. According to the data of rhinograms and scintigrams, the conclusion about the function of each kidney is made separately. By the time of purification of blood from sodium o-iodoppurate, 131I judge the total excretory function of both kidneys.

Radiation loads on the organs and entire body of the patient when using the drug Sodium o-iodoppurate, 131I

Organs and Systems

Equivalent dose mSv / MBq

Bladder

0,9

Lower part of large intestine

0,02

Kidneys

0,03

Ovaries

0,02

Eggs

0,01

Uterus

0,04

Whole body (effective equivalent dose)

0,05

Side effects:

There were no any side effects when using the drug for diagnostic purposes in the indicated amounts.

Form release / dosage:

Solution for intravenous administration.

Packaging:The drug is delivered in hermetically sealed vials, a capacity of 15 ml of 20, 40, 80, 200 MBq
Storage conditions:

The drug is stored at a temperature of 2 - 10 ° C in accordance with "The main sanitary rules for ensuring radiation safety"(OSPORB-99) .In the dark place.

Shelf life:20 days from the date of manufacture.
Terms of leave from pharmacies:For hospitals
Registration number:P N001932 / 01-2003
Date of registration:16.07.2009
Expiration Date:Unlimited
The owner of the registration certificate:NIFHI them. LYKARPOVA NIFHI them. LYKARPOVA Russia
Manufacturer: & nbsp
Information update date: & nbsp24.05.2018
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