Sodium o-iodoppurate, 131 I (Sodium o-Iodohippurate, isotope 131-I)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceSodium iodopyrupate [131I]Sodium iodopyrupate [131I]
Dosage form: & nbspsolution for intravenous administration
Composition:

In 1 ml of the drug contains

Active substances:

iodine-131 4,0-40,0 MBq

Excipients:

sodium o-iodoppurate 10.5 mg

benzyl alcohol 9.0 mg

sodium chloride 9.0 mg

water for injections up to 1.0 ml

Description:

Colorless transparent or slightly yellowish liquid.

Pharmacotherapeutic group:Radiopharmaceutical diagnostic tool
ATX: & nbsp

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

Pharmacodynamics:

Physicochemical characteristics. Sodium o-iodoppurate, 131I radiopharmaceutical diagnostic preparation is an aqueous solution of the sodium salt of orthoiodohippuric acid labeled with iodine-131, the radiochemical purity of the preparation is 98%. Volume activity 4,0 - 40,0 MBq / ml at the date of manufacture of the preparation. Iodine-131 decays with a half-life of 8.05 days and has the most intense component of gamma radiation with an energy of 0.364 MeV (80.6%).The drug is sterile and pyrogen-free, pH 5.5-8.5.

Pharmacodynamics. A radioisotope preparation, according to the rate of excretion of which from the body, to the values ​​and temporal characteristics of accumulation and excretion by the kidneys determine their functional state.

Pharmacokinetics:

Sodium iodohippurate [131I] after intravenous administration quickly leaves the vascular bed, secreted by the epithelium of the renal tubules into the urine. The maximum accumulation of the drug is normal for 2-3 minutes and is about 20%. The half-life of the kidneys is 6-8 minutes. For 1 hour, about 90% of the drug is excreted in urine.

Indications:

Applied in adults for:

- determination of effective renal blood flow (plasma flow);

- studies of total and separate secretory and excretory functions of the kidneys and urodynamics of the upper and lower urinary tract;

- Evaluation of anatomical features and topography of the kidneys;

- detection of violations of the kidney and urinary tract, determining the extent of these disorders in various diseases (renovascular hypertension, malignant formation of the bladder and prostate gland).
Contraindications:Hypersensitivity to the drug and its components, pregnancy, lactation, leukopenia. Restriction on age - up to 18 years.
Dosing and Administration:

Intravenous in an amount of 0.7-1.0 MBq with renography and 9-13 MBq with dynamic scintigraphy.

Renographic and dynamic scintigraphic studies are conducted within 15-20 minutes after the administration of the drug to the patient. When carrying out renography, two scintillation radiation detectors are installed on the kidney area, and the third - on the heart area. 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 the blood from the radiopharmaceutical, the total purifying function of both kidneys

Radiation loads on the organs and tissues of the patient when using the drug "Sodium o-iodiphippurate. 131 I "

Organs

Absorbed dose, mGy / MBq

bladder

0,9

lower intestine

0,02

kidneys

0,03

ovaries

0,02

testicles

0,01

uterus

0,04

whole body (effective equivalent dose), mSv / MBq

0,05
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 doses used, interaction with other drugs was not noted.

Special instructions:

Work with the drug should be carried out in accordance withwith requirements "of the Basic Sanitary Rules for Ensuring Radiation Safetydemolitionti "(OSStandingB-99/2010), "Radiation Safety Standards" (NRB-99/2009) and the "Guidelines for Hygienic Requirements for Radiation Safety during Radionuclide Diagnostics by Radiopharmaceuticals" (MU 2.6.1, 1892-04).

Form release / dosage:

Solution for intravenous administration.

Packaging:Portions of 20, 40, 80, 200 MBq at the set delivery date in hermetically sealed vials for medicinal products 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 OSPORB-99 / 20Yu in a dark place at a temperature of 2 to 10 ° C.

Shelf life:

20 days from the date of manufacture. Do not use after expiry date.

Terms of leave from pharmacies:For hospitals
Registration number:P N003391 / 01
Date of registration:05.06.2009 / 14.01.2014
Expiration Date:Unlimited
The owner of the registration certificate:Federal Center for Design and Development of Nuclear Medicine Facilities of FMBA of Russia, FSUE Federal Center for Design and Development of Nuclear Medicine Facilities of FMBA of Russia, FSUE Russia
Manufacturer: & nbsp
Information update date: & nbsp24.05.2018
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