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Dosage form: & nbspconcentrate for the preparation of a solution for intravenous administration [with act. on the date and time of delivery]
Composition:

In 1 ml of the drug contains:

Active substances:

Iodine-123

not less than 1200 MBq

Acid 15- (p-iodophenyl) -3-methylpentano-decanoic acid

5.0 mg

Excipients:

Ethanol (ethyl alcohol) 96%

up to 1.0 ml

Description:

Colorless, clear liquid.

Pharmacotherapeutic group:Radiopharmaceutical diagnostic tool
ATX: & nbsp
  • Compounds of iodine-123
  • Pharmacodynamics:

    Physicochemical characteristics

    Radiopharmaceutical preparation (RFP) for diagnostic purposes "Yodofen, 123I"is a solution of 15- (p-iodophenyl) -3-methylpentadecanoic acid labeled with iodine-123, in ethanol 96%.

    Volumetric activity of the preparation is not less than 1200 MBq / ml at the time of manufacture. Radiochemical purity of the preparation is not less than 95%; the content of radionuclide impurity iodine-124 is not more than 0.5% at the time of manufacture.

    In the gamma-ray spectrum of iodine-123 there are about 30 lines, the most intense component of which is the 158.97-KeV line (83.4%), there is no beta radiation. The half-life of iodine-123 radionuclide is 13.31 hours.

    Pharmacological properties

    Fatty acids (LC) are the main source of energy for a normally functioning myocardium and are rapidly metabolized by beta oxidation.When scintigraphy or SPECT with labeled fatty acids is evaluated, capture and uchilysis of the LC in myocytes. With various damage to the myocardium (for example, in the state of ischemia), the utilization of LC decreases, which affects the degree and rate of accumulation and elimination of myocardium. The decrease in the level of the initial accumulation of 15- (p-iodophenyl) -3-methylpentadecanoic acid, 123I and the change in the character of excretion indicates the severity of the pathological process. Radiopharmaceutical "Iodofen, 123I"iodine-123 labeled 15- (p-iodophenyl) -3-methylpentadecanoic acid, in which the phenolic ring and the methyl radical interfere with rapid metabolism (LC) in cardiomyocytes, can be effectively used in the diagnosis of heart disease.

    Pharmacokinetics:

    After intravenous administration of "Yodofen, 123I" with blood flow enters the myocardium, where it is extracted by myocytes from plasma and metabolism. From the first minutes there was a high cumulation of RFP in the myocardium, liver, and lungs. By the 30th minute, accumulation of RFP in the heart begins to predominate over accumulation in the liver, which, in combination with long-term RFP retention in the myocardium, makes it possible to perform single-photon emission computed tomography (SPECT) of the heart with "Iodophen, 123I" before starting its excretion and visualize the state of the metabolism of fatty acids in the heart muscle.

    15- (p-Iodophenyl) -3-methylpentadecanoic acid, iodine-123 is cleaved by myocytes to the final metabolite-iodide anion, iodine-123, which determines the accumulation of activity in the thyroid gland.

    The main ways of deducing "Yodofen, l23I" from the body are the kidneys and intestines. 3 hours after the injection, 20-30% of the RFP is excreted by the kidneys. The optimal time for the onset of SPECT of the myocardium is 20-30 minutes after intravenous RFP.

    Indications:

    - "Yodofen, 123I"is used in adults as a diagnostic tool to diagnose the localization of myocardial ischemia in the presence of angina attacks and negative or unconvincing ECG data;

    - for monitoring the state of the myocardium in patients who underwent acute myocardial infarction, acute and chronic myocarditis (endomyocarditis), with cardiomyopathies of various genesis, with hypertension, with atherosclerotic cardiosclerosis;

    - to assess the effectiveness of treatment for heart disease (monitoring).
    Contraindications:

    Hypersensitivity to protein preparations.

    Pregnancy, breast-feeding, age to 18 years.

    Dosing and Administration:

    The study is performed on an empty stomach. To reduce the radiation load 2-3 days before the test, it is necessary to conduct a blockade of the thyroid gland with Lugol solution (5 drops 3 times a day).

    Preparation of the drug is carried out in aseptic conditions by the addition of Iodofen, 123I dropwise to a 10% solution of albumin heated to 40 ° C in a ratio of 1:10 with constant stirring and subsequent sterilization of the resulting solution by filtration through a sterilizing filter "Millipore" (0.22 μm) or the like.

    The sterile solution of Iodofen, 123I in albumin is administered to the patient intravenously, slowly, in the patient's lying position. Recommended doses 110-185 MBK.

    SPECT is carried out after 20-30 minutes and after 4 hours to assess the rate of excretion of RFP from the myocardium.

    For SPECT, a rotary gamma camera is used. Quality control of equipment - according to the generally accepted methodology. Adjustment of the amplitude analyzer is 159 keV, the window is 20%.

    It is necessary to use a collimator for energy above 150 keV, because the bremsstrahlung X-ray radiation of the continuous spectrum ("lead X-ray"), formed as a result of the interaction of gamma quanta with the collimator material,It is not absorbed by the walls of a standard "technetium" collimator and creates intense interference when visualizing the image.

    The system of data collection and processing is either imported or domestic with a package of programs for SPECT. The image matrix is ​​at least 64 x 64 px.

    Evaluation of the distribution pattern of RFPs on tomograms in longitudinal horizontal, longitudinal vertical and transverse planes and the polar map is similar to the evaluation of SPECT myocardium with perfusion RFP ("Technetril", thallium preparations).

    The informative value of the method is significantly increased if the study of myocardial metabolism with the help of Iodophen, 123I is combined with the study of perfusion with the use of conventional techniques and technetium or thallium preparations. In this case, analogous segments are compared on the metabolic and perfusion polar maps, and they are distinguished:

    1. The normal level of accumulation of both RFPs;

    2. Uncoordinated accumulation defects with a predominance of perfusion or metabolic RFP, which corresponds to an ischemic but viable myocardium;

    3. Consistent defects of perfusion and metabolism with an equally sharp decrease in the accumulation level of both RFPs,indicating the presence of scar tissue or areas of nonviable myocardium.

    It is possible to conduct research in the technique of planar scintigraphy.

    Radiation stress on the organs and the whole body with the application of "Yodofen, 123I "

    Organ

    Equivalent dose, mGy / MBq

    A heart

    0,057

    Gonads (m)

    0,008

    The gonads (g)

    0,012

    Whole body

    (effective equivalent dose, mSv / MBq)

    0,01

    Side effects:

    When using the drug, it is possible to develop the following allergic reactions: skin flushing, itching, urticaria, chills, fever, shortness of breath, tachycardia, lowering blood pressure.

    Overdose:Not found.
    Interaction:Not found.
    Special instructions:

    Work with the drug should be carried out in accordance with the "Basic Sanitary Rules for Ensuring Radiation Safety" (OSPORB-99).

    Form release / dosage:Concentrate for the preparation of a solution for intravenous administration, activity of 400, 800, 1200 and 1600 MBq for the set date and time of delivery.
    Packaging:

    In bottles with a capacity of 10 ml, hermetically sealed with rubber stoppers and crimped with metal caps.

    A vial, passport and instructions are placed in a package for transportation of radioactive substances.

    Storage conditions:

    The drug is stored in a place protected from light in accordance with OSPORB-99.

    Shelf life:

    8 hours from the time of certification.

    Terms of leave from pharmacies:For hospitals
    Registration number:LSR-006509/08
    Date of registration:13.08.2008
    Expiration Date:Unlimited
    The owner of the registration certificate:Radium Institute. VGKhlopina NGO, State Unitary Enterprise Radium Institute. VGKhlopina NGO, State Unitary Enterprise Russia
    Manufacturer: & nbsp
    Information update date: & nbsp29.11.2017
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