Ammonium, 13N (Ammonium, 13 N)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspsolution for intravenous administration
Composition:

In 1 ml of the drug contains:

Active substance:

Azot-13 - 200-2000 MBq

Excipients:

Sodium chloride 9.0 mg

Water for injection - up to 1.0 ml

Note. Nitrogen-13 is produced on the proton accelerator in the nuclear reaction 16O (p, α) l3N when irradiating water of a natural isotopic composition under the hydrogen pressure of high purity gas (TU 301-07-27-91). Nitrogen-13 in the preparation is in the chemical form [l3N],NH4Cl without the addition of media.

Description:

A clear, colorless liquid.

Pharmacotherapeutic group:radiopharmaceutical diagnostic tool
ATX: & nbsp
  • Diagnostic radiopharmaceuticals
    • Pharmacodynamics:

    Physicochemical characteristics

    Radiopharmaceutical preparation (RFP) "Ammonium, 13N " is a 0.9% sodium chloride solution containing the nitrogen-13 radionuclide in the chemical form of the ammonium cation, nitrogen-13, without the addition of a carrier.

    Volumetric activity of the preparation from 200 to 2000 MBq / ml at the date and time of manufacture; pH from 5.5 to 7.5, radiochemical purity is not less than 95.0%.

    Radionuclide nitrogen-13 undergoes radioactive decay, accompanied by the emission of positrons, with an average energy of 0.492 MeV. As a result of positron decay, two gamma-ray annihilation quantum with an energy of 0.511 MeV are formed.The half-life of nitrogen-13 is 9.97 minutes.

    Pharmacological properties

    When intravenously administered RFP "Ammonium, 13N " quickly removed from the blood. Normally, when the drug is administered, the following organs are visualized in order of decreasing accumulation: myocardium, liver, kidneys. In other organs, including in the lungs, background accumulation of RFP is observed. "Ammonium, 13N " has cardiotropic properties and is captured in the myocardium in proportion to regional myocardial blood flow. In myocytes, the drug is metabolized into glutamine and in this form is retained in the myocardial tissue. Clearance 13N-activity from the myocardium is slow, which makes it possible to obtain a high-contrast image of the heart with respect to intracavitary blood and surrounding pulmonary tissue. At the same time, increased accumulation of RFP in the liver can cause difficulties in visualizing the lower wall of the myocardium. In other organs and tissues, including in bones, muscles, skin, glands, connective tissue, the preparation accumulates in small amounts.

    Ammonium extraction in the myocardium normally increases linearly with an increase in the rate of myocardial blood flow from 0 to 300 ml / 100 g of tissue / min.Focal hypofixation "Ammonium, 13N " in the myocardium at rest or under conditions of physical or pharmacological load indicates a decrease in the level of myocardial blood flow in this area.

    Pharmacokinetics:

    After intravenous administration RFP quickly leaves the bloodstream and accumulates in the myocardium, liver and kidneys. The drug is excreted through the kidneys into the bladder. The content of the drug in the blood 5 minutes after intravenous injection does not exceed 1-2% of the administered. The accumulation of the drug in the myocardium is 3-4% of the administered dose. The maximum accumulation of "Ammonium, 13N " in myocytes is reached after 5 minutes and remains at this level for another 15-20 minutes, which is sufficient for conducting positron emission tomography. Proceeding from this, a, also taking into account the short period of physical half-life 13N, the optimal time to start the study is 5 minutes after intravenous RFP.

    When using "Ammonium, 13N " with a dynamic scanning protocol, it is possible to perform quantitative data analysis using mathematical modeling.

    Indications:

    RFP "Ammonium, 13N " are used as a diagnostic tool for positron emission tomography in cardiology. The main indications for the study are:

    - determination of the presence, location, prevalence and severity of myocardial ischemia or cicatricial damage;

    - determination of the functional significance of the anatomical lesion detected during angiography;

    - assessment of the viability of the myocardium;

    - control of the effectiveness of treatment of coronary heart disease.

    Contraindications:

    The use of "Ammonium,13N " contraindicated in pregnancy, lactation and for study in children, as clinical trials were conducted only in adults.

    Hypersensitivity reactions are possible.

    Dosing and Administration:

    "Ammonium,13N " in the form of a sterile solution is administered to the patient intravenously struino. From the pharmacokinetic data on the time of maximum accumulation of the drug in organs and tissues it follows that the optimal time for the onset of myocardial scans is 5 minutes after the administration of RFP. The conditions for myocardial examination are preserved for 20 minutes after the administration of RFP.For the quantitative analysis of the data, the study is carried out in a dynamic mode immediately after the introduction of the RFP. The recommended dynamic test protocol includes 6 frames of 10 s, 4 frames of 30 s, 2 frames of 60 s and 2 frames of 600 s (25 min).

    The diagnostic dose for the preparation of positron emission tomography is 350 MBq / m2 surface of the body. The body surface is calculated from the nomogram based on the height and weight of the patient. For one survey use from 350 to 900 MBq of RFP. The drug is injected intravenously in a volume of 0.5 to 2.5 ml. Special training of patients is not required.

    Radiation loads

    Dose coefficients for calculating effective doses to patients when using the drug "Ammonium, 13N " (MU 2.6.1.1798-03)

    Compound

    Dose factors, mSv / MBq

    Adults

    Ammonium, 13N

    0,002

    Dose factor for intravenous administration of "Ammonium,13N " in adults is 2.0 × 10-3 mSv / MBq. When the diagnostic dose of the drug is administered (from 350 to 900 MBq), the effective dose is from 0.7 to 1.8 mSv.

    Absorbed doses of radiation in adult patients with intravenous administration of the drug "Ammonium, 13N " on the organs.

    Organs and tissues

    The absorbed dose of 10-3 (mGy / MBq)

    Blood

    0,1

    Ovaries

    1,0

    Eggs

    1,0

    Bladder

    1,2

    Kidneys

    1,9

    Liver

    3,0

    Myocardium

    4,5
    Side effects:

    When using the drug in accordance with the instructions and in the recommended doses of side effects were not noted.

    Interaction:

    Data on drug interaction are absent.

    Special instructions:

    Work with the drug is carried out in accordance with the "Basic Sanitary Rules for the Provision of Radiation Safety" (OSPRB-99), Methodological Guidelines "Hygienic Requirements for Radiation Safety during Radionuclide Diagnostics by Radiopharmaceuticals" (MU-2.6.1.1892-04).

    Form release / dosage:

    Solution for intravenous administration (with volume activity from 200 to 2000 MBq / ml at the date and time of manufacture).

    Packaging:

    Portions from 500 to 5000 MBq are placed in a sterile glass bottle for medicinal products with a capacity of 10 ml, hermetically sealed with a rubber medical plug of type 1-1 and crimped with an aluminum cap.

    Each vial is placed in a transport container for radioactive substances KT 1-20.

    A passport and instructions for medical use are attached to the vial.

    Storage conditions:

    The drug is stored in accordance with the "Basic Sanitary Rules for Ensuring Radiation Safety" (OSPORB-99).

    Shelf life:

    20 minutes from the date and time of manufacture.

    Do not use after expiry date.

    Terms of leave from pharmacies:For hospitals
    Registration number:P N001001 / 01
    Date of registration:28.09.2010
    The owner of the registration certificate:FGU Russian Scientific Center for Radiology and Surgical TechnologiesFGU Russian Scientific Center for Radiology and Surgical Technologies Russia
    Manufacturer: & nbsp
    Information update date: & nbsp10.03.2016
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