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Dosage form: & nbspcapsules
Composition:

Per 1 capsule:

active substance: carbon-14 (as an aqueous solution /14C / urea) 37 kBq;

Excipients: sodium pyrophosphate (in terms of anhydrous) 200 mg.

Capsule hard gelatin 40 mg:

composition of hard gelatin capsule: gelatin, iron oxide yellow (E 172), titanium dioxide (E 171), purified water.

Description:

Hard gelatin capsules № 4. Body and cap capsules white with a yellowish hue. The contents of the capsules are white powder.

Note. The appearance of the contents of the capsule is guaranteed by the manufacturer.

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

    Physicochemical characteristics

    Radiopharmaceutical diagnostic drug "Ureakaps, 14C "is an aqueous urea solution labeled with carbon-14, and anhydrous (solid inert carrier contained inside the gelatin capsules) dispersed onto the sodium surface of pyrophosphate.

    Isotope 14C is a beta emitter with a half-life T1/2= 5730 years. The average beta-radiation energy of carbon-14 is 49 keV, the maximum is 156 keV. The biological half-life is about 2.5 hours.

    Pharmacodynamics

    Radiopharmaceutical preparation (RFP) "Ureakaps,14C "is used for detection Helicobacter pylori (Hp) in the human body with a non-invasive breath test. The diagnostic method is based on indirect measurement of the presence of the urease enzyme released by Hp. Since urease is not normally present in human tissues, and other bacteria producing urease do not colonize the human stomach, the presence of urease in the stomach means the presence of Hp.

    Capsule "Ureacaps, 14C "is swallowed by the patient.In the stomach in the presence of Hp, and hence urease, labeled urea, contained in the preparation, is hydrolyzed by the enzyme to bicarbonate and ammonium. Bicarbonate in the acidic environment of the stomach decomposes into water and 14CO2, which is absorbed into the blood and released with exhaled air. Samples of exhaled air are taken at regular intervals. A radiometric analysis of these samples is carried out on a liquid scintillation counter. According to the content of the labeled carbon dioxide, the infection of patients with Hp bacteria is established.

    Pharmacokinetics:

    After taking the capsule in patients infected with Hp bacteria, the maximum manifestation 14CO2 at exhalation is observed between 10 and 30 minutes and decreases in accordance with the half-life of 15 minutes. About 10% 14CO2 is absorbed and then gradually excreted by urine with a half-life of about 40 hours.

    If the patient is not infected with Hp, the taken labeled urea It is absorbed in the gastrointestinal tract (GIT) and is distributed in the extracellular and intracellular fluid.

    Within 3 days about 88% of urea is excreted from the body with urine.

    Indications:

    1. A screening method for diagnosing the dissemination of Hp, with gastroenterological and oncological diseases of the digestive tract.

    2. Monitoring the effectiveness of eradication therapy Hp, but not earlier than month after the end of therapy.

    Contraindications:

    - Hypersensitivity to the drug;

    - bVariability;

    - lactation period;

    - dUp to 14 years of age.

    Carefully:

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

    Pregnancy and lactation:

    Do not use during pregnancy.

    If it is necessary to prescribe the drug during lactation, breastfeeding should be discontinued.
    Dosing and Administration:

    The drug is taken internally.

    Preparation of the patient

    1. The patient should not eat for 6 hours before the test. Immediately before the test should not smoke.

    2. 30 days before the test, antibiotics and bismuth preparations are excluded.

    3. For 14 days before the test, treatment with radiopharmaceuticals and / or proton pump inhibitors is excluded, as well as the administration of sucralfates.

    4. The test is recommended before the endoscopy of the digestive tract.

    Dosage and test procedure

    The injected single dose of the drug for diagnosis - 1 capsule, activity 37 kBq.

    During the test, the patient is sitting. The patient takes a capsule and drinks 20 ml of warm water. After 3 minutes the patient also drinks 10 ml of warm water. At 10 minutes after taking the capsule, the patient takes a deep breath and after 5-10 seconds of breath holding slowly exhales air with a plastic tube into the blue absorbing liquid that is in the scintillation vial. When the blue color of the absorbing liquid is discolored, the patient stops exhaling. After this, 7.5 ml of scintillation solution is added to this flask and the radioactivity of the sample is measured on a beta counter.

    Interpretation of results

    The test is considered positive, if the radioactivity of the sample exceeds 200 decays per minute (rpm, DPM), negative - the radioactivity of the sample is less than 50. The result of 50 to 200 - is considered uncertain and requires (if necessary) a re-examination. Re-examination is possible in 24 hours.

    A false negative result is possible if:

    - antibiotics and / or bismuth preparations were taken less than 30 days before the test;

    - proton pump inhibitors were taken less than 14 days before the test;

    - sucralfates were taken less than 14 days before the test;

    - there were difficulties with swallowing the capsule (a possible way out was to collect an additional portion of air for 15-20 minutes);

    - the patient took food less than 6 hours before the test.

    A false positive result is possible if:

    - after resection of the stomach followed by a rapid growth of bacteria that do not release Hp-urease;

    - with achlorhydria;

    - for the chemiluminescence of the sample.

    If the sample count was carried out immediately after the addition of the scintillacin liquid and the count values ​​are in the range of 50-300 r / min, it is recommended to repeat the sample count after 1-2 hours or the next day.

    Radiation loads on the patient's organs when using a radiopharmaceutical "Ureacaps, 14FROM"

    Fat layer

    0,198

    Bones

    0,810

    Lungs

    0,027

    Gonads

    0,016

    Bladder

    0,315

    The critical organ for radiation exposure is the bladder.

    Side effects:There may be allergic reactions.
    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 dosages used, no interaction with other drugs was noted.
    Special instructions:Work with the drug should be carried out in accordance with the "Basic Sanitary rules for ensuring radiation safety "(OSPORB-99)," Norms of Radiation Safety "(NRB - 99/2009), Methodological instructions" Hygienic requirements for radiation safety during radionuclide diagnostics using radiopharmaceuticals "(MU - 2.6.1, 1892- 04).

    Form release / dosage:

    Capsules, 37 kBq.

    Packaging:

    For 25 capsules in bottles for medicines, with a capacity of 15 ml, hermetically sealed with rubber medical closures and crimped aluminum caps.

    For 10 bottles, the passport and instructions for use are placed in a box of foamed polystyrene or in a cardboard box.
    Storage conditions:

    In accordance with the "Basic Sanitary Rules for Ensuring Radiation Safety" (OSPORB-99) and the "Norms of Radiation Safety" (NRB-99/2009) in a dry place. at a temperature of 15-30 ° C, away from heat sources, without exposure to direct sunlight.

    Shelf life:

    2 years.

    Terms of leave from pharmacies:For hospitals
    Registration number:P N003075 / 01
    Date of registration:27.03.2012 / 09.09.2014
    The owner of the registration certificate:NIFHI them. LYKARPOVA NIFHI them. LYKARPOVA Russia
    Manufacturer: & nbsp
    Information update date: & nbsp10.02.2016
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