Iron sulfate, 59Fe (Ferric sulfate, 59Fe)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
Read on
Similar drugsTo uncover
Dosage form: & nbsp

capsules

Composition:

One capsule contains:

Active substances:

Iron-59 - 30 kBq

Excipients:

Dextrose - not more than 300 mg

capsule gelatinous (titanium dioxide - 2.5% gelatin - up to 100% dye crimson - 1.36% iron (III) oxide - 0.85%)

Description:

Capsule gelatinous No. 1, solid, white body, lid orange. The contents of the capsule are white powder.

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

    Physicochemical characteristics

    The iron sulfate, 59Fe - radiopharmaceutical diagnostic product is ferrous sulfate, adsorbed on a filler (dextrose) in a gelatin capsule. The activity of iron-59 is 30 kBq at the time of delivery. The permissible deviation of the values โ€‹โ€‹of the activity of iron-59 in each capsule from the nominal value is ± 10%.

    Radionuclide 59Fe is a beta and gamma emitter with a half-life of 44.5 days.

    The most intense gamma radiation has energies: 0.192 (2.8%) MeV, 1.099 (56.4%) MeV, 1.292 (43.3%) MeV. The most intense beta radiation 59Fe has the following energies: 0.274 (46%) MeV, 0.467 (53%) MeV, 1.566 (0.3%) MeV.

    Pharmacological action

    The capsule, administered on an empty stomach through the mouth, dissolves in the stomach. The principle of the drug is the spread of iron with blood flow and selective accumulation, in particular, in cells of tumor tissue.

    Pharmacokinetics:

    The main amount of radioactive iron after 3 hours is contained in the gastrointestinal tract (stomach -36%, small intestine 33%, large intestine 19% of the administered amount). Radioactivity caused by 59Fe, in blood, kidneys, after three hours slightly exceeds the background, and in the bone marrow, spleen, muscle tissue does not exceed it. Five hours after administration, the radioactivity in the stomach and small intestine is reduced to 14% and 12%, respectively, and increases in the large intestine to 33% of the administered amount, and after 24-48 hours 95% of the injected activity is excreted from the body.

    The level of accumulation of the drug in the tumor reaches 0.7 - 0.9% of the administered amount and does not change within 48 hours.

    Indications:It is recommended to use as a screening method to identify breast pathology.
    Contraindications:

    In patients with a violation of the act of swallowing. Pregnancy, breast-feeding, age to 18 years.

    Dosing and Administration:

    The drug is administered orally.

    A. Methods of conducting the survey. 24 hours before the examination, the patient on an empty stomach takes one capsule with an activity of 30 kBq. After 24-36 hours after the administration of the preparation, the radiation 59Fe on a two-channel scintillation gamma spectrometer from both mammary glands simultaneously. The measurement is carried out two times: before the administration of the drug (own background) and 24-36 hours after administration. The measurement duration is 5-10 minutes.

    B. Interpretation of results. The received spectrograms record the level of accumulation of the drug in each of the mammary glands (with the deduction of background data), on the basis of which a comparative quantitative analysis is carried out. The results of the study are considered positive if the RFP accumulation in one of the mammary glands is exceeded by 1.4 times or more in comparison with the contralateral one.

    Radiation loads on the organs and tissues of the patient when using the drug "Iron sulfate, 59Fe ", capsules 30 kBq.

    Organ

    mGy / kBq

    Adrenal glands

    6x10-6

    Bladder

    5x10-6

    Skeleton

    4ั…10-6

    Brain

    4x10-6

    Breast

    2x10-6

    Gallbladder

    5x10-6

    Stomach

    1,2x10-5

    Exact intestine

    9x10-6

    The upper part of the large intestine

    8x10-6

    Lower part of large intestine

    8x10-6

    Kidneys

    1x10-5

    Liver

    1.5x10-5

    Lungs

    1x10-5

    Muscles

    5x10-6

    Ovaries

    3x10-6

    Testes

    2x10-6

    Pancreas

    8x10-6

    Red marrow

    5x10-6

    Leather

    5x10-6

    Spleen

    2.5x10-5

    Thymus

    5x10-6

    Uterus

    7x10-6

    Equivalent dose (mSv / kBq)

    2x10-3
    Side effects:

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

    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 requirements: "Basic Sanitary Rules for Ensuring Radiation Safety" (OSPORB-99), "Radiation Safety Standards" (NRB-99) and Guidelines "Hygienic Requirements for Radiation Safety in Radionuclide Diagnostics by radiopharmaceuticals "(MU 2.6.1, 1892-04).

    Form release / dosage:

    Capsules 30 kBq.

    Packaging:

    On the set date of delivery in hermetically sealed bottles of 10 or 15 capsules. A vial with a passport and instruction for medical use in a package transport packaging for radioactive substances.

    Storage conditions:The drug is stored with OSPORB-99, in a cool dry place, protected from light.
    Shelf life:

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

    Terms of leave from pharmacies:For hospitals
    Registration number:LSR-009614/09
    Date of registration:30.11.2009 / 11.09.2012
    Expiration Date:Unlimited
    The owner of the registration certificate:Medradiopreparat plant FSUE FMBA of RussiaMedradiopreparat plant FSUE FMBA of Russia Russia
    Manufacturer: & nbsp
    Information update date: & nbsp17.05.2017
    Illustrated instructions
      Instructions
      Up