Fluorodeoxyglucose. 18F (Ftordesoxyglucose, 18 F)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceFludeoxyglucose [18F]Fludeoxyglucose [18F]
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  • Fluorodeoxyglucose. 18F
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  • Fluorodeoxyglucose. 18F
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    • Dosage form: & nbspsolution for intravenous administration [with volume on the date of manufacture]
    Composition:
    1 ml of the preparation contains:
    .Active substance:
    Fluorodeoxyglucose, l8F 40-930 MBq
    Excipients:
    Sodium chloride, water for injection.

    Description:
    Transparent colorless liquid.

    Pharmacotherapeutic group:Radiopharmaceutical diagnostic tool
    ATX: & nbsp

    V.09.I.X   Other radiopharmaceuticals for diagnosis of neoplasms

    Pharmacodynamics:
    F-dedeoxyglucose [F] is an analog of glucose, the main source of energy for brain cells, differing from it only by replacing the hydroxyl group at the second carbon atom with the fluorine-18 isotope. Fluoro-deoxyglucose [l8F], injected intravenously, repeats the initial portion of the glucose metabolic pathway, from the vascular bed to the intercellular space and then into the cells that are phosphorylated with hexokinases. Product
    the reaction - [| 8P] deoxyglucose-6-phosphate, unlike glucose phosphate, does not enter into further reactions and accumulates in cells, this makes it possible to measure transmembrane glucose transport and glycolysis rate in the body tissues.
    The different rates of anaerobic glycolysis in benign and malignant tumors make it possible to use the drug in the differential diagnosis of malignant tumors of various nosological forms and localizations, determine regional distribution and search for distant metastases, and evaluate the effectiveness of treatment in cancer patients. In addition, a different level of glucose consumption by normal and pathological tissue of the brain makes it possible to carry out a refined diagnosis of epilepsy, cerebral diseases of vascular, traumatic genesis.

    Pharmacokinetics:
    After intravenous administration, radiopharmaceutical (RFP) "Fluodeoxyglucose, 18F" accumulates in organs and tissues. The maximum accumulation in the brain is observed in the cortex and deep structures of the brain; in gray matter, the content of the drug is 2 times higher than in white matter.The ratio of heart-lung accumulation is 220: 1, heart-blood and heart-liver is 14: 1 and 10: 1, respectively. Low accumulation of the drug in the liver and its rapid elimination indicate that fluorodeoxyglucose [18F] does not convert to glycogen. About 16% of the administered amount of RFP is excreted from the body by the kidneys during the first 60 minutes, and up to 50% of the drug is excreted after 135 minutes. after injection. The optimal body-to-background ratio when examining the brain is reached 30-40 minutes after intravenous administration of RFP and is maintained for 20-30 minutes.
    The degree of accumulation of the drug "fluorodeoxyglucose, 18F" in the cells of malignant tumors correlates with the degree of their malignancy. The optimal tumor / normal tissue ratio is observed 40-90 minutes after the administration of the drug and is maintained up to 120-150 minutes after administration. The best conditions for the detection of malignant tumors are created with mild hypoglycemia, achieved by fasting for 4-6 hours, and a water load (ingestion of 500-700 ml of water) after the administration of the radiopharmaceutical. Fasting promotes increased uptake of glucose by cells, and the water load accelerates the excretion of the radiopharmaceutical with urine.

    Indications:
    The drug is intended for diagnosis by positron emission tomography of malignant and benign tumors, epilepsy, craniocerebral trauma, cerebrovascular diseases and other types of brain diseases associated with changes in glucose metabolism in adult patients.

    Contraindications:
    The use of the drug is contraindicated during pregnancy and lactation.

    Dosing and Administration:
    The drug "Fluodeoxyglucose, 18F" is injected intravenously with a slow bolus through a catheter, previously installed in the ulnar vein of the subject. The administered dose is 122 MBq per 1 m2 of body surface area, which is determined on the basis of the growth and body weight of the subject. Scanning begins 40 minutes after the administration of the drug and lasts for 20 minutes.
    The number of registered annihilation acts should reach 900,000 - 1 million per one cut. Criterion for pathological accumulation of the drug in certain areas of the brain is an excess of more than 15% relative to the contralateral region of the brain. Radiation loads.
    The estimated radiation dose to the whole body when administered intravenously diagnostic doses (150-555 MBq) is from 3.7 to 13.9 mSv; on the bladder - from 17 to 64 mSv spleen - from 24 to 98 mSv. The effective equivalent dose for the whole body is 0.024 mSv / MBq.

    Side effects:
    There were no adverse reactions during the use of the drug for diagnostic purposes.

    Overdose:
    With a single administration, an overdose is unlikely, due to the lack of pharmacodynamic properties in the preparation.

    Interaction:
    Interaction with other drugs has not been established.

    Special instructions:
    Work with the preparation must be carried out in accordance with the "Basic sanitary rules of radiation safety" ( "OSPORB-99"), "Radiation Safety Standards" (SRS-99) and the Guidelines (MU 2.6.1.1892-04) "Hygienic requirements for radiation safety during nuclear medicine using radiofampreparatov ".

    Form release / dosage:
    Solution for intravenous administration with activity of 40-930 MBq / ml
    Packaging:
    Solution for intravenous administration with the activity of 40-930 MBq / mL at a specified date and time of delivery in an evacuated sterile vial for pharmaceuticals capacity of 10 ml.A vial with a passport is placed in a package for transport packaging for radioactive substances. Instructions for medical use are attached.

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

    Shelf life:
    12 hours from the time of manufacture. Do not use after expiry date.

    Terms of leave from pharmacies:For hospitals
    Registration number:P N001020 / 01
    Date of registration:29.10.2008
    Information update date: & nbsp22.09.2015
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