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, 18 F
    solution in / in 
       
  • Fluorodeoxyglucose, 18F
    solution in / in 
    Medicine and nuclear technologies, LLC     Russia
  • Fluorodeoxyglucose, 18F
    solution in / in 
    PET-TECHNOLOGY, LTD.     Russia
  • Fluorodeoxyglucose. 18F
    solution in / in 
       
  • Fluorodeoxyglucose. 18F
    solution in / in 
       
    • Dosage form: & nbspsolution for intravenous administration
    Composition:

    Composition per ml of solution:

    Active substance:

    Fluorine-18 40-2500 MBq

    Excipient:

    Sodium chloride 9 mg

    Water for injection up to 1.0 ml.

    Description:

    Transparent colorless liquid.

    Physicochemical characteristics

    The preparation is an isotonic sodium chloride solution containing fluorine-18 in the chemical form of 2-fluoro, 18F-2-deoxy-D-glucose ([18F] -fluoseoxyglucose), i.e. D-glucose, in the molecule of which the hydroxyl group in the second position is mixed on the fluorine-18 radionuclide. The preparation is prepared without the addition of a carrier. Volume activity of the solution is from 40 to 2500 MBq / ml at the production date and time, radiochemical purity is not less than 95%, pH 4.5 is 8.0, osmolality is from 239 to 376 mOsm / l.

    The fluorine-18 radionuclide has a half-life of 109.77 min, decays according to the positron type with an average positron energy of 0.250 MeV, and the energy of annihilation gamma radiation is 0.511 MeV.

    Pharmacotherapeutic group:Radiopharmaceutical diagnostic tool
    ATX: & nbsp

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

    Pharmacodynamics:With the introduction of [18F] -fluoseoxiglucose, in norm in decreasing order the percentage of accumulation is visualized the following organs: cerebral cortex, myocardium, renal pelvis and bladder, oropharynx, stomach. [18F] -fluoseoxiglucose can also accumulate in the colon, the muscles of the skeletal musculature. In other organs and tissues, the background accumulation is normal [18F] -fluoseoxyglucose. Hyperfixation [18F] -fluroseoxiglucose is observed in the cerebral cortex and myocardium due to increased glucose metabolism in these organs. [18F] -fluoseoxiglucose, is a nonspecific tumorotropic radiopharmaceutical (RFP) and accumulates in increased amounts in malignant tumor cells and metastases, which is associated with the inherent hyperglycolysis. The degree of accumulation [18F] -fluoseoxiglucose in malignant tumor cells is correlated with the prevalence of the neoplastic process. The drug also allows you to evaluate the effect of the treatment, because with effective treatment, the percentage of accumulation of the drug in tumors decreases, and if ineffectiveness - does not change or increases. [18F] -fluoseoxiglucose is actively transported to cells by protein-transporter, where is subjected to phosphorylation with the formation of [18F] -fluodeoxyglucose-6-phosphate, a product that does not enter into further reactions, and is retained in this form in cancer cells. In unchanged cells of tissues and organs, dephosphorylation is observed with the formation of [18F] -fluoseoxiglucose, which is derived from normal cells and can be redistributed. The best conditions for detecting malignant tumors are created with mild hypoglycemia achieved by fasting for 4-6 hours and with an aqueous load (ingestion of 500-800 ml of water) after the administration of RFP. The patient is offered several times to empty the bladder. Fasting promotes increased uptake of glucose by cells, and the water load accelerates the removal of a label from normal tissues with urine, as a result of which the level of radioactive background and radiation load decrease. In patients with diabetes, the concentration of glucose in the blood should be monitored before the study. Positron emission tomography (PET) is performed only under the condition of normal or reduced concentrationglucose in the blood. [18F] -fluoseoxiglucose is a cardiotropic RFP, and its diagnostic properties is suitable for the study of glucose metabolism in the myocardium. RFP allows to assess the degree of viability of the myocardium when planning reconstructive operations in patients with ischemic heart disease and systolic dysfunction of the left ventricle, to monitor the effectiveness of myocardial treatment.
    Pharmacokinetics:

    After intravenous administration of the drug [18F] -fluoseoxiglucose quickly leaves the bloodstream and gradually accumulates in organs and tissues. From the body [18F] -fluoseoxiglucose is excreted by the kidneys, so the kidneys, ureters and bladder are also visualized in the norm. More than 50% of the administered amount of RFP is excreted from the body with urine in the first 120-135 minutes after the injection.

    In the brain, increased accumulation [18F] -fluoseoxiglucose is observed in the cortex and deep structures, and the content of RFP in the gray matter is 2 times higher than in white. Accumulation [18F] -fluoseoxiglucose in the human myocardium is 3-4% of the administered amount. The optimal body / background ratio for myocardial and headthe brain is reached 35-40 minutes after intravenous administration of the drug and is maintained for another 25-30 minutes, which is sufficient for conducting positron emission tomography.

    The optimal tumor / normal tissue ratio is observed after 45-120 minutes after administration [18F] -fluoseoxiglucose and persists for another 240-360 minutes after the administration of the drug.

    Indications:

    The drug is used as a diagnostic drug for positron emission tomography (PET) for the early detection of malignant tumors, differential diagnosis of malignant tumors, monitoring the effectiveness of specialized treatment of malignant tumors, assessing the viability of the myocardium, diagnosing epilepsy, cerebral trauma, cerebrovascular diseases and brain diseases , associated with a change in metabolism.

    Contraindications:

    Specific contraindications to the use of the drug is not found.

    Use of the drug is contraindicated in case of hypersensitivity to the active substance or to any of the components of the drug; during pregnancy and during breastfeeding.

    Pregnancy and lactation:

    The use of the drug during pregnancy and during breastfeeding is contraindicated.

    Dosing and Administration:

    The drug in the form of a sterile solution is administered to patients intravenously. From pharmacokinetic data on the time of maximum accumulation of fluorodeoxyglucose, 18F in the organs and the rate of its elimination it follows that the optimal time for the onset of scanning of the myocardium and brain is 35-40 minutes after the administration of the drug, while the conditions for the study of the brain and myocardium remain for 60-70 min after its administration. In the "whole body" study, the optimal time to start scanning is 90-120 minutes after intravenous RFP. Optimal conditions for the study of the entire body in cancer patients persist for 4 hours after the administration of RFP. The diagnostic dose of RFP for positron emission tomography of the brain and myocardium is 100-120 MBq per 1 m2 of the body surface of the patient, while generally using 150-240 MBq per study. The body surface area is calculated from the nomogram, based on the weight and height of the patient. The drug is injected intravenously in a volume of 0.5-2.0 ml.

    In a PET whole-body study, the diagnostic dose of the drug is 220 MBq per 1 m of the body surface of the patient; as a rule, use 300-550 MBq per study. The drug is administered intravenously slowly in a volume of up to 10 ml. Before the introduction, the required for a given patient, the dose of fluorodeoxyglucose, 18F dilute with a sterile saline solution, bringing the contents of the syringe to 10 ml, which is necessary to accurately dose the injected activity and reduce the capture of RFP in the brain and myocardium. The radioactivity of the drug remaining in the syringe after the administration should be measured to clarify the dose administered.

    Radiation loads

    Dose factors for the administration of the drug "fluorodeoxyglucose, 18F, solution for intravenous administration "for the calculation of effective doses to patients (MU 2.6.1.1798-03)

    Active substance

    Dose factors, m3v / MBq

    Adults

    1 -2 years

    3-7 years

    8-12 years old

    13-15 years old

    [18F] -

    fludoseoxglucose

    0,019

    0,095

    0,05

    0,036

    0,025

    Dose factor for intravenous administration of fluorodeoxyglucose, 18F- in adults is 19 x 10-3 m3v / MBq. With the introduction of a diagnostic dose of the drug from 150 to 550 MBq, the effective dose is 2.85 - 10.45 m3v.

    Absorbed doses of irradiation with intravenous administration of the preparation [18F] -fluoseoxiglucose in organs in adult patients

    Organs and tissues

    Absorbed dose, 10-3 mGy / MBq.

    Red marrow

    11

    Skeleton

    14

    Eggs

    14

    Ovaries

    15

    Liver

    16

    Lungs

    16

    A heart

    17

    Kidneys

    19

    Stomach

    25

    Pancreas

    27

    Spleen

    39

    Brain

    43

    Bladder

    114
    Side effects:

    Perhaps the development of allergic reactions.

    Overdose:

    Symptoms of overdose are not fixed.

    Interaction:

    Interactions with other drugs have not been observed.

    Special instructions:

    Work with the drug is carried out in accordance with the "Basic Sanitary Rules for Ensuring Radiation Safety (OSPORB-99 / 20Yu)", "Norms of Radiation Safety" (NRB-99/2009), Guidelines "Hygienic requirements for ensuring radiation safety during radionuclide diagnostics with using radiopharmaceuticals "(MU 2.6.1.1892-04).

    Conditions of transportation in a protective container, in accordance with the current regulatory documents ("Rules for the Physical Protection of Radioactive Substances and Radiation Sources in Their Transport" (MP-073-1 1) and "Sanitary Regulations for Radiationsafety of personnel and the population when transporting radioactive materials (substances) "(SanPiN 2.6.1.1281 -03)).

    The best conditions for detecting malignant tumors are created with mild hypoglycemia achieved by fasting for 4-6 hours and with an aqueous load (ingestion of 500-800 ml of water) after the administration of RFP. Fasting promotes increased uptake of glucose by cells, and the water load accelerates excretion [18F] -fluoseoxiglucose from normal tissues with urine, as a result of which the level of radioactive background and radiation load are reduced. In patients with diabetes mellitus before the study, it is necessary to monitor the concentration of glucose in the blood of PET with [18F] -fluoseoxiglucose is carried out only under condition of normal or low concentration of glucose in the blood.

    Effect on the ability to drive transp. cf. and fur:

    Studies on the effect on the ability to drive vehicles, mechanisms have not been carried out. It is not recommended to drive vehicles and engage in other potentially hazardous activities requiring increased concentration and speed of psychomotor reactions within 24 hours after the study.

    Form release / dosage:

    Solution for intravenous administration, with a volume activity of 40-2500 MBq / ml at the date and time of manufacture.

    Packaging:

    Portions with activity from 600 to 37500 MBq for the set date and time of manufacturing in glass bottles of type I with a capacity of 15 ml, sealed with rubber stoppers from chlorobutyl and crimped with an aluminum cap.

    The label is self-adhesive on the vial. The bottle is placed in a protective tungsten container for transport for radioactive substances. To the vial are attached the instruction for medical use and the passport.

    For transportation of the drug to other medical and diagnostic institutions, the vial with the drug in a protective tungsten container, instructions for the medical

    applications and passport are placed in a package for transport packaging for radioactive substances (Type A package).

    Storage conditions:

    Store at a temperature of no higher than 25 ° C, in accordance with the requirements of the "Norms of Radiation Safety" (NRB-99/2009) and the "Basic Sanitary Rules for Ensuring Radiation Safety" (OSPORB-99/2010).

    Shelf life:12 hours from the time and date of manufacture. Do not use after expiry date.
    Terms of leave from pharmacies:For hospitals
    Registration number:LP-004724
    Date of registration:28.02.2018
    Expiration Date:28.02.2023
    The owner of the registration certificate:PET-TECHNOLOGY, LTD.PET-TECHNOLOGY, LTD. Russia
    Manufacturer: & nbsp
    Information update date: & nbsp09.04.2018
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