Fluorodeoxyglucose, 18 F - instructions for use, dose, side effects, contraindications

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: & nbspRAsterol for intravenous administration [with volume on the date of manufacture]

Composition:

Composition per ml of solution:

Active substance: fluorine-18 - 40-2500 MBq;

auxiliary substances: sodium chloride 9.0 mg, water for injection up to 1 ml.

Description:

transparent colorless or slightly yellowish liquid.

Pharmacotherapeutic group:radiopharmaceutical diagnostic tool

ATX: & nbsp

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

Pharmacodynamics:

Normally, with the introduction of this radiopharmaceutical (RFP), the following organs are visualized in order of decreasing accumulation level: cerebral cortex, myocardium, renal pelvis and bladder, oropharynx, stomach. RFP can accumulate in the colon, muscles of skeletal musculature, areas of brown fat accumulation. In other organs and tissues, the background accumulation of RFP is normal.Hyperfixation of RFP is observed in the cerebral cortex and myocardium as a result of an increased level of glucose metabolism in these organs. "Fluorodeoxyglucose, 18F" is a nonspecific RFP tumor tropism and accumulates in high amounts in cells of malignant tumors and metastases, due to the inherent giperglikolizom. The degree of accumulation of fluorodeoxyglucose, 18F in the cells of malignant tumors correlates with the degree of their malignancy. The drug also allows you to evaluate the effect of the treatment, because with effective treatment, the level of accumulation of the drug in tumors decreases, and when ineffectiveness - does not change or increases. Fluorodeoxyglucose, 18F protein is actively transported into cells, conveyors, where it undergoes phosphorylation to form fluorodeoxyglucose-6-phosphate, 18F, product which does not enter into further reactions, and in this form is retained in the cells of malignant tumors. In unaltered cells of tissues and organs dephosphorylation is observed with the formation of fluorodeoxyglucose, 18F, which is excreted from normal cells and can be redistributed.The best conditions for the detection of malignant tumors are created with mild hypoglycemia, achieved by fasting for 4-6 hours and with a water load (intake 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, blood glucose should be monitored prior to testing. PET-examination is carried out only under condition of normal or low blood glucose level. "Fluoro-deoxyglucose, 18F" is a cardiotropic RFP, and by 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 injection of fluorodeoxyglucose, 18F quickly leaves the bloodstream and gradually accumulates in organs and tissues. From the body of fluorodeoxyglucose, 18F is excreted through the kidneys into the bladder, so the kidneys, ureters and bladder are also visualized normally. More than 50% of the administered amount of RFP is excreted from the body with urine in the first 2 hours after the injection. In the brain, increased accumulation of RFP is observed in the cortex and deep structures, and the content of RFP in gray matter is 2 times higher than in white matter. Accumulation of the drug in the human myocardium is 3-4% of the administered amount. The optimal body / background ratio for myocardial and brain examinations is reached 35-40 minutes after intravenous administration of the drug and remains for another 25-30 minutes, which is sufficient for conducting positron emission tomography. The optimal tumor / normal tissue ratio is observed 45-120 minutes after drug administration, and remains for 240-360 minutes after administration.

Indications:

RFP "Fluodeoxyglucose, 18F" is used as a diagnostic drug for positron emission tomography (PET). The main indications for the study are: in oncology:

differential diagnosis of malignant otsukholy of various nosological forms and localizations, including neoplasms of the brain, determination of the prevalence and staging of malignant neoplasms, evaluation of the effectiveness of tumor treatment;

in cardiology:

-evaluation of myocardial viability in the planning of reconstructive operations in patients with coronary heart disease and systolic dysfunction of the left ventricle, monitoring the effectiveness of myocardial treatment; in neurology:

identification of foci of hypometabolism in epilepsy, differential diagnosis of parkinsonism, determination of the degree of brain damage in cases of craniocerebral trauma and cerebrovascular diseases, determination of the effectiveness of treatment of neurological and psychoneurological pathologies.

Contraindications:

Specific contraindications to the use of the drug is not found. The use of RFP "fluorodeoxyglucose, 18F" is contraindicated in pregnancy and lactation.

Dosing and Administration:

"Fluodeodesoxyglucose, 18F" in the form of a sterile solution is administered intravenously to the patient.From the 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 myocardial and brain scans is 35-40 minutes after drug administration, while the conditions for the study of the brain and myocardium persist for another 60 -70 minutes after its introduction. 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 whole body in cancer patients are preserved within 4 hours after the administration of RFP. The diagnostic dose of RFP for conducting positron emission tomography of the brain and myocardium is 100-120 MBq per 1 m2 of the body surface of the patient, with a typical use of 150-240 MBq per study. The surface of the body 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.

With a PET whole-body examination, the diagnostic dose of the drug is 22Q MBq per 1 m2 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 5.0-10.0 ml. Usually, before administration, the dose required for the patient is "fluorodeoxyglucose, 18F" diluted with sterile saline, bringing the contents of the syringe to 5.0-10.0 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 coefficients for calculating effective doses of patients
use of the drug "fluorodeoxyglucose, ¹⁸F"(MU 2.6.1.1798-03).

Compound	Dose factors, mSv / MBq
	Adults	1-2 of the year	3-7 years	8-12 years	13-15 years old
Fluorodeoxyglucose, ¹⁸F	0,019	0,095	0,05	0,036	0,025

Dose coefficient for intravenous administration of "fluorodeoxyglucose, ¹⁸F " in adults is 19 x 10 '³ mSv / MBq. When the diagnostic dose of the drug is administered (from 150 to 550 MBq), the effective dose is 2.85 - 10.45 mSv.

Absorbed doses of radiation in adult patients with intravenous administration
a preparation of fluorodeoxyglucose, ¹⁸F on the organs.

and

Organs and tissues	The absorbed dose of 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:

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

Interaction:

Data on drug interaction are absent.

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

Form release / dosage:solution for intravenous administration [with volume on the date of manufacture] 40-2500 MBK / ml

Packaging:

The drug "fluorodeoxyglucose, 18F". a solution for intravenous administration in batches with activity from 600 to 50000 MBq for the set date and time of manufacture is placed in a sterile glass bottle with a capacity of 15 ml or 20 ml, sealed with a rubber stopper of grade 52-599 / 1 or type 1-1 and crimped with an aluminum cap.A sticker of writing paper or a label or a self-adhesive label is applied to the bottle.

The bottle together with the instruction for medical use is placed in a transport container for radioactive substances.

Storage conditions:

RFP "Fluodeoxyglucose, 18F 'is stored in accordance with the requirements of the" Norms of Radiation Safety "(NRB-99) and the" Basic Sanitary Rules for Ensuring Radiation Safety "(OSPORB-99).

Shelf life:

12 hours from the date and time of manufacture. Do not use after expiry date.

Terms of leave from pharmacies:For hospitals

Registration number:LSR-008507/10

Date of registration:20.08.2010

Information update date: & nbsp22.09.2015

Illustrated instructions

Instructions

Fluorodeoxyglucose, 18 F (Ftordesoxyglucose, 18 F)