Composition, form of production and packaging
Lyophilizate for the preparation of a solution for intravenous administration of white color in the form of powder or porous mass.
Fitin 11 mg
[PRING] tin dichloride dihydrate - 0.275 mg, sodium hydrophosphate dodecahydrate - not more than 37 mg.
The finished product is a colorless, clear liquid.
technetium 99mTc (in the form of technetium 99 m Tc phytate) 185-1480 MBq
[PRING] tin dichloride dihydrate - 0.055 mg, sodium hydrophosphate dodecahydrate - not more than 7.4 mg, phytin - 2.2 mg, sodium chloride - 9 mg, water d / and - up to 1 ml.
Vials (5) - cardboard boxes.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
Tehnefit, 99m Tc - radiopharmaceutical preparation is prepared from lyophilizate and sodium pertechnetate solution, 99m Tc from the technetium-99m generator.
The isotope 99m Tc has a half-life of 6.04 hours. Upon decay of 99m, Tc emits gamma quanta with an energy of 140 KeV and a yield of 90% /
The preparation is intensively absorbed by the reticulo-endothelial system of the liver and spleen.
After intravenous administration, the accumulation of the drug in the liver and spleen reaches a maximum after 30 minutes and is about 80% of the administered amount. The content of the drug in the blood 20 minutes after the injection does not exceed 4%. Removal of the drug from the body occurs through the kidneys and is about 4% of the administered amount in 2 hours.
Pharmacokinetic parameters allow for high-quality visualization of the liver and spleen.
- Scintigraphic evaluation of anatomical and topographic features of the liver and spleen (shape, size, structure) in tumors, cirrhosis, hepatitis and other diseases.
Preparation of the preparation:
- 5 ml of pertechnetate sodium solution with volumetric activity of 185-1480 MBq / ml is injected with a syringe into the vial with lyophilizate, piercing the rubber stopper with a needle;
- Mix the contents of the vial by shaking until the lyophilizate is completely dissolved.
The drug is ready for use immediately after complete dissolution of the lyophilizate. Enter intravenously.
The injected dose: 1.5-2.0 MBq per 1 kg of body weight. One bottle of the finished product can be used to study 5 patients.
Scintigraphy (scans) of the liver and spleen is carried out 30-40 minutes after the injection of the drug.
Scintigrams (scennograms) are assessed by shape, size, distribution, presence and localization of "accumulation defects".
Radiation loads on the organs and the whole body of the patient with the use of the drug Tehnefit, 99m Tc
Organs and systems Absorbed dose, mGy / MBq
Red bone marrow 0.015
Total body (effective equivalent dose), mSv / MBq 0.004
Side effects with the use of the drug for diagnostic purposes are not revealed.
- hypersensitivity to the drug or its components.
The drug is not recommended for patients under the age of 18 years.
PREGNANCY AND LACTATION
Contraindicated in pregnancy.
During breastfeeding, mothers should refrain from breastfeeding the baby within 24 hours after drug administration.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated in acute hepatitis.
APPLICATION FOR CHILDREN
Contraindicated in children under 18 years.
Work with the drug should be carried out in accordance with the "Basic Sanitary Rules for Ensuring Radiation Safety" (OSPORB-99/2010), "Radiation Safety Standards" (NRB-99) and guidelines "Hygienic requirements for ensuring radiation safety during radionuclide diagnostics using radiopharmaceuticals "(MU 126.96.36.1992-04).
With a single administration, an overdose is unlikely, due to the lack of pharmacodynamic properties in the preparation.
When conducting diagnostic studies, interaction with other drugs was not detected.
TERMS OF RELEASE FROM PHARMACY
The drug is released only on applications in specialized medical and diagnostic institutions.
TERMS AND CONDITIONS OF STORAGE
The lyophilizate is stored at a temperature of 2 В° C to 10 В° C. The finished product is stored in accordance with OSPORB-99/2010. Keep out of the reach of children.
It is allowed to deviate from the temperature storage regime (10-25 В° C) during transportation for 1 month.
Shelf life: lyophilizate -1 year from the date of manufacture; preparation Tehnefit, 99m Tc - 5 hours from the time of preparation. Do not use after expiry date.