Tehnefit 99mTc - instructions for use, dose, side effects, contraindications

Active substanceTechnetium [99mTc] phytateTechnetium [99mTc] phytate

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Tehnefit 99mTc

lyophilizate in / in

DIAMED, LLC Russia

Dosage form: & nbsplyophilizate for the preparation of a solution for intravenous administration

Composition:

Lyophilizate in one bottle contains:

Tin dichloride dihydrate - 0.275 mg

Sodium hydrophosphate dodecahydrate - not more than 37.0 mg

Fitin -- 11.0 mg

In 1 ml of the finished product contains:

Active substances:

Technetium-99m in the form of Technetium (^99mTc) phytate - 185-1480 MBq

Excipients:

Tin dichloride dihydrate - 0.055 mg

Sodium hydrophosphate dodecahydrate - not more than 7.4 mg

Fitin - 2.2 mg

Sodium chloride -- 9.0 mg

Water for injections -- up to 1.0 ml

Description:

Liofilizate white in the form of powder or porous mass. The finished product is a colorless, clear liquid.

Physicochemical characteristics

Tehnefit, ^99m Tc - radiopharmaceutical preparation is prepared from lyophilizate and sodium pertechnetate solution,^99m Tc from the technetium-99m generator.

Isotope ^99mTc has a half-life of 6.04 hours. Upon decay ^99m Tc emits gamma quanta with an energy of 140 keV and a yield of 90%.

Pharmacotherapeutic group:Radiopharmaceutical means diagnostic.

ATX: & nbsp

V.09.D.B Technetium 99m colloidal

Pharmacodynamics:

The preparation is intensively absorbed by the reticulo-endothelial system of the liver and spleen.

Pharmacokinetics:

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 input quantity. 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 input quantity for 2 hours.

Pharmacokinetic parameters allow for high-quality visualization of the liver and spleen.

Indications:

Scintigraphic evaluation of anatomical and topographic features of the liver and spleen (shape, size, structure) in tumors, cirrhosis, hepatitis and other diseases.

Contraindications:

Hypersensitivity to the drug or its components. The drug is not recommended for patients under the age of 18 years. The drug is contraindicated in pregnancy, acute hepatitis, hyperthermia.

Pregnancy and lactation:During breastfeeding, mothers should refrain from breastfeeding the baby within 24 hours after drug administration.

Dosing and Administration:

Preparation of the preparation:

- 5 ml of sodium pertechnetate solution with volume activity of 185 - 1480 MBq / ml is injected with a syringe into the vial with lyophilizate, piercing the rubber stopper with a needle;

- stir 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 MB per kg 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 evaluated according to the form, size, distribution pattern, presence and localization of "defects" of accumulation.

Table

Radiation loads

on the organs and the entire body of the patient with the use of the drug Technefeet,^99m Tc

Organs and Systems	Absorbed dose, mGy / MBq
Liver	0,08
Spleen	0,04
Kidneys	0,008
Bladder	0,0009
Red marrow	0,015
Total body (effective equivalent dose), mSv / MBq	0,004

Side effects:

Side effects with the use of the drug for diagnostic purposes are not revealed.

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

Interaction:When conducting diagnostic studies, interaction with other drugs was not detected.

Special instructions:Work with the drug should be carried out in accordance with the "Basic Sanitary Rules for Ensuring Radiation Safety" (OSPORB-99 / 20Yu), "Radiation Safety Standards" (NRB-99) and guidelines "Hygienic requirements for radiation safety during radionuclide diagnostics using radiopharmaceuticals "(MU 2.6.1.1892-04).

Form release / dosage:

Lyophilizate for preparation of solution for intravenous use (vials).

5 bottles in a contour acheive box along with instructions for the use of the drug in a cardboard box.

Transportation.

It is allowed to deviate from the temperature storage regime (10-25 ° C) during transportation for 1 month.

Packaging:(37.700) - In bottles for medicines with a capacity of 10 ml. (5) / In bottles for medicines with a capacity of 10 ml. The vials are sealed with rubber stoppers and crimped with aluminum or aluminum-plastic caps. 5 bottles with lyophilizate are placed in a contour cell package from a polyvinylchloride film. One contour pack of cells, together with the instruction for the use of the preparation "Tehnefit, 99mTc", is placed in a pack of cardboard. / - a pack of cardboard

Storage conditions:The lyophilizate is stored at a temperature of 2 to 10 degrees. C. Temperature deviation (10-25 degrees C) is allowed during transportation for 1 month. The finished product is stored in accordance with OSPORB-99/2010 and MU 2.6.1.1892-04.

Shelf life:

Lyophilizate - 1 year from the date of manufacture.

Preparation Technefeet,^99m Tc - 5 hours from the time of preparation.

Do not use after expiry date.

Terms of leave from pharmacies:For hospitals

Registration number:LS-002365

Date of registration:28.09.2011

The owner of the registration certificate:DIAMED, LLC DIAMED, LLC Russia

Manufacturer: & nbsp

DIAMED, LLC Russia

Information update date: & nbsp27.09.2015

Illustrated instructions

Instructions

Tehnefit 99mTc (Technephyt 99mTc)