SPECT - kits

Colloid (PoltechColloid) – for radiopharmaceutical preparation

 

kit for radiopharmaceutical preparation

SKU: MTcK-2 Categories: , ,

Description

CAUTION!

Colloid (PoltechColloid) – for radiopharmaceutical preparation – solution for injection (code: MTcK-2) will remain in production until the end of April 2024.

The sales of this product would continue until stocks last.

Therapeutic indications:

This medicinal product is for diagnostic use only.

 

Technetium [99mTc] colloidal tin injection is used for scintigraphic diagnostics of reticuloendothelial system of liver and spleen.

Qualitative and quantitative compositions:

1 vial contains:

      • Stannous chloride dihydrate 0.17 mg.

The radionuclide is not part of the kit.

Pharmaceutical form:

Kit for radiopharmaceutical preparation. 

Lyophilisate for solution for injection. 

White powder.

List of excipients:

Sodium fluoride

Povidone

Nitrogen

Posology and method of administration:

This medicinal product is administered intravenously and should be reconstituted before administration to the patient.

Product intended for preparation of radiopharmaceutical technetium [99mTc] colloidal tin injection for intravenous administration.

This radiopharmaceutical may be used only by authorized persons. Safety precautions for careful handling this radiopharmaceutical should be observed.

 

For detailed information on dosage and method of administration please refer to the Summary of Product Characteristics.

Shelf life:

Shelf life of the kit is 1 year.

The radiolabelled product 99mTc-Colloid should be administered within 4 hours of preparation.
Radiochemical purity and stability data of preparation refer to this time at a temperature below 25°C.

Special precautions for storage:

Store in a refrigerator (2–8°C).

During transportation (not longer than 7 days) up to 35°C.

Shelf life after reconstitution and labelling with sodium pertechnetate (99mTc) solution: up to 4 hours at a temperature below 25°C in a suitable radiation lead shield.

Storage should be in accordance with national regulations for radioactive materials.

Nature and content of container:

10 mL glass vials sealed with rubber stopper and an aluminium crimp cap.

Vials are packed in cardboard boxes – pack size of 6 vials.

For detailed information about this product please refer to the Summary of Product Characteristics or Information for the User.