NANOSCAN Kit for radiopharmaceutical preparation Ref.[27559] Active ingredients: Technetium ⁹⁹ᵐTc nanocolloid

Revision Year: 2021  Publisher: Radiopharmacy Laboratory Ltd., Gyár st. 2, 2040 Budaörs, Hungary

Product name and form

NanoScan 500 micrograms, kit for radiopharmaceutical preparation.

Pharmaceutical Form

Kit for radiopharmaceutical preparation.

White powder.

Powder for solution for injection.

To be reconstituted with sodium pertechnetate (99mTc) solution for injection.

Qualitative and quantitative composition

Each vial contains 0.5 mg nanocolloidal human albumin.

At least 95% of human albumin colloidal particles have a diameter ≤80 nm.

NanoScan is prepared from human serum albumin derived from human blood donations tested according to the EEC Regulations.

The radionuclide is not part of the kit.

Excipient(s) with known effects:

Sodium: 0.045 mmol.

For the full list of excipients, see section 6.1

Active Ingredient Description
Technetium ⁹⁹ᵐTc nanocolloid

Technetium ⁹⁹ᵐTc nanocolloid is a colloid formulation of human serum albumin (HSA) labeled with Technetium-99m (Tc-99m) with diagnostic imaging properties. At the chemical concentrations and activities used for diagnostic examinations, nanocolloidal technetium (Tc-99m) albumin does not appear to have any pharmacodynamic activity.

List of Excipients

Stannous(II) Chloride dihydrate
Glucose monohydrate
Sodium dihydrogen phosphate dihydrate, di-Sodium hydrogen phosphate dihydrate
Nitrogen
Hydrochloric acid
Sodium hydroxide

Pack sizes and marketing

8 ml colourless, Type I, brosilicate glass multi-dose vials, closed with chlorobutyl rubber stopper and plastic-aluminium caps (polypropylene-aluminium caps) with turned up edge.

Packsizes:

1 pack contains 6 vials.
Sample package: 2 vials.
Bundle pack of 2 packs of 6 vials.
Bundle pack of 4 packs of 6 vials.

Not all pack sizes may be marketed.

Marketing authorization holder

Radiopharmacy Laboratory Ltd., Gyár st. 2, 2040 Budaörs, Hungary

Drugs

Drug Countries
NANOSCAN Estonia, Malta, Poland, Romania, United Kingdom

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