Products / Radiopharmaceuticals / Albumon H.S.A. Tc-99 labeling kit

Albumon
Kit for the Preparation of Technetium -99m
Human Serum Albumin Injection
Code No.: Tc-MR-1
ATC code: VO9EB02

Description
Albumon is a freeze-dried non-radioactive, sterile, non-pyrogenic kit for intravenous use. When labelled with sodium pertechnetate (99mTcO4) it permits rapid and easy diagnosis. The kit contains 6 vials sealed with rubber caps under nitrogen atmosphere.

Each vial contains
Human Serum Albumin (HSA) 30.0 mg
Tin (II) chloride dihydrate 0.1 mg
Sodium chloride 2.0 mg

Properties
HSA is one of the natural components of the blood. When labelled with sodium pertechnetate and injected, it is distributed homogeneously in the vascular space and serves as a suitable tracer for examination of the dynamics of the circulatory system, and the volume and distribution of the blood.

Indications
Isotope examination and radiocirculography of the central circulation system. Radioisotope angiocardiography.

Determination of ejection fraction, first bolus passage
Examination of myocardial wall motion, detection of shunts and aneurysms.
Scintigraphic imaging of cardiac cavities and blood pools.
Demonstration of pericardial effusion.
Placentallocalization.
Peripheral isotope angiographic ventricular examination etc.

Preparation
Place the vial in a lead-shielded container and swab the rubber closure with sterilising agent.
Aseptically inject sterile Technetium-99m pertechnetate into a vial in a volume of 2.0-5.0 ml, with an activity of up to 2.2 GBq (60 mCi).
Shake the shielded vial vigorously to dissolve the dried mixture, and then allow it to stand for about 20 minutes.
During standing, shake it again for a few times.
Assay the total activity and calculate the volume for injection

The preparation is now ready for intravenous injection. The solution must be used within 6 hours after labelling.

Characteristics of the labelled solution
Sterile non-pyrogenic, non-toxic
Volume 2-5 ml
Colour pale yellow
pH 2.5-5
Radiochemical purity: not more than10%

Quality control of the Albumon kit
Sterility, apyrogenecity and atoxicity according to Pharmacopoeia Hungarica VII. Albumin nativity: agar- and immune-electrophoresis (according to Osserman and Scheidegger) According to USP 26 in mice, at 30 min. injected dose % in
Liver: not more than 15,0%
Stomach: not more than 1,0%
Blood: not less than 30,0%

Dosage and administration
Technetium-99m-Albumon may be administered only by intravenous injection. Placental localisation: 40MBq. For imaging cardiac cavities and blood pools: 200-750MBq.

Contraindications
Technetium-99m human serum albumin is contraindicated in persons with a history of hypersensitivity reactions to products containing human serum albumin. This radiopharmaceutical preparation should not be administered to pregnant or lactating women or persons less than 18 years of age, unless the expected benefits to be gained outweigh the potential risks

Dosimetry
Organs

Shelf-life
12 month below 25 °C

Storage
Store the reconstituted solution for injection not more than 6 hours below 25°C using appropriate radiation shielding.