Draximage MAA
Generic name: technetium Tc 99m albumin aggregated
Dosage form: injection, powder, for solution
Drug class:Radiologic conjugating agents
Medically reviewed by Drugs.com. Last updated on Aug 1, 2020.
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DRAXIMAGE® M AA
Kit for the Preparation of
Technetium Tc 99m
Albumin Aggregated Injection
DIAGNOSTIC - For Intravenous Use
DESCRIPTION
The kit consists of reaction vials which contain the sterile, non-pyrogenic, non-radioactive ingredients necessary to produce Technetium Tc 99m Albumin Aggregated Injection for diagnostic use by intravenous injection.
Each 10 mL reaction vial contains 2.5 mg of albumin aggregated, 5 mg of human serum albumin , 0.06 mg (minimum) stannous chloride (maximum stannous and stannic chloride 0.11 mg) and 1.2 mg of sodium chloride; the contents are in a lyophilized form under an atmosphere of nitrogen. Sodium hydroxide or hydrochloric acid has been used for pH adjustment. No bacteriostatic preservative is present.
The human serum albumin was non-reactive when tested for Hepatitis B Surface Antigen (HBsAg), antibodies to Human Immunodeficiency Virus (HIV-1/HIV-2), antibody to Hepatitis C Virus (anti-HCV) and Antigen to Human Immunodeficiency Virus (HIV-1). The aggregated particles are formed by denaturation of the albumin in a heating and aggregation process. Each vial contains 3 to 8 million particles. By light microscopy, more than 90% of the particles are between 10 and 70 micrometers, while the typical average size is 20 to 40 micrometers; none is greater than 150 micrometers.
Technetium Tc 99m Albumin Aggregated Injection for intravenous use is in its final dosage form when a sterile isotonic sodium pertechnetate solution is added to the vial. No less than 90% of the pertechnetate Tc-99m added to a reaction vial is bound to aggregate at preparation time and remains bound throughout the usage lifetime of the preparation (See Directions For Preparation).
PHYSICAL CHARACTERISTICS
Technetium Tc-99m decays by isomeric transition with a physical half-life of 6.02 hours. The principal photon that is useful for detection and imaging studies is listed in Table 1.
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MEDICAL DEPARTMENTS
Cardiology
Pediatrics
Diabetes Care
Pre-natal Care
Ultrasound Echocardiogram
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