Product Information
Please see Section 19A approved medicine IZOTOP DMSA 1.5 mg powder for solution for injection.
Radpharm DMSA consists of sterile, pyrogen-free lyophilised ingredients which need reconstitution with sodium pertechnetate[99mTc] injection to produce a technetium[99mTc] succimer complex suitable for renal imaging.
The precise structure of the technetium[99mTc] succimer complex is
not known at this time.
Technetium[99mTc] succimer is a diagnostic pharmaceutical administered
by intravenous injection.
PRODUCT INFORMATION
DESCRIPTION
Radpharm DMSA consists of sterile, pyrogen free lyophilised ingredients which need reconstitution with sodium pertechnetate[99mTc] injection to produce a technetium[99mTc] succimer complex suitable for renal imaging.
The precise structure of the technetium[99mTc] succimer complex is
not known at this time.
Technetium[99mTc] succimer is a diagnostic pharmaceutical administered
by intravenous injection.
INDICATIONS
This Kit consists of sterile, pyrogen free lyophilised ingredients which need reconstitution with sodium pertechnetate[99mTc] injection to produce a technetium[99mTc] succimer complex suitable for renal imaging.
SAFETY INFORMATION
DMSA Radpharm is supplied as a carton of 5 sterile, pyrogen free, vacuum sealed multidose 8 mL vials.
Each vial contains 1 mg succimer (meso-2,3-dimercaptosuccinic acid),
0.4 mg stannous chloride anhydrous, 0.7 mg ascorbic acid and 50.0 mg
inositol as a lyophilised powder.
The product contains no preservatives.
ARTG No
ARTG No: 324000
Product Name: Radioisotope calibration system for diagnostic or therapeutic radiopharmaceuticals - Radioisotope calibration system.
Sponsor Name: Global Medical Solutions Australia Pty Ltd
Sponsor’s Own Reference: GMS-Comecer-R2 Cal System
Entry Type: Included
Date of Entry: 25/09/2019