RADPHARM DMSA powder for injection
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Public Assessment Report
(PAR)
02-12-2017
Send request.
Active ingredient:
succimer, Quantity: 1 mg
Available from:
Global Medical Solutions Australia Pty Limited T/A Radpharm Scientific
INN (International Name):
Succimer
Pharmaceutical form:
Injection, powder for
Composition:
Excipient Ingredients: inositol; ascorbic acid; stannous chloride
Administration route:
Intravenous
Units in package:
5x8mL vials
Prescription type:
Not scheduled. Not considered by committee
Therapeutic indications:
INDICATIONS AS AT 25 SEPTEMBER 1996: Technetium (99mTc) succimer may be used as a static renal imaging pharmaceutical and is particularly suited for evaluation of renal cortex, deliniation of renal space occupying lesions, determination of intrarenal function, distribution and identification of ectopic renal sites.
Product summary:
Visual Identification: Lyophilised white powder; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 1 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Authorization status:
Registered
Authorization date:
1991-09-05
Patient Information leaflet
RADPHARM
L4.2
SCIENTIFIC
DMSA RADPHARM
KIT FOR THE PREPARATION OF TECHNETIUM[
99M
TC] SUCCIMER INJECTION FOR RENAL
IMAGING
PRODUCT DATA
AUST R 14326
DESCRIPTION
This Kit consists of sterile, pyrogen free lyophilised ingredients
which need
reconstitution with sodium pertechnetate[
99m
Tc] injection to produce a
technetium[
99m
Tc] succimer complex suitable for renal imaging.
The precise structure of the technetium[
99m
Tc] succimer complex is
not known at this time.
Technetium[
99m
Tc] succimer is a diagnostic pharmaceutical administered
by intravenous injection.
CONTENTS AND PRESENTATION
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.
PHYSICAL CHARACTERISTICS OF TECHNETIUM-99M
Technetium-99m with a physical half life of 6 hours decays by isomeric
transition to technetium-99. Photons associated with this transition
that are
useful for detection and imaging studies are listed in Table 1.
Table 1. Principal Radiation Emission Data
Principal
Radiation
Mean Percent
per Disintegration
Mean Energy (keV)
Gamma-2
89.1
140.5
Reference: D A Weber et al. "MIRD: Radionuclide and decay schemes",
The Society of Nuclear Medicine Inc. New York, 1989.
Table 2. Physical Decay Chart for Technetium-99m
Hours
Fraction
Remaining
Hours
Fraction
Remaining
0
1.000
7
0.445
1
0.891
8
0.397
2
0.794
9
0.354
3
0.707
10
0.315
4
0.630
11
0.281
5
0.561
12
0.250
6
0.500
EXTERNAL RADIATION
The specific gamma ray constant for technetium-99m is 0.19 mGy/MBq-h
at 1 cm. The first half value thickness of lead (Pb) for
technetium-99m is
0.2 mm. Attenuation by lead is given in Table 3.
Table 3. Radiation Attenuation by Lead Shielding
Shield Thickness mm Pb
Coefficient of
Attenuation
0.95
0.1
1.8
0.01
2.7
0.001
3.6
0.0001
PHARMACOLOGY
Technetium[
99m
Tc] succimer exhibits insignificant glomerul
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