RADPHARM DIDA 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
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Active ingredient:
etifenin, Quantity: 20 mg; stannous chloride, Quantity: 0.42 mg
Available from:
Global Medical Solutions Australia Pty Limited T/A Radpharm Scientific
INN (International Name):
Etifenin,stannous chloride
Pharmaceutical form:
Injection, powder for
Composition:
Excipient Ingredients:
Administration route:
Intravenous
Units in package:
5mL x 5
Prescription type:
Not scheduled. Not considered by committee
Therapeutic indications:
INDICATIONS AS AT 25 SEPTEMBER 1996: Technetium (99mTc) etifenin may be used as a hepatobiliary imaging pharmaceutical.
Product summary:
Visual Identification: 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:
Licence status A
Authorization date:
1991-09-05
Patient Information leaflet
STORAGE AND EXPIRY
The DIDA Radpharm vials must be stored at 2
o
C to 8
o
C (Refrigerate. Do not
freeze.) Expiry is 12 months from the date of manufacture. The expiry
date is
stated on the vial and carton.
MANUFACTURER
This product is manufactured by Radpharm Scientific, Unit 3 Oatley
Lane
Belconnen, 2617 ACT Australia.
Approved by TGA September 1996
L3.0
DIDA RADPHARM
KIT FOR THE PREPARATION OF TECHNETIUM [
99M
TC] ETIFENIN INJECTION FOR
HEPATOBILIARY IMAGING
PRODUCT HEPATO 1986/1
AUST R 14329
RADPHARM SCIENTIFIC
PO BOX 223
KIPPAX ACT 2615 AUSTRALIA
TELEPHONE 61 6 251 6533
FACSIMILE 61 6 253 3325
RADPHARM
SCIENTIFIC
DIDA RADPHARM
KIT FOR THE PREPARATION OF TECHNETIUM [
99M
TC] ETIFENIN INJECTION FOR
HEPATOBILIARY IMAGING
PRODUCT DATA
AUST R 14329
DESCRIPTION
This Kit consists of sterile, pyrogen free lypohilised ingredients
which need
reconstitution with sodium pertechnetate [
99m
Tc] injection to produce a
technetium [
99m
Tc] etifenin complex suitable for hepatobiliary imaging.
The precise structure of the technetium [
99m
Tc] etifenin complex is not known at
this time. Technetium [
99m
Tc] etifenin is a diagnostic pharmaceutical
administered by intravenous injection.
CONTENTS AND PRESENTATION
DIDA Radpharm is supplied as a carton of 5 sterile, pyrogen free,
vacuum
sealed multidose 5mL vials.
Each vial contains 20mg etifenin
(N[2,6-diethylacetanilide]iminodiacetic acid)
and 0.42 mg tin(II) chloride anhydrous as a lyophilised powder.
This 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 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 Data and Decay
Schemes”,
The Society of Nuclear Medicine Inc. New York, 1989.
Table 2. Physical Decay chart for Techn
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