RADPHARM
Main information
- Trade name:
- RADPHARM DIDA powder for injection
- Active ingredient:
- Etifenin,stannous chloride
- INN (International Name):
- Etifenin,stannous chloride
- Medicine domain:
- Humans
- Medicine type:
- Allopathic drug
Documents
- for the general public:
- Patient Information leaflet
-
- for the general public:
- Public Assessment Report
-
- for healthcare professionals:
- The information leaflet for this product is not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain it.
Request the information leaflet for healthcare professionals.
Localization
- Available in:
-
Australia
- Language:
- English
Other information
Status
- Source:
- Dept. of Health,Therapeutic Goods Administration - Australia
- Authorization number:
- 14329
- Last update:
- 02-12-2017
Public Assessment Report
Public Summary
Summary for ARTG Entry:
14329
RADPHARM DIDA kit for the production of Technetium (99mTc) etifenin powder for injection multidose vial
ARTG entry for
Medicine Registered
Sponsor
Global Medical Solutions Australia Pty Limited T/A Radpharm Scientific
Postal Address
PO Box 3334 BMDC,BELCONNEN, ACT, 2617
Australia
ARTG Start Date
5/09/1991
Product category
Medicine
Status
Active
Approval area
Drug Safety Evaluation Branch
Conditions
Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Conditions Applying to Therapeutic Goods
Accepted for Registration or Listing as Goods Currently Supplied at the Commencement of the Therapeutic Goods Act 1989"
Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods
Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.
Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered
or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.
Products
1. RADPHARM DIDA powder for injection
Product Type
Single Medicine Product
Effective date
12/01/2012
Warnings
See Product Information and Consumer Medicine Information for this product
Standard Indications
Specific Indications
INDICATIONS AS AT 25 SEPTEMBER 1996: Technetium (99mTc) etifenin may be used as a hepatobiliary imaging pharmaceutical.
Additional Product information
Container information
Type
Material
Life Time
Temperature
Closure
Conditions
Vial
Glass Type I Coloured 1 Years
Store at 2 to 8
degrees Celsius
Not recorded
Refrigerate
Do not Freeze
Pack Size/Poison information
Pack Size
Poison Schedule
5mL x 5
Not scheduled. Not considered by committee
Components
1. Medicine Component
Dosage Form
Injection, powder for
Route of Administration
Intravenous
Visual Identification
White powder
Active Ingredients
Etifenin
20 mg
stannous chloride
.42 mg
© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior
written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.
Public Summary
Page 1 of
Produced at 02.12.2017 at 11:48:40 AEDT
This is not an ARTG Certificate document.
The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.
Visit www.tga.gov.au for contact information
Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation
STORAGE AND EXPIRY
The DIDA Radpharm vials must be stored at 2
C to 8
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 [
Tc] injection to produce a
technetium [
Tc] etifenin complex suitable for hepatobiliary imaging.
The precise structure of the technetium [
Tc] etifenin complex is not known at
this time. Technetium [
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 Technetium-99m.
Hours
Fraction
Remaining
Hours
Fraction
Remaining
1.000
0.445
0.891
0.397
0.794
0.354
0.707
0.315
0.630
0.281
0.561
0.250
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
0.01
0.001
0.0001
PHARMACOLOGY
Following intravenous administration to normal patients, approximately 90% of
the technetium [
Tc] etifenin is cleared from the blood into the liver with less
than 7% excreted via the renal system. High serum bilirubin levels reduce
blood clearance of technetium[
Tc] etifenin, renal excretion is increased and
kidneys have a prolonged visualisation.
INDICATIONS
Technetium [
Tc] etifenin may be used as a hepatobiliary imaging
pharmaceutical.
CONTRAINDICATIONS
None known.
PRECAUTIONS
General.
Radiopharmaceuticals should be used only by physicians who are qualified by
specific training in the safe use and handling of radionuclides.
Contents of the vial/s are intended only for use in the preparation of
technetium[
Tc] etifenin.
The radioactivicty of the dose should be checked with a suitable instrument
immediately prior to administration.
Disposal of all radioactive wastes should be carried out in accordance with the
NH & MRC “Code of Practice for the Disposal of Radioactive Wastes by the
User” (1985)
Use in Pregnancy
Technetium-99m radiopharmaceuticals should only be given to a pregnant
woman if in the judgement of the treating physician the expected benefits
outweigh the potential hazards.
Use during Lactation
Technetium-99m is excreted in human milk. Interruption to breast feeding is not
essential after the administration of technetium[
Tc] etifenin (a mother can be
reassured by advising an interruption of 4h). (Reference: L.K. Harding, A.
Bossuyt, S. Pellet, C. Reiners, J.N. Talbot, “Recommendations for nuclear
medicine physicians regarding breastfeeding mothers”, Eur. J. Nucl.Med., 1995,
22, BP17).
ADVERSE REACTIONS
For each patient, exposure to ionising radiation must be justifiable on the basis
of likely benefit. The activity administered must be such that the resulting dose
is as low as reasonably achievable bearing in mind the need to obtain the
intended diagnostic or therapeutic result.
Exposure to ionising radiation is linked with cancer induction and a potential for
development of hereditary defects. For diagnostic nuclear medicine
investigations the current evidence suggests that these adverse effects will
occur with low frequency because of the low radiation doses incurred.
For most diagnostic investigations using a nuclear medicine procedure the
radiation dose delivered (EDE) is less than 20 mSv. Higher doses may be
justified in some clinical circumstances.
Adverse reactions have not been reported for this product, to date.
Any suspected adverse reaction should be reported to Adverse Drug Reactions
Advisory Committee (ADRAC) TGA, PO Box 100 WODEN ACT 2606.
Tel. 06 289 8670 Fax: 06 289 7694.
DOSAGE AND ADMINISTRATION
Recommended intravenous dose for the normal adult is 90-260 MBq.
Radiation Dosimetry
Table 4. Estimated Absorbed Dose from Intravenous Administration of
Technetium[99mTc] Etifenin.
Organ
mGy/260MBq
Liver
Gall Bladder wall
Kidneys
Bladder wall
Small Intestine
ULI wall
LLI wall
Testes
0.39
Ovaries
Effective Dose:
3.9 mSv/260MBq
Reference for Estimated Absorbed Dose: ICRP Publication 53, Radiation Dose
To Patients from Radiopharmaceuticals (1987).
Reference for Effective Dose: ICRP Publication 62, Radiological Protection in
Biomedical Research (1993).
Procedure
NOTE: If there is no vacuum, discard vial and do not deliver the sodium
pertechnetate [
Tc] injection.
Place DIDA Radpharm in shielding container.
Draw a suitable volume (2 to 6mL) of sodium pertechnetate[
injection eluted from a technetium-99m generator, (up to 2GBq), and
inject into the DIDA Radpharm vial. Mix by inversion for 20 seconds
and leave standing at room temperature for 10 minutes before use.
Determine the radioactivity per millilitre, label the container and
calculate the patient dose.
The technetium[
Tc] etifenin solution is stable at room
temperature and may be used up to 2 hours after preparation.
Stability after Reconstitution with Technetium-99m
After reconstitution of DIDA Radpharm with sodium pertechnetate[
injection, (up to 2 GBq), the technetium[
Tc] etifenin complex is stable at room
temperature for 2 hours.
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22-11-2018
Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type:
Opinion/decision on a Paediatric investigation plan (PIP): Citric acid (as citric acid anhydrous) / sodium chloride / simeticone / macrogol 4000 / sodium citrate /sodium sulfate (as sodium sulfate anhydrous) / potassium chloride (PMF104), decision type: , therapeutic area: , PIP number: P/0223/2018
Europe - EMA - European Medicines Agency
21-11-2018
EU/3/18/2082 (Takeda Pharma A/S)
EU/3/18/2082 (Active substance: 5-{(1R,2R)-2-[(cyclopropylmethyl)amino]cyclopropyl}-N-(tetrahydro-2H-pyran-4-yl)thiophene-3-carboxamide monohydrochloride) - Orphan designation - Commission Decision (2018)7791 of Wed, 21 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/040/18
Europe -DG Health and Food Safety
13-11-2018
EU/3/17/1836 (Zogenix GmbH)
EU/3/17/1836 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7576 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/233/16/T/01
Europe -DG Health and Food Safety
13-11-2018
EU/3/13/1219 (Zogenix GmbH)
EU/3/13/1219 (Active substance: Fenfluramine hydrochloride) - Transfer of orphan designation - Commission Decision (2018)7575 of Tue, 13 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/140/13/T/01
Europe -DG Health and Food Safety
1-11-2018
Dexdomitor (Orion Corporation)
Dexdomitor (Active substance: dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7380 of Thu, 01 Nov 2018
Europe -DG Health and Food Safety
31-10-2018
Evista (Daiichi Sankyo Europe GmbH)
Evista (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7342 of Wed, 31 Oct 2018
Europe -DG Health and Food Safety
26-9-2018
Sileo (Orion Corporation)
Sileo (Active substance: Dexmedetomidine hydrochloride) - Centralised - Yearly update - Commission Decision (2018)6325 of Wed, 26 Sep 2018
Europe -DG Health and Food Safety
24-9-2018
EndolucinBeta (ITG Isotope Technologies Garching GmbH)
EndolucinBeta (Active substance: Lutetium (177 Lu) chloride) - PSUSA - Modification - Commission Decision (2018)6236 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3999/PSUSA/10391/201712
Europe -DG Health and Food Safety
18-9-2018
Lidocaine hydrochloride / phenylephrine hydrochloride / tropicamide: List of nationally authorised medicinal products - PSUSA/00010390/201801
Europe - EMA - European Medicines Agency
10-9-2018
Phenylephrine hydrochloride / tropicamide: List of nationally authorised medicinal products - PSUSA/00010430/201711
Europe - EMA - European Medicines Agency
10-9-2018
Ciprofloxacin hydrochloride / hydrocortisone: List of nationally authorised medicinal products - PSUSA/00000774/201711
Europe - EMA - European Medicines Agency
10-8-2018
Brinavess (Correvio)
Brinavess (Active substance: vernakalant hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5523 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1215/T/31
Europe -DG Health and Food Safety
30-7-2018
Segluromet (Merck Sharp and Dohme B.V.)
Segluromet (Active substance: ertugliflozin / metformin hydrochloride) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5103 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4314/T/2
Europe -DG Health and Food Safety
30-7-2018
Ceplene (Noventia Pharma Srl)
Ceplene (Active substance: Histamine dihydrochloride) - Centralised - Renewal - Commission Decision (2018)5116 of Mon, 30 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/796/R/36
Europe -DG Health and Food Safety
27-7-2018
EU/3/09/645 (Camurus AB)
EU/3/09/645 (Active substance: Octreotide chloride (lipid depot solution)) - Transfer of orphan designation - Commission Decision (2018)5047 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/09/T/03
Europe -DG Health and Food Safety
23-7-2018
Optruma (Eli Lilly Nederland B.V.)
Optruma (Active substance: Raloxifene hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4893 of Mon, 23 Jul 2018
Europe -DG Health and Food Safety
12-7-2018
Econor (Elanco Europe Ltd)
Econor (Active substance: Valnemulin hydrochloride) - Centralised - Yearly update - Commission Decision (2018)4580 of Thu, 12 Jul 2018
Europe -DG Health and Food Safety