RADPHARM

Main information

  • Trade name:
  • RADPHARM DIDA powder for injection
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • RADPHARM DIDA powder for injection
    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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Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-gu

Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-gu

Opinion/decision on a Paediatric investigation plan (PIP): ( 2R)-2-Amino-1-[3-( {2-[p-( 4-{3-[ (3,S-diamino-6-chloro-2-pyrazinyl)ca rbonyl ]guanidino }butyl )phenoxy ]ethyl}{ 3-[ ( 2R)-2-am ino-6-guanidinohexanoyla mino] propyl }amino )propylamino ]-6-guanidino-1-hexanone hexahydrochloride, decision type: , therapeutic area: , PIP number: P/0134/2018

Europe - EMA - European Medicines Agency

28-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Opinion/decision on a Paediatric investigation plan (PIP): naloxone (hydrochloride), decision type: , therapeutic area: , PIP number: P/0146/2018

Europe - EMA - European Medicines Agency

27-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): Fibrinogen,thrombin,aprotinin,calcium chloride, decision type: , therapeutic area: , PIP number: P/0199/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fibrinogen,thrombin,aprotinin,calcium chloride, decision type: , therapeutic area: , PIP number: P/0199/2018

Opinion/decision on a Paediatric investigation plan (PIP): Fibrinogen,thrombin,aprotinin,calcium chloride, decision type: , therapeutic area: , PIP number: P/0199/2018

Europe - EMA - European Medicines Agency

27-11-2018


Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Opinion/decision on a Paediatric investigation plan (PIP): (R)-2-amino-3-phenylpropylcarbamate hydrochloride (solriamfetol), decision type: , therapeutic area: , PIP number: P/0207/2018

Europe - EMA - European Medicines Agency

26-11-2018

Wakix (Bioprojet Pharma)

Wakix (Bioprojet Pharma)

Wakix (Active substance: Pitolisant hydrochloride) - Centralised - Yearly update - Commission Decision (2018)7974 of Mon, 26 Nov 2018

Europe -DG Health and Food Safety

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:

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 (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 (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 (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 (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 (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 (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 (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

10-8-2018

Brinavess (Correvio)

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 (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 (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 (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 (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 (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