RADPHARM

Main information

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

Documents

Localization

  • Available in:
  • RADPHARM DMSA powder for injection
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 14326
  • Last update:
  • 02-12-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

14326

RADPHARM DMSA kit for the production of Technetium (99mTc) succimer 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 DMSA powder for injection

Product Type

Single Medicine Product

Effective date

19/12/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific 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.

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

Do not Freeze

Refrigerate

Pack Size/Poison information

Pack Size

Poison Schedule

5x8mL vials

Not scheduled. Not considered by committee

Components

1. Medicine Component

Dosage Form

Injection, powder for

Route of Administration

Intravenous

Visual Identification

Lyophilised white powder

Active Ingredients

Succimer

1 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 11:50:14 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

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[

Tc] injection to produce a

technetium[

Tc] succimer complex suitable for renal imaging.

The precise structure of the technetium[

Tc] succimer complex is

not known at this time.

Technetium[

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

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

Technetium[

Tc] succimer exhibits insignificant glomerular filtration but

is tubularly secreted with tubular binding in the renal cortex. It binds to

receptors in microsomes of proximal tubular cells. Renal clearance is slow

(10% in 1st hour) with 15% uptake in liver and 40 to 50% uptake in kidneys

at 3 hours. Plasma clearance is triexponential with half-lives of 40 minutes,

2.1 hours and 6 days.

INDICATIONS

Technetium[

Tc] succimer may be used as a static renal imaging

pharmaceutical and is particularly suited for evaluation of renal cortex,

delineation of renal space occupying lesions, determination of intrarenal

function distribution and identification of ectopic renal sites.

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 are intended only for use in the preparation of technetium[

succimer.

The radioactivity 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] succimer (a mother can be

reassured by advising an interruption of 4hr). (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.

Occasional “allergic reactions” have been reported in literature although to

date these have been inadequately described.

DOSAGE AND ADMINISTRATION

Recommended intravenous dose for the normal adult is 60-80 MBq.

Recommended normal child maximum dose is 30 MBq.

Radiation Dosimetry

Table 4. Estimated Absorbed Dose from Intravenous Administration of

Technetium[

Tc] Succimer

Organ

mGy/MBq

Adult

15 year

10 year

5 year

1 year

Adrenals

1.3E-02

1.6E-02

2.4E-02

3.5E-02

6.0E-02

Bladder wall

1.9E-02

2.4E-02

3.5E-02

5.1E-02

9.4E-02

Bone surfaces

3.5E-03

4.3E-03

6.4E-03

9.9E-03

1.2E-02

Breast

1.8E-03

1.8E-03

2.8E-03

4.5E-03

8.4E-03

GI-tract

Stomach

wall

5.5E-03

6.3E-03

9.8E-03

1.3E-02

2.0E-02

Small

intestine

5.2E-03

6.4E-03

1.0E-02

1.5E-02

2.5E-02

ULI wall

5.1E-03

6.3E-03

9.6E-03

1.4E-02

2.3E-02

LLI wall

3.2E-03

4.2E-03

6.7E-03

1.0E-02

1.8E-02

Kidneys

1.7E-01

2.1E-01

2.9E-01

4.2E-01

7.3E-01

Liver

9.7E-03

1.2E-02

1.8E-02

2.5E-02

4.1E-02

Lungs

2.5E-03

3.5E-03

5.2E-03

8.0E-03

1.4E-02

Ovaries

3.7E-03

4.6E-03

7.2E-03

1.1E-02

2.0E-02

Pancreas

9.0E-03

1.1E-02

1.6E-02

2.3E-02

3.7E-02

Red marrow

6.3E-03

7.5E-03

1.0E-02

1.4E-02

2.0E-02

Spleen

1.3E-02

1.7E-02

2.6E-02

3.8E-02

6.1E-02

Testes

1.8E-03

2.4E-03

3.9E-03

6.2E-03

1.2E-02

Thyroid

1.1E-03

1.9E-03

3.1E-03

5.1E-03

9.2E-03

Uterus

4.6E-03

5.5E-03

8.9E-03

1.3E-02

2.3E-02

Other tissue

3.0E-03

3.6E-03

5.2E-03

8.0E-03

1.4E-02

Effective Doses

(mSv/MBq):

8.7E-03

1.1E-02

1.6E-02

2.3E-02

4.0E-02

Reference for Estimated Absorbed Dose: ICRP Publication 53, Radiation

Dose To Patients from Radiopharmaceuticals (1987).

The Effective Doses have been calculated using the weighting factors

given

ICRP

Publication

1990

Recommendations

International

Commission on Radiological Protection (1991).

Procedure

NOTE: If there is no vacuum, discard vial and do not deliver the sodium

pertechnetate[

Tc] injection.

Place DMSA Radpharm vial in shielding container.

Draw a suitable volume (2-5 mL) of sodium pertechnetate[

injection eluted from a technetium-99m generator, (up to 1.5 GBq), and

inject into the DMSA Radpharm vial. Mix by slow 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.

This technetium[

Tc] succimer solution is stable at room temperature

and may be used up to 6 hours after preparation.

Stability after Reconstitution with Technetium-99m

After reconstitution of DMSA Radpharm with sodium pertechnetate[

injection, (up to 1.5 GBq), the technetium[

Tc] succimer complex is stable

at room temperature for 6 hours.

STORAGE AND EXPIRY

The DMSA 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, 54 - 59 Oatley Court,

Belconnen, 2617 ACT Australia.

Approved by TGA 20 September 2006

L4.2

DMSA Radpharm

Kit for the Preparation of Technetium[

99m

Tc] Succimer Injection for

Renal imaging

Product DMS 1987/1

AUST R 14326

Radpharm Scientific

PO Box 3334 BMDC

Belconnen ACT 2617 AUSTRALIA

Telephone 61 2 6251 6533

Facsimile 61 2 6253 3325

E-mail info@radpharm.com.au

Homepage: http://www.radpharm.com.au