SUMMARY CMI

RADPHARM DTPA kit for production of Technetium (99mTc) pentetate powder for injection multidose vial

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using RADPHARM DTPA?

RADPHARM DTPA contains the active ingredient Pentetic acid. RADPHARM DTPA after mixing with Technetium (99mTc) is used in renal perfusion imaging.

For more information, see Section 1. Why am I using RADPHARM DTPA? in the full CMI.

2. What should I know before I use RADPHARM DTPA?

Do not use if you have ever had an allergic reaction to RADPHARM DTPA or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to becomepregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use RADPHARM DTPA? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with RADPHARM DTPA and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use RADPHARM DTPA?

• Your doctor or health care provider will decide how much RADPHARM DTPA you will be given. This depends on your condition and other factors, such a weight

More instructions can be found in Section 4. How do I use RADPHARM DTPA? in the full CMI.

5. What should I know while using RADPHARM DTPA?

For more information, see Section 5. What should I know while using RADPHARM DTPA? in the full CMI.

6. Are there any side effects?

Reported side effects of RADPHARM DTPA include, flushing, dizziness, dyspnoea (difficult or laboured breathing), itch, urticarial (hives), and hypotension (low blood pressure).

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

RADPHARM DTPA kit for production of Technetium (99mTc) pentetate powder for injection multidose vial

Active ingredient(s): Pentetic acid

Consumer Medicine Information (CMI)

This leaflet provides important information about using RADPHARM DTPA. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using RADPHARM DTPA.

Where to find information in this leaflet:

1. Why am I using RADPHARM DTPA?
2. What should I know before I use RADPHARM DTPA?
3. What if I am taking other medicines?
4. How do I use RADPHARM DTPA?
5. What should I know while using RADPHARM DTPA?
6. Are there any side effects?
7. Product details

1. Why am I using RADPHARM DTPA?

RADPHARM DTPA contains the active ingredient Pentetic acid. RADPHARM DTPA is a prescription medicine which is only available to the Healthcare Practitioners for diagnostic use only. It belongs to a group of medicines called radiopharmaceutical agents, which are radioactive. It is administered to you via intravenous injection after mixing with a radioactive solution.

RADPHARM DTPA is mixed with Technetium (99mTc) before injection. RADPHARM DTPA is used to image renal perfusion.

Your doctor may have prescribed RADPHARM DTPA for another purpose. Ask your doctor if you have any questions about why RADPHARM DTPA has been prescribed for you. If you have any concerns, you should discuss these with your doctor.

2. What should I know before I use RADPHARM DTPA?

Warnings

Do not use RADPHARM DTPA if:

• you are allergic to Pentetic acid, or any of the ingredients listed at the end of this leaflet.
• Always check the ingredients to make sure you can use this medicine.

Check with your doctor if you:

• have any other medical conditions
• Take any medicines for any other condition including medicines that you buy without a prescription from the pharmacy, supermarket or health food shop.
• Have any allergies to ingredients listed at the end of this leaflet or any other substances such as foods, preservatives or dyes.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant. Like most medicines, RADPHARM DTPA is not recommended for use during pregnancy. If there is a need to consider RADPHARM DTPA during your pregnancy, your doctor will discuss the benefits and risks of giving it to you

Talk to your doctor if you are breastfeeding or intend to breastfeed. Do not breast feed after the administration of RADPHARM DTPA for a period no less than 12 hours.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect RADPHARM DTPA.

4. How do I use RADPHARM DTPA?

How much to take / use

• Your doctor will decide how much you will be given RAPDHARM DTPA. This depends on your condition and other factors, such as weight.

When to take / use RADPHARM DTPA

• RAPDHARM DTPA will only be given to you by a doctor or licensed health care practitioner. They will decide when you will be given RAPDHARM DTPA.

If you use too much RADPHARM DTPA

If you think that you have been given too much RADPHARM DTPA, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using RADPHARM DTPA?

Things you should do

Call your doctor straight away if you do not feel well during the injection or after being given RADPHARM DTPA

Driving or using machines

Be careful before you drive or use any machines or tools until you know how RADPHARM DTPA affects you.

RADPHARM DTPA may cause dizziness in some people. Make sure you know how you react to RADPHARM DTPA before you drive a car, operate machinery or do anything else that could be dangerous if you are dizzy.

Do not drive or operate machinery until you know how RADPHARD affects you.

Things you should not do

Do not take any other medicines until advised by your doctor.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Serious side effects

Do not be alarmed by this list of side effects. You may not experience any of them.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription and only made available to your doctor or healthcare provider.

What RADPHARM DTPA contains

Do not take this medicine if you are allergic to any of these ingredients.

What RADPHARM DTPA looks like

RADPHARM DTPA is available as a dry white lyophilised powder in an 8mL vacuum sealed tinted vial (Aust R 14327).

An injection is prepared from the vial immediately before it is administered to you.

Who distributes RADPHARM DTPA

Global Medical Solutions Australia Pty Limited T/A Radpharm Scientific
53-57 Oatley Court, BELCONNEN, ACT 2617 Australia

This leaflet was prepared in 07/2022.

Published by MIMS April 2023

1 Name of Medicine

Pentetic acid.

2 Qualitative and Quantitative Composition

Radpharm DTPA Kit consists of sterile, pyrogen free, lyophilised ingredients which need reconstitution with sodium pertechnetate (^99mTc) injection to produce a technetium [^99mTc] pentetate complex. The precise structure of the technetium [^99mTc] pentetate complex is not known at this time.
Each vial contains the following active ingredient and excipient as a lyophilized powder:

Active ingredient.

Excipient.

3 Pharmaceutical Form

Radpharm DTPA is available as a dry white lyophilised powder in multi-dose 8 mL vacuum sealed vials for intravenous injection.

4 Clinical Particulars

4.1 Therapeutic Indications

Technetium [^99mTc] pentetate may be used as a renal perfusion imaging pharmaceutical.

4.2 Dose and Method of Administration

Recommended intravenous dose for the normal adult is 200 MBq.

Radiation dosimetry.

Procedure.

Note.

4.3 Contraindications

None known.

4.4 Special Warnings and Precautions for Use

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 [^99mTc] pentetate.
The radioactivity of the dose should be checked with a suitable instrument immediately prior to administration.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

None known.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

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.
In isolated cases the following adverse reactions have been reported: flushing, dizziness, dyspnoea, itch, urticaria and hypotension.

Reporting suspected adverse effects.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Physical characteristics of technetium-99m.

External radiation.

Clinical trials.

5.2 Pharmacokinetic Properties

Following intravenous administration of technetium [^99mTc] pentetate to normal patients the radiopharmaceutical is rapidly distributed in the extracellular fluid space then cleared from the body through the kidneys. There is minimal binding to renal parenchyma and it clears the kidneys by glomerular filtration.
The images taken in the first minutes demonstrate kidney vascular pool and subsequent images represent technetium [^99mTc] pentetate in both the collecting system and the renal pelvis.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Section 2 Qualitative and Quantitative Composition.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life of the Radpharm DTPA kit can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the vial and carton packaging.
After reconstitution of Radpharm DTPA with sodium pertechnetate [^99mTc] injection, (1 to 3 GBq), the technetium [^99mTc] pentetate complex is stable at room temperature for 5 hours.

6.4 Special Precautions for Storage

The Radpharm DTPA kit must be stored below 25°C.

6.5 Nature and Contents of Container

Radpharm DTPA kit is supplied as a carton of 5 sterile, pyrogen free, vacuum sealed multidose 8 mL glass Type 1 coloured vials with 1888 grey chlorobutyl lyophilisation stopper and aluminium seal with brown flip off.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or radioactive waste material should be disposed off in accordance with Code for the disposal of radioactive wastes by the user which is published on the Australian Radiation Protection and Nuclear Safety Agency (ARPANSA) website as Radiation Protection Series (RPS C-6).

6.7 Physicochemical Properties

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes