Consumer medicine information

Radpharm Leucocyte Labelling Kit

Technetium (99mTc) labelled leucocytes

BRAND INFORMATION

Brand name

Radpharm Leucocyte Labelling Kit

Active ingredient

Technetium (99mTc) labelled leucocytes

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Radpharm Leucocyte Labelling Kit.

SUMMARY CMI

RADPHARM LEUCOCYTE LABELLING KIT

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 LEUCOCYTE LABELLING KIT?

RADPHARM LEUCOCYTE LABELLING KIT contains the active ingredient Sodium Fluoride. RADPHARM LEUCOCYTE LABELLING KIT is used to image acute inflammation or infection.

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

2. What should I know before I use RADPHARM LEUCOCYTE LABELLING KIT?

Do not use if you have ever had an allergic reaction to RADPHARM LEUCOCYTE LABELLING KIT 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 become pregnant or are breastfeeding.

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

3. What if I am taking other medicines?

Some medicines may interfere with RADPHARM LEUCOCYTE LABELLING KIT 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 LEUCOCYTE LABELLING KIT?

  • Your doctor or health care provider will decide how much RADPHARM LEUCOCYTE LABELLING KIT 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 LEUCOCYTE LABELLING KIT? in the full CMI.

5. What should I know while using RADPHARM LEUCOCYTE LABELLING KIT?

Things you should do
  • Inform your doctor or health care provider immediately if you do not feel well during the injection or after being given RADPHARM LEUCOCYTE LABELLING KIT.
Things you should not do
  • Do not take any other medicines until advised by your doctor
Driving or using machines
  • Do not drive or operate machinery until you know how RADPHARM LEUCOCYTE LABELLING KIT affects you.

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

6. Are there any side effects?

Reported side effects of RADPHARM LEUCOCYTE LABELLING KIT include Hypersensitivity reactions with technetium (99mTc) preparations.

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 LEUCOCYTE LABELLING KIT

Active ingredient(s): sodium fluoride

Consumer Medicine Information (CMI)

This leaflet provides important information about using RADPHARM LEUCOCYTE LABELLING KIT. 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 LEUCOCYTE LABELLING KIT.

Where to find information in this leaflet:

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

1. Why am I using RADPHARM LEUCOCYTE LABELLING KIT?

RADPHARM LEUCOCYTE LABELLING KIT contains the active ingredient Sodium Fluoride. RADPHARM LEUCOCYTE LABELLING KIT 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 LEUCOCYTE LABELLING KIT is mixed with an imaging agent Technetium (99mTc) before injection to image areas of inflammation or infection that may be present.

The imaging agent used is a radiotracer called Technetium-99m. Technetium-99m emits small amounts of radiation similar to X-rays. A special camera, called a gamma camera, can detect this radiation and produces an image known as a scan. A nuclear medicine specialist interprets these scans and provides you with information related to your referral that otherwise may not be known or seen on plain X-rays.

Your doctor may have prescribed RADPHARM LEUCOCYTE LABELLING KIT for another purpose. Ask your doctor if you have any questions about why RADPHARM LEUCOCYTE LABELLING KIT 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 LEUCOCYTE LABELLING KIT?

Warnings

Do not use RADPHARM LEUCOCYTE LABELLING KIT if:

  • you are allergic to sodium fluoride, 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

Tell your doctor if you are pregnant or intend to become pregnant. It is not known whether the injection is harmful to an unborn baby when administered to a pregnant woman. If you are pregnant, the nuclear medicine specialist will need to talk to your referring doctor before deciding whether you should have the injection.

Talk to your doctor if you are breastfeeding or intend to breastfeed. Suspend breast-feeding for not less than 12 hours after your nuclear medicine scan. Express milk prior to your scan and store it. Discard breast milk expressed after your scan for at least 12 hours. It is known that Technetium-99m passes into breast milk. Ask your nuclear medicine technologist to confirm how long you should suspend breast-feeding.

Restrict your contact with your baby to no more than 5 hours in the next 24 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 LEUCOCYTE LABELLING KIT.

4. How do I use RADPHARM LEUCOCYTE LABELLING KIT?

How much to take / use

  • Your doctor will decide how much you will be given RADPHARM LEUCOCYTE LABELLING KIT. This depends on your condition and other factors, such as weight.

When to take / use RADPHARM LEUCOCYTE LABELLING KIT

  • RADPHARM LEUCOCYTE LABELLING KIT will only be given to you by by qualified staff with specific training in the safe use and handling of radiopharmaceuticals.
  • Approx 20mLs of blood is taken from your arm. You may feel a pin prick from the needle when it is inserted. This blood is then combined with the LLK Radpharm and mixed for one hour. The blood is then reinjected into a vein in your arm.
  • Depending on your condition you may require multiple scans to help establish clear images to make an accurate diagnosis. The scan is painless and may take up to an hour.

If you use too much RADPHARM LEUCOCYTE LABELLING KIT

If you think that you have been given too much RADPHARM LEUCOCYTE LABELLING KIT, 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 LEUCOCYTE LABELLING KIT?

Things you should do

Call your doctor straight away if you do not feel well during the injection or after being given RADPARM LEUCOCYTE LABELLING KIT.

Drink plenty of fluids, and pass urine frequently, following the scan to help flush the agent from your body.

Things you should not do

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

Driving or using machines

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

Do not drive or operate machinery until you know how RADPHARM LEUCOCYTE LABELLING KIT affects you.

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

Less serious side effectsWhat to do
Hypersensitive reactionsSpeak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
  • No serious side effects reported currently.
N/A

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 practitioner.

What RADPHARM LEUCOCYTE LABELLING KIT contains

Active ingredient
(main ingredient)		Sodium Fluoride
Other ingredients
(inactive ingredients)		Stannous Fluoride, Water for Injections
Potential allergensNone

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

This product contains no preservatives.

What RADPHARM LEUCOCYTE LABELLING KIT looks like

RADPHARM LEUCOCYTE LABELLING KIT is available to your healthcare practitioner or doctor as a composite kit which contains two vials described below:

a) Vial A - clear concentrated liquid for Intravenous Injection in 10 mL vials.

b) Vial B - dry while lyophilized powder in multi-dose 8 mL vacuum sealed vials for intravenous injection.

The Australian Register Number for RADPHARM LEUCOCYTE LABELLING KIT is 14333.

Who distributes RADPHARM LEUCOCYTE LABELLING KIT

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

This leaflet was prepared in 08/2022.

Published by MIMS April 2023

BRAND INFORMATION

Brand name

Radpharm Leucocyte Labelling Kit

Active ingredient

Technetium (99mTc) labelled leucocytes

Schedule

Unscheduled

 

1 Name of Medicine

Sodium fluoride.

2 Qualitative and Quantitative Composition

Radpharm LLK Kit consists of sterile, pyrogen free ingredients which need reconstitution with sodium pertechnetate [99mTc] injection and mixing to produce technetium [99mTc] stannous colloid complex suitable for labelling white blood cells in whole blood.
Each Vial A (solution) and Vial B (lyophilised) contains the following active ingredient and excipient:

Vial A.

6 mL solution of 1 mg/mL sodium fluoride (active ingredient) in Water for Injections BP (excipient).

Vial B.

0.64 mg of stannous fluoride (excipient) as a lyophilised powder.
The product contains no preservatives.

3 Pharmaceutical Form

Radpharm LLK is a composite kit consists of:

Vial A.

Clear concentrated liquid for Intravenous Injection in 10 mL vials.

Vial B.

Dry white lyophilised powder in multidose 8 mL vacuum sealed vials for intravenous injection.

4 Clinical Particulars

4.1 Therapeutic Indications

Technetium [99mTc] labelled leucocytes may be used to image acute inflammation or infection.

4.2 Dose and Method of Administration

Recommended intravenous dose for the normal adult is 400 to 600 MBq.

Radiation dosimetry.

See Table 1.

Heparin preparation.

Aseptically transfer 5 mL of heparin sodium (1000 units/mL) to 45 mL sodium chloride injection and mix. Final heparin sodium concentration is 100 units/mL.

Procedure.

Colloid preparation.

Note.

If there is no vacuum in Vial B, discard and replace before delivering 5 mL from Vial A.
1. Draw 1.5 to 2 GBq sodium pertechnetate [99mTc] injection eluted from a technetium-99m generator into a 5 mL syringe and then draw sodium chloride injection to make a volume of 2.5 mL.
2. Draw 5 mL from Vial A into a syringe and transfer to Vial B. Mix for 20 seconds to dissolve.
3. Aseptically withdraw 1 to 2 mL of this solution into a 2.5 mL syringe and then transfer 0.5 mL via a 0.22 micrometer membrane filter into the syringe containing 2.5 mL sodium pertechnetate [99mTc] injection (step 1 Colloid preparation).

Note.

Filter has void volume of 0.5 mL.
4. Mix by slow rotation for 1 hour to produce ideal technetium [99mTc] stannous colloid integrity and size.
5. Use within 1 hour after mixing.

Summary.

1.5 to 2 GBq sodium pertechnetate [99mTc] injection to 2.5 mL with sodium chloride injection.
5 mL from Vial A ----> Vial B.
Mix to reconstitute for 20 seconds.
0.5 mL from Vial B (via 0.22 micrometer filter) ------> 2.5 mL sodium pertechnetate [99mTc] injection.
Mix by rotation for 1 hour.
After mixing use within 1 hour.
Leucocyte labelling procedure. 1. Draw 20 mL blood into syringe containing 100 units of heparin sodium.
2. Transfer 1.5 mL technetium [99mTc] stannous colloid (Step 4 Colloid Preparation) to 20 mL blood. Mix by rotation for 1 hour.
3. Transfer to sterile 50 mL centrifuge tube.
4. Centrifuge at 400 g (approx. 2000 rpm) for 5 minutes.

Note.

The buffy coat between plasma and red blood cells must be observed.
5. Remove plasma to 1 cm of buffy coat making sure not to disturb cells.
6. Add sufficient sodium chloride injection to replace plasma, mix by inversion and reinject blood.

4.3 Contraindications

None known.

4.4 Special Warnings and Precautions for Use

Clinical.

As there is significant liver/spleen uptake of technetium [99mTc] labelled leucocytes and residual technetium [99mTc] stannous colloid, determination of sites causing fever of unknown origin is not recommended.

General.

Radiopharmaceuticals should only be used by physicians who are qualified by specific training in the safe use and handling of radionuclides.
The contents of the Vial A and B are intended only for use in the preparation of technetium [99mTc] labelled leucocytes.
The radioactivity of the dose should be checked with a suitable instrument immediately prior to administration.

Use in the elderly.

No data available.

Paediatric use.

No data available.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

None known.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category C)
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.
 Technetium-99m is excreted in human milk. It is recommended that interruption to breast feeding is necessary after the administration of technetium [99mTc] labelled leucocytes for a period of not less than 12 hours and contact with the baby should be restricted to 5 hours in 24 hours.

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.
Hypersensitivity reactions have been reported with technetium [99mTc] preparations.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

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.

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 Tables 2 and 3.

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 4.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Technetium [99mTc] labelled leucocytes radiolabels neutrophils and monocytes by phagocytic engulfment of the radiocolloid. The radiocolloid is administered to autologous whole blood, rotated and incubated at room temperature for 1 hour, with a resultant mean labelling efficiency of 85.2% (neutrophils 62.6% and monocytes 22.6%).

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

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 LLK composite 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 slow rotation for 1 hour (step 4 in Colloid preparation) the technetium [99mTc] stannous colloid is stable at room temperature for 1 hour.

6.4 Special Precautions for Storage

Vial A and Vial B must be stored at 2°C to 8°C (Refrigerate. Do not freeze).

6.5 Nature and Contents of Container

Radpharm LLK composite kit is supplied in Vial A and Vial B.
a) Vial A is supplied as a carton of 5 sterile, pyrogen free 10 mL vials glass Type 1 clear vials with grey chlorobutyl non-lyophilisation stopper and aluminium seal with dark grey flip off.
b) Vial B is supplied as a carton of 5 sterile, pyrogen free, vacuum sealed 8 mL Type 1 coloured glass vials with 1888 grey chlorobutyl lyophilisation stopper and aluminium seal with light grey 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.


Chemical Formula: FNa.

CAS number.

7681-49-4.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes