Consumer medicine information

What is in this leaflet?

This leaflet answers some common questions about DRAXIMAGE MACROSALB®. It does not contain all the available information, nor does it take the place of talking to your doctor or treatment provider.

All medicines and diagnostic preparations have risks and benefits. Your doctor has weighed the risks of you receiving DRAXIMAGE MACROSALB® against the expected benefits.

If you have any concerns about being given DRAXIMAGE MACROSALB®, ask your doctor or treatment provider.

Keep this leaflet. You may need to refer to it again.

What DRAXIMAGE MACROSALB® is used for

DRAXIMAGE MACROSALB® is for diagnostic use only.

It is used in the preparation of a radiopharmaceutical, which is a medicinal product containing a small amount of radioactivity.

Such radiopharmaceuticals are given in small amounts to find or rule out a disease. The radiation your body receives is very low and is considered safe. After the radioactive liquid is given to you, it is taken up by the organs of interest or just passes through your body. The radiation is captured by a special camera and pictures are prepared. These pictures allow the nuclear medicine doctor to detect any problems.

DRAXIMAGE MACROSALB® can be used for lung scans. These scans provide information about the structure of the lungs and the blood flow through the lung tissue.

DRAXIMAGE MACROSALB® can also be used to show how the blood flows through the veins.

Your doctor will tell you which specific investigation DRAXIMAGE MACROSALB® will be used for in your case.

Before you are given DRAXIMAGE MACROSALB®

When you must not be given DRAXIMAGE MACROSALB®

Do not use DRAXIMAGE MACROSALB® if you are allergic (hypersensitive) to macroaggregated albumin or any of the ingredients of DRAXIMAGE MACROSALB® listed at the end of this leaflet, or if you have severe pulmonary hypertension (unusually high blood pressure in the arteries of the lungs). The literature contains reports of deaths after the administration of aggregated albumin to patients with preexisting severe pulmonary hypertension. In case of doubt, it is important to consult your doctor.

Before you are given DRAXIMAGE MACROSALB®

Your doctor must know about all of the following before you are given DRAXIMAGE MACROSALB®. Tell your doctor if you:

1. Are pregnant:

The use of radiopharmaceuticals during pregnancy should be considered carefully. Your doctor will only administer this product during pregnancy if a benefit is expected which should outweigh the risks.

2. Are breastfeeding:

Your doctor may advise you to interrupt breastfeeding after the procedure for a period of at least 12 hours and to discard expressed milk during that time. Breastfeeding may be resumed after the prescribed period.

Taking other medicines

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

Your doctor or treatment provider has more information on medicines to be careful with or to avoid when you are given DRAXIMAGE MACROSALB®

If you have not told your doctor about any of the above, tell them before you are given any DRAXIMAGE MACROSALB®

About blood products

This product contains albumin, a derivative of human blood. When medicines are made from human blood or plasma, measures are put in place to prevent infection transmission. Despite this, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.

There are no reports of virus transmissions with albumin manufactured to European Pharmacopoeia specifications by established processes.

How DRAXIMAGE MACROSALB® is given

Your doctor may have special instructions for you to follow to get ready for your procedure.

DRAXIMAGE MACROSALB® is given as an injection into a vein.

DRAXIMAGE MACROSALB® must only be given by a doctor or nuclear medicine technologist. Your doctor is qualified in nuclear medicine and will decide what dose of DRAXIMAGE MACROSALB® you will receive, depending on your condition. The amount of radioactivity you will receive can vary from 37 to 148 MBq (Mega Becquerel, the unit used to express radioactivity).

DRAXIMAGE MACROSALB® is usually given as a single dose and, within minutes after it is given, diagnostic images will be taken.

If you have any questions about taking DRAXIMAGE MACROSALB® or about the diagnostic procedure, ask your doctor.

After being given DRAXIMAGE MACROSALB®

Your doctor may advise you to drink a lot to help the traces of radioactivity leave your body more quickly. This is normal when using diagnostic radiopharmaceuticals. Your doctor will also tell you about any other steps you may need to take following the use of this product.

Do not hesitate to consult your doctor if you are not sure.

Side Effects

Like all medicines, DRAXIMAGE MACROSALB® may cause side effects, although not everybody gets them. Most people have no side effects.

A very small number of patients have experienced allergic reactions such as urticaria (hives or red raised itchy bumps on the skin), nausea and reddening of the face. Local injection site reactions in the form of redness, swelling and itching have also been observed.

Other side effects may include fever, shivering, seizures, sweating, as well as impairments of cardiorespiratory and circulatory functions in the form of changes in respiration, pulse, low blood pressure and fainting.

Importantly, if any side effects gets serious or when in doubt, seek prompt medical attention. If treated immediately, reactions were short-lived.

If you notice side effects not listed in this leaflet, it is important that you speak to your doctor or pharmacist.

Overdose

The dose of DRAXIMAGE MACROSALB® you will receive will be calculated by a qualified nuclear medicine doctor and given to you in a highly specialized setting. Therefore the possibility of overdose is minimal.

Storage

DRAXIMAGE MACROSALB® will be stored by the hospital or clinic.

The hospital or clinic will make sure that DRAXIMAGE MACROSALB® is not used if the expiry date printed on the pack has passed.

Further information

This is not all information that is available on DRAXIMAGE MACROSALB®. If you have any more questions or are not sure about anything, ask your doctor or nuclear medicine technologist.

Product description

What it looks like

DRAXIMAGE MACROSALB® is a white powder. It comes in a 10 mL glass vial.

Ingredients

The active substance is a natural protein from human blood: albumin aggregated.

Each reaction vial contains:

• 2.5 mg of albumin aggregated
• 5.0 mg of albumin
• 0.1 mg of stannous chloride dehydrate
• 1.2 mg of sodium chloride

Australian Registration Number

AUST R315902

Sponsor

DRAXIMAGE MACROSALB® is

Jubilant Pharma Australia PTY Limited
Freshwater Place
Level 13, 2 Southbank
Boulevard,
Southbank, VIC, 3006 Australia

DRAXIMAGE MACROSALB® is distributed in Australia by:

Distributor:
Australian Nuclear Science and Technology Organisation
New Illawarra Road, Lucas
Heights,
New South Wales 2234
Australia
+61 2 9717 3111

This leaflet was prepared in April 2020.

DRAXIMAGE MACROSALB® is a registered trademark of Jubilant DraxImage Inc.

Published by MIMS January 2021

Notes

Distributed by Australian Nuclear Science and Technology Organisation

1 Name of Medicine

Albumin Aggregated.

2 Qualitative and Quantitative Composition

The kit consists of reaction vials which contain the sterile, non-pyrogenic, non-radioactive ingredients necessary to produce Technetium Tc 99m Albumin Aggregated Injection for diagnostic use by intravenous injection.
Each 10 mL reaction vial contains 2.5 mg of albumin aggregated, 5 mg of albumin, 0.06 mg (minimum) stannous chloride (maximum stannous and stannic chloride 0.11 mg) and 1.2 mg of sodium chloride; the contents are in a lyophilized form under an atmosphere of nitrogen. Sodium hydroxide or hydrochloric acid has been used for pH adjustment. No bacteriostatic preservative is present.
The albumin was non-reactive when tested for Hepatitis B Surface Antigen (HBsAg), antibodies to Human Immunodeficiency Virus (HIV-1/HIV-2), antibody to Hepatitis C Virus (anti-HCV) and Antigen to Human Immunodeficiency Virus (HIV-1). The aggregated particles are formed by denaturation of the albumin in a heating and aggregation process. Each vial contains 3 to 8 million particles. By light microscopy, more than 90% of the particles are between 10 and 70 micrometers, while the typical average size is 20 to 40 micrometers; none is greater than 150 micrometers.
Technetium Tc 99m Albumin Aggregated Injection for intravenous use is in its final dosage form when a sterile isotonic sodium pertechnetate solution is added to the vial (The radioisotope is not part of the kit). No less than 90% of the pertechnetate Tc-99m added to a reaction vial is bound to aggregate at preparation time and remains bound throughout the usage lifetime of the preparation (see Section 4.2 Dose and Method of Administration, Directions for preparation).

3 Pharmaceutical Form

Kit for the Preparation of Technetium Tc 99m Albumin Aggregated Injection - Diagnostic - For Intravenous and Intraperitoneal Use.

4 Clinical Particulars

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical Structure and CAS Number are unidentified.
Technetium Tc-99m decays by isomeric transition with a physical half-life of 6.02 hours. The principal photon that is useful for detection and imaging studies is listed in Table 5.
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/DRAMAC05.gif External radiation. The specific gamma ray constant for technetium Tc-99m is 0.78 R/mCi-hr at 1 cm.
The first half value layer is 0.017 cm of lead. A range of values for the relative attenuation of the radiation resulting from the interposition of various thicknesses of lead is shown in Table 6. For example, the use of 0.25 cm thickness of lead will attenuate the radiation emitted by a factor of about 1,000.
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/DRAMAC06.gif To correct for physical decay of this radionuclide, the fractions that remain at selected intervals after the time of calibration are shown in Table 7.
https://stagingapi.mims.com/au/public/v2/images/fulltablegif/DRAMAC07.gif

7 Medicine Schedule (Poisons Standard)

Not scheduled.