DRN 3633 KryptoScan United Kingdom Page 1 of 2

Package leaflet: Information for the user

KryptoScan™

radionuclide generator

Active substance:⁸¹ Rb Rubidium/ ^81mKr Krypton

Read all of this leaflet carefully before you start using this medicine.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor or pharmacist.

-    If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What KryptoScan is and what it is used for

2.    Before you use KryptoScan

3.    How to use KryptoScan

4.    Possible side effects

5.    How to store KryptoScan

6.    Further information

IWhat KryptoScan is and what it is used « for

This medicine is for diagnostic use only.

KryptoScan is used through a scan to examine the:

• lung function and • blood circulation in the lungs.

This medicine contains a radioactive substance, from which another radioactive substance called ^81mKrypton, can be received. ^81mKrypton collects in the lungs when inhaled.

The radioactive substance can be photographed from outside the body, using special cameras which take a scan. This scan shows the distribution of radioactivity within the organ and body. This also gives the doctor valuable information about the structure and function of that organ,

2. Before you use KryptoScan

Do not use KryptoScan

•    No absolute limitations for use are known.

Take special care with KryptoScan

This medicine does involve treatment with radioactivity. Your doctor will only give you this medicine if the benefit outweighs the risk,

KryptoScan is given by specialists, who will take responsibility for any necessary precautions,

Your doctor will inform you if you need to take any special precautions after using this medicine. Contact your doctor if you have any questions.

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

The following medicines can influence the KryptoScan examination:

•    diazepam, a medicine to tranquiilise and induce sleep

•    general anaesthetics

Pregnancy and breast-feeding

•    Pregnancy

Tell your doctor if you are pregnant or think you could be. Your doctor will only administer KryptoScan during pregnancy if it is absolutely necessary, as it could harm the unborn child.

•    Breast-feeding

Tell your doctor if you are breast-feeding as he may delay treatment until breast-feeding is finished. However, if your doctor considers KryptoScan to be absolutely necessary, breast-feeding need not be interrupted,

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

KryptoScan is unlikely to impair the ability to drive and operate machinery.

3, How to use KryptoScan

KryptoScan will always be used in a hospital or similar setting. It will only be administered to you by qualified people trained to safe handle radioactive material.

Your doctor will decide the KryptoScan amount to be used. The lowest dose possible will be used to produce adequate X-ray images,

The usual dose is:

Approximately 18 MBq per kg body weight per scan. 4 to 6 scans are usually sufficient.

MBq is the unit used to measure radioactivity, and defines the activity of a quantity of radioactive material.

Children under 18 years

Lower doses are used for children.

Method of use

This medicine is inhaled using a face mask or airway. The scans will be made as soon as you begin inhaling. You will be asked to stop inhaling between the different scans, so that the camera may be repositioned. This is necessary to acquire different images.

If you use more KryptoScan than you should

It is unlikely that overdose will occur as this medicine is given under control by a doctor. However, if this happens you only need to move away from the source of the inhalation gas to an area free from radioactivity.

If you have any further questions on the use of this product, ask your

doctor.

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4. Possible side effects

Like all medicines, KryptoScan can cause side effects, although not everybody gets them.

However, no side effects have been reported after KryptoScan use.

In the unlikely event that side effects do occur, please tell your doctor or pharmacist.

5, How to store KryptoScan

Do not use KryptoScan after the expiry date stated on the label. Hospital staff will ensure this product is not stored above 25°C,

0_b Further information

What KryptoScan contains

•    The active substance is ⁸¹Rb Rubidium/ ^81mKr Krypton,

The generator produces Krypton gas obtained from Rubidium and available with activities ranging between 75-740 MBq.

•    The other ingredient is a substance which binds Rubidium.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Mallinckrodt Medical B.V., Westerduinweg 3 1755 LE Petten, The Netherlands

PL 12288/0006

Manufacturer

Mallinckrodt Medical B.V., Westerduinweg 3 1755 LE Petten, The Netherlands

This leaflet was last approved in 11/2014.