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KRYPTOSCAN GENERATOR

Active substance(s): KRYPTON-81M / RUBIDIUM-81 / KRYPTON-81M / RUBIDIUM-81

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DRN 3633

Kryptoscan United Kingdom & Northern Ireland

Page 1 of 2

KryptoScan ™
radionuclide generator

Active substance: 81Rb 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

1.

What 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.

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.
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 speci al precautions
after using this medicine. Contact your doctor if you have any
questions.

Using oth er medicin es
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 tranquillise and induce sleep
• general anaesthetics

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.

03633006BYS07a f 12 CON 3633 United Kingdom SPC 1710201 2 f 12 CON 3633 United King dom PIL 17 10201 2

DRN 3633

4.

Kryptoscan United Kingdom & Northern Ireland

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 thi s product is not stored above 25°C.

6•

Further information

What KryptoScan contains
• The active substance is 81Rb Rubidium/ 81m Kr 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 UK Commercial Ltd.
4500 Parkway
Whiteley
Fareham
Hampshire P015 ?NY
United Kingdom
Tel: +44(0)1329224477, Fax: +44(0)1329224442
PL 41744/0005
• Manufacturer
Mallinckrodt Medical B.V., Westerduinweg 3
1755 LE Petten, The Netherlands

This leaflet was last approved in 10/2012.

03633006BYS07a 112 CON 3633 United Kingdom SPC 17102012 / 12 CON 3633 United Kingdom PIL 17102012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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