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CERETEC 500 MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATION

Active substance(s): EXAMETAZIME

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1176464 GBR_1176464 GBR 10.05.12 15.34 Side 1







flushing
feeling sick (nausea)
being sick (vomiting)
general feeling of being unwell, weak or tired
unusual feelings of numbness, tingling,
prickling, burning or creeping on skin.
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 nurse.
5. How to store Ceretec
Ceretec is kept out of the reach and sight of
children.
The product label includes the correct storage
conditions and the expiry date for the batch.
Hospital staff will ensure that the product is stored
and disposed of correctly and not used after the
expiry date stated on the label.
6. Further information
What Ceretec contains
• The active ingredient is exametazime. Each vial
of Ceretec contains 500 micrograms of
exametazine.
• The other ingredients are stannous chloride
dihydrate and sodium chloride.

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What Ceretec looks like and contents of the
pack
Ceretec is supplied as a kit for radiopharmaceutical
preparation. The kit contains five vials. Each vial
contains 500 micrograms of exametazime.
Marketing Authorisation Holder
GE Healthcare Limited
Amersham Place
Little Chalfont
Buckinghamshire HP7 9NA
United Kingdom

Manufacturer
GE Healthcare AS
Nycoveien 1-2
0401 OSLO
Norway
This leaflet was last approved in

November 2012.

Marketing Authorisation
UK: PL 00221/0126
Ceretec is a trademark of GE Healthcare.
GE and the GE Monogram are trademarks of
General Electric Company.

GE Healthcare

PATIENT
INFORMATION

CeretecTM
500 micrograms kit for
radiopharmaceutical
preparation
Exametazime

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1176464 GBR_1176464 GBR 10.05.12 15.34 Side 2

PACKAGE LEAFLET: INFORMATION FOR THE USER
Ceretec 500 micrograms kit for
radiopharmaceutical preparation
Exametazime
(called Ceretec in this leaflet)
Read all of this leaflet carefully before you are
given Ceretec.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your
doctor.
• 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 nurse.
In this leaflet:
1. What Ceretec is and what it is used for
2. Before you are given Ceretec
3. How Ceretec is given
4. Possible side effects
5. How to store Ceretec
6. Further information
1. What Ceretec is and what it is used for
This medicine is for diagnostic use only. It is used
only to help identify illness.

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Ceretec is a ‘radiopharmaceutical’ medicine. It is
given before a scan and helps a special camera
see inside a part of your body.
• It contains an active ingredient called
‘exametazime’. This is mixed with another
ingredient called ‘technetium’ before it is used.

• Once injected it can be seen from outside your
body by a special camera used in the scan.
• The scan can help your doctor see how much
blood is flowing through the brain. This may be
important to know after a stroke, if you have fits
or epilepsy, Alzheimer's disease or a similar type
of dementia. It may also be used in people who
have migraine (headaches) or a brain tumour.
• The scan can help your doctor investigate fever
when the reason for the fever is not known.
• The scan can also help your doctor investigate
sites of infection, such as in your abdomen (the
area around your stomach).
• Some other people are given this medicine to
see swelling (inflammation) in the bowel.
Your doctor or nurse will explain which part of
your body will be scanned.
2. Before you are given Ceretec
You should not be given Ceretec:
• If you are allergic (hypersensitive) to the active
ingredient or any other ingredient. (Listed in
Section 6).
Do not have Ceretec if the above applies to you. If
you are not sure talk to your doctor or nurse.
Take special care with Ceretec
Check with your doctor or nurse before having
Ceretec:
• If the person who will be given this medicine is
a child.
• If you are pregnant or think you could be
pregnant.
• If you are on a low sodium diet.
Taking other medicines
Please tell your doctor or nurse if you are taking
or have recently taken any other medicines,
including medicines obtained without a

prescription. This includes herbal medicines. This is
because some medicines can affect the way
Ceretec works.
No medicines have been reported that affect the way
Ceretec works. But it is still best to tell your doctor or
nurse if you are taking any other medicines.
Pregnancy and breast-feeding
You must tell your doctor if you are pregnant or
think you may be pregnant. Your doctor will only
use this product if it is considered that the benefit
outweighs the risk.
Do not breast-feed if you are given Ceretec.
This is because small amounts of ‘radioactivity’
may pass into the mother’s milk. If you are
breast-feeding, your doctor may wait until you
have finished breast-feeding before using
Ceretec. If it is not possible to wait your doctor
may ask you to:
• stop breast-feeding for 12 hours, and
• use formula feed for your child, and
• express (remove) breast milk and throw away
the milk.
Your doctor will let you know when you can start
breast-feeding again.
Driving and using machines
Ask your doctor if you can drive or use machines
after you have been given Ceretec.
Samples that will be required before you have
Ceretec
• A sample of your blood may be taken.
Important information about Ceretec
When Ceretec is used you are exposed to
radioactivity.
• Your doctor will always consider the possible risks
and benefits before you are given the medicine.
Ask your doctor if you have any questions.

3. How Ceretec is given
Ceretec will be given to you by a specially trained
and qualified person.
• Ceretec will always be used in a hospital or
clinic.
• They will tell you anything you need to know for
its safe use.
Your doctor will decide on the dose that is best
for you.
The usual dose is:
• One single injection.
If a sample of your blood has been taken it will be
mixed with a solution (containing Ceretec and the
ingredient called ‘technetium’) which will then be
given to you as an injection.
4. Possible side effects
Like all medicines, Ceretec can cause side effects,
although not everybody gets them.
Allergic reactions
If you have an allergic reaction when you are in
hospital or a clinic having the scan, tell the doctor
or nurse straight away. The signs may include:
• skin rash or itching or flushing
• swelling of the face
• difficulty in breathing.
In more serious cases reactions may include:
• passing out (unconsciousness), feeling dizzy or
lightheaded.
If any of the side effects above happen after you
leave the hospital or clinic, you should go or be
taken straight to the casualty department of your
nearest hospital.
Other side effects include: Frequency not known
• itchy lumpy rash
• headache
• feeling dizzy
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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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