Ceretec 500 Micrograms Kit For Radiopharmaceutical Preparation
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• 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.
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.
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.
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
GE Healthcare
PATIENT
INFORMATION
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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.
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.
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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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