CERETEC 500 MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATION

Introduction

Package Leaflet: Information for the Patient

Ceretec 500 micrograms kit for radiopharmaceutical preparation

Exametazime

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your nuclear medicine doctor who is supervising the procedure.
• If you experience any side effects, talk to your nuclear medicine doctor, even if they are not listed in this leaflet. See section 4.

Contents of the pack

1. What Ceretec is and what it is used for
2. What you need to know before you are given Ceretec
3. How Ceretec is given
4. Possible side effects
5. Storage of Ceretec
6. Contents of the pack and other information

1. What Ceretec is and what it is used for

This medicine is a radiopharmaceutical for diagnostic use only.

It contains an active ingredient called "exametazime", which is mixed with a radioactive component called "technetium" before use. Once injected, it can be detected from outside the body by a special camera used in the examination.

Ceretec is given before an examination and, along with a special camera, helps to see inside a part of the body.

Ceretec is used for:

• The examination can help your doctor find out how much blood is getting to your brain. This may be important to know after a stroke, a head injury, if you have fits or epilepsy, or to distinguish between Alzheimer's disease and other similar types of dementia. It can also be used to help diagnose brain death.
• The examination can help your doctor investigate a fever of unknown origin.
• The test can also help your doctor investigate infectious foci in your bones (osteomyelitis) or abdomen (the area around your stomach).
• Some people will be given the medicine to look at inflammation in the intestine.

Your doctor will explain which part of your body will be examined.

Receiving Ceretec involves getting a small amount of radioactivity. Your doctor and nuclear medicine doctor have considered that the clinical benefit you will get from the procedure with the radiopharmaceutical outweighs the risk of radiation.

2. What you need to know before you are given Ceretec

Ceretec must not be used

• If you are allergic to Ceretec or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Be especially careful with Ceretec

• If the person to be given this medicine is a child or adolescent.
• If you are pregnant or think you might be pregnant.
• If you are breast-feeding.
• If you are on a low-sodium diet.

Children and adolescents

Tell your nuclear medicine doctor if you are under 18 years old

Using Ceretec with other medicines

Tell your nuclear medicine doctor if you are taking, have recently taken or might take any other medicines, as some medicines may interfere with the interpretation of the images.

Pregnancy and breast-feeding

You must tell your nuclear medicine doctor before you are given Ceretec if there is any chance you may be pregnant, if you have a delayed period or if you are breast-feeding.

In case of doubt, it is important that you consult your nuclear medicine doctor who is supervising the procedure.

If you are pregnant

Your nuclear medicine doctor will only give you this medicine during pregnancy if the benefit is expected to outweigh the risk.

If you are breast-feeding

Do not breast-feed if you receive Ceretec. This is because small amounts of "radioactivity" may pass into breast milk. If you are breast-feeding, your nuclear medicine doctor may wait until you have finished breast-feeding before using Ceretec. If this is not possible, your doctor may ask you to:

• stop breast-feeding for 12 hours or more
• use formula milk to feed your child and
• express and discard your breast milk.

Please consult your nuclear medicine doctor when you can restart breast-feeding.

Driving and using machines

Ceretec is unlikely to affect your ability to drive or use machines. Ask your doctor if you can drive or use machines after receiving Ceretec.

Ceretec contains sodiumand depending on when it is given, the sodium content may be higher than 23 mg (1 mmol), which should be taken into account in the treatment of patients on low-sodium diets.

3. How Ceretec is given

There are strict rules about the use, handling and disposal of radiopharmaceuticals. Ceretec will only be used in specially controlled areas. This product will only be handled and administered by trained and qualified personnel who are able to use it safely. These people will take special care in the safe use of this product and will inform you of their actions.

The nuclear medicine doctor supervising the procedure will decide the amount of Ceretec to be used in your case. This will be the minimum amount necessary to get the desired information.

The recommended amount to be given to an adult is usually between 555-1110 MBq for brain scintigraphy and 185-370 MBq for the in vivo localization of technetium(99mTc)-labelled leucocytes.

MBq: Megabecquerel is the unit used to express radioactivity.

Use in children and adolescents

For children and adolescents, the amount given will be adjusted according to their weight

Administration of Ceretec and performance of the procedure

Tests that will be necessary before you are given Ceretec

• You may have a blood sample taken.

If you have had a blood sample taken, it will be mixed with a solution (which contains Ceretec and the ingredient called "technetium") which will then be given to you by injection.

• Ceretec will always be used in a hospital or clinic
• Ceretec will be given to you by trained and qualified personnel who will provide you with the necessary information about the procedure.

Ceretec is given by intravenous injection.

One injection is enough to perform the procedure that your doctor needs.

After the injection, you will be offered a drink and asked to urinate immediately before starting the procedure.

Duration of the procedure

Your nuclear medicine doctor will inform you about the usual duration of the procedure.

After you have been given Ceretec, you should:

Urinate frequently to eliminate the product from your body.

Your nuclear medicine doctor will inform you if you need to take any special precautions after you have been given this medicine. Consult your nuclear medicine doctor if you have any doubts.

If you have been given more Ceretec than you should

Overdose is unlikely because you will receive a single, precisely controlled dose of Ceretec from your nuclear medicine doctor. However, in case of overdose, you will receive the appropriate treatment.

If you have any further questions about the use of Ceretec, ask your nuclear medicine doctor who is supervising the procedure.

4. Possible side effects

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

Tell your doctor immediately if you have an allergic reaction while you are in the hospital or clinic having the examination. The signs may be:

The frequencies of adverse reactions are defined as follows: frequency not known (cannot be estimated from the available data).

Frequency not known:

• Hypersensitivity including skin rash, erythema, urticaria, angioedema, pruritus, anaphylactic reaction or anaphylactic shock
• Headache, dizziness, paresthesia (e.g. tingling or numbness)
• Flushing
• Nausea, vomiting
• Asthenia (e.g. malaise, fatigue)

If you experience any of the above side effects after you have left the hospital or clinic, go straight to the casualty department of your nearest hospital.

Receiving this radiopharmaceutical involves getting a small amount of ionizing radiation with a very low risk of developing cancer and genetic disorders.

Reporting of side effects:

If you experience any side effects, talk to your doctor, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency (AEMPS) at https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ceretec

You will not need to store this medicine. This medicine is stored under the responsibility of a specialist in suitable premises. The storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

The following information is intended for healthcare professionals only.

Do not use Ceretec after the expiry date which is stated on the label after EXP.

Store the unopened product at any temperature in the range 2-25°C and once reconstituted store at 15-25°C.

The labelled product should be injected within 30 minutes of reconstitution.

6. Contents of the pack and other information

Composition of Ceretec

• The active ingredient is exametazime. Each vial of Ceretec contains 500 micrograms of exametazime.
• The other ingredients are tin(II) chloride dihydrate, sodium chloride and nitrogen gas.

Appearance and pack contents

Ceretec is supplied as a kit for radiopharmaceutical preparation. The kit contains:

• two vials of powder for solution for injection
• five vials of powder for solution for injection

Marketing authorisation holder and manufacturer

GE Healthcare Bio-Sciences, S.A.U

C/ Gobelas, 35-37

28023 Madrid

Spain

Manufacturer:

GE Healthcare AS

Nycoveien 1

NO-0485 Oslo, Norway

Date of last revision of this leaflet: October 2020

Other sources of information

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/

This information is intended for healthcare professionals only.

The full summary of product characteristics of Ceretec is included as a separate document in the product pack, in order to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please consult the summary of product characteristics [the summary of product characteristics must be included in the box).