CERETEC STABILIZED 500 MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATION

Introduction

Package Leaflet: Information for the Patient

Ceretec Stabilized 500 micrograms kit for radiopharmaceutical preparation

Exametazime

Read this package leaflet carefully before this medicine is administered to you because it contains important information for you.

• Keep this package 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 side effects, consult your nuclear medicine doctor, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet

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

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

The examination with Ceretec Stabilized is used to:

• Help your doctor determine how much blood is reaching your brain. This may be important to know after a stroke, a head injury, if you have seizures or epilepsy, or to distinguish between Alzheimer's disease and other similar types of dementia. It may also be used to aid in the diagnosis of brain death.

The administration of Ceretec Stabilized involves receiving a small amount of radioactivity. Your doctor and nuclear medicine doctor have considered that the clinical benefit you will obtain from the procedure with the radiopharmaceutical outweighs the risk of radiation.

2. What you need to know before using Ceretec Stabilized

Ceretec Stabilized must not be used:

• If you are allergic to Ceretec Stabilized or any of the other components (listed in section 6).

Warnings and precautions

Be especially careful with Ceretec Stabilized

• If the person to whom this medicine is to be administered is a child or adolescent.
• If you are pregnant or think you may be pregnant.
• If you are breastfeeding.
• If you are on a low-sodium diet.

Children and adolescents

Ceretec is not recommended for administration to children. Inform your nuclear medicine doctor if you are under 18 years old.

Use of Ceretec Stabilized with other medicines

Tell your nuclear medicine doctor if you are using, have used, or may need to use any other medicine, as some medicines may interfere with the interpretation of the images.

Pregnancy and breastfeeding

You must inform the nuclear medicine doctor before administration of Ceretec Stabilized if there is any possibility that you may be pregnant, if you have a delayed period, or if you are breastfeeding.

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

If you are pregnant

The nuclear medicine doctor will only administer this medicine during pregnancy if the benefit is expected to outweigh the risk.

If you are breastfeeding

Do not breastfeed if you receive Ceretec Stabilized. This is because small amounts of "radioactivity" may pass into breast milk. If you are breastfeeding, the nuclear medicine doctor may wait until you finish breastfeeding before using Ceretec Stabilized. If it cannot be delayed, the doctor may ask you to:

• interrupt breastfeeding for 12 hours or more.
• use artificial milk to feed your child, and
• express breast milk and discard it.

Please consult your nuclear medicine doctor when you can resume breastfeeding.

Driving and using machines

Ceretec Stabilized is unlikely to affect your ability to drive or use machines.

Consult your doctor if you can drive or use machines after receiving Ceretec Stabilized.

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

3. How to use Ceretec Stabilized

There are strict rules on the use, handling, and disposal of radiopharmaceuticals. Ceretec Stabilized will only be used in specially controlled areas. This product will only be handled and administered by trained and qualified personnel 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 Stabilized to be used in your case. This will be the minimum amount necessary to obtain the desired information. The generally recommended amount for administration to an adult ranges from 555-1110 MBq.

MBq: Megabecquerel is the unit used to express radioactivity.

A single injection is sufficient to perform the procedure your doctor needs.

Ceretec Stabilized will always be used in a hospital or clinic.

Ceretec Stabilized will be administered by trained and qualified personnel who will provide you with the necessary information about the procedure.

Administration of Ceretec Stabilized and performance of the procedure

Ceretec Stabilized is administered intravenously.

A single injection is sufficient to perform the procedure 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 administration of Ceretec Stabilized, you should:

Urinate frequently to eliminate the product from your body.

The nuclear medicine doctor will inform you if you need to take special precautions after administration of this medicine. Consult your nuclear medicine doctor if you have any doubts.

If you have been administered more Ceretec Stabilized than you should

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

If you have any further questions about the use of Ceretec Stabilized, ask the nuclear medicine doctor 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 experience an allergic reaction while you are in the hospital or clinic undergoing the examination.

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.
• 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 leaving the hospital or clinic, go directly to the emergency department of the nearest hospital.

The administration of this radiopharmaceutical involves receiving a small amount of ionizing radiation with a very low risk of developing cancer and genetic defects.

Reporting of side effects:

If you experience any side effects, consult your doctor, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ceretec Stabilized

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

The following information is intended only for the specialist.

Do not use Ceretec Stabilized after the expiry date stated on the label, after the abbreviation EXP.

Store the reconstituted product below 25°C. Do not freeze or refrigerate.

The marked and stabilized product must be injected within 6 hours of reconstitution.

6. Contents of the pack and further information

Composition of Ceretec Stabilized

• The active ingredient is exametazime. Each vial of Ceretec Stabilized contains 500 micrograms of exametazime.
• The other components are tin chloride, sodium chloride, nitrogen gas, cobalt (II) chloride hexahydrate, and water for injections.

Appearance and pack contents

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

• five vials of powder for solution for injection and five vials of solution for injection.

Marketing authorization 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 package 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 only for doctors or healthcare professionals:

The complete package leaflet of Ceretec Stabilized is included as a separate document in the product packaging, in order to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please consult the package leaflet [the package leaflet must be included in the box].