Label: Information for the Patient

Ceretec Stabilized 500 micrograms Kit for Radiopharmaceutical Preparation

Exametazima

Read this label carefully before this medication is administered to you, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your nuclear medicine physician who is supervising the procedure.
• If you experience any adverse effects, consult your nuclear medicine physician, even if they are not listed in this label. See section 4

1.What Ceretec is and how it is used

2.What you need to know before starting to use Ceretec

3.How to use Ceretec

4.Possible adverse effects

5.Storage of Ceretec

6.Contents of the package and additional information

This medication is a radiopharmaceutical for diagnostic use only.

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

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

The examination with Ceretec Estabilizado is used for:

•To help your doctor know how much blood reaches your brain. It may be important to know this information after a stroke, a head trauma, if you have seizures or epilepsy, or to distinguish between Alzheimer's disease and another similar type of dementia. It may also be used as a diagnostic aid for brain death.

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

Ceretec Estabilizado should not be used:

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

Warnings and precautions

Be especially careful with Ceretec Estabilizado

• If the person to be administered this medication 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 doctor if you are under 18 years old.

Use of Ceretec Estabilizado with other medications

Inform your nuclear doctor if you are using, have used, or may need to use any other medication, as some medications may interfere with image interpretation.

Pregnancy and breastfeeding

You must inform the nuclear doctor before administering Ceretec Estabilizado if there is any possibility of pregnancy, if you experience a delay in your period, or if you are breastfeeding.

It is essential to consult your nuclear doctor who will oversee the procedure in case of doubt.

If you are pregnant

The nuclear doctor will only administer this medication during pregnancy if the expected benefit outweighs the risk.

If you are breastfeeding

Do not breastfeed if you receive Ceretec Estabilizado. This is because small amounts of "radioactivity" may pass to the breast milk. If you are breastfeeding, the nuclear doctor may wait until you finish breastfeeding before using Ceretec Estabilizado. If this is not possible, the nuclear doctor may ask you to:

•interrupt breastfeeding for 12 hours or more

•use artificial milk to feed your child and

•express and discard breast milk.

Please consult your nuclear doctor when you can resume breastfeeding.

Driving and operating machinery

Ceretec Estabilizado is unlikely to affect your ability to drive or operate machinery.

Consult your doctor if you can drive or operate machinery after receiving Ceretec Estabilizado.

Ceretec Estabilizado 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.

There are strict guidelines for the use, handling, and disposal of radiopharmaceuticals. Ceretec Estabilizado will only be used in specially controlled areas. This product will only be handled and administered by trained and qualified personnel who will use it safely. Those individuals will take special care in the safe use of this product and will inform you of their actions.

The nuclear medicine physician overseeing the procedure will decide on the amount of Ceretec Estabilizado to be used in your case. This will be the minimum amount necessary to obtain the desired information. The generally recommended dose for an adult is between 555-1110 MBq.

MBq: Megabecquerel is the unit used to express radioactivity.

One injection is sufficient to perform the procedure your doctor needs.

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

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

Administration of Ceretec Estabilizado and Procedure Performance

Ceretec Estabilizado is administered intravenously.

One 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.

Procedure Duration

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

After Ceretec Estabilizado Administration, You Must:

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 receiving this medication. Consult with your nuclear medicine doctor if you have any doubts.

If You Have Been Administered More Ceretec Estabilizado Than Necessary

It is unlikely to experience an overdose because you will receive a single, precisely controlled dose of Ceretec Estabilizado from the nuclear medicine doctor overseeing the procedure. However, in the event of an overdose, you will receive the appropriate treatment.

If you have any other questions about the use of Ceretec Estabilizado, ask the nuclear medicine doctor overseeing the procedure.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Inform your doctor immediately if you experience an allergic reaction while in the hospital or clinic undergoing an examination.

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

Unknown frequency:

If you experience any of the adverse effects listed above 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 hereditary defects.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

This medication does not need to be stored by you. This medication will be stored under the responsibility of the specialist in appropriate facilities. Storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

The following information is intended solely for the specialist.

Do not use Ceretc Stabilized after the expiration date that appears on the label, after the CAD abbreviation.

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

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

Composition of Ceretec Stabilized

•The active principle is exametazime. Each vial of Ceretec Stabilized contains 500 micrograms of exametazime.

•The other components are stannous chloride, sodium chloride, nitrogen gas, cobalt (II) chloride hexahydrate, and water for injection preparations.

Appearance of the product and contents of the packaging

Ceretec Stabilized is supplied as a kit of reagents for radio-pharmaceutical preparation. The kit of reagents contains:

•five vials of powder for injectable solution and five vials of an injectable solution.

Holder of the marketing authorization and responsible for manufacturing

GE Healthcare Bio-Sciences, S.A.U

C/ Gobelas, 35-37

28023 Madrid

Spain

Responsible for manufacturing:

GE Healthcare AS

Nycoveien 1

NO-0485 Oslo, Norway

Last review date of this leaflet: October 2020.

Other sources of information

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/

This information is intended solely for doctors or healthcare professionals:

The complete technical file ofCeretec Stabilizedis includedas a separate documentin the packaging of the product, in order to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please, consult the technical file[the technical file must be included in the box].