Ceretec stabilized 500 micrograms kit for radiopharmaceutical preparation

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ceretec Stabilized 500 micrograms kit for the preparation of a radiopharmaceutical

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 questions, ask your nuclear medicine physician who supervises the procedure.
• If you get any side effects, talk to your nuclear medicine physician. This includes any side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Ceretec is and what it is used for
2. What you need to know before Ceretec is used
3. How Ceretec is used
4. Possible side effects
5. How to store Ceretec
6. Contents of the pack and other 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 known as "technetium" prior to use. Once injected, it can be detected from outside the body by a special camera used in scanning.

Ceretec Stabilized is administered before a scan and, together with a special camera, helps to visualize inside a part of the body.

The scan with Ceretec Stabilized is used to:

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

Administration of Ceretec Stabilized involves receiving a small amount of radioactivity. Your doctor and the nuclear medicine physician have determined that the clinical benefit you will obtain from the radiopharmaceutical procedure outweighs the risk from radiation exposure.

2. What you need to know before using Ceretec Stabilized

Ceretec Stabilized must not be used:

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

Warnings and precautions

Exercise special caution with Ceretec Stabilized

• If the person to receive this medicine is a child or adolescent.
• If you are pregnant or think you might 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 physician if you are under 18 years of age.

Use of Ceretec Stabilized with other medicines

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

Pregnancy and breastfeeding

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

If in doubt, it is important that you consult your nuclear medicine physician supervising the procedure.

If you are pregnant

The nuclear medicine physician will only administer this medicine during pregnancy if the expected benefit outweighs the potential risk.

If you are breastfeeding

Do not breastfeed after receiving Ceretec Stabilized. This is because small amounts of radioactivity could pass into breast milk. If you are breastfeeding, the nuclear medicine physician may wait until you have finished breastfeeding before administering Ceretec Stabilized. If waiting is not possible, your physician may instruct you to:

• Interrupt breastfeeding for 12 hours or more
• Use infant formula to feed your baby, and
• Express breast milk and discard it.

Please consult your nuclear medicine physician regarding when you may resume breastfeeding.

Driving and use of machines

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

Consult your physician regarding whether you can drive or operate machinery after receiving Ceretec Stabilized.

Ceretec Stabilized contains sodium, and depending on when it is administered, the sodium content may exceed 23 mg (1 mmol), which should be taken into account when treating patients on sodium-restricted diets.

3. How to use Ceretec Stabilized

There are strict regulations regarding 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 who are skilled in its safe use. These individuals will take particular care in the safe use of this product and will inform you about their actions.

The nuclear medicine physician supervising the procedure will determine the amount of Ceretec Stabilized to be used in your case. This will be the minimum amount necessary to obtain the required information. The generally recommended administered dose for an adult ranges from 555–1110 MBq.

MBq: Megabecquerel is the unit used to express radioactivity.

One injection is sufficient to perform the procedure required by your physician.

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.

One injection is sufficient to perform the procedure required by your physician.

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 physician 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 physician will inform you if you need to take special precautions after receiving this medicine. Consult your nuclear medicine physician if you have any doubts.

If you have been administered more Ceretec Stabilized than you should have

An overdose is unlikely because you will receive a single, precisely controlled dose of Ceretec Stabilized, as determined by the supervising nuclear medicine physician. However, in the event of an overdose, appropriate treatment will be provided.

If you have any further questions about the use of Ceretec Stabilized, please ask the nuclear medicine physician supervising the procedure.

4. Possible adverse effects

Like all medicines, this medicinal product may produce adverse effects, although not everyone will experience them.

Inform your doctor immediately if you experience an allergic reaction while in 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 sensation)
• Flushing
• Nausea, vomiting
• Asthenia (e.g., malaise, fatigue)

If you experience any of the above-mentioned adverse effects after leaving the hospital or clinic, go directly to the nearest hospital emergency department.

Administration of this radiopharmaceutical involves exposure to a small amount of ionizing radiation, with a very low risk of developing cancer and hereditary defects.

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ceretec Stabilized

You will not be required to store this medicinal product. This medicine is stored under the responsibility of the specialist in appropriate facilities. Storage of radiopharmaceuticals must comply with national regulations concerning radioactive materials.

The following information is intended for specialists only.

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

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

The labeled and stabilized product must be administered within 6 hours after reconstitution.

6. Contents of the pack and other information

Composition of Ceretec Stabilized

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

Appearance of the product and contents of the container

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

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

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 the most recent review of this leaflet: October 2020.

Other sources of information

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

This information is intended exclusively for physicians or healthcare professionals:

The complete summary of product characteristics for Ceretec Stabilized is included as a separate document within the product packaging, providing 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 carton].