Ceretec 500 microgramos equipo de reactivos para preparaciÓn radiofarmacÉutica

Label: Information for the Patient

Ceretec 500 micrograms Kit for Radiopharmaceutical Preparation

Exametazima

Read this label carefully before this medication is administered to you because 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 overseeing 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.

This medication 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 the outside of the body by a special camera used in the examination.

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

Ceretec is used for:

• The examination may help your doctor to 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 examination may help your doctor to investigate an unknown origin fever.
• The analysis may also help the doctor to investigate infectious foci, in bones (osteomyelitis) or the abdomen (the area around your stomach).
• Some people will be given the medication to see inflammation in the intestine.

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

The administration of Ceretec 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 should not be used

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

Warnings and precautions

Be especially careful with Ceretec

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

Children and adolescents

Inform your nuclear doctor if you are under 18 years old

Using Ceretec with other medications

Inform your nuclear doctor if you are taking or have recently taken any other medication, as some medications may interfere with image interpretation.

Pregnancy and breastfeeding

You must inform the nuclear doctor before administering Ceretec 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

Your 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. This is because small amounts of "radioactivity" may pass into breast milk. If you are breastfeeding, your nuclear doctor may wait until you have finished breastfeeding before using Ceretec. If this is not possible, your 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 is unlikely to affect your ability to drive or operate machinery. Consult your doctor if you can drive or operate machinery after receiving Ceretec.

Ceretec 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 radioactive medications. Ceretec 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. 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 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 ranges from 555-1110 MBq for cerebral gammagraphy and 185-370 MBq for in vivo localization of technetium-99m labeled leukocytes.

MBq: Megabecquerel is the unit used to express radioactivity.

Use in children and adolescents

The administered dose will be adapted to your weight for children and adolescents.

Ceretec administration and procedure

Tests that will be necessary before Ceretec is administered

• You may have a blood sample taken.

If a blood sample has been taken, it will be mixed with a solution (containing Ceretec and the ingredient called "technetium") that will then be administered to you via injection.

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

Ceretec 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 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 than you should

It is unlikely to have an overdose because you will receive a single, precisely controlled dose of Ceretec from the nuclear medicine physician 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, ask the nuclear medicine physician 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 the examination. The signs may be:

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

Unknown frequencies:

• Hypersensitivity including skin rash, erythema, urticaria, angioedema, pruritus, anaphylactic reaction, or anaphylactic shock
• Headache, dizziness, paresthesia (for example, sensation of tingling or numbness)
• Flushing
• Nausea, vomiting
• Weakness (for example, discomfort, fatigue)

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 that does not appear 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 suitable facilities. Radioactive pharmaceutical storage will be carried out in accordance with national regulations on radioactive materials.

The following information is intended solely for the specialist.

Do not use Ceretec after the expiration date that appears on the label, after CAD.

Store the product unopened at any temperature in the range of 2-25oC and once reconstituted, store it at 15-25oC.

The marked product must be injected within 30 minutes following its reconstitution.

Composition of Ceretec

• The active principle is exametazime. Each vial of Ceretec contains 500 micrograms of exametazime.
• The other components are stannous chloride dihydrate, sodium chloride, and nitrogen gas.

Appearance of the product and contents of the packaging

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

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

Date of the last review of this prospectus: 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 of Ceretec 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 technical file [the technical file must be included in the box].