Ceretec

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Ceretec 0.5 mg kit for radiopharmaceutical preparation, powder for injectable solution

(referred to as Ceretec in this leaflet)
Hexamethylpropyleneamine oxime
Please read all of this leaflet carefully before this medicine is administered to you, as it contains important information for you

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult the nuclear medicine specialist in charge of performing the examination.
• If you experience any side effects, contact the nuclear medicine physician. This applies also to any possible side effects not listed in this leaflet.

Contents of this leaflet:

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 used
4. Possible side effects
5. How Ceretec is stored
6. Contents of the pack and other information

1. What Ceretec is and what it is used for

Ceretec is a radiopharmaceutical for diagnostic use only.
It is used in adults, children, and adolescents (see section 3. How Ceretec is used) solely to assist in identifying possible diseases.
Ceretec is administered before a scan and helps a special device to visualize the inside of a part of your body.

• It contains an active substance called 'exametazime'. This is mixed with another ingredient called 'technetium' before use.
• Once injected, it can be detected from outside your body by the imaging device used for the diagnostic examination.
• The scan can help your doctor assess how blood flows in the brain. This may be important after a stroke, or in cases of chronic ischemia or transient ischemic attack, if you suffer from seizures or epilepsy, or if you have Alzheimer's disease or another similar form of dementia. It may also be used as an adjunctive technique in the diagnosis of brain death.
• The scan can help your doctor investigate a febrile condition when the cause of the fever is unknown.
• The scan may also help your doctor investigate sites of infection, for example in your abdomen (an area around your stomach).
• In other patients, this medicine is administered to visualize swelling (inflammation) in the intestine. Your nuclear medicine physician will explain which part of your body will be scanned.

Use of Ceretec involves exposure to small amounts of radioactivity. Your doctor and nuclear medicine specialist have determined that the clinical benefit of this examination performed with a radiopharmaceutical outweighs the risk associated with exposure to these small amounts of radiation. Please consult your nuclear medicine physician if you have any questions.

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

Do not use Ceretec:

• If you are allergic (hypersensitive) to the active substance or to any of the excipients of this medicine (listed in section 6) before or after labelling.

Warnings and precautions
Talk to your nuclear medicine doctor before using Ceretec:

• if the person to receive this medicine is a child
• if you are pregnant or think you may be pregnant
• if you are breastfeeding
• if you are on a low-sodium diet
  • if you have reduced kidney or liver function

Before receiving Ceretec you must:
Drink plenty of fluids before undergoing the examination, so that you urinate as frequently as possible during the first few hours after the examination.
Children and adolescents
Administration of Ceretec in children and adolescents should be carefully considered based on clinical need and assessment of the risk/benefit ratio.
Other medicines and Ceretec
Inform the nuclear medicine doctor who will perform the examination if you are taking, have recently taken, or might take any other medicines, as they could interfere with Ceretec.
No medicines interfering with Ceretec have been reported.
However, it is always advisable to inform your nuclear medicine doctor or nurse if you are taking other medicines.
Pregnancy and breastfeeding
Ask your nuclear medicine doctor for advice if you are pregnant or breastfeeding, or if you suspect or are planning a pregnancy, before this medicine is administered to you.
In case of doubt, it is important to consult your nuclear medicine doctor in charge of performing the examination.
If you are pregnant
If you are pregnant, your nuclear medicine doctor will only give you this medicine if they consider that the expected benefit outweighs the risk.
If you are breastfeeding
Do not breastfeed if you have been given Ceretec.
This is because small amounts of 'radioactivity' may pass into breast milk.
If you are breastfeeding, your nuclear medicine doctor should wait until the end of breastfeeding before using Ceretec.
If it is not possible to wait, your nuclear medicine doctor will ask you:

• to stop breastfeeding for at least 12 hours, and
• to use infant formula for your baby, and
• to collect your breast milk and discard it. Your doctor will inform you when you can resume breastfeeding.

Driving and using machines
Ask your doctor whether you can drive vehicles or use machinery after Ceretec has been administered to you.
Examinations you may undergo before receiving Ceretec

• A blood sample may be taken from you.

Ceretec contains sodium
This medicine contains 1.77 mg of sodium (the main component of table salt) per vial. This corresponds to 0.09% of the maximum daily recommended dietary intake for an adult.
The amount of sodium may in some cases exceed 1 mmol (23 mg). This should therefore be taken into account if you are on a low-sodium diet.

3. How Ceretec is used

There are strict regulations governing the use, handling, and disposal of radiopharmaceuticals. Ceretec will only be used in designated controlled areas.
This product will be handled and administered exclusively by personnel specifically trained and qualified to use it safely.

Administration of Ceretec and performance of the procedure:
Dose
The nuclear medicine physician responsible for performing the examination will determine the amount of Ceretec to be used in your case.
The minimum necessary dose required to obtain the desired information will be used.
The usual administered quantity for an adult ranges between 185 and 1110 MBq. The megabecquerel (MBq) is the unit of measurement of radioactivity.
The activity to be administered to children and adolescents should be determined based on body weight and should be the lowest reasonably achievable for diagnostic image quality.
A single injection is sufficient to perform the examination.
If a blood sample has been taken from you, it will be mixed with a solution (containing Ceretec and an ingredient called 'technetium'), which will then be administered to you as an injection.

• Ceretec will always be used in a hospital or clinic.
• The staff will ensure the product is used safely and will inform you about the measures taken.

Duration of the procedure
Your nuclear medicine physician will inform you about the duration of the procedure.

After receiving Ceretec, you must:
Urinate as frequently as possible to eliminate the product from your body.
Avoid close contact with infants and pregnant women.
The nuclear medicine specialist will inform you of any special precautions to follow after administration of the medicine. Contact the nuclear medicine specialist for any doubts or questions.

If you have been given more Ceretec than you should have:
Cases of overdose are unlikely, as you will receive a dose controlled by the specialist physician performing the examination. However, in the event of an overdose, you will receive appropriate treatment.
If you have any questions about the use of Ceretec, ask the nuclear medicine physician responsible for performing the examination.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Allergic reactions with unknown frequency
If you experience an allergic reaction while in hospital or at a clinic during the examination, inform your doctor or nurse immediately.
Signs may include:

• skin rash, redness, itching or hot flushes

In more severe cases, reactions may include:

• difficulty breathing
• swelling of the face, lips and tongue (angioedema)
• fainting (loss of consciousness) due to sudden drop in blood pressure, with dizziness or feeling lightheaded

Other side effects with unknown frequency include:

• headache, dizziness
• nausea, vomiting
• general feeling of malaise, fatigue, weakness (asthenia)
• unusual sensations of numbness, tingling, itching (paraesthesia).

If any of the side effects listed above occur after you have left the hospital or clinic, go directly to the nearest hospital emergency department.
With Ceretec, you will be exposed to a small amount of ionizing radiation, carrying a minimal risk of developing cancer or hereditary abnormalities.
If you experience any side effect, contact your nuclear medicine physician. This applies also to any possible side effect not listed in this leaflet.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your nuclear medicine physician. You may also report side effects directly via the national reporting system at the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How Ceretec is stored

This medicinal product must not be stored by the user. Ceretec is stored under the responsibility of a specialist in suitable premises, in accordance with current regulations concerning radioactive materials.
Hospital staff will ensure that the product is properly stored and disposed of, and that it is not used after the expiry date stated on the label.

The following information is intended exclusively for the specialist.

• Ceretec must not be used after the expiry date indicated on the carton after EXP.
• Keep Ceretec out of the sight and reach of children.
• Store below 25°C after reconstitution. Do not freeze or refrigerate.
• The radiolabelled product should be injected within 30 minutes after reconstitution.

6. Package contents and other information

What Ceretec contains

• The active substance is exametazime. Each Ceretec vial contains 0.5 mg of exametazime.
• The other components are: tin dichloride dihydrate, sodium chloride and nitrogen.

Description of the appearance of Ceretec and contents of the pack
Ceretec is supplied as a kit for radiopharmaceutical preparation. The kit contains 1, 2 or 5 vials. Each vial contains a powder for injectable solution.
Marketing Authorisation Holder
GE Healthcare S.r.l.
Via Galeno 36,
20126 Milano
Italy
Manufacturers
GE Healthcare AS
Nycoveien 1
04085 OSLO
Norway
This patient information leaflet was last approved on

The following information is intended exclusively for the physician or healthcare professional:
The complete Summary of Product Characteristics (SmPC) for Ceretec is included within the packaging, at the end of this Patient Information Leaflet, as a tear-off section, in order to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.
Please refer to the SmPC.