Ceretec 500 micrograms reagents kit for radiopharmaceutical preparation
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Ceretec 500 micrograms kit for radiopharmaceutical preparation
Exametazime
Read all of this leaflet carefully before you are given this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your nuclear medicine physician who is supervising the procedure.
- If you get any side effects, talk to your nuclear medicine physician, even if it is a side effect not listed in this leaflet. See section 4.
Contents of this leaflet
- What Ceretec is and what it is used for
- What you need to know before you are given Ceretec
- How Ceretec is used
- Possible side effects
- How to store Ceretec
- Contents of the pack and other information
1. What Ceretec is and what it is used for
This medicine is a radiopharmaceutical for diagnostic use only.
It contains an active substance called "exametazime", which is mixed with a radioactive component known as "technetium" before use. Once injected, it can be detected from outside the body by a special camera used during scanning.
Ceretec is administered prior to a scan and, together with a special camera, helps to visualize the inside of a part of the body.
Ceretec is used for:
- The scan may help your doctor determine how much blood is reaching your brain. This information may be important after a stroke, head injury, if you have 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.
- The scan may help your doctor investigate fever of unknown origin.
- The scan may also help your doctor investigate sites of infection in your bones (osteomyelitis) or abdomen (the area around your stomach).
- Some patients may receive this medicine to detect inflammation in the intestine.
Your doctor will explain which part of your body will be scanned.
Administration of Ceretec involves receiving a small amount of radioactivity. Your doctor and the nuclear medicine physician have determined that the clinical benefit you will obtain from this radiopharmaceutical procedure outweighs the risk from radiation exposure.
2. What you need to know before using Ceretec
Ceretec must not be used
- If you are allergic to Ceretec or to any of the other components of this medicine (listed in section 6).
Warnings and precautions
Exercise special caution with Ceretec
- 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
Inform your nuclear medicine physician if you are under 18 years of age.
Use of Ceretac 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 the images.
Pregnancy and breastfeeding
You must inform the nuclear medicine physician before administration of Ceretec if there is any possibility that you may be pregnant, if you have missed a 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 if you receive Ceretec. 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. If waiting is not possible, your physician may ask you to:
- Interrupt breastfeeding for 12 hours or longer
- Use infant formula to feed your baby, and
- Express and discard your breast milk.
Please consult your nuclear medicine physician regarding when you may resume breastfeeding.
Driving and using machines
Ceretec is considered unlikely to affect the ability to drive or operate machinery. Consult your physician to determine whether you may drive or use machines after receiving Ceretec.
Ceretec contains sodium, and depending on when it is administered, the sodium content may exceed 23 mg (1 mmol), which should be taken into account in the management of patients on sodium-restricted diets.
3. How to use Ceretec
There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. Ceretec will only be used in special controlled areas. This product will be handled and administered solely by trained and qualified personnel who are skilled in its safe use. These individuals will take particular care in ensuring the safe use of this product and will inform you of their actions.
The nuclear medicine physician supervising the procedure will determine the amount of Ceretec to be used in your case. This will be the minimum quantity necessary to obtain the required information.
The amount generally recommended for administration to an adult ranges from 555–1110 MBq for brain scintigraphy and 185–370 MBq for in vivo localization of technetium(99mTc)-labelled leukocytes.
MBq: Megabecquerel is the unit used to express radioactivity.
Use in children and adolescents
For children and adolescents, the administered amount will be adjusted according to body weight.
Administration of Ceretec and performance of the procedure
Tests that may be required before administering Ceretec
- A blood sample may be taken from you.
If a blood sample is taken, it will be mixed with a solution (containing Ceretec and the ingredient called "technetium") which will then be administered to you by injection.
- Ceretec will always be used in a hospital or clinic setting.
- Ceretec will be administered by trained and qualified personnel who will provide you with the necessary information about the procedure.
Ceretec is administered intravenously.
A single 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 typical duration of the procedure.
After receiving Ceretec, you should:
Urinate frequently to help eliminate the product from your body.
The nuclear medicine physician will inform you if you need to take any special precautions after receiving this medicine. Consult your nuclear medicine physician if you have any doubts.
If you have been given more Ceretec than you should
An overdose is unlikely, as you will receive a single dose of Ceretec precisely controlled 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, ask the nuclear medicine physician supervising the procedure.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everybody gets them.
Inform your doctor immediately if you experience an allergic reaction while you are in hospital or clinic undergoing the examination. Signs may include:
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, anaphylactic reaction or anaphylactic shock
- Headache, dizziness, paresthesia (for example, tingling or numbness sensation)
- Flushing
- Nausea, vomiting
- Asthenia (for example, malaise, fatigue)
If you experience any of the adverse effects listed above after leaving the hospital or clinic, go directly to the nearest hospital emergency department.
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 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 via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Ceretec
You will not have to store this medicine. This medicine is stored under the responsibility of the specialist in suitable facilities. Storage of radiopharmaceuticals must comply with national regulations concerning radioactive materials.
The following information is intended for specialists only.
Do not use Ceretec after the expiry date stated on the label, after EXP.
Store the unopened product at any temperature within the range 2-25°C, and after reconstitution, store it at 15-25°C.
The radiolabelled product must be injected within 30 minutes after reconstitution.
6. Contents of the pack and other information
Composition of Ceretec
- The active substance 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 pack
Ceretec is supplied as a kit of reagents for the preparation of a radiopharmaceutical. The reagent kit contains:
- two vials of powder for injectable solution
- five vials of powder for 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 revision 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 of Medicines and Medical Devices (AEMPS) http://www.aemps.es/
This information is intended for healthcare professionals only.
The Summary of Product Characteristics (SmPC) for Ceretec is included as a separate document within the product packaging, providing additional scientific and practical information for healthcare professionals on the administration and use of this radiopharmaceutical.
Please consult the Summary of Product Characteristics [the SmPC must be included in the package].