Irabglu 370 MBq/ml solution for injection
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
IRABGLU 370 MBq/ml solution for injection
Fluorodeoxyglucose (18F)
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, consult your nuclear medicine physician who supervises the procedure.
-
If you experience any side effects, consult your nuclear medicine physician who supervises the procedure, even if they are side effects not listed in this leaflet. See section 4.
Contents of this leaflet
-
What IRABGLU is and what it is used for
-
What you need to know before being given IRABGLU
-
How IRABGLU is given
-
Possible side effects
-
Storage
-
Contents of the pack and other information
1. What IRABGLU is and what it is used for
This medicine is a radiopharmaceutical for diagnostic use only.
The active substance in IRABGLU is fludeoxyglucose (18F), and it is designed for obtaining diagnostic images of certain parts of the body.
Once a small amount of IRABGLU is injected, the medical images obtained using a special camera will allow the physician to visualize and determine the location or progression of your disease.
2. What you need to know before using IRABGLU
IRABGLU must not be used:
- if you are allergic (hypersensitive) to IRABGLU or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your nuclear medicine physician before receiving IRABGLU:
- If you have diabetes and your diabetes is currently uncontrolled
- If you have an infection or an inflammatory disease
- If you have kidney problems
Inform your nuclear medicine physician in the following cases:
- If you are pregnant or think you might be pregnant
- If you are breastfeeding
Before administration of IRABGLU you must:
- Drink plenty of water before starting the procedure to ensure frequent urination during the first hours after completion.
- Avoid any strenuous physical activity
- Fast for at least 4 hours
Children and adolescents
Inform your nuclear medicine physician if you are under 18 years of age.
Use of IRABGLU with other medicines
Inform your nuclear medicine physician if you are taking, have recently taken, or might need to take any other medicines, as certain medicines may interfere with the interpretation of the images by your physician:
- Any medicine that may alter blood glucose concentration (glycaemia), such as medications to reduce inflammation (corticosteroids), medications for seizures (valproate, carbamazepine, phenytoin, phenobarbital), medications affecting the nervous system (epinephrine, norepinephrine, dopamine…)
- Glucose
- Insulin
- Medications used to increase blood cell production
Use of IRABGLU with food and drinks
You must fast for at least 4 hours before receiving this medicine. You should drink plenty of water and avoid consuming liquids containing sugars.
Your physician should measure your blood glucose level before administering the medicine, since a high blood glucose concentration (hyperglycaemia) may interfere with image interpretation by your nuclear medicine physician.
Pregnancy and breastfeeding
You must inform your nuclear medicine physician before administration of IRABGLU if there is any possibility you might be pregnant, if you have a delayed menstrual 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
Your nuclear medicine physician will only administer this medicine during pregnancy if the expected benefit outweighs the potential risk.
If you are breastfeeding
You must stop breastfeeding your child for 12 hours after the injection and discard any milk expressed during this period.
The decision to resume breastfeeding should be made in consultation with the nuclear medicine specialist supervising the procedure.
If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your nuclear medicine physician before receiving this medicine.
Driving and use of machines
IRABGLU is considered unlikely to affect your ability to drive or operate machinery.
IRABGLU contains sodium and ethanol
Patients on low-sodium diets should be aware that this medicine contains 35.4 mg (1.54 mmol) of sodium per dose.
This medicine contains a maximum of 0.17% V/V ethanol (alcohol); this small amount corresponds to 16.7 mg/dose.
3. How to use IRABGLU
There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. IRABGLU 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 special 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 IRABGLU to be used in your case. This amount will be the minimum necessary to obtain the desired information. The generally recommended administered activity for an adult ranges between 100 and 400 MBq (depending on the patient's body weight, the type of camera used for imaging, and the image acquisition mode). The megabecquerel (MBq) is the unit used to express radioactivity.
Use in children and adolescents
In children and adolescents, the administered amount will be adjusted according to body weight.
Administration of IRABGLU and performance of the procedure
IRABGLU is administered intravenously.
A single injection is sufficient to perform the procedure required by your physician.
After the injection, you must remain completely at rest, without reading or speaking. In addition, you will be offered a drink and asked to urinate immediately before starting the procedure.
During image acquisition, you must remain completely still. You must not move or speak.
Duration of the procedure
Your nuclear medicine physician will inform you about the usual duration of the procedure.
IRABGLU is administered as a single intravenous injection 45 to 60 minutes before image acquisition. The actual imaging with the camera lasts between 30 and 60 minutes.
After administration of IRABGLU, you should:
- avoid direct contact with young children and pregnant women during the 12 hours following the injection
- urinate frequently to help eliminate the product from your body
If you have been given more IRABGLU than you should
An overdose is unlikely, as you will receive a single dose of IRABGLU precisely controlled by the supervising nuclear medicine physician. However, in the event of an overdose, appropriate treatment will be administered. Specifically, your nuclear medicine physician may advise you to drink plenty of fluids to facilitate the elimination of IRABGLU from the body (since the primary route of elimination of this medicinal product is renal, i.e., through urine).
If you have any further questions about the use of IRABGLU, ask the nuclear medicine physician supervising the procedure.
4. Possible adverse effects
Like all medicines, this medicinal product may cause adverse effects, although not everyone will experience them.
Administration of this radiopharmaceutical involves exposure to a small amount of ionizing radiation, with a very low risk of developing cancer and hereditary defects.
Your doctor has already considered that the clinical benefit you will obtain from the test with the radiopharmaceutical outweighs the risk due to radiation exposure.
Reporting of adverse effects:
If you experience any type of adverse effect, consult your doctor or nurse, 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 IRABGLU
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 regarding radioactive materials.
The following information is intended for specialists only.
Do not use IRABGLU after the expiry date stated on the container.
Do not use IRABGLU if there are any visible signs of deterioration.
6. Contents of the pack and other information
Composition of IRABGLU
- The active substance is fludeoxyglucose (18F).
Each ml of injectable solution contains 370 MBq of fludeoxyglucose (18F) at the date and time of calibration.
The other components are sodium chloride 0.9%, disodium citrate sesquihydrate, trisodium citrate dihydrate, hydrochloric acid 2 N, absolute ethanol, and water for injectable preparations.
Appearance of the medicinal product and contents of the pack
The activity per vial ranges between 370 MBq and 3700 MBq at the date and time of calibration.
Marketing Authorisation Holder and Manufacturer
Institut Radiofarmàcia Aplicada de Barcelona, S.L.
c/Doctor Aiguader, 88, Floor -1
08003 Barcelona
933 160 983
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)
Date of the most recent review of this summary: March 2018
<----------------------------------------------------------------------------------------------------------------?
This information is intended exclusively for physicians or healthcare professionals:
The full Summary of Product Characteristics for IRABGLU is included as a separate document within the product packaging, to provide 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 package].