250 MBq/ml solution
What Steripet is and what it is used for
This radiopharmaceutical is for diagnostic use only. It is used only as an aid to detect disease.
The active substance found in Steripet is called “fludeoxyglucose”. It is injected before imaging with a special camera that makes it possible to see inside a part of your body. When a small amount of Steripet is injected, the images taken during the examination will help the doctor see where your disease is and how it is progressing.
What you need to know before using Steripet
The steripet must not be used
- If you are allergic to fludeoxyglucose ( 18 F) or any other ingredient in this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor before receiving Steripet:
if you are diabetic and your diabetes is not currently under control
if you have an infection or an inflammatory disease
if you have kidney problems
if you are pregnant or suspect you are pregnant
if you are breastfeeding.
Children and young people
Other medicines and Steripet
Tell your doctor if you are taking, have recently taken, or might take any other medicines as they may affect the doctor’s interpretation of the images, especially:
- medicines that can cause changes in your blood sugar, for example, medicines that- are anti-inflammatory (e.g. corticosteroids )- prevent convulsions (e.g. valproate, carbamazepine, phenytoin, phenobarbital)- affects the nervous system (e.g. adrenaline, norepinephrine, dopamine )
- drugs that increase the production of blood cells
Steripet with food, drink, and alcohol
The time before the examination:
- should you avoid drinks that contain sugar
- should you drink a lot of water (or other drinks that do not contain sugar)?
- you must not eat for at least 4 hours before injecting one
- your doctor will check the amount of glucose in your blood before you are given Steripet
Pregnancy and breastfeeding
You must tell the doctor before receiving Steripet if there is any possibility that you are pregnant, if you have missed your period or if you are breastfeeding. If you are unsure, you must consult the doctor who will conduct the examination.
If you are pregnant
The doctor will only give you this medicine during pregnancy if the expected benefit outweighs the risks.
If you are breast-feeding
You must take a break from breastfeeding for 12 hours after injection one. Give the baby formula and express and discard the breast milk. Discuss with your doctor when breastfeeding can be resumed.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor before receiving this medicine.
Driving ability and use of machinery
Steripet is unlikely to affect your ability to drive or use machines.
The steroid contains sodium
How Steripet is used
There are strict rules regarding the use, handling, and disposal of radiopharmaceuticals. Steripet will only be used in hospitals. This product will only be handled and given to you by people who are trained and qualified to use it safely. They will provide you with the necessary information regarding the examination.
The doctor responsible for the examination decides how much Steripet you will receive. It will be the lowest possible dose to obtain the information needed.
The amount most often recommended for an adult varies between 100 – 400 MBq (mega becquerel, the unit used to measure radioactivity.)
Use for children and adolescents
The dose given to children or adolescents depends on their weight.
How Steripet is given and how the examination is carried out
Steripet is given as a single injection into a vein.
One injection is enough for the examination that the doctor needs. It will be given 45-60 minutes before the examination.
After injection one, you should be completely at rest, without reading or talking. You will be offered water and asked to urinate immediately before the examination.
During the picture taking, you must also be completely at rest, lying down comfortably without reading or talking.
Duration of the survey
Your doctor will tell you how long the examination will take.
The examination normally takes 30-60 minutes.
After receiving a Steripet injection, you should
- Avoid close contact with small children and pregnant women for 12 hours after injection a.
- Urinate frequently to remove Steripet from your body
If you have been given too much Steripet
It is unlikely that you will get an overdose because you will only be given one dose of Steripet by your doctor under controlled conditions. If an overdose should nevertheless occur, you will receive appropriate treatment. The doctor conducting the examination may recommend that you drink a lot to speed up the elimination of Steripet from your body.
Possible side effects
Like all medicines, Steripet can cause side effects, although not everybody gets them.
The steripet emits a small amount of ionizing radiation that only carries a very small risk of cancer and genetic mutation. Your doctor has judged that the clinical benefit obtained from the examination with Steripet is more important than the risk associated with radiation.
How Steripet should be stored
You do not need to store this medicine yourself. The doctor is responsible for the medicine being stored in a suitable place. Steripet is stored by national regulations on radioactive materials.
Contents of the packaging and other information
- The active substance is fludeoxyglucose ( 18 F). 1 ml of Steripet solution contains 250 MBq of fludeoxyglucose ( 18 F) at the date and time of calibration.
- The other ingredients are sodium hydrogen phosphate dihydrate, sodium hydroxide, and water for injections.
Appearance and package sizes of the medicine
Steripet is packaged in a multi-dose vial of clear glass containing between 1 ml and 10 ml of injection solution.
GE Healthcare BV
De Random 8
5612 AP Eindhoven