370 kBq hard capsule
tauroselcholic acid (Se-75)
Read all of this leaflet carefully bef
What Sehcat is and what it is used for
This medicine is a radioactive medicine intended for diagnostic use only. This drug contains an active substance called tauroselcholic acid (Se-75), which is used to identify diseases in certain parts of the gastrointestinal tract.
Using Sehcat exposes you to small amounts of radioactive radiation. Your doctor believes that the clinical benefit of using radioactive medicine outweighs the risks of radiation.
What you need to know before using Sehcat
Do not use Sehcat
- if you are allergic to tauroselcholic acid (Se-75) or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor who is responsible for the examination before you are given Sehcat.
Take special care with Sehcat:
- If your doctor has told you that your liver is not working properly or that there is a blockage in the bile ducts ( obstruction in the bile ducts).
- If you are pregnant or think you may be pregnant.
- If you are breastfeeding.
Before you get Sehcat, you should:
- drink plenty of water before the test to be able to urinate as often as possible during the first hours after the test.
Children and young people
Talk to your doctor if you are under 18 years of age.
Other medicines and Sehcat
Tell your doctor if you are taking, have recently taken, or might take any other medicines. These may affect the interpretation of the images, although it has not been reported that other drugs affect the function of Sehcat.
Sehcat with food, drink, and alcohol
- You will be advised to drink a glass of 15 ml of water before, during, and after swallowing the capsule so that it can easily pass to the stomach.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
If you are pregnant
You must inform your doctor before taking this medicine if you are pregnant, have missed a period, or are breastfeeding. If you are unsure, you must consult the doctor who is supervising the examination. If you are pregnant, your doctor will only give you this medicine if the benefits are expected to significantly outweigh the risks.
If you are breast-feeding
Breast-feeding is not recommended when using this medicine. Discuss this with your doctor before using this medicine.
Driving and using machines
No studies have been performed, but to date, there is no evidence that Sehcat affects the ability to drive or use machines.
Sehcat contains sodium
This medicine contains 3.01 mmol (or 71.04 mg) sodium per dose (capsule). This should be considered by patients on a low-salt diet.
How to use Sehcat
There are strict regulations on how radioactive drugs should be used, handled, and disposed of. Sehcat will only be used in specially controlled locations. This medicine will only be handled and given to you by people who are trained and qualified to use it safely. These people make sure that the medicine is used in a risk-free way and keep you informed of what is happening.
The doctor supervising the examination will decide which dose of Sehcat to use in your case. It will be the minimum amount required to obtain the desired information. The amount usually recommended for an adult is one capsule and the maximum recommended activity is 370 kBq (kilobecquerel, a device used to express radioactivity).
Use of Sehcat and how the survey is conducted
Sehcat is taken by mouth. Usually, one capsule is enough to carry out the tests that the doctor needs to do.
You should sit or stand while taking the capsule.
During the survey
Your doctor will tell you how long the examination is expected to take.
After receiving Sehcat, you should:
- Urinate frequently for the drug to leave the body.
Your doctor will inform you if you need to take any special measures after receiving this medicine. Contact your doctor if you have any questions.
Use for children and adolescents
If the product is given to children, the same dose as for adults should be used.
If you have received too much Sehcat
It is unlikely that you will receive an overdose as you will only receive a single dose of Sehcat which is closely monitored by the doctor supervising the examination. If you still receive an overdose, you will receive appropriate treatment.
If you have any further questions on the use of this product, ask your doctor.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact a doctor immediately or see a hospital if you get the following side effect:
- Allergic reactions ( hypersensitivity reactions ). Symptoms of an allergic reaction may include swelling of the eyelids, face, or lips, low blood pressure, palpitations, sudden itchy rash (hives), sudden wheezing, tightness of the chest, shortness of breath, and dizziness. Adverse reactions that have been reported occur in an unknown number of users.
This radioactive medicine emits small amounts of ionizing radiation with very little risk of cancer and hereditary defects.
How to store Sehcat
You do not need to store this medicine. Healthcare professionals are responsible for storing the medicine in suitable premises. The storage of radioactive medicines takes place by national regulations on radioactive materials.
The following information is intended for medical or healthcare professionals only.
Do not use this medicine after the expiry date which is stated on the label after EXP.
Contents of the packaging and other information
Content declaration
- The active substance is tauroselcholic acid (Se-75). Each Sehcat capsule contains 370 kBq.
- The other ingredients are sodium phosphate dihydrate and the ingredients in the capsule shell are titanium dioxide, quinoline yellow, erythrosine, and gelatin.
What the medicine looks like and the contents of the pack
Sehcat is a hard capsule that comes in a plastic jar (polystyrene) with a polyethylene lid. The capsules are held in place with polyethylene foam pads. The jar should be stored in a lead cover.
Marketing Authorization Holder and Manufacturer
GE Healthcare Buchler GmbH & Co. KG
Gieselweg 1
D-38110 Braunschweig
Germany