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CHOLEDIAM

Active substance(s): MEBROFENIN

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INFORMATION FOR THE USER
CHOLEDIAM
Kit for the preparation of technetium [99mTc]
mebrofenin injection
mebrofenin

Read all of this leaflet carefully before you are given this
medicine because it contains important information for
you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor who
will supervise the procedure.
• If you get any side effects, talk to your doctor. This
includes any possible side effects not listed in this leaflet.

organs and the target tissues. This gives the physician
valuable information for the diagnosis of your disease.
The use of Cholediam does involve exposure to small
amounts of radioactivity. Your doctor has considered that
the clinical benefit that you will obtain from the procedure
with the radiopharmaceutical outweighs the risk due to
radiation.

2. WHAT YOU NEED TO KNOW BEFORE CHOLEDIAM
IS USED
Cholediam must not be used
• if you are allergic (hypersensitive) to mebrofenin or any of
the other ingredients of Cholediam.

In this leaflet:
1. What Cholediam is and what it is used for
2. What you need to know before Cholediam is used
3. How Cholediam is used
4. Possible side effects
5. How Cholediam is stored
6. Contents of the pack and other information

Warnings and precautions
Take special care with Cholediam:
• if you are or think you may be pregnant
• if you are breast-feeding
• Cholediam should only be used and administered by
authorised persons
• your doctor will tell you if you need to take any special
precautions before or after being given this medicine.

1. WHAT CHOLEDIAM IS AND WHAT IT IS USED FOR

Before administration of Cholediam you should
• be fasting for at least 6 hours.

This medicine is a radiopharmaceutical product for
diagnostic use only.
• Cholediam is used to perform scans of the liver, the gall
bladder and the bile duct which are usual paths of bile
excretion.
- This product is used in the preparation of a diagnostic
radiopharmaceutical.
When
injected,
the
radiopharmaceutical temporarily collects in the liver and
is excreted into bile.
- Because the substance contains a small amount of
radioactivity, it can be detected from outside the body
using special cameras, and pictures, known as scans,
can be taken. These scans will show exactly the
distribution of the radiopharmaceutical within the

Speak to your doctor before receiving Cholediam if you:
• have been receiving nutritional formulas intravenously
• have been dieting for a long time
• have just eaten before treatment
• have liver problems.
Children and adolescents
Talk to your doctor if you are under 18 years old.
Other medicines and Cholediam
Tell your doctor if you are taking, have recently taken or
might take any other medicines, since they may interfere
with the interpretation of the images.

It is particularly important to tell your doctor if you are taking
any of the following:
• opioid painkillers such as morphine
• barbiturates used for sedation such as phenobarbital
• vitamin B3 supplements
• cholecystokinin or somatostatin (peptide hormones)
• sincalide used to diagnosis gall bladder or pancreas
problems
• atropine used for heart problems or eye tests
• chemotherapy given via a tube into your hepatic artery.
Pregnancy
• You must inform the doctor before you are given
Cholediam if there is a possibility you might be pregnant,
if you have missed your period or if you are breastfeeding.
• Will supervise the procedure.
• If you are pregnant: the doctor will only administer this
product during pregnancy if a benefit is expected which
would outweigh the risks.
Breast-feeding
• If you are breast-feeding, the doctor will only give you this
product if a benefit is expected which would outweigh the
risks.
You will need to stop breast-feeding for at least 12 hours
after being given this product. Milk expressed during this
time should be thrown away. Please ask your doctor when
you can resume breast-feeding.
Driving and using machines
Effects on the ability to drive and use machines are not
expected.

3. HOW CHOLEDIAM IS USED
There are strict laws on the use, handling and disposal of
radiopharmaceutical products. Cholediam will only be used
in special controlled areas. This product will only be
handled and given to you by people who are trained and
qualified to use it safely. These persons will take special

care for the safe use of this product and will keep you
informed of their actions.
The doctor supervising the procedure will decide on the
quantity of Cholediam to be used in your case. It will be the
smallest quantity necessary to get the desired information.
The quantity to be administered usually recommended from
20 MBq for small children, up to a maximum of 300 MBq
(Megabecquerel - the unit in which radioactivity is
measured) for adults.
Use in children and adolescents
In children and adolescents, the quantity to be administered
will be adapted to the child’s weight.
Administration of Cholediam and conduct of the
procedure
You should have fasted for at least 6 hours before receiving
Cholediam.
The solution is administered by injection into a vein.
One injection is sufficient to provide your doctor with the
information needed.
Duration of treatment:
Scans may be taken at any time following injection. Your
doctor will inform you about the usual duration of the
procedure.
After administration of Cholediam
The doctor will inform you if you need to take any special
precautions after receiving this medicine. Contact your
doctor if you have any questions.
If you have been given more Cholediam than you should
An overdose is unlikely since Cholediam is administered by
a doctor under strictly controlled conditions. However, in
the case of an overdose, you will receive the appropriate
treatment.
Should you have any further question on the use of
Cholediam, please ask the doctor who will supervise the
procedure.

4. POSSIBLE SIDE EFFECTS

Marketing Authorisation Holder and Manufacturer

Like all medicines, this medicine can cause side effects,
although not everybody gets them.

Marketing Authorisation Holder
MEDIAM
85 rue Nelson Mandela
F-59120 Loos
Tel : +33 3 20 49 72 58
Fax : +33 3 20 88 16 71
PL/22879/0001

On very rare occasions, allergic type reactions may occur.
This radiopharmaceutical will deliver low amounts of
ionising radiation associated with the least risk of cancer
and hereditary abnormalities.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via
the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

You will not have to store this medicine. This medicine is
stored under the responsibility of the specialist in
appropriate premises. Storage of radiopharmaceuticals will
be in accordance with national regulation on radioactive
materials.

OF

THE

PACK

This leaflet was last approved in 09/2013.
The following information is intended for medical or
healthcare professionals only:
Please refer to the SmPC.

5. HOW CHOLEDIAM IS STORED

6. CONTENTS
INFORMATION

Manufacturer
GIPHARMA S.r.l.
Str. per Crescentino
I - Saluggia (VC), 13040
Tel :+ 39 0161 487 141
Fax :+ 39 0161 487 140

AND

OTHER

What Cholediam contains
• The active ingredient is mebrofenin.
• The other ingredient is stannous chloride dehydrate.
What Cholediam looks like and contents of the pack
15 ml, colourless, European Pharmacopoeia type I, drawn
glass vials, closed with chlorobutyl rubber stoppers and
aluminium capsules which may be labelled with 740 to 3700
megabecquerel (MBq) of technetium (a radioactive tracer).

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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