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LIPIODOL ULTRA FLUID 480 MG IODINE/ML SOLUTION FOR INJECTION

Active substance(s): IODISED OIL FLUID

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PACKAGE LEAFLET: INFORMATION FOR THE USER

LIPIODOL ULTRA FLUID
480 mg of iodine per ml

Sol ution for i njection
Iodised ethyl-esters of the fatty acids of poppy seed oil
Re a d a l l o f t h i s l e a f l e t c a r e f u l l y b e f o r e yo u s t a r t
us ing thi s me dic ine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor.
In this leaflet:
1. What Lipiodol Ultra Fluid is and what it is used for
2. Before you are given Lipiodol Ultra Fluid
3. How to use Lipiodol Ultra Fluid
4. Possible side effects
5. How to store Lipiodol Ultra Fluid
6. Further information
1. WHAT LIPIODOL ULTRA FLUID IS
AND WHAT IT IS USED FOR
Lipiodol Ultra Fluid is a diagnostic agent. It belongs to the group of
contrast agents used for radiological examinations.

Lipiodol Ultra Fluid is used to enhance the contrast of the images
obtained during radiological examinations. This contrast
enhancement improves the visualisation and outline of certain body
parts.
This medicine is for diagnostic use only.

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2. BEFORE YOU ARE GIVEN LIPIODOL ULTRA FLUID

You should read the information in this section carefully.
You and your doctor should take the information into consideration
before you are given Lipiodol Ultra Fluid.

You should NOT be given Lipiodol Ultra Fluid if:
• you are allergic to iodised ethyl-esters of the fatty acids of poppy
seed oil (the active substance),
• you have an overactive thyroid gland (which can cause increased
appetite, weight loss or sweating),
• you have recently had severe injury or bleeding,
• you are pregnant or think you are pregnant and are due to undergo
hysterosalpingography (examination of the uterus and fallopian
tubes)
• you have inflammation in the pelvis affecting your womb, tubes or
ovaries are due to undergo hysterosalpingography (examination of
the uterus and fallopian tubes).
• you need a bronchography, a type of X-ray examination where dye
is instilled into the lower lung. Lipiodol Ultra Fluid is not suitable for
this X-ray examination.

Take special care with Lipiodol Ultra Fluid
Inform your doctor if the following applies to you:
• you have previously reacted to this contrast agent during an
examination
• you have an history of hypersensitivity to iodine
• you have asthma
• you have a disease affecting your heart or your blood vessels
• you have a disease affecting your lungs
• you have thyroid disorders or a history of thyroid disease
• you are due to undergo a thyroid examination in the near future or
treatment with radioactive iodine

In all these cases, your doctor will only give you Lipiodol Ultra Fluid if
the benefits outweigh the risks. If you are given Lipiodol Ultra Fluid,
your doctor will take the precautions necessary and the administration
of Lipiodol Ultra Fluid will be carefully monitored.

If you are a child or an elderly patient, your doctor will take special
care when using lipiodol Ultra Fluid.

Taking other medicines
Please tell your doctor if you are taking or have recently taken any
other medicines, including medicines obtained without a prescription.
In particular, please inform your doctor or pharmacist if:
• you are taking or have recently taken medicines for:
- heart and blood pressure disorders such as beta-blockers (tablets
for calming the heart and decreasing the blood pressure)
• you have recently received interleukin-2 (a drug used to treat cancer
or to reinforce your immune system, i.e. your internal defence system).

Taking Lipiodol Ultra Fluid with food and drink
There are no known interactions between Lipiodol Ultra Fluid and food
or drinks.
Lipiodol Ultra Fluid is administered by injection. Therefore, there is no
special recommendation regarding intake of food and drink. However,
please check with your doctor if it is required or not to eat or drink
before the examination.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Inform your doctor if:
• you are pregnant or might be pregnant
• your period is late
• you are breast-feeding
The product should not be used during pregnancy unless the benefits
outweigh the risks. Your doctor will decide if the examination with
Lipiodol Ultra Fluid is necessary. Lipiodol Ultra Fluid must not be given
to you if you are pregnant or think you are pregnant and are due to
undergo hysterosalpingography (examination of the uterus and
fallopian tubes).
You should stop breast-feeding if you are given Lipiodol Ultra Fluid.

Driving and using machines
Lipiodol Ultra Fluid is unlikely to affect your ability to drive or use
machines. If you feel unwell after the examination, you should not
drive or use machines.
3. HOW YOU ARE GIVEN LIPIODOL ULTRA FLUID

Lipiodol Ultra Fluid will be administered to you by injection.
During the examination, you will be under the supervision of a doctor.

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A needle may be left in your vein; this will allow the doctor to inject you
with appropriate emergency drugs if necessary. If you experience an
allergic reaction, the administration of Lipiodol Ultra Fluid will be
stopped.
The attending staff knows what precautions have to be taken for the
examination. They are also aware of the possible complications that
can occur.

Dosage
Your doctor will determine the dose you will receive. The dose will
depend on the particular requirement of the examination that you
need and on your body weight.
If too much Lipiodol Ultra Fluid has been administered
to you
You will be given the injection in a medical setting by a trained person.
Therefore, it is highly unlikely that you will be given an overdose. An
overdose can make you feel ill or unwell. Therefore, you should report
any symptom you may have to your doctor. Your doctor will take the
appropriate measures if necessary.
4. POSSIBLE SIDE EFFECTS

Like all medicines, Lipiodol Ultra Fluid can cause side effects,
although not everybody gets them.

There is a small risk that you may have an allergic reaction to Lipiodol
Ultra Fluid. Such reactions can be severe and exceptionally result in
shock (very rare case of allergic reaction that could put your life in
danger).
Any of the symptoms below mentioned may be the first
signs of a shock. Inform your doctor or health
professional immediately if you feel any of them:
• swelling of the face, mouth, lips, eyelids or throat which may cause
you difficulties in swallowing or breathing
• hypotension (low blood pressure)
• breathing difficulties
• whistling breathing
• coughing
• itching
• runny nose

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• sneezing
• throat irritation or tightening
• eye irritation
• skin redness
• urticaria (skin itching nettlerash)

Other possible side effects:
• nausea (feeling sick)
• vomiting
• fever
• pain
• underactive thyroid gland (which can cause tiredness or weight gain)
• overactive thyroid gland (which can cause increased appetite,
weight loss or sweating)
• swelling of the various parts of the body (legs, arms, neck)
• embolism (blockage of blood vessels) in brain, lung, liver and retina.
This can occur without clinical signs.
• Granuloma (roughly spherical mass formed in the body by
accumulation of oily residue and cells)

Most side effects are dose-related and dosage should therefore be
kept as low as possible.

If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor.
5. HOW TO STORE LIPIODOL ULTRA FLUID

Keep out of the reach and sight of children.

Do not use Lipiodol Ultra Fluid after the expiry date which is stated on
the ampoule and on the carton, after the abbreviation “Exp”. The
expiry date refers to the last day of that month.
Do not store above 25°C
Keep the ampoule in the outer carton.

It is unlikely that you will be asked to dispose of any left over Lipiodol
Ultra Fluid. If this happens, ask your doctor what you should do.
These measures will help to protect the environment.

6. FURTHER INFORMATION
What Lipiodol Ultra Fluid contains
The active substance is iodised ethyl-esters of the fatty acids of poppy
seed oil. 1 ml of solution for injection contains 480 mg of iodine.

The other ingredients: Lipiodol Ultra Fluid does not contain any other
ingredients than the iodised ethyl-esters of the fatty acids of poppyseed oil.

What Lipiodol Ultra Fluid looks like and contents of the
pack
Lipiodol Ultra Fluid is a solution for injection.
The solution is a pale yellow, clear oily liquid.

The Lipiodol Ultra Fluid pack contains one ampoule with 10 ml of
solution for injection.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:

Guerbet

BP 57400 - 95943 Roissy CdG cedex - FRANCE
Manufacturer:

Guerbet

16-24 rue Jean Chaptal - 93600 Aulnay-sous-Bois - FRANCE

For any information about this medicine, please contact the local
representative of the Marketing Authorisation Holder:

Guerbet Laboratories Ltd
Avon House
435 Stratford road
Shirley - Solihull B90 4AA
UK
Phone: + 44 1217 338 542

This leaflet was last revised in 04/2011.

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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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