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CLINOLEIC 20%

Active substance(s): OLIVE OIL REFINED / SOYA-BEAN OIL REFINED

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ClinOleic 20% Emulsion for infusion
Refined olive oil and refined soya bean oil

Read all of this leaflet carefully before you are given this
medicine because it contains important information for
you.

Your doctor will take special care with ClinOleic if:

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• This medicine has been prescribed for you. Do not pass it on to others.
It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or nurse. This includes
any possible side effects not listed in this leaflet, see section 4.

The infusion will be stopped immediately if you have any sign of
allergic reaction. Signs include sweating, fever, chills, headache, skin
rash, dyspnoea (difficulty to breathe). This medicinal product contains
soya‑bean oil and egg phospholipids. Soybean and egg proteins may
cause hypersensitivity reactions. Cross-allergic reactions between
soybean and peanut proteins have been observed.

Special clinical monitoring is required at the start of any infusion into your
veins (intravenous infusion).

Certain medications and illnesses can increase the risk of developing
infection or sepsis (bacteria in the blood). There is a particular risk of
infection or sepsis when a tube is placed in your vein. Your doctor will
carefully watch you for any signs of infection.

In this leaflet:
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3
4
5
6

What ClinOleic is and what it is used for
What you need to know before you are given ClinOleic
How ClinOleic is given
Possible side effects
How ClinOleic is stored
Contents of the pack and other information

Your doctor should be aware of:
• severe conditions affecting how your body handles sugars, fats,
proteins or salt (metabolic disorders)
• a severe blood infection (sepsis)
• a severe liver disease
• a blood clotting (coagulation) disorder

Throughout this leaflet ClinOleic 20% will be called
ClinOleic.

If you are not sure if any of the above apply to you, talk to your doctor or
nurse before being given ClinOleic.

1 What ClinOleic is and what it is used for

Special care with use in children (paediatric use)
ClinOleic is suitable for use in young children if its use is monitored
carefully.

ClinOleic is an emulsion of olive oil (80%) and soya bean oil (20%) for
infusion. ClinOleic is a milky looking liquid that is sterile (sometimes called
a sterile emulsion). It contains:
• a source of energy, and
• some fats called essential fatty acids.

Using other medicines
Please tell your doctor, nurse or pharmacist if you are taking or have
recently taken any other medicines. This includes medicines obtained
without a prescription, including herbal medicines.

ClinOleic is used to give you food straight into your blood, when you
cannot take enough food by your mouth. This method of feeding
(parenteral nutrition) is used when food and drink cannot be taken in
through the digestive system for medical reasons.

The olive and soybean oils present in ClinOleic contain vitamin K. This
does not normally affect blood thinning medicines (anticoagulants) like
coumarin. However, if you take anticoagulant medicines you should tell
your doctor.

It is usually given with other things such as sugars (carbohydrates) and
the building blocks for protein (called amino acids).

Pregnancy and breast-feeding

2 What you need to know before you are given ClinOleic

If you are pregnant think you might be pregnant, or are breastfeeding, tell
your doctor. He or she will decide if you can be given ClinOleic.

ClinOleic must not be given if you:

3 How ClinOleic is given

• are allergic (hypersensitive) to the active substances (egg, soybean
or peanut protein) or to any of the other ingredients (see section 6,
“Further information” at the end of this leaflet). Signs of an allergic
reaction include being short of breath, wheezing, rash, itching or
swelling of the face and lips,
• have a problem with the way your body handles fat, especially if tests
show that you have a high amount of fat in your blood,
• have problems with your kidneys (lipod nephrosis) or inflammation of
the pancreases (acute pancreatitis) if accompanied by high levels of fat
in your blood.

ClinOleic will be given to you by a healthcare professional.
• Your doctor will decide how much you will need, the rate it is given to
you and for how long.
• This will depend on the amount of nutrition you need and the reason
you are being given ClinOleic.
• You will usually be given ClinOleic an infusion or drip through a plastic
tube which will be into a vein, usually in your chest.
• Any other medicines or blood that you might need will not be given
through this tube.

Do not use ClinOleic if any of the above apply to you. If you are not sure
talk to your doctor or nurse before using ClinOleic.

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DATE 15 Jan 2015
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BE-30-02-367

If you are given more ClinOleic than you should

If you get any side effects, talk to your doctor, nurse or pharmacist. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly (see details below). By reporting side effects
you can help provide more information on the safety of this medicine.

An overdose can cause a reduction in your body’s ability to remove lipids
from ClinOleic (fat overload syndrome). Your doctor will stop giving you
ClinOleic or reduce the amount you are given until the level of fats in your
blood returns to normal (see also section 4. Possible side effects).

Yellow Card Scheme
www.mhra.gov.uk/yellowcard

If you have any further questions on the use of this product, ask your
doctor or pharmacist.

5 How ClinOleic is stored

4 Possible side effects

• Keep this medicine out of the sight and reach of children.
• Do not store above 25ºC. Do not freeze.
• Do not use ClinOleic after the expiry date which is stated on the label
after EXP. The expiry date refers to the last day of that month.
• ClinOleic must not be used if the container is damaged or the emulsion
is not evenly milky.
• The solution should only be used once. Any leftover solution should
not be reconnected and should be disposed of by your healthcare
professional.

Like all medicines, ClinOleic can cause side effects, although not
everybody gets them. The following side effects may happen with this
medicine:
If you notice any abnormal signs at the beginning of the infusion tell
your doctor or nurse straightaway and your treatment will be stopped
immediately. These signs include sweating, chills, headache and breathing
difficulty
Other side effects have been noticed, occurring more or less frequently:

6 Contents of the pack and other information

The following side effects are common and could affect 1 to 10 users in
100:
– Feeling sick (nausea), being sick (vomiting)
– Decrease of blood pressure
– Increased of sugar level in blood (hyperglycaemia)
– Decreased in blood protein levels (hypoproteinemia)
– Increased level of fats or triglycerides in the blood (hyperlipidaemia,
blood triglycerides increased)
– Swelling of the belly (abdominal distension)
– Yellowing of the skin and eyes caused by gall-bladder problems or
increased levels of bilirubin
– Muscle spasms
– Abnormal liver function test results

What ClinOleic contains
• The active substances are refined olive oil (80%) and refined soybean
oil (20%) making up 200 g in 1000 ml of emulsion
• The other ingredients are glycerol, egg phosphatides, sodium oleate
and sterile water (called ‘water for injections’). It may also contain very
small amounts of sodium hydroxide. This can be used to modify the
acid level of ClinOleic.

What ClinOleic looks like and contents of the pack
ClinOleic is supplied as an emulsion for infusion (slow injection or drip) in
a plastic bag container in a plastic overwrap which contains either 100 ml,
250 ml, 350 ml or 500 ml of emulsion. These pack sizes may not all be
marketed. A 1000 ml volume is also available, for pharmacy use only.

The following side effects are uncommon and could affect 1 to 10 users in
1,000:
– Decrease in the number of white blood cells that could lead to an
infection which lasts longer, is more severe, or occurs more often
than usual
– Failure of the blood circulatory system (circulatory collapse)
– Decreased blood pressure (hypotension)
– Hot flush
– Difficulty breathing
– Pain and discomfort around the stomach area (epigastric
discomfort)
– Inflammation of the liver which can cause jaundice, weight loss and
malaise
– Back pain
– Chills
– Increased level of enzymes from the pancreas

An oxygen absorber/ oxygen indicator sachet is included inside the
overwrap. Before opening the overwrap, the colour of the oxygen indicator
should be checked. It should match the reference colour printed next to
the OK symbol and shown in the printed area of the indicator label. The
sachet should be disposed of after removing the overwrap.

Marketing Authorisation Holder and Manufacturer
The Marketing Authorisation holder is:
Baxter Healthcare Ltd
Caxton Way
Thetford
Norfolk
IP24 3SE

The following side effects have also been reported at an unknown
frequency:
– Longer bleeding or easy bruising
– Swelling of the gallbladder
– Gall stones
– Itching sensation (pruritus)

Send all enquiries to this address.

If you have a reduced ability to remove the lipids contained in ClinOleic,
this may result in a “fat overload syndrome”. It may cause a sudden
worsening in your clinical condition. Fat overload syndrome can result in:
• fever
• pale colour of the skin
• prolonged bleeding and bruising
• yellowing of the skin and the eyes

This leaflet was last revised 09/2014.

All of these symptoms are usually reversible when the infusion is stopped.

Baxter and ClinOleic are trademarks of Baxter International Inc.
BE-30-02-367

ClinOleic is made at:
Baxter SA
Bd. R. Branquart 80
B-7860 Lessines
Belgium

For information about ClinOleic or to request
this leaflet in formats such as audio or
large print please contact the Marketing
Authorisation Holder: Tel: 01635 206345.
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EMEA ARTWORK DESIGN CENTRE
ARTWORK APPROVAL
1st DRAFT
RA TO APPROVE
LAYOUT AND
FORMAT
Country

DATE 15 Jan 2015
PLANT APPROVAL
HALLE ONLY
N/A

Name

N/A

Signature

N/A

Date

N/A

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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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