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OLICLINOMEL N4-720E EMULSION FOR INFUSION

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PACKAGE LEAFLET: INFORMATION FOR THE USER

OLICLINOMEL N4-720 E, Emulsion for Infusion
Read all of this leaflet carefully before you start taking this medicine.






Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even
if their symptoms are the same as yours.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet,
please tell your doctor.

In the leaflet:
1.
2.
3.
4.
5.
6.

What OLICLINOMEL is and what it is used for
Before you use OLICLINOMEL
How to use OLICLINOMEL
Possible side effects
How to store OLICLINOMEL
Further information

1. WHAT OLICLINOMEL IS AND WHAT IS IT USED FOR
OLICLINOMEL is used to provide nutrition in adults and children above two years of age by a tube into a
vein when normal feeding by mouth is not suitable.
OLICLINOMEL must only be used under medical supervision.

2. BEFORE YOU USE OLICLINOMEL
Do not use OLICLINOMEL and tell your doctor if:
• the patient is a premature baby, an infant or a child less than 2 years old.
• you are hypersensitive (allergic) to egg, soya proteins or to any other ingredient of OLICLINOMEL.
• you have severe problems with your kidneys without access to a kidney function replacement
therapy, such as dialysis.
• you have severe problems with your liver.
• your body has problems using amino acids.
• you have problems which affect your blood clotting (coagulation disorders).
• you have especially high level of fats in your blood (hyperlipidaemia).
• you have hyperglycaemia (too much sugar in your blood), which requires more than 6 units

insulin/h.
• you have a high and pathological plasma concentration of one of the electrolytes included

in OLICLINOMEL.
Sometimes treatment with this medicine is not suitable, such as if you have:
• Acute pulmonary oedema (fluid in your lungs), hyperhydration (too much water in your body), heart
failure, dehydration, or in unstable situations such as those following severe injuries, untreated
diabetes mellitus, shock due to a sudden heart failure, heart attack, severe metabolic acidosis
(when the blood is excessively acid), sepsis (general infection which may cause fever, feeling cold
and shivery) and coma.

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In all cases, your doctor will base his/her decision on whether you should receive this medicine on
factors such as age, weight and clinical condition, together with the results of any tests performed.

Take special care with OLICLINOMEL
If any abnormal signs or symptoms of an allergic reaction develop, such as fever, shivering, skin
rashes or breathing difficulties, excessive sweating, nausea and headache, the infusion will be stopped
immediately. This medicinal product contains soya and egg-derived products that may rarely cause
severe allergic reactions.
The balance of water and salt in your body and metabolic disorders will be corrected before starting the
infusion. Your doctor will monitor your condition while you receive this medicine and may change the
dosage or give you additional nutrients such as vitamins, electrolytes and trace elements if he/she feels
it is appropriate.
To check the effectiveness and ongoing safety of the administration, your doctor will perform clinical
and laboratory tests while you are receiving this medicine. If you are given this medicine for several
weeks, your blood will be monitored on a regular basis. These tests are particularly required in case
you suffer from certain conditions, such as a liver disorder, a kidney disorder, a disorder whereby amino
acids cannot be processed by the body, a disorder in which the blood becomes too acidic, a disorder in
which the level of fats and cholesterol is higher than normal, diabetes, or if you suffer from anaemia or
difficulty to stop bleeding.
If the patient is a child, special care will be taken to give the right dosage. Vitamin and trace element
supplementation may be required depending on dose and duration. Increased precautions will
also be taken because of the greater sensitivity of children to risks of infection.

Taking other medicines
OLICLINOMEL must not be administered together with blood through the same infusion tubing. If you
are taking other medicines, obtained with or without medical prescription, you should tell your doctor in
advance so they can check they are compatible.

Pregnancy and Breastfeeding
As for any medicine, if you are pregnant or think that you may be pregnant, or if you are breastfeeding,
you should tell your doctor or nurse in advance, as this medicine may not be suitable for you.

3. HOW TO USE OLICLINOMEL
OLICLINOMEL should only be given in adults and children above two years of age.
It is an emulsion for infusion, that is given through a plastic tube into a vein in your arm or into a large
vein in your chest.
The prescription may be continued for as long as it is needed, depending upon your clinical condition.

Dosage – Adults
Your doctor will decide the amount you are given depending on your individual needs and clinical
condition.
The maximum daily dose is 40 ml of emulsion per kg of body weight. For example: if you weigh 70 kg,
the maximum daily dose should not exceed 2,800 ml of emulsion (40 ml of emulsion times 70 kg).

Dosage – Children above two years of age
Your doctor will decide the dose the child will need and for how long it will be given. This will depend on
age, weight and height, clinical condition, daily fluid volume, energy and nitrogen requirements.
The maximum daily dose is 75 ml of emulsion per kg of body weight. For example: if the patient is
a child weighing 30 kg, the maximum daily dose should not exceed 2250 ml of emulsion (75 ml of
emulsion times 30 kg).

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If you use more OLICLINOMEL than you should
If the dose given is too high or the infusion too fast, the amino acids content may make your blood too
acid and you may have too much fluid in the circulation. The glucose content may increase the glucose
in your blood and urine or the lipid content may increase the triglycerides in your blood. Giving too
high a volume may cause nausea, vomiting, shivering and electrolyte disturbances, in these cases the
infusion should be stopped immediately.
In some severe cases, your doctor may have to give you temporary renal dialysis to help your kidneys
eliminate the excess product.
To prevent these events occurring, your doctor will regularly monitor your condition and test your blood
parameters.
If you have any further questions on the use of this product, ask your doctor.

4. POSSIBLE SIDE EFFECTS
Like all medicines, OLICLINOMEL can cause side effects, although not everybody gets them. If you notice
any changes in the way you feel during or after the treatment, tell your doctor or nurse straight away.
The tests your doctor will perform while you are taking the medicine are meant to minimise side effects.
If any abnormal signs or symptoms of an allergic reaction (hypersensitivity to egg or soybean protein)
develop, such as raised body temperature, shivering, skin rashes or breathing difficulties, excessive
sweating, nausea and headache, the infusion will be stopped immediately.
Other side effects have been noticed, occurring more or less frequently:
• Abnormal blood test for the liver function.
• Increase in the size of the liver (hepatomegaly)
• Rare cases of jaundice (yellowing of the skin or white of the eyes caused by a liver or blood
problem)
• Thrombophlebitis (blood clot in a vein which causes pain, swelling and redness) when a hypertonic
solution is infused
• Decrease in the number of platelets (reduction in the number of cells in charge of blood clotting
which causes bleeding such as nosebleed)
• Reduced ability to remove the lipids contained in OLICLINOMEL may result in a "fat overload
syndrome" which may be caused by overdose but may also occur at the start of an infusion, even
according to instructions, and is associated with a sudden deterioration in the patient's clinical
condition. It is characterised by high levels of fats in your blood, fever, liver fatty infiltration (high
levels of fat in your liver), increase in your liver volume, anaemia (reduction in the red blood cells
which can make the skin pale and cause weakness or breathlessness), a fall in white blood cells
and blood platelets, problem with your blood clotting and coma. All of these symptoms are usually
reversible when the lipid emulsion infusion is stopped.
Rare cases of fall in white blood cells and blood platelets have been reported in children.
If any side effect gets serious, or if you notice any side effect not listed in this leaflet, please tell your
doctor or pharmacist.

5. HOW TO STORE OLICLINOMEL
Keep out of the reach and sight of children.
Do not use OLICLINOMEL after the expiry date, which is stated on the container and the outer packaging.
The expiry date refers to the last day of that month.
Do not freeze.
Store in the original package in order to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.

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6. FURTHER INFORMATION
What OLICLINOMEL contains
The active substances for each bag of the reconstituted emulsion are:
Active substances
Refined soya bean oil + refined
olive oil *
L-alanine
L-arginine
Glycine
L-histidine
L-isoleucine
L-leucine
L-lysine
(as lysine hydrochloride)
L-methionine
L-phenylalanine
L-proline
L-serine
L-threonine
L-tryptophan
L-tyrosine
L-valine
Sodium acetate 3H2O
Sodium glycerophosphate, 5H2O
Potassium chloride
Magnesium chloride 6H2O
Glucose
(as glucose monohydrate)
Calcium chloride 2H2O
Total calories (kcal)
Non-protein calories (kcal)

2500 ml
100.00 g
11.39 g
6.33 g
5.67 g
2.64 g
3.30 g
4.02 g
3.19 g
(3.99 g)
2.20 g
3.08 g
3.74 g
2.75 g
2.31 g
0.99 g
0.22 g
3.19 g
6.12 g
3.83 g
4.47 g
1.02 g
200.00 g
(220.00 g)
0.66 g
2020
1800

* Mixture of refined olive oil (approximately 80%) and refined soya bean oil (approximately 20%).
The other ingredients are purified egg lecithin, glycerol, sodium oleate, sodium hydroxide, glacial acetic
acid, Hydrochloric acid, water for injections.

What OLICLINOMEL looks like and contents of the pack
OLICLINOMEL is an emulsion for infusion package in a three-chamber bag, which is a multi-layer
plastic bag. The inner (contact) layer of the bag material is made from polymers (blend of polyolefinic
copolymers) compatible with constituent (amino acid solutions, glucose solutions and lipid emulsions)
and authorized additives and allowing to make peelable seals. The polymers used for the entire film
structure are made of EVA (poly(ethylene-vinyl acetate)), and of a copolyester.
Before the contents of the three chambers in the bag are mixed, 1 chamber contains a homogenous
liquid with a milky appearance (the lipid emulsion), while the two other chambers (containing the amino
acid solution with electrolytes and the glucose solution with calcium chloride) contain a colourless
or lightly yellow solution. Once mixed, OLICLINOMEL is an emulsion for infusion which looks like a
homogenous and milky-white liquid.
To prevent contact with oxygen from the air the bag is packaged in an oxygen barrier overpouch, which
contains an oxygen absorber sachet.
Pack sizes
2500 ml bag: carton with 2 bags

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Marketing Authorisation Holder
For any information about OLICLINOMEL, please contact the Marketing Authorisation Holder:
Baxter Healthcare Ltd, Caxton Way, Thetford, Norfolk, IP24 3SE, The United Kingdom

Manufacturers
Baxter, Boulevard René Branquart, 80, 7860 Lessines, Belgium
This leaflet was approved in February 2010

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The following information is intended for medical or healthcare professionals only:

OLICLINOMEL N4-720 E, Emulsion for Infusion
1. QUANTITATIVE COMPOSITION
After the contents of the three compartments have been mixed the appearance of the mixture is a
homogenous milk-like emulsion. The mixed emulsion for each of the different bag presentations provides
the following:
Per bag

2500 ml

Nitrogen (g)

9.1

Amino acids (g)

55

Total calories (kcal)

2020

Non-protein calories (kcal)

1800

Glucose calories (kcal)

800

Lipid calories (kcal)

1000

Non-protein calorie/nitrogen ratio (kcal/g N)

200

Sodium (mmol)

70

Potassium (mmol)

60

Magnesium (mmol)

5

Calcium (mmol)

4.5

Phosphate (mmol)**

20

Acetate (mmol)

100

Chloride (mmol)

100

pH

6

Osmolarity (mOsm/l)

800

** Including phosphates provided by the lipid emulsion

2. POSOLOGY AND METHOD OF ADMINISTRATION
The dosage will depend on metabolic requirements, energy expenditure and the patient's clinical
condition.
The administration may be continued for as long as is required by the patient’s clinical conditions.
As a general rule do not exceed doses of 3 g/Kg/day of amino acids and/or 17 g/Kg/day of glucose and/
or 3 g/Kg/day of lipids, except in particular cases.

Dosage and infusion rate – Adults
Average nitrogen requirements are 0.16 to 0.35 g/kg/day (approximately 1 to 2 g of amino acids/kg/day).
Energy requirements vary depending on the patient's nutritional state and level of catabolism. On
average these are 25 to 40 kcal/kg/day.
The recommended duration of the parenteral nutrition infusion is between 12 and 24 hours. Normally,
the flow rate is increased gradually during the first hour without exceeding 3 ml per kilogram of your
bodyweight per hour, and the maximal dose is 40 ml per kilogram of your bodyweight per day.

Dosage and infusion rate – Children above 2 years of age
Average nitrogen requirements are 0.35 to 0.45 g/kg/day (approximately 2 to 3 g of amino acids/kg/day).
Energy requirements vary depending on the patient's age, nutritional state and level of catabolism. On
average these range between 60 and 110 kcal/kg/day.
The dosage is based on fluid intake and daily nitrogen requirements.
These intakes should be adjusted to take account of the child's hydration status.
Usually, the flow rate is increased gradually during the first hour without exceeding 3 ml per kilogram of
bodyweight per hour, and the maximal daily dose is 75 ml/kg of your bodyweight.

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Route of administration
OLICLINOMEL must be administered intravenously through a central or peripheral vein.
Maximum infusion rate
As a general rule, do not exceed 3 ml/kg/hour of the emulsion for infusion, i.e. 0.06 g of amino acids,
0.24 g of glucose and 0.12 g of lipids per kg body weight per hour.
The administration flow rate should be adjusted to take account of the dose being administered, the
characteristics of the final mixture being infused, the daily volume intake and the duration of the
infusion.

3. SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Water and electrolyte equilibration disorders and metabolic disorders must be corrected before starting
the infusion.
Because this product does not contain vitamins or trace elements, any such additions must be defined
and supplementation provided depending on these requirements. The osmolarity of the final admixture
after additions must be defined before administration.
Caution should be exercised in administering OLICLINOMEL to patients with increased osmolarity,
adrenal insufficiency, heart failure or pulmonary dysfunction.
Strict aseptic conditions must be observed when the catheter is inserted or handled all along infusion.
Specific clinical monitoring is required when an intravenous infusion is started.
This medicinal product contains soya oil, which may rarely cause severe hypersensitivity reactions.
The infusion must be stopped immediately if any abnormal signs or symptoms of an allergic reaction
(such as fever, shivering, skin rashes or respiratory difficulties) develop.
Monitor water and electrolyte balance, serum osmolarity, acid/base balance, blood glucose and liver
function tests throughout treatment.
Serum triglyceride concentrations and the ability of the body to remove lipids must be checked
regularly.
Serum triglyceride concentrations must not exceed 3 mmol/l during the infusion. These concentrations
should not be determined before a minimum of a 3-hour period of continuous infusion.
If a lipid metabolism abnormality is suspected, it is recommended that tests be performed daily by
measuring serum triglycerides after a period of 5 to 6 hours without administering lipids. In adults, the
serum must be clear in less than 6 hours after stopping the infusion containing the lipid emulsion. The
next infusion should only be administered when the serum triglyceride concentrations have returned to
normal values.
In addition, regular clinical and laboratory tests are required particularly in cases of:
– Amino acid metabolism disorders.
– Hepatic insufficiency because of the risk of developing or worsening neurological disorders
associated with hyperammonaemia.
– Renal insufficiency, particularly if hyperkalaemia is present; risk of developing or worsening
metabolic acidosis and hyperazotemia if extra-renal waste removal is not being performed.
– Metabolic acidosis (administration of carbohydrates is not recommended in the presence of lactic
acidosis).
– Diabetes mellitus: monitoring of glucose concentrations, glucosuria, ketonuria and, where
applicable, adjustment of insulin dosages.
– Coagulation disorders.
– Anaemia.
– Hyperlipidaemia (because of the presence of lipids in the emulsion for infusion).
The blood count and coagulation factors must be monitored more carefully during long term
administration (several weeks).
Special precautions in paediatrics
Dosage should be adapted according to age, nutritional status and disease and, when necessary,
additional energy or protein will be given orally/enterally.
Vitamin and trace element supplementation is always required. Paediatric formulations should be used.

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4. PRACTICAL INFORMATION ON PREPARATION AND HANDLING
Only use OLICLINOMEL if:
– the bag is undamaged
– the non-permanent seals are intact
– the glucose and amino acid solutions are clear, colourless or slightly yellow
– the lipid emulsion is homogeneous and milk-like.
OLICLINOMEL should be at room temperature before use.
Only administer the product after the non-permanent seals between the three compartments have been
broken and the contents of the three compartments have been mixed as shown below.
1.

2.

Tear from the top to open the overpouch.

Peel the front of the overpouch to reveal the
OLICLINOMEL bag. Discard the overpouch and
oxygen absorber sachet.
4.

3.

Place the bag flat on a horizontal and clean
surface with handle in front of you.
5.

Lift the hanger area to remove solution from the
upper bag. Firmly roll the upper bag until peal seal
is fully open (approximately half way).
6.

Mix by turning the bag upside-down at least
3 times. Ensure a homogenous mixture, with no
evidence of phase separation.

Hang the bag. Twist off the protector from the
administration outlet. Firmly plug the spike
connector.

After opening the bag, the content must be used immediately and must never be stored for a
subsequent infusion.
For single use only. Any unused product or waste material and all necessary devices must be discarded.
Do not connect in series.

Supplementation
Do not add other medicinal products or substances to one of the three components of the bag or to
the reconstituted emulsion without firstly confirming their compatibility with the mixture of the three
components and the stability of the resulting preparation (in particular stability of the lipid emulsion).
However, OLICLINOMEL can be used as such or after supplementation with electrolytes, trace elements
or vitamins, when required.

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Any additions (including vitamins) may be made into the reconstituted mixture (after the non-permanent
seals have been opened and the contents of the three compartments have been mixed).
Vitamins may also be added into the glucose compartment before the mixture has been reconstituted
(before opening the non-permanent seals and before mixing the solutions and the emulsion).
OLICLINOMEL may be supplemented with:
– Electrolytes: take account of the electrolytes already present in the bag: stability has been
demonstrated up to a total quantity of 150 mmol of sodium, 150 mmol of potassium, 5.6 mmol of
magnesium and 5 mmol of calcium per litre of the ternary mixture.
– Organic phosphate: stability has been demonstrated for additions of up to 15 mmol per bag.
– Trace elements and vitamins: stability has been demonstrated up to the recommended daily dose.
Paediatric formulations are required for children.
Additions must be performed under aseptic conditions.
These additions are made into the injection site using a needle:
– Prepare the injection site,
– Puncture the injection site and inject,
– Mix the contents of the bag and the additives.
When making additions, the final osmolarity of the mixture must be measured before administration. The
mixture obtained should be administered through a central or peripheral venous line depending on its
final osmolarity. Administered peripherally a hypertonic emulsion may cause irritation of the vein.

Interactions
The lipids contained in this emulsion may interfere with the results of certain laboratory tests (for
example, bilirubin, lactate dehydrogenase, oxygen saturation, blood haemoglobin) if the blood sample
is taken before the lipids have been eliminated (these are generally eliminated after a period of 5 to 6
hours without receiving lipids).

Incompatibilities
This emulsion for infusion must not be administered simultaneously with blood through the same
infusion tubing because of the possibility of pseudoagglutination.
Incompatibilities may be produced for example by excessive acidity (low pH) or inappropriate content of
divalent cations (Ca2+ and Mg2+), which may de-stabilise the lipid emulsion.
Check compatibility with solutions administered simultaneously through the same giving set, catheter or
cannula.

5. SHELF LIFE
2 years if the overwrap is not damaged.
It is recommended that the product is used immediately after the non-permanent seals between the
3 compartments have been opened. The reconstituted emulsion has, however, been shown to be stable
for a maximum of 7 days at between +2° and +8°C followed by a maximum of 48 h at temperatures not
exceeding +25°C.
After supplementation (electrolytes, trace elements, vitamins) of reconstituted OLICLINOMEL, (see
previous section), chemical and physical in-use stability has been demonstrated for 7 days at
2 to 8°C followed by 48 hours below 25°C. From a microbiological point of view, any admixture should
be used immediately. If not used immediately, in-use storage times and conditions prior to use are the
responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless addition of
supplements has taken place in controlled and validated aseptic conditions.

Baxter and Oliclinomel are trademarks of Baxter International Inc.

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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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