Skip to Content

SMOFLIPID 200MG/ML EMULSION FOR INFUSION

Active substance(s): FISH OIL / MEDIUM CHAIN TRIGLYCERIDES / OLIVE OIL REFINED / REFINED SOYBEAN OIL

View full screen / Print PDF » Download PDF ⇩
Transcript
Leaflet no

SMOFlipid PIL mockup UK/IE (ersätter)

Tryckspecifikation
Format:
Färger:
Utskrift:

630 x 210 mm
PMS svart
anpassat till A3

PACKAGE LEAFLET: INFORMATION FOR THE USER

SMOFlipid 200mg/ml,
emulsion for infusion
Soya-bean oil, medium chain triglycerides,
olive oil, fish oil
Read all of this leaflet carefully before you start using 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 or nurse.
• 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.
What is in this leaflet
1. What SMOFlipid is and what it is used for
2. What you need to know before you are given SMOFlipid
3. How you are given SMOFlipid
4. Possible side effects
5. How to store SMOFlipid
6. Contents of the pack and other information
1. WHAT SMOFLIPID IS AND WHAT IT IS USED FOR
SMOFlipid contains four different lipids (fats); soya-bean oil, medium
chain triglycerides, olive oil and fish oil which is rich in omega-3 fatty
acids. The liquid is a mixture of fats and water which is called a ‘lipid
emulsion’.
- It works by providing energy and fatty acids for your body
- It is put into your body by a drip or an infusion pump
A health care professional will give you SMOFlipid when other
forms of feeding are not good enough or have not worked.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN
SMOFLIPID
You should not be given SMOFlipid
• if you are allergic to soya-bean oil, medium-chain triglycerides,
oilve oil, fish oil or any of the other ingredients of this medicine
(listed in section 6)
• if you are allergic (hypersensitive) to any other products
containing fish, egg, soy or peanut.
• if you have too much fat in the blood (called ‘severe hyperlipemia’)
• if you have serious kidney or liver problems
• if you have sever blood clotting problems (called ‘coagulation
disorders’)
• if you are in acute shock
• if you have fluid in the lungs (called ‘pulmonary oedema’), too
much body fluid (called ‘hyperhydration’) or have heart failure
(due to too much body fluid).

7:e korr 2015-04-24
Niklas Baudin, 018 64 40 91

• if you are in an unstable condition, for example shortly after
serious injury, heart attack, stroke, blood clot (thrombosis),
metabolic acidosis (metabolic disturbance which results in high
acid levels in the blood), or untreated diabetes, blood
poisoning and dehydration.
Warnings and precautions
Talk to your doctor or nurse before having this medicine:
• if you have a problem with high levels of lipids in the blood due
to your body not being able to use fat properly (called
‘impaired lipid metabolism’).
Allergic reactions
If you have an allergic reaction while having SMOFlipid, it needs
to be stopped straight away, Tell the doctor or nurse straight
away if you get any of the following while you are having the
infusion:
- fever (high temperature)
- shivering
- rash
- difficulty breathing
Children
Talk to your doctor or nurse if this medicine is being given to
your newborn child and they have:
- too much of a substance called ‘bilirubin’ in their blood
(hyperbilirubinemia)
- high pressure in their lungs (pulmonary hypertension)
If your newborn child has SMOFlipid for a long time the doctor
will take blood tests to see how it is working.
Other medicines and SMOFlipid
Tell your doctor if you are taking or have recently taken any other
medicines.
In particular, tell your doctor if you are taking or have recently
taken drugs used to stop blood clotting, such as warfarin and
heparin.
- SMOFlipid naturally contains vitamin K1, which can affect
warfarin. However, the vitamin K1 content of SMOFlipid is so slow
that such problems are unlikely.
- Heparin given in clinical doses may at first cause higher levels
of fatty acids in the blood due to liberation of fatty acids from
the tissues into the bloodstream and then less fatty acids are
removed from your blood (decreased trigylceride clearance)
Pregnancy and breast-feeding
It is not known whether is is safe to have SMOFlipid while you are
pregnant or breast-feeding. If you need to have direct feeding
into your vein during pregnancy or breast-feeding, your doctor
will give you SMOFlipid only after careful consideration.
If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor for advice before
you are given this medicine.

Driving and using machines
Not relevant as the medicine is given at the hospital.

The following information is intended for healthcare
professionals only:

Smoflipid contains sodium
This medicinal product contains 5 mmol (115 mg) sodium per
1000 ml. To be taken into consideration by patients on a controlled
sodium diet.

Warnings and precautions
The concentration of triglycerides in serum should not exceed
3 mmol/l during infusion. An overdose may lead to fat overload
syndrome. Special caution should be taken in patients with a
marked risk for hyperlipidemia (e.g. patients with high lipid
dosage, severe sepsis and extremely low birth weight infants).

3. HOW YOU ARE GIVEN SMOFLIPID
SMOFlipid is put into your body by a drip or an infusion pump.
Your doctor will decide your dose depending on your body weight
and your ability to utilise the amount of fat infused.
For medical and health care professionals, please see the “Method
of administration” at the end of this leaflet for more details
regarding dosage and administration.
If you are given more SMOFlipid than you should
In case the dose SMOFlipid given to you is too high, there is a risk
of taking in more fat than your body can handle. This is called ‘fat
overload syndrome’. See section 4, Possible Side Effects, for more
information.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although
not everybody gets them.
Fat overload syndrome
This might happen when your body has problems using fat,
because of having too much SMOFlipid. It may also happen
because of a sudden change in your condition (such as
kidney problems or infection). The fat overload syndrome is
characterized by high levels of fat in the blood (hyperlipidemia),
fever, more fat in your tissues than normal (fat infiltration) and
disorders in various organs of the body and coma. All symptoms
will usually disappear when you stop having the infusion.
Common (may affect up to 1 in 10 people)
• slight rise in body temperature
Uncommon (may affect up to 1 in 100 people)
• shivering
• loss of appetite
• feeling sick (nausea)
• being sick (vomiting)
Rare (may affect up to 1 in 1,000 people)
• allergic reactions (e.g. high temperature, swelling, lowering of
blood pressure, skin rash, redness, headache)
• feelings of hot and cold
• paleness
• bluish discolouration of skin and mucous membranes (due to
reduced oxygen content in the blood)
• pains in neck, back, bones, chest and lower back

Administration of medium-chain fatty acids alone can result in
metabolic acidosis. This risk is to a great extent eliminated by
the simultaneous infusion of the long chain fatty acids included
in SMOFlipid. Concomitant administration of carbohydrates
will further eliminate this risk. Hence, simultaneous infusion of
carbohydrate or a carbohydrate-containing amino acid solution
is recommended. Laboratory tests generally associated with
monitoring of intravenous nutrition should be checked regularly.
These include blood glucose levels, liver functions tests, acid
base metabolism, fluid balance, full blood count and electrolytes.

not show any evidence of phase separation. For single use only.
Any unused emulsion should be discarded.
Additives: SMOFlipid may be aseptically admixed with amino acid,
glucose, and electrolyte solutions to produce “All-In-One” Total
Parenteral Nutrition (TPN) admixtures. Compatibility for different
additives and the storage time of the different admixtures will be
available upon request from the marketing authorisation holder.
Additions should be made aseptically. Any mixture remaining
after infusion must be discarded.

Instructions for use Fresenius Kabi infusion bag
1.

Do not store above 25°C. Do not freeze.
Storage after mixing
If additions are made to SMOFlipid, the admixtures should
be used immediately from a microbiological point of view. If
admixtures are 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 2-8°C, unless
additions have taken place in controlled and validated aseptic
conditions.

A

This medicinal product contains soya-bean oil, fish oil and egg
phospholipids, which may rarely cause allergic reactions. Cross
allergic reaction has been observed between soya-bean and peanut.

The integrity indicator (Oxalert™) A should be
inspected before removing the overpouch. If the
indicator is black the overpouch is damaged and the
product should be discarded.

Any sign or symptom of anaphylactic reaction (such as
fever, shivering, rash or dyspnoea) should lead to immediate
interruption of the infusion.
SMOFlipid should be given with caution to neonates and
prematures with hyperbilirubinemia and cases with pulmonary
hypertension. In neonates, particularly prematures on
long term parenteral nutrition, blood platelet counts, liver
function tests and serum triglycerides should be monitored.

B

2.

SMOFlipid contains up to 5 mmol sodium per 1000ml. To be taken
into consideration by patients on a controlled sodium diet.
The addition of other medicaments or substances to SMOFlipid
should generally be avoided unless compatibility is known.
Method of administration
Intravenous infusion into a peripheral or central vein.
Instructions for use and handling
Use only if the emulsion is homogeneous. For Excel bag: the
integrity indicator (Oxalert) should be inspected before removing
the over-pouch. If the indicator is black, oxygen has penetrated
the over-pouch and the product should be discarded.
Inspect the emulsion visually for phase separation prior to
administration. Ensure that the final emulsion for infusion does

A

B

Remove the overwrap by tearing at the notch and
pulling down along the container. The Oxalert™
sachet A and the oxygen absorber B should be
disposed.
V002/UP
xxx xxx

• raised or lowered blood pressure
• shortness of breath
Very rare (may affect up to 1 in 10,000 people)
• prolonged and convulsive erection in men

3.

5.

7.

Reporting of side effects
If you notice side effects, please tell your doctor or nurse, 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 (see details below). By reporting
side effects you can help provide more information on the safety
of this medicine.
For the UK: you can report side effects directly via the Yellow card
Scheme
www.mhra.gov.uk/yellowcard
For Ireland:
You can also report side effects directly via

If additions are to be made, swab injection site.

Remove set port cover lifting ring with thumb and
forefinger and pulling upwards.

The bag should be with the port side up when the
infusion set is attached. Insert the spike straight
into the set port. Twist and push the spike through
the diaphragm. The spike should be fully inserted
to ensure its retention.

6.
Closed

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What SMOFlipid contains

Place the container on a table and support the
base of the medication port. Fully insert the needle
through centre of injection site. Mix thoroughly by
inverting container several times.

Vented

Use a non-vented infusion set or close the air vent
on a vented set. Follow the instructions for use for
the infusion set.

To hang the bag, invert and place hanger through
container notch.

Refined soya-bean oil
Medium-chain triglycerides
Refined olive Oil
Fish oil, rich in omega-3 fatty acids
The other ingredients are
Glycerol
Egg lecithin
All-rac-α-tocopherol (vitamin E)

Glass bottle
100 ml
10x100 ml
250 ml
10x250 ml
500 ml
10x500 ml

Excel bag
100 ml
10x100 ml
250 ml
10x250 ml
500 ml
12x500 ml

Marketing Authorisation Holder:
Fresenius Kabi Limited
Cestrian Court
Eastgate Way
Manor Park
Runcorn
Cheshire
WA7 1NT
UK
Manufacturer:
Fresenius Kabi AB, SE-751 74 Uppsala, Sweden (plastic bags)
For any information about this medicinal product, please contact
the local representative of the Marketing Authorisation Holder:
This medicinal product is authorised in the Member States
of the EEA under the following names:
Austria, Belgium, Finland, France, Germany, Iceland, Ireland,
Italy, Netherlands, Norway, Sweden, United Kingdom: SMOFlipid
200 mg/ml

The active substances are:
Non-vented

Package sizes

Marketing Authorisation Holder and Manufacturer

HPRA Pharmacovigilance,
Earlsfort Terrace,
IRL - Dublin 2;
Tel: +353 1 6764971;
Fax: +353 1 6762517.
Website: http://www.hpra.ie
E-mail: medsafety@hpra.ie

Keep this medicine out of the sight and reach of children
Do not store above 25°C. Do not freeze. Do not use SMOFlipid after
the expiry date which is stated on the label after EXP. The expiry
date refers to the last day of that month. Do not use SMOFlipid if
you notice that the package is damaged. Use only if the solution is
white and homogenous. For single use only. Any unused product
should be thrown away. Do not re-use it.

8.

What SMOFlipid looks like and contents of the pack
SMOFlipid is a white, homogenous emulsion and is available in
glass bottles or plastic bags.

Not all package sizes may be marketed.

5. HOW TO STORE SMOFLIPID

4.

Water for injections
Sodium hydroxide (pH adjustment)
Sodium oleate

60 mg/ml
60 mg/ml
50 mg/ml
30 mg/ml

Cyprus, Czech Republic, Estonia, Greece, Hungary, Latvia, Lithuania,
Luxembourg, Slovenia, Spain: SMOFlipid 20%
Denmark, Poland, Portugal, Slovakia: SMOFlipid
This leaflet was last revised in April 2015
V002/UP
xxx xxx

Product Name:
SMOFlipid
Type of Packaging:
Leaflet
Material number:
M089329/03 UK
Pharma-Code (Laetus)
9197
Dimension:
420 x 210 mm

Territory:

UK
Dosage:
2-D-Matrix Code
EAN
Code: –
Font:

Colour:




1. Draft

24.04.2015, 09:30

Variable Data:

Black
Fold lines

Arial

Smallest Size: 9

Operator: Roberto Grill +43(0) 699-17181288

M089329/03 UK

PACKAGE LEAFLET: INFORMATION FOR THE USER

SMOFlipid 200 mg/ml

emulsion for infusion
Soya-bean oil, medium chain triglycerides,
olive oil, fish oil







Read all of this leaflet carefully before you start using 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 or nurse.

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.
What is in this leaflet
1. What SMOFlipid is and what it is used for
2. What you need to know before you are given SMOFlipid
3. How you are given SMOFlipid
4. Possible side effects
5. How to store SMOFlipid
6. Contents of the pack and other information
1. What SMOFlipid is and what it is used for
SMOFlipid contains four different lipids (fats); soya-bean oil,
medium chain triglycerides, olive oil and fish oil which is rich in
omega-3 fatty acids. The liquid is a mixture of fats and water
which is called a ‘lipid emulsion’.

It works by providing energy and fatty acids for your body

It is put into your blood by a drip or an infusion pump
A health care professional will give you SMOFlipid when other
forms of feeding are not good enough or have not worked.
2. What you need to know before you are given SMOFlipid
You should not be given SMOFlipid:

if you are allergic to soya-bean oil, medium-chain
tryglycerides, olive oil, fish oil or any of the other ingredients
of this medicine (listed in section 6).

if you are allergic (hypersensitive) to any other products
containing fish, egg, soy or peanut.

if you have too much fat in the blood (called ‘severe
hyperlipemia’).

if you have serious kidney or liver problems.
if you have severe blood clotting problems (called
‘coagulation disorders’).
if you are in acute shock.
if you have fluid in the lungs (called ‘pulmonary oedema’) ,
too much body fluid (called ‘hyperhydration’) or have heart
failure (due to too much body fluid).
if you are in an unstable condition, for example shortly after
serious injury, heart attack, stroke, blood clot (thrombosis),
metabolic acidosis (metabolic disturbance which results in
high acid levels in the blood), or untreated diabetes, blood
poisoning and dehydration.


Warnings and precautions
Talk to your doctor or nurse before having this medicine if you
have a problem with high levels of lipids in the blood due to
that your body cannot use fat properly (called ‘impaired lipid
metabolism’).

Allergic reactions
If you have an allergic reaction while having SMOFlipid, it needs
to be stopped straight away. Tell the doctor or nurse straight
away if you get any of the following while you are having the
infusion:

fever (high temperature)

shivering

rash

difficulty breathing
Children
Talk to your doctor or nurse if this medicine is being given to your
newborn child and they have:

too much of a substance called “bilirubin” in their blood
(hyperbilirubinemia)

a high pressure in their lungs (pulmonary hypertension)
If your newborn child has SMOFlipid for a long time the doctor
will take blood tests to see how it is working.

Other medicines and SMOFlipid
Tell your doctor if you are taking, have recently taken any other
medicines.
In particular, tell your doctor if you are taking or have recently
taken drugs used to stop blood clotting, such as warfarin and
heparin.

V002-GZ




SMOFlipid naturally contains vitamin K1 , which can affect
warfarin. However, the vitamin K1 content in SMOFlipid is
so low that such problems are unlikely.
Heparin given in clinical doses may at first cause higher
levels of fatty acids in the blood due to liberation of fatty
acids from the tissues into the bloodstream and then
less fatty acids are removed from your blood (decreased
triglyceride clearance).

Pregnancy and breast-feeding
It is not known whether it is safe to have SMOFlipid while you are
pregnant or breast-feeding. If you need to have direct feeding
into your vein during pregnancy or breast-feeding, your doctor
will give you SMOFlipid only after careful consideration.
If you are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor for advice before
you are given this medicine.

The following information is intended for medical or healthcare
professionals only:
Warnings and precautions
The concentration of triglycerides in serum should not exceed
3 mmol/l during infusion. An overdose may lead to fat overload
syndrome. Special caution should be taken in patients with a
marked risk for hyperlipidemia (e.g. patients with high lipid
dosage, severe sepsis and extremely low birth weight infants).

Driving and using machines
Not relevant as the medicine is given at the hospital.

Administration of medium-chain fatty acids alone can result in
metabolic acidosis. This risk is to a great extent eliminated by
the simultaneous infusion of the long chain fatty acids included
in SMOFlipid. Concomitant administration of carbohydrates
will further eliminate this risk. Hence, simultaneous infusion of
carbohydrate or a carbohydrate-containing amino acid solution
is recommended. Laboratory tests generally associated with
monitoring of intravenous nutrition should be checked regularly.
These include blood glucose levels, liver functions tests, acid
base metabolism, fluid balance, full blood count and electrolytes.

Smoflipid contains sodium
This medicinal product contains 5 mmol (115 mg) sodium
per 1000 ml. To be taken into consideration by patients on a
controlled sodium diet.

This medicinal product contains soya-bean oil, fish oil and egg
phospholipids, which may rarely cause allergic reactions. Cross
allergic reaction has been observed between soya-bean and
peanut.

3. How you are given SMOFlipid
SMOFlipid is put into your blood by a drip or an infusion pump.
Your doctor will decide your dose depending on your body weight
and your ability to utilise the amount of fat infused.
For medical and health care professionals, please see “Method of
administration” at the end of this leaflet for more details regarding
dosage and administration.
If you are given more SMOFlipid than you should
In case the dose SMOFlipid given to you is too high, there is
a risk of taking in more fat than your body can handle. This is
called ‘fat overload syndrome’. See section 4, Possible side
effects, for more information.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although
not everybody gets them.

Any sign or symptom of anaphylactic reaction (such as fever,
shivering, rash or dyspnoea) should lead to immediate interruption
of the infusion.
SMOFlipid should be given with caution to neonates and
prematures with hyperbilirubinemia and cases with pulmonary
hypertension. In neonates, particularly prematures on long term
parenteral nutrition, blood platelet counts, liver function tests and
serum triglycerides should be monitored.
SMOFlipd contains up to 5 mmol sodium per 1000 ml. To be taken
into consideration by patients on a controlled sodium diet.
The addition of other medicaments or substances to SMOFlipid
should generally be avoided unless compatibility is known.

Method of administration
Intravenous infusion into a peripheral or central vein.
Instructions for use and handling
Use only if the emulsion is homogeneous. For Excel bag: the
integrity indicator (Oxalert) should be inspected before removing
the over-pouch. If the indicator is black, oxygen has penetrated
the over-pouch and the product should be discarded. Inspect the
emulsion visually for phase separation prior to administration.
Ensure that the final emulsion for infusion does not show any
evidence of phase separation. For single use only. Any unused
emulsion should be discarded.
Additives: SMOFlipid may be aseptically admixed with amino
acid, glucose, and electrolyte solutions to produce “All-In-One”
Total Parenteral Nutrition (TPN) admixtures. Compatibility
for different additives and the storage time of the different
admixtures will be available upon request from the marketing
authorisation holder. Additions should be made aseptically. Any
mixture remaining after infusion must be discarded.
Do not store above 25oC. Do not freeze.
Storage after mixing
If additions are made to SMOFlipid, the admixtures should
be used immediately from a microbiological point of view. If
admixtures are 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 2-8°C, unless
additions have taken place in controlled and validated aseptic
conditions.

Fat overload syndrome
This might happen when your body has problems using fat,
because of having too much SMOFlipid. It may also happen
because of a sudden change in your condition (such as
kidney problems or infection). The fat overload syndrome is
characterized by high levels of fat in the blood (hyperlipidemia),
fever, more fat in your tissues than normal (fat infiltration) and
disorders in various organs of the body and coma. All symptoms
will usually disappear when you stop having the infusion.
Common (may affect up to 1 in 10 people)

slight rise in body temperature
Uncommon (may affect up to 1 in 100 people)

shivering

loss of appetite

feeling sick (nausea)

being sick (vomiting)
Rare (may affect up to 1 in 1,000 people)

allergic reactions (e.g. high temperature, swelling, lowering
of blood pressure, skin rash, redness, headache)

feelings of hot and cold

paleness

bluish discolouration of skin and mucous membranes
(due to reduced oxygen content in the blood)

pains in neck, back, bones, chest and lower back

raised or lowered blood pressure

shortness of breath
Very rare (may affect up to 1 in 10,000 people)

prolonged and convulsive erection in men
Reporting of side effects
If you notice any side effects, please tell your doctor or nurse.

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
(see details below). By reporting side effects you can help
provide more information on the safety of this medicine.

For the UK:
you can report side effects directly via the Yellow card Scheme:
www.mhra.gov.uk/yellowcard

Package sizes
Glass bottle
100 ml
10x100 ml
250 ml
10x250 ml
500 ml
10x500 ml

For Ireland:
You can also report side effects directly via
HPRA Pharmacovigilance,
Earlsfort Terrace,
IRL - Dublin 2;
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
E-mail: medsafety@hpra.ie
E-mail: medsafety@hpra.ie

Not all package sizes may be marketed.
Marketing Authorisation Holder and Manufacturer

5. How to store SMOFlipid
Keep this medicine out of the sight and reach of children. Do not
store above 25°C. Do not freeze. Do not use SMOFlipid after
the expiry date which is stated on the label after EXP. The expiry
date refers to the last day of that month. Do not use SMOFlipid if
you notice that the package is damaged. Use only if the solution
is white and homogenous. For single use only. Any unused
product should be thrown away. Do not re-use it.
6. Contents of the pack and other information
What SMOFlipid contains

The active substances are:
Refined soya-bean oil
Medium-chain triglycerides
Refined Olive Oil
Fish oil, rich in omega-3 fatty acids

Excel bag
100 ml
10x100 ml
250 ml
10x250 ml
500 ml
12x500 ml

Marketing Authorisation Holder:
Fresenius Kabi Limited
Cestrian Court
Eastgate Way
Manor Park
Runcorn
Cheshire
WA7 1NT
UK
Manufacturer:
Fresenius Kabi Austria GmbH, A-8055 Graz, Austria (glass bottles)

60 mg/ml
60 mg/ml
50 mg/ml
30 mg/ml

For any information about this medicinal product, please contact
the local representative of the Marketing Authorisation Holder.
This medicinal product is authorised in the Member States
of the EEA under the following names:

The other ingredients are
Glycerol
Egg lecithin
All-rac-α-tocopherol (vitamin E)
Water for injections
Sodium hydroxide (pH adjustment)
Sodium oleate

Austria, Belgium, Finland, France, Germany, Iceland, Ireland,
Italy, Netherlands, Norway, Sweden, United Kingdom:
SMOFlipid 200 mg/ml

Cyprus, Czech Republic, Estonia, Greece, Hungary, Latvia,
Lithuania, Luxembourg, Slovenia, Spain:
SMOFlipid 20%

What SMOFlipid looks like and contents of the pack

Denmark, Poland, Portugal, Slovakia:
SMOFlipid

This leaflet was last revised in April 2015.

SMOFlipid is a white, homogenous emulsion and is available in
glass bottles or plastic bags.



Product Name:
SMOFlipid
Type of Packaging:
Leaflet
Material number:
M080083/01 UK
Pharma-Code (Laetus)
Dimension:
180 x 294 mm

Territory:

UK
Dosage:
2-D-Matrix Code
M080083/01 UK
EAN
Code: –
Font:

Colour:




1. Draft

24.04.2015, 11:00

Variable Data:

Black
Fold lines

Arial

Smallest Size: 8

Operator: Roberto Grill +43(0) 699-17181288

PACKAGE LEAFLET: INFORMATION FOR THE USER

SMOFlipid 200 mg/ml

emulsion for infusion
Soya-bean oil, medium chain triglycerides,
olive oil, fish oil
Read all of this leaflet carefully before you start using 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 or nurse.
• 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.
In this leaflet:
1. What SMOFlipid is and what it is used for
2. What you need to know before you are given SMOFlipid
3. How you are given SMOFlipid
4. Possible side effects
5. How to store SMOFlipid
6. Contents of the pack and other information
1. What SMOFlipid is and what it is used for
SMOFlipid contains four different lipids (fats); soya-bean oil, medium
chain triglycerides, olive oil and fish oil which is rich in omega-3 fatty
acids. The liquid is a mixture of fats and water which is called a ‘lipid
emulsion’.
• It works by providing energy and fatty acids for your body
• It is put into your blood by a drip or an infusion pump
A health care professional will give you SMOFlipid when other forms
of feeding are not good enough or have not worked.
2. What you need to know before you are given SMOFlipid
You should not be given SMOFlipid:
• if you are allergic to soya-bean oil, medium-chain tryglycerides,
olive oil, fish oil or any of the other ingredients of this medicine
(listed in section 6).
• if you are allergic (hypersensitive) to any other products
containing fish, egg, soy or peanut.
• if you have too much fat in the blood (called ‘severe hyperlipemia’).
• if you have serious kidney or liver problems.
• if you have severe blood clotting problems (called ‘coagulation
disorders’).
• if you are in acute shock.
• if you have fluid in the lungs (called ‘pulmonary oedema’) , too
much body fluid (called ‘hyperhydration’) or have heart failure
(due to too much body fluid).
• if you are in an unstable condition, for example shortly after
serious injury, heart attack, stroke, blood clot (thrombosis),
metabolic acidosis (metabolic disturbance which results in high
acid levels in the blood), or untreated diabetes, blood poisoning
and dehydration.

Warnings and precautions
Talk to your doctor or nurse before having this medicine if you have
a problem with high levels of lipids in the blood due to that your body
cannot use fat properly (called ‘impaired lipid metabolism’).
Allergic reactions
If you have an allergic reaction while having SMOFlipid, it needs to

be stopped straight away. Tell the doctor or nurse straight away if you
get any of the following while you are having the infusion:
• fever (high temperature)
• shivering
• rash
• difficulty breathing
Children
Talk to your doctor or nurse if this medicine is being given to your
newborn child and they have:
• too much of a substance called “bilirubin” in their blood
(hyperbilirubinemia)
• a high pressure in their lungs (pulmonary hypertension)
If your newborn child has SMOFlipid for a long time the doctor
will take blood tests to see how it is working.

Other medicines and SMOFlipid
Tell your doctor if you are taking, have recently taken any other
medicines.
In particular, tell your doctor if you are taking or have recently taken
drugs used to stop blood clotting, such as warfarin and heparin.
• SMOFlipid naturally contains vitamin K1 , which can affect
warfarin. However, the vitamin K1 content in SMOFlipid is so low
that such problems are unlikely.
• Heparin given in clinical doses may at first cause higher levels
of fatty acids in the blood due to liberation of fatty acids from
the tissues into the bloodstream and then less fatty acids are
removed from your blood (decreased triglyceride clearance).
Pregnancy and breast-feeding
It is not known whether it is safe to have SMOFlipid while you are
pregnant or breast-feeding. If you need to have direct feeding into
your vein during pregnancy or breast-feeding, your doctor will give
you SMOFlipid only after careful consideration.
If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have a baby, ask your doctor for advice before you
are given this medicine.
Driving and using machines
Not relevant as the medicine is given at the hospital.
Smoflipid contains sodium
This medicinal product contains 5 mmol (115 mg) sodium per 1000 ml.
To be taken into consideration by patients on a controlled sodium diet.
3. How you are given SMOFlipid
SMOFlipid is put into your blood by a drip or an infusion pump. Your
doctor will decide your dose depending on your body weight and
your ability to utilise the amount of fat infused.
For medical and health care professionals, please see “Method of
administration” at the end of this leaflet for more details regarding
dosage and administration.
If you are given more SMOFlipid than you should
In case the dose SMOFlipid given to you is too high, there is a risk
of taking in more fat than your body can handle. This is called ‘fat
overload syndrome’. See section 4, Possible side effects, for more
information.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although
not everybody gets them.

The following information is intended for medical or healthcare professionals only:
Warnings and precautions
The concentration of triglycerides in serum should not exceed 3 mmol/l during infusion. An overdose may lead to fat overload syndrome. Special
caution should be taken in patients with a marked risk for hyperlipidemia (e.g. patients with high lipid dosage, severe sepsis and extremely low birth
weight infants).
Administration of medium-chain fatty acids alone can result in metabolic acidosis. This risk is to a great extent eliminated by the simultaneous
infusion of the long chain fatty acids included in SMOFlipid. Concomitant administration of carbohydrates will further eliminate this risk. Hence,
simultaneous infusion of carbohydrate or a carbohydrate-containing amino acid solution is recommended. Laboratory tests generally associated
with monitoring of intravenous nutrition should be checked regularly. These include blood glucose levels, liver functions tests, acid base metabolism,
fluid balance, full blood count and electrolytes.
This medicinal product contains soya-bean oil, fish oil and egg phospholipids, which may rarely cause allergic reactions. Cross allergic reaction has
been observed between soya-bean and peanut.
Any sign or symptom of anaphylactic reaction (such as fever, shivering, rash or dyspnoea) should lead to immediate interruption of the infusion.
SMOFlipid should be given with caution to neonates and prematures with hyperbilirubinemia and cases with pulmonary hypertension.
In neonates, particularly prematures on long term parenteral nutrition, blood platelet counts, liver function tests and serum
triglycerides should be monitored.
M080083/01 UK

Fat overload syndrome
This might happen when your body has problems using fat,
because of having too much SMOFlipid. It may also happen
because of a sudden change in your condition (such as kidney
problems or infection). The fat overload syndrome is characterized
by high levels of fat in the blood (hyperlipidemia), fever, more fat in
your tissues than normal (fat infiltration) and disorders in various
organs of the body and coma. All symptoms will usually disappear
when you stop having the infusion.

6. Contents of the pack and further information

Common (may affect up to 1 in 10 people)
• slight rise in body temperature

The other ingredients are
Glycerol
Egg lecithin
All-rac-α-tocopherol (vitamin E)
Water for injections
Sodium hydroxide (pH adjustment)
Sodium oleate

Uncommon (may affect up to 1 in 100 people)
• shivering
• loss of appetite
• feeling sick (nausea)
• being sick (vomiting)

What SMOFlipid contains
The active substances are:
Refined soya-bean oil
Medium-chain triglycerides
Refined Olive Oil
Fish oil, rich in omega-3 fatty acids

60 mg/ml
60 mg/ml
50 mg/ml
30 mg/ml

What SMOFlipid looks like and contents of the pack

Rare (may affect up to 1 in 1,000 people)
• allergic reactions (e.g. high temperature, swelling, lowering of
blood pressure, skin rash, redness, headache)
• feelings of hot and cold
• paleness
• bluish discolouration of skin and mucous membranes (due to
reduced oxygen content in the blood)
• pains in neck, back, bones, chest and lower back
• raised or lowered blood pressure
• shortness of breath

SMOFlipid is a white, homogenous emulsion and is available in
glass bottles or plastic bags.

Very rare (may affect up to 1 in 10,000 people)
• prolonged and convulsive erection in men

Marketing Authorisation Holder and Manufacturer

Reporting of side effects
If you notice any side effects, please tell your doctor or nurse. 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 (see details below). By reporting
side effects you can help provide more information on the safety
of this medicine.
For the UK:
you can report side effects directly via the Yellow card Scheme
www.mhra.gov.uk/yellowcard
For Ireland:
You can also report side effects directly via
HPRA Pharmacovigilance,
Earlsfort Terrace,
IRL - Dublin 2;
Tel: +353 1 6764971;
Fax: +353 1 6762517.
Website: www.hpra.ie;
E-mail: medsafety@hpra.ie
5. How to store SMOFlipid
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Do not freeze.
Do not use SMOFlipid after the expiry date which is stated on the
label after EXP. The expiry date refers to the last day of that month.

Package sizes
Glass bottle
100 ml
10x100 ml
250 ml
10x250 ml
500 ml
10x500 ml

Excel bag
100 ml
10x100 ml
250 ml
10x250 ml
500 ml
12x500 ml

Marketing Authorisation Holder:
Fresenius Kabi Limited
Cestrian Court
Eastgate Way
Manor Park
Runcorn
Cheshire
WA7 1NT
UK
Manufacturer:
Fresenius Kabi Austria GmbH, A-8055 Graz, Austria (glass bottles)
For any information about this medicinal product, please contact
the local representative of the Marketing Authorisation Holder.
This medicinal product is authorised in the Member States of
the EEA under the following names:
Austria, Belgium, Finland, France, Germany, Iceland, Ireland, Italy,
Netherlands, Norway, Sweden, United Kingdom:
SMOFlipid 200 mg/ml
Cyprus, Czech Republic, Estonia, Greece, Hungary, Latvia,
Lithuania, Luxembourg, Slovenia, Spain:
SMOFlipid 20%
Denmark, Poland, Portugal, Slovakia:
SMOFlipid

This leaflet was last revised in April 2015.


Do not use SMOFlipid if you notice that the package is damaged.
Use only if the solution is white and homogenous. For single use
only. Any unused product should be thrown away. Do not re-use it.

SMOFlipd contains up to 5 mmol sodium per 1000 ml. To be taken into consideration by patients on a controlled sodium diet.
The addition of other medicaments or substances to SMOFlipid should generally be avoided unless compatibility is known.
Method of administration
Intravenous infusion into a peripheral or central vein.
Instructions for use and handling
Use only if the emulsion is homogeneous. For Excel bag: the integrity indicator (Oxalert) should be inspected before removing the
over-pouch. If the indicator is black, oxygen has penetrated the over-pouch and the product should be discarded. Inspect the emulsion visually for
phase separation prior to administration. Ensure that the final emulsion for infusion does not show any evidence of phase separation. For single use
only. Any unused emulsion should be discarded.
Additives: SMOFlipid may be aseptically admixed with amino acid, glucose, and electrolyte solutions to produce “All-In-One” Total Parenteral
Nutrition (TPN) admixtures. Compatibility for different additives and the storage time of the different admixtures will be available upon request from
the marketing authorisation holder. Additions should be made aseptically. Any mixture remaining after infusion must be discarded.
Do not store above 25oC. Do not freeze.
Storage after mixing
If additions are made to SMOFlipid, the admixtures should be used immediately from a microbiological point of view. If admixtures are 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
2-8°C, unless additions have taken place in controlled and validated aseptic conditions.
V002/GZ

Expand view ⇕

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.

Hide