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SMOFLIPID 200MG/ML EMULSION FOR INFUSION

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

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SMOFlipid PIL - UK (ersätter)
Tryckspecifikation
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630 x 210 mm
PMS svart
anpassat till A3
8 pt

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.
- f 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).

4:e korr 2016-08-26,
Johanna Eriksson

- 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 or might
take 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.
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

----------------------------------------------------------------------------The following information is intended for 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 hyperlipidema (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 test 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.

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.

Instruction for use Fresenius Kabi infusion bag

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.

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.

1. 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.

2.

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.

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

SMOFlipd contains up to 5 mmol sodium per 1000 ml. To be taken
into consideration by patients on a controlled sodium diet.

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

Method of administration
Intravenous infusion into a peripheral or central vein.

The addition of other medicaments or substances to SMOFlipid
should generally be avoided unless compatibility is known.

Instructions for use and handling
Use only if the emulsion is homogeneous.
Infusion 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.

2. 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.

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

3.

4.

5.
Closed

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

Non-vented

3. If no additives are to be used go to figure 5. If additives are
to be used, break off the tamper-evident arrow flag from the
white additive port.

4. Take the syringe containing the additives. Hold the base of
the additive port. Insert the needle horizontally through the
centre of the septum of the additive port and inject the
additives (with known compatibility). Use syringes with needles
of 18 - 23 gauge and length of max. 40 mm.

Vented

5. Use a non-vented infusion set or close the air vent on a vented
set. Follow the instructions for use for the infusion set. Use a
spike with diameter as specified in ISO 8536-4, 5.6 +/- 0.1 mm.

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: http://www.hpra.ie
E-mail: medsafety@hpra.ie

5. How to store SMOFlipid
Keep this medicine out of the sight and reach of children.

6.

7.

8.

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

6. Break off the tamper-evident arrow flag from the blue infusion
port.

7. Hold the base of the infusion port. Insert the spike through
the infusion port, by rotating your wrist slightly until the spike
is inserted.

8. Hang the bag in the hanger cut and start infusion.

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

SMOFlipid is a white, homogenous emulsion and is available in
glass bottles or plastic bags.
Package sizes
Glass bottle
100 ml
10x100 ml
250 ml
10x250 ml
500 ml
10x500 ml

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

Not all package sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
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, Slovenia, Sweden, United Kingdom:
SMOFlipid 200 mg/ml
Cyprus, Czech Republic, Estonia, Greece, Hungary, Latvia, Lithuania,
Luxembourg, Spain: SMOFlipid 20%

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

What SMOFlipid looks like and contents of the pack

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

Denmark, Poland, Portugal, Slovakia: SMOFlipid
This leaflet was last revised in August 2016

v002/UP/BIO

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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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