Patient Medication Information: uses, side effects, how to take - Smoflipid 20%
What SMOFlipid 20% is used for:
SMOFlipid 20% is used in adults and children to provide energy, essential fatty acids and omega-3 fatty acids from fish oil. It is administered into your blood by a drip or an infusion pump.
SMOFlipid 20% is used when you or your child are unable to take food by mouth or when other forms of feeding have not worked (e.g., nasogastric tube, direct catheter).
How SMOFlipid 20% works:
SMOFlipid 20% helps to ensure adequate intake of calories and essential fatty acids. This helps to prevent or treat malnutrition.
The ingredients in SMOFlipid 20% are:
Medicinal ingredients: fish oil, olive oil, soybean oil, triglycerides.
Non-medicinal ingredients: all-rac-α-tocopherol, glycerol, purified egg phospholipids, sodium hydroxide, sodium oleate.
SMOFlipid 20% comes in the following dosage form(s):
Emulsion; 20% (6% soybean oil / 6% medium chain triglycerides / 5% olive oil / 3% fish oil)
Do not use SMOFlipid 20% if you or your child:
- are suffering from a heart attack, acute stroke, metabolic acidosis (too much acid in the blood), severe infection (sepsis), dehydration or a blockage in the arteries.
- have an unstable medical condition.
- are allergic (hypersensitive) to fish, fish oil, eggs, olive oil, triglycerides or any of the non-medicinal ingredients in SMOFlipid 20% (see The ingredients in SMOFlipid 20% are ).
- are allergic to peanuts or soya. SMOFlipid 20% contains soybean oil.
- have especially high levels of fats in your blood (severe hyperlipidemia).
- have severe liver problems.
- have severe blood clotting disorders.
- have severe kidney problems without access to hemofiltration or dialysis.
- are in an acute shock.
- have any of the following serious conditions: fluid accumulation in your lungs, excess water content in your body, heart failure.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you or your child take SMOFlipid 20%. Talk about any health conditions or problems you may have, including if you:
are pregnant or planning to become pregnant.
- are breastfeeding or planning to breastfeed.
- have high level of lipids (fats) in your blood.
have trouble metabolizing (breaking down) fats, which may happen if you have:
- kidney or liver problems
- diabetes
- pancreatitis (inflammation of the pancreas)
- thyroid problems
- serious infection
Other warnings you should know about:
Aluminum Toxicity: This product contains aluminum. Aluminum can build up in your body and become harmful in patients with kidney problems and premature babies. Talk to your healthcare professional if you have kidney problems or are taking any other medicines that also contain aluminum.
Blood tests and monitoring: Your healthcare professional will perform regular blood tests while you or your child are taking SMOFlipid 20%. They will check your blood glucose, electrolyte, and fat levels as well as the health of your blood cells and liver and your body’s fluid balance. Your healthcare professional will decide when to perform these tests and will interpret the results.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with SMOFlipid 20%:
- medicines used to prevent blood clots, such as coumarin derivatives or heparin
SMOFlipid 20% may interfere with certain laboratory tests. It is important to tell any healthcare professional doing tests that you are using SMOFlipid 20%.
How to take SMOFlipid 20%:
- SMOFlipid 20% will be given to you or your child in a hospital or clinic setting by a healthcare professional.
- In all cases aseptic techniques must be followed when administering SMOFlipid 20% to reduce the possibility of infection.
- SMOFlipid 20% will be given directly into a vein as an infusion over 12 to 24 hours.
- SMOFlipid 20% may be mixed by your healthcare professional with carbohydrates, amino acids, salts, vitamins and trace elements which together provide your complete nutritional needs.
Usual dose:
- Your healthcare professional will decide on the dose and flow rate that are right for you or your child based on your medical needs.
Instructions for use and handling:
Before using SMOFlipid 20% inspect the emulsion and the bag. The emulsion should appear milk-like. If there are particles in the emulsion, it is discoloured or the bag is leaking or damaged discard the bag and use a new one.
Each bag should be used only once. If there is any emulsion left in the bag after you have given yourself your dose throw it away. Do not use a partially used bag.
Use SMOFlipid 20% immediately after the overwrap has been removed.
The medicine must be at room temperature to be administered.
Figure 1
Before removing the overwrap from the bag, look at the integrity indicator (Oxalert™). This is the sachet labelled as “A” in Figure 1. If the indicator is black the overwrap is damaged, and the product should be discarded.
Figure 2
Place the bag on the clean, flat surface. 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 discarded.
Figure 9
If additives are to be used break off the tamper-evident arrow flag from the white additive port. If no additives are to be used go to Error! Reference source not found..
Figure 4
Insert the needle horizontally through the centre of the septum of the additive port and inject the additives as instructed by your healthcare professional. Use syringes with needles of 18-23 gauge and a length of max. 40 mm.
Figure 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.
Figure 6
Break off the tamper- evident arrow flag from the blue infusion port.
Non-vented
Vented
to be
closed
Figure 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.
Figure 8
Hang the bag in the hanger cut and start the infusion.
When used in neonates and children below 2 years, SMOFlipid 20% should be protected from light exposure until administration is completed.
Overdose:
If you think that you have received too high a dose or that SMOFlipid 20% was infused too quickly, talk to your healthcare professional immediately. In the case of an overdose there is a risk of receiving too much fat. This is called “fat overload syndrome”. In these cases, the fat infusion should be stopped or, if necessary, continued at a reduced dose. See the Serious side effects and what to do about them table, below for more information.
Possible side effects from using SMOFlipid 20%:
These are not all the possible side effects you may have when taking SMOFlipid 20%. If you or your child experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- nausea, vomiting
- lack of appetite
- chills
- shortness of breath
If you think you, or a person you are caring for, have taken too much SMOFlipid 20%, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Serious side effects and what to do about them
| Symptom / effect | Talk with your healthcare professional | Stop taking drug and get immediate medical help | ||||
|---|---|---|---|---|---|---|
| Only if severe | In all cases | |||||
| RARE | ||||||
| Hypotension (low blood pressure): dizziness, fainting, light-headedness, blurred vision, nausea, vomiting, fatigue (may occur when you go from lying or sitting to standing up) | √ | |||||
| Hypertension (high blood pressure): shortness of breath, fatigue, dizziness or fainting, chest pain or pressure, swelling in your ankles and legs, bluish colour to your lips and skin, racing pulse or heart palpitations | √ | |||||
| Allergic reaction: difficulty swallowing or breathing, wheezing, drop in blood pressure, nausea, vomiting, hives or rash, flushing, headache, swelling of the face, lips, tongue or throat | √ | |||||
| Fat overload syndrome: fever, yellowing of the skin and eyes, abdominal pain, vomiting, pale skin, fatigue, loss of energy, shortness of breath, weakness, swollen lymph nodes, frequent infections, bruising or bleeding for longer than usual if you hurt yourself, coma | √ | |||||
| Parenteral nutrition-associated liver disease (PNALD): abdominal pain, nausea, vomiting, loss of appetite, fatigue, weakness, jaundice (yellowing of the skin or whites of eyes), itching, light coloured stools, dark urine, confusion | √ | |||||
| VERY RARE | ||||||
| Priapism: Long-lasting (greater than 4 hours in duration) and painful erection of the penis | √ | |||||
If you or your child have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Store up to 25 °C. Do not freeze.
Keep out of reach and sight of children.
If you want more information about SMOFlipid 20%:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada Drug Product Database website (Drug Product Database: Access the database); the manufacturer’s website (http://www.fresenius-kabi.ca), or by calling 1-877-821-7724 (toll-free-telephone).
Fresenius Kabi Canada Ltd.
165 Galaxy Blvd, Suite 100
Toronto, ON M9W 0C8
Date of Authorization: 2026-09-17
Fresenius Kabi is a registered trademark of Fresenius SE.