200 mg/ml infusion solution , emulsion
soybean oil, medium-chain triglycerides, olive oil, fish oil
What SMOFlipid is and what it is used for
SMOFlipid contains four different types of fat; soybean oil, medium-chain triglycerides, olive oil, and fish oil that is rich in omega-3 fatty acids. The liquid is a fat emulsion, i.e. a mixture of fat and water.
- It works by supplying energy and fatty acids to your body
- It is given directly into the blood as a drip or with the help of an infusion pump
You are given SMOFlipid by healthcare professionals when other forms of nutrition are insufficient or do not work.
What you need to know before you are given SMOFlipid
You should not be given SMOFlipid:
- if you are allergic to soybean oil, medium-chain triglyceride, olive oil, fish oil, or any other ingredient in this medicine (listed in section 6),
- if you are allergic (hypersensitive) to other products containing fish, egg, soy protein, or peanuts,
- if you have abnormally high levels of fats in your blood (severe hyperlipidemia),
- if you have serious problems with your kidneys or liver,
- if you have problems that strongly affect blood clotting,
- in acute shock,
- if you have fluid in your lungs ( pulmonary edema), too much fluid in your body (hyperhydration), or heart failure due to too much fluid in the body.
- in unstable conditions associated with serious injuries, heart attack, stroke, blood clots, metabolic acidosis (disorder in the metabolism that produces too much acid in the blood), or untreated diabetes, blood poisoning, and dehydration.
Warnings and precautions
Talk to your doctor or nurse before receiving this medicine if you have problems with high levels of fat in the blood due to a lack of ability to break down fat (impaired lipid metabolism).
When used to treat newborns and children under 2 years of age, the solution (in bags and administration sets) should be protected from light exposure until the administration is completed. If SMOFlipid is exposed to ambient light, especially after the addition of trace elements and/or vitamins, peroxides and other degradation products are formed, which can be reduced if the product is protected from light exposure.
Allergic reactions
If you experience an allergic reaction when you are given SMOFlipid, the administration must be stopped immediately. Tell your doctor or nurse right away if you experience any of the following while receiving the infusion:
- fever
- overindulge
- rash
- breathing difficulties
Children
Talk to the doctor or nurse when this medicine is given to your newborn baby if the baby has:
- too high a level of bilirubin in the blood (hyperbilirubinemia),
- too high pressure in the lungs ( pulmonary hypertension ).
If your newborn baby is given SMOFlipid for a longer period, the doctor will take blood samples to check the treatment.
Other medicines and SMOFlipid
Tell your doctor if you have recently taken, or might take any other medicines.
Be especially careful to inform your doctor if you are using, or have recently used, blood-thinning medicines such as warfarin and heparin.
- SMOFlipid has a natural content of vitamin K 1, which can affect warfarin. However, the amount of vitamin K 1 is so small that this problem is unlikely to occur.
- Heparin given in an effective dose can first produce higher levels of fatty acids in the blood due to the release of fatty acids from body tissue into the blood and then because fewer fatty acids disappear from the blood (reduced elimination of triglycerides ).
Pregnancy and breastfeeding
The safety of use during pregnancy and breastfeeding has not been investigated. Sometimes, however, it may be necessary to receive nutrition intravenously and if your doctor gives you SMOFlipid, it will only be after careful consideration.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Driving ability and use of machinery
Not relevant because the medicine is given in a hospital.
SMOFlipid contains sodium
This medicine contains 5 mmol (or 115 mg) sodium per 1000 ml. This should be taken into account by patients prescribed a low-salt diet.
How SMOFlipid is given
SMOFlipid is given directly into the blood as a drip or with an infusion pump. Your doctor decides your dose based on your body weight and ability to assimilate the fat in the infusion fluid.
When used to treat neonates and children under 2 years of age, the solution (in bags and administration sets) should be protected from light exposure until the administration is completed (see section 2).
For healthcare professionals, see ‘Method of administration’ at the end of this leaflet for more detailed information on dosage and administration.
If you are given too much SMOFlipid:
If the amount of SMOFlipid you have received is too large, there is a risk that you have received more fat than your body can take care of. This is called “fat overload syndrome”. See section 4, Possible side effects, for further information.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Fat overload syndrome
This can occur when your body has trouble taking care of fat when you have taken too much SMOFlipid. It can also occur due to a sudden change in your condition (such as kidney problems or an infection ). Fat overload syndrome is characterized by high levels of fat in the blood ( hyperlipidemia ), fever, more fat in your body tissue than normal (fat infiltration), dysfunction of various organs, as well as unconsciousness. All symptoms usually disappear when the infusion is stopped.
Common (may affect up to 1 in 10 users):
- slight increase in body temperature.
Uncommon (may affect up to 1 in 100 users):
- overindulge,
- loss of appetite,
- nausea,
- vomiting.
Rare (may affect up to 1 in 1,000 users):
- allergic reactions (e.g. fever, swelling, drop in blood pressure, rash, redness, headache),
- experience of heat or cold,
- pallor,
- bluish discoloration of the skin and mucous membranes (due to reduced oxygen content in the blood),
- pains in the neck, back, bones, chest, and lower back,
- increased or decreased blood pressure,
- respiratory distress.
Very rare (may affect up to 1 in 10,000 users):
- prolonged and spasmodic erection.
How SMOFlipid should be stored
Keep this medicine out of the sight and reach of children.
Store at a maximum of 25°C. Do not freeze.
Use before the expiry date stated on the packaging. The expiration date is the last day of the specified month.
Do not use this medicine if the packaging is damaged. Use only if the solution is white and homogeneous. For single use only. Any remaining infusion fluid must be discarded. May not be reused.
When used to treat neonates and children under 2 years of age, the solution (in bags and administration sets) should be protected from light exposure until the administration is completed (see section 2).
Contents of the packaging and other information
Contents declaration
- The active substances are:Soya oil, refined 60 mg/mlTriglyceride er, medium 60 mg/mlOlive oil, refined 50 mg/mlFish oil, rich in omega-3 fatty acids 30 mg/ml
- Other ingredients are Glycerol, egg lecithin, All-rac-α-Tocopherol ( vitamin E), Water for injections, Sodium hydroxide ( pH adjustment), and Sodium oleate.
Appearance and package sizes of the medicine
SMOFlipid is a white, homogeneous emulsion that is packaged in a glass bottle or infusion bag.
| Glass bottle | Infusion bag |
|---|---|
| 100 ml | 100 ml |
| 10×100 ml | 10×100 ml |
| 250 ml | 250 ml |
| 10×250 ml | 10×250 ml |
| 500 ml | 500 ml |
| 10×500 ml | 12×500 ml |
| 1000 ml | |
| 6×1000 ml |
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Manufacturer:
Fresenius Kabi AB, 751 74 Uppsala, Sweden ( infusion bag )
Fresenius Kabi Austria GmbH, 8055 Graz, Austria (glass bottle)