200 mg\/ml\u00a0infusion solution\u00a0,\u00a0emulsion
soybean oil, medium-chain triglycerides, olive oil, fish oil<\/p>\n\n\n\n
SMOFlipid contains four different types of fat;\u00a0soybean oil, medium-chain triglycerides, olive oil, and fish oil that is rich in\u00a0omega-3\u00a0fatty acids.\u00a0The liquid is a fat emulsion, i.e. a\u00a0mixture\u00a0of fat and water.<\/p>\n\n\n\n
You are given SMOFlipid by healthcare professionals when other forms of nutrition are insufficient or do not work. 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).<\/p>\n\n\n\n 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\u00a0the administration\u00a0is completed.\u00a0If SMOFlipid is exposed to ambient light, especially after the addition of trace elements and\/or\u00a0vitamins, peroxides and other degradation products are formed, which can be reduced if the product is protected from light exposure.<\/p>\n\n\n\n Allergic reactions<\/strong> Talk to the doctor or nurse when this medicine is given to your newborn baby if the baby has:<\/p>\n\n\n\n If your newborn baby is given SMOFlipid for a longer period, the doctor will take blood samples to check the treatment.<\/p>\n\n\n\n Tell your doctor if you have recently taken, or might take any other medicines.<\/p>\n\n\n\n Be especially careful to inform your doctor if you are using, or have recently used, blood-thinning medicines such as\u00a0warfarin\u00a0and\u00a0heparin.<\/p>\n\n\n\n The safety of use during pregnancy and breastfeeding has not been investigated.\u00a0Sometimes, however, it may be necessary to receive nutrition\u00a0intravenously\u00a0and if your doctor gives you SMOFlipid, it will only be after careful consideration. Not relevant because the medicine is given in a hospital.<\/a><\/p>\n\n\n\n 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. 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.<\/p>\n\n\n\n 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\u00a0the administration\u00a0is completed (see section 2).<\/p>\n\n\n\n For healthcare professionals, see ‘Method of administration’ at the end of this leaflet for more detailed information on\u00a0dosage\u00a0and\u00a0administration.<\/p>\n\n\n\n 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.\u00a0This is called “fat overload syndrome”.\u00a0See section 4, Possible\u00a0side effects, for further information.<\/p>\n\n\n\n Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n Fat overload syndrome<\/strong> Common<\/strong> (may affect up to 1 in 10 users):<\/p>\n\n\n\n Uncommon<\/strong> (may affect up to 1 in 100 users):<\/p>\n\n\n\n Rare<\/strong> (may affect up to 1 in 1,000 users):<\/p>\n\n\n\n Very rare<\/strong> (may affect up to 1 in 10,000 users):<\/p>\n\n\n\n Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n Store at a maximum of 25\u00b0C. Do not freeze.<\/p>\n\n\n\n Use before the expiry date stated on the packaging. The expiration date is the last day of the specified month.<\/p>\n\n\n\n Do not use this medicine if the packaging is damaged.\u00a0Use only if the solution is white and\u00a0homogeneous.\u00a0For single use only.\u00a0Any remaining\u00a0infusion fluid\u00a0must be discarded.\u00a0May not be reused.<\/p>\n\n\n\n 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\u00a0the administration\u00a0is completed (see section 2).<\/p>\n\n\n\n SMOFlipid is a white,\u00a0homogeneous\u00a0emulsion\u00a0that is packaged in a glass bottle or\u00a0infusion bag.<\/p>\n\n\n\n
<\/a><\/p>\n\n\n\nWhat you need to know before you are given SMOFlipid<\/h2>\n\n\n\n
You should not be given SMOFlipid:<\/h2>\n\n\n\n
Warnings and precautions<\/h2>\n\n\n\n
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:<\/p>\n\n\n\nChildren<\/h2>\n\n\n\n
Other medicines and SMOFlipid<\/h2>\n\n\n\n
Pregnancy and breastfeeding<\/h2>\n\n\n\n
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.<\/p>\n\n\n\nDriving ability and use of machinery<\/h2>\n\n\n\n
SMOFlipid contains sodium<\/h2>\n\n\n\n
<\/a><\/p>\n\n\n\nHow SMOFlipid is given<\/h2>\n\n\n\n
If you are given too much SMOFlipid:<\/h2>\n\n\n\n
Possible side effects<\/h2>\n\n\n\n
This can occur when your body has trouble taking care of fat when you have taken too much SMOFlipid.\u00a0It can also occur due to a sudden change in your condition (such as kidney problems or an\u00a0infection\u00a0).\u00a0Fat overload syndrome is characterized by high levels of fat in the blood (\u00a0hyperlipidemia\u00a0), fever, more fat in your body tissue than normal (fat infiltration), dysfunction of various organs, as well as unconsciousness.\u00a0All symptoms usually disappear when the\u00a0infusion\u00a0is stopped.<\/p>\n\n\n\nHow SMOFlipid should be stored<\/h2>\n\n\n\n
Contents of the packaging and other information<\/h2>\n\n\n\n
Contents declaration<\/h2>\n\n\n\n
Appearance and package sizes of the medicine<\/h2>\n\n\n\n