Fresenius Kabi在美国推出Smoflipid 20％为第一种也是唯一的四油类脂质乳液现在可用于肠外营养
商品名：SMOFlipid 20%（斯莫脂肪靜脈輸注液）
中文名：脂肪乳剂/SOY/MCT/橄榄油/鱼油
制造商：Fresenius Kabi USA，LLC
产地国家：美国
藥理類別：营养产品
适应症
当病患口服或经肠营养不可能（营养不良，胃肠外营养（肠外营养）），不足或禁忌时，作为非经肠营养治疗方式的一部分。
用法用量
成人：
标准剂量：是1.0～2.0公克脂肪/公斤体重/天（相当于5-10 毫升/公斤体重/天 ）。
建议输注速率是0.125公克脂肪/公斤体重/小时（相当于0.63毫升SMOFlipid/ 公斤体重/小时），但不得超过0.15公克脂肪/公斤体重/小时(相当于0.75毫升SMOFlipid/ 公斤体重/小时)。
孩童：
建议每日剂量不超过2.0公克脂肪/公斤体重/天（相当于10毫升SMOFlipid/公斤体重/天）。
给药第一周应渐增每日剂量。
输注速率不得超过0.15公克脂肪/公斤体重/小时。
使用方法：
周边或中心静脉输注。
副作用
轻微增加体温
包装规格
SMOFLIPID BAG 20% 100ML APP10  FAT EMUL/SOY/MCT/OLIV/FISH OIL    NDC  63323-0820-00    
SMOFLIPID BAG 20% 250ML APP10  FAT EMUL/SOY/MCT/OLIV/FISH OIL    NDC  63323-0820-74 
SMOFLIPID BAG 20% 500ML APP12  FAT EMUL/SOY/MCT/OLIV/FISH OIL    NDC  63323-0820-50 
注：完整说明书附件：http://www.imedez.com/drugs/smoflipid-20/Product-Information.html

SMOFlipid 20%
uct Information
Manufacture: Fresenius Kabi USA, LLC
Country: United States
Condition: Malnourishment, Parenteral Nutrition (Total Parenteral Nutrition)
Class: Nutritional products
Form: Liquid solution, Intravenous (IV)
Ingredients: Soybean oil, refined, Triglycerides, medium-chain, Triglycerides, medium-chain, Fish oil, rich in omega-3 acids, Purified egg phospholipids, All-rac-α-tocopherol, Glycerol, Sodium oleate, Sodium hydroxide
Lipid Injectable Emulsion, Mfr. Std. Soybean oil, medium chain triglycerides, olive oil and fish oil (6%/ 6%/ 5%/ 3% w/v)
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Fresenius Kabi Launches Smoflipid® in the United States
First and only four-oil lipid emulsion now available for parenteral nutrition
Smoflipid® from Fresenius Kabi is now available in the United States. It is the first and only four-oil lipid emulsion now available for parenteral nutrition.
Fresenius Kabi announced today it has launched Smoflipid® for use in adults. Smoflipid is the only intravenous fat emulsion (IVFE) available in the U.S. containing four oils - soybean oil, medium chain triglycerides (MCT), olive oil and fish oil.
Fresenius Kabi is a global health care company that specializes in life-saving medicines and technologies for infusion, transfusion and clinical nutrition. The company received FDA approval for Smoflipid July 2016.
“Fresenius Kabi is a global leader in clinical nutrition and the introduction of Smoflipid in the U.S. provides the opportunity to grow our clinical nutrition presence and share our expertise,” said John Ducker, president and CEO of Fresenius Kabi USA. “More importantly, Smoflipid is an essential therapy for parenteral nutrition patients and with its availability we have an opportunity to make a meaningful difference in the lives of millions of patients in the U.S.”
“For many years, U.S. clinicians have wanted an alternative to currently available soy-based lipid emulsions,” said Jay M. Mirtallo, M.S., R.Ph, BCNSP, FASHP, a past president and current member, Board of Advisors for the American Society for Parenteral and Enteral Nutrition. “Smoflipid is a new option for clinicians caring for patients requiring parenteral nutrition at a time when leading medical societies have issued guidelines reinforcing the need for alternative oil-based lipids in the U.S.”
The American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) and the Society of Critical Care Medicine (SCCM) issued updated guidelines in 2016 for nutrition support in critically ill adult patients, which, in part said alternative (oil-based) IVFEs may provide an outcome benefit over soy-based IVFEs and when available, consider the use of alternative IVFEs in critically ill patients who require parenteral nutrition.
“Since its first launch in 2004, Smoflipid has been used in more than six million patients throughout the world. With the introduction to the U.S. market, the product will now be available in more than 65 countries,” said Annemarie Diederich, executive vice president and head of Business Unit Parenteral Nutrition, Colloids & Ketosteril, Pharmaceuticals Division, Fresenius Kabi.
Parenteral nutrition is the intravenous administration of amino acids (protein), carbohydrates, lipids (fats), electrolytes, vitamins and other trace elements for patients who cannot digest or absorb sufficient nutrition via the gastrointestinal tract.
About Smoflipid
Smoflipid is the first and only four-oil lipid emulsion available in the U.S. Its balanced lipid profile contains soybean oil, MCT, olive oil and fish oil. Smoflipid is indicated in adults as a source of calories and essential fatty acids for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated.
IMPORTANT SAFETY INFORMATION
WARNING: DEATH IN PRETERM INFANTS
See full prescribing information for complete boxed warning.
• Deaths in preterm infants have been reported in literature.
• Autopsy findings included intravascular fat accumulation in the lungs.
• Preterm and low-birth-weight infants have poor clearance of intravenous lipid emulsion and increased free fatty acid plasma levels following lipid emulsion infusion.
Limitations of Use: The omega-6: omega-3 fatty acid ratio and Medium Chain Triglycerides in Smoflipid have not been shown to improve clinical outcomes compared to other intravenous lipid emulsions.
The usual daily dosage is 1 to 2 grams/kg per day and should not exceed 2.5 grams/kg per day.
Smoflipid is contraindicated in patients with known hypersensitivity to fish, egg, soybean, or peanut protein, or to any of the active ingredients or excipients, severe hyperlipidemia or severe disorders of lipid metabolism with serum triglycerides >1,000 mg/dL.
Monitor for signs or symptoms of hypersensitivity reactions, infection, fat overload, hypertriglyceridemia. Monitor laboratory parameters.