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Product description
sis, severe liver damage, pulmonary disease, sepsis, diseases of the reticuloendothelial system, anaemia or
Lipofundin® N blood coagulation disorders or when there is danger of fat embolism.
Composition Administration of Lipofundin® N should be accompanied by simultaneous carbohydrate infusions making
1000 ml emulsion contains: up to 40% (at least) of the total calorie intake. When Lipofundin® N is administered, the patient’s capaci-
Lipofundin ® N 10% Lipofundin ® N 20% ty to eliminate the infused fat from the circulation must be monitored. The lipaemia must clear between
Soya oil 100.0 g 200.0 g daily infusions. Especially where fat emulsions are administered for extended periods of time, the patient’s
Glycerol 25.0 g 25.0 g haemogram, blood coagulation, liver function and platelet count should be closely monitored.
Egg Lecithin 8.0 g 12 g
Use in pregnancy and lactation:
Sodium Oleate, α- Tocopherol, Water for Injections The safety of Lipofundin® N during pregnancy and lactation has not been assessed, but its use during
Megajoules/l (approx.): 4.5 (1072 kcal) 8.4 (2008 kcal) these periods is not considered to constitute a hazard. Nevertheless, medicines should not be used in
Milliosmols/l (approx.): 345 380 pregnancy, especially during the first trimester, unless the expected benefit is thought to outweigh any
pH: 6.5–8.8 6.5–8.5 possible risk to the foetus.
Lipofundin® MCT/LCT 1 Indications: 40% (at least) of the total calorie intake. ing these periods is not considered to constitute a
Lipofundin® MCT/LCT is indicated as a source of When Lipofundin® MCT/LCT is administered, the hazard. Nevertheless, medicines should not be used
Composition calories and essential fatty acids for patients requir- patient's capacity to eliminate the infused fat from in pregnancy, especially during the first trimester,
1000 ml emulsion contain ing parenteral nutrition. the circulation must be monitored. The lipaemia unless the expected benefit is thought to outweigh
Lipofundin® Lipofundin® must clear between daily infusions. Especially where any possible risk to the foetus.
MCT/LCT 10% MCT/LCT 20% Contraindications: fat emulsions are administered for extended periods
Soybean oil 50.0 g 100.0 g The administration of Lipofundin® MCT/LCT is con- of time, the patient's haemogram, blood coagula- Special warnings:
Mediumchain Triglycerides 50.0 g 100.0 g traindicated in patients demonstrating disturbances tion, liver function and platelet count should be The too rapid infusion of fat emulsions can cause
Glycerol 25.0 g 25.0 g in normal fat metabolism such as pathologic hyper- closely monitored. fluid and/or fat overloading resulting in dilution of
Egg yolk phospholipids* 8.0 g 12.0 g lipaemia, lipoid nephrosis, or acute pancreatitis if Paediatric patients: studies have shown the safety serum electrolyte concentrations, overhydration,
Sodium Oleate, α-Tocopherol*, Water for injections accompanied by hyperlipaemia. It is further con- and effectiveness of Lipofundin® MCT/LCT as part of congested states, pulmonary oedema, impaired pul-
Megajoules/l (approx.): 4.43 (1022 kcal) 7.99 (1908 kcal) traindicated in patients with ketoacidosis or hypox- total parenteral nutrition in neonates and older monary diffusion capacity. A too rapid infusion of
Milliosmols/l (approx.): 345 380 ia, in thromboembolism and in acute shock states. children. Lipofundin® MCT/LCT can also cause hyperketonae-
pH: 6.5-8.8 6.5-8.5 Lipofundin® MCT/LCT has been aproved for usage in mia and/or metabolic acidosis, especially when car-
Precautions for use: this patient population in some countries. bohydrates are not administered simultaneously.
* The amount of egg yolk phospholipids and
Caution should be exercised in administering intra- Registration procedures are currently pursued in
α-tocopherol can vary is some countries. Please
venous fat emulsions in patients with metabolic other countries. As long as approval has not been Subject to sale by pharmacists only.
refer to the country representative. Soybean oil is a
acidosis, severe liver damage, pulmonary disease, obtained in a specific country it is up to the judge-
refined natural product containing neutral triglycer-
sepsis, diseases of the reticuloendothelial system, ment of the responsible physician whether or not to
ides of predominantly unsaturated fatty acids.
anaemia or blood coagulation disorders or when use Lipofundin® MCT/LCT in this patient group.
Medium-chain triglycerides are a mixture of neutral
there is danger of fat embolism. Administration of Use in pregnancy and lactation
triglycerides of mainly caprylic (about 60%) and
Lipofundin® MCT/LCT should be accompanied by The safety of Lipofundin® MCT/LCT during pregnancy B. Braun Melsungen AG
capric acid (about 40%).
simultaneous carbohydrate infusions making up to and lactation has not been assessed, but its use dur- 34209 Melsungen, Germany