SMOFlipid 20%

Refined soya bean oil, medium-chain triglycerides, refined olive oil, fish oil (omega-3).

1000 ml contain: Refined soya bean oil 60.0 g; Medium-chain triglycerides 60.0 g; Refined olive oil 50.0 g; Fish oil (rich in omega-3 acids) 30.0 g.
Total energy: 8.4 MJ/l (= 2000 kcal/l).
pH value: approx. 8.
Osmolality: approx. 380 mOsm/kg H₂O.

Supply of energy and essential fatty acids and omega-3 fatty acids to patients, as part of a parenteral nutrition regimen, when oral or enteral nutrition is impossible, insufficient or contraindicated.

The patient's ability to eliminate the fat infused should govern the dosage and infusion rate (see Precautions).
Adults: The standard dose is 1.0 - 2.0 g fat/kg body weight (b.w.)/day, corresponding to 5 - 10 ml/kg b.w./day.
The recommended infusion rate is 0.125 g fat/kg b.w./hour, corresponding to 0.63 ml SMOFlipid/kg b.w./hour, and should not exceed 0.15 g fat/kg b.w./hour, corresponding to 0.75 ml SMOFlipid/kg b.w./hour.
Neonates and infants: The initial dose should be 0.5 - 1.0 g fat/kg b.w./day followed by a successive increase by 0.5 - 1.0 g fat/kg b.w./day up to 3.0 g fat/kg b.w./day.
It is recommended not to exceed a daily dose of 3 g fat/kg b.w./d, corresponding to 15 ml SMOFlipid/kg b.w./day.
The rate of infusion should not exceed 0.125 g fat/kg b.w./hour.
In premature and low birthweight neonates, SMOFlipid 20% should be infused continuously over about 24 hours.
Children: It is recommended not to exceed a daily dose of 3 g fat/kg b.w./d, corresponding to 15 ml SMOFlipid/kg b.w./day.
The daily dose should be increased gradually during the first week of administration.
The infusion rate should not exceed 0.15 g fat/kg b.w./hour.
Administration: Intravenous infusion into a peripheral or central vein.

Overdose leading to fat overload syndrome may occur as a result of a too rapid infusion rate, or chronically at recommended rates of infusion in association with a change in the patients clinical conditions e.g. renal function impairment or infection.
Overdosage may lead to side effects (see Fat overload syndrome under Adverse Reactions). In these cases, the lipid infusion should be stopped, or if necessary, continued at a reduced dosage.

Hypersensitivity to fish, egg, soya or peanut protein or to any of the active substances or excipients.
Severe hyperlipidemia.
Severe liver insufficiency.
Severe blood coagulation disorders.
Severe renal insufficiency without access to hemofiltration or dialysis.
Acute shock.
General contraindications to infusion therapy: acute pulmonary oedema, hyperhydration, decompensated cardiac insufficiency.
Unstable conditions (e.g. severe post-traumatic conditions, uncompensated diabetes mellitus, acute myocardial infarction, stroke, embolism, metabolic acidosis and severe sepsis and hypotonic dehydration).

The capacity to eliminate fat is individual and should therefore be monitored according to the routines of the clinician. This is in general done by checking the triglyceride levels. Special caution should be taken in patients with a marked risk for hyperlipidemia (e.g. patients with high lipid dosage, severe sepsis and extremely low birth weight infants). The concentration of triglycerides in serum should in general not exceed 3 mmol/l during infusion. An overdose may lead to fat overload syndrome.
This medicinal product contains soya bean oil, fish oil and egg phospholipids, which may rarely cause allergic reactions. Cross allergic reaction has been observed between soya bean and peanut.
SMOFlipid 20% should be given with caution in conditions of impaired lipid metabolism, which may occur in patients with renal failure, diabetes mellitus, pancreatitis, impaired liver function, hypothyroidism, and sepsis.
Clinical data in patients with diabetes mellitus or renal failure are limited.
Administration of medium-chain fatty acids alone can result in metabolic acidosis. This risk is to a great extent eliminated by the simultaneous infusion of the long-chain fatty acids included in SMOFlipid 20%. Concomitant administration of carbohydrates will further eliminate this risk. Hence, simultaneous infusion of carbohydrate or a carbohydrate-containing amino acid solution is recommended. Laboratory test generally associated with monitoring of intravenous nutrition should be checked regularly. These include blood glucose levels, liver function tests, acid-base metabolism, fluid balance, full blood count and electrolytes.
Any sign or symptom of anaphylactic reaction (such as fever, shivering, rash or dyspnoea) should lead to immediate interruption of the infusion.
SMOFlipid 20% should be given with caution to neonates and premature neonates with hyperbilirubinemia and cases with pulmonary hypertension. In neonates, particularly premature neonates on long-term parenteral nutrition, blood platelet counts, liver function tests and serum triglycerides should be monitored.
High levels of lipids in plasma may interfere with some laboratory blood tests, e.g. haemoglobin.
The addition of other medicaments or substances to SMOFlipid 20% should generally be avoided unless compatibility is known.
Driving and using machines: No effects on the ability to drive and operate machines are to be expected.

There are no data available on exposure of SMOFlipid 20% in pregnant or breast-feeding women. There are no studies available on reproductive toxicity in animals. Parenteral nutrition may become necessary during pregnancy and lactation. SMOFlipid 20% should only be given to pregnant and breast-feeding women after careful consideration.

Undesirable effects observed during the administration of fat emulsions: See table.

Click on icon to see table/diagram/image

Should these side effects occur or should the triglyceride level during infusion rise above 3 mmol/l, the infusion of SMOFlipid 20% should be stopped or, if necessary, continued at a reduced dosage.
SMOFlipid 20% should always be a part of a complete parenteral nutritional treatment including amino acids and glucose. Nausea, vomiting and hyperglycemia are symptoms related to conditions indicating parenteral nutrition and may sometimes be associated with parenteral nutrition.
Monitoring of triglycerides and blood glucose levels are recommended to avoid elevated levels, which may be harmful.
Fat overload syndrome: Impaired capacity to eliminate triglycerides can lead to fat overload syndrome which may be caused by overdose. Possible signs of metabolic overload must be observed. The cause may be genetic (individually different metabolism) or the fat metabolism may be affected by ongoing or previous illnesses. This syndrome may also appear during severe hypertriglyceridemia, even at the recommended infusion rate, and in association with a sudden change in the patient's clinical condition, such as renal function impairment or infection. The fat overload syndrome is characterised by hyperlipemia, fever, fat infiltration, hepatomegaly with or without icterus, splenomegaly, anemia, leukopenia, thrombocytopenia, coagulation disorder, hemolysis and reticulocytosis, abnormal liver function tests and coma. The symptoms are usually reversible if the infusion of the fat emulsion is discontinued.
Should signs of a fat overload syndrome occur, the infusion of SMOFlipid 20% should be discontinued.

Heparin given in clinical doses causes a transient increase in lipoprotein lipase release into the circulation. This may initially result in increased plasma lipolysis, followed by a transient decrease in triglyceride clearance.
Soya bean oil has a natural content of vitamin K₁. The content is however so low in SMOFlipid 20% that it is not expected to significantly influence the coagulation process in patients treated with coumarin derivatives.

Instructions for use and handling: Use only if the emulsion is homogeneous.
Inspect the emulsion visually for phase separation prior to administration. Ensure that the final emulsion for infusion does not show any evidence of phase separation.
For single use only. Any unused emulsion should be discarded.
Additives: SMOFlipid 20% may be aseptically admixed with amino acid, glucose, and electrolyte solutions to produce "All-In-One" Total Parenteral Nutrition (TPN) admixtures.
Compatibility for different additives and the storage time of the different admixtures will be available upon request from the marketing authorisation holder.
Additions should be made aseptically.
Any mixture remaining after infusion must be discarded.

Do not store above 25°C. Do not freeze.
Stability after mixing: If additions are made to SMOFlipid 20%, the admixtures should be used immediately from a microbiological point of view. If admixtures are not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C, unless additions have taken place in controlled and validated aseptic conditions.

Parenteral Nutritional Products

B05BA02 - fat emulsions ; Belongs to the class of solutions for parenteral nutrition used in I.V. solutions.

P₁S₁S₃