SMOFLIPID

1 Dosing Considerations The patient’s ability to eliminate the fat infused should determine the dosage and infusion rate. /day. /hour. 0 g/kg/day 70 to 140 g/day Infused volume of SMOFlipid 20% 5 to 10 mL/kg/day 350 to 700 mL/day The recommended duration of infusion for a parenteral nutrition bag is between 12 and 24 hours, depending on the clinical situation.

Treatment with parenteral nutrition may be continued for as long as is required by the patient’s condition. /hour. 4 Administration Intravenous infusion into a peripheral or central vein.

). In these cases, the lipid infusion should be stopped or, if necessary, continued at a reduced dosage. For management of a suspected drug overdose, contact your regional poison control centre. SMOFlipid® Lipid Injectable Emulsion Page 6 of 36 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 2 Dosage Forms, Strengths, Composition and Packaging SMOFlipid 20%, lipid injectable emulsion, is a white homogeneous emulsion.

2 g All-rac-α-tocopherol 16 – 23 mg Sodium hydroxide to adjust pH to pH approx. 8 Sodium oleate 30 mg Water for injection to 100 mL Total energy: 840 kJ (200 kcal) pH: approximately 8 Osmolality 380 mOsm/kg water Pack sizes: 100 mL in bag: Box of 10 units.

250 mL in bag: Box of 10 units. 500 mL in bag: Box of 12 units. 1000 mL in bag: Box of 6 units The packaging consists of an inner bag (primary package) with an oxygen barrier overpouch. An oxygen absorber and an integrity indicator (OxalertTM) are placed between the inner bag and the overpouch.

Route of Administration Dosage Form/Strength/Composition Non-medicinal Ingredients Intravenous Emulsion 20% (6% soybean oil / 6% medium chain triglycerides / 5% olive oil / 3% fish oil) All-rac-α-tocopherol, Glycerol, Purified egg phospholipids, Sodium hydroxide, Sodium oleate, Water for Injection SMOFlipid® Lipid Injectable Emulsion Page 7 of 36 • The primary plastic container is made from a multilayered film specifically designed for parenteral nutrition drug products.

The film is polypropylene based comprising three co- extruded layers. It contains no plasticizers and exhibits virtually no leachables. The container does not contain DEHP (di(2-ethylhexyl)phthalate), PVC or latex. The container is nontoxic and biologically inert.

• The oxygen barrier overpouch consists of polyethylene terephthalate and polyolefin or polyethylene terephthalate, polyolefin and ethylene-vinyl alcohol copolymer (EVOH). • The overpouch, the oxygen absorber and the integrity indicator should be discarded after opening of the overpouch.

). 2 CONTRAINDICATIONS Lipid injectable emulsion is contraindicated in patients with: • Hypersensitivity to fish, egg, soybean or peanut protein or to any of the active ingredients 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 edema, hyperhydration, decompensated cardiac insufficiency.

, severe post-traumatic conditions, uncompensated diabetes mellitus, acute myocardial infarction, stroke, embolism, metabolic acidosis and severe sepsis and hypotonic dehydration). 1 Dosing Considerations The patient’s ability to eliminate the fat infused should determine the dosage and infusion rate.

/day. /hour. 0 g/kg/day 70 to 140 g/day Infused volume of SMOFlipid 20% 5 to 10 mL/kg/day 350 to 700 mL/day The recommended duration of infusion for a parenteral nutrition bag is between 12 and 24 hours, depending on the clinical situation.

Treatment with parenteral nutrition may be continued for as long as is required by the patient’s condition. /hour. 4 Administration Intravenous infusion into a peripheral or central vein. , renal function impairment or infection. An impaired capacity to eliminate triglycerides may lead to “Fat overload syndrome” which may be caused by overdose.

Monitoring for possible signs of metabolic overload is necessary. The cause may be genetic (individual differences in metabolism), or the fat metabolism may be affected by ongoing or previous illnesses. This syndrome may also appear during severe hypertriglyceridemia, 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 characterized by hyperlipidemia, fever, fat infiltration, hepatomegaly with or without jaundice, splenomegaly, anemia, leukopenia, thrombocytopenia, coagulation disorder, hemolysis and reticulocytosis, abnormal liver function tests and coma.

Lipid injectable emulsion is contraindicated in patients with: • Hypersensitivity to fish, egg, soybean or peanut protein or to any of the active ingredients 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 edema, hyperhydration, decompensated cardiac insufficiency. , severe post-traumatic conditions, uncompensated diabetes mellitus, acute myocardial infarction, stroke, embolism, metabolic acidosis and severe sepsis and hypotonic dehydration).