SMOFLIPID is a brand name for Soybean Oil, supplied as a emulsion. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: SMOFlipid 20% (6% soybean oil / 6% medium chain triglycerides / 5% olive oil/ 3% fish oil) is indicated for: • supply of energy and essential fatty acids and omega-3 fatty acids to adult patients, as part of a parenteral nutrition regimen, when oral or enteral nutrition is impossible, insufficient or contra-indicated.…
Verbatim from this product's HC label. Tap a section to expand.
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).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The integrity indicator (OxalertTM) will react with free oxygen and change colour from clear to black in case of damage in the overpouch. 7 WARNINGS AND PRECAUTIONS General Individual capacity to eliminate fat should be monitored according to standard practice, which generally includes checking triglyceride levels.
, patients with high lipid dosage and severe sepsis). Reduction of the dosage or cessation of the lipid emulsion should be considered if serum or plasma triglyceride concentrations during or after infusion exceed 3 mmol/L. An overdose may lead to fat overload syndrome (see 8 ADVERSE REACTIONS).
The addition of other medications or substances to SMOFlipid should generally be avoided unless compatibility is known. Endocrine and Metabolism SMOFlipid 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.
Concomitant administration of carbohydrates will further eliminate this risk. Hence, simultaneous infusion of carbohydrate or a carbohydrate-containing amino acid solution is recommended. Immune This intravenous emulsion contains soybean oil, fish oil and egg phospholipids, which may rarely cause allergic reactions.
Crossed allergic reaction has been observed between soybean and peanut. If a hypersensitivity reaction occurs (anaphylactic reaction -such as fever, shivering, rash or dyspnoea) administration of the emulsion should be discontinued immediately and the appropriate treatment and supportive measures should be undertaken until symptoms have resolved (see 8 ADVERSE REACTIONS).
Monitoring and Laboratory Tests Standard laboratory tests for monitoring parenteral nutrition should be performed regularly. These include blood glucose levels, liver function tests, triglycerides, acid base metabolism, fluid balance, full blood count and electrolytes.
, hemoglobin. 1 Pregnant Women Parenteral nutrition may become necessary during pregnancy. SMOFlipid should only be given to pregnant women after careful consideration. There are no data available on exposure of SMOFlipid in pregnant women.
2 Breast-feeding Parenteral nutrition may become necessary during lactation. SMOFlipid should only be given to breast- feeding women after careful consideration. It is unknown if SMOFlipid is excreted in human milk. Precaution should be exercised because many drugs can be excreted in human milk.
3 Pediatrics No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 4 Geriatrics The metabolism of SMOFlipid does not appear to be affected by advanced age. 1 Adverse Reaction Overview See 7 WARNINGS AND PRECAUTIONS.
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Should signs of a fat overload syndrome occur, the infusion of SMOFlipid should be interrupted. The symptoms are usually reversible if the infusion of the fat emulsion is discontinued. Overdosage may lead to side-effects (see