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SMOFKABIVEN ELECTROLYTE FREE 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: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Dosing Considerations The patient’s ability to eliminate lipids as well as metabolize nitrogen and glucose, and the nutritional requirements should govern the dosage and infusion rate. The dose should be individualized with regard to the patient’s clinical condition and body weight (bw).
g. nutritional state and degree of catabolic stress or anabolism). 15 g nitrogen/kg bw/day) in the normal nutritional state or in conditions with mild catabolic stress. 25 g nitrogen/kg bw/day). g. burns or marked anabolism), the nitrogen need may be even higher.
25 g nitrogen/kg bw/day) and 14 – 35 kcal/kg bw/day of total energy (12 – 27 kcal/kg bw/day of non-protein energy). 32 g nitrogen/kg bw/day) and 12 – 28 kcal/kg bw/day of total energy (8 – 19 kcal/kg bw/day of non-protein energy). Dosing with either SmofKabiven Electrolyte Free or SmofKabiven extra Nitrogen Electrolyte Free covers the needs for the majority of the critically and non-critically ill patients.
In obese patients, the dose should be based on the estimated ideal weight. 15 g/kg bw/h. 08 g lipids/kg bw/h. 04 g lipids/kg/ bw/h. The recommended infusion period is 14 – 24 hours. 33 g lipids/kg bw/day and a total energy of 39 kcal/kg bw/day (corresponding to 31 kcal/kg bw/day of non-protein energy).
9 g lipids/kg bw/day and a total energy content of 28 kcal/kg bw/day (corresponding to 19 kcal/kg bw/day of non-protein energy). The four different package sizes of SmofKabiven Electrolyte Free and five different package sizes of SmofKabiven extra Nitrogen Electrolyte Free are intended for patients with basal, moderately increased or high nutritional requirements.
To provide total parenteral nutrition, trace elements, vitamins, and electrolytes should be added to SmofKabiven Electrolyte Free and SmofKabiven extra Nitrogen Electrolyte Free according to the patient’s individual requirements. 9%); w/v] are intended for infusion into a central vein once the vertical and horizontal seals have been broken and compartments thoroughly mixed.
(See SPECIAL HANDLING INSTRUCTIONS) SmofKabiven Electrolyte Free and SmofKabiven extra Nitrogen Electrolyte Free may only be mixed with other medicinal products for which compatibility has been documented (see SPECIAL HANDLING INSTRUCTIONS).
g. via Y-site) because of the risk of precipitation of ceftriaxone-calcium salt. If the same infusion line is used for sequential administration, the line must be thoroughly flushed with a compatible fluid between infusions. OVERDOSAGE If symptoms of overdose of lipids or amino acids occur, the infusion should be reduced or discontinued.
g. severe post-traumatic conditions, uncompensated diabetes mellitus, acute myocardial infarction, stroke, embolism, metabolic acidosis, severe sepsis, hypotonic dehydration, and hyperosmolar coma) WARNINGS AND PRECAUTIONS General The infusion must be stopped immediately if any signs or symptoms of allergic reactions (such as fever, shivering, sweating, headache, skin rashes, or dyspnea) develop.
9%); w/v] should be infused 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. To avoid risks associated with too rapid delivery, it is recommended to use a continuous and well- controlled infusion, if possible, a volumetric pump.
The amount of individual electrolytes to be added is determined by the clinical condition of the patient and by frequent monitoring of serum levels. Parenteral nutrition should be given with caution in metabolic acidosis, cellular hypoxia and increased serum osmolarity.
Parenteral nutrition infusion may be accompanied by increased urinary excretion of the trace elements, in particular copper and zinc. This should be considered in the dosing of trace elements, especially during long-term parenteral nutrition.
SmofKabiven Electrolyte Free and SmofKabiven extra Nitrogen Electrolyte Free – Product Monograph Page 5 of 60 In malnourished patients, initiation of parenteral nutrition can precipitate fluid shifts resulting in pulmonary edema and congestive heart failure as well as a decrease in the serum concentration of potassium, phosphate, magnesium, and water-soluble vitamins.
These changes can occur within 24 to 48 hours. Therefore, careful and slow initiation of parenteral nutrition is recommended in this patient group, together with close monitoring and appropriate adjustments of fluid, electrolytes, minerals, and vitamins.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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There is no specific antidote for overdose. Emergency procedures should be general supportive measures, with particular attention to respiratory and cardiovascular systems. Close biochemical monitoring would be essential and specific abnormalities treated appropriately.
If hyperglycemia occurs, it should be treated according to the clinical situation either by appropriate insulin administration and/or adjustment of the infusion rate. Additionally, overdose might cause fluid overload, electrolyte imbalances, and serum hyperosmolarity.
In rare serious cases, renal replacement therapy may be considered. SmofKabiven Electrolyte Free and SmofKabiven extra Nitrogen Electrolyte Free – Product Monograph Page 16 of 60 For management of a suspected drug overdose, contact your regional Poison Control Centre.
ACTION AND CLINICAL PHARMACOLOGY Mechanism of Action The primary goal of parenteral nutrition is to provide adequate calories and protein to supply required nutrients and to prevent malnutrition with its associated complications when the patient is unable to receive adequate oral or enteral nutrition.
SmofKabiven Electrolyte Free and SmofKabiven extra Nitrogen Electrolyte Free provide the three macronutrients: glucose (as dextrose), amino acids, and lipids consisting of saturated fatty acids especially MCT (medium- chain triglycerides), […]
SmofKabiven Electrolyte Free and SmofKabiven extra Nitrogen Electrolyte Free must not be given simultaneously with transfusion blood in the same Y-on-site infusion set due to the risk of pseudoagglutination. Since an increased risk of infection is associated with the use of any central vein, strict aseptic precautions should be taken to avoid any contamination during catheter insertion and manipulation.
Fat overload syndrome is a rare condition that has been reported with intravenous lipid formulations. g. coma). The cause of the fat overload syndrome is unclear. The syndrome is usually reversible when the infusion of the lipid emulsion is stopped.
Although it has been most frequently observed when the recommended lipid dosage was exceeded, cases have also been described where the lipid formulation was administered according to instructions. Cardiovascular Fluid status should be closely monitored in patients with pulmonary edema or heart failure.
Endocrine and Metabolism In patients with hyperglycemia, administration of exogenous insulin might be necessary. SmofKabiven Electrolyte Free and SmofKabiven extra Nitrogen Electrolyte Free should be given with caution in conditions of impaired amino acid metabolism and of impaired lipid metabolism, which may occur in patients with renal failure, diabetes mellitus, pancreatitis, impaired liver function, hypothyroidism, and sepsis.
g. hemoglobin. SmofKabiven Electrolyte Free and SmofKabiven extra Nitrogen Electrolyte Free – Product Monograph Page 6 of 60 Immune This intravenous emulsion contains soybean oil, fish oil and egg phospholipids which may rarely cause allergic reactions.
Allergic cross reaction has been observed between soybean and peanut oil. If a hypersensitivity reaction occurs (signs or symptoms of anaphylactic reaction such as fever, shivering, sweating, headache, skin rash, or dyspnoea) infusion of the emulsion must be stopped immediately and the appropriate treatment and supportive measures should be undertaken until the conditions have been resolved.
Renal Use with caution in patients with renal insufficiency. g. hyperphosphatemia and hyperkalemia. Fluid and electrolyte status should be closely monitored in these patients.
Special Populations Pregnant Women:
There are no data available on exposure of SmofKabiven Electrolyte Free and SmofKabiven extra Nitrogen Electrolyte Free in pregnant women. There are no studies available on reproductive toxicity in animals. Parenteral nutrition may become necessary during […]