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SMOFKABIVEN is a brand name for Histidine, 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 or SmofKabiven extra Nitrogen 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 and five different package sizes of SmofKabiven extra Nitrogen are intended for patients with basal, moderately increased or high nutritional requirements.
To provide total parenteral nutrition, trace elements, vitamins, and possibly electrolytes (taking into account the electrolytes already present in SmofKabiven and SmofKabiven extra Nitrogen) should be added to SmofKabiven and SmofKabiven extra Nitrogen 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 and SmofKabiven extra Nitrogen 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.
g. abnormally high or low serum levels of the electrolytes) should be corrected before starting the infusion of SmofKabiven and SmofKabiven extra Nitrogen. SmofKabiven and SmofKabiven extra Nitrogen should be given with caution to patients prone to retaining electrolytes.
Special monitoring is required at the beginning of any intravenous infusion. Should any abnormal sign occur, the infusion must be stopped. SmofKabiven and SmofKabiven extra Nitrogen – Product Monograph Page 5 of 60 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. 9%); w/v] should be taken into account. 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.
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 SmofKabiven and SmofKabiven extra Nitrogen – Product Monograph Page 16 of 60 hyperosmolarity.
In rare serious cases, renal replacement therapy may be considered. 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 and SmofKabiven extra Nitrogen provide the three macronutrients: glucose (as dextrose), amino acids, and lipids consisting of saturated fatty acids especially MCT (medium-chain triglycerides), monounsaturated and polyunsaturated fatty acids (essential fatty acids), with the electrolytes (sodium, potassium, magnesium, calcium, phosphate, zinc, sulphate, chloride, and acetate).
Amino acids provide the basic […]
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.
SmofKabiven and SmofKabiven extra Nitrogen 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.
SmofKabiven and SmofKabiven extra Nitrogen – Product Monograph Page 6 of 60 Endocrine and Metabolism In patients with hyperglycemia, administration of exogenous insulin might be necessary. SmofKabiven and SmofKabiven extra Nitrogen 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. 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 dyspnea) infusion of the emulsion must be stopped immediately and the appropriate […]