Kabiven

Kabiven

Manufacturer:

Fresenius Kabi

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Amino acids, glucose, fat emulsion, electrolytes.
Description
Kabiven is available in a 3-chamber bag system. Each bag contains the following different volumes depending on the 2 pack sizes (see table).

Click on icon to see table/diagram/image
Indications/Uses
Parenteral nutrition for patients and children >2 years when oral or enteral nutrition is impossible, insufficient or contraindicated.
Dosage/Direction for Use
The ability to eliminate fat and metabolize glucose should govern the dosage and infusion rate (see Precautions).
Dosage: The dose should be individualized and the choice of bag size should be made with regard to the patient's clinical condition, body weight and nutritional requirements.
Adults: The nitrogen requirements for maintenance of body protein mass depend on the patient's condition (eg, nutritional state and degree of catabolic stress). The requirements are 0.10-0.15 g nitrogen/kg body weight/day in the normal nutritional state or in conditions with mild metabolic stress. In patients with moderate to high metabolic stress with or without malnutrition, the requirements are in the range of 0.15-0.30 g nitrogen/kg body weight/day (1-2 g amino acid/kg body weight/day). The corresponding commonly accepted requirements are 2-6 g for glucose and 1-2 g for fat.
The dose range of 0.10-0.20 g nitrogen/kg body weight/day (0.7-1.3 g amino acid/kg body weigh/day), which covers the need of the majority of the patients. This corresponds to 19-38 mL Kabiven/kg body weight/day. For a 70-kg patient this is equivalent to 1330-2660 mL Kabiven/day.
The total energy requirement depends on the patient's clinical condition and is most often between 25-35 kcal/kg body weight/day. In obese patients the dose should be based on the estimated ideal weight.
Kabiven is produced in 2 sizes intended for patients with high, moderately increased, basal, or low nutritional requirements. To provide total parenteral nutrition, trace elements and vitamins should be given additionally.
Children: The ability to metabolize individual nutrients must determine the dosage.
In general the infusion for small children (2-10 years) should start with a low dose ie, 12.5-25 mL/kg (corresponding to 0.49-0.98 g fat/kg/day, 0.41-0.83 g amino acids/kg/day and 1.2-2.4 g glucose/kg/day) and increased by 10-15 mL/kg/day up to maximum dosage of 40 mL/kg/day.
For children >10 years the dosage for adults can be applied.
The use of Kabiven is not recommended in children <2 years in whom the amino acid cysteine may be considered conditionally essential.
Infusion Rate: The maximum infusion rate for glucose is 0.25 g/kg/hr. Amino acid dosage should not exceed 0.1 g/kg/hr. Fat dosage should not provide >0.15 g/kg/hr.
The infusion rate should not exceed 2.6 mL/kg body weight/hr (corresponding to 0.25 g glucose, 0.09 g amino acid and 0.1 g fat/kg body weight). The recommended infusion period is 12-24 hrs.
Maximum Daily Dose: 40 mL/kg body weight/day. This is equal to 1 bag (largest size) to a 64 kg-patient and will provide 1.3 g amino acids/kg/day (0.21 g nitrogen/kg/day), 31 kcal/kg/day non-protein energy (3.9 g glucose/kg/day and 1.6 g fat/kg/day).
The maximum daily dose varies with the clinical condition of the patient and may even change from day to day.
Administration: IV infusion only into a central vein. Infusion may be continued for as long as required by the patient's clinical condition.
Overdosage
Nausea, vomiting and sweating have been observed during infusion of amino acids at rates exceeding the recommended maximum rate.
An impaired capacity to eliminate fat may lead to the fat overload syndrome as a result of overdosage, but also at recommended rates of infusion in association with a sudden change in the patient's clinical condition eg, renal function impairment or infection.
The fat overload syndrome is characterized by hyperlipemia, fever, fat infiltration, hepatomegaly, splenomegaly, anaemia, leucopenia, thrombocytopenia, blood coagulation disorders and coma. These changes are invariably reversible on discontinuation of the fat infusion.
If symptoms of overdose occur, the infusion should be slowed down or discontinued.
Additionally, overdose might cause fluid overload, electrolyte imbalances, hyperglycemia and hyperosmolarity.
In some rare serious cases, haemodialysis, hemofiltration or hemodia-filtration may be necessary.
Contraindications
Known hypersensitivity to egg or soy protein or to any of the ingredients of Kabiven. Severe hyperlipemia. Severe liver insufficiency. Severe blood coagulation disorders. Inborn errors of amino acid metabolism. Severe renal insufficiency without access to hemofiltration or dialysis. Acute shock. Hyperglycemia, which requires >6 units insulin/hr. Pathologically elevated serum levels of any of the included electrolytes.
General Contraindications to Infusion Therapy: Acute pulmonary edema, hyperhydration, decompensated cardiac insufficiency and hypotonic dehydration. Hemophagocytotic syndrome. Unstable conditions (eg, severe post-traumatic conditions, uncompensated diabetes, acute myocardial infarction, metabolic acidosis, severe sepsis and hyperosmolar coma).
Infants and children <2 years.
Special Precautions
The ability to eliminate fat should be monitored. It is recommended that this is done by measuring serum triglycerides after a fat-free period of 5-6 hrs. The serum concentration of triglycerides should not exceed 3 mmol/L during infusion.
The bag size, specially the volume and the quantitative composition, should be carefully chosen. These volumes should be adjusted according to the hydration and nutritional status of the children. One reconstituted bag is for single use.
Disturbances of the electrolyte and fluid balance (eg, abnormally high or low serum levels of the electrolytes) should be corrected before starting the infusion.
Special clinical monitoring is required at the beginning of any IV infusion. Should any abnormal sign occur, the infusion must be stopped. 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.
Kabiven should be given with caution in conditions of impaired lipid metabolism, eg in renal insufficiency, uncompensated diabetes mellitus, pancreatitis, impaired liver function, hypothyroidism (with hypertriglyceridemia) and sepsis. If Kabiven is given to patients with these conditions, close monitoring of serum triglycerides is mandatory.
Serum glucose, electrolytes and osmolarity as well as fluid balance, acid-base status and liver enzyme tests (alkaline phosphatase, ALT, AST) should be monitored.
Blood cell count and coagulation should be monitored when fat is given for a longer period.
In patients with renal insufficiency, the phosphate and potassium intake should be carefully controlled to prevent hyperphosphatemia and hyperkalemia.
The amount of individual electrolytes to be added is governed by the clinical condition of the patient and by frequent monitoring of serum levels.
This emulsion is free of vitamins and trace elements. The addition of trace elements and vitamins is always required. For vitamin supplementation, pediatric formulations are recommended to be used.
Parenteral nutrition should be given with caution in metabolic acidosis, lactic acidosis, insufficient cellular oxygen supply and increased serum osmolarity.
Kabiven should be given with caution to patients with a tendency towards electrolyte retention.
Any sign or symptom of anaphylactic reaction (eg, fever, shivering, rash or dyspnea) should lead to immediate interruption of the infusion.
The fat content of Kabiven may interfere with certain laboratory measurements (eg, bilirubin, lactate dehydrogenase, oxygen saturation, Hb) if blood is sampled before fat has been adequately cleared from the bloodstream. Fat is cleared after a fat-free interval of 5-6 hrs in most patients.
IV infusion of amino acids is accompanied by increased urinary excretion of the trace elements copper and, in particular, zinc. This should be considered in the dosing of trace elements, especially during long-term IV nutrition.
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, phosphorus, magnesium and water-soluble vitamins. These changes can occur within 24-48 hrs, therefore careful and slow initiation of parenteral nutrition is recommended together with close monitoring and appropriate adjustments of fluid, electrolytes, minerals and vitamins.
Kabiven should not be given simultaneously with blood in the same infusion set due to the risk of pseudoagglutination.
In patients with hyperglycaemia, administration of exogenous insulin might be necessary.
Adverse Reactions
Kabiven may cause a rise in body temperature (incidence <3%) and, less frequently, shivering, chills and nausea/vomiting (incidence <1%). Transient increases in liver enzymes during IV nutrition have also been reported.
As with all hypertonic solutions for infusion, thrombophlebitis may occur if peripheral veins are used.
Reports of other undesirable effects in conjunction with Kabiven infusions are extremely rare; less than one adverse event per million infusions. Hypersensitivity reactions (anaphylactic reaction, skin rash, urticaria), respiratory symptoms (eg, tachypnea) and hyper/hypotension have been described. Hemolysis, reticulocytosis, abdominal pain, headache, tiredness and priapism have been reported.
Fat Overload Syndrome: An impaired capacity to eliminate Intralipid (the fat component in Kabiven) may lead to the fat overload syndrome as a result of overdosage, but also at recommended rates of infusion in association with a sudden change in the patient's clinical condition, eg renal function impairment or infection.
The fat overload syndrome is characterized by hyperlipemia, fever, fat infiltration, hepatomegaly, splenomegaly, anaemia, leucopenia, thrombocytopenia, blood coagulation disorders and coma. All symptoms are usually reversible if the infusion is discontinued.
Caution For Usage
Kabiven should only be mixed and used if the solutions are clear and colorless or slightly yellow and if the emulsion is white and homogenous.
The contents of the 3 separate chambers have to be mixed before use. After breaking the seals, chemical and physical in-use stability of the mixed 3-chamber bag has been demonstrated for 24 hrs at 25°C.
Only medicinal or nutritional solutions for which compatibility has been documented may be added to Kabiven. Additions should be made aseptically. From a microbiological point of view, the product should be used immediately when additions have been made. If not used immediately, the in-use storage time and conditions prior to use are the responsibility of the user and should normally not be longer than 24 hrs at 2-8°C. If storage cannot be avoided and provided that additions are made under controlled and validated aseptic conditions, the mixed emulsion may be stored up to 6 days at 2-8°C before being used. After removal from storage at 2-8°C, the admixture should be infused within 24 hrs.
Storage
Do not store above 25°C. Store in overpouch. Do not freeze. It is recommended to store the bag in the outer carton. Do not use if package is damaged.
ATC Classification
B05BA10 - combinations ; Belongs to the class of solutions for parenteral nutrition used in I.V. solutions.
Presentation/Packing
Infusion soln 1026 mL/bag, 2053 mL/bag.
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