Kabiven Perifer EF Infusion
Glucose 11% + Vamin 18 Novum + Intralipid 20% parental
1440ml/bag
Radiant Pharmaceutical Ltd.
| Pack size | 1440ml bag |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 2753.00 AED |
Available as:
Indications
Kabiven Perifer EF Infusion is used for:
Parenteral nutrition
Adult Dose
Parenteral nutrition
For adults when oral or enteral nutrition is impossible, insufficient or contraindicated.
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.
The nitrogen requirements for the maintenance of body protein mass depend on the patient’s condition (e.g. nutritional state and degree of catabolic stress). The requirements are 0.10–0.15 nitrogen/kg body weight (b.w.)/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 b.w./day (1.0–2.0 g amino acid/kg b.w./day).
The corresponding commonly accepted requirements are 2.0–6.0 g for glucose and 1.0–2.0 g for fat.
The total energy requirement depends on the patient’s clinical condition and is most often between 20–30 kcal/kg b.w./day. In obese patients, the dose should be based on the estimated ideal weight.
The solution is produced in three sizes intended for patients with moderately increased, basal or low nutritional requirements. To provide total parenteral nutrition, the addition of trace elements, vitamins and supplemental electrolytes may be required.
The dose range of 0.10–0.15 g nitrogen/kg b.w./day (0.7–1.0 g amino acid/kg b.w./day) and a total energy of 20–30 kcal/kg b.w./day corresponds to approximately 27–40 mL/kg b.w./day.
Maximum daily dose
40 mL/kg b.w./day. This is equal to one bag (largest size) to a 64 kg-patient and will provide 0.96 g amino acids/kg b.w./day (0.16 g N/kg b.w./day), 25 kcal/kg b.w./day non-protein energy (2.7 g glucose/kg b.w./day and 1.4 g fat/kg b.w./day).
The maximum daily dose varies with the clinical condition of the patient and may even change from day to day.
Child Dose
Parenteral nutrition
For children aged 2 years and above when oral or enteral nutrition is impossible, insufficient or contraindicated.
Renal Dose
Administration
Intravenous infusion into a central or peripheral vein.
The infusion may be continued for as long as required by the patient's clinical condition. The solution should be used within 24 hours of preparation.
In order to minimize the risk of thrombophlebitis, daily rotation of the infusion site is recommended.
Infusion rate
The maximum infusion rate for glucose is 0.25 g/kg/h.
Amino acid dosage should not exceed 0.1 g/kg/h.
Fat dosage should not provide more than 0.15 g/kg/h.
The infusion rate should not exceed 3.7 mL/kg b.w./hour (corresponding to 0.25 g glucose, 0.09 g amino acid and 0.13 g fat/kg b.w.).
The recommended infusion period for individual bags is 12–24 hours.
Contra Indications
Hypersensitivity to egg-, soya- or peanut protein or to any of the active substances or excipients.
Severe hyperlipaemia
Severe liver insufficiency
Severe blood coagulation disorders
Inborn errors of amino acid metabolism
Severe renal insufficiency without access to haemofiltration or dialysis
Acute shock
Hyperglycemia, which requires more than 6 units insulin/h
Pathologically elevated serum levels of any of the included electrolytes.
General contra-indications to infusion therapy acute pulmonary oedema, hyperhydration and decompensated cardiac insufficiency and hypotonic dehydration
Haemophagocytotic syndrome
Unstable conditions (e.g. severe post-traumatic conditions, uncompensated diabetes, acute myocardial infarction, metabolic acidosis, severe sepsis and hyperosmolar coma)
Infants under 2 years of age
Precautions
Use with caution in conditions of impaired lipid metabolism, in patients with a tendency towards electrolyte retention, in lactic acidosis, increased serum osmolarity and insufficient cellular oxygen supply.
Contains soya-bean oil, fish oil and egg phospholipids which may rarely cause allergic reactions. Cross allergic reaction has been observed between soya-bean and peanut.
Electrolyte and fluid balance disturbances should be corrected prior to infusion.
Special clinical monitoring is required at the beginning of any infusion and should any abnormal sign occur, the infusion must be stopped.
Monitor serum glucose, electrolytes, osmolarity, fluid balance, acid-base status and liver enzyme tests.
When lipids are given for a longer period, monitor blood cell count and coagulation. No clinical experience in children (aged 2 to 16/18 years).
Pregnancy-Lactation
Pregnancy
Reproduction studies in animals have not been conducted. No clinical data are currently available to assess the safety of this solution in pregnancy. The prescriber should consider the benefit/risk relationship before administering this solution to pregnant women.
Lactation
No clinical data are currently available on the use of this solution in breastfeeding women.
Following intravenous infusion, most of the active ingredients contained in this solution are expected to be excreted into human milk, and the safety to the breast-feeding infant has not been adequately established.
The prescriber should consider the benefit/risk relationship before administering this solution to breastfeeding women.
Effects on fertility
No data is available.
Interactions
Heparin given in clinical doses causes a transient release of lipoprotein lipase into the circulation. This may result initially in increased plasma lipolysis followed by a transient decrease in triglyceride clearance.
Other drugs, like insulin, may influence lipase activity but there is no evidence to suggest that this adversely affects therapeutic value.
Soya oil has a natural content of vitamin K1. This may interfere with the therapeutic effect of coumarin derivatives, which should be closely monitored in patients treated with such drugs.
There are no clinical data to show that any of the above-listed interactions are of definite clinical relevance.
Adverse Effects
Side effects of Glucose 11% + Vamin 18 Novum + Intralipid 20% parental :
The infusion 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 intravenous nutrition have also been reported.
Thrombophlebitis is probably the most common adverse event in patients in general surgical wards.
The cause is in most cases due to infusions of saline, glucose or similar fluids and drugs.
Reports of other undesirable effects in conjunction with the included components are extremely rare.
Hypersensitivity reactions (anaphylactic reaction, skin rash, urticaria), respiratory symptoms (e.g. tachypnoea) and hyper/hypotension have been described. Haemolysis, reticulocytosis, abdominal pain, headache, tiredness and priapism have been reported.
Mechanism of Action
Intralipid, the fat emulsion used in this solution provides essential and non-essential long-chain fatty acids for energy metabolism and the structural integrity of cell membranes.
Intralipid in the recommended dosage does not cause hemodynamic changes.
No clinically significant changes in pulmonary function have been described when Intralipid is used properly.
The transient increase in liver enzymes seen in some patients on parenteral nutrition is reversible and disappears when parenteral nutrition is discontinued. Similar changes are also seen in parenteral nutrition without fat emulsions.
Amino acids and electrolytes
The amino acids, constituents of protein in ordinary food, are utilized for tissue protein synthesis and any surplus is channeled to a number of metabolic pathways. Studies have shown a thermogenic effect of amino acid infusion.
Glucose
Glucose should have no pharmacodynamic effects apart from contributing to maintain or replete the normal nutritional status.
Note
Kabiven Perifer 1440ml/bag EF Infusion manufactured by Radiant Pharmaceutical Ltd.. Its generic name is Glucose 11% + Vamin 18 Novum + Intralipid 20% parental. Kabiven Perifer is availble in Bangladesh.
Farmaco BD drug index information on Kabiven Perifer EF Infusion is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.