Combiflex Lipid Central/Combiflex Lipid Peri

Combiflex Lipid Central/Combiflex Lipid Peri

Manufacturer:

JW Life Science

Distributor:

UNILAB, Inc
Full Prescribing Info
Contents
Lipid emulsion, amino acids, electrolytes, glucose.
Indications/Uses
Parenteral Nutrition for adults and children above 2 years of age when oral or enteral nutrition is impossible, insufficient or contraindicated.
Dosage/Direction for Use
The dose should be individualized and the choice of bag size should be made with regard to patient's clinical condition, body weight and nutritional requirements.
Adults patients: The nitrogen requirements for maintenance of body protein mass depend on the patient's condition (e.g. nutritional state and degree of catabolic stress). The requirements are 0.1-0.15 g nitrogen/Kg body weight/day in the normal nutritional state. In patients with moderate to high metabolic stress with or without malnutrition, the requirements are in the range of 0.15-0.3 g nitrogen/Kg body weight/day (1-2 amino acid/Kg body weight/day). The corresponding commonly accepted requirements are 2-6 g for glucose and 1-2 g for fat.
Combiflex Lipid Central: The dose range of 0.1-0.2 g nitrogen/Kg body weight/day (0.7-1.3 g amino acid/Kg body weight/day) which covers the need of the majority of patients. This corresponds to 19 mL-38 mL Lipid Emulsion/Amino Acids/ Electrolytes/Glucose (Combiflex Lipid Central)/Kg body weight/day. For a 70-Kg patient, this is equivalent to 1330 mL-2660 mL Lipid Emulsion/Amino Acids/Electrolytes/Glucose (Combiflex Lipid Central) per day.
The total energy requirement depends on patient's clinical condition and is often between 25-35 kcal/Kg body weight/day. In obese patients the dose should be based on the estimated ideal weight.
Lipid Emulsion/Amino Acids/Electrolytes/Glucose (Combiflex Lipid Central) is produced in two 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.
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 i.e. 12.5-25 mL/Kg (corresponding to 0.48-0.98 g lipid/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 over 10 years of age the dosage for adults can be applied. The use of Lipid Emulsion/Amino Acids/Electrolytes/Glucose (Combiflex Lipid Central) is not recommended in children under 2 years of age in whom the amino acid cysteine may be considered conditionally essential.
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.
Lipid dosage should not provide more than 0.15 g/Kg/h.
The infusion rate should not exceed 2.6 mL/Kg body weight/hour (corresponding to 0.25 g glucose, 0.09 g amino acid and 0.1 lipid/Kg body weight). The recommended infusion period is 12-24 hours.
Maximum daily dose: 40 mL/Kg body weight/day. This is equal to one 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 lipid/Kg/day).
The maximum daily dose varies with the clinical condition of the patient and may even change from day to day.
Method and duration of administration: Intravenous infusion only into a central vein. Infusion may be continued for as long as required by the patient's clinical condition.
Combiflex Lipid Peri: The dosage range of 0.10-0.15 g nitrogen/Kg body weight/day (0.7-1.0 g amino acid/Kg body weight/day) and a total energy of 20-30 kcal body weight/day corresponds to approx. 27-40 mL/Kg body weight per day.
The total energy requirement depends on patient's clinical condition and is often between 20-30 kcal/Kg body weight/day. In obese patients the dose should be based on the estimated ideal weight.
Lipid Emulsion/Amino Acids/Electrolytes/Glucose (Combiflex Lipid Peri) is produced in two 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.
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 i.e. 14-28 mL/Kg (corresponding to 0.48-0.98 g lipid/Kg/day, 0.34-0.67 g amino acids/Kg/day and 0.95-1.9 g glucose/Kg/day) and increased by 10-15 mL/Kg/day up to maximum dosage of 40 mL/Kg/day.
For children over 10 years of age the dosage for adults can be applied. The use of Lipid Emulsion/Amino Acids/Electrolytes/Glucose (Combiflex Lipid Peri) is not recommended in children under 2 years of age in whom the amino acid cysteine may be considered conditionally essential.
Infusion rate: The maximum infusion rate for glucose is 0.25 g/Kg body weight/h. Amino acid dosage should not exceed 0.1 g/Kg body weight/h. Lipid dosage should not provide more than 0.15 g/Kg/h.
The infusion rate should not exceed 3.7 mL/Kg body weight/hour (corresponding to 0.25 g glucose, 0.09 g amino acid and 0.13 lipid per Kg body weight). The recommended infusion period is 12-24 hours. Intravenous infusion into a peripheral or central vein. Infusion may be continued as long as required by patient's clinical condition. In order to minimize the risk of thrombophlebitis for peripheral application, daily rotation of infusion site is recommended.
Overdosage
Nausea, vomiting and sweating have been observed during infusion of amino acids at rates exceeding the recommended maximum rate.
If symptoms of overdosage occur, the infusion should be slowed down or discontinued.
Additionally, overdosage might cause fluid overload, electrolyte imbalances, hyperglycemia, and hyperosmolality.
In some rare serious cases, haemodialysis, haemofiltration or haemo-diafiltration may be necessary.
Contraindications
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 acids metabolism.
Severe renal insufficiency without access to hemofiltration or dialysis.
Acute shock.
Hyperglycemia, which requires more than 6 units insulin/h.
Pathologically elevated serum levels of any of the included electrolytes.
General contraindications to infusion therapy: acute pulmonary edema, 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.
Special Precautions
The ability to eliminate lipid should be monitored. It is recommended that this is done by measuring serum triglycerides after a lipid-free period of 5-6 hours. The serum concentration of triglycerides should not exceed 3 mmol/L during infusion. The bag size, especially 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 (e.g. 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 intravenous 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. Lipid Emulsion/Amino Acids/Electrolytes/Glucose (Combiflex Lipid Central/Combiflex Lipid Peri) should be given with caution in conditions of impaired lipid metabolism due to renal insufficiency, uncompensated diabetes mellitus, pancreatitis, impaired liver function, hypothyroidism (with hypertriglyceridaemia) or sepsis. If Lipid Emulsion/Amino Acids/Electrolytes/Glucose (Combiflex Lipid Central/Combiflex Lipid Peri) is given to patients with these conditions, close monitoring of serum triglyceride concentrations is mandatory. Serum glucose, electrolytes and osmolality as well as fluid balance, acid-base status and liver enzyme tests should be regularly monitored. Blood cell count and coagulation should be monitored when lipid is given for a longer period. In patients with renal insufficiency, the phosphate and potassium intake should be carefully controlled to prevent hyperphosphataemia and hyperkalemia. The amount of supplemental electrolytes should be determined by regular monitoring taking into consideration the clinical condition of the patient. This emulsion is free of vitamins and trace-elements. The addition of trace elements and vitamins is always required. Parenteral nutrition should be given with caution to patients with metabolic acidosis (e.g. lactic acidosis), increased serum osmolarity or those in need of fluid resuscitation. Lipid Emulsion/Amino Acids/Electrolytes/Glucose (Combiflex Lipid Central/Combiflex Lipid Peri) should be given with caution to patients with a tendency towards electrolyte retention. Any sign or symptom of anaphylactic reaction (such as fever, shivering, rash or dyspnea) necessitates immediate interruption of the infusion. The lipid content of Lipid Emulsion/Amino Acids/Electrolytes/Glucose (Combiflex Lipid Central/Combiflex Lipid Peri) may interfere with certain laboratory measurements (e.g. bilirubin, lactate dehydrogenase, oxygen saturation, hemoglobin) if blood is sampled before lipid has been adequately cleared from the bloodstream. Lipid is cleared after a lipid-free interval of 5-6 hours in most patients. This medicinal product contains soy bean oil and egg phospholipids, which may rarely cause allergic reactions. Cross allergic reaction has been observed between soy-bean and peanut.
Intravenous infusion of amino acids may be accompanied by increased urinary excretion of trace elements, particularly zinc. Additional supplements of trace elements may be required in patients requiring long-term intravenous nutrition. In malnourished patients, initiation of parenteral nutrition can precipitate fluid shifts resulting in pulmonary oedema and congestive heart failure. In addition, decreases in the serum concentrations of potassium, phosphorus, magnesium and water soluble vitamins may occur within 24 to 48 hours. Careful and slow initiation of parenteral nutrition is recommended together with close monitoring and appropriate adjustments of fluid, electrolytes, minerals and vitamins.
Lipid Emulsion/Amino Acids/Electrolytes/Glucose (Combiflex Lipid Central/Combiflex Lipid Peri) should not be given simultaneously with blood or blood products in the same infusion set. In patients with hyperglycemia, administration of exogenous insulin might be necessary.
Effects on Ability to Drive and Use Machine: Not applicable.
Combiflex Lipid Peri: Peripheral Infusion: As with all hypertonic solutions, thrombophlebitis may occur if peripheral veins are used for infusions. Several factors contribute to the incidence of thrombophlebitis. These include the type of cannula used and its diameter and length, the duration of infusion, pH and osmolality of infusates, infection and the number of manipulations. It is recommended that venous access sites for Total Parenteral Nutrition should not be used for other intravenous additive or solutions.
Use In Pregnancy & Lactation
No specific studies have been performed to assess the safety of Lipid Emulsion/Amino Acids/Electrolytes/Glucose (Combiflex Lipid Central/Combiflex Lipid Peri) in pregnancy and lactation. The prescriber should consider the benefit/risk relationship before administering Lipid Emulsion/Amino Acids/Electrolytes/Glucose (Combiflex Lipid Central/Combiflex Lipid Peri) to pregnant or breastfeeding women.
Adverse Reactions
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. As with all hypertonic solutions for infusion, thrombophlebitis may occur if peripheral veins are used.
Reports of the undesirable effects in conjunction with the included components are extremely rare. Hypersensitivity reactions (anaphylactic reaction, skin rash, urticaria), respiratory symptoms (e.g. tachypnea) and hyper/hypotension have been described. Haemolysis, reticulocytosis, abdominal pain, headache, nausea, vomiting, tiredness and priapism have been reported.
Lipid overload syndrome: An impaired capacity to eliminate lipid may lead to lipid overload syndrome. This may occur as a result of overdosage, but also at recommended rates of infusion, in association with a sudden change in the patient's clinical condition resulting in severe renal or hepatic impairment.
The lipid overload syndrome is characterized by hyperlipidaemia, fever, hepatosplenomegaly, anaemia, leucopenia, thrombocytopenia, coagulopathies and coma. These changes are invariably reversible on discontinuation of the lipid infusion.
Caution For Usage
Direction for Use and Handling: For single use only: Do not use if package is damaged. The contents of the 3 separate chamber bag should be freshly mixed prior to use. The mixed emulsion is for single use only. Remove the outer wrap. Break the partition by rolling the hanger part. After separation of the peelable seals, the bag should be inverted on several occasions or shake well to blend the solution of amino acids, glucose and lipid uniformly until a homogenous mixture is produced.
Use the product if the amino acids and glucose solutions are clear and colourless or slightly yellow and if the lipid emulsion is white and homogenous.
Combiflex Lipid Central: Only medicinal or nutritional solutions for which compatibility has been documented may be added to Lipid Emulsion/Amino Acids/ Electrolytes/Glucose (Combiflex Lipid Central) Injection. Addition should be made aseptically. Discard the remaining mixture after infusion.
Combiflex Lipid Peri: Only medicinal or nutritional solutions for which compatibility has been documented may be added to Lipid Emulsion/Amino Acids/Electrolytes/Glucose (Combiflex Lipid Peri). Addition should be made especially. Mixing data are delivered upon request. Discard the remaining mixture after infusion.
Storage
Store at temperatures not exceeding 30°C. Do not freeze.
Store in over pouch provided. After breaking the seals, chemical and physical in-use stability of the mixed three chamber bag has been demonstrated for 24 hours at 30°C.
MIMS Class
Parenteral Nutritional Products
ATC Classification
V06DE - Amino acids/carbohydrates/minerals/vitamins, combinations ; Used as general nutrients.
Presentation/Packing
Combiflex Lipid Central: Emulsion for infusion (3-chamber bag) 1,540 mL x 4's. 2,053 mL x 2's.
Combiflex Lipid Peri: Emulsion for infusion (3-chamber bag) 1,440 mL x 4's. 1,920 mL x 2's.
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