ust be producedanaerobically from glycogen or glucose.
Special care must be taken when giving hypertonic dextrose to a diabetic or prediabetic patient. Toprevent severe hyperglycemia in such patients, insulin may be required.
Administration of glucose at a rate exceeding the patient's utilization may lead to hyperglycemia, coma,and death.
Administration of amino acids without carbohydrates may result in the accumulation of ketone bodies inthe blood. Correction of this ketonemia may be achieved by the administration of carbohydrate.
After appropriate dilution, if 10% FreAmine® III (Amino Acid Injection) is to be administered byperipheral vein, care should be taken to assure proper placement of the infusion device within the lumenof the vein. The venipuncture site should be inspected frequently for signs of infiltration.
If venous thrombosis or phlebitis occurs, discontinue infusions or change infusion site and initiateappropriate treatment.
Extraordinary electrolyte losses such as may occur during protracted nasogastric suction, vomiting,diarrhea or gastrointestinal fistula drainage may necessitate additional electrolyte supplementation.
Metabolic acidosis can be prevented or readily controlled by adding a portion of the cations in theelectrolyte mixture as acetate salts and in the case of hyperchloremic acidosis, by keeping the totalchloride content of the infusate to a minimum. 10% FreAmine® III contains less than 3 mEq chloride perliter.
10% FreAmine® III contains phosphorus. Patients, especially those with hypophosphatemia, mayrequire additional phosphate. To prevent hypocalcemia, calcium supplementation should alwaysaccompany phosphate administration. To assure adequate intake, serum levels should be monitoredfrequently.
To minimize the risk of possible incompatibilities arising from mixing this solution with other additives
that may be prescribed, the final infusate should be inspected for cloudiness or precipitation
immediately after mixing, prior to administration, and periodically during administration.
Use only if solution is clear and vacuum is present.
Drug product contains no more than 25 µg/L of aluminum.
Laboratory Tests
Frequent clinical eva luation and laboratory determinations are necessary for proper monitoring
of central venous nutrition.
Laboratory tests should include measurement of blood sugar, electrolyte, and serum protein
concentrations; kidney and liver function tests; and eva luation of acid-base balance and fluid balance.
Other laboratory tests may be suggested by the patient's condition.
Drug Interactions
Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic
techniques. Mix thoroughly. Do not store.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No in vitro or in vivo carcinogenesis, mutagenesis, or fertility studies have been conducted with 10%
FreAmine® III (Amino Acid Injection).
Pregnancy
Teratogenic Effects
Pregnancy Category C
Animal reproduction studies have not been conducted with 10% FreAmine® III (Amino Acid Injection).
It is also not known whether 10% FreAmine® III can cause fetal harm when administered to a pregnantwoman or can affect reproduction capacity. 10% FreAmine® III should be given to a pregnant womanonly if clearly needed.
Labor and Delivery
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