Essential Amino Acid Injection

5.4% NephrAmine® (Essential Amino Acid Injection) is supplied sterile and nonpyrogenic in glass containers with solid stoppers packaged 12 per case.

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.

Protect from light until use.

B. Braun Medical Inc., Bethlehem, PA 18018-3524 USA, 1-800-227-2862, www.bbraun.com In Canada, distributed by: B. Braun of Canada, Ltd., Scarborough, Ontario M1H 2W4, Y36-002-860 LD-450-1. Revised: December 2014

See WARNINGS and Special Precautions for Central Venous Nutrition.

Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis, and hypervolemia.

Symptoms may result from an excess or deficit of one or more of the ions present in the solution infused, therefore, frequent monitoring of electrolyte levels is essential.

Infrequent instances of hyperammonemia have been reported following administration of essential amino acid solutions to patients with massive gastrointestinal hemorrhage, nonuremic infants and pediatric patients or following administration of higher than recommended doses to adult or pediatric patients. Elevated plasma amino acid levels (hypermethionemia) have also been reported in infants especially in higher dosage ranges. Elevated serum ammonia levels, plasma amino acid levels, and clinical symptoms may subside when the infusions are discontinued.

Phosphorus deficiency may lead to impaired tissue oxygenation and acute hemolytic anemia. Relative to calcium, excessive phosphorus intake can precipitate hypocalcemia with cramps, tetany, and muscular hyperexcitability.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

This product contains sodium bisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

Safe and effective use of central venous nutrition requires a knowledge of nutrition as well as clinical expertise in recognition and treatment of the complications which can occur. Frequent clinical evaluation and laboratory determinations are neces s ary 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 evaluation of acid-base balance and fluid balance.

Other laboratory tests may be suggested by the patient's condition.

NephrAmine® does not replace dialysis and conventional supportive therapy in patients with renal failure.

Administration of NephrAmine® to pediatric patients, especially in high dose ranges, may result in hyperammonemia. Administration of NephrAmine® to infants, particularly neonates and low birth weight infants, may result in elevated plasma amino acid levels (e.g., hypermethionemia) and hyperammonemia.

In these very young age groups, amino acid formulations developed specifically for nutritional support of infants and pediatric patients, should be considered.

Clinically significant hypokalemia, hypophosphatemia, or hypomagnesemia may occur as a result of therapy with NephrAmine® and hypertonic dextrose and replacement therapy may become necessary.

Administration of nitrogen in any form to patients with marked hepatic insufficiency or hepatic coma may result in plasma amino acid imbalances, hyperammonemia, or central nervous system deterioration.

NephrAmine® should, therefore, be used with caution in such patients.

The intravenous administration of these solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the solute concentration of the solution infused. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the concentration of the solution.

Conservative doses of amino acids should be given, dictated by the nutritional status of the patient.

In the event of a fluid or solute overload during parenteral therapy, reevaluate the patient's condition and institute appropriate corrective treatment.