Plenamine LYSINE ACETATE, LEUCINE, PHENYLALANINE, VALINE, ISOLEUCINE, METHIONINE, THREONINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, HISTIDINE, PROLINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID, and TYROSINE 1.18 g/100mL; 1.04 g/100mL; 1.04 g/100mL; 960 mg/100mL; 749 mg/100mL; 749 mg/100mL; 749 mg/100mL; 250 mg/100mL; 2.17 g/100mL; 1.47 g/100mL; 1.0 Solution

INDICATIONS AND USAGE Plenamine™ 15% is indicated as an amino acid (nitrogen) source in parenteral nutrition regimens. This use is appropriate when the enteral route is inadvisable, inadequate or not possible, as when: — Gastrointestinal absorption is impaired by obstruction, inflammatory disease or its complications, or antineoplastic therapy; — Bowel rest is needed because of gastrointestinal surgery or its complications such as ileus, fistulae or anastomotic leaks; — Tube feeding methods alone cannot provide adequate nutrition.

DOSAGE AND ADMINISTRATION The appropriate daily dose of amino acids to be used with dextrose or with dextrose and intravenous fat emulsion will depend upon the metabolic status and clinical response of the patient as therapy proceeds. Doses which achieve nitrogen equilibrium or positive balance are the most desirable. The dosage on the first day should be approximately half the anticipated optimal dosage and should be increased gradually to minimize glycosuria; similarly, withdrawal should be accomplished gradually to avoid rebound hypoglycemia.

Fat emulsion coadministration should be considered when prolonged (more than 5 days) parenteral nutrition is required in order to prevent essential fatty acid deficiency (EFAD). Serum lipids should be monitored for evidence of EFAD in patients maintained on fat free TPN. The amount administered is dosed on the basis of amino acids/kg of body weight/day.

In general, two to three g/kg of body weight for neonates and infants with adequate calories are sufficient to satisfy protein needs and promote positive nitrogen balance. In pediatric patients, the final solution should not exceed twice normal serum osmolarity (718 mOsmol/L). DIRECTIONS FOR PROPER USE OF PHARMACY BULK PACKAGE Plenamine™ 15% in a Pharmacy Bulk Package is not intended for direct infusion.

The container closure may be penetrated only once using a suitable unvented sterile transfer device or dispensing set which allows measured dispensing of the contents. The Pharmacy Bulk Package is to be used only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area). Once the closure is penetrated, the contents should be dispensed as soon as possible; the transfer of contents must be completed within 4 hours of closure entry.

The bag may be stored at room temperature (25°C) after the closure has been entered. When using Plenamine™ 15% in patients with a need for fluid volume restriction, it can be diluted as follows: Volume Amount Final Concentration Plenamine™ 15% 500 mL 75 g 7.5% Dextrose 70% 250 mL 175 g 17.5% Intralipid® 20% 250 mL 50 g 5.0% This will provide 1395 kilocalories (kcal) per 1000 mL of admixture with a ratio of 118 non-protein calories per gram of nitrogen and an osmolarity of 1559 mOsmol/L. In patients where the need for fluid restriction is not so marked, either of the following regimens may be used dependent upon the energy needs of the patient.

Volume Amount Final Concentration Plenamine™ 15% 500 mL 75 g 3.75% Dextrose 50% 1000 mL 500 g 25% Intralipid® 20% 500 mL 100 g 5% This will provide 1500 kcal per 1000 mL of admixture with a ratio of 228 non-protein calories per gram of nitrogen and an osmolarity of 1631 mOsmol/L. Volume Amount Final Concentration Plenamine™ 15% 500 mL 75 g 3.75% Dextrose 30% 1000 mL 300 g 15% Intralipid® 10% 500 mL 50 g 2.5% This will provide 935 kcal per 1000 mL of admixture with a ratio of 158 non-protein calories per gram of nitrogen and an osmolarity of 1126 mOsmol/L.

A. Total Parenteral Nutrition (Central Infusion) In unstressed adult patients with no unusual nitrogen losses, a minimum dosage of 0.1 gram nitrogen (4.2 mL of Plenamine™ 15%) plus 4.4 grams (15 calories) of dextrose per kilogram of body weight per day are required to achieve nitrogen balance and weight stability. Intravenous fat emulsion may be used as a partial substitute for dextrose.

This regimen provides a ratio of 150 non-protein calories per gram of nitrogen. For patients stressed by surgery, trauma or sepsis, and those with unusual nitrogen losses, the dosage required for maintenance may be as high as 0.3 to 0.4 grams of nitrogen (13 to 17 mL Plenamine™ 15%) per kilogram of body weight per day, with proportionate increases in non-protein calories. Periodic assessment of nitrogen balance of the individual patient is the best indicator of proper dosage.

Volume overload and glycosuria may be encountered at high dosage, and nitrogen balance may not be achieved in extremely hype…