associated with central nervous system and bone toxicity. tissue loading may occur at even lower rates of administration.

sphate may be added to alternate infusate bottles to avoid precipitation. although the metabolizable acetate ion in plenamine™ 15% diminishes the risk of acidosis, the physician must be alert to the potential appearance of this disorder. initiation and termination of infusions of tpn fluids must be gradual to permit adjustment of endogenous insulin release. undiluted plenamine™ 15% should not be administered peripherally. when administered centrally, it should be diluted with appropriate diluents, e.g., dextrose, electrolytes and other nutrient components, to at least half strength. (see dosage and administration . ) caution against volume overload should be exercised. drug product contains no more than 25 mcg/l of aluminum.

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 hypermetabolic patients under these constraints. concomitant insulin administration may be required to minimize glycosuria. daily laboratory monitoring is essential. use of an infusion pump is advisable to maintain a steady infusion rate during central venous infusion. b. peripheral nutrition in patients for whom central venous catheterization is not advisable, protein catabolism can be reduced by peripheral use of diluted plenamine™ 15% plus non-protein calorie sources. dilution of 250 ml plenamine™ 15% in 750 ml of 10% dextrose will reduce the osmolarity to a level (724 mosmol/l) which is more favorable to the maintenance of the integrity of the walls of the veins. intravenous fat emulsion can be infused separately or simultaneously; if infused simultaneously the fat emulsion will provide a dilution effect upon the osmolarity while increasing the energy supply. parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. to reduce the risk of bacterial contamination, all intravenous administration sets should be replaced at least every 24 hours. usage of admixtures must be initiated within 24 hours after mixing. if storage is necessary during this 24 hour period, admixtures must be refrigerated and completely used within 24 hours of beginning administration.

supply is essential for optimal utilization of amino acids. b. total parenteral nutrition (peripheral infusion) plenamine™ 15% can also be administered as part of a total parenteral nutrition program by peripheral vein when the enteral route is inadvisable and use of the central venous catheter is contraindicated. reduction of protein loss can be achieved by use of diluted plenamine™ 15% in combination with dextrose or with dextrose and intravenous fat emulsion by peripheral infusion. complete peripheral intravenous nutrition can be achieved in patients with low caloric requirements by a plenamine™ 15% dextrose-fat regimen.