Perative Specialized Nutrition with partially hydrolyzed proteins and FOS for metabolic stress

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1 Perative Specialized Nutrition with partially hydrolyzed proteins and FOS for metabolic stress Usage Features Availability Administration Ingredients Protein Fat Carbohydrate Fiber Vitamins and Minerals Osmotic Concentration Renal Solute Load Analysis References Support Materials Usage: PERATIVE is a complete, balanced, ready-to-feed formula designed for metabolically stressed patients with pressure ulcers, multiple fractures, wounds, burns, or surgery who can benefit from supplemental arginine. For tube feeding For supplemental or sole-source nutrition Features: Complete, balanced nutrition Calorically dense (1.3 Cal/mL) and high in protein (20.5% of Cal, 15.8 g/8 fl oz, 66.7 g/l, 100 g/1500 ml) to help meet the elevated energy and protein needs of metabolically stressed patients Partially hydrolyzed, peptide-based for easier absorption. Well tolerated as a tube feeding 1-4 Includes 1.6 g of FOS/8 fl oz (6.5 g/l and 9.8 g/1500 ml). FOS are prebiotics that stimulate the growth of beneficial bacteria in the colon. FOS are fermented to SCFAs that stimulate water and electrolyte uptake in the colon, which is important in the management of diarrhea. Contains arginine at 2.5% of total calories. Arginine is a conditionally essential nutrient that supports wound healing and the immune system 5 Provides at least 100% of the DVs for 24 essential vitamins and minerals in 1500 Cal (1155 ml) Low-residue Lactose- and gluten-free Kosher Caloric Distribution Per 8 fl oz Per Liter Per 1500 ml % Calories Calories

2 Protein, g Fat, g Carbohydrate, g Water, g* * 1 g water = 1 ml water = 1 cc water. Availability: Ready-To-Use 8-fl-oz cans; 24/case Flavor Unflavored List Number Ross Ready-To-Hang 1000-mL prefilled containers; 8/case Flavor Unflavored List Number 1500-mL prefilled containers; 6/case Flavor Unflavored See the Reimbursement section of Ross.com for third-party reimbursement information. The Reimbursement link can be found at the top of each page of Ross.com. Product information and values listed are subject to change. Please refer to product label or packaging for the most current information. Use by date on container. Administration: List Number Use under medical supervision. Not for parenteral use. Tube feeding: Follow physician's instructions. Adjust flow rate and volume according to patient's condition and tolerance. Feed at room temperature. Minimum tube size for gravity feeding is 10 Fr; 8 Fr for pump feeding. Additional fluid requirements should be met by giving water between or after feedings or when flushing the tube. Avoid contamination during preparation and use. Ross Ready-To-Hang: Hang product up to 48 hours after initial spike when clean technique and only one new feeding set are used. Otherwise, hang no longer than 24 hours. The availability of extended hangtime does not supersede your institution s policies, procedures, or good clinical practice guidelines. (See attached PDF at the top of this page, "Ross Ready-To-Hang Suggested Setup Procedure.") Protect contents from light during storage. Click Here To View Administration Schedule. Ingredients: -D water, corn maltodextrin, partially hydrolyzed sodium caseinate, hydrolyzed lactalbumin, canola oil, medium chain triglycerides, fructooligosaccharides, L-arginine, corn oil, magnesium chloride, potassium citrate, calcium phosphate, citric acid, soy lecithin, ascorbic acid, potassium phosphate, choline chloride, carrageenan, potassium chloride, taurine, L-carnitine, zinc sulfate, ferrous sulfate, dl-alpha-tocopheryl acetate, niacinamide, calcium pantothenate, manganese sulfate, cupric sulfate, thiamine chloride hydrochloride, pyridoxine hydrochloride, beta-carotene, riboflavin, vitamin A palmitate, folic acid, biotin, chromium chloride, sodium molybdate, potassium iodide, sodium selenate, phylloquinone, cyanocobalamin and vitamin D3. ( ) Protein: PERATIVE is high in protein 66.7 g/l, a level that promotes anabolism and maintains lean body mass. 6 The protein blend of partially hydolyzed sodium caseinate, hydrolyzed lactalbumin, and L- arginine provides an amino acid profile that meets standards for high-quality proteins. 7 The easily

3 absorbed, peptide-based protein sources help support protein synthesis and tissue repair. 6 PERATIVE also contains dietary nucleotides inherent in the protein source. Supplemental nucleotides are not needed in adults when adequate protein is provided. 8,9 PERATIVE contains arginine at 2.5% of total calories, a level associated with improved outcomes in animal studies. 10,11 Arginine is a conditionally essential amino acid that supports wound healing and the immune system. Formulas that contain supplemental arginine as part of a mixed diet have been found to be associated with a significant reduction in infectious complications. 12 Patients fed PERATIVE had reduced new infection rates compared to a control group fed a standard formula. 1 (Incidence of infection was similar at study entry.) In this same study, on day 1 and 5, nitrogen balance was improved in PERATIVE group vs standard formula. 1 Other studies have demonstrated improved immune cell function, with patients receiving PERATIVE showing improvement or better maintenance of markers of protein nutriture, transferrin, and retinol binding protein, compared to patients receiving a standard high-protein formula. 2,3 Protein Profile Percent of total calories from protein 20.5 Protein content 66.7 g/l Cal/N ratio 122:1 Nonprotein Cal/N ratio 97:1 Fat: The fat blend in PERATIVE contains canola oil, MCT oil, corn oil, soy lecithin. PERATIVE contains 25% of total calories as fat. Consistent with recommendations, 13 PERATIVE contains less than 10% of total calories as omega-6 polyunsaturated fatty acids, and is low in saturated long-chain fatty acids. Fat Profile Percent of total calories from fat 25.0 Total Fat Polyunsaturated fatty acids Monounsaturated fatty acids Saturated fatty acids 37.3 g/l 8.1 g/l 10.1 g/l 17.1 g/l omega-6/omega-3 ratio 4.8:1 Carbohydrate: The carbohydrate sources in PERATIVE are corn maltodextrin (produced by the controlled hydrolysis of cornstarch) and fructooligosaccharides (FOS). The amount and benefits of FOS, the dietary fiber source in PERATIVE, are provided in the Fiber section. Carbohydrate Profile Percent of total calories from carbohydrate 54.5 Total carbohydrate g/l Fiber: Fiber The fiber source in PERATIVE is fructooligosaccharides (FOS). FOS are indigestible, highly fermentable carbohydrates that occur naturally in many foods, such as onions, bananas, tomatoes,

4 honey, garlic, barley, and wheat. FOS do not contribute to residue in the stool. FOS are prebiotics that stimulate the growth of beneficial GI bacteria (eg, bifidobacteria). FOS are fermented to shortchain fatty acids (SCFAs) that perform many beneficial functions within the digestive tract, 14 and help create an unfavorable environment for Clostridium difficile in at-risk patients SCFAs are a preferred energy source for cells of the colon, helping to maintain GI tract integrity. FOS stimulate water and electrolyte uptake in the colon, which is important in the management of diarrhea. This enhanced absorption may have important implications for people with cancer who are experiencing diarrhea. 18 In an in vitro study, FOS fermentation resulted in the greatest growth of acid-producing bacteria and the lowest ph. These factors, in turn, did not support the growth of some pathogenic bacteria, eg, Clostridium difficile. 16 The FOS content of PERATIVE is 1.6 g/8 fl oz (6.5 g/l, 9.8 g/1500 ml). Vitamins and Minerals: PERATIVE provides at least 100% of the DVs for 24 essential vitamins and minerals in 1500 Cal (1155 ml), or just under five 8-fl-oz servings. This is beneficial for patients who cannot tolerate high volumes, or those with elevated energy needs. PERATIVE is fortified with antoxidants to help prevent and reduce the cell damage caused by the production of free radicals. 19 PERATIVE is supplemented with the conditionally essential nutrients taurine and L-carnitine (31 mg/8 fl oz, 135 mg/l, 200 mg/1500 ml), which may become depleted during periods of metabolic stress. 20,21 Taurine has antioxidant properties important in controlling oxidative stress in metabolically stressed patients. 22 Osmotic Concentration: Osmotic concentration is influenced by caloric concentration, level and form of protein and carbohydrates, and level of electrolytes. Osmolality (mosm/kg H 2 O) 460 Osmolarity (mosm/l) 304 Renal Solute Load: Renal solute load represents the solutes excreted per liter of product consumed. The major determinants of renal solute load are dietary protein and electrolytes. Each milliequivalent of sodium, potassium, and chloride contributes approximately 1 mosm to the renal solute load; in adults, each gram of protein contributes approximately 5.7 mosm. Renal Solute Load (RSL) Electrolyte Content (meq/l) Sodium Potassium Chloride Protein content 66.7 g/l x 5.7 = Total RSL 516 Contribution to RSL (mosm/l) Analysis: Nutrient Facts FAN (label number) Cal/mL Energy, Cal Protein, g % of total Calories Fat, g % of total Calories

5 Cholesterol, mg Carbohydrate, g % of total Calories Water, g* Dietary Fiber, g L-carnitine, mg Taurine, mg m-inositol, mg * 1 g water = 1 ml water = 1 cc water. Vitamins Vitamin A, IU Vitamin D, IU Vitamin E, IU Vitamin K, mcg Vitamin C, mg Folic Acid, mcg Thiamin (Vitamin B1), mg Riboflavin (Vitamin B2), mg Vitamin B6, mg Vitamin B12, mcg Niacin, mg Choline, mg Biotin, mcg Pantothenic Acid, mg Includes 1325 IU/8 fl oz (5565 IU/L; 8350 IU/1500 ml) of vitamin A activity from 1.0 mg/8 fl oz (4.2 mg/l; 6.3 mg/1500 ml) of beta-carotene. Minerals Sodium, mg (meq) 245 (10.7) 1040 (45.2) 1560 (67.9) Potassium, mg (meq) 410 (10.5) 1735 (44.4) 2600 (66.5) Chloride, mg (meq) 390 (11.0) 1650 (46.5) 2470 (69.7) Calcium, mg Phosphorus, mg Magnesium, mg Iodine, mcg Manganese, mg Copper, mg Zinc, mg Iron, mg Selenium, mcg Chromium, mcg Molybdenum, mcg Amino Acids

6 Essential Histidine, mg Isoleucine*, mg Leucine*, mg Lysine, mg Methionine, mg Phenylalanine, mg Threonine, mg Tryptophan, mg Valine*, mg Nonessential Alanine, mg Arginine, mg Aspartic Acid, mg Cystine, mg Glutamic Acid, mg Glycine, mg Proline, mg Serine, mg Tyrosine, mg * Branched-chain amino acids. Fatty Acids Linoleic (18:2), mg α-linolenic (18:3), mg Caprylic (8:0), mg Capric (10:0), mg Lauric (12:0), mg Myristic (14:0), mg Palmitic (16:0), mg Stearic (18:0), mg Oleic (18:1), mg Arachidic (20:0), mg Fatty acids equal approximately 95% of total fat. Key for values in parentheses (carbon atoms:double bonds). Other Values Density at 23 C, g/ml ph 6.8 Osmolality, mosm/kg H2O 460 Osmolarity, mosm/l 304 Renal Solute Load, mosm/l 516 Cal to meet 100% RDIs 1500 ml to meet 100% RDIs 1155 Total Cal/g nitrogen 122:1 Nonprotein Cal/g nitrogen 97:1 References: 1. Brown RO, Hunt H, Mowatt-Larssen CA, et al: Comparison of specialized standard enteral formula in trauma patients. Pharmacotherapy 1994;14(3): Henningfield MF, Brantley S, Pierce J, et al: Tolerance and clinical utility of a specialized

7 enteral formula (abstract). FASEB J 1993;7(3):A Zaloga G, Meredith JW, Roberts P, et al: Improved hepatic protein responses with hydrolyzed protein versus intact protein diets after trauma (abstract). Crit Care Med 1992;20:S Mendez C, Jurkovich GJ, Wener MH, et al: Effects of supplemental dietary arginine, canola oil, and trace elements on cellular immune function in critically injured patients. Shock 1996;6: Efron D, Barbul A: Role of arginine in immunonutrition. J Gastroenterol 2000;35: Cerra FB, Benitez MR, Blackburn GL, et al: Applied nutrition in ICU patients. A consensus statement of the American College of Chest Physicians. Chest 1997;111: National Research Council: Recommended Dietary Allowances, ed 10, Washington, DC: National Academy Press, Pizzini RP, Kumar S, Kulkarni AD, et al: Dietary nucleotides reverse malnutrition and starvation-induced immunosuppression. Arch Surg 1990;125: Adjei AA, Takamine F, Yokoyama H, et al: The effects of oral RNA and intraperitoneal nucleoside-nucleotide administration on methicillin-resistant Staphylococcus aureus infection in mice. JPEN 1993;17: Saito H, Trocki O, Wang SL, et al: Metabolic and immune effects of dietary arginine supplementation after burn. Arch Surg 1987;122: Gianotti L, Alexander JW, Pyles T, Fukushima, R: Arginine-supplemented diets improve survival in gut-derived sepsis and peritonitis by modulating bacterial clearance. The role of nitric oxide. Ann Surg 1993;217: Heyland DK, Novak F, Drover JW, et al: Should immunonutrition become routine in critically ill patients? Systematic review of the evidence. JAMA 2001;286: Institute of Medicine: Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein and Amino Acids, Washington DC: National Academies Press, 2002 (prepublication). 14. Prosky L, Hoebregs H: Methods to determine food inulin and oligofructose. J Nutr 1999;129 (suppl 7):1418S-1423S. 15. Gibson G, Wang X: Bifidogenic properties of different types of fructooligosaccharides. Food Microbiol (London) 1994;11: Cummings JH, Macfarlane GT: The control and consequences of bacterial fermentation in the human colon. J Appl Bacteriol 1991;70: Macfarlane GT, Cummings JH: The colonic flora, fermentation, and large bowel digestive function, in Phillips SF, Pemberton JH, Shorter RG (eds): The Large Intestine: Physiology, Pathophysiology, and Disease, pp New York: Raven Press, Jenkins DJ, Kendall CW, Vuksan V: Inulin, oligofructose and intestinal function. J Nutr 1999;129:1431S-1433S. 19. Goodyear-Bruch C, Pierce JD: Oxidative stress in critically ill patients. Am J Crit Care 2002;11: Paauw JD, Davis AT: Taurine concentrations in serum of critically injured patients and ageand sex-matched healthy control subjects. Am J Clin Nutr 1990;52: Iapichino G, Radrizzani D, Colombo A, Ronzoni Gl: Carnitine excretion: A catabolic index of injury. JPEN 1988;12: Fang YZ, Yang S, Wu G: Free radicals, antioxidants and nutrition. Nutrition 2002;18:

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