Pregestimil^®

Pregestimil is an infant formula designed for infants who experience fat malabsorption and who may also be sensitive to intact proteins. Fat malabsorption or steatorrhea may be associated with cystic fibrosis, short bowel syndrome, intractable diarrhea and severe protein calorie malnutrition.

Pregestimil contains 55% of the fat from MCT oil, which is easily absorbed by babies with some GI problems

• Designed for infants with fat malabsorption problems and who may also be sensitive to intact proteins
• Hypoallergenic protein source (extensively hydrolyzed casein)

Has DHA and ARA, important nutrients also found in breast milk, that support brain and eye development^1-8

Available in both powder and Nursette® bottles

• Ready-to-feed formula is virtually isotonic

Additional product features:

• Lactose-free

Pregestimil is designed to provide a sole source of nutrition for infants up to age 6 months, and to provide a major source of nutrition through 12 months of age. Normally, in feeding infants, gradual introduction of solid foods after 4–6 months of age is an important developmental as well as nutritional step.

In cases of chronic malabsorption disorders, Pregestimil is sometimes continued as a milk substitute in the diet of children. This and similar supplemental use of Pregestimil in the diet beyond 12 months of age may make a significant contribution to the maintenance of good nutrition in such patients and is not known to be harmful in any way. When Pregestimil is used as a milk substitute, the total calcium content of the diet should be assessed.

Extended use of Pregestimil (or other infant formulas) as a sole source of diet is most appropriately monitored by physicians and nutritionists on a case-by-case basis.

Ingredients: Powder: Corn syrup solids (43%), casein hydrolysate^* (milk) (17%), medium chain triglycerides (MCT oil) (16%), soy oil (8%), modified corn starch (5%), corn oil (2%), high oleic vegetable oil (safflower or sunflower) (2%) and less than 2%: Mortierella alpina oil^†_, Schizochytrium sp. oil^‡, vitamin A palmitate, vitamin D₃, vitamin E acetate, vitamin K₁, thiamin hydrochloride, riboflavin, vitamin B₆ hydrochloride, vitamin B₁₂, niacinamide, folic acid, calcium pantothenate, biotin, ascorbic acid, choline chloride, inositol, calcium citrate, calcium phosphate, magnesium oxide, ferrous sulfate, zinc sulfate, manganese sulfate, cupric sulfate, sodium iodide, sodium citrate, potassium citrate, potassium chloride, potassium hydroxide, sodium selenite, L-cystine, L-tyrosine, L-tryptophan, taurine, L-carnitine.

Ingredients: 20 Calories/fl oz Ready To Use: Water (87%), corn syrup solids (5%), casein hydrolysate^* (milk) (2%), medium chain triglycerides (MCT oil) (2%) and less than 2%: modified corn starch, soy oil, high oleic vegetable oil (safflower and/or sunflower oils), Mortierella alpina oil^†_, Schizochytrium sp. oil^‡, carrageenan, vitamin A palmitate, vitamin D₃, vitamin E acetate, vitamin K₁, thiamin hydrochloride, riboflavin, vitamin B₆ hydrochloride, vitamin B₁₂, niacinamide, folic acid, calcium pantothenate, biotin, ascorbic acid, choline chloride, inositol, calcium carbonate, calcium hydroxide, calcium phosphate, potassium phosphate, magnesium chloride, ferrous sulfate, zinc sulfate, manganese sulfate, cupric sulfate, sodium citrate, sodium iodide, potassium citrate, sodium selenite, potassium chloride, L-cystine, L-tyrosine, L-tryptophan, taurine, L-carnitine.

Ingredients: 24 Calories/fl oz Ready To Use: Water (84%), corn syrup solids (6%), casein hydrolysate^* (milk) (3%), medium chain triglycerides (MCT oil) (2%), modified corn starch (2%) and less than 2%: soy oil, high oleic vegetable oil (safflower or sunflower oil), Mortierella alpina oil^†, Schizochytrium sp. oil^‡, calcium phosphate, potassium citrate, calcium carbonate, magnesium chloride, potassium phosphate, calcium hydroxide, potassium chloride, sodium citrate, ferrous sulfate, zinc sulfate, cupric sulfate, manganese sulfate, sodium iodide, sodium selenite, ascorbic acid, vitamin E acetate, niacinamide, calcium pantothenate, vitamin A palmitate, vitamin B₁₂, thiamin hydrochloride, vitamin D₃, riboflavin, vitamin B₆ hydrochloride, folic acid, vitamin K₁, biotin, carrageenan, choline chloride, inositol, L-cystine, L-tyrosine, L-tryptophan, taurine, L-carnitine.

Potential Allergens

Pregestimil contains milk-origin protein hydrolysate and soy ingredients. Pregestimil is hypoallergenic. Rarely, however, allergic reactions to extensively hydrolyzed casein formulas have been reported.

AMINO ACID COMPOSITION

Essential and Nonessential Amino Acids

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Dilution Information For Pregestimil

Mixing instructions by the scoop

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Mixing instructions for various concentrations and volume yields

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POWDER

A baby’s health depends on carefully following the instructions below. Use only as directed by a medical professional. Improper hygiene, preparation, use or storage may result in severe harm. Powdered infant formulas are not sterile and should not be fed to premature infants or infants who might have immune problems unless directed and supervised by a doctor. Discuss with parents which formula is appropriate for the baby.

Discuss with parents whether they need to use cooled, boiled water for mixing and whether they need to boil clean utensils, bottles and nipples in water before use.

WARNING: Do not use a microwave oven to warm formula. Serious burns may result

Refer to the product label for the most accurate information.

Failure to follow these instructions could result in severe harm. Once prepared, infant formula can spoil quickly. Either feed immediately or cover and store in refrigerator at 35–40°F (2–4°C) for no longer than 24 hours. Do not use prepared formula if it is unrefrigerated for more than a total of 2 hours. Do not freeze prepared formula. After feeding begins, use formula within 1 hour or discard.

POWDER STORAGE: Store cans at room temperature. After opening can, keep tightly covered, store in dry area and use contents within 1 month. Do not freeze powder and avoid excessive heat.

Use by date on bottom of can.

NURSETTE® BOTTLES

A baby’s health depends on carefully following the instructions below. Use only as directed by a medical professional. Proper hygiene, preparation, use and storage are important when preparing infant formula. Discuss with parents whether they need to boil a clean nipple in water before use.

2 fl oz Nursette Bottles

WARNING: Do not use a microwave oven to warm formula. Serious burns may result.

Failure to follow these instructions could result in severe harm. Opened bottles can spoil quickly. Either feed immediately or replace cap and store in refrigerator at 35–40°F (2–4°C) for no longer than 24 hours. Do not use opened bottle if it is unrefrigerated for more than a total of 2 hours. Do not freeze. After feeding begins, use formula within 1 hour or discard.

Storage: store unopened bottles at room temperature. Avoid excessive heat and prolonged exposure to light. Do not freeze. Pregestimil does not look or taste like milk or soy formulas. It may separate in the refrigerator. Shake well before feeding.

DO NOT USE IF CAP RING IS BROKEN OR MISSING

USE BY DATE ON CARTON AND BOTTLE LABELInspect each bottle for signs of damage. Wash hands thoroughly with soap and water before preparing bottle for feeding. SHAKE BOTTLE WELL and remove cap. Attach nipple unit (not included).

PREGESTIMIL IS AVAILABLE IN POWDER AND READY-TO-FEED LIQUID

Coding systems and reimbursement allowable rates vary by payer:

• Medicare Part B uses HCPCS (Healthcare Common Procedure Coding System) to group products
• Medicaid systems vary by state; some use HCPCS while others use NDC format code or systems of their own—contact your state provider for more information
• Private health insurance and managed care companies may use HCPCS, NDC format code or their own system—contact your provider for more information