Enfamil^® Human Milk Fortifier

Powdered breast milk supplement for premature or low birth weight infants.ⓊD IFANCA®

Indication

Powdered breast milk supplement for premature or low birth weight infants. Four (4) packets of Enfamil® Human Milk Fortifier, the amount usually added to 100 mL preterm human milk, supply the following:

Product Forms


Product	Format	Unit Size	Shelf Life	Item Number	Item Number (as of March 2023)
Enfamil® Human Milk Fortifier	Powder	Four (4) packets 0.71g per packet	12 Months	1173080	3221214

Preparation Of Feedings

POWDER

Enfamil^® Human Milk Fortifier is designed for preterm infants as a nutritional supplement to be added to mother’s human milk.

CAUTION: Nutritionally incomplete. To be used only under the supervision of a physician.

WARNING: The baby’s health depends on carefully following these instructions. Use only as directed by a medical professional. Improper hygiene, preparation, dilution, use or storage may result in severe harm. Although this powder is formulated for premature infants, nutritional powders 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.

Follow hospital rules or the doctor’s instructions for the safe handling of human milk.
To aid mixing, agitate the human milk well. Pour the desired amount into a sterile container and warm to feeding temperature.
Add the powder to the human milk according to the following chart:


Additional Calories Desired	Human Milk	Enfamil® Human Milk Fortifier
2 kcal/30 mL	50mL	1 packet
4 kcal/30 mL	25 mL	1 packet

The baby’s doctor will provide instructions for the desired amount of calories to add.

Failure to follow these instructions could result in severe harm. Once prepared, fortified breast milk can spoil quickly.
Either feed fortified human milk immediately or cover and store in refrigerator at 2-4°C (35-40°F) for no longer than 24 hours. Agitate before each use.
For tube feeding: Once fortified human milk is prepared it can safely remain at room temperature for 4 hours¹ . The Academy of Nutrition and Dietetics (formerly known as the American Dietetic Association) recommends a hang time for fortified breast milk of no longer than 4 hours at room temperature (25°C/77°F)²
For bottle feeding: Pour only the amount of fortified human milk to be fed into a feeding container and feed immediately. Do not use fortified human milk if it is unrefrigerated for more than a total of 2 hours. After feeding begins, do not refrigerate feeding bottle. You must use within 1 hour or discard.
WARNING: Do not use a microwave oven to warm formula. Serious burns may result.

When Using This Product:

1. Monitor and regularly assess blood levels such as serum calcium, sodium, urea nitrogen, albumin, and others. In case of an elevated level, reduce the amount of Enfamil® Human Milk Fortifier used to supplement breast milk. In case of deficiency, additional supplementation with the deficient nutrient may be indicated.

2. Do not administer other nutrient supplements in addition to Enfamil® Human Milk Fortifier unless appropriate tests indicate a need for further supplementation with a particular nutrient.

3. Do not add Enfamil^® Human Milk Fortifier to breast milk in a ratio greater than 1 packet/25 mL.

4. Preterm breast milk collected less than 2 weeks postpartum is particularly rich in nutrients, so fortification with Enfamil^® Human Milk Fortifier is generally not required

If more than 25 packets daily are used, the infant should be monitored for evidence of excessive vitamin A and D intake.

STORAGE: Store Enfamil^® Human Milk Fortifier powder at room temperature. Avoid freezing and excessive heat. Use by date on package.

Neither expressed human milk nor nutritional powders are sterile.

CAUTION: Regarding use in extremely-low-birth-weight infants (ELBW–1 kg or less): Hypercalcemia has been reported in some of these infants on full enteral feeds of mother’s milk supplemented with human milk fortifiers.

1. Telang S, Berseth CL, Ferguson PW, et al. Fortifying fresh human milk with commercial powdered human milk fortifiers does not affect bacterial growth during 6 hours at room temperature. J Am Diet Assoc. 2005;105:1567-1572. 2. Robbins ST, Meyers R, eds. Infant Feedings: Guidelines for Preparation of Human Milk and Formula in Health Care Facilities. Chicago, Ill: American Dietetic Association; 2011

Nutrients


Analysis	per 4 packets
Energy (kcal/kJ)	14/59
Protein (g)	1.1
% of total energy	32
Source: Milk protein isolate, whey protein isolate hydrolysate
Carbohydrate (g)	<0.4
% of total energy	6
Source: Minerals, corn syrup solids, citrates, lactose
Fat (g)	1
% of total energy	62
Source: MCT oil (70%), soy oil (30%)
Linoleic Acid (mg)	140
Linolenic Acid (mg)	17
Minerals
Calcium (mg)	90
Calcium (mMol)	2.3
Phosphorus (mg)	50
Phosphorus (mMol)	1.61
Magnesium (mg)	1
Magnesium (mMol)	0.04
Iron (mg)	1.44
Zinc (mg)	0.72
Manganese (μg)	10
Copper (μg)	44
Sodium (mg)	16
Sodium (mMol)	0.7
Potassium (mg)	29
Potassium (mMol)	0.74
Chloride (mg)	13
Chloride (mMol)	0.37
Vitamins
Vitamin A (IU)	950
Vitamin D (IU)	150
Vitamin E (IU)	4.6
Vitamin K (mg)	0.0044
Vitamin C (mg)	12
Thiamine (mg)	0.15
Riboflavin (mg)	0.22
Niacin (mg)	3
Pantothenic Acid (mg)	0.73
Vitamin B6 (mg)	0.115
Folic Acid (mg)	0.025
Vitamin B12 (mg)	0.00018
Biotin (mg)	0.0027


Other Characteristics
Potential Renal Solute Load (mOsm/4 packets)1	9.8*
Osmolality (mOsm/kg H2O)	+ 35†
Osmolarity (mOsm/L)	Not available

*When added to preterm human milk as recommended (4 packets/100 mL), Enfamil^® Human Milk Fortifier increases potential renal solute load by approximately 9.8 mOsm/4 packets.

^†When added to preterm human milk as recommended (4 packets/100 mL), Enfamil^® Human Milk Fortifier increases osmolality by approximately 35 mOsm/kg water.

1. Fomon SJ, Ziegler EE. Renal solute load and potential renal solute load in infancy. J Pediatr. 1999;134:11-14.

Nutrient values are subject to change. Consult actual product labels for most current information.

Ingredients

Medium Chain Triglycerides (Mct Oil), Milk Protein Isolate, Whey Protein Isolate Hydrolysate, Soybean Oil, Calcium Phosphate, Calcium Glycerophosphate, Calcium Gluconate, And Less Than 2%: Corn Syrup Solids, Soy Lecithin, 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, Magnesium Phosphate, Potassium Phosphate, Ferrous Sulfate, Zinc Sulfate, Cupric Sulfate, Sodium Citrate, Potassium Chloride, Potassium Citrate.