Enfamil® Human Milk Fortifier Acidified Liquid

Commercially sterile, milk-based nutritional supplement to be added to expressed breast milk for premature or low-birth-weight infants.

Last Updated: Tuesday, December 26, 2017 - 19:00

Description/Indication:

Enfamil Human Milk Fortifier Acidified Liquid is to be added to expressed breast milk for feeding premature or low-birth-weight infants. It provides enriched nutrition needed by these special babies while still allowing them to receive their mother’s milk. Enfamil Human Milk Fortifier Acidified Liquid increases the levels of protein, energy, calcium, phosphorus, iron, vitamin D and other nutrients, producing a diet more suited to the nutritional needs of the rapidly growing premature infant.

Product Features:

  • Clinically proven to promote growth, including linear growth1,*:
    • ~21% more protein than Enfamil® Human Milk Fortifier Powder
    • Helps premature infants achieve significantly higher achieved weight, length, head circumference and linear growth rate than Enfamil HMF Powder with the same volume intake1
  • 4 g of protein per 100 Cal when mixed with preterm human milk
  • Protein source is partially hydrolyzed whey protein
  • Commercially sterile, single-dose packaging meets AND and CDC feeding preparation guidelines
  • Clinically proven safe and well tolerated in preterm infants1-3,‡
    • No statistical differences in confirmed NEC (3%), sepsis (12%) or serious adverse events than Enfamil HMF Powder1
  • Shown to significantly improve DHA and ARA status in preterm infants compared to Enfamil HMF Powder4

* Based on the gold standard for clinical research: randomized, prospective, blinded, controlled clinical trials.

† When mixed as directed: EHMFAL + preterm human milk (1 vial + 25 mL).

‡ Studies used EHMFAL vs. Enfamil HMF Powder.

  • Nutrients
    • (Normal Dilution)

      Per 4 Vials

      4 Vials Plus 100 mL

      Per 100 Cal

      (30 Cal)

      Preterm Breast Milk§ (97 Cal)

      Fortified Preterm Breast Milk§

      Protein, g

      2.2

      3.8

      4

      Fat, g

      2.3

      5.8

      6

      Linoleic acid, mg

      230

      710

      730

      Carbohydrate, g

      <1.2

      7.9

      8.1

      Water, g

      15.1

      104

      107

      Vitamins/Other Nutrients

      Vitamin A, IU

      1160

      1210

      1250

      Vitamin D, IU

      188

      200

      210

      Vitamin E, IU

      5.6

      6

      6.2

      Vitamin K, mcg

      5.7

      7.7

      7.9

      Thiamin (Vitamin B1), mcg

      184

      193

      200

      Riboflavin (Vitamin B2), mcg

      260

      290

      300

      Vitamin B6, mcg

      140

      146

      151

      Vitamin B12, mcg

      0.64

      0.66

      0.68

      Niacin, mcg

      3700

      3900

      4000

      Folic acid (Folacin), mcg

      31

      34

      35

      Pantothenic acid, mcg

      920

      1150

      1190

      Biotin, mcg

      3.4

      3.9

      4

      Vitamin C (Ascorbic acid), mg

      15.2

      20

      21

      Minerals

      Calcium, mg

      116

      141

      145

      Phosphorus, mg

      63

      78

      80

      Magnesium, mg

      1.84

      5.1

      5.3

      Iron, mg

      1.76

      1.85

      1.91

      Zinc, mg

      0.96

      1.33

      1.37

      Manganese, mcg

      10

      10.4

      10.7

      Copper, mcg

      60

      98

      101

      Sodium, mg

      27

      55

      57

      Potassium, mg

      45

      95

      98

      Chloride, mg

      28

      86

      89

      * Calculated using values for preterm human breast milk compiled from multiple published studies; protein value used for preterm human milk is 1.62 g/100 mL6.

  • Nutrient Facts
    • Nutrient Density

      Per 4 Vials (30 Cal)

      Protein (% Calories)

      29

      Fat (% Calories)

      65

      Carbohydrate (% Calories)

      6

      Potential Renal Solute Load (mOsm/100 Calories)5

      33*

      Potential Renal Solute Load (mOsm/4 vials)5 Concentrate only

      17.7 per 4 vials

      Lactose-free

      No

      Per 1 Vial

      Per 4 Vials

      EHMFAL + Preterm Human Milk (1 Vial + 25 mL)

      Osmolality (mOsm/kg water)

      326§

      pH

      ~4.3

      ~4.3

      ~4.7

      Per 1 Vial

      Per 4 Vials

      EHMFAL + Preterm Human Milk (1 Vial + 25 mL)

      Osmolality (mOsm/kg water)

      326#

      pH

      ~4.3

      ~4.3

      ~4.7


      * When mixed at normal dilution, 1 vial to 25 mL preterm human milk.

      † 31 mOsm/120 mL when 4 vials added to 100 mL preterm human milk.

      ‡ When added to human milk as recommended, EHMFAL increases osmolality by approximately 36 mOsm/kg water.

  • Product Forms

      Enfamil® Human Milk Fortifier Acidified Liquid is available in an ultra-concentrated liquid.

      When using this information, please note the following:

      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

    • Product: Enfamil® Human Milk Fortifier Acidified Liquid
      Item #: 146301
      Description: Liquid
      Unit Size: 5 mL vial
      Calories/Unit: 7.5
      Product Yield/Unit (fl oz): 5 mL
      Case: 200 vials per case
      HCPCS Code: B4155
      NDC Format Code: 00087-1463-41
  • Composition
    • Ingredients: Water, whey protein isolate hydrolysate (milk), medium chain triglycerides (MCT oil), vegetable oil (soy and high oleic sunflower oils) and less than 2%: Mortierella alpina oil*, Crypthecodinium cohnii oil, pectin, vitamin A palmitate, vitamin E acetate, vitamin D3, vitamin K1, thiamin hydrochloride, riboflavin, vitamin B6 hydrochloride, vitamin B12, niacinamide, folic acid, calcium pantothenate, biotin, ascorbic acid, calcium citrate, calcium phosphate, cupric sulfate, sodium citrate, potassium citrate, calcium chloride, citric acid, ferrous sulfate, magnesium phosphate, zinc sulfate.

      * A source of arachidonic acid (ARA).
      † A source of docosahexaenoic acid (DHA).

  • Potential Allergens
    • Enfamil® Human Milk Fortifier Acidified Liquid contains milk and soy.

  • Preparation of Feedings
    • Human Milk Fortifiers

      The baby’s health depends on carefully following the instructions below. Use only as directed by a medical professional. Improper hygiene,
      preparation, dilution, use or storage may result in severe harm.

      • Follow hospital rules or the baby’s 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 fortifier to breast milk according to the following chart:

      Additional Calories Desired

      Human Milk

      Enfamil Human Milk Fortifier

      2 Calories/fl oz

      50 mL

      1 vial

      4 Calories/fl oz

      25 mL

      1 vial

      Each vial of Enfamil Human Milk Fortifier Acidified Liquid is designed to deliver 5 mL when opened and poured.

      • The baby’s doctor will provide instructions for the desired amount of calories to add.
      • Remove vials from foil pouch and separate number of vials needed.
      • Store remaining vials in foil pouch at room temperature. Once pouch has been opened, vials must be used within 24 hours.
      • Shake vial vigorously to mix contents. Firmly hold vial UPRIGHT by bottom tab and slowly twist top off completely. Add fortifier to human milk.

      Some liquid may remain in cap and vial; disregard this liquid. Discard opened vial and cap promptly. Do not use product that has unusual characteristics.

      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 35–40°F (2–4°C) for no longer than 24 hours. Agitate before each use.

      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, use fortified human milk within 1 hour or discard.

      For tube feeding: Once fortified human milk is prepared, it can remain at room temperature for no longer than a total of 4 hours.

      WARNING: Do not use a microwave oven to warm the fortified human milk. Serious burns may result.

      WARNING: Not for parenteral (I.V.) use. Fortifier is designed to be mixed with breast milk; do not administer directly.

      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.

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

  • References
      1. Moya F, Sisk PM, Walsh KR, et al. A new liquid human milk fortifier and linear growth in preterm infants. Pediatrics. 2012;130:e928-935.
      2. Kurada S, Kamat M, Khilfeh M, et al. Comparison of breast milk with powdered human milk fortifier (PHMF) and Liquid Human Milk Fortifier (LHMF) on nutrition and growth parameters of VLBW infants. Presented at: Pediatric Academic Societies Annual Meeting; May 3-6, 2014; Vancouver, Canada. Abstract 3845.687.
      3. Mayberry L, Wolf S. Tracking nutritional protein management in the preterm infant using Vermont-Oxford benchmarks. FASEB J. 2014;28(1 suppl):LB318.
      4. Berseth CL, Harris CL, Wampler JL, et al. Liquid human milk fortifier significantly improves docosahexaenoic and arachidonic acid status in preterm infants. Prostaglandins Leukot Essent Fatty Acids. 2014;91:97-103.
      5. Fomon SJ, Ziegler EE. Renal solute load and potential renal solute in infancy. J Pediatr. 1999;134:11-14.
      6. Data on file, Mead Johnson Nutrition, September 7, 2010.
  • Preterm Human Milk Caloric Recipes
    • Nutrients per 100 Cal
      ~Cal/fl oz2224
      Preterm human milk + EHMFAL Concentrate50 mL + 5 mL25 mL + 5 mL
      Final volume, mL5530
      Energy, Cal100100
      Protein, g3.34
      Fat, g5.76
      Carbohydrate, g9.38.1
      Water, g118107
      Vitamins/Other Nutrients
      Vitamin A activity, IU7701250
      Vitamin D, IU124210
      Vitamin E, IU3.96.2
      Vitamin K, mcg5.97.9
      Thiamin (Vitamin B<sub>1</sub>), mcg123200
      Riboflavin (Vitamin B<sub>2</sub>), mcg191300
      Vitamin B<sub>6</sub>, mcg93151
      Vitamin B<sub>1</sub>), mcg0.410.68
      Niacin, mcg25004000
      Folic acid (Folacin), mcg2335
      Pantothenic acid, mcg8401190
      Biotin, mcg2.74
      Vitamin C (Ascorbic acid), mg14.621
      Carnitine, mg0.850.72
      Taurine, mg4.94.1
      Minerals
      Calcium, mg101145
      Phosphorus, mg5680
      Magnesium, mg5.15.3
      Iron, mg1.181.91
      Zinc, mg1.041.37
      Manganese, mcg6.510.7
      Copper, mcg83101
      Iodine, mcg2218.4
      Selenium, mcg2.92.5
      Sodium, mg5157
      Potassium, mg8998
      Chloride, mg8889
      Additional Nutrients
      Linoleic acid, mg730730
      Linolenic acid, mg5460
      ARA, mg3238
      DHA, mg2124
      Nutrients per 100 mL
      ~Cal/fl oz0.740.81
      Preterm human milk + EHMFAL Concentrate50 mL + 5 mL25 mL + 5 mL
      Final volume, mL5530
      Energy, Cal7581
      Protein, g2.53.2
      Fat, g4.24.8
      Carbohydrate, g6.96.6
      Water, g8887
      Vitamins/Other Nutrients
      Vitamin A activity, IU5701010
      Vitamin D, IU93167
      Vitamin E, IU2.95
      Vitamin K, mcg4.46.4
      Thiamin (Vitamin B<sub>1</sub>), mcg92161
      Riboflavin (Vitamin B<sub>2</sub>), mcg143240
      Vitamin B<sub>6</sub>, mcg69122
      Vitamin B<sub>12</sub>, mcg0.310.55
      Niacin, mcg18803300
      Folic acid (Folacin), mcg1728
      Pantothenic acid, mcg630960
      Biotin, mcg23.3
      Vitamin C (Ascorbic acid), mg10.916.7
      Carnitine, mg0.640.58
      Taurine, mg3.63.3
      Minerals
      Calcium, mg75118
      Phosphorus, mg4265
      Magnesium, mg3.84.3
      Iron, mg0.881.54
      Zinc, mg0.771.11
      Manganese, mcg4.98.7
      Copper, mcg6282
      Iodine, mcg16.214.8
      Selenium, mcg2.22
      Sodium, mg3846
      Potassium, mg6679
      Chloride, mg6572
      Additional Nutrients
      Linoleic acid, mg540590
      Linolenic acid, mg4048
      ARA, mg2431
      DHA, mg15.619.2
  • Term Human Milk Caloric Recipes
    • Nutrients per 100 Cal
      ~Cal/fl oz2224
      Term Human milk + EHMFAL Concentrate50 mL + 5 mL25 mL + 5 mL
      Final volume, mL5530
      Energy, Cal100100
      Protein, g2.43.2
      Fat, g5.66
      Carbohydrate, g10.18.9
      Minerals, g0.570.73
      Water, g118108
      Vitamins/Other Nutrients
      Vitamin A activity, IU8801350
      Vitamin D, IU116195
      Vitamin E, IU4.46.6
      Vitamin K, mcg3.86.2
      Thiamin (Vitamin B<sub>1</sub>), mcg136210
      Riboflavin (Vitamin B<sub>2</sub>), mcg220320
      Vitamin B<sub>6</sub>, mcg109165
      Vitamin B<sub>12</sub>, mcg0.480.74
      Niacin, mcg27004200
      Folic acid (Folacin), mcg3243
      Pantothenic acid, mcg8301190
      Biotin, mcg2.94.2
      Vitamin C (Ascorbic acid), mg2126
      Choline, mg19.416.5
      Inositol, mg3227
      Total nucleotides, mg3.42.9
      Minerals
      Calcium, mg98143
      Phosphorus, mg5478
      Magnesium, mg5.15.3
      Iron, mg1.141.88
      Zinc, mg0.821.2
      Manganese, mcg6.410.6
      Copper, mcg7393
      Iodine, mcg18.215.5
      Selenium, mcg2.42.1
      Sodium, mg3947
      Potassium, mg8596
      Chloride, mg6873
      Additional Nutrients
      Linoleic acid, mg830820
      Linolenic acid, mg6267
      ARA, mg3238
      DHA, mg2124
      Nutrients per 100 mL
      ~Cal/fl oz0.740.81
      Term Human milk + EHMFAL Concentrate50 mL + 5 mL25 mL + 5 mL
      Final volume, mL5530
      Energy, Cal7581
      Protein, g1.842.6
      Fat, g4.24.8
      Carbohydrate, g7.57.2
      Minerals, g0.430.59
      Water, g8988
      Vitamins/Other Nutrients
      Vitamin A activity, IU6601090
      Vitamin D, IU87158
      Vitamin E, IU3.35.3
      Vitamin K, mcg2.85
      Thiamin (Vitamin B<sub>1</sub>), mcg102167
      Riboflavin (Vitamin B<sub>2</sub>), mcg164260
      Vitamin B<sub>6</sub>, mcg82133
      Vitamin B<sub>12</sub>, mcg0.360.6
      Niacin, mcg20003400
      Folic acid (Folacin), mcg2435
      Pantothenic acid, mcg620960
      Biotin, mcg2.23.4
      Vitamin C (Ascorbic acid), mg1621
      Choline, mg14.513.3
      Inositol, mg2422
      Total nucleotides, mg2.52.3
      Minerals
      Calcium, mg73116
      Phosphorus, mg4163
      Magnesium, mg3.84.3
      Iron, mg0.851.52
      Zinc, mg0.620.97
      Manganese, mcg4.88.6
      Copper, mcg5575
      Iodine, mcg13.612.5
      Selenium, mcg1.821.67
      Sodium, mg2938
      Potassium, mg6478
      Chloride, mg5159
      Additional Nutrients
      Linoleic acid, mg620670
      Linolenic acid, mg4654
      ARA, mg2431
      DHA, mg15.619.2
  • Consumer Reviews