• Enfamil® Human Milk Fortifier Acidified Liquid

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: Monday, November 21, 2016

  • 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, to help meet the latest expert nutrition guidelines for premature infants1.

  • Product Features
      • Well tolerated
      • Commercially sterile, single-dose packaging meets AND and CDC feeding preparation guidelines
      • 4 g of protein per 100 Cal when mixed with human milk*
      • pH ~4.3 (product by itself): pH ~4.7 when mixed with human milk
      • Helps premature infants achieve significantly higher achieved weight, length, head circumference and linear growth rate than Enfamil HMF Powder with the same volume intake2
      • Shown to significantly improve docosahexaenoic and arachidonic acid status in preterm infants compared to Enfamil Human Milk Fortifier Powder3
      • No significant difference in NEC or sepsis in preterm infants <1250 g fed liquid HMF vs powder HMF2
      • Helps improve DHA status compared to our powder HMF3

      DHA and ARA Fatty Acid Nutrients

      • DHA – 24 mg
      • ARA – 38 mg

      * When mixed as directed: EHMF + preterm human milk (1 vial + 25 mL) † Per 100 Calories. ‡ EHMFAL + preterm human milk (1 vial + 25 mL) (per 100 Cal): DHA 24 mg, ARA 38mg. Calculated using values for preterm human breast milk compiled from multiple published studies. Data on file.

  • Nutrients§
    • (Normal Dilution) Per 4 Vials (30 Cal) EHMFAL + preterm human milk|| 1 Vial + 25 mL (Per 100 Cal)
      Protein, g 2.2 4
      Fat, g 2.3 6
      Linoleic acid, mg 230 730
      Carbohydrate, g <1.2 8.1
      Water, g 15.1 107
      (Normal Dilution) Per 4 Vials (30 Cal) EHMFAL + preterm human milk|| 1 Vial + 25 mL (Per 100 Cal)
      Vitamins/Other Nutrients
      Vitamin A, IU 1160 1250
      Vitamin D, IU 188 210
      Vitamin E, IU 5.6 6.2
      Vitamin K, mcg 5.7 7.9
      Thiamin (Vitamin B1), mcg 184 200
      Riboflavin (Vitamin B2), mcg 260 300
      Vitamin B6, mcg 140 151
      Vitamin B12, mcg 0.64 0.68
      Niacin, mcg 3700 4000
      Folic acid (Folacin), mug 31 35
      Pantothenic acid, mug 920 1190
      Biotin, mcg 3.4 4
      Vitamin C (Ascorbic acid), mg 15.2 21
      Choline, mg NA NA
      (Normal Dilution) Per 4 Vials (30 Cal) EHMFAL + preterm human milk|| 1 Vial + 25 mL (Per 100 Cal)
      Minerals
      Calcium, mg 116 145
      Phosphorus, mg 63 80
      Magnesium, mg 1.84 5.3
      Iron, mg 1.76 1.91
      Zinc, mg 0.96 1.37
      Manganese, mcg 10 10.7
      Copper, mcg 60 101
      Iodine, mcg NA 18.4
      Selenium, mcg NA 2.5
      Sodium, mg 27 57
      Potassium, mg 45 98
      Chloride, mg 28 89
      Per 1 Vial Per 4 Vials EHMFAL + preterm Hum milk 1 Vial + 25 mL
      Osmolality (mOsm/kg water) - - +36
      pH ~4.3 ~4.3 ~4.7

      § Product nutrient values and ingredients are subject to change. Please see product label for current information. || Calculated using values for preterm human breast milk compelled form multiple published studies; protein value used for preterm human milk is 1.62 g/100 mL4. ¶ When added to human milk as recommended, EHMFAL increases osmolality by approximately 36 mOsm/kg water. NA = None Added

  • 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)4 17.7 per 4 Vials** (Concentrate only)
      Lactose-Free No
      Galactose-Free No

      # 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.

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

    • Item #: 146301
      Description: Liquid
      Unit Size: 5 mL vial
      Cal./Unit: 7.5
      Prod. Yield / Unit (fl oz): 5 mL
      Case: 200 vials oer case
      Reimbursement Code: 00087-146341

      HCPCS Code

  • Composition
    • Ingredients: Liquid: 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
    • 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.

      Follow hospital rules or the baby's doctor's instructions for the safe handling of breast milk.

      To aid mixing, agitate the breast milk well. Pour the desired amount into a sterile container and warm to feeding temperature.

      Add the fortifier to the breast milk according to the following chart:

      Additional Calories Desired Breast Milk Enfamil Human Milk Fortifier Acidified Liquid
      2 Calories/fl oz 50 mL 1 vial
      4 Calories/fl oz 25 mL 1 vial
      Each vial 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 breast 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 breast 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 breast milk to be fed into a feeding container and feed immediately. Do not use fortified breast milk if it is unrefrigerated for more than a total of 2 hours. After feeding begins, use within 1 hour or discard.

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

      Suggestions When Using This Product:

      1. Consider monitoring acid/base status. 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 Acidified Liquid 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 Acidified Liquid unless appropriate tests indicate a need for further supplementation with a particular nutrient.

      3. Do not add Enfamil Human Milk Fortifier Acidified Liquid to breast milk in a ratio greater than 1 vial/25 mL.

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

      If more than 20 vials daily are used, the infant should be monitored for evidence of excessive vitamins A and D intake.

      Storage

      Store unopened pouches in carton at room temperature. Avoid excessive heat. Do not freeze.

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

      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.

      Expressed human milk is not sterile.

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

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

      Use only as directed. Improper dilution, preparation, handling or storage may be harmful.

  • References
    • 1. Koletzko B, Poindexter B, Uauy R (eds). Nutritional Care of Preterm Infants: Scientific Basis and Practical Guidelines. World Rev Nutr Diet. Basel, Karger, 2014;110:1-314.

      2. Moya F, Sisk PM, Walsh KR, et al. A new liquid human milk fortifier and linear growth in preterm infants. Pediatrics. 2012;130(4):e928-935.

      3. 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. [Epub ahead of print].

      4. Data on file, Mead Johnson Nutrition, September 7, 2010.

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