Phenyl-Free® 1
Phenylalanine-free, iron fortified infant formula with DHA and ARA for infants and young children with documented phenylketonuria (PKU).
ⓊD M IFANCA®
Phenylalanine-free, iron fortified infant formula with DHA and ARA for infants and young children with documented phenylketonuria (PKU).
| Product | Format | Unit Size | Approximate Product Yield at Normal Dilution | Shelf Life | Item Number | Availability |
|---|---|---|---|---|---|---|
| Phenyl-Free® 1 | Powder | 454 g | Yield Not Applicable to Metabolics | 18 Months | 2001922 | Hospital & Retail Pharmacy (on prescription) |
| SKU Number | Product Name | Halal Status | Kosher Status |
|---|---|---|---|
| 2001922 | Phenyl-Free® 1 (Powder) | Halal Certified | Kosher Dairy |
Corn Syrup Solids, Vegetable Oil (Palm Olein Oil, Coconut Oil, Soy Oil, High Oleic Sunflower Oil), Amino Acids (L-Glutamine, L-Leucine, Potassium Aspartate, L-Lysine Hydrochloride, L-Tyrosine, L-Proline, L-Valine, L-Isoleucine, L-Alanine, L-Arginine, L- Threonine, L-Serine, Glycine, L-Histidine, L-Methionine, L-Tryptophan, L-Cystine), Modified Corn Starch, Sugar, Mortierella Alpina Oil*, Crypthecodinium Cohnii Oil†, Ethyl Vanillin, L- Carnitine, Taurine, Ascorbyl Palmitate, Mixed Tocopherols (May contain Potassium Hydroxide), Minerals (Calcium Phosphate, Choline Chloride, Cupric Sulfate, Ferrous Sulfate, Inositol, Magnesium Oxide, Manganese Sulfate, Potassium Chloride, Potassium Citrate, Sodium Citrate, Sodium Iodide, Sodium Selenite And Zinc Sulfate), Vitamins (Ascorbic Acid, Biotin, Calcium Pantothenate, Folic Acid, Niacinamide, Riboflavin, Thiamine Hydrochloride, Vitamin A Palmitate, Vitamin B12, Vitamin B6 Hydrochloride, Vitamin D3, Vitamin E Acetate and Vitamin K1).
*A source of Arachidonic Acid (ARA)
†A Source of Docosahexaenoic Acid (DHA)
| Analysis | per 100 mL | per 100 g |
|---|---|---|
| Energy (kcal/kJ) | 68/280 | 500/2100 |
| Protein equivalent (g) | 2.2 | 16.2 |
| % of total energy | 13 | 13 |
| Source: Amino Acid Premix | ||
| Carbohydrate (g) | 6.9 | 51 |
| % of total energy | 40 | 40 |
| Source: Corn syrup solids, modified corn starch, sugar | ||
| Fat (g) | 3.5 | 26 |
| % of total energy | 47 | 47 |
| Source: Palm olein oil (44%), soy oil (19.5%), coconut oil (19.5%), high oleic sunflower oil (14.5%), ARA & DHA single cell oil blend (2.5%) | ||
| Linoleic Acid (g) | 0.54 | 4 |
| Linolenic Acid (g) | 0.046 | 0.34 |
| ARA (mg) | 24 | 175 |
| DHA (mg) | 11.9 | 88 |
| Minerals | ||
| Calcium (mg) | 89 | 660 |
| Calcium(mMol) | 2.2 | 16.5 |
| Phosphorus (mg) | 59 | 440 |
| Phosphorus (mMol) | 1.92 | 14.2 |
| Magnesium (mg) | 8.9 | 66 |
| Magnesium (mMol) | 0.37 | 2.7 |
| Iron (mg) | 1.3 | 9.6 |
| Zinc (mg) | 1.16 | 8.6 |
| Manganese (mg) | 0.051 | 0.38 |
| Copper (mg) | 0.116 | 0.86 |
| Iodine (mg) | 0.0103 | 0.076 |
| Selenium (mg) | 0.0019 | 0.0141 |
| Sodium (mg) | 32 | 240 |
| Sodium (mMol) | 1.41 | 10.4 |
| Potassium (mg) | 76 | 560 |
| Potassium (mMol) | 1.93 | 14.3 |
| Chloride (mg) | 58 | 430 |
| Chloride (mMol) | 1.64 | 12.1 |
| Vitamins | ||
| Vitamin A (IU) | 210 | 1520 |
| Vitamin D (IU) | 51 | 380 |
| Vitamin E (IU) | 1.35 | 10 |
| Vitamin K (mg) | 0.0059 | 0.044 |
| Vitamin C (mg) | 8.1 | 60 |
| Thiamine (mg) | 0.135 | 1 |
| Riboflavin (mg) | 0.135 | 1 |
| Niacin (mg) | 1.35 | 10 |
| Pantothenic Acid (mg) | 0.51 | 3.8 |
| Vitamin B6 (mg) | 0.135 | 1 |
| Folic Acid (mg) | 0.0135 | 0.1 |
| Vitamin B12 (mg) | 0.00027 | 0.002 |
| Biotin (mg) | 0.0051 | 0.038 |
| Choline (mg) | 16.7 | 124 |
| Inositol (mg) | 11.6 | 86 |
| Carnitine (mg) | 6.9 | 51 |
| Taurine (mg) | 4.1 | 30 |
| Other Characteristics | |
|---|---|
| Potential Renal Solute Load (mOsm/100 mL)1 | 19.5 |
| Osmolality (mOsm/kg H2O)* | 350 |
| Osmolarity (mOsm/L)* | 320 |
| Water (g/100 mL) | 90 |
All metabolic products are for use under the direct and continuing supervision of a doctor or metabolic dietitian.
This product is nutritionally incomplete. Care must be taken to provide enough phenylalanine to support growth, using other foods with this amino acid as required.
Nutritional powders are not sterile.
*100 mL values and Other Characteristics information is based on this product mixed with water to a caloric density of 0.68 kcal/mL.
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.
Mead Johnson Phenyl-Free® 1 is to be used only in the dietary management of infants and young children with documented phenylketonuria under direct and continuing medical supervision.
WARNING: This product is nutritionally incomplete. Care must be taken to provide enough phenylalanine to support growth, using other foods with phenylalanine as required. Medical professionals must carefully and constantly supervise the use of Phenyl-Free® 1 with other foods and liquids and adjust the diet based on frequent blood tests.
Your baby’s health depends on carefully following the instructions below. Proper hygiene, preparation, dilution, use and storage are important when preparing formula. Powdered products are not sterile and should not be fed to premature infants or those persons who might have immune problems unless directed and supervised by your baby’s doctor.
Your baby’s doctor will provide instructions for the correct amount of cooled, boiled water and powder. If instructed to use the scoop in the can, each scoop (unpacked and level) delivers approximately 4.5 g of powder. Store the DRY scoop in this can.
1
Wash hands thoroughly with soap and water before preparing formula. Boil clean bottles, nipples, caps, scoop and utensils in water (2 minutes at a rolling boil).
2
Boil fresh water at a rolling boil for 2 minutes. Cool to room temperature prior to mixing.
3
Pour desired amount of the cooled water into the bottle. Add powder. Cap bottle and SHAKE WELL.
Failure to follow these instructions could result in severe harm. Once prepared, formula can spoil quickly. Either feed immediately or cover and store in refrigerator at 2-4°C (35-40°F) 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 within 1 hour or discard.
WARNING: Do not use a microwave oven to warm formula. Serious burns may result.
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.
WARNING: Not for parenteral (I.V.) use.
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