FREAMINE III- isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan,valine, alanine, arginine, histidine, proline, s erine, glycine, cysteine, phosphoric acid, and sodiumbisulfite injection, solution
B. Braun Medical Inc.
10% FreAmine III
(Amino Acid Injection)
Protect from light until us e.
DESCRIPTION
10% FreAmine® III (Amino Acid Injection) is a sterile, nonpyrogenic, hypertonic solution containing
crystalline amino acids. Each 1000 mL provides a total of 15.3 g of nitrogen in 97 g of amino acids
equal to 95.6 grams of protein equivalent. All amino acids designated USP are the "L"-isomer, with the
exception of Glycine USP, which does not have an isomer.
Each 100 mL contains:
Essential amino acids
Isoleucine USP ............................................................ 0.69 g
Leucine USP ............................................................... 0.91 g
Lysine USP ................................................................. 0.73 g
(added as Lysine Acetate USP .................................. 1.02 g)
Methionine USP .......................................................... 0.53 g
Phenylalanine USP ....................................................... 0.56 g
Threonine USP ............................................................ 0.40 g
Tryptophan USP ......................................................... 0.15 g
Valine USP ................................................................. 0.66 g
Nonessential amino acids
Alanine USP ............................................................... 0.71 g
Arginine USP .............................................................. 0.95 g
Histidine USP ............................................................. 0.28 g
Proline USP ............................................................... 1.12 g
Serine USP ................................................................. 0.59 g
Glycine USP ............................................................... 1.40 g
Cysteine .................................................................... <0.016 g
(as Cysteine HCl•H O USP ................................... <0.024 g)
Phosphoric Acid NF................................................... 0.12 g
Sodium Bisulfite (as an antioxidant) ............................. <0.10 g
Water for Injection USP .............................................. qs
pH adjusted with Glacial Acetic Acid USP
pH: 6.5 (6.0 – 7.0)
Calculated Osmolarity: 950 mOsmol/liter
Concentration of Electrolytes (mEq/liter): Sodium 10
Phosphate (HPO ) 20 (10 mmole P/liter); Acetate Approx. 89(provided as acetic acid and lysine acetate); Chloride <3.
CLINICAL PHARMACOLOGY
10% FreAmine® III provides a physiological ratio of biologically utilizable amino acids inconcentrated form for protein synthesis. Used with concentrated calorie sources such as hypertonicdextrose or fat emulsion, and with electrolytes, vitamins and minerals, it provides total parenteralnutrition. Administered peripherally as an isotonic solution (3%) without nonprotein calories or withminimal caloric supplementation such as 5% dextrose, it provides nutritional support and spares body
protei