Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77)
Hospira, Inc.
ISOLEUCINE
ISOLEUCINE 720 mg in 100 mL
PRESCRIPTION DRUG
New Drug Application
AMINOSYN SULFITE FREE- ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, HISTIDINE, PROLINE, SERINE, TYROSINE, AND GLYCINE INJECTION, SOLUTION HOSPIRA, INC. ---------- AMINOSYN 10% (PH 6) SULFITE-FREE _AN AMINO ACID INJECTION_ Flexible Plastic Container R only DESCRIPTION Aminosyn 10% (pH 6), Sulfite-Free, (an amino acid injection) is a sterile, nonpyrogenic solution for intravenous infusion. Aminosyn 10% (pH 6) is oxygen sensitive. ESSENTIAL AMINO ACIDS (MG/100 ML) AMINOSYN (PH 6) 10% Isoleucine 720 Leucine 940 Lysine (acetate)* 720 Methionine 400 Phenylalanine 440 Threonine 520 Tryptophan 160 Valine 800 *Amount cited is for L-lysine alone and does not include the acetate salt. NONESSENTIAL AMINO ACIDS (MG/100 ML) AMINOSYN (PH 6) 10% Alanine 1280 Arginine 980 Histidine 300 Proline 860 Serine 420 Tyrosine 44 Glycine 1280 ELECTROLYTES (MEQ/LITER) AMINOSYN (PH 6) 10% Potassium (K ) None Chloride (Cl ) None Acetate (C H O ) 111 Includes acetate from acetic acid used in processing and from L-lysine acetate. Adjusted with acetic acid. PRODUCT CHARACTERISTICS AMINOSYN (PH 6) 10% Protein Equivalent (approx. grams/liter) 100 Total Nitrogen (grams/liter) 15.7 Osmolarity (mOsmol/liter) 938 pH 6.0 (5.5 − 6.5) Adjusted with acetic acid. The formulas for the individual amino acids present in Aminosyn 10% (pH 6) are as follows: ESSENTIAL AMINO ACIDS Isoleucine, USP C H NO Leucine, USP C H NO Lysine Acetate, USP C H N O • CH COOH Methionine, USP C H NO S Phenylalanine, USP C H NO Threonine, USP C H NO Tryptophan, USP C H N O Valine, USP C H NO NONESSENTIAL AMINO ACIDS Alanine, USP C H NO Arginine, USP C H N O Histidine, USP C H N O Proline, USP C H NO Serine, USP C H NO Tyrosine, USP C H NO Glycine, USP C H NO ® x ® + - 2 3 2 - b a a b b b 6 13 2 6 13 2 6 14 2 2 3 5 11 2 9 11 2 4 9 3 11 12 2 2 5 11 2 3 7 2 6 14 4 2 6 9 3 2 5 9 2 3 7 3 9 11 3 2 5 2 The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate fr Lesen Sie das vollständige Dokument