देश: संयुक्त राज्य
भाषा: अंग्रेज़ी
स्रोत: NLM (National Library of Medicine)
ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77)
Hospira, Inc.
ISOLEUCINE
ISOLEUCINE 990 mg in 100 mL
PRESCRIPTION DRUG
New Drug Application
AMINOSYN II- ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, HISTIDINE, PROLINE, SERINE, N- ACETYLTYROSINE, AND GLYCINE INJECTION, SOLUTION HOSPIRA, INC. ---------- AMINOSYN II _AN AMINO ACID INJECTION_ PHARMACY BULK PACKAGE – NOT FOR DIRECT INFUSION. FLEXIBLE PLASTIC CONTAINER R only DESCRIPTION Aminosyn II (an amino acid injection) is a sterile, nonpyrogenic solution for intravenous infusion. Aminosyn II is oxygen sensitive. The Pharmacy Bulk Package is a sterile dosage form which contains multiple single doses for use only in a pharmacy bulk admixture program. The formulations are described below: ESSENTIAL AMINO ACIDS (MG/100 ML) AMINOSYN II 10% 15% Isoleucine 660 990 Leucine 1000 1500 Lysine (acetate)* 1050 1575 Methionine 172 258 Phenylalanine 298 447 Threonine 400 600 Tryptophan 200 300 Valine 500 750 *Amount cited is for lysine alone and does not include the acetate. NONESSENTIAL AMINO ACIDS (MG/100 ML) Alanine 993 1490 Arginine 1018 1527 L-Aspartic Acid 700 1050 L-Glutamic Acid 738 1107 Histidine 300 450 Proline 722 1083 Serine 530 795 N-Acetyl-L-Tyrosine 270 405 Glycine 500 750 OTHER CHARACTERISTICS Protein Equivalent (approx. grams/liter) 100 150 ® x ® Total Nitrogen (grams/liter) 15.3 23.0 Osmolarity (mOsmol/liter, actual) 870 1300 pH 5.8 (5.0 − 6.5) 5.8 (5.0 − 6.5) Specific Gravity 1.03 1.05 Electrolytes (mEq/L) Sodium (Na ) 39.8 58.1 Acetate (C H O ) 71.8 107.6 Sodium Hydrosulfite (mg/100mL) 20 20 Solution contains sodium hydroxide for pH adjustment. Figure includes Na from the antioxidant, sodium hydrosulfite and from the pH adjustor. Includes acetate from lysine acetate. The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very sma पूरा दस्तावेज़ पढ़ें