Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77)
Hospira, Inc.
ISOLEUCINE
ISOLEUCINE 462 mg in 100 mL
PRESCRIPTION DRUG
New Drug Application
AMINOSYN RF- ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ARGININE, AND HISTIDINE INJECTION, SOLUTION HOSPIRA, INC. ---------- AMINOSYN -RF 5.2% SULFITE-FREE AN AMINO ACID INJECTION — RENAL FORMULA FLEXIBLE PLASTIC CONTAINER R only DESCRIPTION Aminosyn -RF 5.2%, Sulfite-Free, (an amino acid injection — renal formula) is a sterile, nonpyrogenic solution for intravenous infusion. Aminosyn-RF 5.2% is oxygen sensitive. The solution contains the following crystalline amino acids: MG/100 ML MIN. DAILY NEED (MG**) ESSENTIAL AMINO ACIDS Isoleucine 462 700 Leucine 726 1100 Lysine Acetate* 535 800 Methionine 726 1100 Phenylalanine 726 1100 Threonine 330 500 Tryptophan 165 250 Valine 528 800 NONESSENTIAL AMINO ACIDS Arginine 600 __ Histidine*** 429 __ *Amount cited is for Lysine alone and does not include the acetate salt. **The minimum daily quantities needed to maintain nitrogen balance in the healthy adult. (Rose, W.C., The Sequence of Events Leading to the Establishment of the Amino Acid Needs of Man, Am J. Public Health, 58:2020, 1968.) ***Histidine is considered essential for patients in renal failure. ELECTROLYTES AND PRODUCT CHARACTERISTICS Aminosyn 5.2% Acetate (C H O ) (mEq/Liter) 113 Protein Equivalent (approx. grams/liter) 52.27 Total Nitrogen (grams/liter) 7.93 Osmolarity (mOsmol/liter) 427 pH (Range) 5.2 (4.5 to 6.0 ) ® x ® 2 3 2 − a b a Includes acetate from acetic acid used in processing and from Lysine acetate. Adjusted with acetic acid. Each 500 mL represents three Rose Units of essential amino acids plus arginine and histidine. The formulas for the individual amino acids present in Aminosyn-RF 5.2% 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 Arginine, USP (C H N O ) Histidine, USP (C H N O ) The flexible plastic Belgenin tamamını okuyun