Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77)
Hospira, Inc.
ISOLEUCINE
ISOLEUCINE 620 mg in 100 mL
PRESCRIPTION DRUG
New Drug Application
AMINOSYN- ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, HISTIDINE, PROLINE, SERINE, TYROSINE, AND GLYCINE INJECTION, SOLUTION HOSPIRA, INC. ---------- AMINOSYN SULFITE-FREE _A CRYSTALLINE AMINO ACID SOLUTION_ Flexible Plastic Container R only DESCRIPTION Aminosyn , Sulfite-Free, (a crystalline amino acid solution) is a sterile, nonpyrogenic solution for intravenous infusion. Aminosyn is oxygen sensitive. Five different formulations are available: AMINOSYN FORMULATIONS ESSENTIAL AMINO ACIDS (MG/100 ML) AMINOS YN 3.5% 5% 7% 8.5% 10% Isoleucine 252 360 510 620 720 Leucine 329 470 660 810 940 Lysine (acetate)* 252 360 510 624 720 Methionine 140 200 280 340 400 Phenylalanine 154 220 310 380 440 Threonine 182 260 370 460 520 Tryptophan 56 80 120 150 160 Valine 280 400 560 680 800 * Amount cited is for Lysine alone and does not include the acetate salt. NONESSENTIAL AMINO ACIDS (MG/100 ML) AMINOS YN 3.5% 5% 7% 8.5% 10% Alanine 448 640 900 1100 1280 Arginine 343 490 690 850 980 Histidine 105 150 210 260 300 Proline 300 430 610 750 860 Serine 147 210 300 370 420 Tyrosine 31 44 44 44 44 Glycine 448 640 900 1100 1280 ELECTROLYTES (MEQ/LITER) AMINOS YN 3.5% 5% 7% 8.5% 10% Sodium (Na ) None None None None None Potassium (K ) None None None None None Chloride (Cl ) None None None 35 None Acetate (C H O ) 51 86 105 90 147 Includes chloride from HCl added for processing and pH adjustment. Includes acetate from acetic acid used in processing and from Lysine acetate. ® x ® + + – a 2 3 2 – b a b PRODUCT CHARACTERISTICS AMINOS YN 3.5% 5% 7% 8.5% 10% Protein Equivalent (approx. grams/liter) 35 50 70 85 100 Total Nitrogen (grams/liter) 5.5 7.86 11.00 13.4 15.72 Osmolarity (mOsmol/liter) 322 462 655 802 932 pH 5.2 5.2 5.2 5.2 5.2 Range (4.5 – 6.0 )(4.5 – 6.0 )(4.5 – 6.0 )(4.5 – 6.0 ) (4.5 – 6.0 ) Adjusted with acetic acid. Adjusted with acetic acid and hydrochloric acid. The formulas for the individual amino acids present in Aminosyn are as follows: ESS Lees het volledige document