Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77), LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C), LYSINE ACETATE (UNII: TTL6G7LIWZ) (LYSINE - UNII:K3Z4F929H6), METHIONINE (UNII: AE28F7PNPL) (METHIONINE - UNII:AE28F7PNPL), PHENYLALANINE (UNII: 47E5O17Y3R) (PHENYLALANINE - UNII:47E5O17Y3R), THREONINE (UNII: 2ZD004190S) (THREONINE - UNII:2ZD004190S), TRYPTOPHAN (UNII: 8DUH1N11BX) (TRYPTOPHAN - UNII:8DUH1N11BX), VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7), ALANINE (UNII: OF5
Hospira, Inc.
ISOLEUCINE
ISOLEUCINE 534 mg in 100 mL
INTRAVENOUS
PRESCRIPTION DRUG
Aminosyn-PF 7%, Sulfite-Free, (an amino acid injection — pediatric formula) is indicated for the nutritional support of infants (including those of low birth weight) and young children requiring TPN via either central or peripheral infusion routes. Parenteral nutrition with Aminosyn-PF 7% is indicated to prevent nitrogen and weight loss or treat negative nitrogen balance in infants and young children where (1) the alimentary tract by the oral gastrostomy, or jejunostomy route, cannot or should not be used or adequate protein intake is not feasible by these routes, (2) gastrointestinal absorption of protein is impaired; or (3) protein requirements are substantially increased as with extensive burns. Dosage, route of administration, and concomitant infusion of non-protein calories are dependent on various factors, such as nutritional and metabolic status of the patient, anticipated duration of parenteral nutrition support, and vein tolerance. See DOSAGE AND ADMINISTRATION for additional information. Central
NDC No. Concentration Container (mL) 0409-4178-03 Aminosyn-PF 7%, Sulfite-Free, (an amino acid injection - pediaric formula) 500 Store at 20 to 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.] Protect from freezing. Avoid exposure to light. Revised: June, 2008 Printed in USA EN-1816 Hospira, Inc., Lake Forest, IL 60045 USA
New Drug Application
AMINOSYN-PF- ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, AND TYROSINE INJECTION, SOLUTION HOSPIRA, INC. ---------- AMINOSYN -PF 7% SULFITE-FREE _AN AMINO ACID INJECTION - PEDIATRIC FORMULA_ Flexible Plastic Container Rx only DESCRIPTION Aminosyn -PF 7%, Sulfite-Free, (an amino acid injection — pediatric formula) is a sterile, nonpyrogenic solution for intravenous infusion. Aminosyn -PF 7% is oxygen sensitive. The formulation is described below: AMINOSYN-PF 7% AN AMINO ACID INJECTION — PEDIATRIC FORMULA ESSENTIAL AMINO ACIDS (MG/100 ML) Isoleucine 534 Leucine 831 Lysine (acetate)* 475 Methionine 125 Phenylalanine 300 Threonine 360 Tryptophan 125 Valine 452 * Amount cited is for lysine alone and does not include the acetate salt. NONESSENTIAL AMINO ACIDS (MG/100 ML) Alanine 490 Arginine 861 L-Aspartic Acid 370 L-Glutamic Acid 576 Glycine 270 Histidine 220 Proline 570 Serine 347 Taurine 50 Tyrosine 44 ® ® ® ELECTROLYTES (MEQ/L) Sodium (Na ) (mEq/L) None Potassium (K ) (mEq/L) None Chloride (Clˉ) (mEq/L) None Acetate (C H O ˉ) (mEq/L)32.5 From lysine acetate. PRODUCT CHARACTERISTICS Protein Equivalent (Approx. grams/L)70 Total Nitrogen (grams/L) 10.69 Osmolarity (mOsmol/L) 561 pH (range) 5.5 (5.0 to 6.5) The formulas for the individual amino acids present in Aminosyn-PF 7% are as follows: ESSENTIAL AMINO ACIDS Isoleucine, USP C H NO Leucine, USP C H NO Lysine Acetate, USPC 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 Glycine, USP C H NO Arginine, USP C H N O L-Aspartic Acid C H NO HO CCH CH(NH )CO H L-Glutamic AcidC H NO HO CCH CHCH(NH )CO H Histidine, USP C H N O Proline, USP C H NO Serine, USP C H NO Taurine C H NO S Tyrosine, USP C H NO The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Wat Les hele dokumentet