Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX), 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:
B. Braun Medical Inc.
GLYCERIN
GLYCERIN 3 g in 100 mL
INTRAVENOUS
PRESCRIPTION DRUG
ProcalAmine® is indicated for peripheral administration in adults to preserve body protein and improve nitrogen balance in well-nourished, mildly catabolic patients who require short-term parenteral nutrition. Renal failure. Severe liver disease and hepatic coma. Metabolic disorders associated with impaired nitrogen utilization. Hypersensitivity to one or more amino acids.
ProcalAmine® (3% Amino Acid and 3% Glycerin Injection with Electrolytes) is supplied sterile and nonpyrogenic in 1000 mL intravenous infusion bottles, packaged six per case. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product. Protect from light until use.
New Drug Application
PROCALAMINE- GLYCERIN, ISOLEUCINE, LEUCINE, LYSINE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, GLYCINE, ARGININE, HISTIDINE, PROLINE, SERINE, CYSTEINE, SODIUM ACETATE, MAGNESIUM ACETATE, CALCIUM ACETATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, PHOSPHORIC ACID, AND POTASSIUM METABISULFITE INJECTION B. BRAUN MEDICAL INC. ---------- PROCALAMINE (3% AMINO ACID AND 3% GLYCERIN INJECTION WITH ELECTROLYTES) PROTECT FROM LIGHT UNTIL USE. DESCRIPTION ProcalAmine® (3% Amino Acid and 3% Glycerin Injection with Electrolytes) is a sterile, nonpyrogenic, moderately hypertonic intravenous injection containing crystalline amino acids, a nonprotein energy substrate and maintenance electrolytes. A 1000 mL unit provides a total of 29 g of protein equivalent (4.6 g N) and 130 nonprotein calories. All amino acids designated USP are the "L"-isomer with the exception of Glycine USP which does not have an isomer. Each 100 mL contains: _NONPROTEIN ENERGY SOURCE:_ Glycerin USP (glycerol) .............................................................................. 3.0 g _ESSENTIAL AMINO ACIDS_ Isoleucine USP .......................................................................................... 0.21 g Leucine USP ............................................................................................. 0.27 g Lysine ....................................................................................................... 0.22 g (added as Lysine Acetate USP ................................................................ 0.31 g) Methionine USP ........................................................................................ 0.16 g Phenylalanine USP .................................................................................... 0.17 g Threonine USP .......................................................................................... 0.12 g Tryptophan USP ...................................................................................... 0.046 g Valine USP ........................................ Прочитать полный документ