Страна: Соединенные Штаты
Язык: английский
Источник: 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
B. Braun Medical Inc.
ISOLEUCINE
ISOLEUCINE 0.76 g in 100 mL
INTRAVENOUS
PRESCRIPTION DRUG
Parenteral nutrition with 6.9% FreAmine HBC® (Amino Acid Injection) is indicated to prevent nitrogen loss or treat negative nitrogen balance in adults 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) nitrogen homeostasis is substantially impaired as with severe trauma or sepsis. 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 nutritional support, and vein tolerance. See DOSAGE AND ADMINISTRATION . Central venous infusion should be considered when amino acid solutions are to be admixed with hypertonic dextrose to promote protein synthesis in hypercatabolic or severely depleted patients, or those requiring long-term parenteral nutrition. For moderately catabolic or deplet
6.9% FreAmine HBC® is supplied sterile and nonpyrogenic in 750 mL partial-fill 1000 mL glass intravenous infusion containers with solid stoppers, packaged 6 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
ALANINE, ARGININE, HISTIDINE, PROLINE, SERINE, GLYCINE, CYSTEINE, AND SODIUM BISULFITE INJECTION, SOLUTION B. Braun Medical Inc. ---------- DIRECTIONS FOR USE OF B. BRAUN GLASS CONTAINERS WITH SOLID STOPPERS Designed for use with a vented set. Use 18 to 22 gauge needle size for admixing or withdrawing solutions from the glass bottle. Before use, perform the following checks: 1. Inspect each container. Read the label. Ensure solution is the one ordered and is within the expiration date. 2. Invert container and carefully inspect the solution in good light for cloudiness, haze, or particulate matter; check the bottle for cracks or other damage. In checking for cracks, do not be confused by normal surface marks and seams on bottom and sides of bottle. These are not flaws. Look for bright reflections that have depth and penetrate into the wall of the bottle. Reject any such bottle. 3. To remove the outer closure, lift the tear tab and pull up, over, and down until it is below the stopper (see Figure 1). Use a circular pulling motion on the tab until it breaks away. 4. Grasp and remove the metal disk, exercising caution not to touch the exposed sterile stopper surface. Warning: Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. 5. When adding medication to the container prior to administration, swab the target area of the rubber stopper, inject medication and mix thoroughly by gentle agitation. 6. Refer to Directions for Use of the set being used. Insert the set spike into the bottle through the target area of the rubber stopper. Allow the fluid to flow and remove air from the tubing before administration begins. Hang the container. 7. After admixture and during administration, re-inspect the solution frequently. If any evidence of solution contamination or instability is found or if the patient exhibits any signs of fever, chills or other reactions not readily explainable, discontinue administration immediately and notify the p Прочитать полный документ
FREAMINE HBC- ISOLEUCINE, LEUCINE, LYSINE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, HISTIDINE, PROLINE, SERINE, GLYCINE, CYSTEINE, AND SODIUM BISULFITE INJECTION, SOLUTION B. BRAUN MEDICAL INC. ---------- 6.9% FREAMINE HBC (AMINO ACID INJECTION) PROTECT FROM LIGHT UNTIL USE. DESCRIPTION 6.9% FreAmine HBC® (Amino Acid Injection) is a sterile, nonpyrogenic, hypertonic solution containing crystalline amino acids. A 750 mL partial fill unit provides a total of 7.3 g of nitrogen in 50 g of amino acids equal to 46 grams of protein equivalent. 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: _ESSENTIAL AMINO ACIDS_ Isoleucine USP ............................................................ 0.76 g Leucine USP ............................................................... 1.37 g Lysine ......................................................................... 0.41 g (added as Lysine Acetate USP .................................. 0.58 g) Methionine USP .......................................................... 0.25 g Phenylalanine USP ....................................................... 0.32 g Threonine USP ............................................................ 0.20 g Tryptophan USP ......................................................... 0.09 g Valine USP ................................................................. 0.88 g _NONESSENTIAL AMINO ACIDS_ Alanine USP ............................................................... 0.40 g Arginine USP .............................................................. 0.58 g Histidine USP ............................................................. 0.16 g Proline USP ............................................................... 0.63 g Serine USP ................................................................. 0.33 g Glycine USP ............................................................... 0.33 g Cysteine .................................... Прочитать полный документ