Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
HISTIDINE (UNII: 4QD397987E) (HISTIDINE - UNII:4QD397987E), 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.
HISTIDINE
HISTIDINE 0.25 g in 100 mL
INTRAVENOUS
PRESCRIPTION DRUG
5.4% NephrAmine® (Essential Amino Acid Injection) is indicated for adult and pediatric use, in conjunction with other measures, to provide nutritional support for uremic patients, particularly when oral nutrition is infeasible or impractical. See WARNINGS, PRECAUTIONS, Pediatric Use , Special Precautions in Pediatric Patients , and DOSAGE AND ADMINISTRATION . NephrAmine® is contraindicated in patients with severe, uncorrected electrolyte and acid-base imbalance, hyperammonemia, decreased (subcritical) circulating blood volume, inborn errors of amino acid metabolism, or hypersensitivity to one or more amino acids present in the solution.
5.4% NephrAmine® (Essential Amino Acid Injection) is supplied sterile and nonpyrogenic in glass containers with solid stoppers packaged 12 per case. NDC REF Size 5.4% NephrAmine® (Essential Amino Acid Injection) (Canada DIN 02029464) 0264-1909-55 S9092-SS 250 mL 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
VALINE, 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. 1. Before use, perform the following checks: • Inspect each container. Read the label. Ensure solution is the one ordered and is within the expiration date. • 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 the bottom and sides of the bottle. These are not flaws. Look for bright reflections that have depth and penetrate into the wall of the bottle. Reject any such bottle. 2. 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. 3. 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. 4. 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. 5. 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. 6. 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 physician. 7. Spiking, additions, or Lire le document complet
NEPHRAMINE- HISTIDINE, ISOLEUCINE, LEUCINE, LYSINE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE, AND SODIUM BISULFITE INJECTION, SOLUTION B. BRAUN MEDICAL INC. ---------- 5.4% NEPHRAMINE (ESSENTIAL AMINO ACID INJECTION) PROTECT FROM LIGHT UNTIL USE. DESCRIPTION 5.4% NephrAmine® (Essential Amino Acid Injection) is a sterile, nonpyrogenic solution containing crystalline essential amino acids plus histidine. Each 250 mL unit provides Rose's recommended daily intake of essential amino acids plus 625 mg of histidine, considered essential for uremics. The total nitrogen content of a 250 mL unit is approximately 1.6 grams (10 g of protein equivalent) in 14 grams of amino acids. All amino acids designated USP are the "L" isomer. Each 100 mL contains: Histidine USP ..............................................0.25 g Isoleucine USP..............................................0.56 g Leucine USP.................................................0.88 g Lysine...........................................................0.64 g (added as Lysine Acetate USP....................0.90 g) Methionine USP............................................0.88 g Phenylalanine USP.........................................0.88 g Threonine USP..............................................0.40 g Tryptophan USP...........................................0.20 g Valine USP....................................................0.64 g Cysteine....................................................<0.014 g (as Cysteine HCl•H O USP....................<0.020 g) Sodium Bisulfite (as an antioxidant)..............<0.05 g Water for Injection USP......................................qs pH adjusted with Sodium Hydroxide NF as required. pH: 6.5 (6.0–7.0); Calculated Osmolarity: 435 mOsmol/liter Total Nitrogen: Approx. 0.65 g/100 mL Concentration of Electrolytes (mEq/liter): Sodium 5 Chloride <3; Acetate Approx. 44 1 2 ® 1 2 2 Rose WC: The sequence of events leading to the establishment of the amino acid needs of man. AM J PUBLIC HEALTH; 1968: 5 Lire le document complet