দেশ: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: 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 0.9 g in 100 mL
INTRAVENOUS
PRESCRIPTION DRUG
HepatAmine® is indicated for the treatment of hepatic encephalopathy in patients with cirrhosis or hepatitis. HepatAmine® provides nutritional support for patients with these diseases of the liver who require parenteral nutrition and are intolerant of general purpose amino acid injections, which are contraindicated in patients with hepatic coma. HepatAmine® is contraindicated in patients with anuria, inborn errors of amino acid metabolism, especially those involving branched chain amino acid metabolism such as Maple Syrup Urine Disease and Isovaleric Acidemia, or hypersensitivity to one or more amino acids present in the solution.
HepatAmine® (8% Amino Acid Injection) is supplied sterile and nonpyrogenic in glass 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
ALANI 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. Remove plastic cap (See Figure 1). 3. Swab exposed stopper surface with a suitable disinfectant. 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 transfers should be made immediately after swabbing stopper surface. Check for vacuum at first puncture of stopper. Admixture by needle or syringe should be made through the target area of the rubber stopper; contents should সম্পূর্ণ নথি পড়ুন
HEPATAMINE- ISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANI INJECTION, SOLUTION B. BRAUN MEDICAL INC. ---------- HEPATAMINE (8% AMINO ACID INJECTION) PROTECT FROM LIGHT UNTIL USE. DESCRIPTION HepatAmine® (8% Amino Acid Injection) is a sterile, nonpyrogenic, hypertonic solution containing crystalline amino acids. A 500 mL unit provides a total of 40 g of amino acids and 6 g of nitrogen (38 g of protein equivalent). Each 100 mL contains: _ESSENTIAL AMINO ACIDS_ Isoleucine USP..............................................0.90 g Leucine USP.................................................1.10 g Lysine...........................................................0.61 g (added as Lysine Acetate USP....................0.86 g) Methionine USP............................................0.10 g Phenylalanine USP.........................................0.10 g Threonine USP..............................................0.45 g Tryptophan USP.........................................0.066 g Valine USP...................................................0.84 g _NONESSENTIAL AMINO ACIDS_ Alanine USP..................................................0.77 g Arginine USP.................................................0.60 g Histidine USP.................................................0.24 g Proline USP...................................................0.80 g Serine USP....................................................0.50 g Glycine USP..................................................0.90 g Cysteine....................................................<0.014 g (as Cysteine HCl•H O USP....................<0.020 g) Phosphoric Acid NF....................................0.115 g Sodium Bisulfite (as an antioxidant)................<0.1 g Water for Injection USP......................................qs pH adjusted with Glacial Acetic Acid USP pH: 6.5 (6.0–6.8) ® 2 Calculated Osmolarity: 785 mOsmol/liter Concentration of Electrolytes (mEq/liter): Sodium 10; Chloride <3 Phosphate (HPO ) 20 ( সম্পূর্ণ নথি পড়ুন