部份中文TrophAmine处方资料（仅供参考）
英文名：Amino Acid Injection
商品名：TrophAmine® 
中文名：氨基酸注射液（18AA-Ⅱ）
生产商：B. Braun Medical Inc.
适应症和用法
TrophAmine的营养支持的婴儿 (包括低出生体重) 和年轻的儿科患者需要通过中心或周围的输液路线。用TrophAmine肠外营养可预防婴幼儿和儿童的氮、体重下降或负氮平衡, 其中(1)消化道, 经口服、胃造瘘或空肠途径, 不能或不应使用, 或适当的蛋白质摄入是不可行的这些路线;(2)蛋白质胃肠吸收受损;或(3)蛋白质要求大大增加, 与广泛烧伤。剂量, 管理途径, 以及伴随的非蛋白卡路里的注入取决于各种因素, 如病人的营养和代谢状况, 预期的肠外营养支持时间, 和静脉耐受。
见警告, 预防措施, 儿科使用, 剂量和管理。
中心静脉营养
中心静脉输液应考虑当氨基酸溶液是掺高渗葡萄糖, 以促进蛋白质合成hypercatabolic或严重耗尽的婴儿, 或那些需要长期肠外营养。
外周营养
对于未标明中心静脉通路的中度代谢或衰竭患者, 用5-10%葡萄糖溶液混合的稀释氨基酸溶液可以用外周静脉注入, 如果需要, 补充脂肪乳剂。在儿科患者中, 最终的治疗方法不应超过两次正常血清渗透(718mOsmol/升)。
禁忌
TrophAmine是禁忌的患者未经治疗的无尿, 肝昏迷, 先天错误的氨基酸代谢, 包括那些涉及分支链氨基酸代谢, 如枫糖浆尿病和异戊酸血症, 或对溶液中含有的一种或多种氨基酸过敏。
警告
安全有效地使用肠外营养需要知识的营养, 以及临床专业知识的承认和治疗可能发生的并发症。应经常进行临床评估和实验室测定, 以适当监测肠外营养。研究应包括血糖, 血清蛋白, 肾脏和肝功能测试, 电解质, 血象, 二氧化碳含量, 血清osmolalities, 血液培养和血氨水平。
警告: 本产品含有可能有毒的铝。如果肾脏功能受损, 铝可能会在长期的肠外用药中达到毒性水平。早产新生儿特别有危险, 因为他们的肾脏是不成熟的, 他们需要大量的钙和磷酸盐溶液, 其中含有铝。
研究表明, 肾功能受损的患者, 包括早产新生儿, 在4到5µg/千克/日的情况下, 在与中枢神经系统和骨骼毒性相关的水平上, 接受肠外的铝含量增加。组织负荷可能会发生在更低的管理率。
在肾功能受损或胃肠道出血的情况下, 氨基酸的管理可能会增加已经升高的血尿素氮。任何病因的 azotemia患者不应在不考虑总氮摄入的情况下注入氨基酸。
静脉注射溶液的管理会导致液体和/或溶质过量, 导致血液电解质浓度、水中毒、充血状态或肺水肿的稀释。稀释方法状态的风险与溶液的电解质浓度成反比。溶质超载造成周围和肺水肿的拥挤状态的风险直接与溶液的电解质浓度成正比。
对肝功能不全患者的氨基酸溶液的管理可能导致血浆氨基酸失衡、hyperammonemia、肾前 azotemia、昏迷和昏迷。
Hyperammonemia在婴儿中具有特殊意义, 因为它在遗传代谢缺陷引起的综合征中的发生有时与精神发育迟缓相关, 虽然不一定是因果关系。这种反应似乎是剂量相关的, 更有可能发展在长期治疗。婴儿必须经常测量血氨。这种反应的机制没有明确的定义, 但可能涉及遗传缺陷和不成熟或 subclinically损害肝功能。
应根据患者的营养状况, 给出保守剂量的氨基酸。hyperammonemia症状的发展, 应停止氨基酸的管理, 并重新评估患者的临床状况。
该产品含有焦亚钠, 一种亚硫酸盐, 可能导致过敏型反应, 包括过敏性症状和生命威胁或严重哮喘发作在某些敏感的人。在一般人群中亚硫酸盐敏感性的总体患病率是未知的, 可能很低。在哮喘中, 亚硫酸钠的敏感性比nonasthmatic的人更常见。
如何提供
TrophAmine提供无菌和nonpyrogenic在500毫升玻璃容器与实心塞子。
每个案例的 NDC REF 单位
TrophAmine(6% 氨基酸注射液)
0264-9361-55 S9361-SS 12
TrophAmine(10% 氨基酸注射液)
0264-9341-55 S9341-SS 6
附说明书：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1d88fbe0-eb97-4964-8a78-88940064f8f0
TrophAmine(Injection)
Active ingredient: Isoleucine
Description: TrophAmine (6% and 10% Amino Acid Injections) are sterile, nonpyrogenic, hypertonic solutions containing crystalline amino acids. All amino acids designated USP are the "L"-isomer with the exception of Glycine USP, which does not have an isomer.
Indication:
TrophAmine is indicated for the nutritional support of infants (including those of low birth weight) and young pediatric patients requiring TPN via either central or peripheral infusion routes. Parenteral nutrition with TrophAmine is indicated to prevent nitrogen and weight loss or treat negative nitrogen balance in infants and young pediatric patients 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 nutritional support, and vein tolerance.
See WARNINGS, PRECAUTIONS, Pediatric Use, and DOSAGE AND ADMINISTRATION.
Central Venous Nutrition: 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 infants, or those requiring long-term parenteral nutrition.
Peripheral Parenteral Nutrition: For moderately catabolic or depleted patients in whom the central venous route is not indicated, diluted amino acid solutions mixed with 5���10% dextrose solutions may be infused by peripheral vein, supplemented, if desired, with fat emulsion.
In pediatric patients, the final solution should not exceed twice normal serum osmolarity (718 mOsmol/L).
Contraindication:
TrophAmine is contraindicated in patients with untreated anuria, hepatic coma, inborn errors of amino acid metabolism, including 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.
Non-proprietary/generic name: Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Cysteine hydrochloride, Histidine, N-Acetyl-L-Tyrosine, Tyrosine, Alanine, Arginine, Proline, Serine, Glycine, Aspartic Acid, Glutamic Acid and Taurine
Adverse Outcome:
See "WARNINGS" and "Special Precautions for Central Venous Nutrition." Reactions reported in clinical studies as a result of infusion of the parenteral fluid were water weight gain, edema, increase in BUN, and mild acidosis. Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia.
Local reaction at the infusion site, consisting of a warm sensation, erythema, phlebitis and thrombosis, have been reported with peripheral amino acid infusions, especially if other substances are also administered through the same site.
If electrolyte supplementation is required during peripheral infusion, it is recommended that additives be administered throughout the day in order to avoid possible venous irritation.
Irritating additive medications may require injection at another site and should not be added directly to the amino acid infusate. Symptoms may result from an excess or deficit of one or more of the ions present in the solution; therefore, frequent monitoring of electrolyte levels is essential.
Phosphorus deficiency may lead to impaired tissue oxygenation and acute hemolytic anemia. Relative to calcium, excessive phosphorus intake can precipitate hypocalcemia with cramps, tetany and muscular hyperexcitability.
If an adverse reaction does occur, discontinue the infusion, eva luate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.