| Product Description: | 滋养胺（10％氨基酸注射），500毫升容器，仅Rx，目录号S9341-SS，无菌，单剂量容器，B Braun Medical Inc.，Irvine CA 92614-5895，NDC 0264-9341-55 |
|---|---|
| Status: | Ongoing |
| City: | 尔湾 |
| State: | CA |
| Country: | US |
| Voluntary/Mandated: | Voluntary: Firm Initiated |
| 最初的公司通知： | 信 |
| Distribution Pattern: | Nationwide, Puerto Rico and Spain |
| Classification: | 第一类 |
| Product Quantity: | 17,544 units |
| 召回的原因： | 颗粒物的存在：B。Braun Medical Inc.正在召回几种可在储备样品单元中发现的可见颗粒物而导致的注射产品。 |
| 召回开始日期： | 20131121 |
| Report Date: | 20140507 |
Trophamine
加载...滋养胺召回
获取警报召回时。
问题和答案
副作用和不良反应
安全，有效地使用肠胃外营养需要了解营养知识以及识别和治疗可能发生并发症的临床专业知识。频繁的临床评估和实验室确定对于正确监测肠胃外营养是必要的。Studies should include blood sugar, serum proteins, kidney and liver function tests, electrolytes, hemogram, carbon dioxide content, serum osmolalities, blood cultures, and blood ammonia levels.
WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
研究表明，肾脏功能受损的患者，包括过早的新生儿，他们在4至5 mcg/kg/day的肠胃脂水平以与中枢神经系统和骨骼毒性相关的水平上积累了铝。组织负荷可能以更低的给药速率发生。
在肾功能受损或胃肠道出血的情况下，氨基酸的给药可能会增加已经升高的血液尿素氮。不应将任何原因造成氨基酸的患者注入氨基酸，而不考虑总氮摄入量。
Administration of intravenous solutions can cause fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of the solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentrations of the solutions.
Administration of amino acid solutions to a patient with hepatic insufficiency may result in plasma amino acid imbalances, hyperammonemia, prerenal azotemia, stupor and coma.
Hyperammonemia is ofspecial significance in infants由于其在遗传代谢缺陷引起的综合征中的发生，有时与智力低下有关，尽管不一定是在因果关系中。该反应似乎与剂量有关，并且在长期治疗期间更有可能发展。至关重要的是，在婴儿中经常测量血液。该反应的机制尚未明确定义，但可能涉及遗传缺陷，肝功能不成熟或非临床损害。
应给予保守的氨基酸剂量，由患者的营养状况决定。如果出现高症血症的症状，应停用氨基酸的给药，并重新评估患者的临床状况。
This product contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
法律问题
There is currently no legal information available for this drug.
FDA安全警报
目前，该药物尚无FDA安全警报。
制造商警告
目前还没有生产informa的警告tion available for this drug.
FDA标记更改
There are currently no FDA labeling changes available for this drug.
用途
滋养胺®用于婴儿的营养支持（包括低出生体重）和通过中央或周围输注路线需要TPN的年轻儿科患者。用Trophamine®表示肠胃外营养可预防氮和体重减轻，或治疗婴儿和年轻的儿科患者的负氮平衡，而（1）通过口服，胃造口术或jejunostomy途径，不应或不应使用或不应使用或不应使用或不应使用的消化道。这些路线不可行，足够的蛋白质摄入是不可行的。（2）蛋白质的胃肠道吸收受损；或（3）随着广泛的燃烧，蛋白质的需求大大增加。非蛋白质卡路里的剂量，给药途径和伴随输注取决于各种因素，例如患者的营养和代谢状况，预期的肠胃外营养支持持续时间以及静脉耐受性。看WARNINGS, PRECAUTIONS,Pediatric Use,andDOSAGE AND ADMINISTRATION。
当要与高渗性葡萄糖混合氨基酸溶液以促进超定位或严重枯竭的婴儿或需要长期肠胃外营养的蛋白质合成时，应考虑中央静脉输注。
对于未指示中央静脉途径的中等分解代谢或枯竭的患者，可以将氨基酸溶液与5-10％的葡萄糖溶液混合在一起，并由外周静脉注入，并补充（如果需要），并用脂肪乳液进行补充。在小儿患者中，最终溶液不应超过正常血清渗透压（718 MOSMOL/L）的两倍。
History
目前没有该药物的药物病史。
Other Information
Trophamine®（6％和10％的氨基酸注射）是无菌，非硫化，高渗溶液，含有结晶氨基酸。
除甘氨酸USP外，所有指定USP的氨基酸都是“ L”异构体，没有异构体。
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| Each 100 mL contains: | ||
| Essential Amino Acids | 6% | 10% |
| Isoleucine USP | 0.49 g | 0.82 g |
| Leucine USP | 0.84 g | 1.4 g |
| 赖氨酸 | 0.49 g | 0.82 g |
| (added as Lysine Acetate USP | 0.69 g | 1.2 g) |
| Methionine USP | 0.20 g | 0.34 g |
| Phenylalanine USP | 0.29 g | 0.48 g |
| Threonine USP | 0.25 g | 0.42 g |
| Tryptophan USP | 0.12 g | 0.20 g |
| Valine USP | 0.47 g | 0.78 g |
| Cysteine | <0.014 g | <0.016 g |
| （如半胱氨酸HCl∙h2O USP | <0.020 g | <0.024 g) |
| Histidine USP* | 0.29 g | 0.48 g |
| Tyrosine* | 0.14 g | 0.24 g |
| （添加为酪氨酸USP | 0.044 g | 0.044 g |
| 和N-乙酰基-L-酪氨酸 | 0.12 g | 0.24 g) |
| Nonessential Amino Acids | ||
| Alanine USP | 0.32 g | 0.54 g |
| 精氨酸USP | 0.73 g | 1.2 g |
| Proline USP | 0.41 g | 0.68 g |
| Serine USP | 0.23 g | 0.38 g |
| 甘氨酸USP | 0.22 g | 0.36 g |
| L-天冬氨酸 | 0.19 g | 0.32 g |
| L-Glutamic Acid | 0.30 g | 0.50 g |
| Taurine †,‡ | 0.015 g | 0.025 g |
| 钠硫酸钠NF（作为抗氧化剂） | <0.050 g | <0.050 g |
| Water for Injection USP | qs | qs |
| 用冰川酸USP调节的pH pH: 5.5 (5.0–6.0) |
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| 计算。渗透性（Mosmol/L） | 525 | 875 |
| 总氨基酸（克/升） | 60 | 100 |
| 总氮（克/升） | 9.3 | 15.5 |
| Protein Equivalent (grams/liter) | 58 | 97 |
| 电解质（meq/升） | ||
| 钠 | 5 | 5 |
| §Acetate (CH3库–) | 54.4 | 97 |
| 氯化物 | <3 | <3 |
来源
Trophamine Manufacturers
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B. Braun Medical Inc.
![Trophamine (Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Cysteine Hydrochloride, Histidine, Tyrosine, N-acetyl-tyrosine, Alanine, Arginine, Proline, Serine, Glycine, Aspartic Acid, Glutamic Acid, And Taurine）解决方案[B.Braun Medical Inc.]](//www.lbxkm.com/wp-content/themes/bootstrap/assets/img/loading2.gif)
滋养胺|B. Braun Medical Inc.
The objective of nutritional management of infants and young pediatric patients is the provision of sufficient amino acid and caloric support for protein synthesis and growth.
The total daily dose of TrophAmine® (Amino Acid Injections) depends on daily protein requirements and on the patient's metabolic and clinical response. The determination of nitrogen balance and accurate daily body weights, corrected for fluid balance, are probably the best means of assessing individual protein requirements. Dosage should also be guided by the patient's fluid intake limits and glucose and nitrogen tolerances, as well as by metabolic and clinical response.
婴儿营养中蛋白质津贴的建议范围为每天每公斤体重2至4克蛋白质（2.0至4.0 g/kg/kg/day）。1建议的滋养胺®为2.0至2.5克氨基酸的剂量每天每公斤体重（2.0至2.5 g/kg/kg/kg/kg/kg/kg/kg/kg/kg），最多10千克。对于大于10公斤大于10公斤的婴儿和年轻的儿科患者，氨基酸的总剂量应包括前10千克体重的20至25克/天，每天的体重为10公斤，每天的体重为1.0至1.25 g/天。
通常,TrophAmine®与b·布劳恩的混血50% or 70% Dextrose Injection USP supplemented with electrolytes and vitamins and administered continuously over a 24 hour period.
每日总摄入量应适合患者的年龄和大小。每天每公斤体重125毫升的液体剂量适合大多数TPN婴儿。尽管在严重的高蛋白代谢或耗尽患者中可能较高的氮需求可能更高，但由于液体摄入量，氮或葡萄糖不耐症，可能无法提供额外的氮。
Cysteine is considered to be an essential amino acid in infants and young pediatric patients. An admixture of cysteine hydrochloride to the TPN solution is therefore recommended. Based on clinical studies, the recommended dosage is 1.0 mmole of L-cysteine hydrochloride monohydrate per kilogram of body weight per day.
In many patients, provision of adequate calories in the form of hypertonic dextrose may require the administration of exogenous insulin to prevent hyperglycemia and glycosuria. To prevent rebound hypoglycemia, a solution containing 5% dextrose should be administered when hypertonic dextrose solutions are abruptly discontinued.
为了防止必需的脂肪酸缺乏（E.F.A.D.），应考虑长时间（超过5天）肠胃外营养时考虑脂肪乳液共同给药。应监测血清脂质以获取E.F.A.D.的证据。在无脂肪TPN的患者中。
提供足够的细胞内电解质，主要是钾，镁和磷酸盐，是最佳利用氨基酸所必需的。另外，必须给出足够数量的主要细胞外电解质钠，钙和氯化物。在患有高氯性或其他代谢酸份的患者中，可以将钠和钾作为乙酸盐盐添加，以提供碳酸氢盐前体。计算每日电解质摄入时，必须考虑Trophamine®的电解质含量。血清电解质（包括镁和磷）应经常监测。
还应提供适当的维生素，矿物质和微量元素。
中央静脉营养。氨基酸和葡萄糖的高渗混合物可以通过连续输注通过中央静脉导管，可以安全地给药，尖端位于上腔静脉。初始输注率应慢，并逐渐增加到建议的每天每公斤体重60-125毫升。如果管理率应该落后于计划，则不应尝试“赶上”计划的进气。除了满足蛋白质需求外，尤其是在治疗的前几天，给药率还受患者的葡萄糖耐量的控制。氨基酸和葡萄糖的每日摄入应逐渐增加到最大所需剂量，如频繁确定血液和尿液中葡萄糖水平所示。
Peripheral Parenteral Nutrition. For patients in whom the central venous route is not indicated and who can consume adequate calories enterally, TrophAmine® (Amino Acid Injections) may be administered by peripheral vein with or without parenteral carbohydrate calories. Such infusates can be prepared by dilution with B. Braun's Sterile Water for Injection or 5%–10% Dextrose Injection to prepare isotonic or slightly hypertonic solutions for peripheral infusion. It is essential that peripheral infusion be accompanied by adequate caloric intake. In pediatric patients, the final solution should not exceed twice normal serum osmolarity (718 mOsmol/L).
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Trophamine®可以与含有磷酸盐或已补充磷酸盐的溶液混合。为了避免降水，应考虑添加溶液中钙和镁离子的存在。
Care must be taken to avoid incompatible admixtures. Consult with pharmacist.
1 Suskind RM：儿科营养教科书，乌鸦出版社，纽约，1981年。
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