| 产品描述： | Clinimix E 4.25/10不含亚硫酸盐（4.25％的氨基酸，带有钙的10％葡萄糖中的电解质）注射，2000毫升清晰双室容器袋，仅RX。DIST：Baxter Healthcare Corporation，一个Baxter Parkway，Deerfield，IL60015。NDC0338-1115-04。 |
|---|---|
| 地位： | 正在进行 |
| City: | Deerfield |
| State: | IL |
| 国家： | 我们 |
| 自愿/要求： | Voluntary: Firm Initiated |
| Initial Firm Notification: | Letter |
| Distribution Pattern: | 美国全国 |
| 分类： | Class I |
| 产品数量： | 7,068袋 |
| Reason For Recall: | 颗粒物的存在：颗粒物包括木材，柠檬酸钠和葡萄糖。 |
| 记起Initiation Date: | 20131118 |
| 报告日期： | 20140326 |
Clinimix e
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Questions & Answers
Side Effects & Adverse Reactions
Additives may be incompatible including fat emulsions. Consult with pharmacist, if available.
When introducing additives, use aseptic techniques. Mix thoroughly.
由于可能发生威胁生命的事件，因此应谨慎行事，以确保没有在任何肠胃外养分混合物中形成沉淀物。
这些clinimix e无硫酸盐（带有钙的电解质的氨基酸）注射，must beadmixed prior to infusion. For admixing instructions see DIRECTIONS FOR USE OF PLASTIC CONTAINER.
The infusion of hypertonic nutrient injections into a peripheral vein may result in vein irritation, vein damage, and thrombosis. After mixing, strongly hypertonic nutrient injections should only be administered through an indwelling intravenous catheter with the tip located in a large central vein, such as the superior vena cava.
用电解质/葡萄糖对这些混合氨基酸的适当给药，需要了解液体和电解质平衡和营养以及在识别和治疗可能发生的并发症方面的临床专业知识。
频繁的临床评估和实验室确定对于在给药过程中进行适当监测是必要的。Studies should include blood sugar, serum proteins, kidney and liver function tests, electrolytes, complete blood count with differential, carbon dioxide combining power or content, serum osmolarities, blood cultures, and blood ammonia levels.
Administration of amino acid solutions to a patient with hepatic insufficiency may result in serum amino acid imbalances, hyperammonemia, stupor, and coma.
高症血症是婴儿的特殊意义。This reaction appears to be related to a deficiency of the urea cycle amino acids of genetic or product origin. It is essential that blood ammonia be measured frequently in infants.
Conservative doses of these admixed amino acid with electrolytes/dextrose with calcium injections should be given to patients with known or suspected hepatic dysfunction. Should symptoms of hyperammonemia develop, administration should be discontinued and the patient’s clinical status be reevaluated.
Administration of amino acid solutions in the presence of impaired renal function presents special issues associated with retention of electrolytes.
These admixed injections should not be administered simultaneously with blood through the same infusion set because of the possibility of pseudoagglutination.
In very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolality and possible intracerebral hemorrhage.
警告：该产品包含可能有毒的铝。如果肾脏功能受损，铝可能会延长肠胃外的毒性水平。过早的新生儿特别有风险，因为它们的肾脏不成熟，并且需要大量含有铝的钙和磷酸盐溶液。
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
目前尚无该药物可用的制造商警告信息。
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
CLINIMIX E sulfite-free (Amino Acid with Electrolytes in Dextrose with Calcium) Injections are indicated as a caloric component in a parenteral nutrition regimen and as the protein (nitrogen) source for offsetting nitrogen loss or for treatment of negative nitrogen balance in patients where:
(1) the alimentary tract cannot or should not be used,
(2) gastrointestinal absorption of protein is impaired, or
（3）蛋白质的代谢需求大大增加，就像广泛的燃烧一样。
Central vein infusion should be used when amino acid solutions are admixed with hypertonic dextrose to promote protein synthesis such as for hypercatabolic or depleted patients or those requiring long term parenteral nutrition.
对于未指示中央静脉途径的患者，可能会被周围静脉注入低葡萄糖浓度的氨基酸溶液。
历史
There is currently no drug history available for this drug.
Other Information
Clinimix E无硫酸盐（带有钙的电解质的氨基酸）注射是无菌的，非硫化的，在清晰双腔室容器中的无源性，高渗溶液。
出口端口室中用电解质的无亚氨基酸注射是带有电解质的必需氨基酸和非必需氨基酸的溶液。
在注射葡萄糖注射钙ion port chamber are solutions for fluid replenishment and caloric supply.
在腔室之间打开密封并彻底混合后，将混合产物用于静脉内使用。有关混合产物的成分，pH，渗透压，离子浓度和热量含量，请参见表1。
清晰双室容器是脂质兼容的塑料容器（PL 2401塑料）。可以从容器内部渗透到覆盖物中的水量不足以显着影响溶液。与塑料容器接触的溶液可能会以非常少量的塑料从塑料中浸出某些化学成分；但是，生物测试支持塑料容器材料的安全性。
Sources
Clinimix E制造商
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Baxter Healthcare Corporation
![Clinimix e(Leucine, Phenylalanine, Lysine, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Serine, Tyrosine, Sodium Acetate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride, Calcium Chloride, Dextrose) Injection [Baxter Healthcare Corporation]](//www.lbxkm.com/wp-content/themes/bootstrap/assets/img/loading2.gif)
Clinimix e| Baxter Healthcare Corporation
如果患者长时间无法接受口腔营养，则应考虑肠胃外营养的全部机构。
The total daily dose of CLINIMIX E sulfite-free (Amino Acid with Electrolytes in Dextrose with Calcium) Injections depends on the patient’s metabolic requirement 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 nitrogen requirements.
蛋白质蛋白质的建议饮食津贴1范围从成年人的体重约0.75 g/kg到三个月大的婴儿的1.68 g/kg。但是，必须认识到，蛋白质以及营养不良患者的蛋白质以及热量需求可能会大大增加。足够卡路里的成年人的每日氨基酸剂量约为1.0至1.5 g/kg的体重，通常足以满足蛋白质需求并促进氮平衡。
For the initial treatment of trauma or protein calorie malnutrition, higher doses of protein with corresponding quantities of carbohydrates will be necessary to promote adequate patient response to therapy. The severity of the illness being treated is the primary consideration in determining proper dose level. Such higher doses, especially in infants, must be accompanied by more frequent laboratory evaluation.
Care should be exercised to insure the maintenance of proper levels of serum potassium. Quantities of 60 to 180 mEq of potassium per day have been used with adequate clinical effect. It may be necessary to add quantities of this electrolyte to these admixed injections, depending primarily on the amount of carbohydrate administered to and metabolized by the patient.
Total daily fluid requirements can be met beyond the volume of amino acids solution by supplementing with noncarbohydrate or carbohydrate-containing electrolyte solutions.
维护维生素，其他电解质和微量元素应根据需要进行管理。
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.
Fat emulsion administration should be considered when prolonged (more than 5 days) parenteral nutrition is required in order to prevent essential fatty acid deficiency (EFAD). Serum lipids should be monitored for evidence of EFAD in patients maintained on fat-free TPN.
Intravenous fat emulsions provide approximately 1.1 kcal per mL (10%), 2.0 kcal per mL (20%), or 3.0 kcal per mL (30%) and may be admixed along with amino acid with electrolytes/dextrose with calcium injections in the CLARITY Container to supplement caloric intake.
Depending upon the clinical condition of the patient, approximately 3 liters of solution may be administered per 24 hour period. When used postoperatively, the therapy should begin with 1000 mL on the first postoperative day. Thereafter, the dose may be increased to 3000 mL per day.
Do not administer unless seal between chambers is opened, other seals are intact, and solution is clear and thoroughly mixed.
在溶液和容器允许的情况下，应在给药前在视觉上检查肠胃外药物的颗粒物和变色。在可能的情况下，建议在所有肠胃外溶液的给药过程中使用最终过滤器。
A slight yellow color does not alter the quality and efficacy of this product.
添加剂可能不兼容。完整的信息不可用。那些已知不兼容的添加剂不应使用。如果有的话，请咨询药剂师。如果根据医生的明智判断，建议介绍添加剂，请使用无菌技术。引入添加剂时，请彻底混合。
Do not store solutions containing additives. These amino acid with electrolytes/dextrose with calcium injections should be used promptly after mixing. Any storage with additives should be under refrigeration and limited to a brief period of time, less than 24 hours.
1Food and Nutrition Board National Academy of Sciences - National Research Council (Revised 1989).
Pediatric Use:Use of CLINIMIX E sulfite-free (Amino Acid with Electrolytes in Dextrose with Calcium) Injections in pediatric patients is governed by the same considerations that affect the use of any amino acid solution in pediatrics. The amount administered is dosed on the basis of grams of amino acids/kg of body weight/day. Two to 3 g/kg of body weight for infants with adequate calories are generally sufficient to satisfy protein needs and promote positive nitrogen balance. Solution administrations by peripheral vein should not exceed twice normal serum osmolarity (718 mOsmol/L).
Central Vein Administration:氨基酸与电解质/葡聚糖的高渗混合物可以通过连续输注通过中央静脉导管，可以安全地给予钙的注射剂。除了满足氮需求外，尤其是在治疗的头几天，通过频繁确定尿糖和血糖水平来控制给药率，尤其是在治疗的头几天。用电解质/葡萄糖注射钙的每日摄入氨基酸应逐渐增加至最大所需剂量。
由于持续的内源性胰岛素的产生，这些混合注射剂的施用突然停止可能导致胰岛素反应。肠胃外营养混合物应缓慢拔出。
Peripheral Vein Administration:For patients requiring parenteral nutrition in whom the central vein route is not indicated, low concentration amino acid with electrolytes/dextrose with calcium injections may be administered by peripheral vein. In pediatric patients, the final solution should not exceed twice normal serum osmolarity (718 mOsmol/L).
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