CLINIMIX E（amino acids with electrolytes in dextrose with calcium）多种电解质添加剂是一种无菌，无热原，浓缩的细胞内和细胞外离子溶液，用于静脉输注，仅作为维持电解质补充剂稀释后。 它不含磷酸盐，也不含抑菌剂，抗菌剂或添加缓冲剂。pH为6.6（6.0至7.5）。可能含有盐酸，用于调节pH值。 渗透压浓度为6.2mOsmol/mL（计算值）。
批准日期：2018年5月份14日 公司：百特医药
CLINIMIX E（氨基酸，含葡萄糖和钙的电解质[amino acids with electrolytes in dextrose with calcium]）注射液，用于静脉注射
最初的美国批准：1997年
作用机制
CLINIMIX E用作患者营养的补充剂，肠胃外提供常量营养素（氨基酸和右旋糖）和微量营养素（电解质）。
氨基酸提供构成蛋白质的结构单元，用于合成蛋白质和其他生物分子，或被氧化成尿素和二氧化碳作为能量来源。
施用的右旋糖被氧化成二氧化碳和水，产生能量。
适应症和用法
当口腔或肠内营养不可能，不足或禁忌时，CLINIMIX E被指示为需要肠外营养的患者的卡路里，蛋白质和电解质来源。 CLINIMIX E可用于治疗患者的负氮平衡。
剂量和给药
有关制备，给药，使用说明，剂量考虑因素的信息，请参阅完整的处方信息，包括成人和儿科的推荐剂量，以及肾功能不全患者的剂量调整。
剂量形式和强度
CLINIMIX E注射剂具有多种强度。有关每种配方的详细说明，请参阅完整的处方信息。
禁忌症
•在新生儿（年龄小于28天）内使用头孢曲松共同治疗。
•已知对一种或多种氨基酸或葡萄糖过敏。
•先天性氨基酸代谢错误。
•由于心输出量低导致肺水肿或酸中毒的患者。
警告和注意事项
•肺血管沉淀引起的肺栓塞：如果出现肺部窘迫的迹象，停止输液并开始医学评估。
•头孢曲松的沉淀：不要通过Y-位点与CLINIMIX E同时给予头孢曲松。
•超敏反应：监测体征和症状，如果发生反应则停止输注。
•感染风险，再喂养并发症和高血糖症或高渗性高血糖状态：监测体征和症状;监测实验室参数。
•静脉损伤和血栓形成：渗透压≥900mOsm/ L的溶液必须通过中心导管输注。
•肝胆疾病：监测肝功能参数和氨水平。
•铝毒性：肾功能不全患者（包括早产儿）的风险增加。
•肠外营养相关肝病：长期接受肠外营养的患者，特别是早产儿的风险增加;监测肝功能检查，如果出现异常，可考虑停药或减量。
•电解质不平衡和液体过载：心功能不全或肾功能不全的患者可能需要调整液体，蛋白质和电解质含量。
不良反应
•不良反应包括利尿，外渗，糖尿，高血糖和高渗性昏迷。
要报告疑似不良反应，请致电1-866-888-2472联系百特医疗保健公司，或致电1-800-FDA-1088或www.fda.gov/medwatch联系FDA
用于特定人群
•儿童使用：低血糖/高血糖风险增加：监测血清葡萄糖浓度。
如何提供/存储和处理
CLINIMIX E（具有钙的葡萄糖中具有电解质的氨基酸）注射（无亚硫酸盐）可以1000mL和2000mL体积获得（参见表9）。
混合后，产品代表 
CLINIMIX E 2.75/5无亚硫酸盐（2.75％氨基酸与电解质在5％葡萄糖和钙）注射 1000mL  NDC：0338-1142-03  代码：2B7735
CLINIMIX E 2.75/5无亚硫酸盐（2.75％氨基酸与电解质在5％葡萄糖和钙）注射 2000mL  NDC
CLINIMIX E 4.25/5无亚硫酸盐（4.25％氨基酸与电解质在5％葡萄糖和钙）注射 1000mL  NDC：0338-1144-03 代码：2B7737
CLINIMIX E 4.25/5无亚硫酸盐（4.25％氨基酸与电解质在5％葡萄糖和钙）注射 2000mL  NDC：0338-1113-04代码：2B7716
CLINIMIX E 4.25/10无亚硫酸盐（4.25％氨基酸与电解质在10％葡萄糖和钙）注射 1000mL  NDC：0338-1145-03 代码：2B7738
CLINIMIX E 4.25/10无亚硫酸盐（4.25％氨基酸与电解质在10％葡萄糖和钙）注射 2000mL  NDC：0338-1115-04 代码：2B7717
CLINIMIX E 5/15无亚硫酸盐（5％氨基酸，含15％葡萄糖和钙的电解质）注射液 1000mL  NDC：0338-1147-03 代码：2B7740
CLINIMIX E 5/15无亚硫酸盐（5％氨基酸，含15％葡萄糖和钙的电解质）注射液 2000mL  NDC：0338-1123-04 代码：2B7721
CLINIMIX E 5/20无亚硫酸盐（5％氨基酸与电解质在20％葡萄糖和钙中）注射 1000mL  NDC：0338-1148-03 代码：2B7741 
CLINIMIX E 5/20无亚硫酸盐（5％氨基酸与电解质在20％葡萄糖和钙中）注射 2000mL  NDC：0338-1125-04 代码：2B7722
尽量减少CLINIMIX E的暴露，加热并避免过热。
防止冻结。
在室温（25°C/77°F）下储存CLINIMIX E（可在最高40°C/104°F下短暂储存）。
一旦打开保护性透明外包装，冷藏保存限制为9天。
如果先前已打开或损坏保护性透明外包装，请勿使用。有关混合溶液的储存，请参阅剂量和管理。
完整资料附件：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8469d6fb-d6ef-476f-8cc3-0905192de0a8
CLINIMIX (Amino Acid in Dextrose) Injections and CLINIMIX E (Amino Acid with Electrolytes in Dextrose with Calcium) Injections
Essential components of PN therapy available in a sterile, dual-chamber, clarity container
Variety of formulations, available in 1L and 2L bags, offer clinical flexibility to support patient specific needs
Up to 100 grams of protein in a 2 L bag
The only available manufacturer-prepared premix PN solution with and without electrolytes
Allows for the addition of lipids to the bag or the option to deliver lipids separately via IV piggyback
Appropriate for Pediatric and Adult patient populations
INDICATIONS AND IMPORTANT RISK INFORMATION
Indications
CLINIMIX (amino acids in dextrose) Injections and CLINIMIX E(amino acids with electrolytes in dextrose with calcium) Injections are indicated as a source of calories and protein (and electrolytes for CLINIMIX E) for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX and CLINIMIX E may be used to treat negative nitrogen balance in patients.
Important Risk Information
CLINIMIX and CLINIMIX E Injections are contraindicated in patients with known hypersensitivity to one or more amino acids or dextrose; in patients with inborn errors of amino acid metabolism due to risk of severe metabolic and neurologic complications; and in patients with pulmonary edema or acidosis due to low cardiac output. In addition, CLINIMIX E is contraindicated in neonates (less than 28 days of age) receiving concomitant treatment with ceftriaxone, even if separate infusion lines are used, due to the risk of fatal ceftriaxone calcium salt precipitation in the neonate’s bloodstream.
Pulmonary vascular precipitates causing pulmonary vascular emboli and pulmonary distress have been reported in patients receiving parenteral nutrition. Excessive addition of calcium and phopshate increases the risk of the formation of calcium phosphate precipitates. The solution should be inspected for precipitates before admixing, after admixing, and again before administration. If signs of pulmonary distress occur, stop the infusion and initiate a medical eva luation.
Precipitation of ceftriaxone-calcium can occur when ceftriaxone is mixed with CLINIMIX E, in the same intravenous administration line. Do not administer ceftriaxone simultaneously with CLINIMIX E via a Y-site.
Stop infusion immediately and treat patient accordingly if signs or symptoms of a hypersensitivity reaction develop.
Monitor for signs and symptoms of early infections.
Refeeding severely undernourished patients may result in refeeding syndrome. Thiamine deficiency and fluid retention may also develop. Monitor severely undernourished patients and slowly increase nutrient intakes.
CLINIMIX and CLINIMIX E solutions containing more than 5% dextrose have an osmolarity of ≥ 900 mOsm/L and must be infused through a central catheter.
CLINIMIX and CLINIMIX E contain no more than 25 mcg/L of aluminum which may reach toxic levels with prolonged administration in patients with renal impairment. Preterm infants are at greater risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions which contain aluminum. Patients with renal impairment, including preterm infants, 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.
Parenteral Nutrition Associated Liver Disease (PNALD) has been reported in patients who receive parenteral nutrition for extended periods of time, especially preterm infants. If CLINIMIX and CLINIMIX E treated patients develop liver test abnormalities consider discontinuation or dosage reduction.
Use CLINIMIX and CLINIMIX E with caution in patients with cardiac insufficiency or renal impairment due to increased risk of electrolyte and fluid volume imbalance.
Monitor renal and liver function parameters, ammonia levels, fluid and electrolyte status, serum osmolarity, blood glucose, blood count and coagulation parameters throughout treatment. In situations of severely elevated electrolyte levels, stop CLINIMIX and CLINIMIX E until levels have been corrected.
Adverse reactions include diuresis, extravasation, glycosuria, hyperglycemia, and hyperosmolar coma