部份中文氨基酸处方资料（仅供参考）
通用名：复方氨基酸注射液
商品名：CLINISOL 15%
英文名：CompoundAminoAcidInjection
本品为复方制剂
药理毒理
氨基酸是构成人体蛋白和酶类的基本单位，是合成激素的原料，参与人体新陈代谢和各种生理机能，在生命中显示特殊的作用。
药代动力学
适应症
用于大面积烧伤、创伤及严重感染等应激状态下肌肉分解代谢亢进、消化系统功能障碍、营养恶化及免疫功能下降病人的营养支持；以及用于手术后病人，营养的改善。
用法和用量
1、本品经中心静脉长时间应用时，应与葡萄糖（或脂肪乳）、维生素、电解质、微量元素等注射液联合应用，以期达到营养全面支持的目的。
2、本品经外周静脉应用时，可用等量5%葡萄糖注射液稀释后，缓慢滴注。
3、输注速度：外周静脉输注时，将药液稀释后，一般以30~40滴/分钟为宜；中心静脉输液时遵医嘱。
4、输注量应以病人的年龄、体重、营养状态、病情不同而定，一般成人每日250~1000毫升（按氨基酸含量计算为0.5g/kg~1.5g/kg）。
不良反应
输注过快或过浓时，可产生呕吐、发热等不良反应。由于含有抗氧化剂焦亚硫酸钠，因此偶可诱发过敏反应（尤其哮喘病人）。
注意事项
1、使用时应监测肝功能，肝功能明显异常时慎用；严重肝、肾功能损害的病人不宜使用。
2、使用前应仔细检查药液，如有药液浑浊、生霉、瓶身和瓶口破裂、封口松动漏气等情况时切勿使用。
3、药液应一次用完，剩余药液不可再用。
4、本品遇冷析出结晶，用前可浸泡于40~50℃温水中使其溶解，放至体温后再用。
包装规格
CLINISOL INJ 500ML CS24  PARENTERAL AMINO ACID 15% NO.1  BAXTER GENERAL HEALTHCARE  00338-0502-03            
CLINISOL SULF/FR 15% 2000ML 6  PARENTERAL AMINO ACID 15% NO.1  BAXTER GENERAL HEALTHCARE  00338-0502-06            
完整说明书附件：https://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm?archiveid=75973
Clinisol
Generic Name: lysine, leucine, phenylalanine, valine, histidine, isoleucine, methionine, threonine, tryptophan, alanine, arginine, glycine, proline, glutamic acid, serine, aspartic acid and tyrosine
Dosage Form: injection
Clinisol Description
15% Clinisol - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package is a sterile, clear, nonpyrogenic, hypertonic solution of essential and nonessential amino acids. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion.
The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). Exposure to temperatures above 25ºC/77ºF during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however, the safety of the plastic has been confirmed in tests in animals according to USP biological test for plastic containers as well as by tissue culture toxicity studies.
Each 100 mL of 15% Clinisol - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package contains:
linisol - Clinical Pharmacology
15% Clinisol - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package administered parenterally will provide biologically utilizable source material for protein synthesis when used with concentrated calorie sources, electrolytes, vitamins and minerals.
Central Infusion
15% Clinisol - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package is intended for use in a pharmacy admixture program and as such is restricted to the preparation of admixtures for intravenous use. 15% Clinisol - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package given by central venous infusion in combination with energy sources, vitamins, trace elements and electrolytes, will meet the requirements for weight maintenance or weight gain. The energy component may be derived solely from dextrose or may be provided by a combination of dextrose and intravenous fat emulsion.
Peripheral Infusion
15% Clinisol - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package, when diluted to an appropriate osmolarity level (718 mOsmol/L) can also be administered by a peripheral vein when use of a central venous catheter is contraindicated.
Indications and Usage for Clinisol
15% Clinisol - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package is indicated as an adjunct in the offsetting of nitrogen loss or in the 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) metabolic requirements for protein are substantially increased, as with extensive burns.
Contraindications
Hypersensitivity to one or more amino acids
Severe liver disease or hepatic coma
Anuria
Metabolic disorders involving impaired nitrogen utilization
Warnings
Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Because of the potential for life-threatening events, caution should be taken to ensure that precipitates have not formed in any parenteral nutrient admixture.
This injection is for compounding only, not for direct infusion.
Once container closure has been penetrated, withdrawal of contents should be completed within 4 hours. After initial entry, maintain contents at room temperature (25ºC/77ºF).
Any admixture storage should be under refrigeration and limited to a brief period of time, preferably less than 24 hours.
Administration of amino acid solutions at excessive rates or to patients with hepatic insufficiency may result in plasma amino acid imbalances, hyperammonemia, prerenal azotemia, stupor and coma. Conservative doses of amino acids should be given to these patients, dictated by the nutritional status of the patient. Should symptoms of hyperammonemia develop, amino acid administration should be discontinued and the patient's clinical status reeva luated.
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.
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 μg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
Precautions
General
In order for parenterally administered amino acids to be retained by the body and utilized for protein synthesis adequate calories must be administered concurrently.
The administration of 15% Clinisol - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package as part of total parenteral nutrition (TPN) with large volumes of hyperosmotic fluids requires periodic monitoring of the patient for signs of hyperosmolarity, hyperglycemia, glycosuria and hypertriglyceridemia.
During parenteral nutrition with concentrated dextrose and amino acid solutions, essential fatty acid deficiency syndrome may develop but may not be clinically apparent. Early demonstration of this condition can only be accomplished by analysis of plasma lipids. The syndrome may be prevented or corrected by appropriate treatment with intravenous fat emulsions.
For complete nutritional support, TPN regimens must also include multiple vitamins and trace elements. Potentially incompatible ions such as calcium and phosphate may be added to alternate infusate containers to avoid precipitation.
Initiation and termination of infusions of TPN fluids must be gradual to permit adjustment of endogenous insulin release.
Caution should be exercised against volume overload.
Do not administer unless solution is clear.
TPN delivered through a central or large peripheral vein is a special technique requiring a team effort by physician, nurse and pharmacist. The responsibility for administering this therapy should be confined to those trained in the procedures and alert to signs of complications. Complications known to occur from the placement of central venous catheters include sepsis and vein irritation due to hypertonicity of the infused solution. The risk of sepsis is present during intravenous therapy, especially when using central venous catheters for prolonged periods. It is imperative that the preparation of admixtures and the placement and care of the catheters be accomplished under controlled aseptic conditions. It is essential that a carefully prepared protocol, based on current medical practices be followed.
Drug product contains no more than 25 μg/L of aluminum.
Laboratory Tests
Frequent clinical eva luations and laboratory determinations are necessary for proper monitoring during administration.
Laboratory tests should include blood glucose, serum electrolytes, liver and renal function, serum osmolarity, blood ammonia, serum protein, pH, hematocrit, and WBC. When 15% Clinisol - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package is combined with electrolytes, care should be used in administering this solution to patients with congestive heart failure, renal failure, edema, adrenal hyperactivity, acid base imbalance and those receiving diuretics or antihypertensive therapy. Serum electrolytes should be monitored daily.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Long term animal studies with 15% Clinisol - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package have not been performed to eva luate the carcinogenic potential, mutagenic potential or effects on fertility.
Pregnancy:
Teratogenic Effects Pregnancy Category C.
Animal reproduction studies have not been conducted with 15% Clinisol - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package. It is also not known whether 15% Clinisol - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 15% Clinisol - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package should be given to a pregnant woman only if clearly needed.
Nursing Mothers:
Caution should be exercised when 15% Clinisol - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package is administered to a nursing woman.
Pediatric Use:
Safety and effectiveness of 15% Clinisol - sulfite-free (Amino Acid) Injection in pediatric patients have not been established by adequate and well-controlled studies. However, the use of amino acid injections in pediatric patients as an adjunct in the offsetting of nitrogen loss or in the treatment of negative nitrogen balance is referenced in the medical literature. See Dosage and Administration.
Adverse Reactions
Local reactions consisting of a warm sensation, erythema, phlebitis and thrombosis at the infusion site have occurred with peripheral intravenous infusion of amino acids. In such cases the infusion site should be changed promptly to another vein. Generalized flushing, fever and nausea also have been reported during peripheral infusions of amino acid solutions.
The following metabolic complications have been reported with administration of TPN: metabolic acidosis and alkalosis, hypophosphatemia, hypocalcemia, osteoporosis, glycosuria, hyperglycemia, hyperosmolar nonketotic states and dehydration, rebound hypoglycemia, osmotic diuresis and dehydration, elevated liver enzymes, hypo- and hypervitaminosis, electrolyte imbalances, hyperammonemia, coma and death.
Sepsis has been reported following intravenous therapy, especially when using central venous catheters for prolonged periods.
Complications known to occur from the placement of central venous catheters are pneumothorax, hemothorax, hydrothorax, artery puncture and transection injury to the brachial plexus, malposition of the catheter, formation of arteriovenous fistula, phlebitis, thrombosis and air and catheter emboli.
Clinisol Dosage and Administration
Doses which achieve nitrogen equilibrium or positive balance are the most desirable. The dosage on the first day should be approximately half the anticipated optimal dosage and should be increased gradually to minimize glycosuria; similarly, withdrawal should be accomplished gradually to avoid rebound hypoglycemia.
Fat emulsion coadministration should be considered when prolonged (more than 5 days) parenteral nutrition is required in order to prevent essential fatty acid deficiency (EFAD).
Pediatric Use:
Use of 15% Clinisol - sulfite-free (Amino Acid) Injection 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 three g/kg of body weight for infants with adequate calories are generally sufficient to satisfy protein needs and promote positive nitrogen balance. Solutions administered by peripheral vein 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.
A slight yellow color does not alter the quality and efficacy of this product.
Additives may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. When compounding admixtures, use aseptic technique. Mix thoroughly. Do not store any unused portion of 15% Clinisol - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package.
Central Vein Infusion
In unstressed adult patients with no unusual nitrogen losses, a minimum dosage of 0.1 gram nitrogen (4.2 mL of 15% Clinisol - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package) plus 4.4 grams (15 calories) of dextrose/fat emulsion per kilogram of body weight per day is required to achieve nitrogen balance and weight stability. For patients stressed by surgery, trauma or sepsis, and those with unusual nitrogen losses, the dosage required for maintenance may be as high as 0.3 to 0.4 grams of nitrogen (13 to 17 mL 15% Clinisol - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package) per kilogram of body weight per day, with proportionate increases in non-protein calories. Periodic assessment of nitrogen balance of the individual patient is the best indicator of proper dosage. Use of an infusion pump is advisable to maintain a steady infusion rate during central venous infusion.
Peripheral Infusion
In patients for whom central vein catheterization is not advisable, admixtures with 15% Clinisol - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package can be administered by peripheral vein. Dilution of 250 mL 15% Clinisol - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package in 750 mL of 10% dextrose will reduce the osmolarity to a level (718 mOsmol/L) which is more favorable to the maintenance of the integrity of the walls of the veins. If infused simultaneously, fat emulsion will provide a dilution effect upon the osmolarity, as well. In pediatric patients, the final solution should not exceed twice normal serum osmolarity (718 mOsmol/L).
DIRECTIONS FOR USE OF VIAFLEX PLASTIC PHARMACY BULK PACKAGE CONTAINER
Do not use if overpouch has been previously opened or damaged.
To Open
Tear overpouch at notch and remove solution container. Visually inspect the container. If the Admin port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. Some opacity of the plastic may be observed and will diminish gradually. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard.
Preparation for Admixing
1.The Pharmacy Bulk Package is to be used only in a suitable aseptic work area.
2.Suspend container.
3.Remove plastic protector from port.
4.Attach a suitable sterile transfer device or dispensing set which allows measured dispensing of the contents. Refer to complete directions accompanying device.
5.VIAFLEX containers should not be written on directly since ink migration has not been investigated. Affix accompanying label for date and time of entry.
How is Clinisol Supplied
15% Clinisol - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package is available in VIAFLEX plastic containers as follows.
2B6187
500 mL
NDC 0338-0502-03
2B6189
2000 mL
NDC 0338-0502-06
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended the product be stored at room temperature (25ºC/77ºF).