部分中文胃肠外营养补充剂-氨基酸处方资料（仅供参考）
中文名称：氨基酸
英文名称：amino acid
氨基酸（Amino acid）是构成蛋白质(protein)的基本单位，赋予蛋白质特定的分子结构形态，使它的分子具有生化活性。蛋白质是生物体内重要的活性分子，包括催化新陈代谢的酶。
两个或两个以上的氨基酸化学聚合成肽，一个蛋白质的原始片段，是蛋白质生成的前体。 氨基酸（amino acids）广义上是指既含有一个碱性氨基又含有一个酸性羧基的有机化合物，正如它的名字所说的那样。但一般的氨基酸，则是指构成蛋白质的结构单位。在生物界中，构成天然蛋白质的氨基酸具有其特定的结构特点，即其氨基直接连接在α-碳原子上，这种氨基酸被称为α-氨基酸。α-氨基酸是肽和蛋白质的构件分子，在自然界中共有20种。除α-氨基酸外，细胞还含有其他氨基酸。
氨基酸是构成生命大厦的基本砖石之一。
构成蛋白质的氨基酸都是一类含有羧基并在与羧基相连的碳原子下连有氨基的有机化合物，目前自然界中尚未发现蛋白质中有氨基和羧基不连在同一个碳原子上的氨基酸。
氨基酸(氨基酸食品)是蛋白质(蛋白质食品)的基本成分。蜂王浆中含有20多种氨基酸。除蛋白氨酸、缬氨酸、异亮氨酸、赖氨酸、苏氨酸、色氨酸、苯丙氨酸等人体本身不能合成、又必需的氨基酸外，还含有丰富的丙氨酸、谷氨酸、天门冬氨酸、甘氨酸、胱氨酸、脯氨酸、酷氨酸、丝氨酸等。科学家分析了蜂王浆(蜂王浆食品)中29种游离氨基酸及其衍生物，脯氨酸含量最高，占总氨基酸含量的58%。
据分析，氨基酸中的谷氨酸，不仅是人体一种重要的营养成分，而且是治疗肝病、神经系统疾病和精神病的常用药物，对肝病、精神分裂症、神经衰弱均有疗效
天然的氨基酸现已经发现的有300多种，其中人体所需的氨基酸约有22种，分非必需氨基酸和必需氨基酸（人体无法自身合成）。另有酸性、碱性、中性、杂环分类，是根据其化学性质分类的。
必需氨基酸（essential amino acid）：
指人体（或其它脊椎动物）不能合成或合成速度远不适应机体的需要，必需由食物蛋白供给，这些氨基酸称为必需氨基酸。
共有10种其作用分别是： 
①赖氨酸（Lysine ）促进大脑发育，是肝及胆的组成成分，能促进脂肪代谢，调节松果腺、乳腺、黄体及卵巢，防止细胞退化；
②色氨酸（Tryptophan）促进胃液及胰液的产生； 　　
③苯丙氨酸（Phenylalanine）参与消除肾及膀胱功能的损耗； 　　
④蛋氨酸（又叫甲硫氨酸）（Methionine）；参与组成血红蛋白、组织与血清，有促进脾脏、胰脏及淋巴的功能； 　　
⑤苏氨酸（Threonine）有转变某些氨基酸达到平衡的功能； 　　
⑥异亮氨酸（Isoleucine ）参与胸腺、脾脏及脑下腺的调节以及代谢；脑下腺属总司令部作用于甲状腺、性腺； 　　
⑦亮氨酸（Leucine ）作用平衡异亮氨酸； 　　
⑧缬氨酸（Valine）作用于黄体、乳腺及卵巢。
⑨精氨酸（arginine）精氨酸与脱氧胆酸制成的复合制剂（明诺芬）是主治梅毒、病毒性黄疸等病的有效药物。　　
⑩组氨酸histidine 　　
人体虽能够合成Arg和His，但合成的量通常不能满足正常的需要，因此，这两种氨基酸又被称为半必需氨基酸。
非必需氨基酸（nonessentialamino acid）指人（或其它脊椎动物）自己能由简单的前体合成，不需要从食物中获得的氨基酸。
例如甘氨酸、丙氨酸等氨基酸。
理化特性
1、都是无色结晶。 　　
熔点约在230℃以上，大多没有确切的熔点，熔融时分解并放出CO2；都能溶于强酸和强碱溶液中，除胱氨酸、酪氨酸、二碘甲状腺素外，均溶于水；除脯氨酸和羟脯氨酸外，均难溶于乙醇和乙醚。
2、具有两性。 　　
有碱性[二元氨基一元羧酸，例如赖氨酸（lysine）]；
酸性[一元氨基二元羧酸，例如谷氨酸（Glutamic acid）]；
中性[一元氨基一元羧酸，例如丙氨酸（Alanine）]三种类型。
大多数氨基酸都呈显不同程度的酸性或碱性，呈显中性的较少。
所以既能与酸结合成盐，也能与碱结合成盐。 　　
由于有不对称的碳原子，呈旋光性。同时由于空间的排列位置不同，又有两种构型：D型和L型，组成蛋白质的氨基酸，都属L型。
由于以前氨基酸来源于蛋白质水解（现在大多为人工合成），而蛋白质水解所得的氨基酸均为α-氨基酸，所以在生化研究方面氨基酸通常指α-氨基酸。至于β、γ、δ……ω等的氨基酸在生化研究中用途较小，大都用于有机合成、石油化工、医疗等方面。
氨基酸及其衍生物品种很多，大多性质稳定，要避光、干燥贮存。
功能
氨基酸是构成生物体蛋白质并同生命活动有关的最基本的物质，是在生物体内构成蛋白质分子的基本单位，与生物的生命活动有着密切的关系。
它在抗体内具有特殊的生理功能，是生物体内不可缺少的营养成分之一。
构成人体的基本物质，是生命的物质基础
人体构成基本物质之一
构成人体的最基本的物质，有蛋白质、脂类、碳水化合物、无机盐、维生素、水和食物纤维等。 　
作为构成蛋白质分子的基本单位的氨基酸，无疑是构成人体内最基本物质之一。 
生命代谢的物质基础
生命的产生、存在和消亡，无一不与蛋白质有关，正如恩格斯所说：“蛋白质是生命的物质基础，生命是蛋白质存在的一种形式。”如果人体内缺少蛋白质，轻者体质下降，发育迟缓，抵抗力减弱，贫血乏力，重者形成水肿，甚至危及生命。一旦失去了蛋白质，生命也就不复存在，故有人称蛋白质为“生命的载体”。可以说，它是生命的第一要素。
蛋白质的基本单位是氨基酸。如果人体缺乏任何一种必需氨基酸，就可导致生理功能异常，影响机体代谢的正常进行，最后导致疾病。同样，如果人体内缺乏某些非必需氨基酸，会产生机体代谢障碍。
氨基酸在人体内通过代谢可以发挥下列一些作用：
①合成组织蛋白质；
②变成酸、激素、抗体、肌酸等含氨物质；
③转变为碳水化合物和脂肪；
④氧化成二氧化碳和水及尿素，产生能量。
因此，氨基酸在人体中的存在，不仅提供了合成蛋白质的重要原料，而且对于促进生长，进行正常代谢、维持生命提供了物质基础。如果人体缺乏或减少其中某一种，人体的正常生命代谢就会受到障碍，甚至导致各种疾病的发生或生命活动终止。
由此可见，氨基酸在人体生命活动中显得多么需要。

Generic Name: amino acid injection
Dosage Form: injection
6%and 10% Premasol-sulfite-free(Amino Acid)Injections
in VIAFLEX Plastic Container
PHARMACY BULK PACKAGE
NOT FOR DIRECT INFUSION
Rx Only
Premasol Description
6% and 10% Premasol-sulfite-free(Amino Acid)Injections are sterile, nonpyrogenic, hypertonic solutions containing crystalline amino acids provided in a Pharmacy Bulk Package. 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 25°C/77°F 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, at not more than 0.2 part per million); however, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies. Intravenous fat emulsion should not be administered in polyvinyl chloride (PVC) containers that use di-2-ethylhexyl phthalate (DEHP) as a plasticizer, because the fat emulsion facilitates the leaching of DEHP from these containers.
Premasol-Clinical Pharmacology
6% and 10% Premasol-sulfite-free (Amino Acid)Injections provide a mixture of essential and nonessential amino acids as well as taurine and a soluble form of tyrosine, N-Acetyl-L-Tyrosine (NAT). This amino acid composition has been specifically formulated to provide a well tolerated nitrogen source for nutritional support and therapy for infants and young children. When administered in conjunction with cysteine hydrochloride, 6% and 10% Amino Acid Injections result in the normalization of the plasma amino acid concentrations to a profile consistent with that of a breast-fed infant.
The rationale for 6% and 10% Amino Acid Injections is based on the observation of inadequate levels of essential amino acids in the plasma of infants receiving total parenteral nutrition (TPN) using conventional amino acid solutions. These formulas were developed through the application of specific pharmacokinetic multiple regression analysis relating amino acid intake to the resulting plasma amino acid concentrations.
Clinical studies in infants and young children who required TPN therapy showed that infusion of 6% and 10% Amino Acid Injections with a cysteine hydrochloride admixture resulted in a normalization of the plasma amino acid concentrations. In addition, weight gains, nitrogen balance, and serum protein concentrations were consistent with an improving nutritional status.
When infused with hypertonic dextrose as a calorie source, supplemented with cysteine hydrochloride, electrolytes, vitamins, and minerals, Premasol - sulfite-free (Amino Acid) Injections provide total parenteral nutrition in infants and young children, with the exception of essential fatty acids.
It is thought that the acetate from lysine acetate and acetic acid, under the conditions of parenteral nutrition, does not impact net acid-base balance when renal and respiratory functions are normal. Clinical evidence seems to support this thinking; however, confirmatory experimental evidence is not available.
The amount of chloride present in Premasol - sulfite-free (Amino Acid) Injections is not of clinical significance. The addition of cysteine hydrochloride will contribute to the chloride load.
The electrolyte content of any additives that are introduced should be carefully considered and included in total input computations.
Indications and Usage for Premasol
6% and 10% Premasol-sulfite-free (Amino Acid)Injections are indicated for the nutritional support of infants (including those of low birth weight) and young children requiring TPN via either central or peripheral infusion routes. Parenteral nutrition with Premasol - sulfite-free (Amino Acid) Injections is indicated to prevent nitrogen and weight loss or treat negative nitrogen balance in infants and young children 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 Dosage and Administration for additional information.
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.
Contraindications
Premasol - sulfite-free (Amino Acid) Injections are 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.
Warnings
This injection is for compounding only, not for direct infusion.
Safe, effective use of parenteral nutrition requires a knowledge of nutrition as well as clinical expertise in recognition and treatment of the complications which can occur. Frequent eva luation and laboratory determinations are necessary for proper monitoring of parenteral nutrition. 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.
Administration of amino acids in the presence of impaired renal function or gastrointestinal bleeding may augment an already elevated blood urea nitrogen. Patients with azotemia from any cause should not be infused with amino acids without regard to total nitrogen intake.
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 of special significance in infants as its occurrence in the syndrome caused by genetic metabolic defects is sometimes associated, although not necessarily in a causal relationship, with mental retardation. This reaction appears to be dose related and is more likely to develop during prolonged therapy. It is essential that blood ammonia be measured frequently in infants. The mechanisms of this reaction are not clearly defined but may involve genetic defects and immature or subclinically impaired liver function.
Conservative doses of amino acids should be given, dictated by the nutritional status of the patient. Should symptoms of hyperammonemia develop, amino acid administration should be discontinued and 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
Clinical eva luation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid-base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such eva luation. Significant deviations from normal concentrations may require the use of additional electrolyte supplements.
Strongly hypertonic nutrient solutions should be administered via an intravenous catheter placed in a central vein, preferably the superior vena cava.
Care should be taken to avoid circulatory overload, particularly in patients with cardiac insufficiency.
Special care must be taken when giving hypertonic dextrose to a diabetic or pre-diabetic patient. To prevent severe hyperglycemia in such patients, insulin may be required.
Administration of glucose at a rate exceeding the patient's utilization rate may lead to hyperglycemia, coma, and death.
Administration of amino acids without carbohydrates may result in the accumulation of ketone bodies in the blood. Correction of this ketonemia may be achieved by the administration of carbohydrates.
Peripheral administration of 6% and 10% Premasol - sulfite-free (Amino Acid) Injections require appropriate dilution and provision of adequate calories. Care should be taken to assure proper placement of the needle within the lumen of the vein. The venipuncture site should be inspected frequently for signs of infiltration. If venous thrombosis or phlebitis occurs, discontinue infusions or change infusion site and initiate appropriate treatment.
Extraordinary electrolyte losses such as may occur during protracted nasogastric suction, vomiting, diarrhea, or gastrointestinal fistula drainage may necessitate additional electrolyte supplementation.
Metabolic acidosis can be prevented or readily controlled by adding a portion of the cations in the electrolyte mixture as acetate salts and in the case of hyperchloremic acidosis, by keeping the total chloride content of the infusate to a minimum. Premasol - sulfite-free (Amino Acid) Injections contain less than 3 mEq chloride per liter.
Premasol - sulfite-free (Amino Acid) Injections contain no added phosphorus. Patients, especially those with hypophosphatemia, may require the addition of phosphate. To prevent hypocalcemia, calcium supplementation should always accompany phosphate administration. To assure adequate intake, serum levels should be monitored frequently.
To minimize the risk of possible incompatibilities arising from mixing this solution with other additives that may be prescribed, the final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration, and periodically during administration.
Do not use unless solution is clear and seal is intact.
Drug product contains no more than 25 µg/L of aluminum.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No in vitro or in vivo carcinogenesis, mutagenesis, or fertility studies have been conducted with 6% and 10% Premasol - sulfite-free (Amino Acid) Injections.
Usage in Pregnancy
Pregnancy Category C.
Animal reproduction studies have not been conducted with 6% and 10% Premasol - sulfite-free (Amino Acid) Injections. It is also not known whether Premasol - sulfite-free (Amino Acid) Injections can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
Special Precautions for Central Venous Nutrition
Administration by central venous catheter should be used only by those familiar with this technique and its complications.
Central venous nutrition may be associated with complications which can be prevented or minimized by careful attention to all aspects of the procedure, including solution preparation, administration, and patient monitoring. It is essential that a carefully prepared protocol, based on current medical practices, be followed, preferably by an experienced team.
Although a detailed discussion of the complications is beyond the scope of this insert, the following summary lists those based on current literature.
Technical.
The placement of a central venous catheter should be regarded as a surgical procedure. One should be fully acquainted with various techniques of catheter insertion as well as recognition and treatment of complications. For details of techniques and placement sites, consult the medical literature. X-ray is the best means of verifying catheter placement. 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 embolus.
Septic.
The constant risk of sepsis is present during central venous nutrition. Since contaminated solutions and infusion catheters are potential sources of infection, it is imperative that the preparation of parenteral nutrition solutions and the placement and care of catheters be accomplished under controlled aseptic conditions.
Solutions should ideally be prepared in the hospital pharmacy in a laminar flow hood. The key factor in their preparation is careful aseptic technique to avoid inadvertent touch contamination during mixing of solutions and subsequent admixtures.
Parenteral nutrition solutions should be used promptly after mixing. Any storage should be under refrigeration and limited to a brief period of time, preferably less than 24 hours.
Consult the medical literature for a discussion of the management of sepsis during central venous nutrition. In brief, typical management includes replacing the solution being administered with a fresh container and set, and the remaining contents are cultured for bacterial or fungal contamination. If sepsis persists and another source of infection is not identified, the catheter is removed, the proximal tip cultured, and a new catheter reinserted when the fever has subsided. Non-specific, prophylactic antibiotic treatment is not recommended. Clinical experience indicates that the catheter is likely to be the prime source of infection as opposed to aseptically prepared and properly stored solutions.
Metabolic.
The following metabolic complications have been reported: metabolic acidosis, hypophosphatemia, alkalosis, hyperglycemia and glycosuria, osmotic diuresis and dehydration, rebound hypoglycemia, elevated liver enzymes, hypo- and hypervitaminosis, electrolyte imbalances, and hyperammonemia in children. Frequent clinical eva luation and laboratory determinations are necessary, especially during the first few days of venous nutrition, to prevent or minimize these complications.
Adverse Reactions
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.
Overdosage
In the event of a fluid or solute overload during parenteral therapy, reeva luate the patient's condition, and institute appropriate corrective treatment.
Premasol Dosage and Administration
The objective of nutritional management of infants and young children is the provision of sufficient amino acid and caloric support for protein synthesis and growth.
The total daily dose of 6% and 10% Premasol - sulfite-free (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.
Recommendations for allowances of protein in infant nutrition have ranged from 2 to 4 grams of protein per kilogram of body weight per day (2.0 to 4.0 g/kg/day)1. The recommended dosage of Premasol - sulfite-free (Amino Acid) Injections is 2.0 to 2.5 grams of amino acids per kilogram of body weight per day (2.0 to 2.5 g/kg/day) for infants up to 10 kilograms. For infants and young children larger than 10 kilograms, the total dosage of amino acids should include the 20 to 25 grams/day for the first 10 kg of body weight plus 1.0 to 1.25 g/day for each kg of body weight over 10 kilograms.
Typically, Premasol - sulfite-free (Amino Acid) Injections are admixed with 50% or 70% Dextrose Injection USP supplemented with electrolytes and vitamins and administered continuously over a 24 hour period.
Total daily fluid intake should be appropriate for the patient's age and size. A fluid dose of 125 mL per kilogram body weight per day is appropriate for most infants on TPN. Although nitrogen requirements may be higher in severely hypercatabolic or depleted patients, provision of additional nitrogen may not be possible due to fluid intake limits, nitrogen, or glucose intolerance.
Cysteine is considered to be an essential amino acid in infants and young children. 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.
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). Serum lipids should be monitored for evidence of EFAD in patients maintained on fat free TPN.
The provision of sufficient intracellular electrolytes, principally potassium, magnesium, and phosphate, is required for optimum utilization of amino acids. In addition, sufficient quantities of the major extracellular electrolytes sodium, calcium, and chloride, must be given. In patients with hyperchloremic or other metabolic acidoses, sodium and potassium may be added as the acetate salts to provide bicarbonate precursor. The electrolyte content of 6% and 10% Premasol - sulfite-free (Amino Acid) Injections must be considered when calculating daily electrolyte intake. Serum electrolytes, including magnesium and phosphorus, should be monitored frequently.
Appropriate vitamins, minerals and trace elements should also be provided.
1.Suskind RM: Textbook of Pediatric Nutrition, Raven Press, New York, 1981.
Central Venous Nutrition.
Hypertonic mixtures of amino acids and dextrose may be safely administered by continuous infusion through a central venous catheter with the tip located in the superior vena cava. Initial infusion rates should be slow, and gradually increased to the recommended 60-125 mL per kilogram of body weight per day. If administration rate should fall behind schedule, no attempt to “catch up” to planned intake should be made. In addition to meeting protein needs, the rate of administration, particularly during the first few days of therapy, is governed by the patient's glucose tolerance. Daily intake of amino acids and dextrose should be increased gradually to the maximum required dose as indicated by frequent determinations of glucose levels in blood and urine.
Peripheral Parenteral Nutrition.
For patients in whom the central venous route is not indicated and who can consume adequate calories enterally, Premasol - sulfite-free (Amino Acid) Injections may be administered by peripheral vein with or without parenteral carbohydrate calories. Such infusates can be prepared by dilution with 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.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
A slight yellow color does not alter the quality and efficacy of the product.
Premasol - sulfite-free (Amino Acid) Injections may be admixed with solutions which contain phosphate or which have been supplemented with phosphate. The presence of calcium and magnesium ions in an additive solution should be considered when phosphate is also present, in order to avoid precipitation.
Care must be taken to avoid incompatible admixtures. Consult with pharmacist.
Parenteral nutrition solutions should be used promptly after mixing. Any storage should be under refrigeration and limited to a brief period of time, preferably less than 24 hours.
Directions for use of VIAFLEX plastic Pharmacy Bulk Package container
To Open
Tear overpouch across top at slit and remove solution container. Discard overpouch and sachet. Visually inspect the container.  If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired.
For compounding only, not for direct infusion.
Preparation for Admixing
1.The Pharmacy Bulk Package is to be used only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area).
2.Suspend container from eyelet support.
3.Remove plastic protector from outlet port at bottom of container.
4.Attach solution transfer set. Refer to complete directions accompanying set. Note: The closure shall be penetrated only one time with a suitable sterile transfer device or dispensing set which allows measured dispensing of the contents.
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.
6.Once container closure has been penetrated, withdrawal of contents should be completed without delay. After initial entry, maintain contents at room temperature (25°C/77°F) and dispense within 4 hours.
Intravenous fat emulsion should not be administered in polyvinyl chloride (PVC) containers that use di-2-ethylhexyl phthalate (DEHP) as a plasticizer, because the fat emulsion facilitates the leaching of DEHP from these containers.
How is Premasol Supplied
6% and 10% Premasol - sulfite-free (Amino Acid) Injections are supplied in VIAFLEX plastic Pharmacy Bulk Package containers in the following sizes and concentrations:
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 (25°C/77°F). Brief exposure up to 40°C/104°F does not adversely affect the product.
Protect from light until immediately prior to use.
Do not remove container from overpouch until ready to use.
Do not use if overpouch has been previously opened or damaged
http://www.webmd.com/drugs/2/drug-94124/premasol-6-25-iv/details