部份中文人血白蛋白处方资料（仅供参考）
药品名称
通用名称：人血白蛋白
英文名称：Human Albumin
成份
主要组成成分：人血白蛋白。本品来源于健康人血浆，经两次60°C、10小时加热灭活病毒处理。
辅料：辛酸钠，乙酰色氨酸
性状
本品为黄色或绿色至棕色略黏稠的澄明液体；不应有异物、浑浊或沉淀。
适应症
1.失血创伤、烧伤引起的休克。
2.脑水肿及损伤引起的颅压升高。
3.肝硬化及肾病引起的水肿或腹水。
4.低蛋白血症的防治。
5.新生儿高胆红素血症。
6.用于心肺分流术、烧伤的辅助治疗、血液透析的辅助治疗和成人呼吸窘迫综合征。
用法用量
用法
一般采用静脉滴注或静脉推注。为防止大量注射时机体组织脱水，可采用5%葡萄糖注射液或氯化钠注射液适当稀释作静脉滴注（宜用备有滤网装置的输血器）。滴注速度应以每分钟不超过2ml为宜，但在开始15分钟内，应特别注意速度缓慢，逐渐加速至上述速度。
用量
使用剂量由医师酌情考虑，一般因严重烧伤或失血等所致休克，可直接注射本品5～10g，隔4～6小时重复注射1次。在治疗肾病及肝硬化等慢性白蛋白缺乏症时，可每日注射本品5～10g，直至水肿消失，血清白蛋白含量恢复正常为止。
注意事项
1.药液呈现混浊、沉淀、异物或瓶子有裂纹、瓶盖松动、过期失效等情况不可使用。
2.本品开启后，应一次输注完毕，不得分次或给第二人输用。
3.输注过程中如发现病人有不适反应，应立即停止输用。
4.有明显脱水者应同时补液。
5.运输及贮存过程中严禁冻结。
不良反应
使用本品一般不会产生不良反应，偶可出现寒颤、发热、颜面潮红、皮疹、恶心呕吐等症状，快速输注可引起血管超负荷导致肺水肿，偶有过敏反应。
禁忌
1.对白蛋白有严重过敏者。
2.高血压患者，急性心脏病者、正常血容量及高血容量的心力衰竭患者。
3.严重贫血患者。
4.肾功能不全者。
特殊人群
孕妇
对孕妇或可能怀孕妇女的用药应慎重，如有必要应用时，应在医师指导和严密观察下使用。
儿童用药
未进行此项实验且无可靠参考文献。
老年用药
未进行此项实验且无可靠参考文献
药物相互作用
本品不宜与血管收缩药，蛋白水解酶或含酒精溶剂的注射液混合使用。
药物过量
因本品有高渗作用，过量注射时，可造成脱水、机体循环负荷增加、充血性心力衰竭和肺水肿。
药理毒理
药理作用
1.增加血容量和维持血浆胶体渗透压：白蛋白占血浆胶体渗透压的80%，主要调节组织与血管之间水分的动态平衡。由于白蛋白分子量较高，与盐类及水分相比，透过膜内速度较慢，使白蛋白的胶体渗透压与毛细管的静力压抗衡，以此维持正常与恒定的血容量；同时在血循环中，1g白蛋白可保留18ml水，每5g白蛋白保留循环内水分的能力约相当于100ml血浆或200ml全血的功能，从而起到增加循环血容量和维持血浆胶体渗透压的作用。
2.运输及解毒：白蛋白能结合阴离子也能结合阳离子，可以输送不同的物质，也可以将有毒物质输送到解毒器官。
3.营养供给：组织蛋白和血浆蛋白可互相转化，在氮代谢障碍时，白蛋白可作为氮源为组织提供营养。
毒理研究
未进行此项实验且无可靠参考文献。

INDICATIONS AND USAGE
Hypovolemia
Hypovolemia is a possible indication for BUMINATE 25%, Albumin (Human), 25% Solution. Its effectiveness in reversing hypovolemia depends largely upon its ability to draw interstitial fluid into the circulation. It is most effective with patients who are well hydrated.
When hypovolemia is long standing and hypoalbuminemia exists accompanied by adequate hydration or edema, 25% albumin is preferable to 5% protein solutions. 4,6 However, in the absence of adequate or excessive hydration, 5% protein solutions should be used or 25% albumin should be diluted with crystalloid.
Although crystalloid solutions and colloid-containing plasma substitutes can be used in emergency treatment of shock, Albumin (Human) has a prolonged intravascular half-life.9 When blood volume deficit is the result of hemorrhage, compatible red blood cells or whole blood should be administered as quickly as possible.
Hypoalbuminemia
General
Hypoalbuminemia is another possible indication for use of BUMINATE 25%, Albumin (Human), 25% Solution. Hypoalbuminemia can result from one or more of the following: 5
Inadequate production (malnutrition, burns, major injury, infections, etc.)
Excessive catabolism (burns, major injury, pancreatitis, etc.)
Loss from the body (hemorrhage, excessive renal excretion, burn exudates, etc.)
Redistribution within the body (major surgery, various inflammatory conditions, etc.)
When albumin deficit is the result of excessive protein loss, the effect of administration of albumin will be temporary unless the underlying disorder is reversed. In most cases, increased nutritional replacement of amino acids and/or protein with concurrent treatment of the underlying disorder will restore normal plasma albumin levels more effectively than albumin solutions. Occasionally hypoalbuminemia accompanying severe injuries, infections or pancreatitis cannot be quickly reversed and nutritional supplements may fail to restore serum albumin levels. In these cases, BUMINATE 25%, Albumin (Human), 25% Solution might be a useful therapeutic adjunct.
Burns
An optimum regimen for the use of albumin, electrolytes and fluid in the early treatment of burns has not been established, however, in conjunction with appropriate crystalloid therapy, BUMINATE 25%, Albumin (Human), 25% Solution may be indicated for treatment of oncotic deficits after the initial 24 hour period following extensive burns and to replace the protein loss which accompanies any severe burn.4,6
Adult Respiratory Distress Syndrome (ARDS)
A characteristic of ARDS is a hypoproteinemic state which may be causally related to the interstitial pulmonary edema. Although uncertainty exists concerning the precise indication of albumin infusion in these patients, if there is a pulmonary overload accompanied by hypoalbuminemia, 25% albumin solution may have a therapeutic effect when used with a diuretic.4
Nephrosis
BUMINATE 25%, Albumin (Human), 25% Solution may be a useful aid in treating edema in patients with severe nephrosis who are receiving steroids and/or diuretics.
Cardiopulmonary Bypass Surgery
BUMINATE 25%, Albumin (Human), 25% Solution has been recommended prior to or during cardiopulmonary bypass surgery, although no clear data exist indicating its advantage over crystalloid solutions. 4,6,10
Hemolytic Disease of the Newborn (HDN)
BUMINATE 25%, Albumin (Human), 25% Solution may be administered in an attempt to bind and detoxify unconjugated bilirubin in infants with severe HDN.
There is no valid reason for use of albumin as an intravenous nutrient.
DOSAGE AND ADMINISTRATION
BUMINATE 25%, Albumin (Human), 25% Solution must be administered intravenously. This solution may be administered in conjunction with or combined with other parenterals such as whole blood, plasma, saline, glucose or sodium lactate. The addition of four volumes of normal saline or 5% glucose to 1 volume of BUMINATE 25%, Albumin (Human), 25% Solution gives a solution which is approximately isotonic and isosmotic with citrated plasma.
Albumin solutions should not be mixed with protein hydrolysates or solutions containing alcohol.
RECOMMENDED DOSAGES
Hypovolemic Shock
The dosage of BUMINATE 25%, Albumin (Human), 25% Solution must be individualized. As a guideline, the initial treatment should be in the range of 100 to 200 mL for adults and 2.5 to 5 mL per kilogram body weight for children. This may be repeated after 15 to 30 minutes, if the response is not adequate. For patients with significant plasma volume deficits, albumin replacement is best administered in the form of 5% Albumin (Human).
Upon administration of additional albumin or if hemorrhage has occurred, hemodilution and a relative anemia will follow. This condition should be controlled by the supplemental administration of compatible red blood cells or compatible whole blood.
Burns
The optimal therapeutic regimen for administration of crystalloid and colloid solutions after extensive burns has not been established. When BUMINATE 25%, Albumin (Human), 25% Solution is administered after the first 24 hours following burns, the dose should be determined according to the patient's condition and response to treatment.
Hypoalbuminemia
Hypoalbuminemia is usually accompanied by a hidden extravascular albumin deficiency of equal magnitude. This total body albumin deficit must be considered when determining the amount of albumin necessary to reverse the hypoalbuminemia. When using patient's serum albumin concentration to estimate the deficit, the body albumin compartment should be calculated to be 80 to 100 mL per kg of body weight.5,6 Daily dose should not exceed 2 g of albumin per kilogram of body weight.
Hemolytic Disease of the Newborn
BUMINATE 25%, Albumin (Human), 25% Solution may be administered prior to or during exchange transfusion in a dose of 1 g per kilogram body weight.11
PREPARATION FOR ADMINISTRATION
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Remove cap from bottle to expose center portion of rubber stopper.
Clean stopper with germicidal solution.
ADMINISTRATION
Follow directions for use printed on the administration set container. Make certain that the administration set contains an adequate filter.
HOW SUPPLIED
BUMINATE 25%, Albumin (Human), 25% Solution is supplied in 20 mL, 50 mL and 100 mL bottles.
STORAGE
Store BUMINATE 25%, Albumin (Human), 25% Solution at room temperature, not to exceed 30°C (86°F). Avoid freezing to prevent damage to the bottle.

附：日文原处方资料：http://www.info.pmda.go.jp/go/pack/6343410X4087_1_04/
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产地国家：日本
原产地英文药品名：
Albumin Human
中文参考药品译名：
人血白蛋白
原产地英文商品名：
25% intravenous human albumin（献血アルブミン）50ml(12.5g/50ml)/bottle
中文参考商品译名：
25％静脉人血白蛋白（献血アルブミン）50毫升（12.5克/50毫升）/瓶  1瓶
生产厂家英文名：
Mitsubishi Tanabe Pharma
生产厂家中文参考译名：
田边三菱制药
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产地国家：日本
原产地英文药品名：
Albumin Human
中文参考药品译名：
人血白蛋白
原产地英文商品名：
25% intravenous human albumin（献血アルブミン）20ml(5g/20ml)/bottle
中文参考商品译名：
25％静脉人血白蛋白（献血アルブミン）20毫升（5克/20毫升）/瓶  1瓶
生产厂家英文名：
Mitsubishi Tanabe Pharma
生产厂家中文参考译名：
田边三菱制药
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产地国家：日本
原产地英文药品名：
Albumin Human
中文参考药品译名：
人血白蛋白
原产地英文商品名：
5% intravenous human albumin（献血アルブミン）100ml(5g/100ml)/bottle
中文参考商品译名：
5％静脉人血白蛋白（献血アルブミン）100毫升（5克/100毫升）/瓶  1瓶
生产厂家英文名：
Mitsubishi Tanabe Pharma
生产厂家中文参考译名：
田边三菱制药
-------------------------------------------------------------------
产地国家：日本
原产地英文药品名：
Albumin Human
中文参考药品译名：
人血白蛋白
原产地英文商品名：
5% intravenous human albumin（献血アルブミン）20ml(5g/20ml)/bottle
中文参考商品译名：
5％静脉人血白蛋白（献血アルブミン）250毫升（12.5克/250毫升）/瓶  1瓶
生产厂家英文名：
Mitsubishi Tanabe Pharma
生产厂家中文参考译名：
田边三菱制药