部分中文人血白蛋白处方资料（仅供参考）
【药品名称】人血白蛋白
【英文名称】Human Albumin
【药理毒理】
药物治疗分类
血浆成份，体积置换。
药效学
人血白蛋白占血浆蛋白总量的一半以上，大约占肝脏合成蛋白质总量的10％左右。
将20％人血白蛋白输入人体所产生的血液渗透压大约相当于输入血浆所产生血液渗透压的4倍。
作用：白蛋白最重要的生理作用之一是其血液渗透压维持作用以及其对低分子量物质的运载作用。白蛋白对循环血液容量起稳定调节作用，同时是激素、酶、药物和毒素等物质的运输体。
临床前实验安全性资料
全身性毒性
人血白蛋白是人类血浆的正常组分，其作用与人体生理状态下白蛋白的作用相同。
单一剂量毒性实验的意义不大，不能有效地评估白蛋白的毒性、致死量和量效关系。
重复给药毒性实验在实际操作中并不现实，由干反复给予异源蛋白可以使动物模型体内产生相应的抗体，急性试验未发现动物模型出现任何毒性表现。
致突变作用
迄今为止，未见报道表明白蛋白与胚胎毒性、致癌作用和潜在致突变性有关。
【适应证】
血容量扩张压不足时增加扩张压力。
使用时稀释成4-5％的具有长期疗效的，等扩张力血容量替代溶液。
治疗白蛋白缺乏症。
【用法用量】
剂量
本品作为血浆替代品的使用量取决于患者个体的需要，剂量取决于体循环参数。
白蛋白的最重要的作用是维持胶体渗透压。通常认为胶体渗透压的最低限是20mmHg(2.7kPa)。
医疗上使用胶体渗透压的测量值或由总蛋白量间接计算而得的数值来确定剂量。给患者使用低百分含量或高百分含量的注射液取决于患者蛋白质的缺乏性和需要补充的体液量。
根据所给公式，计算治疗烧伤所需剂量。
根据下式以克为单位计算所需白蛋白的剂量
[(所需总蛋白质g/L-实际总蛋白质g/L)x血容量[升]*(=40ml/k9体重)]×2
*根据年龄，成人的生理血容量大约为40ml/kg体重。计算儿童的使用剂量时一定要考虑此因素。
例如：
使一个体重为70公斤的患者的蛋白质从35g/L升至50g／L，需要蛋白质84g或者420ml的白蛋白20％注射液。
[(50-35)x2.8*]×2=84
*血容量的计算：40×70/1000=2.8
上式只能给出一个大约的参考值来决定所用白蛋白的浓度，乘数2函盖了血管外的所有缺损因素。对于严重白蛋白缺损的患者，此因子有可能太小，但其作为一个指针依然有其价值。对于己知的血容量，利用血细胞比容和血容量成反比例这一关系，可以确定血细胞比容值。
使用方法：
可用生理盐水把本品适当稀释，操作需在无菌条件下。
如大剂量使用本品时，应该将其加热至室温或体温状态。
静脉注射必须使用无菌的，无热源的一次性注射器一在刺入前，本注射液瓶口的塞子必须用适当的杀菌剂进行杀菌。将注射头插入瓶内后，要立即开始使用
人血白蛋白20％低盐注射液使用方便，适用静脉注射。滴注速率应根据患者的个人状态和适应症来调整，但对高浓度的注射液一般为1-2ml/分钟，对4-5％的注射液为5ml/分钟。
在血浆交换时，注射速率不应超过30ml/分钟，如果使用4-5％人血白蛋白注射液进行血浆交换，可在连续三天内，每天交换1-1.5倍的血容量，此法被建议用来控制血凝状态。
如果大量使用本品，就应考虑患者的循环参数：如果人血白蛋白20％低盐注射液需要量超过200ml，就应该增加相应量的电解质溶液以维持正常的循环平衡，或者使用5％的白蛋白注射液进行连续治疗。
20％白蛋白注射液的胶体渗透压大约是血浆渗透压的4倍。因此，当使用高浓度的白蛋白注射液时，必须十分小心以确保患者的水合作用。相应地对患者仔细看护，以防止患者循环系统的超载和水量过多。
对凝血的控制，推荐检测血细胞比容：如有必要，必须使用足够量的其它血液成份(凝集素、电解质、血小板、红细胞)，至少当血细胞比容低于30Vol％时，就应考虑使用红细胞浓缩液，
【不良反应】偶见荨麻疹、寒战、发热或血压下降。 
【贮藏】
2℃-25℃避光保存。
放到儿童不能触及的地方。
产品容器一经打开，须立即使用。
用剩下的注射液必须抛弃。
【制剂】
①注射剂：25%50ml。
②冻干粉针剂：10g/瓶。、20g/瓶。 
HUMAN ALBUMIN GRIFOLS-albumin human injection, solution 
Instituto Grifols, S.A.
Albumin (Human) U.S.P.
Human Albumin Grifols® 25%
Description
Albumin (Human), Human Albumin Grifols® 25% is a sterile aqueous solution for single dose intravenous administration containing 25% human albumin (weight/volume). Human Albumin Grifols® 25% is prepared by a cold alcohol fractionation method from pooled human plasma obtained from venous blood. The product is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate per gram of protein. Human Albumin Grifols® 25% is osmotically equivalent to five times its volume of normal citrated plasma.
A liter of Human Albumin Grifols® 25% solution contains 130-160 milliequivalents of sodium ion.
The aluminium content of the solution is not more than 200 micrograms per liter during the shelf life of the product.
The product contains no preservatives.
Human Albumin Grifols® 25% is heated at 60 °C for ten hours. No positive assertion can be made, however, that this heat treatment completely destroys the causative agents of viral hepatitis. There are no known cases of viral hepatitis which have resulted from the administration of Human Albumin Grifols® 25%.
Clinical Pharmacology
Albumin is a highly soluble, globular protein (MW 66,500), accounting for 70-80% of the colloid osmotic pressure of plasma.
Therefore, it is important in regulating the osmotic pressure of plasma1,2. Human Albumin Grifols® 25% supplies the oncotic equivalent of approximately 5 times its volume of human plasma. It will increase the circulating plasma volume by an amount approximately 3.5 times the volume infused within 15 minutes, if the recipient is adequately hydrated3. This extra fluid reduces hemoconcentration and decreases blood viscosity. The degree and duration of volume expansion depend upon the initial blood volume.
When treating patients with diminished blood volume, the effect of infused albumin may persist for many hours. The hemodilution lasts for a shorter time when albumin is administered to individuals with normal blood volume.
Albumin is also a transport protein and binds naturally occurring, therapeutic, and toxic materials in the circulation2.
Albumin is distributed throughout the extracellular water and more than 60% of the body albumin pool is located in the extravascular fluid compartment. The total body albumin in a 70 kg man is approximately 320 g; it has a circulating life span of 15-20 days, with a turnover of approximately 15 g per day1.
Indications and Usage
Albumin (Human), Human Albumin Grifols® 25% is indicated:
For the prevention and treatment of hypovolemic shock2,4, and
in conjunction with exchange transfusion in the treatment of neo-natal hyperbilirubinemia2.
Concentrated Albumin (Human) solutions (e.g., 25%) have also been used successfully to induce diuresis in some patients with acute nephrosis1 who were refractory to other forms of treatment. However, Albumin (Human) has no role in the management of chronic nephrosis.
More dilute Albumin (Human) solutions (e.g., 5%) have been used as pump priming fluids during cardiopulmonary bypass. However, an adequate blood volume can also be maintained during bypass with crystalloid as the only priming fluid without a significant difference in the clinical outcome achieved1,2.
Conditions in which Albumin (Human) use is usually not justified:
Postoperative hypoproteinemia. Major surgery or other injury of capillary walls may lead to substantial losses of circulating albumin over and above those due to bleeding1,2,4,5. However, this redistribution of albumin in the body rarely causes clinically significant hypovolemia, hence treatment with Albumin (Human) is usually not indicated.
Renal dialysis. Patients undergoing long-term hemodialysis may occasionally require Albumin (Human) for the treatment of an acute volume or oncotic deficit1. Such patients who receive Albumin (Human) should be carefully monitored for signs of circulatory overload, to which they are particularly sensitive.
Paracentesis or Acute liver failure. Removal of even large volumes of ascites fluid is usually well tolerated. However, if significant hypovolemia and/or cardiovascular function changes ensue, Albumin (Human) can provide short-term benefit. Similarly, in patients with acute liver failure, Albumin may have a stabilizing effect, but the therapy must be guided by individual circumstances1. Albumin (Human) is of no value in the management of chronic cirrhosis.
Unless the pathologic condition responsible for hypoalbuminemia can be corrected, administration of Albumin (Human) can afford only symptomatic relief. There is NO valid reason for the use of Albumin (Human) as an intravenous nutrient.
Contraindication
Human Albumin Grifols® 25% is contraindicated in patients with severe anemia or cardiac failure in the presence of normal or increased intravascular volume.
The use of Human Albumin Grifols® 25% is contraindicated in patients with a history of allergic reactions to albumin.
Warnings
Solutions of Albumin (Human), Human Albumin Grifols® 25% should not be used if they appear turbid or if there is sediment in the bottle. Do not begin administration more than 4 hours after the container has been entered. Discard unused portion.
Human Albumin Grifols® 25% is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating certain viruses by pasteurization. Despite these measures, such products can still potentially transmit disease. A theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD) also is considered extremely remote. No cases of transmission of viral diseases or CJD have ever been identified for albumin. There is also the possibility that unknown infectious agents may be present in such products. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Grifols Biologicals, at 888-GRIFOLS (888-474-3657). The physician should discuss the risks and benefits of this product with the patient.
There exists a risk of potentially fatal hemolysis and acute renal failure from the inappropriate use of Sterile Water for Injection as a diluent for Albumin (Human) 25%. Acceptable diluents include 0.9% Sodium Chloride or 5% Dextrose in Water.
Precautions
Human Albumin Grifols® 25% should be administered with caution to patients with low cardiac reserve.
Rapid infusion may cause vascular overload with resultant pulmonary edema. Patients should be closely monitored for signs of increased venous pressure.
A rapid rise in blood pressure following infusion necessitates careful observation of injured or postoperative patients to detect and treat severed blood vessels that may have bled at a lower pressure.
Patients with marked dehydration require administration of additional fluids. Human Albumin Grifols® 25% may be administered with the usual dextrose and saline intravenous solutions. However, certain solutions containing protein hydrolysates or alcohol must not be infused through the same administration set in conjunction with Human Albumin Grifols® 25% since these combinations may cause the proteins to precipitate.
Pregnancy category C. Animal reproduction studies have not been conducted with Albumin (Human). It is also not known whether Albumin (Human) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Albumin (Human) should be given to a pregnant woman only if clearly needed.
Adverse Reactions
Allergic or pyrogenic reactions are characterized primarily by fever and chills; urticaria, rash, nausea, vomiting, tachycardia, headache and hypotension have also been reported. Should an adverse reaction occur, slow or stop the infusion for a short period of time which may result in the disappearance of the symptoms. If administration has been stopped and the patient requires additional Human Albumin Grifols® 25%, material from a different lot should be used.
Human Albumin Grifols® 25% particularly if administered rapidly, may result in vascular overload with resultant pulmonary edema.
Dosage and Administration
Albumin (Human), Human Albumin Grifols® 25% is administered intravenously. The total dosage will vary with the individual
In adults, an initial infusion of 100 mL is suggested. Additional amounts may be administered as clinically indicated.
The initial dosage in children will vary with the clinical state and body weight. A dose one-quarter to one-half the adult dose may be administered, or dosage may be calculated on the basis of 1-3 mL per kg of body weight.
For infants suffering from hemolytic disease of the newborn the appropriate dose for binding of free serum bilirubin is 1 gram per kilogram of body weight. This may be administered before or during the exchange procedure6.
In the treatment of the patient in shock with greatly reduced blood volume, Human Albumin Grifols® 25% may be administered as rapidly as necessary in order to improve the clinical condition and restore normal blood volume. This may be repeated in 15-30 minutes if the initial dose fails to prove adequate. In the patient with a slightly low or normal blood volume, the rate of administration should be 1 mL per minute. The usual rate of administration in children should be one-quarter the adult rate.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution container permit.
Directions for Use (When Administration Set is Used)
Flip off plastic cap on top of the vial and expose rubber stopper. Cleanse exposed rubber stopper with a suitable germicidal solution, being sure to remove any excess. Observe aseptic technique and prepare sterile intravenous equipment as follows:
Close clamp on administration set (delivers approximately 19 drops/mL).
With bottle upright, thrust piercing pin straight through stopper center. Do not twist or angle.
Immediately invert bottle to automatically establish proper fluid level in drip chamber (half full).
Attach infusion set to administration set, open clamp and allow solution to expel air from tubing and needle, then close clamp.
Make venipuncture and adjust flow.
Discard all administration equipment after use. Discard any unused contents.
Directions for Use (When Administration Set is Not Used)
Flip off plastic cap on top of the vial and expose rubber stopper. Cleanse exposed rubber stopper with a suitable germicidal solution, being sure to remove any excess. Observe aseptic technique and prepare sterile intravenous equipment as follows:
Using aseptic technique, attach filter needle to a sterile disposable plastic syringe.
Insert filter needle into Albumin (Human), Human Albumin Grifols® 25% vial.
Aspirate Human Albumin Grifols® 25% from the vial into the syringe.
Remove and discard the filter needle from the syringe.
Attach desired size needle to syringe.
Discard all administration equipment after use. Discard any unused contents.
How Supplied
- 50 mL vial Human Albumin Grifols® 25%
- 100 mL vial Human Albumin Grifols® 25%
Storage
Human Albumin Grifols® 25% is stable for three years providing storage temperature does not exceed 30 °C. Protect from freezing.
Caution
Federal (USA) law prohibits dispensing without a prescription.
References
Tullis, J.L., "Albumin: 1. Background and Use, 2. Guidelines for Clinical Use". JAMA 237; 355-360, 460-463, 1977.
Finlayson, J.S., "Albumin Products" Seminars in Thrombosis and Hemostasis, Vol 6, pp. 85-120, 1980.
Janeway, C.A., "Human Serum Albumin: Historical Review" in: Proceedings of the Workshop on Albumin. Sgouris, JT and René A (eds). DHEW Publication No. (NIH) 76-925, Washington, D.C., U.S. Government Printing Office, 1976, pp. 3-21.
Houser, C.J., et al., "Oxygen Transport Responses to Colloids and Crystalloids in Critically III Surgical Patients". Surgery, Gynecology and Obstetrics, Vol. 150, pp. 811-816, June 1980.
Peters, T., J.R., "Serum Albumin" in: The Plasma Proteins, 2nd Ed., Putnam F.W. (ed), New York Academic Press, Vol 1, 133-181, 1975.
Tsao, Y.C., Yu V.Y.H., "Albumin in the Management of Neonatal Hyperbilirubinemia". Arch Dis Childhood, Vol. 47, pp. 250-256, 1972.
Manufactured by Instituto Grifols, S.A.
Barcelona – SPAIN
U.S. Licence No. 1181
Distributed by Grifols Biologicals, Inc.
Los Angeles - CA 90032
Revised: January 2007
3025176
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 50 ML VIAL
NDC 61953-0002-1
Albumin (Human) U.S.P. Human Albumin Grifols® 25%
12.5 g 50 mL Rx only.
Dosage and directions for administration, see package insert.
Store at temperatures not exceeding 30 °C
DO NOT USE IF TURBID. DO NOT BEGIN ADMINISTRATION MORE THAN 4 HOURS AFTER THE CONTAINER HAS BEEN ENTERED.
Manufactured by Instituto Grifols, S.A. Barcelona – SPAIN U.S. License No. 1181
Distributed by Grifols Biologicals, Inc. Los Angeles – CA 90032

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 100 ML VIAL
NDC 61953-0002-2
Albumin (Human) U.S.P. Human Albumin Grifols® 25%
25 g 100 mL Rx only.
CONTENTS: Each 100 mL contains 25 grams Albumin (Human) in aqueous diluent.
Osmotically equivalent to 500 mL of plasma. Sodium range 130-160 milliequivalents per liter.
Dosage and directions for administration, see package insert.
Contains no preservatives. Store at temperatures not exceeding 30 °C
DO NOT USE IF TURBID.
DO NOT BEGIN ADMINISTRATION MORE THAN 4 HOURS AFTER THE CONTAINER HAS BEEN ENTERED.
Manufactured by Instituto Grifols, S.A. Barcelona – SPAIN U.S. License No. 1181
Distributed by Grifols Biologicals, Inc. Los Angeles – CA 90032

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 50 ML CARTON
GRIFOLS
NDC 61953-0002-1
Albumin (Human) U.S.P.
Human Albumin Grifols®
25% Solution
12.5 g 50 mL
DO NOT USE IF TURBID.
DO NOT BEGIN ADMINISTRATION MORE THAN 4 HOURS AFTER THE CONTAINER HAS BEEN ENTERED.

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 100 ML CARTON
GRIFOLS
NDC 61953-0002-2
Albumin (Human) U.S.P.
Human Albumin Grifols®
25% Solution
25 g 100 mL
DO NOT USE IF TURBID.
DO NOT BEGIN ADMINISTRATION MORE THAN 4 HOURS AFTER THE CONTAINER HAS BEEN ENTERED.

HUMAN ALBUMIN GRIFOLS 
albumin (human)   injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 61953-0002
Route of Administration INTRAVENOUS DEA Schedule      
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Albumin Human (Albumin Human)  Albumin Human 12.5g  in 50mL
Inactive Ingredients
Ingredient Name Strength
Sodium Chloride  
Sodium Caprylate  
Sodium Acetyltryptophanate  
Water  
Product Characteristics
Color      Score     
Shape  Size 
Flavor  Imprint Code 
Contains     
Packaging
NDC Package Description Multilevel Packaging
1 61953-0002-1 1 VIAL In 1 CARTON contains a VIAL
1  50  mL In 1 VIAL This package is contained within the CARTON (61953-0002-1)
2 61953-0002-2 1 VIAL In 1 CARTON contains a VIAL
2  100 mL In 1 VIAL This package is contained within the CARTON (61953-0002-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103352 06/11/2003 
Labeler - Instituto Grifols, S.A. (465562213) 
Establishment
Name Address ID/FEI Operations
Instituto Grifols, S.A.  475610684 MANUFACTURE
Revised: 01/2007Instituto Grifols, S.A.