药品名称: 通用名称：人血白蛋白 英文名称：Human Albumin 成份:人血白蛋白 适应症: 1.20%的人血白蛋白适用于治疗因严重失血、创伤和烧伤引起的低血容量休克以扩充危急状况下的血容量。 2.低白蛋白血症及肾病接受类固醇和／或利尿剂治疗的水肿病人和肝硬化引起的水肿等。 用法用量: 依据患者病情和临床治疗需要由医生决定并调整所使用的白蛋白浓度、剂量、输注速率。剂量20%人血白蛋白使用剂量由医师酌情考虑。推荐剂量：治疗低血容量病人时，成人首次给予12.5-25g，婴幼儿为0.6-1. 不良反应: 潮红、风疹、发热、恶心等轻微反应较少见。这些反应在调低输注速率或停止输注后一般会很快消失。严重的反应如休克是非常罕见的。在这样的情况下-必须立即停止输注，同时采取相应的治疗措施。有关病毒安全性的信息见. 禁忌: 对白蛋白制品或任何辅料过敏者 注意事项: 如有过敏可疑或过敏性反应发生，必须立即停止输注，并采取适宜的治疗措施。如果发生休克，按目前的休克医疗方案给予抗休克治疗。在以下高血容量状况或血液稀释情况下，会给病人带来特定的危险，使用白蛋白时应格外小. 该信息登录才能查看，请登录 孕妇及哺乳期妇女用药: 尚未对怀孕期间的妇女使用人血白蛋白的安全性做过对照临床试验。从使用人血白蛋白的临床经验得出，人血白蛋白对怀孕阶段、胎儿及新生儿无有害影响的预期。没有做过人血白蛋白的动物生殖研究。不过人血白蛋白实属人体. 儿童用药: 尚未进行有关该项的实验。 老年用药: 尚未进行有关该项的实验。 药物相互作用: 尚不清楚人血白蛋白与其它药品有任何特异性的相互作用。人血白蛋白不可与其它药品相混和，包括全血和红细胞浓缩液。 药物过量: 剂量过大或输注速率过快可能发生循环血容量过多。一旦出现心血管超负荷的早期临床症状 (头痛、呼吸困难、颈静脉充血)，或者血压升高、中心静脉压升高和肺水肿时，必须立即停止输注并仔细监测病人的血液动力学指标。 药理作用: 本品药物治疗分类为血浆代用品和血浆蛋白成分，ATC分类编码：B05AA01。在血浆中人体白蛋白数量超过血浆总蛋白的一半，占肝蛋白质合成的10%。物理化学数据：5%的人血白蛋白对于正常血浆有轻微的低胶体. 毒理研究: 人血白蛋白是人体血浆的正常组分，其作用与生理学上的白蛋白一样。在动物试验中，单一剂量的毒性测试是无实际意义的并且不足以用来评价毒性、致死剂量、或剂量一效应关系。重复剂量的毒性试验是不可行的，因为动物模. 药代动力学: 在正常情况下，人体内的白蛋白总量按体重计算，为4-5gkg体重，其中血管内占40-45%，55-60%在血管外分布。毛细血管通透性的增高会改变白蛋白的动力学特性。严重烧伤或败血症性休克时会导致人血白蛋. 性状: 本品应为略粘稠、黄色或绿色至棕色澄明液体，不应出现浑浊。 贮藏: 人血白蛋白必须避光贮藏，温度不超过25℃。不可冰冻。本品可直接由静脉输注使用。如果大剂量输注时，在使用前必须将产品复温到人体或室内的温度。溶液浑浊或有沉淀时不可使用，这表明溶液里的蛋白质不稳定或溶液已. 包装: 玻璃瓶，50ml/瓶 有效期: 36个月，本药品不得超出包装标签上所表示的有效日期外使用. BUMINATE 25% IV SOLUTION This medicine is a yellow, clear vial. Generic Name: albumin (human) Dosage Form: injection Albutein 25% Generic Name: albumin (human) Dosage Form: injection INDICATIONS AND USAGE Albumin (Human) U.S.P., Albutein® 25% Solution is indicated: 1.For treatment of hypovolemic shock.1,2 2.As an adjunct in hemodialysis for patients undergoing long-term dialysis or for those patients who are fluid-overloaded and cannot tolerate substantial volumes of salt solution for therapy of shock or hypotension.3 3.In cardiopulmonary bypass procedures; however, the optimum regimen of fluids has not been established. Conditions in which Albutein® 25% MAY BE indicated: •Adult respiratory distress syndrome (ARDS).3,4 •Major injury or surgery resulting in increased albumin loss or inadequate synthesis.3,5 •Acute nephrosis not responding to cyclophosphamide or steroid therapy. Steroid therapy may increase edema which may respond to combined therapy of albumin with a diuretic.3 •Acute liver failure or ascites where the therapeutic use is regulated by the individual circumstances.3 Unless the pathologic condition responsible for hypoalbuminemia can be corrected, administration of albumin can afford only symptomatic relief. There is NO valid reason for the use of albumin as an intravenous nutrient. DOSAGE AND ADMINISTRATION Albutein® 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. In the treatment of the patient in shock with greatly reduced blood volume, Albutein® 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. If dilution of Albutein® 25% is clinically desirable, compatible diluents include sterile 0.9% Sodium Chloride solution or sterile 5% Dextrose in Water.6 DIRECTIONS FOR USE: (50 mL and 100 mL) When an Administration Set is Used Flip off plastic cap on top of the vial and expose rubber stopper. Cleanse exposed rubber stopper with suitable germicidal solution, being sure to remove any excess. Observe aseptic technique and prepare sterile intravenous equipment as follows: 1.Close clamp on administration set. 2.With bottle upright, squeeze drip chamber, thrust piercing pin straight through stopper center. Do not twist or angle. 3.Immediately invert bottle, release drip chamber to automatically establish proper fluid level in drip chamber (half full). 4.Attach infusion set to administration set, open clamp and allow solution to expel air from tubing and needle, then close clamp. 5.Make venipuncture and adjust flow. 6.Discard all administration equipment after use. Discard any unused contents. When an Administration Set is Not Used Flip off plastic cap on top of the vial and expose rubber stopper. Cleanse exposed rubber stopper with suitable germicidal solution, being sure to remove any excess. Observe aseptic technique and prepare sterile intravenous equipment as follows: 1.Using aseptic technique, attach filter needle to a sterile disposable plastic syringe. 2.Insert filter needle into Albutein® 25%. 3.Aspirate Albutein® 25% from the vial into the syringe. 4.Remove and discard the filter needle from the syringe. 5.Attach desired size needle to syringe. 6.Discard all administration equipment after use. Discard any unused contents. DOSAGE FORMS AND STRENGTHS Albutein® 25% is a sterile, aqueous solution for single dose intravenous administration containing 25% human albumin (weight/volume). It is available in the following presentations: •12.5 g albumin/50 mL single dose vial. •25 g albumin/100 mL single dose vial. CONTRAINDICATIONS Albutein® 25% is contraindicated in patients with severe anemia or cardiac failure in the presence of normal or increased intravascular volume. The use of Albutein® 25% is contraindicated in patients with a history of allergic reactions to albumin. WARNINGS AND PRECAUTIONS Warnings Following reports that 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)7, if dilution is required, acceptable diluents include 0.9% Sodium Chloride or 5% Dextrose in Water.6 Albutein® 25% is made from pooled human plasma. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases, including a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD). Although no cases of transmission of viral diseases or CJD have ever been identified for albumin, the risk of infectious agents cannot be totally eliminated. The physician should weigh the risks and benefits of the use of this product and should discuss these with the patient. Solutions of Albutein® 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. Precautions Albutein® 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 not have bled at a lower pressure. Patients with marked dehydration require administration of additional fluids. Albutein® 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 Albutein® 25% since these combinations may cause the proteins to precipitate. See also PATIENT COUNSELING INFORMATION (17). ADVERSE REACTIONS The most common adverse reactions include fever and chills, rash, nausea, vomiting, tachycardia and hypotension. 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 Albutein® 25%, material from a different lot should be used. Albutein® 25%, particularly if administered rapidly, may result in vascular overload with resultant pulmonary edema. To report SUSPECTED ADVERSE REACTIONS, contact Grifols Biologicals Inc. at 1-888-GRIFOLS (1-888-474-3657) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C. Animal reproduction studies have not been conducted with Albutein® 25%. It is also not known whether Albutein® 25% can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Albutein® 25% should be given to a pregnant woman only if clearly needed. Pediatric Use Albutein® 25% is indicated in conjunction with exchange transfusion in the treatment of neonatal hyperbilirubinemia. The pediatric use of Albutein® 25% has not been clinically evaluated. The dosage will vary with the clinical state and body weight of the individual. Typically, a dose one-quarter to one-half the adult dose may be administered, or dosage may be calculated on the basis of 0.6 to 1.0 gram per kilogram of body weight (2.4 to 4 mL of Albutein® 25%). For jaundiced 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 which may be administered during the procedure.8 The usual rate of administration in children should be one-quarter the adult rate. Therefore, physicians should weigh the risks and benefits of the use of Albutein® 25% in the pediatric population. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. DESCRIPTION Albutein® 25% is a sterile, aqueous solution for single dose intravenous administration containing 25% human albumin (weight/volume). Albutein® 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 albumin. Albutein® 25% is osmotically equivalent to five times its volume of normal human plasma. Albutein® 25% contains 130-160 milliequivalents of sodium ion per liter and has a pH of 7.0 ± 0.3. The aluminum content of the solution is not more than 200 micrograms per liter during the shelf life of the product. The product contains no preservatives. Albutein® 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. CLINICAL PHARMACOLOGY Mechanism of Action There are no known cases of viral hepatitis which have resulted from the administration of Albutein® 25%. 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 plasma.1,3 Albutein® 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 hydrated.9 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 circulation.1 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. Albumin has a circulating life span of 15-20 days, with a turnover of approximately 15 g per day.3 HOW SUPPLIED/STORAGE AND HANDLING Albutein® 25% is supplied as a sterile, aqueous solution for single dose intravenous administration containing 25% human albumin (weight/volume). It is available in the following vial sizes: •50 mL vial Albutein® 25% (NDC 68516-5216-1). •100 mL vial Albutein® 25% (NDC 68516-5216-2). Storage Albutein® 25% is stable for three years provided that storage temperature does not exceed 30 °C. Protect from freezing. ----------------------------------------------- 产地国家: 德国 原产地英文商品名: Albumin DS 25% VL 50ML 原产地英文药品名: Albumin Human 原产地英文化合物名称: Albumin Human 中文参考商品译名: 人血白蛋白 25% 50毫升瓶 中文参考药品译名: 人血白蛋白 中文参考化合物名称: 人血白蛋白 曾用名: 白蛋白 生产厂家中文参考译名: 贝林公司 生产厂家英文名: Behring