部分中文人血白蛋白处方资料（仅供参考）
【药品名称】
品　　名：基立福人血白蛋白
汉语拼音：Human ALBumin Grifols 25% 50ml
【性狀】
本品為略粘稠、黃色或綠色至棕色澄明液體。
【藥理作用】
1.增加血容量和維持血漿膠體滲透壓：白蛋白佔血漿膠體滲透壓的80%，主要調節組織與血管之間水分的動態平衡。由於白蛋白分子量較高，與鹽類及水分相比，透過膜內速度較慢，使白蛋白的膠體滲透壓與毛細管的靜力壓抗衡，以此維持正常與恒定的血容量；同時在血迴圈中，1g白蛋白可保留18ml水，每5g白蛋白保留迴圈內水分的能力約相當於100ml血漿或200ml全血的功能，從而起到增加迴圈血容量和維持血漿膠體滲透壓的作用。
2.運輸及解毒：白蛋白能結合陰離子也能結合陽離子，可以輸送不同的物質，也可以將有毒物質輸送到解毒器官。
3.營養供給:組織蛋白和血漿蛋白可互相轉化，在氮代謝障礙時，白蛋白可作為氮源為組織提供營養。
【適應症】
1.失血創傷、燒傷引起的休克。
2.腦水腫及損傷引起的顱壓升高。
3.肝硬化及腎病引起的水腫或腹水。
4.低蛋白血症的防治。
5.新生兒高膽紅素血症。
6.用於心肺分流術、燒傷的輔助治療、血液透析的輔助治療和成人呼吸窘迫綜合徵。
【用法用量】
用法：一般採用靜脈滴注或靜脈推注。為防止大量注射時機體組織脫水，可採用5%葡萄糖注射液或氯化鈉注射液適當稀釋作靜脈滴注（宜用備有濾網裝置的輸血器）。滴注速度應以每分鐘不超過2ml為宜，但在開始15分鐘內，應特別注意速度緩慢，逐漸加速至上述速度。
用量：使用劑量由醫師酌情考慮，一般因嚴重燒傷或失血等所致休克，可直接注射本品5～10g，隔4～6小時重復注射1次。在治療腎病及肝硬化等慢性白蛋白缺乏症時，可每日注射本品5～10g，直至水腫消失，血清白蛋白含量恢復正常為止。
【不良反應】
使用本品一般不會產生不良反應，偶可齣現寒顫、發熱、顏面潮紅、皮疹、噁心嘔吐等症狀，快速輸注可引起血管超負荷導致肺水腫，偶有過敏反應。
【禁忌】
1.對白蛋白有嚴重過敏者。
2.高血壓患者，急性心臟病者、正常血容量及高血容量的心力衰竭患者。
3.嚴重貧血患者。
4.腎功能不全者。
【注意事項】
1.藥液呈現混濁、沉澱、異物或瓶子有裂紋、瓶蓋鬆動、過期失效等情況不可使用。
2.本品開啟後，應一次輸注完畢，不得分次或給第二人輸用。
3.輸注過程中如發現病人有不適反應，應立即停止輸用。
4.有明顯脫水者應同時補液。
5.運輸及貯存過程中嚴禁凍結。
【孕婦及哺乳期婦女用藥】
對孕婦或可能懷孕婦女的用藥應慎重，如有必要應用時，應在醫師指導和嚴密觀察下使用。
【藥物相互作用】
本品不宜與血管收縮藥，蛋白水解 或含酒精溶劑的注射液混合使用。
【藥物過量】
因本品有高滲作用，過量注射時，可造成脫水、機體迴圈負荷增加、充血性心力衰竭和肺水腫。
【規格】25％/50ml
【貯藏】2～8℃，避光保存
Human Albumin Grifols® 25%
Albumin (Human) U.S.P.
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 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 day.1
Indications and Usage
Albumin (Human), Human Albumin Grifols® 25% is indicated: a. For the prevention and treatment of hypovolemic shock2,4, andb. in conjunction with exchange transfusion in the treatment of neo-natal hyperbilirubinemia.2c. 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.d. 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 achieved.1,2 Conditions in which Albumin (Human) use is usually not justified:a. Postoperative hypoproteinemia. Major surgery or other
injury of capillary walls may lead to substantial losses of circulating albumin over and above those due to bleeding.1,2,4,5 However, this redistribution of albumin in the body rarely causes clinically significant hypovolemia, hence treatment with Albumin (Human) is usually not indicated.b. 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.c. 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 circumstances.1 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.
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 USA, at 703-860-5057.
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 individualIn 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 onehalf 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.
附件:
201152318440317.pdf

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产地国家: 美国
原产地英文商品名:
HUMAN ALBUMIN GRIFOLS 25% 50MLS/VIAL
原产地英文药品名:
ALBUMIN HUMAN
中文参考商品译名:
基立福25%人血白蛋白 50毫升/瓶
中文参考药品译名:
人血白蛋白
生产厂家中文参考译名:
基立福
生产厂家英文名:
Grifols