亚玛Albuminar

人血白蛋白Human Albumin

静脉输注溶液

生产企业：CSL Behring L.L.C.(美国杰特杯林生物制品有限公司)

Albuminar-20是人類血清白蛋白20％溶液（Normal Serum Albumin（Human）20％）。它是根據Cohn步驟將成人靜脈血漿在低溫控制下，以化學分離法製備，並以巴斯德低溫滅菌法60℃下滅菌10小時，再以0.016M之Sodium acetyltryptophanate phanate及0.016M之Sodium caprylate作安定劑。
Albuminar-20溶液每100ml含20Gm之血漿白蛋白，滲透力相當於400ml之正常血清，溶液pH值以Sodum bicarbonate, Sodium hydroxide或Acetie acid調整，每公升重要的電解質濃度約為：鈉：130～160mEq，鉀：n. m. t 1mEq，本品不含任何防腐劑，並據照美國FDA之規定配製，完全符合美國藥典標準。本品以靜脈輸注方式投予。

【作用】
Albuminar-20具高滲透性，因而可以調整循環血量，除非在嚴重脫水情況下，當靜脈注射50ml之20％白蛋白，可以在15分鐘內吸收約140ml之液體進入循環系統。這些液體可以減少血液濃度及黏稠度，所增加之體積視原血量而定，當循環血量減少，則注射白蛋白可使血液稀釋維持數小時，若血量正常，則維持時間較短。白蛋白不像全血或血漿；白蛋白因經加熱至60℃10小時，故被認為無病毒性肝炎之危險。Albuminar可以與其他注射液合用而無混合禁忌。如Saline、Glucose、Sodium lactate，本品不含其他細胞成份，故不會因重覆使用而造成過敏現象，且無需作交互配伍反應，非常方便。

【適應症】
低蛋白血症、休克、燒傷

【說明】
休克：用於休克及其他燒傷、外傷、手術或感染引起的休克等緊急情況需補充血量，若紅血球喪失過多則需輸全血。
燒傷：單獨用本品或將本品加入生理食鹽水或葡萄糖溶液可預防明顯的血濃縮，並維持電解質平衡。因穿透性改變，嚴重灼傷後輸注之白蛋白僅有少量留滯血管內。但使用膠體、電解質和水來治療灼傷的方法仍未確立。
低血蛋白：（有或無水腫）當血中蛋白質含量低且造成循環血流量減少時，可注射本品，雖然注射後會立即產生利尿作用，因此要得到最好的效果應持續使用直到回復正常血漿白蛋白濃度。

【禁忌】
本品禁用於嚴重貧血，心衰竭及已知對白蛋白過敏之患者。

【注意事項】
1.溶液混濁後即不可使用，因為本品不含抗菌之防腐劑，故需於4小時內用完。
2.如果有脫水現象，則應該在注射本品後或注射同時補充液體，大量使用本品後可能會產生貧血現象，則應補充全血。
3.若快速的注入高濃度的白蛋白，會使血壓快速上升，應注意觀察受傷病人是否因血壓變高而增加出血部位。
4.當病人心餘量低（Low Cardiac Reserve）或並不缺少白蛋白則需小心使用，因為迅速增加血漿量會造成循環困難及肺水腫。
5.高血壓患者，注射速度要很慢，可將200ml白蛋白溶液與200ml之10％Glucose溶液混合，以每小時10Gm之白蛋白（100ml）注射之。
6.本品係由人類血漿製得，自人類血漿所製得之產品，可能存在著某些感染源，例如致病性之病毒。藉由篩檢血漿之捐血者，檢驗某些現有病毒感染源，再經由去活化及／或去除某些病毒，即可降低此產品傳染感染源之危險性。惟縱然採取上述實施，此類產品仍有可能存在某些未知的感染源。因此，所有感染病人，均應直接向診療醫師及製造廠或代理商報告。請與你的醫師討論使用此產品之風險及利益。 
孕婦使用分類：C級
本品無動物生殖方面之研究，亦不知懷孕時使用本品是否會對胎兒造成傷害或影響生殖能力。所以孕婦只有在確切需時才能投予使用。

【副作用】
本品發生副作用相當低，偶有噁心、嘔吐、唾液分泌增加及發熱現象。

【用法、用量】
本藥限由醫師使用。
1.Albuminar-20可以直接靜脈給藥而不必稀釋，但也可用生理食鹽水或5％Glu. cose溶液稀釋。當稀釋成每公升含250ml之Albuminar時，則約與Citrated plasma等張及等滲。
2.當以未稀釋之白蛋白注射於正常血量之病人時，注射速率應該滅慢（約1分鐘1ml），以免使血漿量增加太快。
3.在休克的治療，白蛋白之用量和治療期長短應該根據病人血壓之反應、肺充血及血球容積來調整，初劑量為Albuminar-20 100ml，若開始給藥後反應不足，則在30分鐘內再度給藥，若注射250ml後，仍有持續之蛋白質流失情形或出血反應，則需給予全血或其他之血液成份。
4.燒傷的治療方法包括使用白蛋白、類晶體、電解質及水，選用何者為最佳療法目前仍未確立，一般建議的療法是在最初24小時，給予大量的類晶體溶液來維持血漿量，24小時以後通常需要更多的白蛋白，但較少之類晶體溶液來維持血漿量，24小時以後通常需要更多的白蛋白，但較少之類晶體溶液以維持血漿白蛋白於2.5g／100ml或全血清蛋白量於5.2g／100ml，本品之治療期視蛋白質經腎臟排除後之損失程度、皮膚灼傷面積及白蛋白合成之減少而定。當白蛋白量增為4.0g／100ml會增加異化速率。
5.在治療低血蛋白時，250～350ml之20％白蛋白溶液可以減少水腫並使血漿蛋白質回復至正常值，由於此種病人通常有正常之血量，注射速度不可超過3ml／min，以免造成循環困難。
6.非經腸內吸收之藥品，在投予前應在包裝許可之情況下，檢視有無異物或變色。

【原产地英文商品名】ALBUMINAR-5% IV SOLUTION 500mL/Vial
【原产地英文药品名】ALBUMIN HUMAN
【中文参考商品译名】
注：以下产品是不同的价格和不同的规格，购买时请以电话咨询为准！
·亚玛 5% IV溶液 500毫升/瓶
·亚玛 5% IV溶液 250毫升/瓶
·亚玛 25% IV溶液 50毫升/瓶
·亚玛 25% IV溶液 100毫升/瓶
【生产厂家中文参考译名】杰特贝林
【生产厂家英文名】CSL BEHRING

ALBUMINAR®-25 (Aventis Behring)
ALBUMIN (HUMAN) U.S.P., 25%

Rx only
DESCRIPTION

Albumin (Human) 25%, Albuminar®-25 is a sterile aqueous solution of albumin obtained from large pools of adult human venous plasma by low temperature controlled fractionation according to the Cohn process. It is stabilized with 0.02 M sodium acetyltryptophanate and 0.02 M sodium caprylate and pasteurized at 60°C for 10 hours.

The plasma used in the manufacture of this product has been tested and found negative for HBV, HCV, and HIV-1 by an investigational test procedure referred to as Nucleic Acid Testing (NAT) using Polymerase Chain Reaction (PCR) Technology. Investigational testing is being performed to determine the effectiveness of NAT to detect low levels of viral material. The significance of a negative result is unknown since the effectiveness of the test has not been established.

Albumin (Human) 25%, Albuminar®-25 is a solution containing in each 100 mL, 25 grams of serum albumin, osmotically equivalent to 500 mL of normal human plasma. The pH of the solution is adjusted with sodium bicarbonate, sodium hydroxide, or acetic acid. Approximate concentrations of significant electrolytes per liter are: sodium--130-160 mEq; and potassium--n.m.t. 1 mEq. The solution contains no preservative. This product has been prepared in accordance with the requirements established by the Food and Drug Administration and is in compliance with the standards of the United States Pharmacopeia.

Albumin (Human) 25%, Albuminar®-25, is to be administered by the intravenous route.

The heat treatment step employed in the manufacture of Albumin (Human) 25%, Albuminar®-25, pasteurization of the final container at 60°C for 10 hours, has been validated in a series of in vitro experiments for its capacity to inactivate Human Immunodeficiency Virus type 1 (HIV-1), and the following model viruses: Bovine Viral Diarrhea Virus (BVDV-an enveloped virus used as a model for hepatitis C virus), Pseudorabies (PrV-a large, enveloped virus), and Encephalomyocarditis Virus (EMC - a small non-enveloped virus). For each virus studied, three independent experiments were conducted using Albumin (Human) 5%, Albuminar®-5 and Albumin (Human) 25%, Albuminar®-25 with the following results. 1
Pasteurization (60°C for 10 hours) Viral Reduction Studies
(log 10 reduction) Virus Albumin (Human) 5%,
Albuminar®-5 Albumin (Human) 25%,
Albuminar®-25
HIV-1 >5.44, >6.38 and >6.31 >5.50, >6.57 and >6.64
BVDV >6.01, >6.76 and >6.55 >5.99, >5.81 and >5.32
PrV >7.30, >7.68 and >7.63 >7.32, >7.20 and >7.42
EMC >7.38, >7.97 and >7.97 >7.10, >7.89 and >7.87
CLINICAL PHARMACOLOGY
Albumin (Human) 25%, Albuminar®-25 is active osmotically and is therefore important in regulating the volume of circulating blood. When injected intravenously, 50 mL of 25% albumin draws approximately 175 mL of additional fluid into the circulation within 15 minutes, except in the presence of marked dehydration. This extra fluid reduces hemoconcentration and blood viscosity. The degree of volume expansion is dependent on the initial blood volume. When the circulating blood volume has been depleted, the hemodilution following albumin administration persists for many hours. In individuals with normal blood volume, it usually lasts only a few hours.

Albumin, unlike whole blood or plasma, is considered free of the danger of homologous serum hepatitis. Albumin (Human) 25%, Albuminar®-25 may be given in conjunction with other parenteral fluids such as saline, dextrose or sodium lactate. It is convenient to use since no crossmatching is required and the absence of cellular elements removes the danger of sensitization with repeated infusions.
INDICATIONS AND USAGE
SHOCK - Albumin is indicated in the emergency treatment of shock and in other similar conditions where the restoration of blood volume is urgent. If there has been considerable loss of red blood cells, transfusion with packed red blood cells is indicated.

BURNS - Albumin or Albumin in either normal saline or dextrose is indicated to prevent marked hemoconcentration and to maintain appropriate electrolyte balance.

HYPOPROTEINEMIA with or without edema - Albumin is indicated in those clinical situations usually associated with a low concentration of plasma protein and a resulting decreased circulating blood volume. Although diuresis may occur soon after albumin administration has been instituted, best results are obtained if albumin is continued until the normal serum protein level is regained.
CONTRAINDICATIONS
Albumin (Human) 25%, Albuminar®-25 may be contraindicated in patients with severe anemia or cardiac failure and in patients with a history of allergic reactions to human albumin.
WARNINGS
Infusion of protein-containing solutions such as Albuminar®-25 that have been excessively or inappropriately diluted with hypotonic solutions such as sterile water for injection may result in severe hemolysis and acute renal failure. Please refer to the DOSAGE AND ADMINISTRATION section for information about the recommended diluents for Albuminar®-25, which are normal saline and 5% dextrose.

Do not use if the solution is turbid. Since this product contains no antimicrobial preservative, do not begin administration more than 4 hours after the container has been entered.

Albumin (Human) U.S.P., 25%, Albuminar®-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 and/or removing certain viruses during manufacture. The manufacturing procedure for Albumin (Human) 25%, Albuminar®-25 includes processing steps designed to reduce further the risk of viral transmission. Stringent procedures utilized at plasma collection centers, plasma testing laboratories, and fractionation facilities are designed to reduce the risk of viral transmission. Albuminar®-25 is pasteurized in the final container at 60.0 +/- 0.5°C for 10 - 11 hours. Virus elimination/inactivation is also achieved by the cold alcohol fractionation process. (See DESCRIPTION section for further information on viral reduction measures). Despite these measures, such products may still potentially contain human pathogenic agents, including those not yet known or identified. Thus the risk of transmission of infectious agents cannot be totally eliminated. Any infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Aventis Behring at 800-504-5434. The physician should discuss the risks and benefits of this product with the patient.

Albumin is a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases. 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.
PRECAUTIONS
GENERAL
If dehydration is present additional fluids must accompany or follow the administration of albumin. Administration of large quantities of albumin should be supplemented with or replaced by packed red blood cells to combat the relative anemia which would follow such use. The quick response of blood pressure which may follow the rapid administration of concentrated albumin necessitates careful observation of the injured patient to detect bleeding points which failed to bleed at lower blood pressure. Albumin (Human) 25%, Albuminar®-25 should be administered with caution to patients with low cardiac reserve or with no albumin deficiency because a rapid increase in plasma volume may cause circulatory compromise (e.g. hypertension, hypotension, or pulmonary edema). In cases of hypertension, a slower rate of administration is desired - 200 mL of albumin solution may be mixed with 300 mL of 10% dextrose solution and administered at a rate of 10 grams of albumin (100 mL) per hour.

If anaphylactic or severe anaphylactoid reactions occur, discontinue infusion immediately. Infusion rates and the patient's clinical state should be monitored closely during infusion.

INFORMATION FOR PATIENT - Some viruses, such as parvovirus B19 or hepatitis A are particularly difficult to remove or inactivate at this time. Parvovirus B19 may most seriously affect pregnant women, or immune-compromised individuals. The majority of parvovirus B19 and hepatitis A infections are acquired by environmental (community acquired) sources.

PREGNANCY CATEGORY C - Animal reproduction studies have not been conducted with Albumin (Human) 25%, Albuminar®-25. It is also not known whether Albuminar®-25 can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Albuminar®-25 should be given to a pregnant woman only if clearly needed.

PEDIATRIC USE - No clinical studies using Albumin (Human) 25%, Albuminar®-25 have been conducted in pediatric patients. Safety and effectiveness in pediatric patients have not been established. However, extensive experience in patients suggests that children respond to Albumin (Human) 25%, Albuminar®-25 in the same manner as adults.
ADVERSE REACTIONS
The incidence of untoward reactions to Albumin (Human) 25% is low. Reports have been received of anaphylaxis, which may be severe, and hypersensitivity reactions (including urticaria, skin rash, pruritus, edema, erythema, hypotension and bronchospasm). Nausea, vomiting, increased salivation, chills and febrile reactions have also been reported (see also PRECAUTIONS ).
DOSAGE AND ADMINISTRATION
Albumin (Human) 25%, Albuminar®-25 may be given intravenously without dilution or it may be diluted with normal saline or 5% dextrose before administration. 200 mL per liter gives a solution which is approximately isotonic and iso-osmotic with citrated plasma.

When undiluted albumin solution is administered in patients with normal blood volume, the rate of infusion should be slow enough (1 mL per minute) to prevent too rapid expansion of plasma volume.

In the treatment of shock the amount of albumin and duration of therapy must be based on the responsiveness of the patient as indicated by blood pressure, degree of pulmonary congestion, and hematocrit. The initial dose may be followed by additional albumin within 15 - 30 minutes if the response is deemed inadequate. If there is continued loss of protein, it also may be desirable to give packed red blood cells.

In the treatment of burns an optimal regimen involving use of albumin, crystalloids, electrolytes and water has not been established. Suggested therapy during the first 24 hours includes administration of large volumes of crystalloid solution to maintain an adequate plasma volume. Continuation of therapy beyond 24 hours usually requires more albumin and less crystalloid solution to prevent marked hemoconcentration and maintain electrolyte balance. Duration of treatment varies depending upon the extent of protein loss through renal excretion, denuded areas of skin and decreased albumin synthesis. Attempts to raise the albumin level above 4.0 g/100 mL may only result in an increased rate of catabolism.

In the treatment of hypoproteinemia, 200 to 300 mL of 25% albumin may be required to reduce edema and to bring serum protein values to normal. Since such patients usually have approximately normal blood volume, doses of more than 100 mL of 25% albumin should not be given faster than 100 mL in 30 to 45 minutes to avoid circulatory embarrassment. If slower administration is desired, 200 mL of 25% albumin may be mixed with 300 mL of 10% dextrose solution and administered by continuous drip at a rate of 100 mL of this dextrose solution an hour.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
HOW SUPPLIED
Albumin (Human), Albuminar®-25 is supplied as a 25% solution in:

20 mL vials containing 5 grams of albumin (NDC 0053-7680-01)

50 mL vials containing 12.5 grams of albumin (NDC 0053-7680-32)

100 mL vials containing 25 grams of albumin (NDC 0053-7680-33)

Albumin (Human), Albuminar®-25 is also supplied as a 25% solution in vials with administration set.

50 mL vials containing 12.5 grams of albumin (NDC 0053-7680-02)

100 mL vials containing 25 grams of albumin (NDC 0053-7680-03)

Store between 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature].

The packaging of this product contains dry natural rubber.

REFERENCES
Data on file.

BIBLIOGRAPHY
Finlayson, J.S.: Albumin Products. Seminars in Thrombosis and Hemostasis 6:85 - 120, 1980.

Tullis, J.L.: Albumin. JAMA 237:355-360 and 460-463, 1977.

Rudolf, A.M.: Pediatrics . 18th ED., p. 1839, Appleton and Lange, 1987.

Revised March 2001   12522-03

Manufactured by:

Aventis Behring L.L.C.

Kankakee, IL 60901 U.S.A.

U.S. License No. 1281

Albuminar^® 25

Albumin (Human) U.S.P. 25

Albumin (Human) 25% is indicated in the emergency treatment of shock due to burns, trauma, operations, and infections; in the treatment of severe injuries; and in other similar conditions where the restoration of blood volume is urgent. 

• Natural plasma protein product
• Safe and effective therapy for over 50 years

Broad Therapeutic Applications

• Plasma expansion and replacement - trauma, burns, and shock
• Conditions where restoration of blood volume is urgent
• Hypoproteinemia

Safety at the Source

• Source plasma screening for human immunodeficiency virus (HIV) 1 and 2 and for other vial indicators, including markers for hepatitis B virus and hepatitis C virus
• 100% of plasma comes from repeat donors, who are routinely tested at the time of each donation

Effective Viral Inactivation

• Pasteurization (heat treatment in aqueous solution) at 60°C for 10 hours - a demonstrated viral inactivation method that inactivates lipid-enveloped and certain non-lipid-enveloped viruses

NDC Number	Product Description
0053-7680-32	50 mL
0053-7680-33	100 mL

Important Safety Information

Albuminar® is contraindicated in patients with severe anemia or cardiac failure and in patients with a history of allergic reactions to human albumin.

Albuminar® is derived from human plasma, as with all plasma-derived products, the risk of transmission of infectious agents, including viruses, and theoretically, the Creutzfeldt-Jakob (CJD) disease agent, cannot be completely eliminated. As with any pharmaceutical, the physician should weigh the risks and benefits of administration.

*アルブミナー5％静注12.5g/250mL