human albumin alburaas,raas headquarters上海莱士-九游会旗舰厅

date approved: apr. 02, 2007

date revised: oct. 24, 2013

                        alburass® -human albumin

    read the package insert carefully and under the instruction of physician

warning

this product is human-plasma-derived. although the screening and testing

measures of infectious agents and viral removal and inactivation added in the

manufacture process, theoretically, there is still potential risk in the transmission of

some known and even unknown infectious agents. the risk-benefit analysis should

be taken before administration.

product name

generic name: human albumin

ingredients

active ingredients: human albumin

alburaas® is manufactured from human plasmaof healthy donors and for 2 steps virus inactivation

heat treated at 60℃ for 10 hours.

excipients : sodium caprylate, sodium acetyltryptophan.

characters

alburaas® is a clear, slightly viscous liquid,slightly yellow, green or brown in colour, and should

not be turbid.

indications

1. shock due to loss of blood, trauma or burns.

2. intracranial hypertension due to cerebral edema or brain injuries.

3. edema or ascites due to liver cirrhosis or nephrotic syndrome.

4. treatment of hypoproteinemia.

5. neonatal hyperbilirubinermia.

6. auxiliary treatment of heart-pulmo bypass or burns, auxiliary treatment of hemodialysis, and adult respiratory distress syndrome (ards).

specifications

alburaas® is available in the following:

protein concentration of 5%, 2g in 40ml/vial

protein concentration of 10%, 5g in 50ml/vial

protein concentration of 20%, 10g in 50ml/vial

protein concentration of 25%, 12.5g in 50ml/vial

dosage and administration

administration: generally, alburaas® must be injected by slow intravenous infusion or by phleboclysis. alburaas® can also be infused after it is appropriately diluted by 5% dextrose injection or sodium chloride injection (it is recommended to use transfusion set with filter) to prevent dehydrationof tissues when a large amount of alburaas® is infused. the rate of infusion shoud not exceed 2ml per minute, during the first 15 minutes, infusion rate should be particularly slow, then gradually be increased to the above rate.

dosage: alburaas® should be prescribed by the physician. in the case of hypovolemic shock due to loss of blood, trauma or burns, the initial treatment should be in the range of 5g to 10g for adults. this may be repeated after 4 to 6 hours, if the response is not adequate. in the case of edema or ascites due to liver cirrhosis or nephrotic syndrome, the recommended dosage is from 5g to 10g every day until edema or ascites disappear and the level of plasma albumin came back normal.

adverse reactions

adverse reactions following the infusion of alburaas® are rare, but such reactions as chills,fever, flushing, urticaria, nausea or vomit may occur occasionally. too rapid infusion may cause an acute circulatory overload and pulmonary edema.allergic reactions also infrequency.

contraindications

1. patients suffering from severe allergic reactions to albumin.

2. patients suffering from hypertension, acute heart disease, heart failure with normo-volemia or hyper-volemia.

3. patients suffering from servere anermia.

4. patients suffering from renal dysfunction.

precautions

1. the product must not be used if the solution appears to be turbid or contains any sediment or foreign matter, or there is any crack on the bottle, the cap of the product is loose, or the product has been expired.

2. one vial product must be used for single ifusion, and should not be used for other infusion or other patients.

3. in case patients have any uncomfortable reaction during the course of infusion, the administration should be stopped immediately.

4. in severe dehydrated patients the contemporary administration of other crystalloid solutions can be indicated.

5. alburaas® should not be frozen during transportation or storage.

pregnancy and lactation

caution should be taken in pregnant women and women who probably are pregnant.

if administration is required, the course of administration should be instructed and strictly monitored by the physicial.

pediatric use

no relevant trials were performed of alburaas®.

geriatric use

no relevant trials were performed and no relevant reference of alburaas®.

drug interactions

some injection containing vasoconstricing drugs, protein hydrolase or alcohol must rot be either mixed or infused with alburaas®.

overdose

as alburaas® is hyperosmotic, over dosage infused can cause of hydration, circulatory overload, heart failure with hyper-volemia, and pulmonary edema.

pharmacology and toxicology

pharmacology:

1. increasing the volume of circulating blood and maintaining the colloidal osmotic pressure of plasma: albumin shakes up approximately 80% of the colloidal osmotic pressure of plasma, mainly adjusts dynamic balance of water between human tissues and blood vessel. because of high molecular weight of albumin the rate of albumin permeating the endomembrane is lower than that of salts and water, colloidal osmotic pressure of albumin balances the static pressure of capillary vessel, which maintains normal and constant volume of circulating blood; meanwhile, 1g albumin can hold 18ml water in circulation, and the water holding capability of each 5g albumin is equal to that of 100ml plasma or 200ml whole blood, so that albumin has functions of increasing the volume of circulating blood and maintaining the colloidal osmotic pressure of plasma.

2. transportation and detoxication: albumin can combine both negative and positive ions, transport variable matters, and also transport toxicants to detoxicating organs.

3. supplying nutriments: tissue proteins and plasma proteins can transform each other. when nitrogen metabolic cycle blocked, albumin as a nitrogen source can supply nutriments to tissues.

toxicolology: no relevant trials and no relevant reference of alburaas®.

pharmacokinetics

no relevant test were performed of alburaas®.

storage and shipping

for specifications of 2g in 40ml/vial, 5g in 50ml/ vial, and 10g in 50ml/vial: store and ship at 2-8℃, protected from light.

for specification of 12.5g in 50ml/vial: store and ship at 10~30℃, protected from light.

package

glass bottle, one vial per package.

shelf life

for specifications of 2g in 40ml/vial, 5g in 50ml/vial,and 10g in 50ml/vial: currently 60 months.

for specification of 12.5g in 50ml/vial: currently 36

months

standard for implementation

volume ⅲ of "pharmacopoeia of the people's republic of china" (2010)

product license no.

2g, 40ml/vial: 国药准字s10930019;

5g, 50ml/vial: 国药准字s10930020;

10g, 50ml/vial: 国药准字s10920009;

12.5g, 50ml/vial: 国药准字s20013053;

shanghai raas blood products co., ltd.

address: no. 2009 wangyuan road, fengxian, shanghai, p. r. china

zip code: 201401

tel: (86-21)-22130888 fax: (86-21)-64626161

service hot line: 400-820-1126

web site: http://www.raas-corp.com