human albumin

[Name of the Medicinal Product]

Generic Name: Human Albumin

English Name: Human Albumin

Chinese Pinyin: Ren Xue Baidanbai

[Composition]

Active ingredients: human albumin

Excipients: Sodium Caprylate, Sodium Chloride, WFI

[Characters]

It is slightly viscous, yellow or green to brown clear liquid without turbidity.

[Indications]

1. Hemorrhagic shocks caused by trauma or burn.

2. Increased intracranial pressure caused by cerebral edema or injury.

3. Edema or ascites caused by cirrhosis or nephrosis.

4. Preventive treatment to hypoalbuminemia.

5. Hyperbilirubinemia of newborns.

6. Adjuvant therapy to cardiopulmonary bypass, burn or hemodialysis, and adult respiratory distress syndrome (ARDS).

[Strengths]

2 g per container (10％ 20 ml): each container containing 2 g of protein with protein concentration of 10% and filling quantity of 20 ml.

[Administration and Dosage]

Administration:

Inject i.v.gtt or i.v. In order to prevent dehydration of body tissues during large-scale injection, the product may be diluted with 5% glucose injection or sodium chloride injection for intravenous drip (It is appropriate to use blood transfusion apparatus with sieve). The dripping speed shall not exceed 2 ml/min. Note that the foresaid speed is gradually achieved, for the speed should be kept very slow within the first 15 minutes.

Dosage: at the direction of the physician. For shocks caused by severe burns or blood loss, inject 5～10 g of this product directly, inject twice after 4～6 hours. For chronic albumin deficiency such as nephrosis and cirrhosis, inject 5～10 g of the product daily till the disappear of edema and the serum albumin recovers back to normal.

[Adverse Reactions]

Generally no adverse reactions occur after infusion. Occasionally shivering, pyrexia, face flushing, rash, nausea and vomiting and etc. may appear. Rapid infusion may cause pulmonary edema due to vascular overload, occasionally anaphylaxis.

[Contraindications]

1. Serious hypersensitivity to albumin.

2. Hypertension, acute heart disease, heart failure due to normal blood volume or hypervolemia.

3. Severe anemia.

4. Renal insufficiency.

[Warnings and Precautions]

1. Do not use the product if any turbidity, precipitation, foreign matters appear or crack in container, loose stopper or expired shelf life is found.

2. Once the container is opened, the product shall be used up at one time. Divided dosing or injection to a second person is prohibited.

3. The injection shall be stopped immediately when any discomforts occur to the subjects.

4. Fluid infusion should be given to subjects with clear signs of dehydration.

5. Do not freeze during storage and shipment.

[Pregnancy and Nursing Mothers]

Caution should be exercised when the product is given to women who are or may become pregnant. The product should be used under guidance and close observation of the physician if necessary.

[Pediatric Use]

Targeted study on this monograph has not been conducted, and there are no systematic and reliable references either.

[Geriatric Use]

Targeted study on this monograph has not been conducted, and there are no systematic and reliable references either.

[Drug Interactions]

The product should not be mixed for use with vasoconstrictor, proteolytic enzyme or alcohol-contained injections.

[Overdosage]

The product is hyperosmotic, and overuse could result in dehydration, load increase of body cycle, congestive heart failure and pulmonary edema.