Human Serum Albumin for Organ Transplantation

[Name of the Medicinal Product]
Generic Name: Human Albumin
[Composition]
Active ingredients: human albumin
Excipients: CH3(CH2)6CO2Na, NaCl, WFI
[Characters] 
It is a clear, slightly viscous liquid without turbidity, slightly yellow, green or brown in color.
[Indications]
1. Hemorrhagic shocks caused by injury 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. The product may be diluted with 5% glucose injection or sodium chloride injection for intravenous drip by 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 the product twice at an interval of 4～6 hours. For chronic albumin deficiency such as nephrosis and cirrhosis, inject daily 5～10 g of the product till the disappear of edema and the serum albumin back to normal.
[Adverse Reactions]
Generally no adverse reactions occur after infusion. Occasionally shivering, pyrexia, face flushing, rash, nausea and vomiting may appear. Rapid infusion may cause pulmonary edema due to vascular overload, occasionally anaphylaxis. 
[Contraindications]
The product should not be used for people with the following conditions:
1. 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 any leakage of 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 only if clearly needed.
[Pediatric Use]
Study on this monograph has not been conducted with this product, and there are not systematic and reliable references either. 
[Geriatric Use] 
Study on this monograph has not been conducted with this product, and there are not 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. 
[Pharmacology & Toxicology]
1. Increasing blood volume and maintaining plasma colloid osmotic pressure: The albumin constitutes 80% of the plasma colloid osmotic pressure and mainly regulates the dynamic balance of water content between tissues and vessels. Since the albumin has higher molecular weight than salts and water, it penetrates the membranes more slowly, when the colloid osmotic pressure of albumin rivals the static pressure of capillaries, so as to maintain the normal and constant blood volume. During blood circulation, 1 g of albumin will retain 18 ml of water, and the water retention ability of every 5 g of albumin equals to 100 ml of plasma or 200 ml of whole blood. Therefore, it can increase the blood volume and maintain the plasma colloid osmotic pressure.
2. Transportation and detoxification: The albumin can combine with both anions and cations, so it can transport different substances, and even transport toxic substances to detoxifying organs. 
3. Nutrition supply: Histones and plasma proteins are interconvertible. When metabolic disturbance of nitrogen occurs, the albumin can supply nutrition as nitrogen source. 
[Pharmacokinetics] 
Study on this monograph has not been conducted with this product, and there are not systematic and reliable references either. 
[Storage] Store and ship at 2-30°C, protected from light. 
[Packaging] Borosilicate glass vial, sealed with bromobutyl rubber stopper, packaging of 1 vial per carton. 
[Shelf Life] 36 months starting from the date of production. 
[Product Standard] Chinese Pharmacopeia Volume III (2010)
[National Drug Approval Number] GYZZ S10950007
[Manufacturer]
Name: Hualan Biological Engineering Inc.                             Tel: 86-373-3559991
Address: Jia No.1, Hualan Ave., Xinxiang, Henan, China                Fax: 86-373-3559911
Website: www.hualanbio.com                                           Zip code: 453003