Human Immunoglobulin (pH4) for Intravenous Injection-HUALAN BIO

Impeccable Safety Records of Product

    Hulan Bio has set up the concept that good quality depends on the advanced design since the day when the company was founded. Because Hualan adopted advanced technology and equipment and fully implemented strict quality management, no case of virus infection after using the product of our company was found or reported in the past twenty years since the day on which our product was marketed. Since carried out the national lot release system, inspect the products as batch and Supervisors appointed by the SFDA randomly inspect products. The plasma products is safe and reliable.

Unite Advanced Manufacturing Process
    Hualan employs world-class manufacturing equipment and strict quality management. Under the high level purification condition, we realize the highest utilization ratio of plasma by means of world advanced united manufacturing process. Conditions of plasma protein component separation are soft, which effectively maintains high purity and stability of protein particles and product and high activity of plasma protein.

Guarantee of Blood Resource Safety
    Plasma used for manufacturing the product comes from healthy people in areas where incidence of the disease are low. Hualan is the first manufacturer in China who uses the plasmapheresis machine, automatic vial washing and sterile filling line, “Look Back” system and 90 days’ ”window period” system, so that effectively guarantees the safety of product and people who donate plasma.
    For the test for source plasma, ELISA is adopted several times to test hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (Anti-HCV) and HIV 1+2 virus antibody (Anti-HIV1+2); and the Nucleic Acid Amplification Techniques (NAT) is adopted to test HBV-DNA, HCV-RNA and HIV-RNA. The tests are conducted according to standards of the EU and WHO.

Directions for use of Human Immunoglobulin (pH4) for Intravenous Injection
Please read these directions carefully and consult the physician before use.
This product is made of human blood plasma. Although the source plasma has been screened for relevant pathogens, and the viruses have been removed and inactivated during production, there are still potential risks of spreading some known and unknown pathogens. Therefore, the decision to use the product should be based on careful consideration of the potential benefits and risks.

[Name of the Medicinal Product]
Generic Name: Human Immunoglobulin (pH4) for Intravenous Injection
[Composition]
Active ingredients: human immunoglobulin
Excipients: Tween-80, maltose, WFI
[Characters]
It is a clear, colorless or light yellow liquid. Opalescence may occur but without turbidity. 
[Indications]
1. Primary immunoglobulin deficiency diseases, such as X-linked hypoimmunoglobinemia, common variable immunodeficiency disease (CVID), IgG subclass deficiency, etc. 
2. Secondary immunoglobulin deficiency diseases, such as severe infections, neonatal sepsis, etc.
3. Autoimmune diseases (AID), such as primary thrombocytopenic purpura, Kawasaki disease (KD), etc. 
[Strengths] 
5 g per container (5％ 100 ml): Each container containing 5 g of protein with protein concentration of 5% and filling quantity of 100 ml. 
[Administration and Dosage] 
Administration: inject i.v.gtt or i.v.gtt after diluted 1～2 folds with 5% glucose injection. The beginning dripping speed shall be 1.0 ml/min (approximately 20 drops/min). If no adverse reactions occur within the first 15 minutes, speed up; but the maximum speed shall not exceed 3.0 ml/min (approximately 60 drops/min).
Dosage: at the direction of the physician. Different dosages are recommended for different diseases as follows: 
1. Primary immunoglobulin deficiency diseases: Initial dose: 400 mg/kg BW. Maintenance dose: 200～400 mg/kg BW; the dosing interval shall depend on the serum lgG level and the conditions of patients, generally once a month. 
2. Primary thrombocytopenic purpura: 400 mg/kg BW every day for consecutive 5 days. Maintenance dose: 400 mg/kg BW; the dosing interval shall depend on the platelet count and the conditions of patients, generally once a week.
3. Severe infections: 200～300 mg/kg BW every day for consecutive 2～3 days.
4. Kawasaki disease: The product shall be used within 10 days after disease attack. 2.0 g/kg BW for children. It shall be used up at one time. 
[Adverse Reactions]
Generally no adverse reactions occur after infusion. Transient headache, malaise or nausea may occur occasionally, which may possibly be related to infusion speed or individual difference. These adverse reactions are mild and usually occur within one hour after infusion, therefore periodical observations should be exercised for the conditions and the vital signs of patients. Slow down or suspend the infusion if necessary. No special treatment is needed. The adverse reactions may occur after infusion to some patients, but will be relieved spontaneously within 24 hours. 
[Contraindications] 
1. Those with a history of hypersensitivity to human immunoglobulin, or with other severe anaphylaxis.
2. Those with selective lgA deficiency with lgA antibody. 
[Warnings and Precautions]
1. The product is for intravenous infusion exclusively. 
2. Dilute the product with 5% glucose injection, as required. Diabetics shall use with caution. 
3. 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.
4. Once the container is opened, the product shall be used up at one time. Divided dosing or injection to a second person is prohibited.
5. Patients with severe acid-base unbalance shall use with caution.
[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 other drugs. 
[Overdosage]
Study on this monograph has not been conducted with this product, and there are not systematic and reliable references either.
[Pharmacology & Toxicology]
The lgG antibodies of broad-spectrum anti-virus, bacteria and other pathogens contained as well as the immune network formed by the immunoglobulin idiotypic antibody contribute the dual therapeutic effects as immune replacement and immune regulation of the product. After intravenous infusion, it will rapidly increase the lgG of the recipients, thus improve their anti-infection ability and immune regulatory function.
[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 S10970032
[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                                           Mail: hualan@hualanbio.com