Hualan's Human Immunoglobulin (pH4) for Intravenous Injection

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.