Human Immunoglobulin (pH4) for Intravenous Injection (HUALAN))

[Composition]
1. Human immunoglobulin is lgG.
2. Main Excipients: Maltose content: 90~110mg/ml, Polysorbate 80 content: Not higher than
100μg/ml.
[Characters]
It is a clear, colorless or light yellow liquid. Light opalescence may occur.
[Indications]
1.This product is suitable for treatment:
Primary immunoglobulin deficiency diseases, hypothyroidism 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]
2.5 g /vial (5％, 50 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 gradually; but the maximum speed shall not exceed 3.0 ml/min (approximately 60 drops/min).