Human Immunoglobulin (pH4) for Intravenous Injection
A colorless or pale yellow clear or slightly opalescent liquid
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.
5g (5% 100mL);2.5g (5% 50mL);1.25g (5% 25mL)
[Usage 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.