Human Immunoglobulin(pH4)Prescribing Information

Generic Name:Human Immunoglobulin(pH4)for Intravenous Injection

·Human Immunoglobulin,sourced from healthy human plasma

·Main excipient: Maltose 90-110g/L

·Molecular Weight:150000

Should be a colorless or light yellow clear liquid,with slight opalescence.Should be free from foreign matter, floccules, and precipitates.

·Patents with known hypersensitivity to human immunoglobulin or a history of other severe

allergic reactions;

·Patents with selective IgA deficiency who have lgA antibodies.

·Primary Immunoglobulin Deficiency Syndromes,such asX- linked agammaglobulinemia, common variable immunodeficiency,immunoglobulin G subclass deficiency, etc.

·Secondary Immunoglobulin Deficiency Syndromes,such as severe infections, neonatal sepsis,etc.

·Autoimmune Diseases,such as idiopathic thrombocytopenic purpura,Kawasaki disease,etc.

Store and transport at 2~8℃,protected from light.Do not freeze.

Dosage:

·Primary Immunoglobulin Deficiency or Hypogammaglobulinemia:

·Initial Dose:400mg/Kg body weight;

·Maintenance Dose:200~400mg/Kg body weight,with dosing interval determined by the patient's serum lgG level and clinica condition,generally once a month.

·Idiopathic Thrombocytopenic Purpura(ITP):

·Initial Dose:400mg/Kg body weight/day,for 5 days;

·Maintenance Dose:400mg/Kg body weight/dose,with dosing interval determined by platelet count and clinical condition,generally once a week.

·Kawasaki Disease:To be used within 10 days of onset.Pediatric therapeutic dose is 2.0g/Kg body

weight by intravenous infusion,administered as a single infusion.

·Severe Infection:200~300mg/Kg body weight/day,for 2~3 days.

Administration:

For intravenous drip infusion,use an infusion set with a filter.nfusion rate:The initialinfusion of this product should be slow,1.0 ml/minute(10~20 drops/minute)for adults;if no adversereactions occur after 15 minutes,the rate can be gradually increased,with the maximum infusion rate notexceeding 3.0 ml/minute (approximately 60 drops/minute).The drip rate for children should beappropriately reduced.

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