Intravenous human immunoglobulin (pH4)
Function and Efficacy
This product contains broad-spectrum IgG antibodies against viruses, bacteria or other pathogens. In addition, the unique type of immunoglobulin and the unique type antibody form a complex immune network, so it has the dual therapeutic effects of immune replacement and immune regulation. After intravenous infusion, it can quickly increase the IgG level in the recipient's blood and enhance the body's anti-infection ability and immune regulation function.
Ingredients
Main ingredients: More than 95% of the protein in this product is immunoglobulin. This product is made from healthy human plasma, separated and purified by low-temperature ethanol protein separation, anti-complement activity is removed, and virus inactivation treatment is performed. Accessories: maltose.
| Name | Description | Content | CAS NO. | Manufacturer |
|---|---|---|---|---|
| MaltoseExcipients |
This product contains broad-spectrum IgG antibodies against viruses, bacteria or other pathogens. In addition, the unique type of immunoglobulin and the unique type antibody form a complex immune network, so it has the dual therapeutic effects of immune replacement and immune regulation. After intravenous infusion, it can quickly increase the IgG level in the recipient's blood and enhance the body's anti-infection ability and immune regulation function. More |
69-79-4 | 11 |
Appearance
This product is a colorless or light yellow clear liquid with a slight opalescence and should not be turbid.
Indication
1. Primary immunoglobulin deficiency, such as X-linked hypoimmunoglobulinemia, common variable immunodeficiency, immunoglobulin G subtype deficiency, etc. 2. Secondary immunoglobulin deficiency, such as severe infection, neonatal sepsis, etc. 3. Autoimmune diseases, such as idiopathic thrombocytopenic purpura, Kawasaki disease.
Usage and Dosage
Usage: intravenous drip or dilute 1-2 times with 5% glucose solution for intravenous drip, the initial drip rate is 1.0ml/min (about 20 drops/min). If there is no adverse reaction after 15 minutes, the speed can be gradually increased, and the fastest drip rate shall not exceed 3.0ml/min (about 60 drops/min). Dosage: follow the doctor's advice. Recommended dose 1. Primary immunoglobulin deficiency or hypoimmunoglobulinemia: first dose: 400mg/kg body weight: maintenance dose: 200-400mg/kg body weight. The dosing interval depends on the patient's serum IgG level and condition, generally once a month. 2. Primary thrombocytopenic purpura: 400mgkg body weight per day for 5 consecutive days. The maintenance dose is 400mg/kg body weight each time, and the interval depends on the platelet count and condition, generally once a week. 3. Severe infection: 200-300mg/kg body weight per day for 2-3 consecutive days. 4. Kawasaki disease: Use within 10 days of onset. The therapeutic dose for children is 2.0/kg body weight, once infused.
Adverse Reactions
Generally, there are no adverse reactions. Very few patients experience transient headaches, palpitations, nausea and other adverse reactions during infusion, which may be related to the rapid infusion speed or individual differences. Most of the above reactions are mild and often occur within one hour after the start of infusion. Therefore, it is recommended to regularly observe the patient's general condition and vital signs during the entire infusion process. If necessary, slow down or suspend the infusion. Generally, no special treatment is required and the patient can recover on his own. Some patients may experience the above reactions after the end of the infusion, and generally they can recover on their own within 24 hours.
Precautions
1. Those who are allergic to human immunoglobulin or have other severe allergic history. 2. Those with selective IgA deficiency with anti-IgA antibodies.
Special Population Medication
Precautions for children: Not yet clear Precautions for pregnancy and lactation: Use with caution in pregnant women or women who may become pregnant. If necessary, use under the guidance of a physician and under close observation Precautions for the elderly: Not yet clear
Drug Interactions
This product should be infused alone and should not be mixed with other drugs.
Storage
Store at 2-8℃ away from light
Packaging Specification
Each bottle contains 2.5 grams of protein. Protein content is 5%.
Validity Period
36 months
Manufacturer
Guangdong Shuanglin Bio-Pharmacy Co., Ltd.
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Founded in:
1995-11-20 -
Address:
No. 1, Xinfeng East Road, Donghai Island, Zhanjiang City -
Tax NO.:
91440800232100924M -
Registered Funds:
1,039.6 million yuan -
Website:
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Email: