What Is Intravenous Immune Globulin?

This strain is isolated and extracted from normal human plasma by low-temperature ethanol method, and refined through further processing and virus inactivation. This product is a complete, unmodified natural lgG antibody with a purity of up to 98%. It contains no preservatives and antibiotics and is intended for intravenous infusion. Compared with intramuscular injection of gamma globulin, it has a faster effect and a significant effect. advantage.

Human immunoglobulin for intravenous injection

This strain is isolated and extracted from normal human plasma by low-temperature ethanol method, and refined through further processing and virus inactivation. This product is a complete, unmodified natural lgG antibody with a purity of up to 98%. It contains no preservatives and antibiotics and is intended for intravenous infusion. Compared with intramuscular injection of gamma globulin, it has a faster effect and a significant effect. advantage.

Chinese name

Human immunoglobulin for intravenous injection

Subject

medicine

Use

injection

Purity

98%

More than 95% of the protein in this product is immunoglobulin [character] White loose body with no sign of melting. After reconstitution, it is colorless or light yellow clear liquid with slight opalescence.

This product should be a colorless or pale yellow clear liquid, with a slight opalescence, and there should be no foreign matter, floc and precipitation.

This product contains broad-spectrum IgG antibodies against viruses, bacteria, or other pathogens. In addition, the idiotypic and idiotypic antibodies of immunoglobulins can form complex immune networks, so they have the dual therapeutic effects of immune substitution and immune regulation. After intravenous injection, it can rapidly increase the IgG level in the recipient's blood and enhance the body's anti-infective ability and immune regulation function.

This product contains broad-spectrum virus and bacterial IgG antibodies, which has a conditioning and neutralizing effect. After intravenous infusion, it can rapidly increase the IgG level in the recipient's blood.

(1) Primary immunoglobulin deficiency, such as X-linked hypoimmunoglobulinemia, common variant immunodeficiency disease, immunoglobulin G subtype deficiency disease, etc.

(2) Secondary immunoglobulin deficiency diseases, such as severe infection, neonatal sepsis, etc.

(3) Autoimmune diseases, such as primary thrombocytopenic purpura.

Primary or secondary immunoglobulin IgG deficiency or hypoxia; primary thrombocytopenic purpura; severe infections caused by various bacteria and viruses; Kawasaki disease: other indications: can be used for other immune regulatory disorders and corrections, Such as rheumatoid arthritis, myasthenia gravis, autoimmune anemia, and immunity-free simple red cell aplastic anemia, can also be used to generate anti-

Take fresh blood from healthy blood donors and mix each batch with at least 1,000 healthy blood donors. The immunoglobulin components are extracted by fractional precipitation using a low-temperature ethanol protein separation method, and are obtained through processes such as ultrafiltration or freeze-drying, dealcoholization, concentration, and virus inactivation. The purity of the immunoglobulin should be not less than 98%. It is formulated into a solution with an immunoglobulin G of not less than 5%, which can be added with an appropriate amount of stabilizer, sterilized and filtered, and sterile filled.

1gG content is 50g / 1, 1gG content is 1g / 20ml / bottle, 1.25g / 25ml / bottle, 2.5g / 50ml / bottle, 5g / 100ml / bottle, 10g / 200ml / bottle.

This product is completely produced according to GMP, with reliable quality; good stability; it is separated and extracted by the international advanced low-temperature ethanol pressure filtration process, and the product has high purity; it is double-inactivated with 60 ° C pasteurization and low pH incubation Process processing to ensure product safety;

This product should be used after one infusion (the unused part should be discarded), no score or second person infusion. If the solution appears turbid, frozen, foreign body, flocculent, and undisturbed sediment, etc., it can not be used; this product should be infused strictly separately. Should not be mixed with other drugs or solutions, if necessary, can be diluted with 5% glucose solution. Diabetic patients and those with severe acid-base metabolism disorders should be used with caution. This product is for intravenous infusion only. If an uncomfortable reaction is found during the infusion, the infusion should be stopped immediately and appropriate treatment given.

Take this product and follow the "Chinese Biological Product Regulations".

(1) As determined by the immunodiffusion method, only a precipitation line is produced with anti-human serum, and no precipitation line is produced with anti-horse and anti-bovine serum.

(2) As determined by immunoelectrophoresis, the main precipitation line should be immunoglobulin G.

Check the following items according to the method stipulated in the "Chinese Biological Products Regulations".

The pH should be 3.8 to 4.4.

If the sugar content is maltose, it should be 9.0% to 11.0%; if it is sorbitol or glucose, it should be 4.0% to 6.0%.

The purity should not be less than 98.0%.

The sum of the immunoglobulin G monomer and dimer should not be less than 98.0%.

The immunoglobulin G should not be lower than 90% of the labeled amount.

Anti-complement activity must not exceed 50%.

Kallikrein activator should not exceed 35 international units per 1ml.

Anti-A anti-B hemagglutinin should not exceed 1:64.

Take this product for thermal stability. After holding in the water bath at 57 ± 0.5 for 4 hours, no gelation or flocculation should occur.

HCV antibodies should be tested with a nationally approved kit and should be negative.

HIV <[1 + 2]> antibodies should be tested negative with nationally approved kits and should be negative.

Take this product for abnormal toxicity, check it according to law, and meet the requirements.

Take this product on pyrogen, inject 0.5g of immunoglobulin per 1kg of rabbit weight, check according to law, and it should meet the requirements.

Take this product aseptically and inspect it according to law, and it should meet the requirements.

Take this product and determine the hepatitis B surface antibody by radioimmunoassay according to the "Chinese Biological Products Regulations". Each 1g of immunoglobulin G contains hepatitis B surface antibody of not less than 6.0 international units. Take this product separately and determine the diphtheria antibody titer according to the "Chinese Biological Products Regulations" passive hemagglutination method. Each 1g of immunoglobulin G contains diphtheria antibodies of not less than 2.0 hemagglutination units.