Immunel r-25

Immunel-desc

IMMUNELr-25

(5% – 1,25g / 25ml – pH-4,0)

Human Normal Immunoglobulin for Intravenous Injection (IVIG/pH-4,0)

Original preservative-free double viral inactivation patent technology

U.S. Patent (Patent No. US006338849B1)

Australian Patent Certificate (Patent No.756017)

 Chinese Patent (Patent No. ZL98112108X)

Human Immunoglobulin for Intravenous Injection (called IVIG for short) has been on the market for more than 40 years. There have been many studies about this product covering many disciplines of medicine. IVIG has been widely welcomed by clinicians.

IVIG is a highly concentrated solution of immune globulins (primarily IgG) prepared from more than 10,000 normal human plasma donations, containing 107 types of antibodies. With an unarguable immunoreplacement action, IVIG is indicated for the treatment of both primary and secondary immunodeficiency disorders.

Nowadays, using IVIG for the treatment of autoimmune and inflammatory diseases is gradually accepted by clinicians, and the credit should go to Imbach and his colleagues, who by chance found that IVIG could effectively increase the platelet count in PID patients with idiopathic thrombocytopenic purpura (ITP).

They later tried this therapy in other ITP patients and achieved great success. It indicates that IVIG not only can be used as an immunoreplacement therapy, but also has an important undiscovered action, namely, immunoregulatory action.

The U.S. FDA and the EMEA (European Medicines Agency) have explicitly defined the indications of IVIG.  IVIG is approved by the FDA to treat six conditions: primary immunodeficiencies, immune mediated thrombocytopenia, chronic B-cell lymphocytic leukemia, pediatric HIV-1 infection, Kawasaki syndrome, and recent bone marrow transplantation, while the EMEA approved two more indications, i.e., Guillain-Barre Syndrome (GBS) and multiple myeloma, besides those approved by the FDA. The indications approved by the Chinese SFDA also include secondary immunoglobulin deficiency syndromes, such as severe infections and septicemia of newborns. But, from the literatures available in China as well as in the European and American countries we can see that, the off-label indications of IVIG have far exceeded the number of the approved ones, and more than 30 off-label indications have been reported in literatures.