Hepatect CP contains the active substance human anti-hepatitis B immunoglobulin, which protects you against hepatitis B. Hepatitis B is an inflammation of the liver caused by the hepatitis B virus. Hepatect CP is a solution for infusion (given into a vein) and is available in vials which contain 2 ml (100 International Units [IU]), 10 ml (500 IU), 40 ml (2000 IU) and 100 ml (5000 IU).

Human hepatitis B immunoglobulin contains mainly immunoglobulin G (IgG), with a high specific content of antibodies against the surface antigen of the hepatitis B virus (HBs).

Hepatect CP is administered to provide immediate and long-term immune protection:

• in the prevention of infection with the hepatitis B virus in patients who are at risk of infection with the virus hepatitis B, who were not vaccinated or did not receive the full vaccination schedule.
• in the prevention of infection in case of liver transplantation, in patients who have positive tests for hepatitis B.
• in newborns whose mothers are carriers of the hepatitis B virus.
• for the protection of patients in whom vaccination against hepatitis B did not provide adequate protection.

The active substance in HEPATECT CP is human immunoglobulin against hepatitis B for intravenous administration.

Hepatect CP contains human plasma proteins 50 mg/ml of which immunoglobulin G (IgG) at least 96%. The concentration of antibodies against hepatitis B is 50 IU/ml. The maximum concentration of immunoglobulin A (IgA) is 2000 micrograms/ml. The distribution of IgG subclasses is approximately: 59 % IgG₁, 35 % IgG₂, 3 % IgG₃, 3 % IgG₄. 

The other ingredients are glycine and water for injections.

Hepatect CP is presented as a box with a vial of 2 ml, 10 ml, 40 ml or 100 ml infusion solution. Not all pack sizes may be marketed.