PLEASE NOTE: MEDICINAL PRODUCT NO LONGER AUTHORIZED
What is ImmunoGam?
ImmunoGam is a solution for injection containing the active substance human hepatitis B immunoglobulin.
What is ImmunoGam used for?
ImmunoGam is used to ensure protection from the hepatitis B virus.ImmunoGam confers "passive" protection, ie it provides the antibodies the body needs to fight the virus, rather than stimulating the body to produce its own. ImmunoGam can be used in the following individuals who need immediate protection:
• people accidentally exposed to the virus whose vaccination could be incomplete;
• patients who have undergone hemodialysis (a blood purification technique used in people with kidney problems). In these patients the product is used until vaccination against the virus becomes effective;
• infants of mothers carrying the virus;
• subjects continuously at risk of contracting hepatitis B infection who have not responded to vaccination.
The medicine can only be obtained with a prescription.
How is ImmunoGam used?
ImmunoGam is given as an intramuscular injection (into a muscle). It is strongly recommended that all people receiving ImmunoGam also be given a hepatitis B vaccine.
People accidentally exposed to the virus should receive at least 500 international units (IU) as soon as possible and preferably within 24-72 hours of exposure. Hemodialysis patients should receive between 8 and 12 IU per kilo of body weight up to a maximum of 500 IU every two months. Infants of hepatitis B virus carrier mothers should receive between 30 and 100 IU / kg at birth or as soon as possible after birth. The dose may need to be repeated until children show an immune response to the virus after vaccination. Finally, people continuously at risk of hepatitis B infection who have not shown an immune response after vaccination can receive 500 IU (in adults) or 8 IU / kg (in children) every two months.
Physicians should also consider other official guidelines when choosing the dose and posology for ImmunoGam
How does ImmunoGam work?
The active substance in ImmunoGam, human hepatitis B immunoglobulin, is a purified antibody extracted from human blood. Antibodies are proteins in the blood that help the body fight infections and other diseases. ImmunoGam protects against the hepatitis B virus by keeping human hepatitis B immunoglobulin levels high enough so that they can bind to the virus and stimulate the immune system to destroy it.
Medicinal products containing human hepatitis B immunoglobulins have been used in the European Union (EU) for many years.
How has ImmunoGam been studied?
Although ImmunoGam itself has not been tested in experimental models, the applicant submitted sufficient data from studies conducted on similar medicinal products.
ImmunoGam was tested in only one main study involving 253 infants of mothers carrying the virus and 42 adults potentially exposed to the virus. All people receiving ImmunoGam were also given a hepatitis B vaccine. The main measure of effectiveness was the number of people who remained without hepatitis B infection. Patient follow-up lasted a maximum of one year. only a small number of adults participated, the assessment of the medicine's benefits was mainly based on the results obtained in children.
What benefit has ImmunoGam shown during the studies?
ImmunoGam guaranteed effective protection against hepatitis B virus infection. Of the 178 children who completed the study, 174 (98%) remained free of hepatitis B infection. This result is comparable to the observed protection rate. with similar treatments in the published literature. The results in adults also provided some supportive data showing that ImmunoGam protects against hepatitis B virus infection.
What are the risks associated with ImmunoGam?
ImmunoGam side effects are not common. However, the following side effects are seen in 1 to 10 patients in 1,000: headache, dizziness, nausea, arthralgia (pain in the joints), back pain, myalgia (pain in the muscles), fatigue (tiredness) ), injection site induration, feeling sick, injection site pain and pyrexia (fever).
ImmunoGam must not be used in people who may be hypersensitive (allergic) to the active substance, to any of the other substances or to human immunoglobulins, especially if they have a deficiency (very low level) of immunoglobulin A (IgA) and if they have antibodies against the "IgA.
Why has ImmunoGam been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that ImmunoGam's benefits are greater than its risks and recommended that it be given marketing authorization.
Learn more about ImmunoGam
On March 16, 2010, the European Commission granted Cangene Europe Limited a "Marketing Authorization" for ImmunoGam, valid throughout the European Union. The "Marketing Authorization" is valid for five years, after which it can be renewed.
For the full version of ImmunoGam's EPAR, click here. For more information on ImmunoGam therapy, read the package leaflet (included with the EPAR).
Last update of this summary: 01-2010.
The information on ImmunoGam published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
