This document is a summary of the European Public AssessmentlongerReport (EPAR) for ImmunoGam. It
explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing auth risati a d its recommendations on the conditions of use for ImmunoGam.
What is ImmunoGam used for?
ImmunoGam is used to provide protection against the hepatitis B virus. ImmunoGam provides ‘passive’ protection. This means that it supplies the antibodies the body needs to fight the virus rather than stimulating the body to pr duce its own. ImmunoGam can be used in the following people, who need immediate protection:
• people accidentally ex osed to the virus who are not known to have been vaccinated fully;
The medi ine an only be obtained with a prescription.
How is ImmunoGam used?
ImmunoGam is given as an injection into a muscle. It is highly recommended that all those r c iving
possible and preferably within 24 to 72 hours of exposure. Haemodialysed patients should eceived 8 to 12 IU per kilogram body weight up to a maximum of 500 IU, every two months. Newb rn babies whose mothers are carriers of the hepatitis B virus should receive 30 to 100 IU/kg at birth r as soon as possible after birth. This may need to be repeated until the babies show an immune response against the virus after vaccination. Finally, people at continuous risk of hepati is B infec ion who did not show an immune response after vaccination may be given 500 IU (in ad l s) or 8 IU/kg (in children) every two months.