Hepatitis B Immunoglobulin P pre-filled syringes
Marketed by Dexa Medica
Ingredients in every ml
|Human Protein||100 - 170 mg|
|Immunoglobulin at least||95 %|
|Antibodies to Hbs antigen at least||200 IU|
Each package contains
|ATC Level 1||J - Antiinfectives for systemic use|
|ATC Level 2||J06 - Immune Sera and Immunoglobulins|
|ATC Level 3||J06B - Immunoglobulins|
FOR ALL AGES
– Prevention of hepatitis B in case of accidental exposure in non-immunised subjects (including persons whose vaccination is incomplete or status unknown):
12 IU/kg body weight, at least 500 IU, depending in the intensity of exposure, as soon as possible after exposure, and preferably within 72 hours
– Immunoprophylaxis of hepatitis B in haemodialysed patients:
8 to 12 IU/kg body weight (maximal 500 IU), every 2 months until seroconversion following vaccination.
– Prevention of hepatitis B in the newborn, of hepatitis B virus carrier-mother, at birth or as soon as possible after birth:
30 to 100 IU/kg body weight (normally 1 ml). The hepatitis B immunoglobulin administration may need to be repeated until seroconversion following vaccination.
In all these situations, vaccination against hepatitis B virus is highly recommended. The first vaccine dose can be injected the same day as human hepatitis B immunoglobulin, however in different sites. In subjects who did not show an immune response (no measurable hepatitis B antibodies) after vaccination, and for whom continuous prevention is necessary, administration of 500 IU to Adults and 8 IU/kg body weight to children every 2 months can be considered; a minimum protective antibody titre is considered to be 10 mIU/ml.
Immunoprophylaxis of hepatitis B
– In case of accidental exposure in non-immunised subjects (including persons whose vaccination is incomplete or status unknown)
– In haemodialysed patients, until vaccination has become effective.
– In the newborn of a hepatitis B virus carrier-mother
– In subjects who did not show an immune response (no measurable hepatitis B antibodies) after vaccination and for whom a continuous prevention is necessary due to the continuous risk of being infected with hepatitis B.
National and/or WHO guidelines regarding protection against hepatitis B infection should be observed.