Immunoprophylaxis of hepatitis B

Active Ingredient: Human hepatitis B immunoglobulin

Indication for Human hepatitis B immunoglobulin

Population group: only minors (0 - 18 years old) , adults (18 years old or older)
Therapeutic intent: Preventive action
  • 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.

For this indication, competent medicine agencies globally authorize below treatments:

30-100 IU/kg once

For:

Route of admnistration

Intravenous

Defined daily dose

30 - 100 [iU] per kg of body weight

Dosage regimen

From 30 To 100 [iU] per kg of body weight once every day

Detailed description

Prevention of hepatitis B in the newborn, of a hepatitis B virus carrier-mother, at birth or as soon as possible after birth: 30-100 IU (0.6-2 ml)/kg. The hepatitis B immunoglobulin administration may be repeated until seroconversion following vaccination.

Dosage considerations

Clinical experience in newborns of hepatitis B virus carrier mothers has shown, that human hepatitis B immunoglobulin solution intravenously used at an infusion rate of 2 ml in-between 5 to 15 minutes has been well tolerated.

500 IU once

For:

Route of admnistration

Intravenous

Defined daily dose

500 - 500 [iU]

Dosage regimen

From 500 To 500 [iU] once every day

Detailed description

Prevention of hepatitis B in case of accidental exposure in non-immunised subjects:

At least 500 IU (10 ml), depending on the intensity of exposure, as soon as possible after exposure, and preferably within 24-72 hours.

Dosage considerations

Human hepatitis B immunoglobulin solution should be infused intravenously at an initial rate of 0.1 ml/kg/hr for 10 minutes. In case of adverse reaction, either the rate of administration must be reduced or the infusion stopped. If well tolerated, the rate of administration may gradually be increased to a maximum of 1 ml/kg/hr.

8-500 IU once

For:

Route of admnistration

Intravenous

Defined daily dose

8 - 500 [iU]

Dosage regimen

From 8 To 500 [iU] once every day

Detailed description

Immunoprophylaxis of hepatitis B in haemodialysed patients: 8-12 IU (0.16-0.24 ml)/kg with a maximum of 500 IU (10 ml), every 2 months until seroconversion following vaccination.

Dosage considerations

Human hepatitis B immunoglobulin solution should be infused intravenously at an initial rate of 0.1 ml/kg/hr for 10 minutes. In case of adverse reaction, either the rate of administration must be reduced or the infusion stopped. If well tolerated, the rate of administration may gradually be increased to a maximum of 1 ml/kg/hr.

Active ingredient

Human hepatitis B immunoglobulin

Human hepatitis B immunoglobulin solution for infusion contains mainly immunoglobulin G (IgG) with a specifically high content of antibodies against hepatitis B virus surface antigen (HBs). It is used for the immunoprophylaxis of hepatitis B and the prevention of hepatitis B virus re-infection after liver transplantation for hepatitis B induced liver failure.

Read more about Human hepatitis B immunoglobulin

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