HEPATECT CP Solution for infusion Ref.[9855] Active ingredients: Human hepatitis B immunoglobulin

Posology

Prevention of hepatitis B re-infection after liver transplantation for hepatitis B induced liver failure:

In adults: 10 000 IU on the day of transplantation, peri-operatively then 2000-10 000 IU (40-200 ml)/day for 7 days, and as necessary to maintain antibody levels above 100-150 IU/l in HBV-DNA negative patients and above 500 IU/l in HBV-DNA positive patients.

In children: Posology should be adjusted according to body surface area, on the basis of 10 000 IU/1.73 m².

Immunoprophylaxis of hepatitis B:

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.

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.

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.

In all these situations, vaccination against hepatitis B virus is highly recommended. The first vaccine dose can be injected on 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 (10 ml) to adults and 8 IU (0.16 ml)/kg to children every 2 months can be considered; a minimum protective antibody titre is considered to be 10 mIU/mL.

Hepatic impairment

No evidence is available to require a dose adjustment.

Renal impairment

No dose adjustment unless clinically warranted, see section 4.4.

Elderly

No dose adjustment unless clinically warranted, see section 4.4.

Method of administration

Intravenous use.

Hepatect CP should be infused intravenously at an initial rate of 0.1 ml/kg/hr for 10 minutes. See section 4.4. 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.

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

Overdose of immunoglobulins may lead to fluid overload and hyperviscosity, particularly in patients at risk, including elderly patients or patients with cardiac or renal impairment (see section 4.4).

2 years.

Store in a refrigerator (2°C–8°C). Do not freeze.

Keep the vial in the outer carton in order to protect from light.

Hepatect CP is a ready-for-use solution for infusion provided in vials (Type II glass) with a stopper (bromobutyl) and a cap (aluminium):

Pack size of 1 vial with 2 ml, 10 ml, 40 ml or 100 ml solution.

The product must be brought to room or body temperature before use.

The solution should be administered immediately after opening the receptacle.

The solution should be clear or slightly opalescent and colourless to pale yellow.

Do not use solutions that are cloudy or have deposits.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.