Hepatect CP

/ Kamada

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/1.73m².
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.
– 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.
This medicinal product 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.
Clinical experience in newborns of hepatitis B virus carrier mothers has shown, that this drug intravenously used at an infusion rate of 2 ml in-between 5 to 15 minutes has been well tolerated.

Prohylaxis against hepatitis B in adults and children over two years of age who have not been vaccinated against hepatitis B (including persons whose vaccination is incomplete or missing) who are at risk of infection with hepatitis B by accidental contact with hepatitis B virus containing material following percutaneous exposure (e.g., accidental needle stick) or direct mucous membrane contact. When the administration of an intramuscular hepatitis B immunoglobin is not possible. The immunoglobin should be administered in association with hepatitis B vaccine. Prophylaxis against re-infection of a transplanted liver in patients who carry the surface antigen of the hepatitis B virus. Immunoprophylaxis of hepatitis B in the newborn of a hepatitis B virus carrier mother.

• Hypersensitivity to the active substance or to any of the excipients.
• Patients with selective IgA deficiency who developed antibodies to IgA, as administering an IgA-containing product can result in anaphylaxis.

See prescribing information for full details.

See prescribing information for full details.

Live attenuated virus vaccines
Immunoglobulin administration may impair for a period of at least 6 weeks and up to 3 months the efficacy of live attenuated virus vaccines such as rubella, mumps, measles and varicella .After administration of this product, an interval of 3 months should elapse before vaccination with live attenuated virus vaccines. In case of measles vaccination, this impairment may persist for up to 1 year. Therefore, patients receiving measles vaccine should have their antibody status checked.
Loop diuretics
Avoidance of concomitant use of loop diuretics.
Paediatric population:
The listed interactions apply to adults and children.

Pregnancy:
The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials and therefore should only be given with caution to pregnant women and breast-feeding mothers. Intravenous immunoglobulin G have been shown to cross the placenta, increasingly in the third trimester. Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the foetus and the neonate are expected.
Breast-feeding:
Immunoglobulins are excreted into human milk. No negative effects on the breastfed newborns/infants are anticipated.
Fertility:
Clinical experience with immunoglobulins suggests that no harmful effects on fertility are to be expected.

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.

• Store in a refrigerator (2°C – 8°C). Do not freeze.
• Keep the vial in the outer carton in order to protect from light.
• This medicinal product has minor influence on the ability to drive and use machines. Patients who experience adverse reactions during treatment should wait for these to resolve before driving or operating machines.