Composition: 1 ml solution contains: protein 50 mg of which human immunoglobulin is at least 95%. Content if anti-HBs antibodies 50IU. The solution contains no preservatives.
Indications: Prophylaxis of hepatitis B virus infection in persons who have had contact with HbsAg positive material (needle-stick injuries, mucosal contact); in persons who have close contact with patients suffering from hepatitis B, or who have had brief contact with them; in patients and staff of dialysis units; prophylaxis in newborns of HBs-antigen positive mothers; patients with a haemorragic diathesis who require an acute hepatitis B prophylaxis. Prophylaxis of reinfection with hepatitis B virus HBv after orthotopic lives transplantation (OLT).
Contraindications: Hepatect CP is contraindicated in patients who are intolerant to human immunoglobulin as for example in patients with pathological immunoglobulin-G or immunoglobulin –A deficiencies.
Dosage instructions and duration of administration: Unless otherwise prescribed for prophylaxis of hepatitis B virus infection in persons who have had contact with HbsAg positive material (needle-stick injuries, mucosal contact); in persons who have close contact with patients suffering from hepatitis B, or who have had brief contact with them the following guidelines apply:0.12-0.20 ml/kg Hepatect CP i.v.(minimum 10 ml Hepatect CP i.v.), if possible within 6 hours after exposure, simultaneously with the first active immunization. For prophylaxis in persons at high risk of hepatitis B infection (e.g. in dialysis units): inject 10 ml Hepatect CP after screening for HbsAg and anti-HBs antibodies. Injection should be repeated at intervals of 2 months provided the monthly anti-Hbs antibody assay does not reveal the necessity for earlier administration. The immunization program should be continued until the onset of a seroconversion if the risk of needle-stick injuries continues. Once there is an active formation of anti-HBs antibodies a passive administration is no longer necessary. Immediately after birth, and simultaneously with the first active immunization, a dose of 0.4 ml/kg (but not less than 2 ml) of Hepatect CP i.v. For dosage recommendation for HBv reinfection prophylaxis after OLT see package insert and instructions for use.
Route of administration: The solution has to be administrated slowly by intravenous injection. (1 ml/min) Hepatect CP should be warmed to room temperature or body temperature before administration. Inject clear solution only! The solution does not contain any preservatives. Therefore once opened ampoules should be used immediately since otherwise sterility and apyrgenicity can no longer be guaranteed.
Storage-life : Hepatect CP has be stored in the refrigerator at +2 to +80 C. At this temperature Hepatect CP has a storage-life of two years. The product should no longer be used after the expiry date give on the packing.
Presentations: Ampoules with 2 ml, ampoules with 10 ml, Bottle of 40 ml(for additional information see package insert).