50 IU/ml; solution for infusion
2. Qualitative and quantitative composition
Human hepatitis B immunoglobulin.
Human protein 50 g/l of which at least 96 % is IgG, with a content of antibodies to Hepatitis B virus surface antigen (HBs) of 50 IU/ml
Each vial of 2 ml contains: 100 IU
Each vial of 10 ml contains: 500 IU
Each vial of 40 ml contains: 2000 IU
Each vial of 100 ml contains: 5000 IU
Distribution of IgG subclasses:
IgG2: 35 %
IgG3: 3 %
IgG4: 3 %
IgA max 2,000 micrograms/ml.
For excipients, see section 6.1.
Special warnings and precautions for use
Thromboembolic complications have been associated with the use of normal IVIg. Therefore, caution is recommended especially for patients with thrombotic risk factors.
Patients should be monitored for serum anti-HBs antibody levels regularly.
Certain severe adverse drug reactions may be related to the rate of infusion. The recommended infusion rate given under "4.2 Method of administration" must be closely followed. Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period.
Certain adverse reactions may occur more frequently
− in case of high rate of infusion,
− in patients with hypo- or agammaglobulinemia with or without IgA deficiency.
Specific allergic reactions are rare.
Hepatect CP contains IgA. Individuals who are deficient in IgA have the potential for developing IgA antibodies and may have anaphylactic reactions after administration of blood components containing IgA. The physician must therefore weigh the benefit of treatment with Hepatect CP against the potential risk of hypersensitivity reactions.
Rarely, human hepatitis B immunoglobulin can induce a fall in blood pressure with anaphylactic reaction, even in patients who had tolerated previous treatment with immunoglobulin.
Suspicion of allergic or anaphylactic type reactions requires immediate discontinuation of the injection. In case of shock, standard medical treatment for shock should be implemented.