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If the recipient is a carrier of HbsAg, there is no benefit in administering Hepatitis B Immunoglobulin P Behring.
Do not inject intravasculary.
Ensure that Hepatitis B Immunoglobulin P Behring is not administered into a blood vessel because of the risk of shock.
True hypersensitivity reactions are rare. Hepatitis B Immunoglobulin P Behring contains a small quantity of 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.
Rarely human hepatitis B immunoglobulin can induce a fall in blood pressure with anaphylactic reactions, even in patients who had tolerated previous treatment with human immunoglobulin.
Therapeutic measures depend on the nature and severity of the event. The current medical standards for shock treatment are to be observed.
Patients should be observed for at least 20 mins after administration of Hepatitis B Immunoglobulin P Behring.
Particularly in cases of inadvertent IV injection, patients should be observed for longer term (at least 1 hr) after administration.
Important information about some of the ingredients of Hepatitis B Immunoglobulin P Behring: It contains <1 mmol (23 mg) sodium per dose ie, essentially “sodium free”.
Virus Safety: Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.
The measures taken are considered effective for enveloped viruses eg, HIV, HBV and HCV, and for the non-enveloped viruses HAV and parvovirus B19. There is reassuring clinical experience regarding the lack of hepatitis A or parvovirus B19 transmission with immunoglobulins and it is also assumed that the antibody content makes an important contribution to the viral safety.
It is strongly recommended that every time that Hepatitis B Immunoglobulin P Behring is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
Effects on the Ability to Drive or Operate Machinery: No effects on the ability to drive and use machines have been observed.
Use in pregnancy & lactation: The safety of Hepatitis B Immunoglobulin P Behring for use in human pregnancy has not been established in controlled clinical trials. Long lasting clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, on the foetus or the neonate are to be expected.
