IMMUNOHBs Special Precautions

Ensure that IMMUNOHBs is not administered into a blood vessel, because of the risk of shock.
If the recipient is a carrier of HBsAg, there is no benefit in administering this product.
True hypersensitivity reactions are rare.
IMMUNOHBs 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. The physician must therefore weigh the benefit of treatment with IMMUNOHBs against the potential risk of hypersensitivity reactions.
Rarely, human hepatitis B immunoglobulin can induce a fall in blood pressure with anaphylactic shock, even in patients who have tolerated previous treatment with immunoglobulins.
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.
The product contains 3.9 mg sodium per ml. Depending on the total dose required, this should be taken into consideration in patients on a controlled sodium diet.
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 such as HIV, HBV and HCV and for the non-enveloped viruses such as HAV.
The measures taken may be of limited value against non-enveloped viruses such as 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 IMMUNOHBs 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.
Interference with serological testing: After injection of immunoglobulin the transitory rise of the various passively transferred antibodies in the patient's blood may result in misleading positive results in serological testing.
Passive transmission of antibodies to erythrocyte antigens, e.g. A, B, D may interfere with some serological tests for red cell antibodies, for example the antiglobulin test (Coombs' test).
Effects on the ability to drive and use machines: IMMUNOHBS does not affect the ability to drive and use machines.
Fertility: Clinical experience with immunoglobulins shows that no harmful effects on fertility are to be expected.
Use in Children: No specific measures or monitoring are required for the paediatric population.