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Ensure that TETANUS GAMMA is not administered into a blood vessel, because of the risk of shock (see Contraindications).
True hypersensitivity reactions are rare.
TETANUS GAMMA 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 TETANUS GAMMA against the potential risk of hypersensitivity reactions (see Contraindications).
Rarely, human tetanus immunoglobulin can induce a fall in blood pressure with anaphylactic reaction, even in patients who had tolerated previous treatment with human 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.
Viral 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 such as human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) and for the non-enveloped viruses such as hepatitis A virus (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 TETANUS GAMMA 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 ability to drive and use machines: TETANUS GAMMA has no or negligible influence on the ability to drive and use machines.
Fertility: The impact of treatment with TETANUS GAMMA on fertility has not been evaluated in controlled clinical trials. However, clinical experience with immunoglobulins suggests that no harmful effects on fertility are to be expected.
Use in Children: No specific data are available for paediatric population. The special warnings and precautions for use mentioned previously apply also in children and adolescents (0-18 years).
