Post-exposure prophylaxis:

Immediate prophylaxis after tetanus prone injuries in patients not adequately vaccinated, in patients whose immunisation status is not known with certainty, and in patients with severe deficiency in antibody production or vaccinated patients with high risk wounds.

4.2.1 Posology

Prophylaxis of tetanus prone wounds:

• 250 IU, unless the risk is thought to be extremely high

• The dose may be increased to 500 IU in:

The volume of solution that needs to be administered to give 250 IU is stated on the label.

DO NOT EXCEED THE RECOMMENDED DOSE.

4.2.2 Method of administration

Human Tetanus Immunoglobulin should be administered via the intramuscular route.

If a large volume (> 2mL for children or > 5 mL for adults) is required, it is recommended to administer this in divided doses at different sites.

When simultaneous vaccination is necessary, the immunoglobulin and the vaccine should be administered at two different sites.

If intramuscular administration is contra-indicated (bleeding disorders), the injection can be administered subcutaneously. However, it should be noted that there are no clinical efficacy data to support administration by the subcutaneous route.

Hypersensitivity to any of the components.

Hypersensitivity to human immunoglobulins.

Ensure that Human Tetanus Immunoglobulin is not administered into a blood vessel, because of the risk of shock.

True allergic reactions are rare.

Human Tetanus Immunoglobulin 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 Human tetanus Immunoglobulin against the potential risk of hypersensitivity reactions.

Rarely, human tetanus immunoglobulin can induce a fall in blood pressure with anaphylactic reaction, even in patients who have 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.

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 hepatitis A and parvovirus B19 viruses.

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 Human Tetanus Immunoglobulin 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.

Live attenuated virus vaccines

Immunoglobulin administration may interfere with the development of an immune response to live attenuated virus vaccines, such as rubella, mumps, and varicella, for a period of up to 3 months. After administration of this product, an interval of at least 3 months should elapse before vaccination with live attenuated virus vaccines. In the case of measles, this impairment may persist for up to 5 months.

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).

The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials. Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the foetus and the neonate are to be expected.

No effects on ability to drive and use machines have been observed.

There are no robust data on the frequency of undesirable effects from clinical trials. The following undesirable effects have been reported with intramuscular immunoglobulins:

Anaphylactic reactions occur rarely and are more likely in patients who have antibodies to IgA, or who have had an allergic reaction after blood transfusion or treatment with plasma derivatives.

As with all intramuscular injections, some short term discomfort can be expected at the injection site and in rare instances local induration, which can be minimised by deep intramuscular injection.

For risk of transmission of virus infections, see Section 4.4.

Consequences of an overdose are not known.