HUMAN TETANUS IMMUNOGLOBULIN Solution for injection Ref.[8382] Active ingredients: Tetanus immunoglobulin

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:
  • infected wounds, where surgically appropriate treatment cannot be achieved within 24 hours
  • deep or contaminated wounds with tissue damage and reduced oxygen supply, as well as foreign body injury (e.g. bites, stings or shots).

Method of administration

Intramuscular route.

If a large volume (>2 ml 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.

For prophylaxis, if intramuscular administration is contraindicated (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.

For acute therapy, if intramuscular administration is not clinically appropriate, an alternative intravenous product may be used if available.

Consequences of an overdose are not known.

2 years.

From a microbiological point of view, unless the method of opening precludes the risk of microbial contamination, the medicinal product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.

Store in a refrigerator (2°C to 8°C).

Storage for up to one week at room temperature (up to 25°C) in the unopened package is not detrimental.

Do not freeze.

Keep the vial in the outer carton in order to protect from light.

For storage conditions after first opening of the medicinal product, see section 6.3.

Vials are for single use only.

5 ml glass vial (Type I Ph.Eur.) with stopper (halobutyl rubber), with an overseal (aluminium) and tamper-evident cap (polypropylene).

This medicinal product should be brought to room or body temperature before use.

The colour can vary from colourless to pale-yellow and is either clear or slightly opalescent. Do not use solutions that are cloudy or have deposits.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.