TETAVAX single dose, suspension for injection in a prefilled syringe

4.1 Therapeutic Indications

Tetanus prevention and, in particular:

• Post-exposure tetanus prophylaxis for recent wounds that may have been contaminated with tetanus spores in subjects who have not had any primary vaccination or for whom primary vaccination is incomplete or uncertain,
• Neonatal tetanus prophylaxis in non-immunised women either of childbearing age or pregnant in countries where neonatal tetanus is frequent,
• Primary vaccination,
• Booster injections.

4.3 Contraindications

The lethal risk associated with tetanus excludes any potential contraindication and imposes post-wound exposure prophylaxis

In other cases:

• Hypersensitivity to one of the ingredients of the vaccine.
• Usual contraindications for all vaccinations: vaccination should preferably be postponed in case of fever, acute disease or chronic progressive illness.
• Hypersensitivity reaction or neurological disorder after a previous injection of vaccine.

4.2 Posology and Method of Administration

Posology

Post-tetanus exposure prophylactic vaccination:

When dealing with minor wounds, the doctor must evaluate the risks of Clostridium tetani infection at the injured site.

Disinfecting, debriding the wound and administering the vaccine excepted, the subject must, in some cases, be passively immunized with a human tetanus immunoglobulin injected at a different site (See table hereafter).

Post-tetanus exposure prophylaxis recommendations are summarized below:

Subjects who have had tetanus must have a primary immunization because the antibody response clinically generated by this disease is not sufficient.

Neonatal Tetanus Prophylaxis:

Women of childbearing age or pregnant women that have not yet been immunized must have 2 successive injections at least 4 weeks apart, the first one shall preferably be administered 90 days or more before birth.

Primary Immunization:

Whenever adults must be vaccinated, the schedule includes 2 successive injections one or two months apart followed by a booster dose 6 to 12 months after the second injection.

Booster injection:

1 injection of 0.5 ml ten years after primary immunization and every ten years thereafter.

Method of Administration

Given the adsorbed nature of the vaccine, it is recommended to administer it by the intramuscular route in order to minimize local reactions. The recommended sites are the anterolateral face of the thigh or arm.

The deep subcutaneous route may also be used.

The intradermal route must not be used.