Tetraxim Vaccine

4.1 Therapeutic indications

This vaccine is indicated in the joint prevention of diphtheria, tetanus, pertussis and poliomyelitis according to official recommendations:

• for primary vaccination in infants from the age of 2 months,
• for booster vaccination

4.3 Contraindications

• Hypersensitivity:
  • to any of the active substances of TETRAXIM,
  • to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information,
  • to glutaraldehyde, neomycin, streptomycin, or polymyxin B (used during the manufacturing process and which may be present in trace amounts)
  • to a pertussis vaccine (acellular or whole cell).
• Life-threatening reaction after previous administration of the same vaccine or a vaccine containing the same substances.
• Vaccination must be postponed in case of febrile or acute disease.
• Evolving encephalopathy.
• Encephalopathy within 7 days of administration of a previous dose of any vaccine containing pertussis antigens (whole cell or acellular pertussis vaccines).

4.2 Posology and method of administration

TETRAXIM (DTaP-IPV) is a full dose formulation.

Posology

Primary vaccination: Primary immunization can be given as 3 doses at an interval of 1–2 months starting at the age of 2 or 3 months i.e., according to the official schedule, at the age of 2, 3, 4 months or 3, 4, 5 months or 2, 4, 6 months.

Booster vaccination: 1 injection in the second year of life, i.e., usually, between 16 and 18 months.

Tetraxim can also be administered to children aged 4 through 13 years who were previously immunized with an acellular vaccine or a whole-cell pertussis vaccine. Tetraxim is a high dose diphtheria vaccine. A low dose diphtheria vaccine is usually recommended at this age as per official recommendation.

Booster doses in 4 through 13 years old individuals should be given in accordance with official recommendation.

For primary vaccination and for the first booster dose, this vaccine may be administered by reconstituting the Haemophilus influenzae type b conjugate vaccine (Act-HIB) or administered at the same time as this vaccine, but at two separate injection sites.

Method of administration

Administer via the intramuscular route.

Administration should preferably be performed in the antero-lateral side of the thigh (middle third) in infants and in the deltoid area in children aged between 4 through 13 years.