PENTAXIM VACCINE

4.1 Therapeutic Indications

PENTAXIM (DTaP-IPV-Hib) is indicated for the joint prevention of diphtheria, tetanus, pertussis, poliomyelitis and invasive Haemophilus influenzae type b infections (meningitis, septicaemia, cellulitis, arthritis, epiglottitis, etc.,),

• for primary vaccination in infants from the age of 2 months,
• for booster vaccination, one year after primary vaccination during the second year of life.

This vaccine does not protect against infections caused by the other types of Haemophilus influenzae nor against meningitis caused by other micro-organisms.

4.3 Contraindications

• Hypersensitivity:
  • to one of the active substances of PENTAXIM,
  • 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,
  • glutaraldehyde, neomycin, streptomycin, or polymyxin B (used during manufacturing, and which may be present in trace amounts),
  • pertussis vaccine (acellular or “whole cell”).
• Severe reaction after a previous injection of the vaccine or a vaccine containing the same substances.
• Vaccination should be postponed in case of fever or acute illness.
• Progressive encephalopathies.
• Encephalopathy within 7 days of a previous dose of any vaccine containing pertussis antigens (“whole cell” or acellular pertussis vaccine).

4.2 Posology and Method of Administration

PENTAXIM should be administered according to current official recommendations.

Posology

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

Booster vaccination: 1 injection one year after primary vaccination, i.e., usually between 16 and 18 months.

Method of Administration

Administer intramuscularly (IM).

Administration will preferably be in the anterolateral aspect of the thigh (middle third) in infants and in the deltoid region in children.

For instructions on reconstitution of the medicinal product before administration, see Section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

After reconstitution, the suspension is cloudy and whitish.