HEXAXIM SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE

Therapeutic indications

Hexaxim (DTaP-IPV-HB-Hib) is indicated for primary and booster vaccination of infants and toddlers from six weeks to 24 months of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib).

The use of this vaccine should be in accordance with official recommendations.

Contraindications

History of an anaphylactic reaction after a previous administration of Hexaxim.

Hypersensitivity to the active substances, to any of the excipients listed in section List of excipients – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information, to trace residuals (glutaraldehyde, formaldehyde, neomycin, streptomycin and polymyxin B), to any pertussis vaccine, or after previous administration of Hexaxim or a vaccine containing the same components or constituents.

Vaccination with Hexaxim is contraindicated if the individual has experienced an encephalopathy of unknown aetiology, occurring within 7 days following prior vaccination with a pertussis containing vaccine (whole cell or acellular pertussis vaccines).

In these circumstances pertussis vaccination should be discontinued and the vaccination course should be continued with diphtheria, tetanus, hepatitis B, poliomyelitis and Hib vaccines.

Pertussis vaccine should not be administered to individuals with progressive neurologic disorder, uncontrolled epilepsy or progressive encephalopathy until treatment for the condition has been established, the condition has stabilised and the benefit clearly outweighs the risk.

Posology and method of administration

Posology

Primary vaccination:

The primary vaccination consists of 3 doses of 0.5 ml to be administered at intervals of at least four weeks and as per schedules 6, 10, 14 weeks; 2, 3, 4 months; 3, 4, 5 months; 2, 4, 6 months.

All vaccination schedules including the WHO Expanded Program on Immunisation (EPI) at 6, 10, 14 weeks of age can be used whether or not a dose of hepatitis B vaccine has been given at birth.

Where a dose of hepatitis B vaccine is given at birth;

• Hexaxim can be used for supplementary doses of hepatitis B vaccine from the age of 6 weeks. If a second dose of hepatitis B vaccine is required before this age, monovalent hepatitis B vaccine should be used.
• Hexaxim can be used for a mixed hexavalent/pentavalent/hexavalent combined vaccine immunisation schedule in accordance with official recommendations.

The use of this vaccine should be in accordance with official recommendations.

Booster vaccination:

After a 3-dose primary vaccination with Hexaxim, a booster dose should be given, preferably during the second year of life, at least 6 months after the last priming dose.

Booster doses should be given in accordance with the official recommendations. As a minimum, a dose of Hib vaccine must be administered.

After a 3-dose primary vaccination with Hexaxim (2, 3, 4 months; 3, 4, 5 months; 2, 4, 6 months) and in the absence of hepatitis B vaccination at birth, it is necessary to give a hepatitis B vaccine booster dose. Hexaxim can be considered for the booster.

When a hepatitis B vaccine is given at birth, after a 3-dose primary vaccination, Hexaxim or a pentavalent DTaP-IPV/Hib vaccine can be administered for the booster.

Hexaxim may be used as a booster in individuals who have previously been vaccinated with another hexavalent vaccine or a pentavalent DTaP-IPV/Hib vaccine associated with a monovalent hepatitis B vaccine.

WHO-EPI schedule (6, 10, 14 weeks):

After a WHO-EPI schedule, a booster dose should be given

• As a minimum, a booster dose of polio vaccine should be given
• In absence of hepatitis B vaccine at birth, a hepatitis B vaccine booster must be given
• Hexaxim can be considered for the booster

Other paediatric population

The safety and efficacy of Hexaxim in children over 24 months of age have not been established.

Method of administration

Immunisation must be carried out by intramuscular (IM) injection. The recommended injection sites are the antero-lateral area of the upper thigh (preferred site) or the deltoid muscle in older children (possibly from 15 months of age).

For instructions on handling, see section Special precautions for disposal and other handling – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.