HEXAXIM SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE

INJECTION, SUSPENSION

**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_.