Hexaxim Dosage/Direction for Use

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 schedule 6, 10, 14 weeks; 2, 3, 4 months; 3, 4, 5 months; 2, 4, 6 months or 2 doses of 0.5 ml to be administered at intervals of at least eight weeks and as per schedule 3, 5 months in accordance with the official recommendations.
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.
Booster vaccination: After a 3-dose primary vaccination with Hexaxim, a booster dose should be given.
After a 2-dose primary vaccination with Hexaxim, a booster dose must be given.
Booster doses should be given at least 6 months after the last priming dose and in accordance with the official recommendations. As a minimum, a dose of Hib vaccine must be administered.
In addition: 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 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 the 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 infants less than 6 weeks of age have not been established. No data are available. No data are available in older children (see Adverse Reactions and Pharmacology: Pharmacodynamics under Actions).
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 Special precautions for disposal and other handling under Cautions for Usage.