Posology: The primary vaccination schedule consists of two or three doses (of 0.5 ml) which should be administered according to official recommendations (see the table as follows and Pharmacology: Pharmacodynamics under Actions for schedules evaluated in clinical trials).
Booster doses should be given in accordance with the official recommendations, but, as a minimum, a dose of Hib conjugate vaccine must be administered. Infanrix hexa can be considered for the booster if the antigen composition is in accordance with the official recommendations. (See Table 5.)
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The Expanded Program on Immunisation schedule (at 6, 10, 14 weeks of age) may only be used if a dose of hepatitis B vaccine has been given at birth.
Where a dose of hepatitis B vaccine is given at birth, Infanrix hexa can be used as a replacement for supplementary doses of hepatitis B vaccine from the age of six weeks. If a second dose of hepatitis B vaccine is required before this age, monovalent hepatitis B vaccine should be used.
Locally established immunoprophylactic measures against hepatitis B should be maintained.
Paediatric population: The safety and efficacy of Infanrix hexa in children over 36 months of age have not been established. No data are available.
Method of administration: Infanrix hexa is for deep intramuscular injection, preferably at alternating sites for subsequent injections.
For instructions on reconstitution of the medicinal product before administration, see Cautions for Usage.