Posology : מינונים

4.2   Posology and method of administration

Posology
The immunisation schedules for Infanrix hexa should be based on official recommendations.

Primary vaccination:

The primary vaccination schedule consists of three doses of 0.5 ml (such as 2, 3, 4 months; 3, 4, 5 months; 2, 4, 6 months). There should be an interval of at least 1 month between doses.
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.

Locally established immunoprophylactic measures against hepatitis B should be maintained.

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.

Booster vaccination:

After vaccination with 3 doses (e.g. 2, 3, 4 months; 3, 4, 5 months; 2, 4, 6 months) of Infanrix hexa a booster dose must be given at least 6 months after the last priming dose and preferably before 18 months of age.

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 composition is in accordance with the official recommendations.

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 section 6.6.