Posology : מינונים

4.2           Posology and method of administration

Posology
Table 1: Summary of posology

Age at first dose                  Primary                    Intervals between                      Booster Immunisation                  Primary Doses
Yes, one dose
Three doses each of               Not less than 1             between 12 and 15 0.5 ml                          month                   months of age with Infants, 2 months                                                                              an interval of at to 5 monthsa                                                                                  least 6 months Two doses                         Not less               between the primary each of 0.5 ml                  than 2 months              series and booster dose b,c
Yes, one dose in the second year of life with an interval infants, 6 months              Two doses each of                 Not less than 2 of at least 2 months to 11 months                      0.5 ml                          months between the primary series and booster dose c
Yes, one dose with an interval children, 12
Two doses each of                 Not less than 2            of 12 months to 23 months to 23                                                                          months between the 0.5 ml                          months months                                                                              primary series and booster dose c

A booster dose
Children, 2 years                                                                                  should be to 10 years                                                                                    considered in Two doses each of                 Not less than 1                 individuals at 0.5 ml                           month                     continued risk of exposure to
Adolescents (from                                                                                meningococcal 11 years) and                                                                                 disease, based on adults*                                                                                         official recommendations d a The  first dose should be given no earlier than 2 months of age. The safety and efficacy of Bexsero in infants less than 8 weeks of age has not yet been established. No data are available.
b
In case of delay, the booster should not be given later than 24 months of age.
c
See section 5.1. The need for, and timing of, further booster doses has not yet been determined.
d
See section 5.1.
* There are no data in adults above 50 years of age.


Method of administration
The vaccine is given by deep intramuscular injection, preferably in the anterolateral aspect of the thigh in infants or in the deltoid muscle region of the upper arm in older subjects.

Separate injection sites must be used if more than one vaccine is administered at the same time.

The vaccine must not be injected intravenously, subcutaneously or intradermally and must not be mixed with other vaccines in the same syringe.

For instructions on the handling of the vaccine before administration, see section 6.6.