Posology : מינונים

4.2    Posology and method of administration

Synflorix SPC V8.0 June 2020                        Page 1 of 21
Posology
The immunisation schedules for Synflorix should be based on official recommendations.

Infants from 6 weeks to 6 months of age

Three-dose primary series
The recommended immunisation series to ensure optimal protection consists of four doses, each of 0.5 ml. The primary infant series consists of three doses with the first dose usually given at 2 months of age and with an interval of at least 1 month between doses. The first dose may be given as early as 6 weeks of age. A booster (fourth) dose is recommended at least 6 months after the last primary dose and may be given from the age of 9 months onwards (preferably between 12 and 15 months of age) (see sections 4.4 and 5.1).

Preterm newborn infants (born between 27–36 weeks gestation)

In preterm infants born after at least 27 weeks of gestational age, the recommended immunisation series consists of four doses, each of 0.5ml. The primary infant series consists of three doses with the first dose given at 2 months of age and with an interval of at least 1 month between doses. A booster (fourth) dose is recommended at least 6 months after the last primary dose (see sections 4.4 and 5.1).

Unvaccinated infants and children ≥ 7 months of age

– infants aged 7–11 months: The vaccination schedule consists of two primary doses of 0.5 ml with an interval of at least 1 month between doses. A booster (third) dose is recommended in the second year of life with an interval of at least 2 months after the last primary dose.

– children aged 12 months –5 years: The vaccination schedule consists of two doses of 0.5 ml with an interval of at least 2 months between doses.

It is recommended that subjects who receive a first dose of Synflorix complete the full vaccination course with Synflorix.

Special populations
In individuals who have underlying conditions predisposing them to invasive pneumococcal disease (such as sickle cell disease (SCD) or Human Immunodeficiency Virus (HIV) infection) Synflorix may be given(see sections 4.4 and 5.1):
- in infants as described under “Three-dose primary series” above.
- in unvaccinated children ≥ 7 months of age and under 2 years of age as described under “Unvaccinated infants and children ≥ 7 months of age” above.


Paediatric population
The safety and efficacy of Synflorix in children over 5 years of age have not been established.

Method of administration

The vaccine should be given by intramuscular injection. The preferred sites are anterolateral aspect of the thigh in infants or the deltoid muscle of the upper arm in young children.