Synflorix Suspension for Injection (Prefilled Syringe)

INJECTION, SUSPENSION

**3.2 Posology and method of administration** _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. _Posology_ The immunisation schedules for Synflorix should be based on official recommendations. _Infants from 6 weeks to 6 months of age_ _3-dose primary series_ The recommended immunisation series to ensure optimal protection consists of 4 doses, each of 0.5 ml. The primary infant series consists of 3 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 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 3.4 and 4.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _2-dose primary series_ Alternatively, when Synflorix is given as part of a routine infant immunisation programme, a series consisting of 3 doses, each of 0.5 ml may be given. The first dose may be given as early as 6 weeks of age with a second dose administered 2 months later. A booster (third) 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 section 4.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _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 4 doses, each of 0.5 ml. The primary infant series consists of 3 doses with the first dose given at 2 months of age and with an interval of at least 1 month between doses. A booster dose is recommended at least 6 months after the last primary dose (see sections 3.4 and 4.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Previously unvaccinated older infants and children_ - 7–11 months of age: 2 doses of 0.5 ml with an interval of at least 1 month between doses. A third dose is recommended in the second year of life with an interval of at least 2 months between doses. - 12 months – 5 years of age: 2 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 Human Immunodeficiency Virus (HIV) infection, sickle cell disease (SCD) or splenic dysfunction), Synflorix may be given according to the above mentioned schedules, except that a 3-dose schedule should be given as primary vaccination in infants starting vaccination from 6 weeks to 6 months of age (see sections 3.4 and 4.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Paediatric population_ The safety and efficacy of Synflorix in children over 5 years of age have not been established.