SYNFLORIX SUSPENSION FOR INJECTION (PREFILLED SYRINGE) [SIN13775P]

Product Info

SYNFLORIX SUSPENSION FOR INJECTION (PREFILLED SYRINGE)

[SIN13775P]

3.1 Therapeutic indications

Active immunisation against invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants and children from 6 weeks up to 5 years of age (prior to the 5^th birthday). See sections 3.4 and 4.1 for information on protection against specific pneumococcal serotypes – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

The use of Synflorix should be determined on the basis of official recommendations taking into consideration the impact on pneumococcal diseases in different age groups as well as the variability of the epidemiology in different geographical areas.

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.

3.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients, or to any of the carrier proteins.

As with other vaccines, the administration of Synflorix should be postponed in subjects suffering from acute severe febrile illness. However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination.