Basic Information
Synflorix Suspension for Injection (Prefilled Syringe)
INJECTION, SUSPENSION
Regulatory Information
SIN13775P
March 19, 2010
Prescription Only
Therapeutic
INTRAMUSCULAR
August 10, 2023
June 3, 2025
XJ07AL52
Company Information
GLAXOSMITHKLINE PTE LTD
GLAXOSMITHKLINE PTE LTD
Active Ingredients
Strength: 3-6 μg DT/dose (total DT content)
Strength: 3 μg PS18C; 5.45-10.00 μg TT/dose
Strength: 5-10 μg/dose (total TT content)
Strength: 1 μg PS23F; 0.39-0.74 μg PD/dose
Strength: 1 μg PS1; 1.11-1.67 μg PD/dose
Strength: 9-16 μg PD/dose (total PD content)
Strength: 3 μg PS4; 3.33-6.67 μg PD/dose
Strength: 3 μg PS19F; 3.33-6.00 μg DT/dose
Strength: 1 μg PS6B; 0.56-0.95 μg PD/dose
Strength: 1 μg PS7F; 0.87-1.43 μg PD/dose
Strength: 1 μg PS9V; 1.00-1.82 μg PD/dose
Strength: 1 μg PS14; 1.00-1.82 μg PD/dose
Strength: 16 μg/dose (total PS content)
Strength: 1 μg PS5; 0.67-1.25 μg PD/dose
Detailed Information
Contraindications
**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.
Indication Information
**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 5th 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.