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MLT_GIB/OTH/0007/17m
Date of preparation: March 2018

Synflorix safety information

The safety assessment of Synflorix was based on clinical trials assessing primary vaccination and booster dose vaccination of Synflorix in more than 22,000 children and pre-term infants.*

Safety was also assessed in 435 previously unvaccinated children from 2 to 5 years old, of which 285 subjects received two doses of Synflorix.

The most frequently reported local adverse reactions were: redness at the injection site (41%) and irritability (55%). 1

Following booster vaccination, the most common adverse reactions were: pain at the injection site (51%) and irritability (53%). 1

The majority of these reactions were mild to moderate and not long lasting. The incidence of pain at the injection site increased with age, experienced by both infants younger than 12 months of age (39%) and in children older than 12 months of age (58%). 1

Synflorix must not be used in children hypersensitive to the active substances or any other ingredients contained in the vaccine. 1

In children with acute severe febrile illness, vaccination should be postponed; presence of a mild infection e.g. a cold, should not result in the defferal of vaccination. 1

Synflorix should be given with caution to individuals with thrombocytopaenia or any coagulation disorder. 1

In common with other vaccines, serious adverse events such as apnoea in premature infants, syncope, convulsions and hypotonic-hyporesponsive episodes have been reported infrequently. 1

Synflorix should under no circumstances be administered intravascularly or intradermally. 1

Synflorix may be given to individuals who have underlying conditions predisposing them to invasive pneumococcal disease (such as sickle cell disease, or Human Immunodeficiency Virus infection or splenic dysfunction) 1

Synflorix was immunogenic and has a similar reactogenicity and safety profile in high-risk populations to that in healthy children. 1

*The safety and efficacy of Synflorix in children over 5 years of age have not been established. 1

This information does not contain all safety information. For a complete description of adverse events, special warnings and precautions, please consult the full SPC before prescribing this medicine, which you can access by clicking on product SPC.

 

Reference:

  1. Synflorix Summary of Product Characteristics,GlaxoSmithKline.

 

Synflorix is a trade mark of the GlaxoSmithKline group of companies.