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Important Safety Information

Indications and clinical use:

SYNFLORIX is indicated for active immunization of infants and children from 6 weeks up to 5 years of age against diseases caused by Streptococcus pneumoniae serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F and cross-reactive 19A: 1

  • invasive disease (including sepsis, meningitis, bacteraemic pneumonia, pleural empyema and bacteraemia)
  • pneumonia
  • acute otitis media (AOM)

Not for use in adults.

Geriatrics (>65 years of age): Not studied.

Relevant warnings and precautions:

  • Intended for use in children up to 5 years of age; children <5 years should receive appropriate-for-age vaccination series
  • In acute, severe, febrile illness, postpone administration
  • Should not be administered intravascularly or intradermally
  • Will not protect against pneumococcal serogroups or serotypes that are not included in the vaccine, except the cross-reactive serotype 19A
  • Potential risk of apnoea and need for respiratory monitoring for 48-72 hours when administering the primary immunization series to very premature infants and particularly for those with a previous history of respiratory immaturity
  • Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection
  • Should be given with caution to individuals with thrombocytopenia or any coagulation disorder
  • As with any vaccine, a protective immune response may not be elicited in all vaccines

For more information:

Please consult the Product Monograph at
http://ca.gsk.com/media/591956/synflorix.pdf for important information relating to adverse reactions, drug interactions, and dosing information which have not been discussed in this piece.

To request a Product Monograph, or to report an adverse event, please call 1-800-387-7374.

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