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

Synflorix prescribing considerations

Contraindications 1

  • Hypersensitivity to the active substances or to any recipients, including sodium chloride, or to any of the carrier proteins
  • Immunisation should be postponed in patients with acute severe febrile illness
  • The presence of a minor infection, such as a cold, should not result in the deferral of the vaccination

Special warnings and precautions for use 1

  • Before vaccination, it is good clinical practice to perform a clinical examination and review the individual’s medical history (especially any previous vaccination and possible side effects)
  • As with all injectable vaccines, appropriate medical treatment and supervision should always be available in case of a severe allergic reaction (an anaphylactic event) following the vaccine administration
  • The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity. As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
  • Synflorix should under no circumstances be administered intravascularly or intradermally
  • No data are available on subcutaneous administration of Synflorix
  • In children as of 2 years of age, syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. It is important that procedures are in place to avoid injury from faints.
  • As for other vaccines administered intramuscularly, Synflorix should be given with caution to individuals with thrombocytopaenia or any coagulation disorder since bleeding may occur following an intramuscular administration to these subjects
  • Official recommendations for the immunisation against diphtheria, tetanus and Haemophilus influenzae type b should also be followed. There is insufficient evidence that Synflorix provides protection against pneumococcal serotypes not contained in the vaccine except the cross-reactive serotype 19A or against non-typeable Haemophilus influenzae. Synflorix does not provide protection against other micro-organisms.

For a complete list and description of Special warnings and precautions for use, please consult the full SPC before prescribing.
 

Reference:

  1. Synflorix Summary of Product Characteristics,GlaxoSmithKline.

 

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