Synflorix prescribing considerations
- 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.