Synflorix Special Precautions

It is good clinical practice to precede vaccination by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events) and a clinical examination.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
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.
Synflorix should under no circumstances be administered intravascularly or intradermally. No data are available on subcutaneous administration of Synflorix.
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 thrombocytopenia or any coagulation disorder since bleeding may occur following an intramuscular administration to these subjects.
There is insufficient evidence that Synflorix provides protection against pneumococcal serotypes not contained in the vaccine or against non-typeable Haemophilus influenzae. Synflorix does not provide protection against other microorganism.
As with any vaccine, Synflorix may not protect all vaccinated individuals against invasive pneumococcal disease or otitis media caused by the serotypes in the vaccine. Protection against otitis media caused by pneumococcal serotypes in the vaccine is expected to be substantially lower than protection against invasive disease. In addition, as otitis media is caused by many microorganism other than the Streptococcus pneumoniae serotypes represented in the vaccine, the overall protection against otitis media is expected to be limited.
Synflorix will not protect against pneumococcal serogroups other than those included in the vaccine. Although antibody response to diphtheria toxoid, tetanus toxoid and Protein D (protein D is highly conserved in all Haemophilus influenzae strains including NTHi) occurs, immunization with Synflorix does not substitute routine immunization with diphtheria, tetanus or Haemophilus influenzae type b (Hib) vaccines. Official recommendations for the immunizations against diphtheria, tetanus and Hib should also be followed.
As with any vaccine, a protective immune response may not be elicited in all vaccinees.
Safety and immunogenicity data are available for HIV infected infants, children with SCD and children with splenic dysfunction (see Pharmacology: Pharmacodynamics under Actions and Adverse Reactions). Safety and immunogenicity data for Synflorix are not available for individuals in other specific immunocompromised groups and vaccination should be considered on an individual basis.
Children with impaired immune responsiveness, whether due to the use of immunosuppressive therapy, a genetic defect, HIV infection, or other causes, may have reduced antibody response to active immunization.
For children at high-risk for pneumococcal disease (such as children with SCD, asplenia, HIV infection, chronic illness or those who have other immunocompromising conditions), the appropriate-for-age Synflorix vaccination series should be given (see Dosage & Administration). The use of pneumococcal conjugate vaccine does not replace the use of 23-valent pneumococcal polysaccharide vaccines should be given according to local recommendations in those children.
Prophylactic administration of antipyretics before or immediately after vaccines administration can reduce the incidence and intensity of post-vaccination febrile reactions. Data however, suggest that the use of prophylactic paracetamol might reduce the immune response to pneumococcal vaccines. The clinical relevance of this observation remains unknown.
The use of prophylactic antipyretic medicinal products is recommended: For all children receiving Synflorix simultaneously with vaccines containing whole cell pertussis because of higher rate of febrile reactions (see Adverse Reactions); For children with seizure disorders or with a prior history of febrile seizures.
Antipyretic treatment should be initiated according to local treatment guidelines.
The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering the primary immunization 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.