Special Warning : אזהרת שימוש

4.4    Special warnings and precautions for use

Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.

Prior to immunisation

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic reaction following the administration of the vaccine.

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 thrombocytopenia or any coagulation disorder since bleeding may occur following an intramuscular administration to these subjects.

Information on protection conferred by the vaccine

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 (see section 5.1) or against non- typeable Haemophilus influenzae. Synflorix does not provide protection against other micro- organisms.

As with any vaccine, Synflorix may not protect all vaccinated individuals against invasive pneumococcal disease, pneumonia or otitis media caused by the serotypes in the vaccine and the cross-reactive serotype 19A. In addition, as otitis media and pneumonia are caused by many micro- organisms other than the Streptococcus pneumoniae serotypes represented by the vaccine, the overall protection against these diseases is expected to be limited and substantially lower than protection against invasive disease caused by the serotypes in the vaccine and serotype 19A (see section 5.1).

In clinical trials, Synflorix elicited an immune response to all ten serotypes included in the vaccine, but the magnitude of the responses varied between serotypes. The functional immune response to serotypes 1 and 5 was lower in magnitude than the response against all other vaccine serotypes. It is not known whether this lower functional immune response against serotypes 1 and 5 will result in lower protective efficacy against invasive disease, pneumonia or otitis media caused by these serotypes (see section 5.1).


Synflorix SPC V8.0 June 2020                      Page 3 of 21
Children should receive the dose regimen of Synflorix that is appropriate to their age at the time of commencing the vaccination series (see section 4.2).

Immunosuppressive therapy and immunodeficiency

Children with impaired immune responsiveness, whether due to the use of immunosuppressive therapy, a genetic defect, HIV infection, prenatal exposure to anti-retroviral therapy and/or to HIV, or other causes, may have reduced antibody response to vaccination.

Safety and immunogenicity data are available for HIV infected infants (asymptomatic or with mild symptoms according to WHO classification), HIV negative infants born from HIV positive mothers, children with sickle cell disease and children with splenic dysfunction (see sections 4.8 and 5.1).
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 (see section 4.2).

The use of pneumococcal conjugate vaccine does not replace the use of 23-valent pneumococcal polysaccharide vaccines in children ≥ 2 years of age with conditions (such as sickle cell disease, asplenia, HIV infection, chronic illness, or those who have other immunocompromising conditions) placing them at higher risk for invasive disease due to Streptococcus pneumoniae. Whenever recommended, children at risk who are ≥ 24 months of age and already primed with Synflorix should receive 23-valent pneumococcal polysaccharide vaccine. The interval between the pneumococcal conjugate vaccine (Synflorix) and the 23-valent pneumococcal polysaccharide vaccine should not be less than 8 weeks. There are no data available to indicate whether the administration of pneumococcal polysaccharide vaccine to Synflorix primed children may result in hyporesponsiveness to further doses of pneumococcal polysaccharide or to pneumococcal conjugate vaccine.

Prophylactic use of antipyretics

Prophylactic administration of antipyretics before or immediately after vaccine administration can reduce the incidence and intensity of post-vaccination febrile reactions. Clinical data generated with paracetamol and ibuprofen suggest that the prophylactic use of paracetamol might reduce the fever rate, while prophylactic use of ibuprofen showed a limited effect in reducing fever rate. The clinical data suggest that paracetamol might reduce the immune response to Synflorix. However, the clinical relevance of this observation is not known.

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 section 4.8).
- for children with seizure disorders or with a prior history of febrile seizures.
Antipyretic treatment should be initiated according to local treatment guidelines.
Synflorix contains sodium
This medicinal product contains less than 1 mmol sodium (23 mg ) per dose , i.e essentially "sodium free"

Effects on Driving

4.7    Effects on ability to drive and use machines

Not relevant.