Prevenar 20 Special Precautions

Do not inject PREVENAR 20 intravascularly.
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.
Hypersensitivity: As with all injectable vaccines, appropriate medical treatment and supervision must always be readily available in case of a rare anaphylactic event following the administration of the vaccine (see Adverse Reactions).
Concurrent illness: As with other vaccines, the administration of PREVENAR 20 should be postponed in individuals 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.
Thrombocytopenia and coagulation disorders: As with all injectable vaccines, the vaccine must be administered with caution to individuals with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration.
The risk of bleeding in patients with coagulation disorders needs to be carefully evaluated before intramuscular administration of any vaccine, and subcutaneous administration should be considered if the potential benefit clearly outweighs the risks.
Protection against pneumococcal disease: PREVENAR 20 will only protect against Streptococcus pneumoniae serotypes included in the vaccine, and will not protect against other microorganisms that cause invasive disease, pneumonia or otitis media.
As with any vaccine, PREVENAR 20 may not protect all individuals receiving the vaccine from pneumococcal disease.
Immunocompromised individuals: Safety and immunogenicity data on PREVENAR 20 are not available for individuals in immunocompromised groups and vaccination should be considered on an individual basis.
Based on experience with pneumococcal vaccines, some individuals with altered immunocompetence may have reduced immune responses to PREVENAR 20.
Individuals 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. The clinical relevance of this is unknown.
Effects on ability to drive and use machines: PREVENAR 20 has no or negligible influence on the ability to drive and use machines. However, some of the effects mentioned under Adverse Reactions may temporarily affect the ability to drive or use machines.
Use in Children: As with all injectable pediatric vaccines, the potential risk of apnea should be considered when administering the primary immunization series to preterm infants. The need for monitoring for at least 48 hours after vaccination should be considered for every preterm infant born ≤28 weeks of gestation who remain hospitalized at the time of the recommended administration. As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.