PREVNAR® 20 Warnings and Precautions

(pneumococcal 20-valent conjugate vaccine)

5 WARNINGS AND PRECAUTIONS

   

5.1 Management of Acute Allergic Reactions

Appropriate medical treatment and supervision used to manage immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur following administration of Prevnar 20.

5.2 Altered Immunocompetence

Safety and immunogenicity data on Prevnar 20 are not available for individuals in immunocompromised groups and vaccination should be considered on an individual basis.

Based on experience with pneumococcal vaccines, individuals with altered immunocompetence may have reduced immune responses to Prevnar 20.

5.3 Apnea in Premature Infants

Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer Prevnar 20 to infants born prematurely should be based on consideration of the individual infant’s medical status and the potential benefits and possible risks of vaccination.

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Warnings and Precautions

5 WARNINGS AND PRECAUTIONS

   

5.1 Management of Acute Allergic Reactions

Appropriate medical treatment and supervision used to manage immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur following administration of Prevnar 20.

5.2 Altered Immunocompetence

Safety and immunogenicity data on Prevnar 20 are not available for individuals in immunocompromised groups and vaccination should be considered on an individual basis.

Based on experience with pneumococcal vaccines, individuals with altered immunocompetence may have reduced immune responses to Prevnar 20.

5.3 Apnea in Premature Infants

Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer Prevnar 20 to infants born prematurely should be based on consideration of the individual infant’s medical status and the potential benefits and possible risks of vaccination.
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