HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use PREVNAR 13 safely and effectively. See full prescribing information for PREVNAR 13.
PREVNAR 13 (Pneumococcal 13-valent Conjugate Vaccine
[Diphtheria CRM197 Protein])
Suspension for intramuscular injection
Initial U.S. Approval: 2010
INDICATIONS AND USAGE
In children 6 weeks through 5 years of age (prior to the 6th birthday), Prevnar 13 is indicated for:
In children 6 years through 17 years of age (prior to the 18th birthday), Prevnar 13 is indicated for:
In adults 18 years of age and older, Prevnar 13 is indicated for:
Limitations of Prevnar 13 Use and Effectiveness
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
0.5 mL suspension for intramuscular injection, supplied in a single-dose prefilled syringe. (3)
Severe allergic reaction (e.g., anaphylaxis) to any component of Prevnar 13 or any diphtheria toxoid-containing vaccine. (4)
WARNINGS AND PRECAUTIONS
Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer an intramuscular vaccine, including Prevnar 13, 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. (5.3)
To report SUSPECTED ADVERSE REACTIONS, contact Wyeth Pharmaceuticals LLC. at 1-800-438-1985 or VAERS at 1-800-822-7967 or http://vaers.hhs.gov.
USE IN SPECIFIC POPULATIONS
Pediatric Use: Safety and effectiveness of Prevnar 13 in children below the age of 6 weeks have not been established. (8.4)
See 17 for PATIENT COUNSELING INFORMATION.
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