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PREVNAR® 13 Index Section (pneumococcal 13-valent conjugate vaccine - diphtheria CRM197 protein)

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

1.1 Children 6 Weeks Through 5 Years of Age

1.2 Children 6 Years Through 17 Years of Age

1.3 Adults 18 Years of Age and Older

1.4 Limitations of Prevnar 13 Use and Effectiveness

2 DOSAGE AND ADMINISTRATION

2.1 Preparation for Administration

2.2 Administration Information

2.3 Vaccination Schedule for Infants and Toddlers

2.4 Vaccination Schedule for Unvaccinated Children 7 Months Through 5 Years of Age

2.5 Vaccination Schedule for Children 6 Years Through 17 Years of Age

2.6 Vaccination Schedule for Adults 18 Years of Age and Older

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Management of Allergic Reactions

5.2 Altered Immunocompetence

5.3 Apnea in Premature Infants

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience With Prevnar 13 in Children 6 Weeks Through 17 Years of Age

6.2 Clinical Trials Experience With Prevnar 13 in Adults ≥18 Years of Age

6.3 Post-marketing Experience With Prevnar 13 in Infants and Toddlers

7 DRUG INTERACTIONS

7.1 Concomitant Immunizations

7.2 Immunosuppressive Therapies

7.3 Antipyretics

7.4 Prior Vaccination with PPSV23

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

8.6 High Risk Populations

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

14.1 Efficacy Data

14.2 Prevnar 13 Clinical Trials in Children 6 Weeks Through 17 Years of Age

14.3 Prevnar 13 Immunogenicity Clinical Trials in Adults

14.4 Concomitant Vaccine Administration

15 REFERENCES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

*
Sections or subsections omitted from the full prescribing information are not listed.
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