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PREVNAR® 13 (pneumococcal 13-valent conjugate vaccine - diphtheria CRM197 protein)
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PREVNAR® 13 Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
1.1 Children 6 Weeks Through 5 Years of Age
In children 6 weeks through 5 years of age (prior to the 6th birthday),...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Preparation for Administration
Since this product is a suspension containing an adjuvant, shake vigorously immediately prior to use to...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
Prevnar 13 is a suspension for intramuscular injection available in 0.5 mL single-dose prefilled syringes.
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Contraindications
4 CONTRAINDICATIONS
Severe allergic reaction (e.g., anaphylaxis) to any component of Prevnar 13 or any diphtheria toxoid-containing vaccine [see Description (11)]...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Management of Allergic Reactions
Epinephrine and other appropriate agents used to manage immediate allergic reactions must be...
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Adverse Reactions
6 ADVERSE REACTIONS
Because clinical trials are conducted under widely varying conditions, adverse-reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of...
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Drug Interactions
7 DRUG INTERACTIONS
7.1 Concomitant Immunizations
In clinical trials with infants and toddlers, Prevnar 13 was administered concomitantly with the following US-...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
All pregnancies have a...
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Description
11 DESCRIPTION
Prevnar 13, Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) is a sterile suspension of saccharides of the capsular antigens of Streptococcus...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Prevnar 13, comprised of pneumococcal polysaccharides conjugated to a carrier protein (CRM197...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Prevnar 13 has not been evaluated for the potential to cause carcinogenicity,...
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Clinical Studies
14 CLINICAL STUDIES
14.1 Efficacy Data
Prevnar Efficacy Data
...
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References
15 REFERENCES
ClinicalTrials.gov identifiers for studies included below:
- Study 1 NCT00205803
- Study 2 NCT00373958
- Study 3 NCT00444457
- Study 4 NCT00452452
- Study 5...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
Prefilled Syringe, 1 Dose (10 per package) – NDC 0005-1971-02.
Prefilled Syringe, 1 Dose (1 per package) – NDC 0005-1971-05.
After shipping, Prevnar 13 may arrive at...
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Patient Counseling Information
17 PATIENT COUNSELING INFORMATION
Prior to administration of this vaccine, inform the individual, parent, guardian, or other responsible adult of the following:
- The potential benefits and risks of immunization...
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