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PREVNAR 20™ (pneumococcal 20-valent conjugate vaccine)
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PREVNAR 20™ Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
Prevnar 20™ is a vaccine indicated for active immunization for the prevention of pneumonia and invasive disease caused by Streptococcus...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
For intramuscular administration only.
2.1 Preparation
Do not mix Prevnar 20 with other...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
Prevnar 20 is a suspension for intramuscular injection available in a 0.5 mL single-dose pre-filled syringe.
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Contraindications
4 CONTRAINDICATIONS
Severe allergic reaction (e.g., anaphylaxis) to any component of Prevnar 20 or to diphtheria toxoid [see Description (11)].
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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...
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Adverse Reactions
6 ADVERSE REACTIONS
In adults 18 through 59 years of age, the most commonly reported solicited adverse reactions >10% were pain at the injection site (>70%), muscle pain (>50%), fatigue (>40%), headache (>30...
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Drug Interactions
7 DRUG INTERACTIONS
7.1 Prior Vaccination with PNEUMOVAX 23
Receipt of PPSV23 1 to 5 years prior to Prevnar 20 resulted in diminished OPA geometric mean titers (GMTs...
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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 20, Pneumococcal 20-valent Conjugate Vaccine is a sterile suspension of saccharides of the capsular antigens of S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A,...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Protection against pneumococcal disease is conferred mainly by opsonophagocytic killing of S....
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Prevnar 20 has not been evaluated for the potential to cause carcinogenicity,...
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Clinical Studies
14 CLINICAL STUDIES
14.1 Prevnar 13 Adult Efficacy Data
Efficacy and effectiveness of Prevnar 13 are relevant to Prevnar 20, since the vaccines are manufactured...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
Pre-filled Syringe, 1 Dose (10 per package) – NDC 0005-2000-10.
Pre-filled Syringe, 1 Dose (1 per package) – NDC 0005-2000-02.
After shipping, Prevnar 20 may arrive at...
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Medication Guide
17 PATIENT COUNSELING INFORMATION
Prior to administration of this vaccine, inform the individual of the following:
- The potential benefits and risks of immunization with Prevnar 20...
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