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PREVNAR 20™ (pneumococcal 20-valent conjugate vaccine)
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PREVNAR 20™ Quick Finder
1 INDICATIONS AND USAGE
Prevnar 20® is a vaccine indicated for
- •
- active immunization for the prevention of invasive disease caused by Streptococcus...
2 DOSAGE AND ADMINISTRATION
For intramuscular administration only.
2.1 Preparation
Do not mix Prevnar 20 with other...
3 DOSAGE FORMS AND STRENGTHS
Prevnar 20 is a suspension for intramuscular injection available in a 0.5 mL single-dose pre-filled syringe.
4 CONTRAINDICATIONS
Do not administer Prevnar 20 to individuals with a severe allergic reaction (e.g., anaphylaxis) to any component of Prevnar 20 or to diphtheria toxoid [see Description...
5 WARNINGS AND PRECAUTIONS
5.1 Management of Acute Allergic Reactions
Appropriate medical treatment and supervision used to manage immediate...
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction...
7 DRUG INTERACTIONS
7.1 Prior Vaccination With PNEUMOVAX 23
In adults, receipt of PPSV23 1 to 5 years prior to Prevnar 20 resulted in...
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
...
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,...
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Protection against pneumococcal disease is conferred mainly by antibodies (immunoglobulin G [IgG] directed against...
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Prevnar 20 has not been evaluated for the potential to...
14 CLINICAL STUDIES
14.1 Prevnar and Prevnar 13 Efficacy Data
Efficacy and effectiveness of Prevnar and Prevnar 13 are relevant to Prevnar...
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...
17 PATIENT COUNSELING INFORMATION
Prior to administration of this vaccine, inform the individual of the following:
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- The potential benefits and risks of immunization with Prevnar 20 [...
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