PREVNAR 20 (pneumococcal 20-valent conjugate vaccine) Patient information | Pfizer Medical Information - US

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HIGHLIGHTS OF PRESCRIBING INFORMATION

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1 INDICATIONS AND USAGE

Prevnar 20® is a vaccine indicated for

•: active immunization for the prevention of invasive disease caused by Streptococcus...

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2 DOSAGE AND ADMINISTRATION

For intramuscular administration only.

2.1 Preparation

Do not mix Prevnar 20 with other...

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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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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...

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5 WARNINGS AND PRECAUTIONS

5.1 Management of Acute Allergic Reactions

Appropriate medical treatment and supervision used to manage immediate...

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6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction...

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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...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

...

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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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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Protection against pneumococcal disease is conferred mainly by antibodies (immunoglobulin G [IgG] directed against...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Prevnar 20 has not been evaluated for the potential to...

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14 CLINICAL STUDIES

14.1 Prevnar and Prevnar 13 Efficacy Data

Efficacy and effectiveness of Prevnar and Prevnar 13 are relevant to Prevnar...

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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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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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This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

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To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

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FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.