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

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PREVNAR® 13 Quick Finder

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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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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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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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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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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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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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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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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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

All pregnancies have a...

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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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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Prevnar 13, comprised of pneumococcal polysaccharides conjugated to a carrier protein (CRM197...

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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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14 CLINICAL STUDIES

14.1 Efficacy Data

Prevnar Efficacy Data

...
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15 REFERENCES

ClinicalTrials.gov identifiers for studies included below:

  1. Study 1 NCT00205803
  2. Study 2 NCT00373958
  3. Study 3 NCT00444457
  4. Study 4 NCT00452452
  5. Study 5...
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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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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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US Govt. License No. 3

LAB-0469-18.0
CPT Code 90670

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Report Adverse Event
Pfizer Safety

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.