HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the... |

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
PREVNAR® 13 (pneumococcal 13-valent conjugate vaccine - diphtheria CRM197 protein)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
PREVNAR® 13 Quick Finder
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),...
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...
3 DOSAGE FORMS AND STRENGTHS
Prevnar 13 is a suspension for intramuscular injection available in 0.5 mL single-dose prefilled syringes.
4 CONTRAINDICATIONS
Severe allergic reaction (e.g., anaphylaxis) to any component of Prevnar 13 or any diphtheria toxoid-containing vaccine [see Description (11)]...
5 WARNINGS AND PRECAUTIONS
5.1 Management of Allergic Reactions
Epinephrine and other appropriate agents used to manage immediate allergic reactions must be...
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...
7 DRUG INTERACTIONS
7.1 Concomitant Immunizations
In clinical trials with infants and toddlers, Prevnar 13 was administered concomitantly with the following US-...
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
All pregnancies have a...
11 DESCRIPTION
Prevnar 13, Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) is a sterile suspension of saccharides of the capsular antigens of Streptococcus...
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Prevnar 13, comprised of pneumococcal polysaccharides conjugated to a carrier protein (CRM197...
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Prevnar 13 has not been evaluated for the potential to cause carcinogenicity,...
14 CLINICAL STUDIES
14.1 Efficacy Data
Prevnar Efficacy Data
...15 REFERENCES
ClinicalTrials.gov identifiers for studies included below:
- Study 1 NCT00205803
- Study 2 NCT00373958
- Study 3 NCT00444457
- Study 4 NCT00452452
- Study 5...
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...
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...
To interact with the Medical Information Digital Assistant click here.
Contact Pfizer Medical Information to speak with a professional regarding your medical question on a Pfizer prescription product: (800) 438-1985
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.
If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.
(800)-332-1088.