FDA records indicate that there are no current recalls for this drug.
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Pneumovax 23 Recall
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Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
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FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
PNEUMOVAX® 23 is a vaccine indicated for active immunization for the prevention of pneumococcal disease caused by the 23 serotypes contained in the vaccine (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F). PNEUMOVAX 23 is approved for use in persons 50 years of age or older and persons aged ≥2 years who are at increased risk for pneumococcal disease.
PNEUMOVAX 23 will not prevent disease caused by capsular types of pneumococcus other than those contained in the vaccine.
History
There is currently no drug history available for this drug.
Other Information
PNEUMOVAX 23 (Pneumococcal Vaccine Polyvalent) is a sterile, liquid vaccine consisting of a mixture of purified capsular polysaccharides from Streptococcus pneumoniae types (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F).
PNEUMOVAX 23 is a clear, colorless solution. Each 0.5-mL dose of vaccine contains 25 micrograms of each polysaccharide type in isotonic saline solution containing 0.25% phenol as a preservative. The vaccine is used directly as supplied. No dilution or reconstitution is necessary.
The vial stoppers, syringe plunger stopper and syringe tip cap are not made with natural rubber latex.
Sources
Pneumovax 23 Manufacturers
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Merck Sharp & Dohme Corp.
Pneumovax 23 | Merck Sharp & Dohme Corp.
For intramuscular or subcutaneous injection only.
2.1 Preparation Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. If either of these two conditions exists, the vaccine should not be administered. Do not mix PNEUMOVAX 23 with other vaccines in the same syringe or vial. Use a separate sterile syringe and needle for each individual patient to prevent transmission of infectious agents from one person to another.
Single-Dose and Multidose Vials
Withdraw 0.5 mL from the vial using a sterile needle and syringe free of preservatives, antiseptics, and detergents.
Single-Dose, Prefilled Syringe
The package does not contain a needle. Attach a sterile needle to the prefilled syringe by twisting in a clockwise direction until the needle fits securely on the syringe. 2.2 AdministrationAdminister PNEUMOVAX 23 intramuscularly or subcutaneously into the deltoid muscle or lateral mid-thigh. Do not inject intravascularly or intradermally.
Single-Dose and Multidose Vials
Administer a single 0.5-mL dose of PNEUMOVAX 23 using a sterile needle and syringe.
Single-Dose, Prefilled Syringe
Administer the entire contents of the single-dose, prefilled syringe per standard protocol using a sterile needle.
2.3 RevaccinationThe Advisory Committee on Immunization Practices (ACIP) has recommendations for revaccination against pneumococcal disease for persons at high risk who were previously vaccinated with PNEUMOVAX 23. Routine revaccination of immunocompetent persons previously vaccinated with a 23-valent vaccine, is not recommended.{1,2}
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