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Pneumovax

"Infection with Streptococcus pneumoniae bacteria can make children very sick.

It causes blood infections, pneumonia, and bacterial meningitis, mostly in young children. (Meningitis is an infection of the covering of the brain.) Pne"...

Pneumovax 23

INDICATIONS

Indications And Use

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.

Limitations Of Use

PNEUMOVAX 23 will not prevent disease caused by capsular types of pneumococcus other than those contained in the vaccine.

DOSAGE AND ADMINISTRATION

For intramuscular or subcutaneous injection only.

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.

Administration

Administer 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.

Revaccination

The 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

HOW SUPPLIED

Dosage Forms And Strengths

PNEUMOVAX 23 is a clear, sterile solution supplied in a (0.5-mL dose) single-dose vial, a 5-dose vial, and a single-dose, prefilled syringe. [See DESCRIPTION and Storage and Handling]

PNEUMOVAX 23 is supplied as follows:

NDC 0006-4739-00 — one 5-dose vial, color coded with a purple cap and stripe on the vial labels and cartons.

NDC 0006-4943-00 — a box of 10 single-dose vials, color coded with a purple cap and stripe on the vial labels and cartons.

NDC 0006-4837-03 — a box of 10 single-dose, pre-filled Luer-Lok™ syringes with tip caps, color coded with a violet plunger rod and purple stripe on the syringe labels and cartons.

Storage And Handling

  • Store at 2-8°C (36-46°F).
  • All vaccine must be discarded after the expiration date.

REFERENCES

1. Centers for Disease Control and Prevention. Prevention of Pneumococcal Disease. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR. 46(No. RR-8): 1-25, 1997. Available from: http://www.cdc.gov/mmwr/PDF/rr/rr4608.pdf

2. Centers for Disease Control and Prevention. Prevention of Pneumococcal Disease Among Infants and Children --- Use of 13-Valent Pneumococcal Conjugate Vaccine and 23-Valent Pneumococcal Polysaccharide Vaccine, MMWR 59(RR11): 1-18, 2010. http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5911a1.htm?s_cid=rr5911a1_e

Manuf. and Dist. by: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA. Revised: June 2014

Last reviewed on RxList: 9/19/2014
This monograph has been modified to include the generic and brand name in many instances.

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