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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

INDICATIONS

PNEUMOVAX 23 is indicated for vaccination against pneumococcal disease caused by those pneumococcal types included in the vaccine. Effectiveness of the vaccine in the prevention of pneumococcal pneumonia and pneumococcal bacteremia has been demonstrated in controlled trials in South Africa, France and in case-control studies.

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

Vaccination with PNEUMOVAX (pneumococcal vaccine polyvalent) 23 is recommended for selected individuals as follows:

- routine vaccination for persons 50 years of age or older
- persons aged ≥ 2 years with certain chronic conditions or in special environments or social settings.1,31

The ACIP has vaccine specific recommendations for the prevention of pneumococcal disease. Available from: http://www.cdc.gov/mmwr/PDF/rr/rr4608.pdf1 and http://www.cdc.gov/vaccines/recs/provisional/downloads/pneumo-Oct-2008-508.pdf31

Timing of Vaccination

Pneumococcal vaccine should be given at least two weeks before elective splenectomy, if possible.

For planning cancer chemotherapy or other immunosuppressive therapy (e.g., for patients with Hodgkin's disease or those who undergo organ or bone marrow transplantation), pneumococcal vaccination should be administered at least two weeks prior to the initiation of immunosuppressive therapy. Vaccination during chemotherapy or radiation therapy should be avoided. Based on literature reports, pneumococcal vaccine may be given as early as several months following completion of chemotherapy or radiation therapy for neoplastic disease.32,33 In Hodgkin's disease, immune response to vaccination may be impaired for two years or longer after intensive chemotherapy (with or without radiation). During the two years following the completion of chemotherapy or other immunosuppressive therapy, antibody responses improve in some patients as the interval between the end of treatment and pneumococcal vaccination increases.32

Persons with asymptomatic or symptomatic HIV infection should be vaccinated as soon as possible after their diagnosis is confirmed.

Use With Other Vaccines

The ACIP states that pneumococcal vaccine may be administered at the same time as influenza vaccine (by separate injection in the other arm) without an increase in side effects or decreased antibody response to either vaccine.1 In contrast to pneumococcal vaccine, influenza vaccine is recommended annually, for appropriate populations.34

Revaccination

The ACIP has recommendations for revaccination against pneumococcal disease in persons at high risk who were previously vaccinated with PNEUMOVAX 23 or the pneumococcal conjugate vaccine.1,31,35

If PNEUMOVAX (pneumococcal vaccine polyvalent) 23 is used for revaccination, a single 0.5 ml dose is administered subcutaneously or intramuscularly.

DOSAGE AND ADMINISTRATION

Do not inject intravenously or intradermally.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. PNEUMOVAX (pneumococcal vaccine polyvalent) 23 is a clear, colorless solution. The vaccine is used directly as supplied. No dilution or reconstitution is necessary. Phenol 0.25% has been added as a preservative.

It is important to use a separate sterile syringe and needle for each individual patient to prevent transmission of infectious agents from one person to another.

Withdraw 0.5 ml from the vial using a sterile needle and syringe free of preservatives, antiseptics, and detergents.

Administer a single 0.5 ml dose of PNEUMOVAX (pneumococcal vaccine polyvalent) 23 subcutaneously or intramuscularly (preferably in the deltoid muscle or lateral mid-thigh), with appropriate precautions to avoid intravascular administration.

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

Use With Other Vaccines

The ACIP states that pneumococcal vaccine may be administered at the same time as influenza vaccine (by separate injection in the other arm) without an increase in side effects or decreased antibody response to either vaccine.1 In contrast to pneumococcal vaccine, influenza vaccine is recommended annually, for appropriate populations.35

HOW SUPPLIED

No. 4739 — PNEUMOVAX (pneumococcal vaccine polyvalent) 23 is supplied as one 5-dose vial of liquid vaccine, color coded with a purple cap and stripe on the vial labels and cartons, NDC 0006-4739-00.

No. 4943 — PNEUMOVAX (pneumococcal vaccine polyvalent) 23 is supplied as a single-dose vial of liquid vaccine, in a box of 10 single-dose vials, color coded with a purple cap and stripe on the vial labels and cartons, NDC 0006-4943-00.

Manuf. and Dist by: MERCK&COJNC, Whitehouse Station, NJ 08889, USA. Issued March 2010

REFERENCES

NOTE: The ACIP recommends routine vaccination for immunocompetent persons 65 years of age and older.

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

31. Centers for Disease Control and Prevention. ACIP Provisional Recommendations for Use of Pneumococcal Vaccines. [Internet]. 2008 October 22 [cited 2009 June 5]. Available from: http://www.cdc.gov/vaccines/recs/provisional/downloads/pneumo-oct-2008-508.pdf

32. Siber, G.R.; Weitzman, S.A.; Aisenberg, A.C.: Antibody response of patients with Hodgkin's disease to protein and polysaccharide antigens, Rev. Infect. Dis. (Suppl): S144-S159, March-April 1981.

33. Shildt, R.A.; Boyd, J.F.; McCracken, G.S.; Schiffman, G.; Giolma, J.P.: Antibody response to pneumococcal vaccine in patients with solid tumors and lymphomas, Med. Ped. Oncol. 11:305-309,1983

34. Carlson, A.J.; Davidson, W.L.; McLean, A.A.; Vella, P.P.; Weibel, R.E.; Woodhour, A.F.; Hilleman, M.R.: Pneumococcal vaccine dose, revaccination, and coadministration with influenza vaccine (40596), Proc. Soc. Exper. Biol. & Med. 161:558-563, 1979.

35. Centers for Disease Control and Prevention. Preventing Pneumococcal Disease Among Infants and Young Children, MMWR 2000; 49 (No. RR-9): Pages 25-27. Available from: http://www.cdc.gov/mmwr/PDF/rr/rr4909.pdf

36. Siber, G.R.; Gorham, C.; Martin, P.; Corkery, J.C.; Schiffman, G.: Antibody response to pretreatment immunization and post-treatment boosting with bacterial polysaccharide vaccines in patients with Hodgkin's disease, Ann. Intern. Med. 104:467-475, 1986.

37. Vaccine Adverse Event Reporting System - United States, Morbidity and Mortality Weekly Report. 39(41): 730-33, October 19,1990.

38. Kelton, J.G.: Vaccination-associated relapse of immune thrombocytopenia, J.A.M.A. 245(4): 369-371,1981.

Last reviewed on RxList: 12/7/2010
This monograph has been modified to include the generic and brand name in many instances.

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