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Menactra

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Menactra

Menactra

INDICATIONS

Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine is indicated for active immunization of individuals 2 through 55 years of age for the prevention of invasive meningococcal disease caused by N meningitidis serogroups A, C, Y and W-135.

Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine is not indicated for the prevention of meningitis caused by other microorganisms or for the prevention of invasive meningococcal disease caused by N meningitidis serogroup B.

Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine is not indicated for treatment of meningococcal infections.

Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine is not indicated for immunization against diphtheria.

Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine may not protect 100% of individuals.

DOSAGE AND ADMINISTRATION

Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine should be administered as a single 0.5 mL injection by the intramuscular route, preferably in the deltoid region.

Do not administer this product intravenously, subcutaneously, or intradermally.

The need for, or timing of, a booster dose of Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine has not yet been determined.

Parenteral drug products should be inspected visually for container integrity, particulate matter and discoloration prior to administration, whenever solution and container permit.

Concomitant Administration with Other Vaccines

Safety and immunogenicity data are available on concomitant administration of Menactra vaccine with Typhim Vi, and Td vaccines (see CLINICAL PHARMACOLOGY and ADVERSE REACTIONS sections). Concomitant administration of Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine with Td did not result in reduced tetanus, diphtheria or meningococcal antibody responses (see Table 5) compared with Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine administered 28 days after Td.13 However, for meningococcal serogroups C, Y and W-135, bactericidal antibody titers (GMTs) and the proportion of participants with a 4-fold or greater rise in SBA-BR titer were higher when Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine was given concomitantly with Td than when Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine was given one month following Td. The clinical relevance of these findings has not been fully evaluated.13

Concomitant administration of Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine with Typhim Vi vaccine did not result in reduced antibody responses to any of the vaccine antigens (see Table 6).13

The safety and immunogenicity of concomitant administration of Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine with vaccines other than Typhim Vi or Td vaccines have not been determined.

Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine must not be mixed with any vaccine in the same syringe. Therefore, separate injection sites and different syringes should be used in case of concomitant administration (see CLINICAL PHARMACOLOGY section).

HOW SUPPLIED

BD Luer-Lok® latex-free syringe, 0.5 mL. Product No. 49281-589-11

BD Luer-Lok® latex-free syringe, 0.5 mL (5 x 0.5 mL syringes per package). Product No. 49281-589-15

Vial, 1 Dose (5 per package). Product No. 49281-589-05

Luer-Lok is a registered trademark of Becton Dickinson and Company.

Storage

Store at 2° to 8°C (35° to 46°F). DO NOT FREEZE. Product that has been exposed to freezing should not be used. Do not use after expiration date.

REFERENCES

13. Data on file, Sanofi Pasteur Inc. - 092503.

Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine is a registered trademark of Sanofi Pasteur Inc. Product Information as of October 2007. Manufactured by: Sanofi Pasteur Inc. Swiftwater PA 18370 USA. FDA rev date: 10/18/2007

Last reviewed on RxList: 10/30/2007
This monograph has been modified to include the generic and brand name in many instances.

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