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Menomune

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Menomune

Menomune

INDICATIONS

Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined, is indicated for active immunization against invasive meningococcal disease caused by these serogroups.5

Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined may be used to prevent and control outbreaks of serogroup C meningococcal disease.5 For evaluation and management of suspected outbreaks, it is recommended that the health-care workers consult the MMWR for guidance.5

Routine vaccination is recommended for the following high-risk groups:5

  1. Deficiencies in late Complement components (C3, C5-C9).
  2. Functional or actual asplenia.
  3. Persons with laboratory or industrial exposure to N meningitidis aerosols.
  4. Travelers to, and residents of, hyperendemic areas such as sub-Saharan Africa. For information concerning geographic areas for which vaccination is recommended, contact CDC at 404-332-4559.

The American College Health Association (ACHA) also recommends that college students consider vaccination to reduce the risk for potentially fatal meningococcal disease.19

Vaccinations also should be considered for household or institutional contacts of persons with meningococcal disease and for medical and laboratory personnel at risk ofexposure to meningococcal disease.

This vaccine will not stimulate protection against infections caused by organisms other than Groups A, C, Y and W-135 meningococci.

Protective antibody levels may be achieved within 7 to 10 days after vaccination.5

Menomune (meningococcal polysaccharide vaccine) - A/C/Y/W-135 vaccine is not to be used for treatment ofactual infection.

Menomune (meningococcal polysaccharide vaccine) - A/C/Y/W-135 vaccine will not protect against other etiologic agents, including N meningitidis serogroup B, that cause meningitis.

Menomune (meningococcal polysaccharide vaccine) - A/C/Y/W-135 vaccine is not indicated for infants and children younger than 2 years of age except as short-term protection of infants 3 months and older against Group A.11

As with any vaccine, vaccination with Menomune (meningococcal polysaccharide vaccine) - A/C/Y/W-135 vaccine may not protect 100% of individuals.

For persons remaining at high-risk, especially children who were first vaccinated at <4 years of age, revaccination may be indicated.5 (See DOSAGE AND ADMINISTRATION section.)

DOSAGE AND ADMINISTRATION

Parenteral drug products should be inspected visually for extraneous particulate matter and/or discoloration prior to administration whenever solution and container permit. If either of these conditions exist, the vaccine should not be administered.

Reconstitute the vaccine using only the diluent supplied for this purpose. Draw the volume of diluent shown on the diluent label into a suitable size syringe and inject into the vial containing the vaccine. Shake vial until the vaccine is dissolved.

The immunizing dose is a single injection of 0.5 mL administered subcutaneously.

Special care should be taken to avoid injecting the vaccine intradermally, intramuscularly, or intravenously since clinical studies have not been done to establish safety and efficacy of the vaccine using these routes of administration.

Primary Immunization

For both adults and children, vaccine is administered subcutaneously as a single 0.5 mL dose. Protective antibody levels may be achieved within 7 to 10 days after vaccination.5

Revaccination

Revaccination of a single 0.5 mL dose administered subcutaneously may be indicated for individuals at high-risk of infection, particularly children who were first vaccinated when they were less than 4 years of age; such children should be considered for revaccination after 2 or 3 years if they remain at high-risk. Although the need for revaccination in older children and adults has not been determined, antibody levels decline rapidly over 2 to 3 years, and if indications still exist for immunization, revaccination may be considered within 3 to 5 years.5,18

Simultaneous administration of Menomune (meningococcal polysaccharide vaccine) - A/C/Y/W-135 vaccine can be given concurrently with other vaccines at separate sites and separate syringes.27 However, due to the combined endotoxin content, the vaccine should NOT be administered at the same time as whole-cell pertussis or whole-cell typhoid vaccines.20,21 (See WARNINGS section.)

HOW SUPPLIED

Vial, 1 Dose, with 0.78 mL vial of diluent (contains NO preservative). Product No. 49281-489-01

Vial, 1 Dose (5 per package) with 0.78 mL vial ofdiluent (5 per package) (contains NO preservative). Product No. 49281-489-05

Vial, 10 Dose, with 6 mL vial of diluent (contains preservative) for administration with needle and syringe (NOT to be used with jet injector). Product No. 49281-489-91

CPT® Code: 90733

CPT is a registered trademark of the American Medical Association.

Storage

Store freeze-dried vaccine and reconstituted vaccine, when not in use, at 2°to 8°C (35°to 46°F). Discard remainder of multidose vials of vaccine within 35 days after reconstitution. The single dose vial should be used within 30 minutes after reconstitution.

REFERENCES

5. Recommendation of the Advisory Committee on Immunization Practices (ACIP). Control and prevention of meningococcal disease and control and prevention of serogroup C meningococcal disease: evaluation and management of suspected outbreaks. MMWR 46: No. RR-5, 1997

11. Frasch CE. Meningococcal vaccines; past, present and future. Ed. K. Cartwright. John Wiley and Sons Ltd, 1995

18. Lennon D, et al. Successful intervention in a Group A meningococcal outbreak in Auckland, New Zealand. Pediatr Infect Dis J 11: 617-623, 1992

19. Collins MJ, et al. Student Health Centers urged to alert students to danger of the disease and provide campus vaccination programs. American College Health Association (ACHA), Baltimore, MD, Press Release 1997

20. Kuronen T, et al. Adverse reactions and endotoxin content of polysaccharide vaccines. Develop Biol Standard, Vol. 34: 117-125, 1977

21. Peltola H, et al. Meningococcus group A vaccine in children three months to five years of age: adverse reactions and immunogenicity related to endotoxin content and molecular weight of the polysaccharide. J Pediatr Vol 92: No 5, 818-822, 1978

27. American Academy of Pediatrics, Meningococcal infections. In: Peter G, ed. 1997 Red Book: Report of the Committee on Infectious Diseases. 24th ed. Elk Grove Village, IL: American Academy of Pediatrics; 361, 1997

Manufactured by: Sanofi Pasteur Inc., Swiftwater PA 18370, USA. Product information as of December 2005. FDA rev date: n/a

Last reviewed on RxList: 9/18/2008
This monograph has been modified to include the generic and brand name in many instances.

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