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Menomune

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Menomune

Menomune

WARNINGS

This product contains dry natural latex rubber as follows: The stopper to the vial contains dry natural latex rubber.

Ifthe vaccine is used in persons receiving immunosuppressive therapy, the expected immune response may not be obtained.

Menomune (meningococcal polysaccharide vaccine) - A/C/Y/W-135 vaccine should NOT be given at the same time as whole-cell pertussis or whole-cell typhoid vaccines due to combined endotoxin content.20,21

PRECAUTIONS

General

Care is to be taken by the health-care provider for the safe and effective use ofMenomune (meningococcal polysaccharide vaccine) - A/C/Y/W-135 vaccine.

EPINEPHRINE INJECTION (1:1000) MUST BE IMMEDIATELY AVAILABLE TO COMBAT UNEXPECTED ANAPHYLACTIC OR OTHER ALLERGIC REACTIONS.

Prior to an injection of any vaccine, all known precautions should be taken to prevent adverse reactions. This includes a review of the patient's history with respect to possible sensitivity to the vaccine or similar vaccines and to possible sensitivity to dry natural latex rubber.

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.

Health-care providers should obtain the previous immunization history of the vaccinee, and inquire about the current health status of the vaccinee.

A separate, sterile syringe and needle or a sterile disposable unit should be used for each patient to prevent transmission of hepatitis and other infectious agents from person to person. Needles should not be recapped and should be disposed of according to biohazard waste guidelines.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Menomune (meningococcal polysaccharide vaccine) - A/C/Y/W-135 vaccine has not been evaluated in animals for its carcinogenic, mutagenic potentials or impairment offertility.

Pregnancy Category C

Animal reproduction studies have not been conducted with Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135. It is also not known whether Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 should be given to a pregnant woman only ifclearly needed.

Although there is limited data, studies to date have found no evidence of teratogenicity of the polysaccharide quadrivalent meningococcal vaccine when given to pregnant women.25

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Menomune (meningococcal polysaccharide vaccine) - A/C/Y/W-135 vaccine is administered to a nursing woman.

Pediatric Use

SAFETY AND EFFECTIVENESS OF MENOMUNE (meningococcal polysaccharide vaccine) - A/C/Y/W-135 VACCINE IN CHILDREN BELOW THE AGE OF 2 YEARS HAVE NOT BEEN ESTABLISHED.

REFERENCES

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

25. Letson GW, et al. Meningococcal vaccine in pregnancy: an assessment ofinfant risk. Pediatr Infect Dis J 17 (3), 261-263, 1998

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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