Menomune® - A/C/Y/W-135, Meningococcal Polysaccharide
Vaccine, Groups A, C, Y and W-135 Combined, is indicated for active
immunization for the prevention of invasive meningococcal disease caused by Neisseria
meningitidis serogroups A, C, Y, and W-135. Menomune - A/C/Y/W-135 vaccine
is approved for use in persons 2 years of age and older. Menomune - A/C/Y/W-135
vaccine does not prevent N meningitidis serogroup B disease.
DOSAGE AND ADMINISTRATION
The package contains a vial of lyophilized vaccine and a
vial of diluent. The lyophilized vaccine should be a white or off-white color
to a light beige color. The diluent used for reconstitution is a clear liquid.
After removing the “flip-off” caps, cleanse the
vaccine and diluent vial stoppers with a suitable germicide. Do not remove the
vial stoppers or metal seals holding them in place. Using a suitable sterile
needle and syringe and aseptic technique, withdraw the supplied diluent (0.6 mL
for single dose presentation and 6.0 mL for multidose presentation) (Refer to
Figure 1) and inject into the vial containing the lyophilized vaccine (Refer to
Figure 2). Swirl the vial until the vaccine is thoroughly dissolved (Refer to
Figure 3). When reconstituted, the vaccine should be a clear, colorless liquid.
Parenteral drug products should be inspected visually for
particulate matter and discoloration prior to administration, whenever solution
and container permit. If either of these conditions exists, the vaccine should
not be administered.
Using a suitable sterile needle and syringe and aseptic
technique, withdraw (Refer to Figure 4) and administer a 0.5 mL dose of
Menomune - A/C/Y/W-135 vaccine by subcutaneous injection. Use a separate
sterile needle and syringe and aseptic technique for each dose withdrawn from
the multidose vial.
Do not administer this product intravenously or
The preferred site of administration is the deltoid
Menomune vaccine: Instructions for reconstitution
For the single-dose presentation, withdraw 0.6
mL of the supplied diluent; for the multidose presentation, withdraw 6.0
Insert the syringe needle through the stopper of the vial
of lyophilized Menomune vaccine component and inject the diluent into the vial.
Swirl the vial until the lyophilized vaccine component is
After reconstitution, withdraw 0.5 mL of Menomune vaccine
and administer subcutaneously. Use the single-dose presentation immediately
after reconstitution. The multidose presentation may be used for up to 35 days
after reconstitution if stored at 2° to 8°C.
The vaccine should not be combined through reconstitution
or mixed with any other vaccine.
Vaccine supplied in single dose vials should be used immediately
after reconstitution. Vaccine supplied in multidose vials may be used for up to
35 days after reconstitution if stored at 2° to 8°C (35° to 46°F). [See HOW
SUPPLIED/Storage and Handling]
Primary immunization with Menomune - A/C/Y/W-135 vaccine
consists of a single 0.5 mL dose administered subcutaneously.
The ACIP (Advisory Committee on Immunization Practices)
has specific recommendations for use of meningococcal vaccines.1,2,3
The ACIP has recommendations for revaccination against
meningococcal disease for persons at high risk who were previously vaccinated
with Menomune - A/C/Y/W-135 vaccine.1,3 If Menomune - A/C/Y/W-135
vaccine is used for revaccination, the dose is 0.5 mL administered subcutaneously.
Dosage Forms And Strengths
Menomune - A/C/Y/W-135 vaccine is supplied as a
lyophilized vaccine, in a single dose or a multidose (10 dose) vial, with
corresponding single dose or multidose vial of diluent. The lyophilized vaccine
is reconstituted with the diluent [see DOSAGE AND ADMINISTRATION]. After
reconstitution, each dose consists of a 0.5 mL solution for injection. See
DESCRIPTION for the complete listing of ingredients.
Storage And Handling
One single dose vial of lyophilized vaccine (NDC 49281-487-58) with one 0.6 mL vial of diluents (NDC 49281-466-08) (contains no
preservative). Supplied as package NDC 49281-489-01.
One 10 dose vial of lyophilized vaccine (NDC 49281-488-78) with one 6.0 mL vial of diluents (NDC 49281-466-91) (contains
preservative). Supplied as package NDC 49281-489-91.
Store lyophilized vaccine, diluent, and reconstituted
vaccine, when not in use, at 2° to 8°C (35° to 46°F). Do not freeze.
Do not use after the expiration date shown on the vial
labels of the lyophilized vaccine and diluent.
Discard remainder of reconstituted vaccine from multidose
vials within 35 days after reconstitution. Vaccine from single dose vials
should be used immediately after reconstitution.
1 Centers for Disease Control and Prevention. Prevention
and control of meningococcal disease: recommendations of the Advisory Committee
on Immunization Practices (ACIP). MMWR 2005;54 (No. RR - 7): 1-21.
2 Centers for Disease Control and Prevention. Revised
recommendations of the Advisory Committee on Immunization Practices to
vaccinate all persons aged 11-18 years with meningococcal conjugate vaccine.
3 Centers for Disease Control and Prevention.
Recommendation from the Advisory Committee on Immunization Practices (ACIP) for
use of quadrivalent meningococcal conjugate vaccine (MCV4) in children aged
2-10 years at increased risk for invasive meningococcal disease. MMWR
Manufactured by: Sanofi Pasteur Inc., Swiftwater PA 18370
USA. Revised: Apr 2013