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Menomune

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Menomune

INDICATIONS

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

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 Use a separate sterile needle and syringe and aseptic technique for each dose withdrawn from the multidose vial.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 intramuscularly.

The preferred site of administration is the deltoid region.

Menomune vaccine: Instructions for reconstitution

Figure 1

Withdraw 0.6 mL of the supplied diluent - Illustration

For the single-dose presentation, withdraw 0.6 mL of the supplied diluent; for the multidose presentation, withdraw 6.0 mL.

Figure 2

Insert the syringe needle through the stopper of the vial - Illustration

Insert the syringe needle through the stopper of the vial of lyophilized Menomune vaccine component and inject the diluent into the vial.

Figure 3

Swirl the vial - Illustration

Swirl the vial until the lyophilized vaccine component is thoroughly dissolved.

Figure 4

Withdraw 0.5 mL of Menomune vaccine -  Illustration

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

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

Revaccination

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.

HOW SUPPLIED

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.

Storage

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.

REFERENCES

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. MMWR 2007;56:794-5.

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 2007;56:1265-6.

Manufactured by: Sanofi Pasteur Inc., Swiftwater PA 18370 USA. Revised: Apr 2013

Last reviewed on RxList: 9/18/2014
This monograph has been modified to include the generic and brand name in many instances.

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