Menomune – A/c/y/w-135 Combined

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 Use a separate sterile needle and syringe and aseptic technique for each dose withdrawn from the multidose vial.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

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 of lyophilized Menomune vaccine component and inject the diluent into the vial.

Figure 3

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

Figure 4

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 (16.2).]

2.2. 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)

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.

2.1. 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

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 of lyophilized Menomune vaccine component and inject the diluent into the vial.

Figure 3

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

Figure 4

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 (16.2).]

2.2. 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)

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.