Menomune – A/c/y/w-135 Combined
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
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.
History
There is currently no drug history available for this drug.
Other Information
Menomune – A/C/Y/W-135, Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined, is a vaccine for subcutaneous injection. Menomune – A/C/Y/W-135 vaccine consists of a sterile lyophilized preparation of the group-specific polysaccharide antigens from N meningitidis, Group A, Group C, Group Y, and Group W-135. N meningitidis are cultivated on Mueller Hinton casein agar (7) and grown in Watson Scherp casamino acid media (8). The purified polysaccharide is extracted from the N meningitidis cells and separated from the media by procedures which include centrifugation, detergent precipitation, alcohol precipitation, solvent or organic extraction, and diafiltration. No preservative is added during manufacture.
The diluent (0.6 mL) for the single dose presentation contains sterile, pyrogen-free distilled water without preservative. The diluent (6 mL) for the multidose presentation contains sterile, pyrogen-free distilled water and thimerosal, a mercury derivative, which is added as a preservative for the reconstituted vaccine. [See How Supplied/Storage and Handling (16).]
After reconstitution with diluent, the vaccine is a clear colorless liquid solution. Each 0.5 mL dose contains 50 mcg of polysaccharide from each of serogroups A, C, Y, and W-135. Reconstituted vaccine from a multidose vial also contains 25 mcg mercury per dose.
Each dose of vaccine contains 2.5 mg to 5 mg of lactose added as a stabilizer. (9)
Potency is evaluated by measuring the molecular size of each polysaccharide component using a column chromatography method as standardized by the US Food and Drug Administration (FDA) and the World Health Organization (WHO) (10) for Meningococcal Polysaccharide Vaccine.
Sources
Menomune – A/c/y/w-135 Combined Manufacturers
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Sanofi Pasteur Inc.
![Menomune – A/c/y/w-135 Combined (Neisseria Meningitidis Group A Capsular Polysaccharide Antigen, Neisseria Meningitidis Group C Capsular Polysaccharide Antigen, Neisseria Meningitidis Group Y Capsular Polysaccharide Antigen And Neisseria Meningitidis Group W-135 Capsular Polysaccharide Antigen) Kit [Sanofi Pasteur Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Menomune – A/c/y/w-135 Combined | Sanofi Pasteur Inc.
2.1. AdministrationThe 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 ImmunizationPrimary 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. RevaccinationThe 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.
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Sanofi Pasteur Inc.
Menomune – A/c/y/w-135 Combined | Sanofi Pasteur Inc.
2.1. AdministrationThe 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 ImmunizationPrimary 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. RevaccinationThe 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.
![Menomune – A/c/y/w-135 Combined (Neisseria Meningitidis Group A Capsular Polysaccharide Antigen, Neisseria Meningitidis Group C Capsular Polysaccharide Antigen, Neisseria Meningitidis Group Y Capsular Polysaccharide Antigen, And Neisseria Meningitidis Group W-135 Capsular Polysaccharide Antigen) Kit [Sanofi Pasteur Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=0b91a360-c0d8-45ba-bf1a-836c995376bb&name=menomune-05.jpg)
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