Tuesday, April 11, 2017 by Gregory Van Dyke
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Menomune® – A/C/Y/W-135 vaccine safely and effectively. See full prescribing information for Menomune® – A/C/Y/W-135 vaccine.
See full insert sheet at this link at the Natural News Reference website.
Menomune® – A/C/Y/W-135, Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined
Solution for subcutaneous injection
Initial U.S. Approval: 1981
INGREDIENTS AND EXCIPIENTS
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.
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.
The vial stopper of the lyophilized vaccine is made with natural rubber latex. The vial stopper of the diluent is not made with natural rubber latex.
INDICATIONS AND USAGE
Menomune – A/C/Y/W-135 vaccine is a vaccine indicated for active immunization against 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. (1)
DOSAGE AND ADMINISTRATION
Single 0.5 mL subcutaneous injection. (2)
DOSAGE FORMS AND STRENGTHS
Menomune – A/C/Y/W-135 vaccine is supplied as a single dose or multidose (10 dose) vial of lyophilized vaccine, with corresponding single dose or multidose vial of diluent. After reconstitution of the lyophilized vaccine with the diluent, each dose consists of a 0.5 mL solution for injection. (3)
Do not administer to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to Menomune – A/C/Y/W-135 vaccine or any component of the vaccine. (4)
WARNINGS AND PRECAUTIONS
The stopper to the vial of lyophilized vaccine contains natural rubber latex which may cause allergic reactions. (5.1)
Common (>10%) adverse events in children 2 to 10 years of age were injection site pain, drowsiness, irritability, and diarrhea. (6)
Common (>10%) adverse events in persons 11 to 55 years of age were pain, redness, and induration at the injection site, headache, fatigue, malaise, arthralgia, and diarrhea. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Sanofi Pasteur Inc. at 1-800-822-2463 (1-800-VACCINE) or VAERS at 1-800-822-7967 or http://vaers.hhs.gov.
Do not mix Menomune – A/C/Y/W-135 vaccine with other vaccines in the same syringe or vial. (7)
Immunosuppressive therapies may reduce the immune response to Menomune – A/C/Y/W-135 vaccine. (7)
No safety and immunogenicity data are available on the concomitant administration of Menomune – A/C/Y/W-135 vaccine with other US licensed vaccines. (7)
USE IN SPECIFIC POPULATIONS
Pregnancy Category C. Animal reproduction studies have not been conducted with Menomune – A/C/Y/W-135 vaccine. It is also not known whether Menomune – A/C/Y/W-135 vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Menomune – A/C/Y/W-135 vaccine should be given to a pregnant woman only if clearly needed.
It is not known whether Menomune – A/C/Y/W-135 vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Menomune – A/C/Y/W-135 vaccine is administered to a nursing woman.
Safety and effectiveness of Menomune – A/C/Y/W-135 vaccine in children below the age of 2 years have not been established.
During a meningococcal serogroup A epidemic in sub-Saharan Africa, children 3 months to 16 years of age were vaccinated with a high molecular weight serogroup A/C meningococcal polysaccharide vaccine. In case-control studies, after 1 year of observation, vaccine efficacy against meningococcal serogroup A disease was estimated to be 87% [90% Confidence Interval (CI), 52% to 96%], overall. After 3 years, efficacy was estimated to be 67% (90% CI, 40% to 82%) among children who were 4-16 years of age at the time of vaccination and 8% (90% CI, -102% to 58%) among children who were 1-3 years of age at the time of vaccination. (5)
The efficacy of a serogroup C meningococcal vaccine in infants and young children was evaluated in a placebo-controlled trial during a serogroup C epidemic in Brazil. Vaccine efficacy was estimated to be 12% (95% CI, -55% to 62%) among children 6 to 23 months of age and 55% (95% CI, -4% to 72%) among children 24 to 36 months of age. (6)
Clinical studies of Menomune – A/C/Y/W-135 vaccine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.