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Prior to administration of Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine, the health-care professional should inform the patient, parent, guardian, or other responsible adult of the potential benefits and risks to the patient (see ADVERSE REACTIONS and WARNINGS sections). The patient, parent or guardian should be given the Vaccine Information Statement, which is required by the National Childhood Vaccine Injury Act of 1986 to be given prior to immunization. These materials are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines). Patients, parents or guardians should be instructed to report any suspected adverse reactions to their health-care professional who should report these events to Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370 or call 1-800-822-2463.
Patients, parents or guardians should be informed that the US Department of Health and Human Services has established a Vaccine Adverse Event Reporting System (VAERS) to accept all reports of suspected adverse events after the administration of any vaccine and be given the contact information for VAERS (see ADVERSE REACTIONS, Reporting of Adverse Events section).
Females of childbearing potential should be informed that Sanofi Pasteur Inc. maintains a pregnancy registry to monitor fetal outcomes of pregnant women exposed to Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine. If they are pregnant or become aware they were pregnant at the time of Menactra (polysaccharide diphtheria toxoid conjugate vaccine) vaccine immunization, they should contact their healthcare professional or Sanofi Pasteur Inc. at 1-800-822-2463 (see PRECAUTIONS section).
Last reviewed on RxList: 10/30/2007
This monograph has been modified to include the generic and brand name in many instances.
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