"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
As part of the child's or adult's immunization record, the date, lot number and manufacturer of the vaccine administered MUST be recorded.11-13
Patients should be fully informed of the benefits and risks of immunization with Tetanus (tetanus toxoid) Toxoid vaccine.
The physician should inform the patients about the potential for adverse reactions that have been temporally associated with Tetanus Toxoid (tetanus (tetanus toxoid) toxoid) administration. The health-care provider should provide the Vaccine Information Statements (VISs) which are required by the National Childhood Vaccine Injury Act of 1986 to be given with each immunization. Parents or guardians should be instructed to report any adverse reactions to their health-care provider.
IT IS EXTREMELY IMPORTANT WHEN THE CHILD OR ADULT PATIENT RETURNS FOR THE NEXT DOSE IN THE SERIES, THE PARENT, GUARDIAN, OR ADULT PATIENT SHOULD BE QUESTIONED CONCERNING OCCURRENCE OF ANY SYMPTOMS AND/OR SIGNS OF AN ADVERSE REACTION AFTER THE PREVIOUS DOSE (SEE CONTRAINDICATIONS; ADVERSE REACTIONS SECTIONS).
The health-care provider should inform the parent, guardian, or adult patient of the importance of completing the immunization series, unless a contraindication to further immunization exists.
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, including but not limited to the reporting of events required by the National Childhood Vaccine Injury Act of 1986.5 The toll-free number for VAERS forms and information is 1-800-822-7967.
12. CDC. National Childhood Vaccine Injury Act: requirements for permanent vaccination records and for reporting of selected events after vaccination. MMWR 37:197-200, 1988
Last reviewed on RxList: 6/6/2006
This monograph has been modified to include the generic and brand name in many instances.
Additional Tetanus Information
Tetanus - User Reviews
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