"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"...
Parents should be fully informed of the benefits and risks of immunization with Haemophilus b Conjugate Vaccine (Diphtheria Toxoid-Conjugate). Information sheets are available from the Centers for Disease Control and Prevention (CDC) or the State Health Department.
Prior to administration of Haemophilus b Conjugate Vaccine (Diphtheria Toxoid-Conjugate), the parent or guardian should be asked about the recent health status of the infant or child to be injected.
The physician should inform the parents or guardian about the significant adverse reactions that have been temporally associated with Haemophilus b Conjugate Vaccine (Diphtheria Toxoid-Conjugate) administration, informed consent should be obtained and recorded, and the parent should inform the physician if any of these events occur.
As part of the child's immunization record, the date, lot number and manufacturer of the vaccine administered should be recorded.32,33
32. National Childhood Vaccine Injury Act of 1986 (Amended 1987)
33. 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: 3/9/2009
This monograph has been modified to include the generic and brand name in many instances.
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