"The U.S. Food and Drug Administration today allowed marketing of the Eclipse System for the treatment of fecal incontinence (FI) in adult women.
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There have been post-marketing reports of infants who received more than one dose or a replacement dose of RotaTeq after regurgitation [see DOSAGE AND ADMINISTRATION]. In limited post-marketing experience of reported overdosage, the adverse events reported after incorrect administration of higher than recommended doses of RotaTeq were similar to adverse events observed with the approved dosage and schedule.
A demonstrated history of hypersensitivity to any component of the vaccine.
Infants who develop symptoms suggestive of hypersensitivity after receiving a dose of RotaTeq should not receive further doses of RotaTeq.
Severe Combined Immunodeficiency Disease
Infants with Severe Combined Immunodeficiency Disease (SCID) should not receive RotaTeq. Post-marketing reports of gastroenteritis, including severe diarrhea and prolonged shedding of vaccine virus, have been reported in infants who were administered RotaTeq and later identified as having SCID [see ADVERSE REACTIONS].
History Of Intussusception
Infants with a history of intussusception should not receive RotaTeq.
Last reviewed on RxList: 9/29/2014
This monograph has been modified to include the generic and brand name in many instances.
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