"June 15, 2011 -- A vaccine that prevents the most common cause of severe diarrhea and dehydration in babies was associated with a potentially life-threatening bowel disorder in a large study from Mexico and Brazil, but the risk was small."...
A demonstrated history of hypersensitivity to any component of the vaccine.
Infants who develop symptoms suggestive of hypersensitivity after receiving a dose of ROTARIX should not receive further doses of ROTARIX.
Gastrointestinal Tract Congenital Malformation
Infants with a history of uncorrected congenital malformation of the gastrointestinal tract (such as Meckel's diverticulum) that would predispose the infant for intussusception should not receive ROTARIX.
History Of Intussusception
Infants with a history of intussusception should not receive ROTARIX [see WARNINGS AND PRECAUTIONS]. In postmarketing experience, intussusception resulting in death following a second dose has been reported following a history of intussusception after the first dose [see ADVERSE REACTIONS].
Severe Combined Immunodeficiency Disease
Infants with Severe Combined Immunodeficiency Disease (SCID) should not receive ROTARIX. Postmarketing reports of gastroenteritis, including severe diarrhea and prolonged shedding of vaccine virus, have been reported in infants who were administered live, oral rotavirus vaccines and later identified as having SCID [see ADVERSE REACTIONS].
Last reviewed on RxList: 9/26/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Rotarix Information
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