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Human medicines European public assessment report (EPAR): RotaTeq, rotavirus vaccine, live, Date of authorisation: 26/06/2006, Revision: 37, Status: Authorised

The most common side effects with RotaTeq (seen in more than 1 patient in 10) are pyrexia (fever), diarrhoea and vomiting. Very rarely (seen in less than 1 patient in 10,000), a serious condition called intussusception (in which part of the bowel becomes enfolded within another part of the bowel, leading to a blockage) has been reported after the use of rotavirus vaccines. For the full list of all side effects reported with RotaTeq, see the package leaflet.

RotaTeq must not be used in babies who are hypersensitive (allergic) to the active substance or any of the other ingredients, or who showed signs of allergy after receiving a dose of RotaTeq or another vaccine against rotavirus in the past. RotaTeq must not be given to babies who have had intussusception in the past or who have problems with their bowel that could put them at risk of intussusception. It must also not be used in babies whose immune system is weakened. Vaccination with RotaTeq should be postponed in babies who have a sudden high fever, diarrhoea or vomiting.

RotaTeq should never be injected under any circumstances.

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