Post-marketing data

Gastrointestinal disorders:

Rare: intussusception*
gastroenteritis with vaccine viral shedding in infants with Severe Combined Immunodeficiency
(SCID) disorder.

*Preliminary data from a large post-marketing epidemiological safety study in Mexico indicate a possible increased risk of intussusception in the 31 day period following the first dose. The relative incidence of intussusception with ROTARIX in the 31 day period following the administration of the first dose was 1.752 (99%CI 0.997-3.08) compared to the remaining period up to 1 year of age. Spontaneous reports of intussusception have been received mostly within 7 days after the first dose. These observations are limited to the first dose and not seen following administration of the second dose. It has not been established whether ROTARIX affects the overall incidence of intussusception (see PRECAUTIONS).



The vaccination course consists of two doses. The first dose should be given between 6 and 14 weeks of age. The interval between the two doses should not be less than 4 weeks. The vaccine course should be completed by the age of 24 weeks as safety has not been assessed in older children.

ROTARIX may be given to preterm infants with the same posology (see Adverse reactions).

In clinical trials, spitting or regurgitation of the vaccine has rarely been observed and, under such circumstances, a replacement dose was not given. However, in the unlikely event that an infant spits out or regurgitates most of the vaccine dose, a single replacement dose may be given at the same vaccination visit.
It is strongly recommended that infants who receive a first dose of ROTARIX complete the 2-dose regimen with ROTARIX.


ROTARIX is for ORAL use only.
There are no restrictions on the infant’s consumption of food or liquid, including breast milk, either before or after vaccination.


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