Intussusception (including death), recurrent intussusception (including death), hematochezia, gastroenteritis with vaccine viral shedding in infants with Severe Combined Immunodeficiency Disease (SCID). Blood and Lymphatic System Disorders...
Read moreThe temporal association between vaccination with ROTARIX and intussusception was evaluated in a hospital-based active surveillance study that identified infants with intussusception at participating hospitals in Mexico. Using a self-controlled...
Read moreKawasaki disease has been reported in 18 (0.035%) recipients of ROTARIX and 9 (0.021%) placebo recipients from 16 completed or ongoing clinical trials. Of the 27 cases, 5 occurred following ROTARIX in clinical trials that were either not...
Read moreIn a controlled safety study conducted in Latin America and Finland, the risk of intussusception was evaluated in 63,225 infants (31,673 received ROTARIX and 31,552 received placebo). Infants were monitored by active surveillance including...
Read moreContraindications Hypersensitivity 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...
Read morePost-marketing data Gastrointestinal disorders: Rare: intussusception* haematochezia gastroenteritis with vaccine viral shedding in infants with Severe Combined Immunodeficiency (SCID) disorder. *Preliminary data from a large post-marketing...
Read moreIn a clinical study, 1009 preterm infants were administered ROTARIX lyophilised formulation or placebo (198 were 27-30 weeks gestational age and 801 were 31-36 weeks gestational age). The first dose was administered from 6 weeks after birth...
Read moreInteractions Co-administration studies have demonstrated that ROTARIX can be given concomitantly with any of the following administered either as monovalent or as combination vaccines: diphtheria-tetanus-acellular pertussis vaccine (DTPa)...
Read moreROTARIX has not been evaluated for carcinogenicity or mutagenicity. (VAN’s Note: This means that it hasn’t been safety tested to see if it causes cancer or if it mutates into another illness). Impairment of Fertility ROTARIX has not...
Read moreExcretion Excretion of the vaccine virus in the stools occurs after vaccination and lasts for 10 days on average with peak excretion around the 7th day. Viral antigen particles detected by ELISA were found in 50% of stools after the first dose...
Read moreThe immunologic mechanism by which ROTARIX protects against rotavirus gastro-enteritis is not entirely understood. A relationship between antibody responses to rotavirus vaccination and protection against rotavirus gastro-enteritis has not been...
Read moreIngredients: ROTARIX is a liquid suspension of the live attenuated RIX4414 strain of human rotavirus of the G1P[8] type for use in the prevention of rotavirus gastro-enteritis. The virus strain derived from the 89-12 strain is obtained by...
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