Basic Information
RotaTeq
SOLUTION
Regulatory Information
SIN13303P
June 22, 2007
Prescription Only
Therapeutic
ORAL
August 10, 2023
May 30, 2025
XJ07BH01
Company Information
Active Ingredients
Strength: 2.0 X exponential 6 infectious units
Strength: 2.3 X exponential 6 infectious units
Strength: 2.2 X exponential 6 infectious units
Strength: 2.8 X exponential 6 infectious units
Strength: 2.2 X exponential 6 infectious units
Detailed Information
Contraindications
**V. CONTRAINDICATIONS** The administration of RotaTeq should be postponed in subjects suffering from acute diarrhea or vomiting. Hypersensitivity to any component of the vaccine. Individuals who develop symptoms suggestive of hypersensitivity after receiving a dose of RotaTeq should not receive further doses of RotaTeq. Subjects with congenital malformation of the gastrointestinal tract. Infants who have known or suspected immunodeficiency. Asymptomatic HIV infection is not expected to affect the safety or efficacy of RotaTeq. However, in the absence of sufficient data, administration of RotaTeq to asymptomatic HIV subjects is not recommended. Individuals with Severe Combined Immunodeficiency Disease (SCID). Cases of gastroenteritis associated with vaccine virus have been reported post-marketing in infants with SCID. Previous history of intussusception.
Indication Information
**III. INDICATIONS** RotaTeq is an oral pentavalent vaccine indicated for the prevention of severe rotavirus gastroenteritis in infants and children (See II. CLINICAL PHARMACOLOGY section – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).