RotaTeq Oral Vaccine

Prevention of Rotavirus diarrhea

May be taken with or without food.

2-Dose Regimen Prevention of rotavirus gastroenteritis Total of two 1 ml doses administered orally Administer first dose to infants beginning at 6 weeks of age Administer second dose after an interval of at least 4 weeks and prior to 24 weeks of age

Subjects with history of intussusception. Subjects with Severe Combined Immunodeficiency (SCID) disorder The presence of a minor infection, such as a cold, is not a contraindication for immunisation.

Rotavirus is one of the important causes of severe acute gastroenteritis in infants and young children. There are 2 commercially available forms of rotavirus vaccine. A live, attenuated monovalent vaccine derived from human strain indicated for prevention of rotavirus gastroenteritis caused by G1, G3, G4 and G9 serotypes; Human Rota Virus, Live attenuated Vaccine as a live, pentavalent human-bovine reassortant vaccine indicated for prevention of gastreoenteritis caused by rotavirus serotypes G1, G2, G3 and G4. Although presence of porcine cirovirus (PCV1 and PCV2) DNA have been detected in the rotavirus vaccine, current available information shows that there is no evidence that PCV1 or PCV2 poses a safety risk to humans. Exact immunologic mechanism of action is not fully understood although it is known that vaccine viruses replicate in the small intestine and promote active immunity.

History of GI disorders including chronic GI disorders, chronic diarrhoea, congenital abdominal disorders, abdominal surgery; growth retardation. Defer admin in infants suffering from acute diarrhoea, vomiting or severe acute febrile illness. Monitor infant after vaccination for signs of intussusceptions (e.g. severe abdominal pain, persistent vomiting, bloating, blood in stools, and/or high fever) or Kawasaki disease (E.g fever, skin rash, red eyes, red mouth, swollen hands and feet, swollen gland). Use with caution in presence of non-vaccinated or immunodeficient contacts due to a theoretical risk of live vaccine virus transmission via excretion in the stool. Use in immunocompromised/potentially immunocompromised infants or post-exposure prophylaxis have not been evaluated.

>10% Diarrhea (24.1%),Vomiting (15.2%),Otitis media (14.5%),Fever (17-43%),Fussiness/irritability (3-52%) 1-10% Nasopharyngitis (6.9%),Bronchospasm (1.1%),Faltulence (2%)

Immunosuppressive therapies may diminish a patient's immune response to the vaccine. Simultaneous immunisation with other age-appropriate vaccines including live virus vaccines, toxoids, inactivated or recombinant vaccines is not expected to interfere with the immunologic responses to the vaccine.