Generic Name and Formulations:
Live, attenuated human G1P rotavirus vaccine; lyophilized pwd for oral administration after reconstitution; preservative-free.
Indications for ROTARIX:
Prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) in infants and children.
<6 weeks or >24 weeks of age: not recommended. Each oral dose is 1mL. Give 1st dose beginning at 6 weeks of age, 2nd dose at least 4 weeks later; complete 2-dose series by 24th week of age. May give a replacement dose at same vaccination visit if dosing is incomplete or regurgitated.
Uncorrected congenital GI tract malformation (eg, Meckel's diverticulum) (increased risk of intussusception). History of intussusception. Severe combined immunodeficiency disease.
Acute diarrhea or vomiting (delay immunization). Chronic GI disorders. Immunodeficiency or immunosuppressed close contacts (live virus shedding may allow transmission to others). Latex allergy. Pregnancy (Cat.C): not applicable.
May give with concomitant vaccines (eg, DTaP, Hep B, Inactivated Poliovirus Vaccine Combined, Hib conjugate). Immunosuppressants (eg, irradiation, chemotherapy, high-dose steroids): may get suboptimal response.
Fussiness/irritability, cough/runny nose, fever, loss of appetite, vomiting, diarrhea, dehydration, pneumonia; rare: Kawasaki disease.
Report adverse events to VAERS at (800) 822-7967 and to GlaxoSmithKline at (888) 825-5249.
Vials—10 (w. prefilled diluent in oral applicator)
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