ROTARIX Rx

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ROTARIX

Vaccines
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Generic Name and Formulations:

Live, attenuated human G1P[8] rotavirus vaccine; lyophilized pwd for oral administration after reconstitution; preservative-free.

Company:

GlaxoSmithKline

Select therapeutic use:

Indications for ROTARIX:

Prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) in infants and children.

Adult:

Not applicable.

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.

Contraindications:

Uncorrected congenital GI tract malformation (eg, Meckel's diverticulum) (increased risk of intussusception). History of intussusception. Severe combined immunodeficiency disease.

Warnings/Precautions:

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.

Interactions:

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.

Adverse Reactions:

Fussiness/irritability, cough/runny nose, fever, loss of appetite, vomiting, diarrhea, dehydration, pneumonia; rare: Kawasaki disease.

Note:

Report adverse events to VAERS at (800) 822-7967 and to GlaxoSmithKline at (888) 825-5249.

Generic Availability:

NO

How Supplied:

Vials—10 (w. prefilled diluent in oral applicator)

ROTARIX 1ml applicators (Qty:1)

appx. price $127.00