Rotarix

Rotarix

vaccine, rotavirus

Manufacturer:

GlaxoSmithKline Indonesia
Concise Prescribing Info
Contents
Per 1.5 mL Live attenuated human rotavirus RIX4414 strain not <106 CCID50
Indications/Uses
Prevention of gastroenteritis caused by Rotavirus.
Dosage/Direction for Use
Oral vaccination course consists of 2 doses. The 1st dose may be administered from 6 wk. There should be an interval of at least 4 wk between doses. The vaccination course should be completed by 24 wk.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity after previous administration or to any component of Rotarix. History of intussusception, uncorrected congenital malformation of the GIT eg, Meckel's diverticulum, severe combined immunodeficiency disorder (SCID).
Special Precautions
For oral use only & do not inject. Postpone vaccination in subjects w/ acute severe febrile illness, diarrhea or vomiting. Infants w/ GI illnesses; symptoms indicative of intussusception; immunosuppressed infant, patients w/ immunodeficient close contacts eg, individuals w/ malignancies, immunocompromised or on immunosuppressive therapy. A protective immune response may not be elicited in all vaccinees. Does not protect against gastroenteritis due to other pathogens than rotavirus. Not for use in adults.
Adverse Reactions
Drug Interactions
Concomitant use of oral polio vaccine (OPV) may slightly reduce the immune response to rotavirus vaccine.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J07BH01 - rota virus, live attenuated ; Belongs to the class of rota virus diarrhea viral vaccines.
Presentation/Packing
Form
Rotarix vaccine (oral)
Packing/Price
1.5 mL x 1's
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