Serum - Protection from birth onwards
Rotavirus Vaccine, Live Attenuated Oral, I.P. (Freeze-Dried)
Rotavirus Vaccine, Live Attenuated (Oral) is indicated for active immunization of healthy infants from the age of 6 weeks for the prevention of gastroenteritis due to rotavirus infection when administered as a 3-dose series
Rotavirus Vaccine, Live Attenuated (Oral) is for ORAL ADMINISTRATION ONLY AND MUST NOT BE ADMINISTERED PARENTERALLY
Rotavirus Vaccine, Live Attenuated (Oral) should be administered as a 3-dose regimen, 4 weeks apart, beginning at 6 weeks of age. Based on recommendations from the World Health Organization, if the routine childhood immunizations are initiated later than 6 weeks of age and/or at a longer dose interval than 4-weeks, Rotavirus Vaccine, Live Attenuated (Oral) can still be administered, by itself or concomitantly with DTP, inactivated poliovirus vaccine (IPV), oral poliovirus vaccine (OPV), H. influenzae type b conjugate (Hib) vaccine, and hepatitis B vaccine. There are no restrictions on the infant's consumption of food or liquid, including breast milk, either before or after vaccination with Rotavirus Vaccine, Live Attenuated (Oral).
It is recommended that infants who receive Rotavirus Vaccine, Live Attenuated (Oral) as the first dose should complete the three dose series with Rotavirus Vaccine, Live Attenuated (Oral). There is no data on safety, immunogenicity or efficacy of Rotavirus Vaccine, Live Attenuated (Oral) when administered interchangeably with other available rotavirus vaccines.
In case that an incomplete dose is administered (the baby spits up or regurgitates most of the vaccine), a single replacement dose may be administered at the same vaccination visit*. The baby may continue to receive the remaining doses as per schedule.
*Physician's discretion is advised
Any unused vaccine or waste material should be disposed off in accordance with local requirements. The reconstituted vaccine should also be inspected visually for any foreign particulate matter and/or abnormal physical appearance prior to administration.
In the event of either being observed, discard the vaccine. The vaccine must not be mixed with other medicinal products.
