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PRODUCTS SUPPLIED IN INDIA

Serum - Protection from birth onwards

Rotasiil Liquid

Live Attenuated (Oral) Rotavirus Vaccine

pharma

INDICATION

ROTASIIL-Liquid 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. The three-dose regimen should be completed by one year of age.

ROUTE OF ADMINISTRATION

ROTASIIL-Liquid is for ORAL ADMINISTRATION ONLY AND MUST NOT BE ADMINISTERED PARENTERALLY

DOSAGE

ROTASIIL-Liquid should be administered as a 3-dose regimen, 4 weeks apart, beginning at 6 weeks of age. The three dose regimen should be completed by one year of age. ROTASIIL-Liquid may be co-administered with other routine childhood immunizations (i.e., Diphtheria, Tetanus and Pertussis [DTwP], Hepatitis B vaccine, H. influenzae type b (Hib) vaccine, inactivated polio vaccine (IPV) and Oral Polio Vaccine [OPV]). Because of the typical age distribution of rotavirus gastroenteritis, rotavirus vaccination of children > 24 months of age is not recommended. 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, RROTASIIL-Liquid can still be administered, by itself or concomitantly with DTwP. There are no restrictions on the infant's consumption of food or liquid, including breast milk, either before or after vaccination with ROTASIIL-Liquid.

It is recommended that infants who receive ROTASIIL-Liquid as the first dose should complete the three dose series with ROTASIIL-Liquid. There is no data on safety, immunogenicity or efficacy of ROTASIIL-Liquid 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

PRESENTATION:
2 ml - 1 dose ampoule