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Rotasiil-Liquid

Rotasiil-Liquid Dosage/Direction for Use

rotavirus vaccine

Manufacturer:

Serum Institute of India

Distributor:

Faberco
Full Prescribing Info
Dosage/Direction for Use
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, ROTASIIL-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.
Dosage administration: Each single oral dose of ROTASIIL-Liquid is 2 ml in volume. The vaccine is available as ready to use either one plastic ampoule or a strip of five plastic ampoules of ROTASIIL-Liquid. If the integrity of the vaccine ampoule has been compromised, that particular plastic ampoule must be discarded. The content of plastic ampoule should 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 is dispensed as a single dose and is for one time use only. Any unused vaccine or waste material should be disposed-off in accordance with local requirements. The vaccine must not be mixed with other medicinal products.
For administration of vaccine orally refer to "Instructions for Use" under Cautions for Usage.
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