Description
Contents
- Live attenuated rotavirus vaccine.
Indications/Uses
- ROTASIIL 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.
Dosage/Direction for Use
- ROTASIIL is for ORAL ADMINISTRATION ONLY AND MUST NOT BE ADMINISTERED PARENTERALLY.
Dosage: ROTASIIL 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, ROTASIIL 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. Because of the typical age distribution of rotavirus gastroenteritis, rotavirus vaccination of children >24 months of age is not recommended. There are no restrictions on the infant’s consumption of food or liquid, including breast milk, either before or after vaccination with ROTASIIL.
It is recommended that infants who receive ROTASIIL as the first dose should complete the three dose series with ROTASIIL. There is no data on safety, immunogenicity or efficacy of ROTASIIL 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 (physician’s discretion is advised). The baby may continue to receive the remaining doses as per schedule.
Dosage administration: Each single oral dose of ROTASIIL is 2.5 ml in volume. The administration of a single dose vaccine requires one vial of freeze-dried vaccine, one vial of citrate bicarbonate buffer, one adapter and syringe for vaccine reconstitution and administration. Only the specific buffer diluent provided must be used for reconstitution. If the integrity of either the vaccine or buffer diluent vial has been compromised, that particular vial must be discarded. The content of vial containing buffered diluent should be inspected visually for any foreign particulate matter and/or abnormal physical appearance prior to reconstitution. Reconstituted vaccine must be used immediately. If not used immediately, it can be held for a period of maximum 6 hours, provided, a syringe (fresh syringe if it is the second dose, else use the syringe used for reconstitution) is used to cap the opening of the vial adapter and the entire assembly is stored at 2 to 8°C.
The vaccine vial monitor, for this type of vaccine is attached to the vial cap and should be discarded when the vaccine is being reconstituted. 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. Any unused vaccine or waste material should be disposed of in accordance with local requirements.
For Reconstitution instructions for ROTASIIL refer Instructions for use and handling under Cautions for Usage.
