Rotavac 5D Dosage/Direction for Use

Posology: ROTAVAC 5D should be administered as a 3-dose regimen, 4 weeks apart, beginning at 6 weeks of age. ROTAVAC 5D may be co-administered with other routine childhood vaccination (i.e., Diphtheria, Tetanus and Pertussis [DTwP], Haemophilus Influenzae type B, Hepatitis B vaccine and Oral/injectable Polio Vaccine [OPV&IPV]). Based on recommendations from the World Health Organization (Rotavirus vaccines WHO Position Paper, January 2013 in Weekly Epidemiological Report No.5, 2013, 88, 49-64), if the routine childhood vaccination are initiated later than 6 weeks of age and/or at a longer dose interval than 4-weeks, ROTAVAC 5D can still be co-administered with DTaP & DTwP.
It is recommended that infants who receive ROTAVAC 5D as the first dose should complete the 3-dose regimen with ROTAVAC 5D. There is no data on safety, immunogenicity or efficacy when ROTAVAC 5D is administered interchangeably with other rotavirus vaccines.
Pediatric Population: The upper age limit for the 3-dose primary schedule of Rotavirus vaccine should be administered to children by the age of 8 months (34 weeks) (Centre for Disease Control and Prevention, http://www.cdc.gov/vaccines/vpd-vac/rotavirus/vac-faqs.htm).
In case of interrupted primary series, resume vaccination without repeating previous dose (1). According to the WHO recommendation, rotavirus immunisation is permitted up to 24 months of age (2,3).
Method of administration: ROTAVAC 5D is for oral use only and SHOULD NOT BE INJECTED. Care should be taken not to contaminate the multi-dose dropper of the vaccine with saliva of the babies. Once opened, multi-dose vials should be kept at +2°C and +8°C.
In case, an incomplete dose is administered (the baby spits up or regurgitates most of the vaccine), it is not recommended to administer a single replacement dose at the same vaccination visit. The baby may continue to receive the remaining doses as per schedule. However, in clinical trials, the reported incidence of spitting or vomiting is <0.5%.
*Physician's discretion is advised.
Multi-dose vials of ROTAVAC 5D from which one or more doses of vaccine have been removed during an immunization session may be used in subsequent immunization sessions for up to a maximum of 28 days after opening, provided that all of the following conditions are met (as described in the WHO Policy Statement: Multi-Dose Vial Policy (MDVP) Revision 2014 WHO/IVB/14.07).
Once opened, multi-dose vials should be kept between +2°C and +8°C.
The Vaccine is currently pre-qualified by WHO.
The vaccine is approved for use for up to 28 days after opening of the vial, as determined by WHO (http://www.who.int/immunization_standards/vaccine_quality/PQ_vaccine_list_en/en/).
The expiry date of the vaccine has not passed.
The vaccine vial has been, and will continue to be, stored at the recommended temperature; furthermore, the vaccine vial monitor is visible on the vaccine label and is not past its discard point, and the vaccine has not been damaged by freezing.