Rotarix Dosage

Reconstitution Instructions for Oral Administration

For oral use only. Not for injection.

Reconstitute only with accompanying diluent. Do not mix ROTARIX with other vaccines or solutions.

	Remove vial cap and push transfer adapter onto vial (lyophilized vaccine).
	Shake diluent in oral applicator (white, turbid suspension). Connect oral applicator to transfer adapter.
	Push plunger of oral applicator to transfer diluent into vial. Suspension will appear white and turbid.
	Withdraw vaccine into oral applicator.
	Twist and remove the oral applicator.
Ready for oral administration.	Do not use a needle with ROTARIX. Not for injection.

Recommended Dose and Schedule

The vaccination series consists of two 1-mL doses administered orally. The first dose should be administered to infants beginning at 6 weeks of age. There should be an interval of at least 4 weeks between the first and second dose. The 2-dose series should be completed by 24 weeks of age.

Safety and effectiveness have not been evaluated if ROTARIX were administered for the first dose and another rotavirus vaccine were administered for the second dose or vice versa.

In the event that the infant spits out or regurgitates most of the vaccine dose, a single replacement dose may be considered at the same vaccination visit.

Infant Feeding

Breast-feeding was permitted in clinical studies. There was no evidence to suggest that breast-feeding reduced the protection against rotavirus gastroenteritis afforded by ROTARIX. There are no restrictions on the infant’s liquid consumption, including breast-milk, either before or after vaccination with ROTARIX.