ROTARIX Presentations

ROTARIX is supplied in two presentations, a vial and oral dosing applicator presentation and an oral dosing applicator only presentation.

Vial and Oral Dosing Applicator Presentation

The vial contains the lyophilized vaccine component, and the oral dosing applicator contains the diluent. The contents of the vial must be reconstituted with the diluent to form ROTARIX prior to administration.

Oral Dosing Applicator Only Presentation

The oral dosing applicator only presentation contains ROTARIX and does NOT require reconstitution or dilution before use.

Preparation and Administration

​Vial and Oral Dosing Applicator Presentation

​Use accompanying diluent to reconstitute the lyophilized vaccine component to form ROTARIX. After reconstitution, each dose of 1 mL is administered orally.

​See Figure 1​ for preparation and administration steps.

​Figure 1. Preparation and Administration steps of Vial and Oral Dosing Applicator Presentation

For oral administration only. Have the infant seated in a reclining position. Place the oral dosing applicator towards the inner cheek. Administer the entire contents of the oral dosing applicator into the infant’s mouth.

​Oral Dosing Applicator Only Presentation

​The ROTARIX oral dosing applicator only presentation does NOT require reconstitution or dilution before use. Each dose of 1.5 mL is administered orally.

​See Figure 2​ for preparation and administration steps.

​Figure 2. Preparation and Administration Steps of Oral Dosing Applicator Only Presentation

​For oral administration only. Have the infant seated in a reclining position. Place the oral dosing applicator towards the inner cheek. Administer the entire contents of the oral dosing applicator into the infant’s mouth.

Dosing and Schedule

The vaccination series consists of two 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

Breastfeeding was permitted in clinical studies. There was no evidence to suggest that breastfeeding 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.