For oral use only. Not for injection.
Posology: The vaccination series consists of three ready-to-use liquid doses of RotaTeq administered orally to infants.
The first dose of RotaTeq should be administered at 6 to 12 weeks of age; the subsequent doses should be administered at 4- to 10-week intervals. The third dose should not be given after 32 weeks of age.
There are no restrictions on the infant's consumption of food or liquid, including breast milk, either before or after vaccination with RotaTeq.
RotaTeq may be given to pre-term infants according to their chronological age.
If for any reason an incomplete dose is administered (e.g., infant spits or regurgitates the vaccine), a replacement dose is not recommended, since such dosing was not studied in the clinical trials. The infant should continue to receive any remaining doses in the recommended series.
The vaccine is to be administered orally without mixing with any other vaccines or solutions. Do not reconstitute or dilute.
Each dose is supplied in a container consisting of a squeezable plastic, latex-free dosing tube with a twist-off cap, allowing for direct oral administration. The dosing tube is contained in a pouch.
To administer the vaccine: Tear open the pouch and remove the dosing tube.
Clear the fluid from the dispensing tip by holding tube vertically and tapping cap.
Open the dosing tube in 2 easy motions: 1. Puncture the dispensing tip by screwing cap clockwise until it becomes tight.
2. Remove cap by turning it counterclockwise.
Administer dose by gently squeezing liquid into infant's mouth toward the inner cheek until dosing tube is empty. (A residual drop may remain in the tip of the tube.)
Discard the empty tube and cap in approved biological waste containers according to local regulations.
Use with Other Vaccines: RotaTeq can be administered with diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccine, inactivated or oral poliovirus vaccine (IPV or OPV), Haemophilus influenzae type b conjugate vaccine, hepatitis B vaccine, pneumococcal conjugate vaccine, meningococcal group C conjugate vaccine, and hexavalent vaccines.
Concomitant administration of RotaTeq and oral poliovirus vaccine (OPV) does not affect the immune response to the poliovirus antigens. Although concomitant administration of OPV may reduce some immune responses to rotavirus vaccine there is evidence that a high level of efficacy against severe rotavirus gastroenteritis is maintained. The immune responses to RotaTeq are unaffected when OPV is administered two weeks after RotaTeq.