Generic name: ROTAVIRUS G1 P7(5) LIVE ANTIGEN, A 2200000[iU] in 2mL, ROTAVIRUS G2 P7(5) LIVE ANTIGEN, A 2800000[iU] in 2mL, ROTAVIRUS G3 P7(5) LIVE ANTIGEN, A 2200000[iU] in 2mL, ROTAVIRUS G4 P7(5) LIVE ANTIGEN, A 2000000[iU] in 2mL, ROTAVIRUS G6 P1A(8) LIVE ANTIGEN, A 2300000[iU] in 2mL
Dosage form: oral solution
FOR ORAL USE ONLY. NOT FOR INJECTION.
The vaccination series consists of three ready-to-use liquid doses of RotaTeq administered orally starting at 6 to 12 weeks of age, with the subsequent doses administered at 4- to 10-week intervals. The third dose should not be given after 32 weeks of age [see Clinical Studies (14)].
There are no restrictions on the infant’s consumption of food or liquid, including breast milk, either before or after vaccination with RotaTeq.
Do not mix the RotaTeq vaccine with any other vaccines or solutions. Do not reconstitute or dilute [see Dosage and Administration (2.2)].
For storage instructions [see How Supplied/Storage and Handling (16.1)].
Each dose is supplied in a container consisting of a squeezable plastic dosing tube with a twist-off cap, allowing for direct oral administration. The dosing tube is contained in a pouch [see Dosage and Administration (2.2)].
Use with Other Vaccines
Instructions for Use
|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.)|
|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.
|Discard the empty tube and cap in approved biological waste containers according to local regulations.|
More about RotaTeq (rotavirus vaccine)
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- During Pregnancy
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- Drug class: viral vaccines
Other brands: Rotarix