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RotaTeq® is indicated for the prevention of rotavirus gastroenteritis in infants and children caused by the serotypes G1, G2, G3, and G4 when administered as a 3-dose series to infants between the ages of 6 to 32 weeks. The first dose of RotaTeq should be administered between 6 and 12 weeks of age [see DOSAGE AND ADMINISTRATION].
DOSAGE AND ADMINISTRATION
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].
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 Instructions For Use].
For storage instructions [see Storage and Handling].
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 Instructions For Use].
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.
Dosage Forms And Strengths
RotaTeq, 2 mL for oral use, is a ready-to-use solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 – 2.8 x 106 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 106 IU per aggregate dose.
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.
RotaTeq, 2 mL, a solution for oral use, is a pale yellow clear liquid that may have a pink tint. It is supplied as follows:
NDC 0006-4047-41 package of 10 individually
pouched single-dose tubes.
NDC 0006-4047-20 package of 25 individually pouched single-dose tubes.
The plastic dosing tube and cap do not contain latex.
Storage And Handling
Store and transport refrigerated at 2-8°C (36-46°F). RotaTeq should be administered as soon as possible after being removed from refrigeration. For information regarding stability under conditions other than those recommended, call 1-800-MERCK-90.
Protect from light.
RotaTeq should be discarded in approved biological waste containers according to local regulations.
The product must be used before the expiration date.
Manuf. and Dist. By Merclk Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC., Whitehouse Station, NJ 08889, USA. Revised: 06/2013
Last reviewed on RxList: 9/29/2014
This monograph has been modified to include the generic and brand name in many instances.
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