Rx Item-Rotateq 2 Ml Suspension 25X2Ml By Merck

ROTATEQ- human rotavirus a type g1p7(5) strain wi79 live antigen, human rotavirus a type g2p7(5) strain sc2 live antigen, human rotavirus a type g3p7(5) strain wi78 live antigen, human rotavirus a type g4p7(5) strain brb live antigen and human rotavirus a type g6p1a(8) strain wi79 live antigen solution
Merck Sharp & Dohme Corp.
1 INDICATIONS AND USAGE

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 (2)].
2 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 (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)].
3 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[8] 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.
4 CONTRAINDICATIONS
4.1 Hypersensitivity

A demonstrated history of hypersensitivity to any component of the vaccine.

Infants who develop symptoms suggestive of hypersensitivity after receiving a dose of RotaTeq should not receive further doses of RotaTeq.

RX ITEM-Rotateq 2 Ml Suspension 25X2Ml B
NDC 00006-4047-20 UPC/GTIN No.3-00064-04720-2 Mfg.Part No.404720

Rotateq 2 Ml Suspension 25X2Ml By Merck
BRAND: ROTATEQ NDC: 00006-4047-20,6404720 UPC: 3-00064-04720-2,300064047202 Merck & Co.

ROTAVIRUS VACCINE,LIVE OR
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