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INDICATIONS AND USAGE FOR ROTATEQ

RotaTeq is indicated for the prevention of rotavirus gastroenteritis in infants
and children caused by Types G1, G2, G3, G4, and G9 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.

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This site is intended only for residents of the United States, its territories,
and Puerto Rico. Copyright © 2019 Merck Sharp & Dohme Corp., a subsidiary of
Merck & Co., Inc.

All rights reserved. US-STE-00262 03/19

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ROTATEQ: EASE OF ADMINISTRATION


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INDICATIONS AND USAGE FOR ROTATEQ

RotaTeq® (Rotavirus Vaccine, Live, Oral, Pentavalent) is indicated for the
prevention of rotavirus gastroenteritis in infants and children caused by Types
G1, G2, G3, G4, and G9 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.

The vaccination series consists of 3 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.

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SELECTED SAFETY INFORMATION FOR ROTATEQ

RotaTeq should not be administered to infants with a demonstrated history of
hypersensitivity to the vaccine or any component of the vaccine.
Infants with Severe Combined Immunodeficiency Disease (SCID) should not receive
RotaTeq. Post-marketing reports of gastroenteritis, including severe diarrhea
and prolonged shedding of vaccine virus, have been reported in infants who were
administered RotaTeq and later identified as having SCID.


SELECTED SAFETY INFORMATION FOR ROTATEQ

RotaTeq® (Rotavirus Vaccine, Live, Oral, Pentavalent) should not be administered
to infants with a demonstrated history of hypersensitivity to the vaccine or any
component of the vaccine.

Infants with Severe Combined Immunodeficiency Disease (SCID) should not receive
RotaTeq. Post-marketing reports of gastroenteritis, including severe diarrhea
and prolonged shedding of vaccine virus, have been reported in infants who were
administered RotaTeq and later identified as having SCID.

Infants with a history of intussusception should not receive RotaTeq.

No safety or efficacy data are available from clinical trials regarding the
administration of RotaTeq to infants who are potentially immunocompromised.

In a post-marketing observational study in the US, cases of intussusception were
observed in temporal association within 21 days following the first dose of
RotaTeq, with a clustering of cases in the first 7 days.

No safety or efficacy data are available for administration of RotaTeq to
infants with a history of gastrointestinal disorders.

Vaccine virus transmission from vaccine recipient to nonvaccinated contacts has
been reported. Caution is advised when considering whether to administer RotaTeq
to individuals with immunodeficient contacts.

In clinical trials, the most common adverse events included diarrhea, vomiting,
irritability, otitis media, nasopharyngitis, and bronchospasm.

In post-marketing experience, intussusception (including death) and Kawasaki
disease have been reported in infants who have received RotaTeq.

RotaTeq may not protect all vaccine recipients against rotavirus.

Before administering RotaTeq® (Rotavirus Vaccine, Live, Oral, Pentavalent),
please read the accompanying Prescribing Information. The Patient Product
Information also is available.

INDICATIONS AND USAGE FOR ROTATEQ

RotaTeq® (Rotavirus Vaccine, Live, Oral, Pentavalent) is indicated for the
prevention of rotavirus gastroenteritis in infants and children caused by Types
G1, G2, G3, G4, and G9 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.

The vaccination series consists of 3 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.

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