Worldwide
RotaTeq (Rotavirus Vaccine, Live, Oral, Pentavalent)
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Prescribing Information
and
Patient Product Information.
Information for Parents and Family
 What You Need to Know About Rotavirus
 How RotaTeq Can Help Protect Your Baby
 When to Get Your Baby Vaccinated
 Patient Product Information
 Prescribing Information
 Important Safety Information
 To Report Side Effects, 1-800-FDA-1088

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Information for Health Care Professionals
The information on this site is intended for health care professionals in the United States and is not intended for the general public.
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Health care professionals in Canada,
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    RotaTeq is a vaccine that helps prevent rotavirus gastroenteritis. Rotavirus is the most common cause of severe diarrhea in infants. RotaTeq is not a shot; the vaccine is given by mouth. Your child will receive 3 doses of the vaccine. The first dose is given when your child is 6 to 12 weeks of age, the second dose is given 4 to 10 weeks later, and the third dose is given 4 to 10 weeks after the second dose. The last (third) dose should be given to your child by 32 weeks of the age.
    During your baby’s first well visits, ask your health care professional about RotaTeq.
    Important Safety Information
    RotaTeq may not fully protect all children who get the vaccine.
    RotaTeq should not be given to infants who are allergic to any part of the vaccine.
    Your child should not get RotaTeq if he or she has Severe Combined Immunodeficiency Disease (SCID).
    The most common side effects reported after taking RotaTeq were diarrhea, vomiting, fever, runny nose, sore throat, wheezing or coughing, and ear infection. You can ask your health care professional for a more complete list of side effects.
    Other reported side effects include: hives; Kawasaki disease (a serious condition that can affect the heart, symptoms may include fever, rash, red eyes, red mouth, swollen glands, swollen hands and feet, and if untreated, can be life threatening).
    Call your child’s doctor or go to the emergency department right away if, following any dose of RotaTeq, your child has vomiting, diarrhea, severe stomach pain, blood in their stool or change in bowel movements. These may be signs of a serious and life-threatening problem called intussusception. Intussusception can happen even when no vaccine has been given and the cause is usually unknown. Contact your doctor or go to the emergency department right away if your child has any symptoms of intussusception, even if it has been several weeks since the last vaccine dose.
    There are some important things your doctor needs to know about your baby. Tell your doctor if your baby is sick with fever, diarrhea, or vomiting, or is not growing or gaining weight as expected. Tell your doctor if your baby or someone in regular close contact with your baby has a weakened immune system from a disease (like cancer, HIV/AIDS, or a blood disorder) or from medicine (such as steroids). Also tell your doctor if your baby has received a blood transfusion or blood products recently or if he or she was born with gastrointestinal problems, had a blockage, or had abdominal surgery.
    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
    Please read the Patient Product Information and discuss it with your doctor or health care professional. Also available is the physician Prescribing Information.
 
   
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