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RotaTeq is a vaccine that can help protect babies against common types of rotavirus. Rotavirus is the most common cause of severe diarrhea in infants.
Every year in the United States, rotavirus is estimated to be responsible for up to 70,000 hospitalizations and approximately 250,000
emergency-room visits among children younger than 5 years of age. |
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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 age. |
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Rotavirus can cause mild, moderate, or severe symptoms. Your doctor can't predict which babies will have serious cases. |
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Rotavirus can cause high fever, multiple episodes of vomiting and diarrhea, and can quickly lead to dehydration (loss of body fluids). |
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Dehydration is the most serious complication associated with rotavirus infection. If your child has a severe case of rotavirus and becomes very dehydrated, it can be life threatening. |
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RotaTeq was extensively tested in a large study and was approved by the Food and Drug Administration (FDA) in February 2006. |
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Talk to your doctor today about RotaTeq. |
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| Important Selected Safety Information |
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| 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. |
| 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. Also available is the physician Prescribing Information. |
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This site is intended only for residents of the United States,
its territories, and Puerto Rico.
Residents of Canada, click
here.
PDVA-1000331-0000 |
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