Trade.Information

RotaTeq is a vaccine that can help protect your child from getting a virus infection that can cause fever,

vomiting, and diarrhea. The vaccine is given by mouth at 3 different times, each about one to two months

apart. Nearly all children become infected with the rotavirus by the time they are 5 years old.

RotaTeq helps protect against diarrhea and vomiting only if they are caused by the rotavirus. It does not

protect against diarrhea and vomiting that are caused by anything else.

RotaTeq may not fully protect all children that get the vaccine, and if your child already has the virus it will

not help them.

Infection with the Rotavirus is the most common cause of severe diarrhea in infants. Sometimes the

diarrhea and vomiting can be severe and lead to the loss of body fluids (dehydration) and even to death.

Signs that your infant is dehydrated include:

If your infant shows signs that they are dehydrated, you should call the doctor immediately.

There are some things your doctor should know before your child gets the vaccine. You should tell your

doctor if your child:

vaccination.

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steroids) or has received a blood transfusion or blood products within the past 42 days.

immune system. For example, a person in the house with cancer or one who is taking medicines

that may weaken their immune system.

Your child should not get the vaccine if:

the end of this leaflet.

Intussusception is a serious and life-threatening event that occurs when a part of the intestine (the tube

that goes from the stomach to the anus) gets blocked or twisted. Cases of intussusception can occur

when no vaccine has been given and the cause is usually unknown. However, a different rotavirus

vaccine was associated with intussusception and is no longer available.

In clinical trials, RotaTeq was studied in 70,000 infants (35,000 infants received RotaTeq and 35,000

received placebo), and no increased risk of intussusception was found. However, since RotaTeq has

been on the market, cases of intussusception in infants who received RotaTeq have been reported to the

Vaccine Adverse Event Reporting System (VAERS). Intussusception occurred at various times after

vaccination with RotaTeq. Some of these infants required hospitalization and surgery on their intestine or

a special enema to treat this problem.

Call your child’s doctor right away if your child has vomiting, diarrhea, severe stomach pain, blood in their

stool or change in their bowel movements as these may be signs of intussusception. It is important to

contact your doctor if you have questions or if your child has any of these symptoms, at any time after

vaccination, even if it has been several weeks since the last vaccine dose.

The most common side effects reported after taking RotaTeq were diarrhea, vomiting, fever, runny nose

and sore throat, wheezing or coughing, and ear infection.

These are NOT all the possible side effects of RotaTeq. You can ask your doctor or health care provider

for a more complete list.

If your child seems to be having any side effects that are not mentioned in this leaflet, please call your

doctor or other healthcare provider. If the condition continues or worsens, you should seek medical

attention.

You, as a parent or guardian may also report any adverse reactions to your child’s health care provider or

directly to the Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1-800-

Your child may get RotaTeq at the same time as other childhood vaccines.

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 age.

Your health care provider will gently squeeze the vaccine into your child’s mouth (see Figure 1). Your

infant may spit out some or all of it. If this happens, the dose does not need to be given again during that

All 3 doses of the vaccine should be given to your child by 32 weeks of age. Your health care provider

will tell you when your child should come for the follow-up doses. It is important to keep those

appointments. If you forget or are not able to go back at the planned time, ask your health care provider

for advice.

This leaflet gives a summary of certain information about the vaccine. If you have any questions or

concerns about RotaTeq, talk to your health care provider. You can also visit www.rotateq.com.

Active Ingredient: 5 live rotavirus strains (G1, G2, G3, G4, and P1).

Inactive Ingredients: sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium

hydroxide, polysorbate 80 and also fetal bovine serum.