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Rotarix

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Rotarix

Rotarix

PATIENT INFORMATION

ROTARIX®
(ROW-tah-rix)
Rotavirus Vaccine, Live, Oral

Read this Patient Information carefully before your baby gets ROTARIX (rotavirus vaccine, live, oral suspension) and before your baby receives the next dose of ROTARIX (rotavirus vaccine, live, oral suspension) . This leaflet is a summary of information about ROTARIX (rotavirus vaccine, live, oral suspension) and does not take the place of talking with your baby's doctor.

What is ROTARIX (rotavirus vaccine, live, oral suspension) ?

ROTARIX (rotavirus vaccine, live, oral suspension) is a vaccine that protects your baby from a kind of virus (called a rotavirus) that can cause bad diarrhea and vomiting. Rotavirus can cause diarrhea and vomiting that is so bad that your baby can lose too much body fluid and need to go to the hospital.

Rotavirus vaccine is a liquid that is given to your baby by mouth. It is not a shot.

Who should not take ROTARIX (rotavirus vaccine, live, oral suspension) ?

Your baby should not get ROTARIX (rotavirus vaccine, live, oral suspension) if a doctor has told you that your baby's digestive system has a defect (is not normal).

Tell your doctor if your baby:

  • Has had an allergic reaction to the last dose of ROTARIX (rotavirus vaccine, live, oral suspension) .
  • Is allergic to any ingredient of ROTARIX (rotavirus vaccine, live, oral suspension) or to latex.
  • Has problems with his/her immune system.
  • Has cancer.
  • Will be in close contact with someone who has problems with his/her immune system or is getting treated for cancer.

If your baby has been having diarrhea and vomiting, your doctor may want to wait before giving your baby a dose of ROTARIX (rotavirus vaccine, live, oral suspension) .

Call your child's doctor right away if your child has vomiting, diarrhea, severe stomach pain, severe crying, blood in their stool or change in his/her bowel movements as these may be signs of a serious problem called intussusception. It is important to contact your doctor if you have questions or if your child has any of these symptoms, even if it has been several weeks since the last vaccine dose.

How is ROTARIX (rotavirus vaccine, live, oral suspension) given?

ROTARIX (rotavirus vaccine, live, oral suspension) is a liquid that is dropped into your baby's mouth and swallowed.

Figure 1. Administration of ROTARIX (rotavirus vaccine, live, oral suspension)

Administration of ROTARIX - Illustration

Your baby will get the first dose at around 6 weeks old.

The second dose will be at least 4 weeks after the first dose (before 6 months old).

Be sure to plan the time for your baby's second dose with the doctor because it is important that your baby gets both doses of ROTARIX (rotavirus vaccine, live, oral suspension) before your baby is 6 months old.

The doctor may decide to give your baby shots at the same time as ROTARIX (rotavirus vaccine, live, oral suspension) .

Your baby can be fed normally after getting ROTARIX (rotavirus vaccine, live, oral suspension) .

What are possible side effects of ROTARIX (rotavirus vaccine, live, oral suspension) ?

The most common side effects of ROTARIX (rotavirus vaccine, live, oral suspension) are:

Call your doctor right away or go to the emergency department if your baby has any of these problems after getting ROTARIX (rotavirus vaccine, live, oral suspension) because these may be signs of a serious problem:

  • Bad vomiting
  • Bad diarrhea
  • Bloody bowel movement
  • High fever
  • Severe stomach pain (if your baby brings his/her knees to his/her chest while crying or screaming).

Talk to your baby's doctor if your baby has any other problems that concern you.

What are the ingredients in ROTARIX?

ROTARIX contains weakened human rotavirus.

ROTARIX (rotavirus vaccine, live, oral suspension) also contains dextran, sorbitol, xanthan, and Dulbecco's Modified Eagle Medium (DMEM). The ingredients of DMEM are as follows: sodium chloride, potassium chloride, magnesium sulphate, ferric (III) nitrate, sodium phosphate, sodium pyruvate, D-glucose, concentrated vitamin solution, L-cystine, L-tyrosine, amino acids solution, L-glutamine, calcium chloride, sodium hydrogenocarbonate, and phenol red. ROTARIX (rotavirus vaccine, live, oral suspension) contains no preservatives.

The dropper used to give your baby ROTARIX (rotavirus vaccine, live, oral suspension) contains latex.

Last reviewed on RxList: 10/30/2009
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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