- It is used to prevent very bad stomach problems caused by rotavirus infection.
- If your child has an allergy to this drug or any part of this drug.
- If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If your child has any of these health problems: Birth defect of the stomach or bowel (like Meckel diverticulum) that has not been fixed by surgery, loose stools (diarrhea) or is throwing up, or severe combined immunodeficiency disease (SCID).
- If your child has ever had a very bad type of bowel blockage or twisting (intussusception).
- Tell dentists, surgeons, and other doctors that your child is using this drug.
- If your child has a latex allergy, talk with the doctor.
- This drug may not protect all people who use it. Talk with the doctor.
- Tell the doctor if your child will be in close contact with people who have a weak immune system. This includes people with cancer, immune system problems, or who take drugs that weaken the immune system. There is a chance of spreading the vaccine virus to these people.
If your child is pregnant or breast-feeding a baby:
- Tell the doctor if your child is pregnant or becomes pregnant. You will need to talk about the benefits and risks of your child using this drug while pregnant.
- Tell the doctor if your child is breast-feeding a baby. You will need to talk about any risks to the baby.
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Wheezing or coughing.
- Ear pain.
- The chance of a very bad type of bowel blockage or twisting may be raised in infants and children after taking this drug. Most of the time, this has happened within 7 days after the first dose. Sometimes, this can happen up to many weeks after the last dose. Call the doctor right away if your child has blood in the stools; high fever; or very bad loose stools (diarrhea), throwing up, or stomach pain.
- Rarely, a very bad health problem called Kawasaki disease has happened with this drug. This health problem can affect the heart and can be deadly if left untreated. Call the doctor right away if your child has high fever, rash, red eyes or mouth, swollen glands, or swelling in the arms or legs.
- Feeling fussy.
- Runny nose.
- Not hungry.
- Throwing up.
- Crying that is not normal.
- Loose stools (diarrhea).
- Sore throat.
- It is given by mouth only.
- Call your child’s doctor to find out what to do.
- This drug will be given to your child in a hospital or doctor’s office. You will not store it at home.
- If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
- Do not share your child’s drug with others and do not give anyone else’s drug to your child.
- Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
- Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
- Keep all drugs out of the reach of children and pets.
- Check with your pharmacist about how to throw out unused drugs.
- Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, pharmacist, or other health care provider.
- If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
If you have any questions or concerns, talk with a member of your healthcare team. You can reach them Monday through Friday from 9:00 am to 5:00 pm at ____________________. After 5:00 pm, during the weekend, and on holidays, please call____________________. If there’s no number listed, or you’re not sure, call 212-639-2000.