RotaTeq

RotaTeq is used for:

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Preventing certain types of rotavirus infection in infants and children.

RotaTeq is a live viral vaccine for rotavirus. RotaTeq works by helping your immune system to protect you from rotavirus.

Do NOT use RotaTeq if:

• you are allergic to any ingredient in RotaTeq

Contact your doctor or health care provider right away if any of these apply to you.

Before using RotaTeq :

Some medical conditions may interact with RotaTeq . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have any type of cancer, infection, fever, or other current illness
• if you or someone regularly in close contact with you have a history of a weakened immune system (eg, HIV infection, AIDS) or certain blood problems (eg, leukemia, lymphoma, cancer of the bone marrow or lymphatic system)
• if you or someone regularly in close contact with you take medicine that may weaken the immune system, including an immunosuppressant (eg, cyclosporine) or a corticosteroid (eg, prednisone)
• if you have stomach or bowel problems (eg, blockage); chronic diarrhea and failure to thrive; birth defects; or have had stomach or bowel surgery
• if you have had a recent blood or plasma transfusion, or have received immune globulin

Some MEDICINES MAY INTERACT with RotaTeq . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Corticosteroids (eg, prednisone), immunosuppressants (eg, cyclosporine), or medicines to treat cancer because they may decrease RotaTeq 's effectiveness

Ask your health care provider if RotaTeq may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use RotaTeq :

Use RotaTeq as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with RotaTeq . Talk to your pharmacist if you have questions about this information.
• Take RotaTeq by mouth with or without food.
• Do not mix this vaccine with any other vaccines or solutions. Do not dilute RotaTeq .
• If you miss a dose of RotaTeq , contact your doctor right away.

Ask your health care provider any questions you may have about how to use RotaTeq .

Important safety information:

• RotaTeq should not be used in CHILDREN younger than 6 weeks or older than 32 weeks of age; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using RotaTeq while you are pregnant. It is not known if RotaTeq is found in breast milk. If you are or will be breast-feeding while you use RotaTeq , check with your doctor. Discuss any possible risks to your baby.

Possible side effects of RotaTeq :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

No COMMON side effects have been reported with RotaTeq .

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the stool; diarrhea; severe or persistent stomach pain; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

RotaTeq is usually handled and stored by a health care provider. If you are using RotaTeq at home, store RotaTeq as directed by your pharmacist or health care provider. Protect from light. Keep RotaTeq out of the reach of children and away from pets.

General information:

• If you have any questions about RotaTeq , please talk with your doctor, pharmacist, or other health care provider.
• RotaTeq is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about RotaTeq . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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