Rotavirus Pentavalent Live Vaccine (Recombinant, Human) (Bovine) Oral suspension

What is this medicine?

ROTAVIRUS VACCINE ORAL SOLUTION (ROH tuh vahy ruhs vak seen) is used to help prevent a virus infection that can cause fever, vomiting, and diarrhea.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• blood disorder
• cancer
• diarrhea or vomiting
• fever or infection
• growth problems
• immune system problems in infant or in household member
• stomach or intestine problems
• an unusual or allergic reaction to rotavirus vaccine, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

This vaccine is given by mouth. It is given by a health care professional.

A copy of Vaccine Information Statements will be given before each vaccination. Read this sheet carefully each time. The sheet may change frequently.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 6 weeks old for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Keep appointments for follow-up (booster) doses as directed. It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• adalimumab
• anakinra
• etanercept
• infliximab
• medicines that suppress your immune system
• medicines to treat cancer

This medicine may also interact with the following medications:

• immunoglobulins
• steroid medicines like prednisone or cortisone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Report any side effects to your doctor. This vaccine, like all vaccines, may not fully protect everyone.

It may be possible to to pass the rotavirus to others. Talk to your doctor if the infant has close contact with people who are sick or have immune system problems.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• blood in the stool
• breathing problems
• diarrhea or other change in bowel movements
• high fever or infection
• seizures
• stomach pain
• trouble passing urine or change in the amount of urine
• vomiting

Side effects that usually do not require immediate medical attention (report these side effects to your doctor or health care professional if they continue or are bothersome):

• irritable
• low-grade fever
• runny nose
• sore throat

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

This vaccine is only given in a clinic, pharmacy, doctor's office, or other health care setting and will not be stored at home.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.