Rotarix 10exp6 CCID50/1.5 mL oral suspension

Generic name:
Rotavirus vaccine - oral

Pronunciation
(roe-TUH VYE-russ)

Brand name(s)
Rotarix , Rotateq

This vaccine is used to prevent a certain virus infection (rotavirus) in infants and young children. Rotavirus can cause fever, vomiting, and diarrhea. Although nearly all children become infected with this virus before they are 5 years old, some severe cases can lead to a dangerous (rarely fatal) loss of body fluids (dehydration). Most severe cases occur in children between 6 to 24 months old. This vaccine contains live virus that has been weakened. It works by causing the body to produce its own protection (antibodies) against rotavirus. Like any vaccine, it may not fully protect your child from rotavirus, and it will not help if your child already has the virus. This vaccine does not prevent fever, vomiting, or diarrhea from other causes.

Read all vaccine information available from your health care professional before receiving the vaccine. If you have any questions, ask your health care professional.

This vaccine is given by mouth by a health care professional, usually in 2 or 3 separate doses (depending on the brand). The doses are given at least 4 to 10 weeks apart. For the best protection, it is important to receive all scheduled doses.

This vaccine is usually given at the same time as other vaccines.

Mild fever, diarrhea, or vomiting may occur. If any of these effects last or get worse, tell the health care professional promptly.

Remember that this medication has been prescribed because the health care professional has judged that the benefit to your child is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell the health care professional right away if any of these serious side effects occur:

• high fever (higher than 102 degrees F/39 degrees C)

Rarely, a certain serious intestinal problem (intussusception) has occurred in babies after receiving this vaccine. Intussusception happens when a part of the intestine gets blocked or twisted. The risk may be higher within 21 days after receiving the first dose of rotavirus vaccine, especially in the first 7 days. Get medical help right away if you notice symptoms such as bloody stools or sudden severe abdominal pain/diarrhea. In babies, symptoms may include pulling the knees to the chest and crying, or crying when the abdomen is touched.

A very serious allergic reaction to this vaccine is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact the health care professional.

Contact the health care professional for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may call the Vaccine Safety Section at Public Health Agency of Canada at 1-866-844-0018.

Before your child takes this vaccine, tell the health care professional if your child is allergic to it; or if he/she has any other allergies. This product may contain inactive ingredients (such as latex found in the packaging of some products), which can cause allergic reactions or other problems. Talk to your health care professional for more details.

Before using this vaccine, tell your health care professional your child's medical history, especially of:

• current fever/illness
• current vomiting/diarrhea
• stomach/intestinal problems (such as blockage, intussusception)
• not gaining weight/growing as expected
• blood disorders (such as hemophilia)
• immune system disorders (such as due to HIV infection, SCID, certain cancers such as leukemia/lymphoma, cancer or radiation treatment)

Family or household members with cancer or weakened immune systems may rarely become infected with this virus if they have regular close contact with a child who takes this vaccine. People in close contact with your child should practice good hygiene such as washing hands thoroughly after diaper changes and feedings. Ask the health care professional for more details.

This vaccine is not used by adults. It is unlikely to be used during pregnancy or by a mother while breastfeeding. Consult the health care professional if you have any questions about this vaccine.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your health care professional. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this vaccine include:

• corticosteroids taken by mouth or given by injection (such as dexamethasone)
• drugs that weaken the immune system (such as azathioprine, cyclosporine, cancer chemotherapy, corticosteroids such as prednisone)
• recent blood transfusion

Not applicable.

Keep all medical and lab appointments.

It is important that your child receives each vaccination as scheduled. Be sure to ask when each dose should be received and make a note on a calendar to help you remember. If an appointment is missed, contact the health care professional for advice.

Store in the refrigerator. Do not freeze. Protect from light. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.