This medication is a vaccine. It 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 helps the body produce immunity (protection) to prevent infection with rotavirus or to lessen the severity of an infection. 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 the Vaccine Information Statement and, if available, the Patient Information Leaflet provided by your health care provider before receiving this vaccine. If you have any questions, ask your health care provider.
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 persist or worsen, tell the doctor or pharmacist promptly.
Remember that the doctor has prescribed this medication because he or she 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 doctor right away if any of these serious side effects occur: persistent/high fever greater 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, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: 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 doctor or pharmacist.
Contact your doctor 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 report side effects to Health Canada at 1-866-234-2345.
Before your child takes this vaccine, tell the doctor or pharmacist 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 pharmacist for more details.
Before using this vaccine, tell your doctor or pharmacist 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 cancer (such as leukemia, lymphoma), blood disorders (such as hemophilia), immune system problems (such as HIV/AIDS, SCID).
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. Consult the doctor for more details.
The doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring your child for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.
Before using this vaccine, tell the doctor or pharmacist of all prescription and nonprescription/herbal products your child may use, especially of: corticosteroids taken by mouth or given by injection (such as dexamethasone), drugs that weaken the immune system (such as azathioprine, cyclosporine, cancer chemotherapy), recent blood transfusion.
This document does not contain all possible interactions. Therefore, before using this product, tell the doctor or pharmacist of all the products your child uses. Keep a list of the medications with you, and share the list with the doctor and pharmacist.
If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Keep all regular medical and laboratory 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 doctor for advice.
Refrigerate between 36-46 degrees F (2-8 degrees C). Do not freeze. Discard the product if it has been frozen. Keep all medicines 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 the pharmacist or local waste disposal company for more details about how to safely discard this product.
Information last revised June 2013. Copyright(c) 2013 First Databank, Inc.
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