Rotarix contains up to five strains of rotavirus. It is made from both human and animal sources.

Infection with rotavirus can affect the digestive system of babies and young children, causing severe stomach or intestinal illness.

Rotarix oral vaccine is used to help prevent this disease in children.

Rotarix works by exposing your child to a small dose of the virus, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

Rotarix is for use in children between the ages of 6 weeks and 24 weeks old. The first dose should be administered to infants beginning at 6 weeks of age. There should be an interval of at least 4 weeks between the first and second dose. The 2-dose series should be completed by 24 weeks of age.

Like any vaccine, Rotarix may not provide protection from disease in every person.

Your child should not receive Rotarix if he or she has severe combined immunodeficiency disease (SCID). This vaccine should not be given if the child has a history of an intestinal problem called intussusception.

Before taking this medicine

Your child should not receive Rotarix if he or she has ever had a life-threatening allergic reaction to a rotavirus oral vaccine, if the child has ever had intussusception (a blockage of the intestines), or if the child has severe combined immunodeficiency disease (SCID).

If your child has any of these other conditions, Rotarix may need to be postponed or not given at all:

• HIV or AIDS;

• a current stomach illness or diarrhea;

• a congenital stomach disorder or recent stomach surgery;

• cancer, lymphoma, leukemia or other blood disease;

• if the child has recently received drugs that weaken the immune system (such as steroids, medicines to treat psoriasis or rheumatoid arthritis, medicines to prevent organ transplant rejection, chemotherapy or radiation);

• if the child has recently received a blood transfusion; or

• if the child is allergic to latex rubber.

Your child can still receive a vaccine if he or she has a minor cold. In the case of a more severe illness with a fever or any type of infection, wait until the child gets better before receiving Rotarix.

Tell the doctor if anyone living with or caring for the child has cancer or a weak immune system, or is receiving radiation/chemotherapy or using steroids.

Your child will receive Rotarix in a clinic, hospital, or doctor's office. Rotarix is given as an oral (by mouth) liquid.

Rotarix is given in a series of 2 doses. The first dose is usually given when the child is 6 weeks old. The second dose is then given at least 4 weeks after the first dose, but before the child reaches 24 weeks of age.

Your child's booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by your local health department.

Tell your doctor if your child spits up or vomits within 1 or 2 hours after receiving a dose of this vaccine. The child may need to receive a replacement dose to be fully protected from rotavirus.

Always wash your hands after handling the diapers of a child who has been given Rotarix. Small amounts of the virus may be passed in the child's stool and could possibly infect others who come into contact with the child's stool.

Usual Pediatric Dose for Gastroenteritis:

1 mL, orally, for 2 doses, administered at least 4 weeks apart

Comments:

Administer beginning at 6 weeks of age; the 2 dose series of Rotarix should be completed by 24 weeks of age.
If the infant spits out or regurgitates most of the dose, a single replacement dose may be considered at the same visit.

Your child should not receive Rotarix if he or she has ever had a life-threatening allergic reaction to a rotavirus oral vaccine, if the child has ever had intussusception (a blockage of the intestines), or if the child has severe combined immunodeficiency disease (SCID).

If your child has any of these other conditions, Rotarix may need to be postponed or not given at all:

• HIV or AIDS;

• a current stomach illness or diarrhea;

• a congenital stomach disorder or recent stomach surgery;

• cancer, lymphoma, leukemia or other blood disease;

• if the child has recently received drugs that weaken the immune system (such as steroids, medicines to treat psoriasis or rheumatoid arthritis, medicines to prevent organ transplant rejection, chemotherapy or radiation);

• if the child has recently received a blood transfusion; or

• if the child is allergic to latex rubber.

Your child can still receive a vaccine if he or she has a minor cold. In the case of a more severe illness with a fever or any type of infection, wait until the child gets better before receiving Rotarix.

Tell the doctor if anyone living with or caring for the child has cancer or a weak immune system, or is receiving radiation/chemotherapy or using steroids.

Contact the doctor if your child misses a booster dose or if he or she gets behind schedule. Be sure your child receives all recommended doses.

An overdose of Rotarix is unlikely to occur.

For up to 15 days after receiving rotavirus vaccine, the child should avoid coming into contact with anyone who has a weak immune system. There is a chance that the virus could be passed from the child to that person.

Avoid receiving the doses of Rotarix in different clinics or from different doctors. Your child should receive the same brand of rotavirus oral vaccine for all doses given. Different brands of this vaccine may not have the same dosing or booster schedule.

Get emergency medical help if you have signs of an allergic reaction to Rotarix: hives; difficult breathing; swelling of the face, lips, tongue, or throat.

Your child should not receive a booster vaccine if he or she had a life threatening allergic reaction after the first shot.

Keep track of any and all side effects your child has after receiving Rotarix. When the child receives a booster dose, you will need to tell the doctor if the previous shot caused any side effects.

Rotarix may cause intussusception, a blockage of the intestines. Call the doctor at once if your child has severe stomach pain, severe or ongoing diarrhea or vomiting, bloody stools, high fever.

Becoming infected with rotavirus is much more dangerous to your child's health than receiving Rotarix. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

Also call the doctor at once if the child has:

• a seizure;

• ear pain, drainage from the ear;

• chest pain, wheezing, feeling short of breath;

• pain or burning with urination; or

• high fever, redness of the skin or eyes, swollen hands, peeling skin rash, chapped or cracked lips.

Common Rotarix side effects may include:

• ear infection;

• fussiness or crying;

• loss of appetite, diarrhea, vomiting;

• fever;

• wheezing, cough; or

• runny nose, sore throat.

This is not a complete list of side effects and others may occur. Call the doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1 800 822 7967.

Before receiving Rotarix, tell the doctor about all other vaccines your child has received.

Also tell the doctor if your child has recently received drugs or treatments that can weaken the immune system, including:

• steroid medicine;

• cancer treatments;

• medicine to treat or prevent malaria;

• medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders; or

• medicines to treat or prevent organ transplant rejection.

If you child is using any of these medications, he or she may not be able to receive the vaccine, or may need to wait until the other treatments are finished.

This list is not complete. Other drugs may affect Rotarix, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.