Rotavirus Vaccine, Live, Oral, Pentavalent, MSD

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about RotaTeq.

It does not contain all the available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines, including vaccines, have risks and benefits. Your doctor has weighed the risks of your child taking RotaTeq against the benefits they expect it will have.

If you have any concerns about this vaccine, ask your doctor, nurse or pharmacist.

Keep this leaflet. You may need to read it again.

What RotaTeq is used for

RotaTeq is a viral vaccine that helps protect your child against gastroenteritis (diarrhoea and vomiting) caused by rotavirus infection.

Rotavirus gastroenteritis may cause fever, vomiting, and diarrhoea. These symptoms can lead to the loss of body fluids (dehydration) and even death.

Rotavirus is the chief cause of severe dehydrating diarrhoea among infants and young children around the world. Before the vaccine was used, the virus was the cause for about 25 million physician visits per year. It also accounted for 2.1 million hospital admissions, and 352,000 to 592,000 deaths per year worldwide.

Rotavirus infects the small intestine and usually starts with fever and vomiting, followed by diarrhoea. The diarrhoea can be mild to severe and generally lasts 3-9 days. Severe vomiting and diarrhoea (more than 5 times each day) lasts an average of 3-6 days. Nearly all children are infected with rotavirus by the time they are 5 years old. This is true even where standards of hygiene are high.

How it works

RotaTeq works by causing your body to produce its own protection (antibodies) against the most common types or "strains" of rotavirus.

As with other vaccines, RotaTeq may not fully protect all those who get it. Some children may already have the virus but not yet show signs of being sick. In those cases, the vaccine may not be able to prevent the illness.

RotaTeq helps protect against diarrhoea and vomiting only if they are caused by rotavirus. It does not protect against them if they are caused by anything else.

Before you take RotaTeq

Before your child starts to take it

Tell your doctor if:

  1. Your child has any medical conditions, especially the following:
  • diseases which decrease the immune system, for example, HIV infection or AIDS
  • cancer
  • blood disorders
  • diarrhoea or vomiting
  • has not been gaining weight
  • is not growing as expected
  • was born with gastrointestinal problems, or has had an intestinal blockage

Tell your doctor if your child has an infection or a high temperature.
Your doctor may decide to delay giving RotaTeq. A mild fever or upper respiratory infection (cold) by itself is not a reason to delay taking the vaccination.

  1. Your child is taking any medicines that may weaken the immune system
  2. Your child has regular close contact with a member of the family or household who has a weakened immune system. For example, a person in the house with cancer or one who is taking medicines that may weaken their immune system.
  3. Your child has any allergies to any other medicines or vaccines, or any other substances, such as food, preservatives or dyes.

Tell your doctor if your child has had a blood or plasma transfusion in the last 42 days. Your doctor may decide to delay vaccination.

When your child must not take it

Your child should not get the vaccine if :

  • He or she has an allergic reaction after getting a dose of the vaccine.
  • He or she is allergic to any of the ingredients of the vaccine. A list of the ingredients can be found at the end of this leaflet.
  • He or she has Sev