Human Rotavirus (live attenuated oral vaccine) oral liquid

Consumer Medicine Information

What is in this leaflet?

Please read this leaflet carefully before your child receives ROTARIX vaccine.

This leaflet answers some common questions about ROTARIX. It does not contain all of the available information.

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

All medicines and vaccines have risks and benefits. Your doctor has weighed the expected benefits of your child having ROTARIX against the possible risks.

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

Keep this leaflet with the vaccine. You may need to read it again.

What is ROTARIX used for?

ROTARIX is a viral vaccine that helps to protect your child against gastro-enteritis (diarrhoea and vomiting) caused by rotavirus infection.

Rotavirus infection is the most common cause of severe diarrhoea in infants and young children. Rotavirus is easily spread by hand-to-mouth contact with stool from an infected person. Most children with rotavirus diarrhoea recover on their own. Some children become very ill with severe vomiting, diarrhoea and life-threatening loss of fluids that requires hospitalisation. Rotavirus infections are responsible for hundreds of thousands of deaths worldwide every year especially in developing countries, where nutrition and health care are not optimal.

When a person is given the vaccine, the immune system (the body’s natural defences) will make antibodies against the most commonly occurring types of rotavirus. These antibodies may help protect against disease caused by these types of rotavirus.

As with all vaccines, ROTARIX may not completely protect all people who are vaccinated against the disease it is intended to prevent. The vaccine will not protect against gastro-enteritis caused by other types of viruses or organisms.

ROTARIX is not addictive.

Before having ROTARIX

ROTARIX should not be given if:

  • your child has previously had an allergic reaction to ROTARIX or any of the ingredients listed toward the end of this leaflet. (See “Ingredients”) Signs of an allergic reaction include itchy skin rash, shortness of breath and swelling of the face or tongue.
  • your child was born with a defect of the gastro-intestinal system.
  • your child has a rare inherited illness which affects their immune system called Severe Combined Immunodeficiency (SCID).
  • your child has a severe infection with a high temperature. It might be necessary to postpone the vaccination until recovery. A minor infection such as a cold should not be a problem, but talk to your doctor first.
  • your child has diarrhoea or is vomiting. It might be necessary to postpone the vaccination until recovery.
  • your child has previously had intussusception (part of the intestine gets blocked or twisted).
  • the expiry date (EXP) printed on the pack has passed.
  • the packaging is torn or shows signs of tampering.

Tell your doctor if:

  • your child is allergic to foods, dyes, preservatives or any other medicines.
    In these cases, your doctor can determine the right time of vaccination for your child.
  • your child is taking any prescription or OTC (over-the-counter) medicines. Some vaccines may be affected by other vaccines or medicines. Your doctor, nurse or pharmacist will be able to tell you what to do if ROTARIX is to be given with another vaccine or medicine.
  • your child has a history of chronic gastrointestinal disease.

How is ROTARIX given?

The doctor or nurse will administer the recommended dose of ROTARIX to your child. THE VACCINE WILL BE GIVEN ORALLY.

How much is given

ROTARIX is given as a 1.5 mL liquid dose.

How it is given

ROTARIX is given into the mouth. Un