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Vaccine product guide

ROTARIX

Rotavirus, live attenuated (human, RIX4414) · Rotavirus (infants)

Health Canada DIN 02300591. Check the product and formulation on your record before using a schedule.

Plan doses for this product →
DIN
02300591
Family
Rotavirus
Guidance checked
2026-09-27
← All Rotavirus (infants) products

About this vaccine

Rotavirus vaccine helps protect babies against a common stomach infection called rotavirus, which causes severe diarrhea and vomiting.

ROTARIX is listed under Health Canada DIN 02300591. The product record and monograph below describe this formulation; the dose schedule comes from the Canadian Immunization Guide.

At a glance

Brand
ROTARIX
DIN
02300591
Vaccine
Rotavirus, live attenuated (human, RIX4414)
Presentation
1.5 mL · oral suspension · infants 6 weeks to under 8 months
Live vaccine
Yes

Age and suitability depend on the product, the person and the reason for vaccination. Use the planner for a starting point and confirm with a healthcare professional.

Official sources

Use the DIN to confirm this exact product in Health Canada's Drug Product Database.

A listed product may not be stocked or publicly funded.

Before and after your vaccination

  • Bring your immunization record if you have one, so earlier doses can be checked.
  • Tell the healthcare professional about a serious reaction to a previous vaccine or an ingredient, and mention any health conditions or medicines that could affect your vaccination.
  • After the dose, stay where you can be observed for at least 15 minutes. Tell someone right away if you feel faint or develop symptoms of an allergic reaction.
  • Keep a record of the vaccine name, date and dose you received.

These steps come from the Canadian Immunization Guide's administration practices and acute reactions guidance.

Practical guidance for ROTARIX

The details below are adapted from a Pharmasist patient handout linked to the same product monograph. The current Canadian Immunization Guide determines the dose schedules shown later.

What this vaccine helps prevent

  • Rotavirus vaccine helps protect babies against a common stomach infection called rotavirus, which causes severe diarrhea and vomiting.
  • Rotavirus spreads very easily from hand to mouth, especially through contact with an infected person's stool.
  • Most children recover from rotavirus infection on their own, but some become very sick with severe vomiting, diarrhea, and dangerous fluid loss that needs hospital care.

What to mention before a dose

  • Tell the doctor or nurse if your child has ever had a bowel blockage called intussusception.
  • Tell the doctor or nurse if your child was born with a problem in their stomach or intestines.
  • Tell the doctor or nurse if your child has a rare inherited condition affecting the immune system called Severe Combined Immunodeficiency (SCID).
  • Tell the doctor or nurse if your child has any illness or takes any medicine that weakens their immune system.
  • Tell the doctor or nurse if anyone in your household has a weakened immune system, since the vaccine virus can be passed in your child's stool for a short time after vaccination.
  • Tell the doctor or nurse if your child has diarrhea, is vomiting, or has a high fever, since vaccination may need to be delayed until they recover.
  • Tell the doctor or nurse if your child has had an allergic reaction to a rotavirus vaccine before.

How it is given

  • This vaccine is given by mouth as liquid drops, straight from the applicator, into the side of your child's cheek.
  • It is given as two separate doses, with at least four weeks between them, and both doses must be given before your child is 24 weeks old.
  • If your child spits up or brings back most of the dose, the doctor or nurse may give a single replacement dose at the same visit.
  • This vaccine can be given at the same visit as your child's other routine vaccines.

Important things to know

  • In rare cases, this vaccine has been linked to a bowel blockage called intussusception, most often within a week of the first dose. Get medical help right away if your child has severe stomach pain, keeps vomiting, has blood in their stool, or has a swollen belly, especially in the days after vaccination.
  • After vaccination, the vaccine virus can be present in your child's stool for about ten days. Anyone changing your child's diaper during this time should wash their hands well afterward, especially if they have a weakened immune system.
  • Children with a rare condition called SCID should not receive this vaccine, as it can cause a serious infection in these children.

Effects you may notice

  • Fussiness or irritability is common.
  • Diarrhea is common.
  • Loss of appetite can happen.
  • Vomiting can happen.
  • A mild fever can happen.
  • Cough or a runny nose can happen.
  • Gas or an upset stomach can happen.

When to contact a healthcare professional

  • Contact your doctor if your child seems unusually unwell after vaccination.
  • Contact your doctor if your child has ongoing diarrhea or vomiting that concerns you.
  • Contact your doctor if you notice blood in your child's stool, even if it seems mild.
  • Contact your doctor about any side effect that worries you or does not go away.

When to get emergency help

  • Get emergency help if your child has severe stomach pain, will not stop vomiting, has blood in their stool, or has a swollen belly. These can be signs of a bowel blockage.
  • Get emergency help if your child has a high fever after vaccination.
  • Get emergency help for signs of a severe allergic reaction: hives, an itchy rash, swelling of the face or tongue, or trouble breathing.

Other medicines and vaccines

  • Tell the doctor or nurse about any medicines your child takes, including anything that might affect their immune system.
  • Tell the doctor or nurse if your child has recently had any other vaccine.

Key points to remember

  • Wash your hands well after changing your child's diaper for about ten days after each dose.
  • Bring your child's vaccination record to every appointment.
  • Ask your doctor or healthcare professional any questions you have about this vaccine.

The practical points are adapted from the Pharmasist reference for ROTARIX and its matching product monograph.

Dose schedules

These are Canadian Immunization Guide schedules associated with this DIN. The right schedule depends on age, health, prior doses and reason for vaccination. Public health recommendations may differ from a product monograph's authorized schedule.

Rotavirus (ROTARIX) — two oral doses

2 doses

Two oral doses at least 4 weeks apart, started at 6 to under 15 weeks of age and finished before 8 months.

First dose from 6 weeks of age and before 15 weeks of age; second dose at least 4 weeks later; every dose before 8 months of age. Not given to infants with severe combined immunodeficiency or a history of intussusception. An infant whose first dose was inadvertently given at 15 weeks or later still completes the series, all doses before 8 months.

Check your dose plan →

Pregnancy and breastfeeding

Family guidance on pregnancy: Not applicable: an infant vaccine given from 6 weeks to under 8 months of age.

Family guidance on breastfeeding: Not applicable; a breastfed infant receives the vaccine as usual.

This guidance applies to the vaccine family. Confirm this product's details in the monograph and with your clinician. Immunization in pregnancy and breastfeeding: Canadian Immunization Guide — Chapter updated August 2026.

References and product information

General information only. A suggested date is not an appointment or a prescription; a healthcare professional confirms what you need. Clinical rules reviewed on 2026-09-27.

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