Rotarix oral suspension – vaccine against rotavirus gastroenteritis in infants

Rotarix is an oral vaccine containing live, weakened (attenuated) human rotavirus, strain RIX4414. It is given by mouth as 1.5 ml of suspension from an oral applicator and helps protect infants older than 6 weeks against gastroenteritis (diarrhoea and vomiting) caused by rotavirus.

Rotavirus is the most common cause of severe diarrhoea in infants and young children; it spreads easily via dirty hands after contact with the stool of an infected person. Most children recover on their own, but some become seriously ill with life-threatening fluid loss. The vaccine stimulates antibodies against the most common rotavirus types but – like other vaccines – may not fully protect every vaccinated child.

How does Rotarix protect a baby from rotavirus and when is the vaccine given?

Key facts about the medicine

What is Rotarix used for?

According to the official leaflet, Rotarix is a viral vaccine that helps protect a child older than 6 weeks against gastroenteritis (diarrhoea and vomiting) caused by rotavirus infection.

After vaccination the child’s immune system produces antibodies against the most common rotavirus types. The vaccine does not protect against diarrhoea of other causes.

How is it used and dosed?

• If the child spits out or vomits most of the dose, another dose may be given at the same visit.
• The second dose should also be Rotarix – a different rotavirus vaccine is not recommended for the second dose.
• There are no restrictions on food or drink before or after vaccination; breastfeeding may continue.
• If you miss the scheduled appointment, consult your doctor.

Special patient groups

• Preterm infants (born at or before 28 weeks of gestation): a brief pause in breathing (apnoea) may occur 2–3 days after vaccination – vaccination is carried out under the supervision of healthcare staff.
• Children in close contact with an immunocompromised person, children with a gastrointestinal disorder, children not gaining weight and height as expected, and children with a disease or medicines lowering resistance: discuss with the doctor before vaccination.

Contraindications – when the medicine must not be used

Rotarix must not be given:

• if the child is allergic to rotavirus vaccines or any of the excipients (signs: itchy rash, difficulty breathing, swelling of the face or tongue);
• if the child has previously had intussusception (one part of the bowel telescoping into another);
• if the child was born with a bowel malformation that could lead to intussusception;
• if the child has severe combined immunodeficiency;
• if the child has a severe infection with high fever – vaccination should be postponed until recovery (a mild infection such as a cold is usually not a problem, but ask the doctor);
• if the child has diarrhoea or is vomiting – vaccination may be postponed until recovery.

Precautions and warnings

• Tell the doctor if the mother took medicines during pregnancy that may weaken the immune system.
• Pay special attention to hand hygiene after every nappy change – vaccine virus may be shed in the stool.
• The vaccine contains sucrose; if the child has an intolerance to some sugars, tell the doctor.
• As with other vaccines, protection may not be complete in every child.

Interactions with other medicines, alcohol and food

Tell the doctor about all medicines the child receives. Rotarix can be given at the same time as other routinely recommended vaccines: against diphtheria, tetanus, whooping cough, Haemophilus influenzae type b, oral or inactivated polio vaccine, hepatitis B, and conjugate pneumococcal and meningococcal serogroup C vaccines.

The vaccine is not mixed with other vaccines or solutions.

Pregnancy and breastfeeding

The vaccine is intended for infants. Breastfeeding: according to clinical trial data, breastfeeding does not reduce the protection provided by Rotarix, so breastfeeding can continue during the vaccination period.

Driving and using machines

Not applicable – the vaccine is given to infants.

Possible side effects

• Common (up to 1 in 10 doses): diarrhoea; irritation at the site of administration.
• Uncommon (up to 1 in 100 doses): abdominal pain, flatulence, skin inflammation (dermatitis).
• Reported after marketing: very rarely hives; very rarely intussusception (severe stomach pain, persistent vomiting, blood in the stool, swollen abdomen and/or fever); blood in the stool; apnoea in preterm babies (born at or before 28 weeks); in children with SCID – gastroenteritis and shedding of vaccine virus in the stool.

Report suspected adverse reactions to your doctor, pharmacist or ALIMS.

Overdose, missed dose and stopping treatment

• Spat out or vomited dose: the doctor may give another dose at the same visit.
• Missed appointment: consult the doctor – both doses should be given by 24 weeks of age.
• Second dose: it is recommended that the second dose is also Rotarix.

Related information

• Which probiotic to choose for diarrhoea

Composition, packaging and manufacturer

• Active substance: human rotavirus, live, attenuated, strain RIX4414 – at least 10^6 CCID50 per 1.5 ml.
• Excipients: sucrose, disodium adipate, Dulbecco’s Modified Eagle Medium (DMEM), water for injections.
• Appearance: clear, colourless liquid free of particles.
• Pack: glass oral applicator (prefilled syringe, type I) of 1.75 ml containing 1.5 ml oral suspension with a grey butyl rubber plunger stopper, in a carton.
• Manufacturer: GlaxoSmithKline Biologicals S.A., Rixensart, Belgium. Authorisation number: 515-01-04357-19-001 of 15 September 2020; transfer to Evropa Lek Pharma d.o.o. Belgrade: 515-01-00297-21-001 of 28 July 2021.

Storage

• Keep out of the sight and reach of children.
• Store in a refrigerator (2 °C to 8 °C); do not freeze.
• Store in the original package to protect from light.
• Administer the vaccine immediately after opening.

Frequently asked questions

By what age must a baby receive Rotarix?

The first dose can be given from 6 weeks of age, and both doses must be received by 24 weeks of age, at least 4 weeks apart. Completing vaccination before 16 weeks is recommended.

What if the baby spits out or vomits the vaccine?

According to the leaflet, if the child spits out or vomits most of the dose, another dose may be given at the same visit.

Can I breastfeed before and after vaccination?

Yes. There are no restrictions on food and drink, and breastfeeding does not reduce the protection provided by Rotarix, so it can continue during the vaccination period.

Which symptoms after the vaccine need urgent examination?

Persistent vomiting, severe stomach pain, blood in the stool, a swollen abdomen and/or high fever – these may be signs of very rare intussusception. In preterm babies, watch breathing in the first 2–3 days.

Sources

• ALIMS – Patient Information Leaflet Rotarix oral suspension (September 2020, in Serbian)
• ALIMS – Summary of Product Characteristics Rotarix oral suspension (in Serbian)
• ALIMS – list of marketing authorisation transfers 1 July – 31 August 2021 (Rotarix, in Serbian)

Sources checked on: 23 October 2026.