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. Under no circumstance should this vaccine be given by injection.

When will it be given?

Your child will receive two doses of the vaccine. Each dose will be given on a separate occasion with an interval of at least 4 weeks between the two doses. The first dose will be given between 6 and 14 weeks of age and the second dose must be given by 24 weeks of age.

There are no restrictions on your child’s consumption of food or liquids, including breast milk, either before or after vaccination.

In the unlikely event that an infant spits out or regurgitates most of the vaccine dose, a single replacement dose may be given at the same vaccination visit.

It is important that you follow the instructions of your doctor or nurse regarding return visits for the follow-up dose.

IF A DOSE IS MISSED

If you forget to go back to your doctor at the scheduled time, ask your doctor for advice.

After having ROTARIX

Things you must do

After your child has received ROTARIX, contact your doctor/health care professional right away if your child experiences severe stomach pain, persistent vomiting, blood in stools, a swollen belly and/or high fever.

If you are in close contact with a recently vaccinated baby/child, ensure your hands are washed thoroughly:

• after changing nappies
• before eating or handling food.

What are the side-effects?

Check with your doctor as soon as possible if you think your child is experiencing any side effects or allergic reactions due to having ROTARIX, even if the problem is not listed below.

Like other medicines, ROTARIX can cause some side-effects. If they occur, they are most likely to be minor and temporary. However, some may be serious and need medical attention.

Side effects that occurred during clinical trial use of ROTARIX include:

The most commonly reported side-effects are:

• loss of appetite, irritability, fever, fatigue, diarrhoea, vomiting, regurgitation of food, flatulence, abdominal pain (see also below for signs of very rare side effects of intussusception), crying, disturbed sleep, sleepiness and constipation.

Rarely reported side-effects are:

• chest infection, hoarseness, runny nose, dermatitis, rash and muscle cramp.

Side effects that occurred during routine use of ROTARIX include:

Rare (these may occur with up to 1 in 1,000 doses of the vaccine)

• blood in stools
• children with a rare inherited illness called Severe Combined Immunodeficiency (SCID) may have an inflamed stomach or gut (gastroenteritis) and pass the vaccine virus in their stools. The signs of gastroenteritis may include feeling sick, being sick, stomach cramps or diarrhoea.

Very rare (these may occur with up to 1 in 10,000 doses of the vaccine):

• intussusception (part of the intestine gets blocked or twisted). The signs may include severe stomach pain, persistent vomiting, blood in stools, a swollen belly and/or high fever. Contact a doctor/health care professional right away if your child experiences one of these symptoms.

Tell your doctor immediately if you notice any of the following:

• Wheezing, swelling of the lips/mouth, difficulty in breathing, hayfever, lumpy rash (hives) or fainting. These could be symptoms of an allergic reaction.

This is not a complete list of all possible side-effects. Others may occur in some people and there may be some side-effects not yet known.

Tell your doctor or pharmacist if you notice any side effects from your child’s vaccine which are not mentioned here.

Do not be alarmed by this list of possible side-effects. Your child may not experience any of them.

How do I store ROTARIX?

ROTARIX is usually stored at the doctor’s clinic or surgery, or at the pharmacy. But if you need to store ROTARIX always:

• Keep ROTARIX in the refrigerator stored between +2 C and +8 C. Do not freeze. Do not store it in the bathroom, or leave it in the car. Avoid exposing the vaccine to sunlight. HEAT CAN DESTROY THE VACCINE.
• Keep the vaccine out of the reach of children.
• Keep ROTARIX in the original pack until it is time for it to be given.

Ask your pharmacist what to do with any left over ROTARIX that has expired or has not been used.

Product Description

What ROTARIX looks like

ROTARIX is presented as a suspension for oral administration.

ROTARIX is supplied as a clear, colourless liquid, free of visible particles, presented in a single dose squeezable tube (fitted with a membrane and a cap), or as 5 single dose tubes (connected by a bar – pack size of 50 tubes) or a single dose oral applicator (syringe type applicator with a plunger stopper).

Ingredients

The active ingredient of ROTARIX is live attenuated human rotavirus RIX4414 strain.

ROTARIX also contains sucrose, di-sodium adipate, Dulbecco’s Modified Eagle Medium (DMEM), and sterile water.

Supplier

Your ROTARIX is supplied by:

GlaxoSmithKline Australia Pty Ltd
Level 4, 436 Johnston Street
Abbotsford, Victoria, 3067
Australia.

Distributed in New Zealand by:

GlaxoSmithKline NZ Ltd
Private Bag 106600
Downtown Auckland
Ph: (09) 367 2900
Fax: (09) 367 2910

Where to go for further information

Pharmaceutical companies are not in a position to give people an individual diagnosis or medical advice. Your doctor or pharmacist is the best person to give you advice on the treatment of your condition.

This leaflet was prepared on 08 September 2021.

The information provided applies only to: ROTARIX.

Trade marks are owned by or licensed to the GSK group of companies.

ROTARIX: AUST R 146776, 326141 and 320221

© 2021 GSK group of companies or its licensor.

Version 11.0

Published by MIMS July 2023

1 Name of Medicine

Human Rotavirus (live attenuated oral vaccine).

2 Qualitative and Quantitative Composition

Rotarix is a liquid suspension of the live attenuated RIX4414 strain of human rotavirus of the G1P(8) type for use in the prevention of rotavirus gastroenteritis. The virus strain derived from the 89-12 strain is obtained by propagation on a well characterised Vero cell line.
Each 1.5 mL dose of the vaccine contains not less than 10^6.0 CCID₅₀ (cell culture infectious dose 50%) of the RIX 4414 strain of human rotavirus.
The manufacture of this product includes exposure to bovine derived materials at the very early steps of the production process. No bovine materials are used in routine production. No evidence exists that any case of vCJD (considered to be the human form of bovine spongiform encephalopathy) has resulted from the administration of any vaccine product.
The vaccine also contains sucrose. For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Rotarix is presented as a clear, colourless liquid, free of visible particles, for oral administration only.

4 Clinical Particulars

4.1 Therapeutic Indications

Rotarix is indicated for the prevention of rotavirus gastroenteritis. (See Section 5.1 Pharmacodynamic Properties, Clinical trials).

4.2 Dose and Method of Administration

Dosage.

Administration.

Instructions for use and handling.

Instructions for administration of the vaccine in oral applicator (syringe type applicator with a plunger stopper).

Instructions for administration of the vaccine in tube.

1. Pull off the cap.

2. Repeatedly flick the top of the tube until it is clear of any liquid.

3. Position the cap to open the tube.

4. To open the tube.

1. Check the membrane has been pierced.

2. What to do if the membrane has not been pierced.

1. Position the child to give the vaccine.

2. Administer the vaccine.

Instructions for administration of the vaccine presented as 5 single dose tubes connected by a bar.

1. Check the expiry date on the connecting bar.

2. Check the liquid in the oral tubes is clear, colourless and free from any particles.

3. Check that each individual oral tube is not damaged and is still sealed.

1. To separate one oral tube from the others starting at one end.

2. To open the separated oral tube.

1. To position the child to receive the vaccine.

2. To administer the vaccine orally.

4.3 Contraindications

Rotarix should not be administered to subjects with known hypersensitivity to any components of the vaccine (see Section 6.1 List of Excipients), or to subjects having shown signs of hypersensitivity after previous administration of rotavirus vaccines.
Rotarix should not be administered to subjects with any history of chronic gastrointestinal disease including any uncorrected congenital malformation (such as Meckel's diverticulum) of the gastrointestinal tract.
Subjects with history of intussusception.
Subjects with severe combined immunodeficiency (SCID) disorder (see Section 4.8 Adverse Effects (Undesirable Effects)).
As with other vaccines, administration of Rotarix should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection, such as a cold, is not a contraindication for immunisation.

4.4 Special Warnings and Precautions for Use

Rotarix should under no circumstances be injected.
It is good clinical practice that vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events) and a clinical examination.
The administration of Rotarix should be postponed in subjects suffering from diarrhoea or vomiting.
Administration of Rotarix may be considered with caution in infants with gastrointestinal illnesses, when, in the opinion of the physician, the risk of rotavirus infection by withholding the vaccine entails a greater risk to the infant. No safety or efficacy data are available for the administration of Rotarix to infants with gastrointestinal illnesses.
Administration of Rotarix in immunosuppressed infants, including infants on immunosuppressive therapy, should be based on careful consideration of potential benefits and risks.
The risk of intussusception has been evaluated in a large safety trial (including 63,225 infants) conducted in Latin America and Finland. No increased risk of intussusception was observed in this clinical trial following administration of Rotarix when compared with placebo (see Section 4.8 Adverse Effects (Undesirable Effects)).
Data from postmarketing studies indicate an increased incidence of intussusception shortly after the administration of the first dose and second dose of Rotarix (see Section 4.8 Adverse Effects (Undesirable Effects)). Whether vaccination with Rotarix affects the overall risk of intussusception has not been established. The overall incidence of intussusception remains rare.
Therefore, healthcare professionals should follow up on any symptoms suggestive of intussusception after rotavirus vaccine administration. These symptoms can include severe abdominal pain or distress, persistent vomiting, bloody stools, palpable abdominal mass, abdominal bloating and/or high fever.
Parents/ guardians should be advised to seek medical advice promptly where these signs/ symptoms are evident.
Rotarix should not be administered in subjects with a predisposition for intussusception (see Section 4.3 Contraindications).
Excretion of the vaccine virus in the stools occurs after vaccination and lasts for 10 days on average with peak excretion around the 7th day. Viral antigen particles detected by ELISA were found in 50% of stools after the first dose and 4% of stools after the second dose. When these stools were tested for the presence of live vaccine strain, 17% were positive. In two comparative controlled trials, vaccine shedding after vaccination with Rotarix liquid formulation was comparable to that observed after vaccination with Rotarix lyophilised formulation.
In clinical trials, cases of transmission of excreted vaccine virus to seronegative contacts of vaccinees have been observed without causing any clinical symptoms.
There is a potential risk for transmission to nonvaccinated contacts. Therefore Rotarix should be administered with caution to infants with close contacts who are immunodeficient, such as household members with malignancies or who are otherwise immunocompromised or receiving immunosuppressive therapy. Contacts of recent vaccinees should be advised to observe personal hygiene (e.g. washing their hands when changing children's nappies).
As with any vaccine, a protective immune response may not be elicited in all vaccinees (see Section 5.1 Pharmacodynamic Properties, Clinical trials).
The extent of protection that Rotarix might provide against rotavirus strains that have not been circulating in clinical trials is currently unknown (see Section 5.1 Pharmacodynamic Properties, Clinical trials).
Rotarix does not protect against gastroenteritis due to pathogens other than rotavirus.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Coadministration studies have demonstrated that Rotarix can be given concomitantly with any of the following administered either as monovalent or as combination vaccines: diphtheria tetanus acellular pertussis vaccine (DTPa), Haemophilus influenzae type b vaccine (Hib), inactivated polio vaccine (IPV), hepatitis B vaccine (HBV), hexavalent vaccines DTPa-HBV-IPV/Hib, pneumococcal conjugate vaccine and meningococcal serogroup C conjugate vaccine. The studies demonstrated that the immune responses and the safety profiles of the administered vaccines were unaffected.
Clinical studies, involving more than 2,000 subjects, were performed where Rotarix and oral polio vaccine (OPV) were administered two weeks apart. The immune response to Rotarix and OPV was unaffected. In three immunogenicity studies, involving approximately 1,200 subjects, Rotarix was concomitantly administered with OPV. The immune response to OPV, as well as the response to Rotarix after the second dose, were unaffected. Rotarix can be concomitantly administered with OPV if this is in accordance with local recommendations. In the absence of local recommendations, an interval of two weeks between the administration of OPV and Rotarix should be respected.
Although antibodies to rotavirus may be detected in breast milk, the available data show no reduction in efficacy when Rotarix is administered to breastfed infants.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Clinical trial experience.

Solicited adverse events.

Unsolicited adverse events.

Serious adverse events.

Safety in preterm infants.

Safety in infants with human immunodeficiency (HIV) infection.

Post marketing data.

Gastrointestinal disorders.

Blood and lymphatic disorders.

Vascular disorders.

Reporting suspected adverse effects.

4.9 Overdose

Some cases of overdose have been reported. In general, the adverse event profile reported in these cases was similar to that observed after administration of the recommended dose of Rotarix.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Rotavirus is likely to affect all children up to the age of five years of age. The peak incidence of rotavirus gastroenteritis is between 6-24 months of age. Dehydration from rotavirus gastroenteritis can lead to hospitalisation, which is most common in children under 2 years of age.

Mechanism of action.

Clinical trials.

Protective efficacy in Europe.

Between dose efficacy.

Protective efficacy in Latin America.

Protective efficacy in Africa.

^# Note.

5.2 Pharmacokinetic Properties

Not relevant to vaccines.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Rotarix also contains sucrose, di-sodium adipate, Dulbecco's Modified Eagle Medium and sterile water.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine. See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store at 2°C to 8°C. (Refrigerate. Do not freeze.) Store in the original package, in order to protect from light.

6.5 Nature and Contents of Container

1.5 mL of oral suspension in an oral applicator (Type I, Ph. Eur.) with a plunger stopper (butyl rubber). Pack sizes of 1, 5, 10, 25, 50 or 100.
1.5 mL of oral suspension in a squeezable tube Low Density Polyethylene (LDPE) fitted with a membrane and a cap (polypropylene). Pack sizes of 1 or 10.
1.5 mL of oral suspension in a squeezable tube (LDPE) presented in a multi monodose (5 single dose) squeezable tube presentation with a connecting bar. Pack size of 50 tubes.
Not all pack sizes and container types may be distributed in Australia.

6.6 Special Precautions for Disposal

Discard the empty tube and cap according to local regulations.

6.7 Physicochemical Properties

Not relevant to vaccines.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes