ROTARIX®
Rotavirus Vaccine, live attenuated
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 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 infections 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 has a history of chronic gastrointestinal disease.
- 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. - 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.
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 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. The first dose will be
given at the earliest at 6 weeks of age. The two doses should be given before
the age of 24 weeks. Each dose will be given on a separate occasion with an
interval of at least 4 weeks between the two doses.
There are no restrictions on your child's consumption of food or liquids,
including breast milk, either before or after vaccination.
Repeat dosing is not indicated if an infant should spit out, regurgitate or
vomit during or after a dose of the vaccine. The vaccination course should be
completed as recommended above.
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
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.
The most commonly reported side-effects are:
- loss of appetite, irritability, fever, fatigue, diarrhoea, vomiting,
regurgitation of food, flatulence, abdominal pain, crying, disturbed sleep,
sleepiness and constipation.
Rarely reported side-effects are:
- chest infection, hoarseness, runny nose, dermatitis, rash and muscle
cramp.
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
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 supplied as a whitish powder in a single dose glass vial with a
separate pre-filled syringe of solvent and an adapter (transfer device) which
allows easy transfer of the solvent into the vial containing the powder for
mixing the vaccine.
Ingredients
The active ingredient of ROTARIX is live attenuated human rotavirus RIX4414
strain.
ROTARIX also contains sucrose, dextran 40, sorbitol, amino acids,
Dulbecco's Modified Eagle Medium (DMEM), calcium carbonate, xanthan gum and
water for injections.
The manufacture of this product includes exposure to bovine derived
materials. 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.