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TWINRIX® (720/20) and TWINRIX®

JUNIOR (360/10)
Combined hepatitis A and hepatitis B vaccine

CONSUMER MEDICINE INFORMATION LEAFLET


viruses - hepatitis A and hepatitis  day-care centre staff
In this leaflet, TWINRIX refers B viruses. particularly where children
to both TWINRIX (720/20) and have not been toilet
TWINRIX JUNIOR (360/10). Hepatitis A trained
Symptoms of hepatitis A  staff and residents of
WHAT IS IN THIS LEAFLET usually begin 3 to 6 weeks homes for the intellectually
after coming into contact with disabled
This leaflet answers some of the virus. These consist of  sewerage workers
the common questions about nausea (feeling sick), fever,  food handlers
TWINRIX vaccine. It does not aches and pains. After a few  homosexual men
contain all the available days the skin and/or the whites  people in contact with an
information. It does not take of the eyes may become infected person
the place of talking to your yellowish (jaundice). The  people with chronic liver
doctor or pharmacist. severity and type of symptoms disease or liver
can vary. Hepatitis A is often transplants, or people who
All medicines and vaccines milder in young children. Most receive certain blood
have risks and benefits. Your people recover completely but products.
doctor has weighed the the illness is usually severe
possible risks of you or your enough to keep adults off work Hepatitis B
child having TWINRIX against for about a month. The hepatitis B virus is found
the expected benefits. in body fluids such as blood,
The hepatitis A virus can be semen, vaginal secretions, or
passed from person to person saliva of infected people.
If you have any concerns
in food and drink, or by You can catch the virus if it
about receiving TWINRIX
swimming in water can enter your bloodstream.
talk to your doctor, nurse or
contaminated by sewage. Ways this can happen are
pharmacist.
Hepatitis A is very common in through:
many parts of the world and
Keep this leaflet with this the risk of infection is greatest
vaccine. You may need to  injection (eg needlestick
in those areas where hygiene
read it again. injury, or sharing needles
and sanitation are poor.
for IV drug use)
Vaccination is recommended
WHAT TWINRIX IS USED  sexual intercourse
for travellers to all developing
FOR countries, including people in  sores, cuts or tiny wounds
the armed forces. coming into contact with
infected fluids (eg from a
TWINRIX is a combination
Hepatitis A occurs in Australia, human bite, sharing
vaccine used to prevent
but is not common. Some razors or toothbrushes, or
hepatitis A and hepatitis B
working with human blood
infection. The vaccine works groups of people however are
at a higher risk of exposure to or body fluids)
by causing the body to
the disease. Vaccination is  an infected mother
produce its own protection
recommended for these passing the virus onto her
(antibodies) against these
people: baby during or shortly
diseases.
after birth.
Hepatitis A and hepatitis B are  nursing staff and healthcare
workers in contact with Some people infected with
infectious diseases, which
patients in childrens wards, hepatitis B may not look or
cause the liver to become
infectious diseases wards, feel sick yet others will get
inflamed (swollen). These
emergency rooms and symptoms. Symptoms may
diseases are caused by
intensive care units not appear for 6 weeks to 6

1
months after infection. with hepatitis A or hepatitis B
Sometimes people will only virus at the time of vaccination,  you have/ your child has
have mild flu-like symptoms, TWINRIX may not prevent the an allergy to baker’s
but other people can disease in these people. yeast.
become very ill. They may
be extremely tired, and have BEFORE RECEIVING TWINRIX  you are or think you may
dark urine, pale faeces, be pregnant or if you
yellowish skin and/or eyes intend to become
DO NOT HAVE TWINRIX IF:
(jaundice), and other pregnant. Your doctor will
symptoms possibly requiring  you have/ your child has had
an allergic reaction to discuss with you the
hospitalisation. There is a possible risks and
risk of serious liver disease, TWINRIX, or any ingredient
benefits of receiving
such as cirrhosis (liver contained in this vaccine
(e.g. neomycin sulphate). TWINRIX during
scarring) and liver cancer for pregnancy.
all chronic hepatitis B The ingredients are listed at
the end of this leaflet. Signs
carriers.
of an allergic reaction may  you are breast feeding. It
include an itchy skin rash, is not known if TWINRIX
Some groups of people are passes into breast milk,
at a higher risk of exposure shortness of breath and
swelling of the face or however the vaccine is
to hepatitis B. Vaccination is not expected to cause
recommended for these tongue.
problems for breast-fed
people: babies.
If you have/ your child has had
 some healthcare workers
TWINRIX before and became
 abusers of injectable you have/ your child has any
unwell, tell your doctor, nurse
drugs medical conditions, such as:
or pharmacist before the
 people with many sexual vaccine is given.
partners - severe heart or lung
 homosexual men  you have/ your child has disease
 haemodialysis patients or had an allergic reaction to - a liver or kidney problem
people who receive certain any other hepatitis A or - an immune deficiency
blood products hepatitis B vaccine. condition (eg. HIV positive)
 people with chronic liver - a nervous system illness
disease or hepatitis C - or a bleeding disorder;
 you have/ your child has a
 people in contact with a severe infection with a high
hepatitis B carrier or an temperature. A minor  you have/ your child has
infected person infection such as a cold allergies to any other
 staff and residents of should not be a problem, medicines or substances,
institutions for the but talk to your doctor such as dyes, foods or
intellectually disabled about this before being preservatives.
 inmates and prison staff at vaccinated.
some correctional  you have/ your child has
institutions  the expiry date printed on received another vaccine
 some travellers to areas the pack has passed. recently, or are taking
where the incidence of any prescription or OTC
(over-the-counter)
hepatitis B is high  the packaging is torn or
medicines. In particular
shows signs of tampering.
There is no specific mention if you are taking
treatment for hepatitis A or medicines which
If you are not sure whether
hepatitis B. Vaccination is suppress the immune
TWINRIX should be given, talk
the best way to protect system, such as steroids
to your doctor or nurse. Do or cyclosporin.
against infection. not give this vaccine to
anyone else; your doctor has Fainting can occur following, or
TWINRIX will not protect prescribed it specifically for
against hepatitis caused by even before, any needle
you or your child. injection, therefore tell the
other agents or viruses (such
as hepatitis C or hepatitis E). doctor or nurse if you/your
BEFORE RECEIVING TWINRIX child fainted with a previous
If a person is already infected TELL YOUR DOCTOR IF: injection.

2
 First dose: at an elected date IF YOU MISS A DOSE
Some vaccines may be  Second dose: 1 month later If you miss a scheduled dose,
affected by other vaccines or  Third dose: 6 months after the talk to your doctor and arrange
medicines. Your doctor or first dose another visit as soon as
pharmacist will be able to tell possible.
you what to do if TWINRIX is For adults, TWINRIX (720/20)
to be given with another can also be given as a total of WHILE YOU ARE USING
vaccine or medicine. three doses over 3 weeks (a 0, TWINRIX
7, 21 day schedule). However,
the body’s immune response to THINGS YOU MUST DO:
HOW TWINRIX IS GIVEN this rapid schedule may be Keep your follow up visits with
reduced compared to the above the doctor or clinic. It is
The doctor or nurse will give schedule. Therefore, this rapid important that the follow-up
TWINRIX as an injection. If schedule should only be used doses of TWINRIX are given at
you have any concerns under special circumstances
the correct times. This will
about how this vaccine is to (e.g. adult travellers wanting to ensure the best effect of the
be given, talk to your doctor be vaccinated within one month vaccine in protecting you
or pharmacist. of departure). A booster dose is against hepatitis A and
recommended at 12 months.
hepatitis B.
Children (1 to 15 years inclusive)
HOW MUCH IS GIVEN THINGS TO BE CAREFUL
TWINRIX (720/20) is generally
The dose using TWINRIX OF:
given as a total of two doses 6 to
(720/20) is 1 mL. Be careful driving or operating
12 months apart. Each dose is
The dose using TWINRIX machinery until you know how
given on a separate visit. The
JUNIOR (360/10) is 0.5 mL TWINRIX affects you.
first dose will be given on an
TWINRIX should not normally
elected date. The second dose
HOW IT IS GIVEN interfere with your ability to
will be given 6 to 12 months after
TWINRIX will be injected into drive a car or operate
the first dose.
your upper arm muscle in machinery. But in some
adults and older children, and people vaccination can cause
 First dose: at an elected date
into the thigh muscle in dizziness or lightheadedness.
infants. For some people with  Second dose: 6 to 12 months
Make sure you know how you
bleeding problems, the dose after the first dose. react to TWINRIX before you
may need to be given under drive a car or operate
the skin (subcutaneously). In children who are travelling to machinery, or do anything that
Each dose of TWINRIX is for areas where there is a risk of could be dangerous if you feel
single use only. Any residual exposure to hepatitis B, dizzy or lightheaded.
vaccine must be discarded. TWINRIX Junior (360/10) should
be given as a total of 3 doses
The vaccine should never be over 6 months ( a 0, 1, 6 month
schedule). SIDE EFFECTS
given intravenously.
It is important to return at the Tell your doctor, nurse or
WHEN IT IS GIVEN
recommended times for follow pharmacist as soon as
Adults up doses. possible if you or your child
TWINRIX (720/20) is do not feel well during or
generally given as a total of Your doctor will advise on the after a dose of TWINRIX.
three doses over 6 months. possible need for extra doses,
Each dose is given on a and future booster dosing. TWINRIX helps protect most
separate visit. The first dose people from hepatitis A and
will be given on an elected hepatitis B, but it may have
date. The remaining two unwanted side effects in a few
doses will be given one people. All medicines and
month, and six months after vaccines can have side effects.
the first dose. Most of the time they are not
serious; however, sometimes

3
they can be. Some side  feelings of numbness,
effects may need medical weakness and/ or fatigue TWINRIX is usually stored at
treatment. in limbs, tingling in the doctor’s clinic or surgery,
fingers or toes, or at the pharmacy. But if you
Ask your doctor or  generalised stiffness, need to store TWINRIX
pharmacist to answer any visual changes, difficulty always:
questions you may have. passing urine
 swollen glands, unusual  Keep TWINRIX in the
Most unwanted effects with bleeding, bleeding or refrigerator stored between
TWINRIX are mild and usually bruising more easily than +2 C and +8 C. THE PACK
clear up within a few days. normal SHOULD NEVER BE
These effects, generally occur  drooping eyelids or FROZEN. FREEZING
around the injection site sagging facial muscles DESTROYS THE
(soreness, redness, swelling).  sudden headache, neck VACCINE.
Fatigue, headache, fever and stiffness, dislike of bright
generally feeling unwell have lights, convulsions (fits)  Keep the vaccine out of the
also been reported, as have reach of children.
feeling sick and vomiting.  As with all vaccines given
by injection there is a very  Keep TWINRIX in the
MILD EVENTS that have small risk of serious allergic original pack until it is time
been reported after hepatitis reaction. This may occur for it to be given.
A or hepatitis B vaccination. days to weeks after
 Tell your doctor if you vaccination. Contact your Ask your pharmacist what to
notice any of the doctor immediately or go to do with any left over TWINRIX
following that are the casualty department of that has expired or has not
troublesome or ongoing: your nearest hospital if any been used.
 soreness, redness, of the following happens:
swelling, bruising, hard
 swelling of limbs, face,
lump or itching around PRODUCT DESCRIPTION
eyes, inside of nose, mouth
the injection site
or throat
 headache, fatigue, fever,
 shortness of breath, WHAT IT LOOKS LIKE:
dizziness, disturbed
breathing or swallowing TWINRIX comes in prefilled
sleep, fainting
difficulties syringes or glass vials. It is a
 feeling sick or vomiting,
 hives, itching (especially of white, slightly milky liquid.
gut pain, diarrhoea, loss
the hands or feet),
of appetite
reddening of skin INGREDIENTS:
 cough, sore throat, (especially around the The active ingredients of
respiratory infections. ears), or severe skin TWINRIX are killed hepatitis A
 ringing in the ears, neck reactions virus and the surface protein of
stiffness  unusual tiredness or the hepatitis B virus (from
 sweating, chills, flushing weakness that is sudden genetically engineered yeast
or generally feeling and severe. cells). The vaccine is not
unwell infectious, and will not give you
 muscle aches and pains, Other side effects not listed hepatitis A or hepatitis B.
painful joints above, can also occur during or
 immediate injection site soon after a dose of TWINRIX. Two different vaccine strengths
pain, stinging and Check with your doctor, nurse are available:
burning feeling or pharmacist if you or your
child have any other effects.  TWINRIX (720/20): 720
MORE SERIOUS EVENTS ELISA units of killed
that have been reported Do not be alarmed by this list of hepatitis A virus and 20
rarely after hepatitis A or possible side effects. You or micrograms of the hepatitis
hepatitis B vaccination. your child may not experience B surface protein.
 Tell your doctor immediately any.  TWINRIX JUNIOR (360/10):
if you notice any of the 360 ELISA units of killed
following: STORAGE hepatitis A virus and 10

4
micrograms of the hepatitis SPONSOR:
B surface protein. GlaxoSmithKline Australia Pty Ltd
Level 4,
Inactive ingredients in the 436 Johnston Street
vaccine are: aluminium Abbotsford, Victoria, 3067
hydroxide, aluminium
phosphate, sodium chloride, TWINRIX is a registered trade
amino acid supplement, mark of the GlaxoSmithKline
formaldehyde, neomycin group of companies.
sulphate, polysorbate 20,
sodium phosphate - dibasic, © 2016 GSK group of companies.
sodium phosphate - All rights reserved.
monobasic, trometamol and
water. Date of Preparation:
15 September 2016
TWINRIX is made without
any human blood or blood Version 4.0
products.

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.

FURTHER INFORMATION

TWINRIX is only available if


prescribed by a doctor.

TWINRIX (720/20) is available


as:
Prefilled syringes in packs of 1
and 10 (AUST R 140575)

TWINRIX JUNIOR (360/10) is


available as:
Prefilled syringes in packs of 1
and 10 (AUST R 140576)
MANUFACTURER

GlaxoSmithKline Biologicals
S.A
rue de l'Institut 89,
1330 Rixensart,
Belgium.

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