Patient
Information Leaflet
Havrix®
Monodose® (Hepatitis A)
Vaccine
Please read all of this leaflet before this vaccine
is given.
-
Keep this leaflet. You may need to read it
again.
-
If you have further questions, please ask your
doctor or your pharmacist.
In this leaflet:
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1. What Havrix Monodose is and what it is used
for
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2. Before having Havrix Monodose
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3. How Havrix Monodose is given
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4. Possible side effects
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5. Storing Havrix Monodose
1. What
Havrix Monodose is and what it is used for?
Havrix
Monodose is a vaccine containing hepatitis A virus. The
virus is not alive so this vaccine cannot cause
hepatitis A infection.
When you are
given Havrix Monodose vaccine your body will make
antibodies (your body’s natural defence system) against
the hepatitis A virus. These antibodies will protect you
against hepatitis A infection from about 2 to 4 weeks
after the injection. To ensure long term protection, you
should receive a booster vaccination 6 to 12 months
after your primary dose. However, as long as you receive
the booster within 5 years, you should still be fully
protected. Once you have had your booster vaccination,
you should remain protected for up to 25 years and are
not expected to need an additional dose of Havrix.
Some general
information on hepatitis A infection is given at the end
of this leaflet.
Having this
vaccine will only protect you against hepatitis A and
not against any other type of hepatitis virus or any
other illness that can cause hepatitis (inflammation of
the liver).
Havrix
Monodose is a cloudy white injectable liquid vaccine in
a prefilled syringe that contains a single 1 ml dose.
Each 1 ml dose of the vaccine contains 1440 ELISA units
of hepatitis A viral protein.
The vaccine
is available in packs of 1 or 10 prefilled syringes.
2.
Before having Havrix Monodose
Do
not have Havrix Monodose if the answer is “Yes” to
any of the following:
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Have you ever had an allergic reaction to any
vaccine intended to protect against hepatitis A
infection?
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Do you think you may be allergic to Havrix
Monodose or any of the ingredients listed above?
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Have you ever had a severe allergic reaction to
neomycin or any other antibiotic?
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Are you aged 15 years or younger? A lower dose
vaccine is available for people who are 15 years
and younger.
If you
are not sure about the answers to any of these
questions, ask your doctor or nurse.
Havrix Monodose may have to be
delayed if the answer to the following is “Yes”:
-
Do you have a severe fever (high temperature)?
Take
special care with Havrix Monodose
If you
answer “Yes” to any of the following questions, talk
to your doctor or nurse before the vaccine is given.
You can still have Havrix Monodose, but you may not
develop enough antibody after a single injection to
protect you against infection. Sometimes, you may
also need to have an injection of antibody to try to
protect you until the vaccine starts to work. This
can be given at the same time as you have the
vaccine but will be injected into the opposite arm.
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Are you on dialysis for kidney disease?
-
Do you have a poor immune system (for example,
have you been told that your immunity to
infections is low or are you taking steroid
tablets or other medicines that can lower your
immunity to infections)?
In these
cases, your doctor or nurse may decide that extra
doses of Havrix Monodose should be given and may
take a blood test to measure the antibody levels in
your blood before or after you have the vaccine.
Is it
possible or have you been told that you may already
have been infected with hepatitis A virus but are
not yet showing signs of the infection? For example,
do you live or work with someone who has got
hepatitis A recently? If so, the vaccine may not be
able to prevent you showing signs of the illness.
In this
case, your doctor or nurse may decide to give you an
injection of human antibodies to help prevent you
having the illness.
Pregnancy
Women
who are pregnant may sometimes be vaccinated. Talk
to your doctor or nurse if you are, or if you think
that you might be, pregnant.
Breast-feeding
Women
who are breast feeding may sometimes be vaccinated.
Talk to your doctor or nurse if you are breast
feeding.
Driving and using machines
Having
this vaccine should not affect your ability to drive
or operate machinery.
Taking/using other medicines
Please
tell your doctor or nurse if you are taking, or have
recently taken, any other medicine. You can be given
other vaccines at the same time as Havrix Monodose.
You will be given these vaccines at different
injection sites.
3. How
Havrix Monodose is given
Havrix
Monodose (1ml) is injected into the muscle in your upper
arm.
The first
dose of vaccine should protect people with normal
immunity from infection with hepatitis A virus within
2-4 weeks after the injection. Protection should last
for at least 1 year.
To ensure
that you are protected for up to 25 years you should
have a second (booster) dose of the vaccine 6 to 12
months after the first injection. Having 2 doses within
1 year is the best way to make sure that you are
protected, and that protection will last for up to 25
years without interruption.
If you miss
the date for your booster injection but you have a
second dose within 5 years of the first dose, you should
still be protected from hepatitis A infection for up to
25 years.
If you do
not manage to have a second dose within 5 years of the
first dose, your doctor may decide that you should start
again and have 2 doses of the vaccine within 1 year.
The vaccine
is for people aged 16 years and over. Children (1 to 15
years of age) should be given Havrix Junior Monodose.
4.
Possible side effects
Like all
medicines, including all vaccines, Havrix Monodose can
have side effects.
Very rarely
some people can have severe allergic reactions after
having the vaccine, these usually happen very soon after
the injection. These can involve difficulty breathing,
tightness in the throat, rapidly spreading rashes,
dizziness, loss of consciousness because of very low
blood pressure, and a very fast heart beat.
These severe
reactions need urgent medical help.
Therefore,
you may be asked to stay in the surgery or vaccination
area for a short time after the vaccine has been given
to check that an immediate allergic reaction does not
occur.
Please tell
your doctor or nurse if you develop any of these or any
other worrying effects after leaving the clinic, it is
urgent to get medical help.
Very rarely
some people have had a fit (convulsion) after having the
vaccine. If this happens, tell your doctor immediately.
Extremely
rarely there may be reactions involving the nerves. You
should tell your doctor immediately if you notice any of
the following: pins and needles, loss of feeling or
numbness, problems moving your arms or legs or
difficulty with walking and moving about.
The
commonest side effects are a mild soreness, redness or
hardness at the site of the injection. This should last
only a few days.
Less
commonly you may feel generally unwell, or have a rash,
fever, tiredness, headache, sickness, diarrhoea or loss
of appetite.
Occasionally
tests for liver function can become abnormal for a short
time.
Very rarely
some people have joint or muscle pain following
vaccination. If you notice any side effects not
mentioned in this leaflet, please tell your doctor or
nurse.
5.
Storing Havrix Monodose
Your doctor
or nurse will usually have supplies of Havrix Monodose
and will have stored it correctly.
However, if
you have been given a prescription for Havrix Monodose
to collect from your pharmacist (chemist), you should
store the vaccine carefully in its outer container, in a
refrigerator between 2°C and 8°C. The vaccine should not
be frozen. The doctor or nurse will check that the
expiry date on the outer package has not passed.
Disease
information on hepatitis A
Hepatitis A
virus causes an infection of the liver. You can catch
the virus by eating or drinking contaminated food or
water. The virus is present in the stools (motions) of
infected people, even when they may have no signs of the
infection. You can catch hepatitis A infection in any
country but the risk is highest in places and countries
where sanitation and food and water hygiene are poor.
After
catching the virus, it can be up to six weeks before
signs of illness are seen. Some people have the virus
and never get ill but they can still infect other people
during this time.
The main
signs of the illness include a headache, fever, sickness
and jaundice (yellowing of the skin and eyes). These
signs are all due to an inflammation of the liver while
it is infected with the virus.
Most
patients get better usually after a couple of months,
but a few people may take up to a year to make a full
recovery. Whilst recovering, people affected with
hepatitis A may be unable to work, they may not be able
to drink alcohol and may need to avoid certain foods
according to their doctors’ advice. Severe complications
are very rare but sometimes the liver stops working and
very special hospital care is needed until the infection
gets better.
There are
many other types of virus that can cause hepatitis. The
signs may be the same as in hepatitis A infection but
the other viruses are not always caught through food and
drink.
Havrix
Monodose can help to protect you against infection with
the hepatitis A virus only.
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