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HAVRIX JUNIOR MONODOSE VACCINE

Active substance(s): HEPATITIS A VIRUS ANTIGEN / HEPATITIS A VIRUS ANTIGEN

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Read all of this leaflet carefully before your child receives this vaccine
because it contains important information for your child.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This vaccine has been prescribed for your child. Do not pass it on to others.
It may harm them.
• If your child gets any side effects talk to your doctor, nurse or pharmacist. This
includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1 What Havrix Junior Monodose is and what it is used for
2 What you need to know before your child receives Havrix Junior Monodose
3 How Havrix Junior Monodose is given
4 Possible side effects
5 How to store Havrix Junior Monodose
6 Contents of the pack and other information
1 What Havrix Junior Monodose is and what it is used for
Havrix Junior Monodose is a vaccine containing the hepatitis A virus. It is used to boost
the body’s immune system to help protect against hepatitis A infection in children and
adolescents from 1 year up to and including 15 years of age.
How Havrix Junior Monodose works
• The virus is not alive so this vaccine cannot cause hepatitis A infection.
• When your child is given Havrix Junior Monodose their body will make antibodies
(the body’s natural defence system) against the hepatitis A virus.
• After 2 to 4 weeks, these antibodies will have been produced and will protect your
child against hepatitis A infection.
• To ensure long term protection, your child should receive a second (booster) vaccination
6 to 12 months after their first dose. As long as the booster is given within 3 years,
they should still be fully protected. Once the booster vaccination is given, they are not
expected to need an additional dose of Havrix.
• Having this vaccine will only protect against hepatitis A and not against any other
type of hepatitis virus or any other illness that can cause hepatitis (inflammation of
the liver).
Some general information on hepatitis A infection is given at the end of this leaflet.
2 What you need to know before your child receives Havrix Junior
Monodose
Havrix Junior Monodose should not be given if:
• your child is allergic (hypersensitive) to any of the ingredients of Havrix (listed in
section 6)
• your child is allergic to any other hepatitis A vaccine or neomycin, an antibiotic that
may be present in very small amounts
• your child is aged 16 years or over, as another product, Havrix Monodose is
recommended for this age group
• your child has a high temperature (fever). The presence of a minor infection such as a
cold should not be a problem. Talk to your doctor first.
Do not give your child Havrix if any of the above apply to them. If you are not sure, talk
to their doctor, nurse or pharmacist before they have Havrix.
Warnings and precautions
Check with the doctor, nurse or pharmacist before Havrix Junior Monodose is given if:
• your child is on dialysis for a kidney problem
• your child already has the hepatitis A virus or is living with someone who has caught
the hepatitis A virus recently
• your child has any problem with the way their body fights disease
(immunosuppression).
If any of the above apply to your child, Havrix Junior Monodose can still be given, but
your child may not develop enough antibodies after a single injection to protect them
against infection.
In these cases, the doctor or nurse may decide that extra doses of Havrix Junior
Monodose should be given and may take a blood test to measure the antibody levels in
the blood before or after the vaccine is given.
Sometimes, an antibody injection will be given to try and protect your child until the
vaccine starts to work. This can be given at the same time as they have the vaccine but
will be injected into the opposite arm.
Fainting can occur (mostly in adolescents) following, or even before, any needle injection.
Therefore tell the doctor or nurse if your child fainted with a previous injection.
Other medicines or vaccines and Havrix Junior Monodose
Tell your doctor or nurse if your child is taking, about to be given or has recently taken,
any other medicine. Havrix Junior Monodose can be given at the same time as most
other routine childhood vaccines. These vaccines will be given at different injection sites.
In particular talk to your doctor if:
• your child is taking a medicine that can affect the way in which their body
fights disease. Your child should not have Havrix if they are taking this type of
medicine
Pregnancy and breast-feeding
• Women who are pregnant may sometimes be vaccinated. If they are over
16, they should not receive the Havrix Junior Monodose, but should have the
Havrix Monodose vaccine instead.
• Talk to their doctor or nurse if the person to be vaccinated thinks they are, or
that they might be, pregnant.
• Talk to their doctor or nurse if the person to be vaccinated is breast-feeding.
It is sometimes possible to have the vaccine if they are breast-feeding.
Important information about some of the ingredients of Havrix Junior
Monodose
Please tell your doctor if your child has had an allergic reaction to neomycin
(antibiotic).
3 How Havrix Junior Monodose is given
• H
 avrix Junior Monodose is for use in children and adolescents from 1 year up
to and including 15 years of age.
• Adolescents 16 years and above should receive Havrix Monodose.
• A single dose of 0.5 ml is injected into the muscle in the upper arm.
• The first dose of vaccine should protect your child from infection with
hepatitis A virus within 2 to 4 weeks. Protection should last for at least 1 year.
• The best way to ensure that protection continues for at least 10 years is to
receive a second (booster) dose of the vaccine. This should be given 6 to
12 months after the first injection.
• If the date for the booster injection is missed but a second dose is given
within 3 years of the first dose, protection against hepatitis A infection should
still continue for at least 10 years.
• If a second dose is not given within 3 years of the first dose, the doctor may
decide that vaccination should start again, with 2 doses of vaccine within
1 year.
4 Possible side effects
Like all medicines, this vaccine can have side effects, although not everybody gets them.
Allergic reactions (these may occur with up to 1 in 10,000 doses of the vaccine)
See your doctor straight away, if your child has an allergic reaction. The signs may include:
• local or widespread rashes that may be itchy or blistering
• swelling of the eyes and face
• difficulty in breathing or swallowing

481665

Package Leaflet:
Information for the User

• a sudden drop in blood pressure
• a very fast heart beat
• loss of consciousness.
These signs usually start very soon after the injection has been given to
your child. See a doctor straight away if they happen after leaving the
clinic.
Other side effects include:
Very common (these may occur with more than 1 in 10 doses of the vaccine):
• Irritability
• Pain and redness at the injection site
Common (these may occur with up to 1 in 10 doses of the vaccine):
• Loss of appetite
• Headache
• Drowsiness
• Nausea
• Swelling or hard lump at the injection site
• Generally feeling unwell
• Fever
Uncommon (these may occur with up to 1 in 100 doses of the vaccine):
• Diarrhoea and vomiting
• Rash
Rare (these may occur with up to 1 in 1000 doses of the vaccine):
• Abnormal sensation such as of burning, prickling, tickling or tingling, pins and
needles, loss of feeling or numbness
• Itching
• Fatigue
• Chills
Not known: frequency cannot be estimated from the available data
• Fits or seizures
• Inflammation of the blood vessels, often with skin rash
• Hives, red, often itchy spots which starts on the limbs and sometimes on the face and
the rest of the body.
• Joint pain
Occasionally tests for liver function can become abnormal for a short time. Extremely
rarely there may be reactions involving the nerves. You should tell your doctor
immediately if your child has problems moving their arms or legs or difficulty with
walking and moving about.
If any of the side effects gets serious or if you notice any side effects not mentioned in
this leaflet, please tell your doctor or nurse.
If your child gets any side effects, talk to your doctor, pharmacist or nurse. This includes
any possible side effects not listed in this leaflet. You can also report side effects directly
via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this
medicine.
5 How to store Havrix Junior Monodose







Keep out of the sight and reach of children.
Store between 2°C and 8°C in a refrigerator.
Do not freeze.
Store in the original package with this leaflet in order to protect from light.
Do not use after the expiry date which is stated on the label and carton.
Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will
help protect the environment.

6 Contents of the pack and other information
What Havrix Junior Monodose contains
• The active ingredient is inactivated hepatitis A virus. Each 0.5 ml dose of the vaccine
contains 720 ELISA units of hepatitis A viral protein, adsorbed on aluminium
hydroxide, hydrated.
• The other ingredients are polysorbate 20, amino acids for injection, disodium
phosphate, monopotassium phosphate, sodium chloride, potassium chloride and
water for injections.
What Havrix Junior Monodose looks like and contents of the pack
Havrix Junior Monodose is a cloudy white injectable liquid vaccine in a pre-filled syringe
that contains a single 0.5 ml dose.
The vaccine is available in packs of 1 or 10 pre-filled syringes.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder:
SmithKline Beecham Ltd,
Stockley Park West, Uxbridge,
Middlesex, UB11 1BT
Manufacturer:
GlaxoSmithKline Biologicals s.a., Rixensart, Belgium.
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio please
call, free of charge:

0800 198 5000 (UK only).
Please be ready to give the following information:
Product name
Havrix Junior Monodose
Reference number
10592/0080
This is a service provided by the Royal National Institute of Blind People.
This leaflet was last revised in April 2016
Havrix and Monodose are registered trade marks of the GSK group of companies
© 2016 GSK group of companies. All rights reserved.
General 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 bowel movement
(motion) 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 6 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 sickness, yellowing of the skin and eyes (jaundice),
fever and headache. 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 weeks or months, but a few people
may take up to a year to make a full recovery. While 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 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 viruses are not always caught through food and drink.

Page 1 of 1

PHARMA CODE N° 1396

PHARMA CODE N° 1396

Havrix® Junior Monodose® Vaccine
Suspension for injection in a pre-filled syringe
Hepatitis A (inactivated) vaccine (adsorbed)

481645

Sometimes, an antibody injection will be given to try and protect your child until the
vaccine starts to work. This can be given at the same time as they have the vaccine
but will be injected into the opposite arm.
Fainting can occur (mostly in adolescents) following, or even before, any needle
injection. Therefore tell the doctor or nurse if your child fainted with a previous
injection.

Havrix® Junior Monodose® Vaccine
Suspension for injection in a pre-filled syringe
Hepatitis A (inactivated) vaccine (adsorbed)

Package Leaflet: Information for the User
Read all of this leaflet carefully before your child receives this
vaccine because it contains important information for your child.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This vaccine has been prescribed for your child. Do not pass it on
to others. It may harm them.
• If your child gets any side effects talk to your doctor, nurse or
pharmacist. This includes any possible side effects not listed in
this leaflet.
What is in this leaflet:
1 What Havrix Junior Monodose is and what it is used for
2 What you need to know before your child receives Havrix Junior Monodose
3 How Havrix Junior Monodose is given
4 Possible side effects
5 How to store Havrix Junior Monodose
6 Contents of the pack and other information

1 What Havrix Junior Monodose is and what it is used for
Havrix Junior Monodose is a vaccine containing the hepatitis A virus. It is used to
boost the body’s immune system to help protect against hepatitis A infection in
children and adolescents from 1 year up to and including 15 years of age.
How Havrix Junior Monodose works
• The virus is not alive so this vaccine cannot cause hepatitis A infection.
• When your child is given Havrix Junior Monodose their body will make
antibodies (the body’s natural defence system) against the hepatitis A virus.
• After 2 to 4 weeks, these antibodies will have been produced and will protect
your child against hepatitis A infection.
• To ensure long term protection, your child should receive a second (booster)
vaccination 6 to 12 months after their first dose. As long as the booster is given
within 3 years, they should still be fully protected. Once the booster vaccination
is given, they are not expected to need an additional dose of Havrix.
• Having this vaccine will only protect against hepatitis A and not against
any other type of hepatitis virus or any other illness that can cause hepatitis
(inflammation of the liver).
Some general information on hepatitis A infection is given at the end of this
leaflet.

2 What you need to know before your child receives Havrix Junior
Monodose
Havrix Junior Monodose should not be given if:
• your child is allergic (hypersensitive) to any of the ingredients of Havrix (listed in
section 6)
• your child is allergic to any other hepatitis A vaccine or neomycin, an antibiotic
that may be present in very small amounts
• your child is aged 16 years or over, as another product, Havrix Monodose is
recommended for this age group
• your child has a high temperature (fever). The presence of a minor infection
such as a cold should not be a problem. Talk to your doctor first.
Do not give your child Havrix if any of the above apply to them. If you are not
sure, talk to their doctor, nurse or pharmacist before they have Havrix.
Warnings and precautions
Check with the doctor, nurse or pharmacist before Havrix Junior Monodose is
given if:
• your child is on dialysis for a kidney problem
• your child already has the hepatitis A virus or is living with someone who has
caught the hepatitis A virus recently
• your child has any problem with the way their body fights disease
(immunosuppression).
If any of the above apply to your child, Havrix Junior Monodose can still be given,
but your child may not develop enough antibodies after a single injection to
protect them against infection.
In these cases, the doctor or nurse may decide that extra doses of Havrix Junior
Monodose should be given and may take a blood test to measure the antibody
levels in the blood before or after the vaccine is given.

Other medicines or vaccines and Havrix Junior Monodose
Tell your doctor or nurse if your child is taking, about to be given or has recently
taken, any other medicine. Havrix Junior Monodose can be given at the same time
as most other routine childhood vaccines. These vaccines will be given at different
injection sites.
In particular talk to your doctor if:
• your child is taking a medicine that can affect the way in which their body fights
disease. Your child should not have Havrix if they are taking this type of medicine
Pregnancy and breast-feeding
• Women who are pregnant may sometimes be vaccinated. If they are over 16,
they should not receive the Havrix Junior Monodose, but should have the Havrix
Monodose vaccine instead.
• Talk to their doctor or nurse if the person to be vaccinated thinks they are, or that
they might be, pregnant.
• Talk to their doctor or nurse if the person to be vaccinated is breast-feeding. It is
sometimes possible to have the vaccine if they are breast-feeding.
Important information about some of the ingredients of Havrix Junior Monodose
Please tell your doctor if your child has had an allergic reaction to neomycin (antibiotic).

Occasionally tests for liver function can become abnormal for a short time.
Extremely rarely there may be reactions involving the nerves. You should tell
your doctor immediately if your child has problems moving their arms or legs
or difficulty with walking and moving about.
If any of the side effects gets serious or if you notice any side effects not
mentioned in this leaflet, please tell your doctor or nurse.
If your child gets any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety
of this medicine.

5 How to store Havrix Junior Monodose







Keep out of the sight and reach of children.
Store between 2°C and 8°C in a refrigerator.
Do not freeze.
Store in the original package with this leaflet in order to protect from light.
Do not use after the expiry date which is stated on the label and carton.
Do not throw away any medicines via wastewater or household waste. Ask
your pharmacist how to throw away medicines you no longer use. These
measures will help protect the environment.

6 Contents of the pack and other information
3 How Havrix Junior Monodose is given
• H
 avrix Junior Monodose is for use in children and adolescents from 1 year up to
and including 15 years of age.
• Adolescents 16 years and above should receive Havrix Monodose.
• A single dose of 0.5 ml is injected into the muscle in the upper arm.
• The first dose of vaccine should protect your child from infection with hepatitis A
virus within 2 to 4 weeks. Protection should last for at least 1 year.
• The best way to ensure that protection continues for at least 10 years is to receive
a second (booster) dose of the vaccine. This should be given 6 to 12 months after
the first injection.
• If the date for the booster injection is missed but a second dose is given within
3 years of the first dose, protection against hepatitis A infection should still
continue for at least 10 years.
• If a second dose is not given within 3 years of the first dose, the doctor may decide
that vaccination should start again, with 2 doses of vaccine within 1 year.

4 Possible side effects
Like all medicines, this vaccine can have side effects, although not everybody gets them.
Allergic reactions (these may occur with up to 1 in 10,000 doses of the vaccine)
See your doctor straight away, if your child has an allergic reaction. The signs may
include:
• local or widespread rashes that may be itchy or blistering
• swelling of the eyes and face
• difficulty in breathing or swallowing
• a sudden drop in blood pressure
• a very fast heart beat
• loss of consciousness.
These signs usually start very soon after the injection has been given to your child.
See a doctor straight away if they happen after leaving the clinic.
Other side effects include:
Very common (these may occur with more than 1 in 10 doses of the vaccine):
• Irritability
• Pain and redness at the injection site
Common (these may occur with up to 1 in 10 doses of the vaccine):
• Loss of appetite
• Headache
• Drowsiness
• Nausea
• Swelling or hard lump at the injection site
• Generally feeling unwell
• Fever
Uncommon (these may occur with up to 1 in 100 doses of the vaccine):
• Diarrhoea and vomiting
• Rash
Rare (these may occur with up to 1 in 1000 doses of the vaccine):
• Abnormal sensation such as of burning, prickling, tickling or tingling, pins and
needles, loss of feeling or numbness
• Itching
• Fatigue
• Chills
Not known: frequency cannot be estimated from the available data
• Fits or seizures
• Inflammation of the blood vessels, often with skin rash
• Hives, red, often itchy spots which starts on the limbs and sometimes on the face
and the rest of the body.
• Joint pain

What Havrix Junior Monodose contains
• The active ingredient is inactivated hepatitis A virus. Each 0.5 ml dose of the
vaccine contains 720 ELISA units of hepatitis A viral protein, adsorbed on
aluminium hydroxide, hydrated.
• The other ingredients are polysorbate 20, amino acids for injection, disodium
phosphate, monopotassium phosphate, sodium chloride, potassium chloride
and water for injections.
What Havrix Junior Monodose looks like and contents of the pack
Havrix Junior Monodose is a cloudy white injectable liquid vaccine in a
pre-filled syringe that contains a single 0.5 ml dose.
The vaccine is available in packs of 1 or 10 pre-filled syringes.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder:
SmithKline Beecham Ltd,
Stockley Park West, Uxbridge,
Middlesex, UB11 1BT
Manufacturer:
GlaxoSmithKline Biologicals s.a., Rixensart, Belgium.
Other formats:
To listen to or request a copy of this leaflet in Braille, large print or audio
please call, free of charge:

0800 198 5000 (UK only).
Please be ready to give the following information:
Product name
Havrix Junior Monodose
Reference number 10592/0080
This is a service provided by the Royal National Institute of Blind People.
This leaflet was last revised in April 2016
Havrix and Monodose are registered trade marks of the GSK group of companies
© 2016 GSK group of companies. All rights reserved.
General 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
bowel movement (motion) 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 6 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 sickness, yellowing of the skin and eyes
(jaundice), fever and headache. 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 weeks or months, but a few
people may take up to a year to make a full recovery. While 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 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 viruses are not always caught
through food and drink.

Page 1 of 1

MINIATURE PHARMA CODE N° 153
MINIATURE PHARMA CODE N° 153

481648

Havrix® Junior
Monodose® Vaccine

Package Leaflet:
Information for the User

Havrix® Junior Monodose® Vaccine
Suspension for injection Hepatitis A (inactivated)
vaccine (adsorbed)
Read all of this leaflet carefully before your
child receives this vaccine because it contains
important information for your child.
• Keep this leaflet. You may need to read it
again.
• If you have any further questions, ask your
doctor or pharmacist.
• This vaccine has been prescribed for your
child. Do not pass it on to others. It may
harm them.
• If your child gets any side effects talk to
your doctor, nurse or pharmacist. This
includes any possible side effects not listed
in this leaflet.
What is in this leaflet:
1 What Havrix Junior Monodose is and what
it is used for
2 What you need to know before your child
receives Havrix Junior Monodose
3 How Havrix Junior Monodose is given
4 Possible side effects
5 How to store Havrix Junior Monodose
6 Contents of the pack and other
information
1 What Havrix Junior Monodose is and
what it is used for
Havrix Junior Monodose is a vaccine
containing the hepatitis A virus. It is used
to boost the body’s immune system to help
protect against hepatitis A infection in
children and adolescents from 1 year up to
and including 15 years of age.
How Havrix Junior Monodose works
• The virus is not alive so this vaccine cannot
cause hepatitis A infection.
• When your child is given Havrix Junior
Monodose their body will make antibodies
(the body’s natural defence system) against
the hepatitis A virus.
• After 2 to 4 weeks, these antibodies will
have been produced and will protect your
child against hepatitis A infection.
• To ensure long term protection, your
child should receive a second (booster)
vaccination 6 to 12 months after their first
dose. As long as the booster is given within
3 years, they should still be fully protected.
Once the booster vaccination is given, they
are not expected to need an additional
dose of Havrix.
• Having this vaccine will only protect against
hepatitis A and not against any other type
of hepatitis virus or any other illness that can
cause hepatitis (inflammation of the liver).
Some general information on hepatitis A
infection is given at the end of this leaflet.
2 What you need to know before your
child receives Havrix Junior Monodose
Havrix Junior Monodose should not be given if:
• your child is allergic (hypersensitive) to
any of the ingredients of Havrix (listed in
section 6)
• your child is allergic to any other hepatitis
A vaccine or neomycin, an antibiotic that
may be present in very small amounts
• your child is aged 16 years or over, as
another product, Havrix Monodose is
recommended for this age group
• your child has a high temperature (fever).
The presence of a minor infection such as a
cold should not be a problem. Talk to your
doctor first.
Do not give your child Havrix if any of the
above apply to them. If you are not sure, talk
to their doctor, nurse or pharmacist before
they have Havrix.
Warnings and precautions
Check with the doctor, nurse or pharmacist
before Havrix Junior Monodose is given if:
• your child is on dialysis for a kidney problem

• your child already has the hepatitis A virus
or is living with someone who has caught
the hepatitis A virus recently
• your child has any problem with
the way their body fights disease
(immunosuppression).
If any of the above apply to your child,
Havrix Junior Monodose can still be given,
but your child may not develop enough
antibodies after a single injection to protect
them against infection.
In these cases, the doctor or nurse may decide
that extra doses of Havrix Junior Monodose
should be given and may take a blood test
to measure the antibody levels in the blood
before or after the vaccine is given.
Sometimes, an antibody injection will be
given to try and protect your child until the
vaccine starts to work. This can be given at
the same time as they have the vaccine but
will be injected into the opposite arm.
Fainting can occur (mostly in adolescents)
following, or even before, any needle
injection. Therefore tell the doctor or nurse
if your child fainted with a previous injection.
Other medicines or vaccines and Havrix
Junior Monodose
Tell your doctor or nurse if your child is taking,
about to be given or has recently taken, any
other medicine. Havrix Junior Monodose
can be given at the same time as most other
routine childhood vaccines. These vaccines will
be given at different injection sites.
In particular talk to your doctor if:
• your child is taking a medicine that can
affect the way in which their body fights
disease. Your child should not have Havrix
if they are taking this type of medicine
Pregnancy and breast-feeding
• Women who are pregnant may sometimes
be vaccinated. If they are over 16, they
should not receive the Havrix Junior
Monodose, but should have the Havrix
Monodose vaccine instead.
• Talk to their doctor or nurse if the person
to be vaccinated thinks they are, or that
they might be, pregnant.
• Talk to their doctor or nurse if the person
to be vaccinated is breast-feeding. It is
sometimes possible to have the vaccine if
they are breast-feeding.
Important information about some of the
ingredients of Havrix Junior Monodose
Please tell your doctor if your child has had
an allergic reaction to neomycin (antibiotic).
3 How Havrix Junior Monodose is given
• Havrix Junior Monodose is for use in
children and adolescents from 1 year up to
and including 15 years of age.
• Adolescents 16 years and above should
receive Havrix Monodose.
• A single dose of 0.5 ml is injected into the
muscle in the upper arm.
• The first dose of vaccine should protect
your child from infection with hepatitis
A virus within 2 to 4 weeks. Protection
should last for at least 1 year.
• The best way to ensure that protection
continues for at least 10 years is to receive
a second (booster) dose of the vaccine. This
should be given 6 to 12 months after the
first injection.
• If the date for the booster injection is
missed but a second dose is given within
3 years of the first dose, protection against
hepatitis A infection should still continue
for at least 10 years.
• If a second dose is not given within 3 years
of the first dose, the doctor may decide
that vaccination should start again, with
2 doses of vaccine within 1 year.

Page 1 of 2

4 Possible side effects
Like all medicines, this vaccine can have side
effects, although not everybody gets them.
Allergic reactions (these may occur with up
to 1 in 10,000 doses of the vaccine)
See your doctor straight away, if your child has
an allergic reaction.
The signs may
include:
• local or
widespread rashes
that may be itchy
or blistering
• swelling of the eyes and face
• difficulty in breathing or swallowing
• a sudden drop in blood pressure
• a very fast heart beat
• loss of consciousness.
These signs usually
start very soon
after the injection
has been given to your child. See a doctor
straight away if they happen after leaving
the clinic.
Other side effects include:
Very common (these may occur with more
than 1 in 10 doses of the vaccine):
• Irritability
• Pain and redness at the injection site

6 Contents of the pack and other
information
What Havrix Junior Monodose contains
• The active ingredient is inactivated
hepatitis A virus. Each 0.5 ml dose of
the vaccine contains 720 ELISA units of
hepatitis A viral protein, adsorbed on
aluminium hydroxide, hydrated.
• The other ingredients are
polysorbate 20, amino acids for
injection, disodium phosphate,
monopotassium phosphate, sodium
chloride, potassium chloride and water
for injections.
What Havrix Junior Monodose looks like
and contents of the pack
Havrix Junior Monodose is a cloudy
white injectable liquid vaccine in a vial
that contains a single 0.5 ml dose.
The vaccine is available in packs of 1 or
10 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation holder:
SmithKline Beecham Ltd,
Stockley Park West, Uxbridge,
Middlesex, UB11 1BT
Manufacturer:
GlaxoSmithKline Biologicals s.a., Rixensart,
Belgium.

Common (these may occur with up to 1 in
10 doses of the vaccine):
• Loss of appetite
• Headache
• Drowsiness
• Nausea
• Swelling or hard lump at the injection site
• Generally feeling unwell
• Fever

0800 198 5000 (UK only).

Uncommon (these may occur with up to 1 in
100 doses of the vaccine):
• Diarrhoea and vomiting
• Rash

Please be ready to give the following
information:
Product name
Havrix Junior Monodose
Reference number 10592/0080

Rare (these may occur with up to 1 in
1000 doses of the vaccine):
• Abnormal sensation such as of burning,
prickling, tickling or tingling, pins and
needles, loss of feeling or numbness
• Itching
• Fatigue
• Chills

This is a service provided by the Royal
National Institute of Blind People.
This leaflet was last revised in April 2016
Havrix and Monodose are registered trade
marks of the GSK group of companies
© 2016 GSK group of companies. All rights
reserved.

Not known: frequency cannot be
estimated from the available data
• Fits or seizures
• Inflammation of the blood vessels, often
with skin rash
• Hives, red, often itchy spots which starts on
the limbs and sometimes on the face and
the rest of the body.
• Joint pain
Occasionally tests for liver function can
become abnormal for a short time. Extremely
rarely there may be reactions involving
the nerves. You should tell your doctor
immediately if your child has problems
moving their arms or legs or difficulty with
walking and moving about.
If any of the side effects gets serious or if you
notice any side effects not mentioned in this
leaflet, please tell your doctor or nurse.
If your child gets any side effects, talk to your
doctor, pharmacist or nurse. This includes
any possible side effects not listed in this
leaflet. You can also report side effects
directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help
provide more information on the safety of
this medicine.
5 How to store Havrix Junior Monodose
• Keep out of the sight and reach of children.
• Store between 2°C and 8°C in a
refrigerator.
• Do not freeze.
• Store in the original package with this
leaflet in order to protect from light.
• Do not use after the expiry date which is
stated on the label and carton.
• Do not throw away any medicines via
wastewater or household waste. Ask your
pharmacist how to throw away medicines
you no longer use. These measures will
help protect the environment.

Other formats:
To listen to or request a copy of this leaflet in
Braille, large print or audio please call, free
of charge:

General 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 bowel movement
(motion) 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
6 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 sickness,
yellowing of the skin and eyes (jaundice), fever
and headache. 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 weeks or months, but a few
people may take up to a year to make a full
recovery. While 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 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 viruses are
not always caught through food and drink.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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