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HEPATYRIX SUSPENSION FOR INJECTION

Active substance(s): HEPATITIS A VIRUS ANTIGEN HM 175 STRAIN / SALMONELLA TYPHI VI POLYSACCHARIDE / HEPATITIS A VIRUS ANTIGEN HM 175 STRAIN / SALMONELLA TYPHI VI POLYSACCHARIDE

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473745
GSK-BEL-Wavre-BEWAV
United Kingdom-GBR
Hepatyrix
N/A
BIO_DRW202

Hepatyrix

Read all of this leaflet carefully before you
start receiving this vaccine because it contains
important information for you.
• 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 you. Do not pass
it on to others.
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. See section 4
In this leaflet:
1. What Hepatyrix is and what it is used for
2. What you need to know before you receive Hepatyrix
3. How Hepatyrix is given
4. Possible side effects
5. How to store Hepatyrix
6. Contents of the pack and other information

1 What Hepatyrix is and what it is used for
N/A
N/A
1
K

0

0

TEXT SIZE CONTAINED IN THIS ARTWORK
Body text size: 12pt
Leading: 14.5pt
Horizontal Scale: 100%
Smallest text size: 12pt
Microtext: No

Biologicals
Additional Information Panel
Unfolded dimensions: 210x422mm
Folded dimensions: 210x25mm
2D Pharmacode value: N/A

473745

Hepatyrix is a vaccine which helps prevent hepatitis A and
typhoid fever. Hepatitis A is an infectious illness of the liver
caused by a virus. Typhoid fever is an infectious illness caused
by a type of bacteria called Salmonella typhi.
This vaccine should only be given to adults and teenagers
aged 15 years and above.

2 What you need to know before you
receive Hepatyrix
Hepatyrix should not be given:
• if you are allergic to:
- Hepatyrix or any of the other ingredients of this
vaccine (listed in section 6)
- Neomycin, an antibiotic used to treat skin infections
• if you are allergic to any other hepatitis A injection or any
other typhoid injection
• if you have a high temperature (fever)
Hepatyrix should not be given if any of the above applies to
you. If you are not sure, talk to your doctor or pharmacist
before having Hepatyrix.
Warnings and precautions
Talk to your doctor or pharmacist before you are given
Hepatyrix:
• if you have a weakened immune system (for example due
to HIV infection or due to medicines that suppress the
immune system). You may not get the full benefits from
Hepatyrix
If you are not sure if any of the above apply to you, talk to
your doctor before having Hepatyrix.
Fainting can occur (mostly in adolescents) following, or even
before, any needle injection. Therefore tell the doctor or
nurse if you fainted with a previous injection.

How Hepatyrix works
Hepatyrix contains inactive hepatitis A virus and a very small
part of the bacterium which cause typhoid fever.
• The hepatitis A virus is not alive, so this vaccine cannot
cause hepatitis A infection.
• There are no live bacteria in this vaccine, so it cannot cause
typhoid fever.
• When you are given the vaccine it will trigger the body’s
immune system to prepare itself to protect against these
viruses in the future.
• Like other vaccines, Hepatyrix may not be totally effective
in protecting you against hepatitis A and typhoid fever.
• Hepatyrix will not protect you if you have already caught
hepatitis A or typhoid fever.
• Hepatyrix will only prevent diseases caused by Hepatitis A
virus and by the bacterium Salmonella typhi.
Hepatitis A virus causes an infection of the liver. Typhoid fever
is an infectious illness caused by a type of bacteria called
Salmonella typhi.
Both diseases are caught and spread by eating or
drinking contaminated food or water. The viruses are
present in the bowel movement (motion) of infected
people, even when they may have no signs of the
infection. The diseases can occur in any country, but the
risk is highest in places and countries where sanitation
and food and water hygiene are poor.
The main signs of hepatitis A infection include a headache,
fever, sickness and yellowing of the skin and eyes
(jaundice). Most patients usually get better in a few weeks,
but it may take some months to make a full recovery.
Rarely, hepatitis A infection can also cause serious liver
disease and very rarely death.
The main signs of typhoid fever include headache, pains
in the stomach, constipation or diarrhoea, fever and, in
some people, a rash. Patients normally get better after
about four weeks, but relapses can occur. If it is not
treated properly, typhoid can also be fatal.

Other medicines and Hepatyrix
Tell your doctor or pharmacist if you are taking, have recently
taken, might take any other medicines, including other vaccines.
Hepatyrix can be given at the same time as most other
routine vaccines. The doctor will ensure that the vaccines
are injected separately and into different parts of the body.
Hepatyrix must not be mixed with other vaccines in the same
syringe.
In particular talk to your doctor:
• if you are to be given ‘yellow fever vaccine’
• if you need an injection of immunoglobulins (antibodies
obtained from blood donors)

The following information is intended for medical or
healthcare professional only
The vaccine’s normal appearance is a cloudy white
suspension, which may sediment during storage. Shake the
container well to distribute the suspension uniformly before
administering the vaccine.
The vaccine should be inspected visually for extraneous

particulate matter and/or discolouration prior to
administration. Any unused vaccine or waste material should
be disposed of safely in accordance with local regulations.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your doctor or
pharmacist for advice before you are given this vaccine.
Driving and using machines
Hepatyrix may affect your ability to drive or use machines.
Do not drive or use machines if you are feeling unwell.

3 How Hepatyrix is given
How your vaccine is given
Hepatyrix will be given:
• as an injection in to the muscle of the upper arm
• at least two weeks before departure, to give the
immune system time to respond and start to protect
you against infection
Please tell your doctor if you have bleeding disorders or
suffer from excessive bleeding. In this case, Hepatyrix
may exceptionally be given deep into the skin. Since
bleeding may occur while being vaccinated, firm
pressure should be applied to the injection site for at
least two minutes after the injection. Protection may be
less if Hepatyrix is injected deep into the skin.

Hepatyrix, Typherix and Havrix are registered trade marks of
the GSK group of companies
© 2014 GSK group of companies. All rights reserved.

Page 1 of 2

MINIATURE PHARMA CODE N° 1996

MINIATURE PHARMA CODE N° 1996

2

Package Leaflet: Information for the user
® suspension for injection
Hepatitis A (inactivated) and Typhoid Polysaccharide vaccine (adsorbed).

2
473745
GSK-BEL-Wavre-BEWAV
United Kingdom-GBR
Hepatyrix
N/A

How much is given
• You will receive Hepatyrix as a single 1 ml dose.
• If you have not previously received a hepatitis A
vaccine, one dose of Hepatyrix will protect you from
hepatitis A infection for at least 1 year.
• You may be given another injection, called a “booster
injection”, of an inactivated hepatitis A vaccine any
time between 6 and 12 months after a single dose
of Hepatyrix. This is to give you long term (up to 10
years) protection against the hepatitis A virus.
• If you have already been given a hepatitis A vaccine,
you may be given Hepatyrix as a booster vaccination
against hepatitis A and this will also protect you
against typhoid fever. A single dose of 1 ml may be
given to you between 6 and 12 months after the first
dose of hepatitis A vaccine.
• One dose of Hepatyrix should protect you from typhoid
fever for at least 3 years. If after 3 years you remain at
risk of catching typhoid fever you should arrange to
see your doctor to receive a purified typhoid vaccine.

4 Possible side effects
Like all vaccines, this vaccine can cause side effects, although
not everybody gets them. The following side effects may
happen with this vaccine:

BIO_DRW202

N/A
N/A
1
K

0

0

Allergic reactions (these may occur with up to 1 in 10,000
doses of the vaccine)
If you have an allergic reaction, see your doctor straight
away. The signs may include:
• your face swelling
• low blood pressure
• difficulty breathing
• your skin going blue
• loss of consciousness
These signs usually start very soon after the injection has
been given to you. 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)
• pain and redness at the injection site
Common (these may occur with up to 1 in 10 doses of the
vaccine)
• swelling at the injection site
• feeling generally unwell
• headache
• general aches
• a high temperature (fever)
• feeling sick
• itching

TEXT SIZE CONTAINED IN THIS ARTWORK
Body text size: 12pt
Leading: 14.5pt
Horizontal Scale: 100%
Smallest text size: 12pt
Microtext: No

Biologicals
Additional Information Panel
Unfolded dimensions: 210x422mm

Very Rare (these may occur with up to 1 in 10,000
doses of the vaccine)
• fainting
• skin rashes
• fits (convulsions)
• joint or muscle pains
• problems with your nerves, signs may include: pins
and needles, loss of feeling or numbness, problems
moving your arms and legs or difficulty with walking
and moving about
Other side effects have been noted with the individual
hepatitis A vaccine so there is a possibility that they
may also happen with Hepatyrix, these include:
• being sick (vomiting) and loss of appetite

Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. 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 Hepatyrix






 eep this vaccine out of the sight and reach of children.
K
Store in a refrigerator (2°C - 8°C).
Do not freeze.
Protect from light.
Do not use this vaccine after the expiry date which is
stated on the label and the carton. The expiry date refers
to the last day of that month.
• Store in the original package with this leaflet.
• 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 to
protect the environment

6 Contents of the pack and other information
What Hepatyrix contains:
The active substances are:
• 25 micrograms of the Vi polysaccharide antigen (a part of
the Salmonella typhi (Ty2 strain) bacterium that causes
typhoid fever)
• 1440 ELISA units of hepatitis A viral protein
The other ingredients are sodium chloride, water for
injections.
What Hepatyrix looks like and contents of the pack
Hepatyrix is presented as a white and milky suspension. It
is provided in single dose (1 ml) glass pre-filled syringes.
Hepatyrix is available in packs of 1 and 10 with needles or
packs of 1, 10, 20, and 50 without needles, however 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.
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
Hepatyrix
Reference number 10592/0136
This is a service provided by the Royal National Institute
of Blind People.
This leaflet was last revised in November 2014
Hepatyrix is a registered trade mark of the GSK group
of companies.
© 2014 GlaxoSmithKline group of companies. All rights
reserved.

Folded dimensions: 210x25mm
2D Pharmacode value: N/A

473745

Page 2 of 2

473617

Package Leaflet: Information for the user

Hepatyrix®
suspension for injection
Hepatitis A (inactivated) and
Typhoid Polysaccharide vaccine (adsorbed).
Read all of this leaflet carefully before you start receiving this
vaccine because it contains important information for you.
• 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 you. Do not pass it on to
others.
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4
In this leaflet:
1. What Hepatyrix is and what it is used for
2. What you need to know before you receive Hepatyrix
3. How Hepatyrix is given
4. Possible side effects
5. How to store Hepatyrix
6. Contents of the pack and other information

1 What Hepatyrix is and what it is used for
Hepatyrix is a vaccine which helps prevent hepatitis A and typhoid fever.
Hepatitis A is an infectious illness of the liver caused by a virus. Typhoid fever is
an infectious illness caused by a type of bacteria called Salmonella typhi.
This vaccine should only be given to adults and teenagers aged 15 years and
above.
How Hepatyrix works
Hepatyrix contains inactive hepatitis A virus and a very small part of the
bacterium which cause typhoid fever.
• The hepatitis A virus is not alive, so this vaccine cannot cause hepatitis A
infection.
• There are no live bacteria in this vaccine, so it cannot cause typhoid fever.
• When you are given the vaccine it will trigger the body’s immune system to
prepare itself to protect against these viruses in the future.
• Like other vaccines, Hepatyrix may not be totally effective in protecting you
against hepatitis A and typhoid fever.
• Hepatyrix will not protect you if you have already caught hepatitis A or
typhoid fever.
• Hepatyrix will only prevent diseases caused by Hepatitis A virus and by the
bacterium Salmonella typhi.
Hepatitis A virus causes an infection of the liver. Typhoid fever is an infectious
illness caused by a type of bacteria called Salmonella typhi.
Both diseases are caught and spread by eating or drinking contaminated food
or water. The viruses are present in the bowel movement (motion) of infected
people, even when they may have no signs of the infection. The diseases can
occur in any country, but the risk is highest in places and countries where
sanitation and food and water hygiene are poor.
The main signs of hepatitis A infection include a headache, fever, sickness and
yellowing of the skin and eyes (jaundice). Most patients usually get better in a
few weeks, but it may take some months to make a full recovery. Rarely, hepatitis
A infection can also cause serious liver disease and very rarely death.
The main signs of typhoid fever include headache, pains in the stomach,
constipation or diarrhoea, fever and, in some people, a rash. Patients normally
get better after about four weeks, but relapses can occur. If it is not treated
properly, typhoid can also be fatal.

2 What you need to know before you receive Hepatyrix
Hepatyrix should not be given:
• if you are allergic to:
-- Hepatyrix or any of the other ingredients of this vaccine (listed in section 6)
-- Neomycin, an antibiotic used to treat skin infections
• if you are allergic to any other hepatitis A injection or any other typhoid
injection
• if you have a high temperature (fever)
Hepatyrix should not be given if any of the above applies to you. If you are not
sure, talk to your doctor or pharmacist before having Hepatyrix.
Warnings and precautions
Talk to your doctor or pharmacist before you are given Hepatyrix:
• if you have a weakened immune system (for example due to HIV infection or
due to medicines that suppress the immune system). You may not get the full
benefits from Hepatyrix

If you are not sure if any of the above apply to you, talk to your doctor before
having Hepatyrix.
Fainting can occur (mostly in adolescents) following, or even before, any needle
injection. Therefore tell the doctor or nurse if you fainted with a previous injection.
Other medicines and Hepatyrix
Tell your doctor or pharmacist if you are taking, have recently taken, might take any
other medicines, including other vaccines.
Hepatyrix can be given at the same time as most other routine vaccines. The doctor
will ensure that the vaccines are injected separately and into different parts of the
body. Hepatyrix must not be mixed with other vaccines in the same syringe.
In particular talk to your doctor:
• if you are to be given ‘yellow fever vaccine’
• if you need an injection of immunoglobulins (antibodies obtained from blood
donors)
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning
to have a baby, ask your doctor or pharmacist for advice before you are given this
vaccine.
Driving and using machines
Hepatyrix may affect your ability to drive or use machines. Do not drive or use
machines if you are feeling unwell.

3 How Hepatyrix is given
How your vaccine is given
Hepatyrix will be given:
• as an injection in to the muscle of the upper arm
• at least two weeks before departure, to give the immune system time to respond
and start to protect you against infection
Please tell your doctor if you have bleeding disorders or suffer from excessive
bleeding. In this case, Hepatyrix may exceptionally be given deep into the skin.
Since bleeding may occur while being vaccinated, firm pressure should be applied
to the injection site for at least two minutes after the injection. Protection may be
less if Hepatyrix is injected deep into the skin.
How much is given
• You will receive Hepatyrix as a single 1 ml dose.
• If you have not previously received a hepatitis A vaccine, one dose of Hepatyrix
will protect you from hepatitis A infection for at least 1 year.
• You may be given another injection, called a “booster injection”, of an
inactivated hepatitis A vaccine any time between 6 and 12 months after a single
dose of Hepatyrix. This is to give you long term (up to 10 years) protection
against the hepatitis A virus.
• If you have already been given a hepatitis A vaccine, you may be given Hepatyrix
as a booster vaccination against hepatitis A and this will also protect you against
typhoid fever. A single dose of 1 ml may be given to you between 6 and 12 months
after the first dose of hepatitis A vaccine.
• One dose of Hepatyrix should protect you from typhoid fever for at least 3 years.
If after 3 years you remain at risk of catching typhoid fever you should arrange
to see your doctor to receive a purified typhoid vaccine.

4 Possible side effects
Like all vaccines, this vaccine can cause side effects, although not everybody gets
them. The following side effects may happen with this vaccine:
Allergic reactions (these may occur with up to 1 in 10,000 doses of the vaccine)
If you have an allergic reaction, see your doctor straight away. The signs may
include:
• your face swelling
• low blood pressure
• difficulty breathing
• your skin going blue
• loss of consciousness
These signs usually start very soon after the injection has been given to you. 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)
• pain and redness at the injection site
Common (these may occur with up to 1 in 10 doses of the vaccine)
• swelling at the injection site
• feeling generally unwell
• headache
• general aches
• a high temperature (fever)
• feeling sick
• itching
Very Rare (these may occur with up to 1 in 10,000 doses of the vaccine)
• fainting
• skin rashes
• fits (convulsions)
• joint or muscle pains
• problems with your nerves, signs may include: pins and needles, loss of feeling or
numbness, problems moving your arms and legs or difficulty with walking and
moving about

Other side effects have been noted with the individual hepatitis A vaccine so
there is a possibility that they may also happen with Hepatyrix, these include:
• being sick (vomiting) and loss of appetite
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 Hepatyrix






Keep this vaccine out of the sight and reach of children.
Store in a refrigerator (2°C - 8°C).
Do not freeze.
Protect from light.
Do not use this vaccine after the expiry date which is stated on the label
and the carton. The expiry date refers to the last day of that month.
• Store in the original package with this leaflet.
• 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 to protect the environment

6 Contents of the pack and other information
What Hepatyrix contains:
The active substances are:
• 25 micrograms of the Vi polysaccharide antigen (a part of the Salmonella
typhi (Ty2 strain) bacterium that causes typhoid fever)
• 1440 ELISA units of hepatitis A viral protein
The other ingredients are sodium chloride, water for injections.
What Hepatyrix looks like and contents of the pack
Hepatyrix is presented as a white and milky suspension. It is provided in single
dose (1 ml) glass pre-filled syringes. Hepatyrix is available in packs of 1 and
10 with needles or packs of 1, 10, 20, and 50 without needles, however 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.
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
Reference number

Hepatyrix
10592/0136

This is a service provided by the Royal National Institute of Blind People.
This leaflet was last revised in November 2014
Hepatyrix is a registered trade mark of the GSK group of companies.
© 2014 GlaxoSmithKline group of companies. All rights reserved.

The following information is intended for medical or healthcare professional only
The vaccine’s normal appearance is a cloudy white suspension, which may
sediment during storage. Shake the container well to distribute the suspension
uniformly before administering the vaccine.
The vaccine should be inspected visually for extraneous particulate matter
and/or discolouration prior to administration. Any unused vaccine or waste
material should be disposed of safely in accordance with local regulations.
Hepatyrix, Typherix and Havrix are registered trade marks of the GSK group of
companies
© 2014 GSK group of companies. All rights reserved.

Expand Transcript

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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