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TYPHERIX SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE

Active substance(s): SALMONELLA TYPHI VI POLYSACCHARIDE / SALMONELLA TYPHI VI POLYSACCHARIDE

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Typhoid Polysaccharide vaccine

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 only. 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.

474476
GSK-BEL-Wavre-BEWAV
United Kingdom-GBR
Typherix

What is in this leaflet:

• as an injection into the muscle of the upper arm

3 How Typherix is given

• at least two weeks before the risk of being exposed to typhoid fever.

1 What Typherix is and what it is used for

N/A

Typherix is a vaccine which helps prevent typhoid fever, an infectious
illness caused by a type of bacteria called Salmonella typhi.

N/A

This vaccine can be given to both adults and children aged 2 years and
over. In this leaflet, any reference to ‘you’ can also mean ‘your child’.

K

0

How Typherix works
Typherix contains a small part of the bacterium which causes typhoid
fever. This is not infectious and cannot make you ill.
• When you are given the vaccine it will trigger the body’s immune
system to prepare itself to protect against typhoid fever in the future.
• Typherix will only prevent disease caused by the bacterium Salmonella
typhi and not against salmonella bacteria that can cause food
poisoning or gastroenteritis.

0

3 How Typherix is given

2 What you need to know before you receive Typherix

6 Contents of the pack and other information

1

Driving and using machines
Typherix may affect your ability to drive or use machines. Do not
drive or use machines if you are feeling unwell.

How your vaccine is given
Typherix will be given:

5 How to store Typherix

BIO_DRW202

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.

1 What Typherix is and what it is used for

4 Possible side effects
N/A

Package Leaflet: Information for the User

Typhoid fever is an infectious illness caused by a bacterium, Salmonella
typhi. It is caused and spread by eating or drinking contaminated food or
water. Since the bacterium is present in the bowel movement (motion),
the infection can occur in any country, but it more commonly occurs in
places or countries with poor personal or public hygiene.
The main signs of the illness include headache, pains in the stomach,
constipation or diarrhoea and a fever that may last for one or two weeks.
Patients normally get better after about four weeks, but relapses can occur.

How much is given
• Both adults and children above 2 years of age will receive a 0.5 ml dose.
• If you remain at risk of catching typhoid fever, your doctor may
recommend a second dose of Typherix within 3 years of the first dose.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

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.
The 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:
Common (these may occur with up to 1 in 10 doses of the vaccine)
• pain, redness and swelling at the injection site

2 What you need to know before you receive Typherix

• general aches and pains

• if you are allergic to Typherix or any of the other ingredients of this
vaccine (listed in section 6)

• feeling generally unwell

Typherix should not be given if the above applies to you. If you are not
sure, talk to your doctor or pharmacist before having Typherix.
Warnings and precautions
Talk to your doctor or pharmacist before you are given Typherix
Body text size: 10 pt
Leading: 12 pt
Horizontal Scale: 100%
Smallest text size: 10 pt
Microtext: No

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

• headache

Typherix should not be given:

• if you have a high temperature (fever).

TEXT SIZE CONTAINED IN THIS ARTWORK

• a high temperature (fever)

• feeling sick
• itching
Very Rare (these may occur with up to 1 in 10,000 doses of the vaccine)
• severe rashes (urticaria)

• if you have any bleeding disorders or suffer from excessive
bleeding. Since bleeding may occur while being vaccinated, firm
pressure should be applied to the injection site for at least two
minutes after the injection.

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.

• if you have a poor immune system or you are taking medicines
such as steroid tablets that may affect your immune system.

By reporting side effects, you can help provide more information on
the safety of this medicine.

If you are not sure any of the above apply to you, talk to your
doctor or pharmacist before having Typherix.
Fainting can occur (mostly in adolescents) following, or even
before, any needle injection. Therefore tell the doctor or nurse if
you/your child fainted with a previous injection.
Other medicines and Typherix
Tell your doctor or pharmacist if you are taking, have recently taken,
might take any other medicines including other vaccines.
Typherix can be given at the same time as some other vaccines. Your
doctor will ensure that the vaccines are injected separately and into
different parts of the body.

5 How to store Typherix
• 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

The following information is intended for healthcare professional only
Vaccines should be inspected for any foreign particulate matter and/or
variation of physical aspect. In the event of either being observed, discard
the vaccine.
Shake before use.

Page 1 of 2

MINIATURE PHARMA CODE N° 1759

MINIATURE PHARMA CODE N° 1759

2

Typherix

474476

® solution for injection in a pre-filled syringe

• 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 Typherix contains

2
474476
GSK-BEL-Wavre-BEWAV

• The active substance is 25 micrograms of the Vi polysaccharide
antigen, a part of the Salmonella typhi (Ty2 strain) bacterium
that causes typhoid fever.
• The other ingredients are sodium chloride, disodium phosphate
dihydrate, sodium dihydrogen phosphate dihydrate, phenol and
water for injections.
What Typherix looks like and contents of the pack
• Typherix is a clear colourless solution.
• Typherix is available as 0.5 ml pre-filled syringes and is available in
packs of 1, 10, 50 or 100, however not all pack sizes may be marketed.

United Kingdom-GBR

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder:
SmithKline Beecham Ltd, Stockley Park West, Uxbridge, Middlesex, UB11 1BT

Typherix
N/A

Manufacturer:
GlaxoSmithKline Biologicals s.a., Rixensart, Belgium.

BIO_DRW202

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

N/A

0800 198 5000 (UK only).

N/A
1
K

Please be ready to give the following information:
Product name
Typherix
Reference number
10592/0126
This is a service provided by the Royal National Institute of Blind People.

0

This leaflet was last revised in: May 2015
Typherix is a registered trade mark of the GSK group of companies.
© 2015 GSK group of companies. All rights reserved.

0

TEXT SIZE CONTAINED IN THIS ARTWORK
Body text size: 10 pt
Leading: 12 pt
Horizontal Scale: 100%
Smallest text size: 10 pt
Microtext: No

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

474476

Page 2 of 2

474505

3
474505

Package Leaflet: Information for the User

Typherix®

GSK-BEL-Wavre-BEWAV-St.Amand

solution for injection in a pre-filled syringe
Typhoid polysaccharide vaccine

United Kingdom-GBR
Typherix

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 only. 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.
What is in this leaflet:
1 What Typherix is and what it is used for
2 What you need to know before you receive Typherix
3 How Typherix is given
4 Possible side effects
5 How to store Typherix
6 Contents of the pack and other information

N/A
BIO_DRW183

N/A
N/A
1
K

0

1 What Typherix is and what it is used for
Typherix is a vaccine which helps prevent typhoid fever, an infectious
illness caused by a type of bacteria called Salmonella typhi.
This vaccine can be given to both adults and children aged 2 years and
over. In this leaflet, any reference to ‘you’ can also mean ‘your child’.
How Typherix works
Typherix contains a small part of the bacterium which causes typhoid
fever. This is not infectious and cannot make you ill.
• When you are given the vaccine it will trigger the body’s immune
system to prepare itself to protect against typhoid fever in the future.
• Typherix will only prevent disease caused by the bacterium Salmonella
typhi and not against salmonella bacteria that can cause food poisoning
or gastroenteritis.
Typhoid fever is an infectious illness caused by a bacterium, Salmonella
typhi. It is caused and spread by eating or drinking contaminated food or
water. Since the bacterium is present in the bowel movement (motion),
the infection can occur in any country, but it more commonly occurs in
places or countries with poor personal or public hygiene.
The main signs of the illness include headache, pains in the stomach,
constipation or diarrhoea and a fever that may last for one or two weeks.
Patients normally get better after about four weeks, but relapses can occur.

0

2 What you need to know before you receive Typherix

Biologicals
Additional Information Panel

Typherix should not be given:
• if you are allergic to Typherix or any of the other ingredients of this
vaccine (listed in section 6)
• if you have a high temperature (fever).
Typherix should not be given if the above applies to you. If you are not
sure, talk to your doctor or pharmacist before having Typherix.
Warnings and precautions
Talk to your doctor or pharmacist before you are given Typherix

Unfolded dimensions: 385x325mm
Folded dimensions: 130x55mm
2D Pharmacode value: 474505CGV

• if you have any bleeding disorders or suffer from excessive bleeding.
Since bleeding may occur while being vaccinated, firm pressure should be
applied to the injection site for at least two minutes after the injection.
• if you have a poor immune system or you are taking medicines such as
steroid tablets that may affect your immune system.
If you are not sure any of the above apply to you, talk to your doctor or
pharmacist before having Typherix.
Fainting can occur (mostly in adolescents) following, or even before, any
needle injection. Therefore tell the doctor or nurse if you/your child fainted
with a previous injection.
Other medicines and Typherix
Tell your doctor or pharmacist if you are taking, have recently taken, might
take any other medicines including other vaccines.
Typherix can be given at the same time as some other vaccines. Your doctor
will ensure that the vaccines are injected separately and into different parts
of the body.
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
Typherix may affect your ability to drive or use machines. Do not drive or
use machines if you are feeling unwell.

3 How Typherix is given
How your vaccine is given
Typherix will be given:
• as an injection into the muscle of the upper arm
• at least two weeks before the risk of being exposed to typhoid fever.
How much is given
• Both adults and children above 2 years of age will receive a 0.5 ml dose.
• If you remain at risk of catching typhoid fever, your doctor may
recommend a second dose of Typherix within 3 years of the first dose.
If you have any further questions on the use of this medicine, ask your
doctor or pharmacist.

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.
The 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:
Common (these may occur with up to 1 in 10 doses of the vaccine)
• pain, redness and swelling at the injection site
• a high temperature (fever)
• headache
• general aches and pains
• feeling generally unwell
• feeling sick
• itching
Very Rare (these may occur with up to 1 in 10,000 doses of the vaccine)
• severe rashes (urticaria)

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 Typherix






 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 Typherix contains
• The active substance is 25 micrograms of the Vi polysaccharide
antigen, a part of the Salmonella typhi (Ty2 strain) bacterium that
causes typhoid fever.
• The other ingredients are sodium chloride, disodium phosphate
dihydrate, sodium dihydrogen phosphate dihydrate, phenol and
water for injections.
What Typherix looks like and contents of the pack
• Typherix is a clear colourless solution.
• Typherix is available as 0.5 ml pre-filled syringes and is available
in packs of 1, 10, 50 or 100, 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
Typherix
Reference number
10592/0126
This is a service provided by the Royal National Institute of Blind People.
This leaflet was last revised in: May 2015
Typherix is a registered trade mark of the GSK group of companies.
© 2015 GSK group of companies. All rights reserved.

The following information is intended for healthcare professional only
Vaccines should be inspected for any foreign particulate matter and/or variation of physical aspect.
In the event of either being observed, discard the vaccine.
Shake before use.

TEXT SIZE CONTAINED IN THIS ARTWORK
Body text size: 10pt
Smallest text size: 10pt

Leading: 12pt

Horizontal Scale: 100%
Microtext: No

Page 1 of 1

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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