TYPHERIX®

Typhoid Vaccine

What is in this leaflet

This leaflet answers some of the common questions about TYPHERIX vaccine. It
does not contain all the available information. It does not take the place of
talking to your doctor or pharmacist.

All medicines and vaccines have risks and benefits. Your doctor has weighed
the possible risks of you or your child having TYPHERIX against the expected
benefits.

If you have any concerns about receiving TYPHERIX talk to your doctor,
nurse or pharmacist.

Keep this leaflet with this vaccine. You may need to read it again.

What TYPHERIX is used for

TYPHERIX is a vaccine used to prevent typhoid fever in adults and children
aged two and above. The vaccine works by causing the body to produce its own
protection (antibodies) against this disease.

Typhoid fever is caused by bacteria called Salmonella typhi. Typhoid
fever can cause persistent high fever which may last for 10-14 days, tiredness,
headache, stomach pains and a rose coloured rash. In severe cases, it may cause
tears and bleeding in the intestines. The death rate can be as high as 12% if
left untreated.

Some antibiotics can be used to treat typhoid fever. However, vaccination
is the best way to protect against infection.

Before receiving TYPHERIX

When you must not have TYPHERIX

Tell your doctor if:

• you have/your child has had an allergic reaction to TYPHERIX, or any
  ingredient contained in this vaccine. The ingredients are listed at the end of
  this leaflet. Signs of an allergic reaction may include an itchy skin rash,
  shortness of breath and swelling of the face or tongue.
• you have/your child has had an allergic reaction to any other typhoid
  vaccine
• you have/your child has a severe infection with a high temperature. A
  minor infection such as a cold should not be a problem, but talk to your
  doctor about this before being vaccinated
• the expiry date printed on the pack has passed
• the packaging is torn or shows signs of tampering.

If you are not sure whether TYPHERIX should be given, talk to your doctor or
nurse.

Before receiving TYPHERIX

Tell your doctor if:

• you are or think you may be pregnant or if you intend to become pregnant.
  Your doctor will discuss with you the possible risks and benefits of receiving
  TYPHERIX during pregnancy
• you are breast-feeding. It is not known if TYPHERIX passes into breast
  milk, however the vaccine is not expected to cause problems for breast-fed
  babies
• you have/your child has any medical conditions, such as:
  • an immune deficiency condition (e.g. HIV positive)
  • a bleeding disorder.
• you have/your child has allergies to any other medicines or substances,
  such as dyes, foods or preservatives
• you have/your child has received another vaccine recently, or are taking
  any prescription or OTC (over-the-counter) medicines. In particular, mention
  if you are taking medicines which suppress the immune system, such as steroids
  or cyclosporin.

Some vaccines may be affected by other vaccines or medicines. Your doctor or
pharmacist will be able to tell you what to do if TYPHERIX is to be given with
another vaccine or medicine.

Use in children

TYPHERIX can be used in children two years of age and older.

How TYPHERIX is given

The doctor or nurse will give TYPHERIX as an injection. If you have any
concerns about how this vaccine is to be given, talk to your doctor or
pharmacist.

TYPHERIX will be injected into the upper arm muscle.

The vaccine should never be given intravenously.

How much is given

For adults and children the TYPHERIX dose is 0.5 mL.

When is it given

Only one injection of TYPHERIX is generally needed. TYPHERIX should be given
at least two weeks prior to travelling to an area where you may be at risk of
coming into contact with typhoid fever. A single dose of TYPHERIX should be
given every three years to those people who remain at risk of typhoid fever.

Your doctor will advise on the possible need for future booster dosing.

While you are using TYPHERIX

Things to be careful of:

Be careful driving or operating machinery until you know how TYPHERIX affects
you. TYPHERIX should not normally interfere with your ability to drive a car or
operate machinery. But in some people vaccination can cause dizziness or
lightheadedness. Make sure you know how you react to TYPHERIX before you drive a
car or operate machinery, or do anything that could be dangerous if you feel
dizzy or lightheaded.

Side-Effects

Tell your doctor, nurse or pharmacist as soon as possible if you or your
child do not feel well during or after a dose of TYPHERIX.

TYPHERIX helps protect most people from typhoid fever, but it may have
unwanted side effects in a few people. All medicines and vaccines can have side
effects. Most of the time they are not serious; however, sometimes they can be.
Some side effects may need medical treatment.

Most unwanted effects with TYPHERIX are mild and usually clear up within a
few days. Ask your doctor or pharmacist to answer any questions you may have.

Mild events that have been reported after TYPHERIX vaccination

Tell your doctor if you notice any of the following that are troublesome or
ongoing:

• soreness, redness, swelling, itching around the injection site
• headache, fatigue, general aches, feeling sick, nausea.

As with all vaccines given by injection there is a very small risk of serious
allergic reaction. This may occur days to weeks after vaccination. Contact your
doctor immediately or go to the Accident and Emergency department of your
nearest hospital if any of the following happens:

• swelling of limbs, face, eyes, inside of nose, mouth or throat
• shortness of breath, breathing or swallowing difficulties
• hives, itching (especially of the hands or feet), reddening of skin
  (especially around the ears), or severe skin reactions.

Other side effects not listed above, can also occur during or soon after a
dose of TYPHERIX. Check with your doctor, nurse or pharmacist if you or your
child have any other effects.

Do not be alarmed by this list of possible side effects. You or your child
may not experience any.

Storage

TYPHERIX is usually stored at the doctor's clinic or surgery, or at the
pharmacy. But if you need to store TYPHERIX always:

• Keep TYPHERIX in the refrigerator stored between +2°C and +8°C. THE PACK
  SHOULD NEVER BE FROZEN. FREEZING DESTROYS THE VACCINE.
• Keep the vaccine out of the reach of children.
• Keep TYPHERIX in the original pack until it is time for it to be given.

Ask your pharmacist what to do with any left over TYPHERIX that has expired
or has not been used.

Product Description

What it looks like

TYPHERIX comes in prefilled syringes. It is a clear, colourless liquid.

Ingredients

The active ingredient of TYPHERIX is a surface protein of the Salmonella
typhi bacteria. The vaccine is not infectious, and will not give you
typhoid.

Inactive ingredients in the vaccine are: sodium chloride, phosphate buffer
(sodium phosphate, disodium phosphate), phenol and water for injections.

TYPHERIX is made without any human blood or blood products, or any other
substances of human origin.