Patient Medication Information: uses, side effects, how to take - Typherix
What the vaccine is used for:
TYPHERIX® is a vaccine that may be given to persons 2 years of age and older to help prevent against typhoid fever, an infectious illness caused by a type of bacteria called Salmonella typhi.
What it does:
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.
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.
When it should not be used:
Please see WARNINGS AND PRECAUTIONS section.
What the medicinal ingredient is:
Each 0.5 mL dose contains 25 micrograms of the Vi polysaccharide antigen, a part of the Salmonella typhi (Ty2 strain) bacterium that causes typhoid fever.
What the important nonmedicinal ingredients are:
TYPHERIX® contains the following non-medicinal ingredients: sodium chloride, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, phenol and water for injections.
For a full listing of nonmedicinal ingredients see Part 1 of the product monograph.
What dosage forms it comes in:
TYPHERIX® is presented in a single dose prefilled syringe.
WARNINGS AND PRECAUTIONS
TYPHERIX® should not be given if you have previously had had any allergic reaction to TYPHERIX®, or any ingredient contained in TYPHERIX®. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
TYPHERIX® will only prevent disease caused by the bacterium Salmonella typhi and not against salmonella bacteria that can cause food poisoning or gastroenteritis.
BEFORE you use TYPHERIX® talk to your health professional if:
- you or your child have/has a severe infection with a high temperature. In these cases, the vaccination will be postponed until recovery. A minor infection such as a cold should not be a problem, but talk to your health professional first.
- you or your child have/has a bleeding problem or bruise(s) easily.
- you or your child have/has a weakened immune system, for example due to HIV infection or due to medicines that suppress the immune system. You or your child may not get the full benefit from TYPHERIX®.
Fainting can occur following, or even before, any needle injection, therefore tell your health professional if you/your child fainted with a previous injection.
| INTERACTIONS WITH THIS VACCINE |
Please tell your health professional if you/your child are/is taking or have/has recently taken any other medicines, including medicines obtained without a prescription or have/has recently received any other vaccine.
TYPHERIX®™ may not work as well if you/your child are/is taking medicines that reduce the effectiveness of your/your child’s immune system to fight infection
TYPHERIX® can be given at the same time as some other vaccines. Your health professional will ensure that the vaccines are injected separately and into different parts of the body.
| PROPER USE OF THIS VACCINE |
Usual dose:
Your health professional will give TYPHERIX® as an injection into the muscle. TYPHERIX® is given as one injection of 0.5 mL at least 2 weeks before being exposed to typhoid fever.
If you remain at risk of catching typhoid fever, your health professional may recommend a second dose of TYPHERIX® within 3 years of the first dose.
Overdose:
In case of overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
A vaccine, like any medicine, may cause serious problems, such as severe allergic reactions. The risk of TYPHERIX® causing serious harm is extremely small. The small risks associated with TYPHERIX® are much less than the risk associated with getting the disease.
Allergic reactions (these may occur with up to 1 in 10,000 doses of the vaccine)
If you have an allergic reaction, see your health professional 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 health professional 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)
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your health professional.
This is not a complete list of side effects. For any unexpected effects while taking TYPHERIX®, contact your health professional.
Keep out of reach and sight of children. Store in a refrigerator (2°C to 8°C). Do not freeze. Store in the original package in order to protect from light.
HOW TO STORE IT
REPORTING SUSPECTED SIDE EFFECTS
To monitor vaccine safety, the Public Health Agency of Canada collects case reports on adverse events following immunization. For health care professionals: If a patient experiences an adverse event following immunization, please complete the appropriate Adverse Events following Immunization (AEFI) Form and send it to your local Health Unit in your province/territory. For the General Public: Should you experience an adverse event following immunization, please ask your doctor, nurse, or pharmacist to complete the Adverse Events following Immunization (AEFI) Form. If you have any questions or have difficulties contacting your local health unit, please contact Vaccine Safety Section at Public Health Agency of Canada: By toll-free telephone: 1-866-844-0018 By toll-free fax: 1-866-844-5931 By email: caefi@phac-aspc.gc.ca At the following website: http://www.phac-aspc.gc.ca/im/vs-sv/index-eng.php By regular mail: The Public Health Agency of Canada Vaccine Safety Section 130 Colonnade Road Ottawa, Ontario K1A 0K9 Address Locator 6502A NOTE: Should you require information related to the management of the side effect, please contact your health care provider before notifying the Public Health Agency of Canada. The Public Health Agency of Canada does not provide medical advice. |
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found at:
http://www.gsk.ca
or by contacting the sponsor, GlaxoSmithKline Inc.
7333Mississauga Road
Mississauga, Ontario
L5N 6L4
1-800-387-7374
Last revised:
© 2014 GlaxoSmithKline Inc. All Rights Reserved
TYPHERIX® is a registered trademark, used under license by GlaxoSmithKline Inc.
HAVRIX© is a registered trademark, used under license by GlaxoSmithKline Inc.
TYPHIM Vi® is a trademark of Sanofi Pasteur Limited.