Typhim vi

Package leaflet: Information for the user

TYPHIM Vi, solution for injection in pre-filled syringe
Typhoid vaccine, polysaccharide
Please read all of this leaflet carefully before the vaccine is administered, as 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, pharmacist or nurse.
• This vaccine has been prescribed for a specific individual. Do not pass it on to others. If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What TYPHIM Vi vaccine is and what it is used for
2. Important information before using TYPHIM Vi vaccine
3. How to use TYPHIM Vi vaccine
4. Possible side effects
5. How to store TYPHIM Vi vaccine
6. Contents of the pack and other information

1. What TYPHIM Vi vaccine is and what it is used for

TYPHIM Vi is a vaccine. Vaccines are used to protect against infectious diseases.
This vaccine helps protect adults, adolescents and children over 2 years of age against typhoid fever.
Typhoid fever is caused by a bacterium called Salmonella typhi. The main symptoms of this disease are: high fever (40°C), headache, insomnia, dizziness, nosebleeds, loss of appetite, nausea, diarrhoea and disturbances of consciousness.
After administration of TYPHIM Vi vaccine, the body's natural defence system produces its own protection against the disease caused by this bacterium.
TYPHIM Vi vaccine is recommended for people travelling to endemic areas (regions where the disease occurs and affects a large part of the population), migrants, medical personnel and military personnel.

2. Important information before using TYPHIM Vi vaccine
When not to use TYPHIM Vi vaccine:

• if the adult or child has a known allergy to the active substance or to any of the other ingredients of this vaccine (listed in section 6), to formaldehyde or to casein (which are used in the manufacturing process and may be present in trace amounts);
• if the adult or child is unwell and has a high fever, vaccination should be postponed until recovery.

Warnings and precautions

• This vaccine protects against the disease (typhoid fever) caused by the bacterium Salmonella typhi, but does not protect against infections caused by related bacteria (Salmonella paratyphi A or B) or non-typhoidal Salmonella strains.
• This vaccine is not indicated for children under 2 years of age, as it is not sufficiently effective.
• If the adult or child has a weakened immune system due to:
• treatment with corticosteroids, cytotoxic drugs, radiotherapy or other treatments that may weaken the immune system, the doctor may decide to delay vaccination until the end of treatment.
• human immunodeficiency virus (HIV) infection or other diseases that may weaken the immune system, vaccination is recommended even though protection may not be as effective as in individuals with a normally functioning immune system.
• Special caution is required if the adult or child suffers from haemophilia or is prone to bruising or bleeding.

Fainting may occur (particularly in adolescents) during or even before any injection.
Therefore, inform your doctor or nurse if you or your child has previously fainted following an injection.

TYPHIM Vi vaccine and other medicines
TYPHIM Vi vaccine may be administered simultaneously (but at separate injection sites) with vaccines against hepatitis A and B, yellow fever, diphtheria, tetanus, poliomyelitis, rabies and meningitis caused by Neisseria meningitidis A or C.
Tell your doctor or pharmacist about any medicines you are currently taking, have recently taken or might take in the future.

Pregnancy, breastfeeding and fertility
Reproduction studies in animals have not been conducted with TYPHIM Vi vaccine. Data on the use of this vaccine in pregnant women are limited. Therefore, the vaccine is not recommended during pregnancy. It should only be administered if clearly needed, after careful consideration of the risks and benefits.
The vaccine may be given during breastfeeding.
If you are pregnant, think you may be pregnant, are planning to become pregnant or are breastfeeding, consult your doctor before receiving this vaccine.

Driving and using machines
No studies on the effect of this vaccine on the ability to drive and use machines have been conducted.

TYPHIM Vi vaccine contains sodium
TYPHIM Vi vaccine contains less than 1 mmol (23 mg) of sodium per dose, i.e. the vaccine is considered "sodium-free".

3. How to use the TYPHIM Vi vaccine

Dosage
VACCINE FOR ADULTS, ADOLESCENTS AND CHILDREN OVER THE AGE OF 2 YEARS ONLY.
A single dose (0.5 ml) is sufficient.
If the person remains at risk of infection, revaccination should be carried out every 3 years.
The vaccination schedule is the same for adults, adolescents and children.
Method of administration
The vaccine should be administered to the patient intramuscularly or subcutaneously by a healthcare professional.
This vaccine must never be administered intravenously.
If you have any further doubts regarding the use of this vaccine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, the TYPHIM Vi vaccine can cause adverse reactions, although not
everyone will experience them.
Severe allergic reactions:
Anaphylactic and anaphylactoid reactions, including anaphylactic shock, which may include one
or more of the following symptoms:
• hives, skin rash
• swelling of the face and (or) neck
• difficulty breathing, bluish discoloration of the tongue or lips
• low blood pressure, rapid heartbeat and weak pulse, cold skin, dizziness
and possible fainting
These symptoms usually occur very quickly after injection, while the patient is still
in the clinic or doctor's office. If any of these symptoms occur after
leaving the place where the injection was administered, seek medical advice IMMEDIATELY.
Other adverse reactions
Most adverse reactions occur within 3 days after vaccination. Most of them resolve
spontaneously within 1 to 3 days after onset. Adverse reactions have been reported with the following frequency:
Very common: may affect more than 1 in 10 people

• Pain at the injection site, redness (erythema) at the injection site, swelling/edema at the injection site, induration at the injection site
• Headache
• Muscle pain
• General malaise
• Fatigue, unusual weakness

Common: may affect up to 1 in 10 people

• Fever

Uncommon: may affect up to 1 in 100 people

• Itching at the injection site (pruritus at injection site)

Frequency not known: frequency cannot be estimated from available data

• Serum sickness-like illness: joint pain, skin rash, swollen lymph nodes and general malaise. These symptoms usually occur within 2 to 4 weeks after vaccination.
• Fainting in response to injection (vasovagal fainting)
• Cough, wheezing, respiratory disorders (asthma)
• Nausea, vomiting, diarrhea, abdominal pain
• Rash, sometimes swollen and itchy (pruritus, skin rash, urticaria)
• Joint pain

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02 222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store the TYPHIM Vi vaccine

Keep the vaccine out of the sight and reach of children.
Do not use this vaccine after the expiry date (EXP) stated on the packaging.
The expiry date refers to the last day of the stated month.
Store in a refrigerator (2°C – 8°C). Do not freeze.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What TYPHIM Vi vaccine contains
The active substance in one dose of vaccine (0.5 ml) is:
Purified capsular polysaccharide (Vi) of Salmonella typhi (Ty2 strain) – 25 micrograms
The other components are: phenol, buffer solution containing: sodium chloride, disodium phosphate
dihydrate, sodium dihydrogen phosphate dihydrate, water for injections

What TYPHIM Vi vaccine looks like and contents of the pack
TYPHIM Vi vaccine is available as an injection solution (0.5 ml in a prefilled syringe with attached needle) – pack of 1.
The solution is clear and colourless.

Marketing Authorisation Holder
Sanofi Winthrop Industrie
82 Avenue Raspail
94250 Gentilly, France

Manufacturer
Sanofi Winthrop Industrie, 1541 avenue Marcel Mérieux, 69280 Marcy l’Etoile, France
Sanofi Winthrop Industrie, Voie de l’Institut - Parc Industriel d’Incarville, B.P 101, 27100 Val de
Reuil, France
Sanofi-Aventis Zrt., Building DC5, Campona Utca 1., Budapest District XXII 1225, Hungary

Information intended exclusively for medical professionals:

TYPHIM Vi vaccine must not be mixed with other vaccines in the same syringe.