Tiphim Vi

Package Leaflet: Information for the Patient

TYPHIM Vi,solution for injection in a pre-filled syringe
Vaccine against typhoid fever, polysaccharide

Read the package leaflet carefully before using the vaccine, as it contains important information for the patient.

• 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 specifically for you. 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.

Table of Contents of the Leaflet:

• 1. What is TYPHIM Vi vaccine and what is it 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 is TYPHIM Vi vaccine and what is it 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, diarrhea, and impaired consciousness.
After receiving the TYPHIM Vi vaccine, the body's natural defense system produces its own protection against the disease caused by this bacterium.
TYPHIM Vi vaccine is recommended for people traveling to endemic areas (areas where the disease is common and affects a large part of the population), migrants, healthcare workers, and military personnel.

2. Important information before using TYPHIM Vi vaccine

When not to use TYPHIM Vi vaccine:

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 paratyphiA or B) or by non-typhoid Salmonellastrains.
• This vaccine is not indicated for children under 2 years of age, as it is not effective enough.
• use of corticosteroid drugs, cytotoxic drugs, radiotherapy, or other treatments that may weaken the immune system, the doctor may wait until the treatment is completed.
• HIV infection (human immunodeficiency virus) or other diseases that may weaken the immune system, it is recommended to administer the vaccine even if the protection may not be as good as in the case of a person with a normally functioning immune system.
• Special care should be taken if the patient has hemophilia or is prone to bruising or bleeding.

Fainting can occur (especially in adolescents) after, or even before, any needle injection.
Therefore, the doctor or nurse should be informed if the patient or their child has experienced fainting spells during previous injections.

TYPHIM Vi vaccine and other medicines

TYPHIM Vi vaccine can be administered simultaneously (but in separate locations) with vaccines against hepatitis A and B, yellow fever, diphtheria, tetanus, poliomyelitis, rabies, and meningitis caused by Neisseria meningitidisA or C.
Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and any medicines you plan to take.

Pregnancy, breastfeeding, and fertility

No studies have been conducted on the effects of TYPHIM Vi vaccine on reproduction in animals. Data on the use of the vaccine in pregnant women are limited. Therefore, the vaccine is not recommended during pregnancy. It should only be administered if necessary, after weighing the risks and benefits.
The vaccine can be administered during breastfeeding.
In pregnancy, during breastfeeding, or if you think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this vaccine.

Driving and using machines

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

TYPHIM Vi vaccine contains sodium

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

3. How to use TYPHIM Vi vaccine

Dosage

VACCINE EXCLUSIVELY FOR ADULTS, ADOLESCENTS, AND CHILDREN OVER 2 YEARS OF AGE.
A single dose (0.5 ml) is sufficient.
If the person is still at risk of infection, the vaccination should be repeated 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 by a healthcare professional.
This vaccine should never be administered intravascularly.
If you have any further questions about the use of this vaccine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, TYPHIM Vi vaccine can cause side effects, although not everybody gets them.

Severe allergic reactions:

Anaphylactic reactions, anaphylactoid reactions, including anaphylactic shock, which may include one or more of the following symptoms:
o
hives, skin rash
o
swelling of the face and (or) neck
o
difficulty breathing, blue discoloration of the tongue or lips
o
low blood pressure, rapid heartbeat, and weak pulse, cold skin, dizziness, and possible fainting
These symptoms usually occur very soon 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 given, seek medical attention IMMEDIATELY.

Other side effects

Most side effects occur within 3 days of vaccination. Most of them resolve on their own within 1 to 3 days of onset. Side effects 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 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 the injection site)

Frequency not known: frequency cannot be estimated from the available data

• Serum sickness-like reaction: 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 symptoms (asthma)
• Nausea, vomiting, diarrhea, abdominal pain
• Rash, sometimes swollen and itchy (pruritus, skin rash, urticaria)
• Joint pain

Reporting side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store TYPHIM Vi vaccine

Store the vaccine out of 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 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 required. 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 the vaccine (0.5 ml) is:
Purified capsular polysaccharide (Vi) Salmonella typhi(Ty2 strain) - 25 micrograms
The other ingredients 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 a solution for injection (0.5 ml in a pre-filled syringe with attached needle) – pack of 1.
The solution is clear and colorless.

Marketing authorization 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 XXII 1225, Hungary
Date of last revision of the leaflet: December 2024

Information intended for healthcare professionals only:

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