Tit - Shhepionka durovo-temzhcova

Patient Information Leaflet

Read the contents of the leaflet before using the vaccine.

• Keep this leaflet, you may need to read it again.
• Ask your doctor or nurse if you need advice or more information.

This vaccine has been prescribed for a specific person and should not be given to others.

TYT - Typhoid and Tetanus Vaccine

Vaccinum febris typhoidi et tetani
Typhoid and tetanus vaccine.
Suspension for injection.
20-dose vaccine
1 dose (0.5 ml) contains:

Active Substances:

• Inactivated Salmonella typhibacteria, not less than 5x10⁹and not more than 1x10¹⁰
• Tetanus toxoid, not less than 20 IU

Excipients:

Phenol, sodium chloride, disodium phosphate dodecahydrate, sodium dihydrogen phosphate
Available packaging: (20 doses) in a type I glass vial, closed with a bromobutyl rubber stopper.
10 ml suspension in a cardboard box.
1 vial of 10 ml in a cardboard box.

Marketing Authorization Holder:

Biotechnology Institute of Serum and Vaccines BIOMED S.A.
30-224 Krakow
Al. Sosnowa 8

Table of Contents:

1. What is TYT - Typhoid and Tetanus Vaccine and what is it used for
2. How to use TYT - Typhoid and Tetanus Vaccine
3. How to store TYT - Typhoid and Tetanus Vaccine
4. Possible side effects
5. Storage of TYT - Typhoid and Tetanus Vaccine
6. Other necessary information about TYT - Typhoid and Tetanus Vaccine

1. What is TYT - Typhoid and Tetanus Vaccine and what is it used for

TYT - Typhoid and Tetanus Vaccine is a suspension for injection containing inactivated Salmonella typhibacteria and tetanus toxoid. The vaccine protects against typhoid fever and tetanus. It provides protection against the toxic effects of the bacteria that cause typhoid fever and against the tetanus toxin. The vaccine induces active immunity against these diseases. The vaccine is used to boost immunity in children and adults.

Clostridium tetani, which is then concentrated and purified. After administration of the vaccine, the human body produces antibodies against typhoid fever and tetanus, and also develops an immune memory mechanism.

Indications for use

• for mass vaccinations in epidemic threat,
• for individual vaccination in high-risk groups (communal service workers and travelers to countries where typhoid fever is endemic).

Vaccination is recommended for persons who have not been vaccinated against tetanus.

2. Before using TyT - Typhoid and Tetanus Vaccine if:

• Hypersensitivity (allergy) to the active substance or to any of the excipients has been diagnosed.
• Acute diseases with fever are present. Mild infections are not a contraindication to vaccination.
• Chronic diseases are in the exacerbation phase. In these cases, vaccination should be performed after the exacerbation of the disease has subsided.
• The woman is pregnant or breastfeeding (lactation).
• The child is under 5 years old.
• The adult is over 60 years old.

Special caution should be exercised when using TyT - Typhoid and Tetanus Vaccine if:
Adverse reactions described in point 4 have occurred or any other unusual adverse reactions have occurred after the previous dose of the vaccine.
Vaccination with TyT - Typhoid and Tetanus Vaccine should be preceded by a medical examination and a survey of the overall health status and previously performed and recorded vaccinations.
This procedure allows for the prediction of the risk of adverse reactions after vaccination.
Due to the risk of anaphylactic shock associated with vaccination, the vaccination room should be equipped with a standard anti-shock kit.

After the injection, the patient should remain under medical observation for 30 minutes.

Pregnancy:

Do not use.

Breastfeeding:

Do not use.

Ability to drive and use machines:

The vaccine does not affect the ability to drive and use machines.

4. Side effects:

Like any vaccine, TyT - Typhoid and Tetanus Vaccine may cause side effects, but they do not occur in everyone.

Common (may occur in up to 1 in 10 people):

• pain, redness, and swelling at the injection site,
• fever,
• headache,
• muscle pain,
• weakness.

Uncommon (may occur in up to 1 in 100 people):

• enlarged lymph nodes,
• chills,
• nausea.

Rare (may occur in up to 1 in 1000 people):

• allergic reactions (e.g. rash, itching, urticaria),
• dizziness.

Very rare (may occur in up to 1 in 10,000 people):

• anaphylactic shock (severe allergic reaction).

Reporting side effects
If any side effects occur, they should be reported to the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.

How to use TyT - Typhoid and Tetanus Vaccine

Shake before use.
After shaking, the vaccine is a homogeneous, white or off-white suspension. During storage, a white sediment forms at the bottom of the vial, and a clear supernatant (liquid) forms above it.
Visually inspect the vaccine for any foreign particles or changes in appearance. If any changes are observed, do not use the vaccine.
Before administration, check the expiration date on the packaging. Do not use the vaccine after the expiration date.
Dosage for primary and booster vaccination:
Primary vaccination

• Administer the first and second doses of the vaccine at an interval of 1 month.
• Administer the third dose of the vaccine 12 months after the first dose.

Booster vaccination
Administer single doses of the vaccine at intervals of 3-5 years.
In case of overdose: If a higher dose of TyT - Typhoid and Tetanus Vaccine is administered than recommended, seek medical attention immediately.

4. Possible side effects

Like any vaccine, TyT - Typhoid and Tetanus Vaccine may cause side effects. Rarely, the following adverse reactions may occur after vaccination:

• Local reactions at the injection site: pain, redness, swelling.
• Systemic reactions: fever, chills, headache, weakness.
• In rare cases, allergic reactions may occur.

In case of any side effect, inform your doctor or pharmacist.
In patients undergoing immunosuppressive treatment or with immune deficiencies, the response to the vaccine may be reduced. In such cases, it is recommended to postpone vaccinations until the end of therapy and to determine the level of antibodies after vaccination.
Inform your doctor about all medications taken recently, even those available without a prescription.

5. Storage of TyT - Typhoid and Tetanus Vaccine

Store the vaccine out of the reach and sight of children.
Do not use the vaccine after the expiration date stated on the packaging.
Store in a refrigerator at 2-8°C.
Do not freeze. If frozen, destroy the vaccine.
To protect from light, store the vial in the outer packaging.
After the first opening of the vial, the vaccine can be stored for a maximum of 10 days at 2-8°C (in a refrigerator) within the validity period of the vaccine.

6. Other information