Ty-vaccine dual

Package leaflet: Information for the user

Ty-Szczepionka durowa
injection suspension
Typhoid vaccine
Not less than 5x10 and not more than 1x10 Salmonella typhi bacteria /0.5 ml;
20-dose vaccine, 1 dose (0.5 ml)
Please read this leaflet carefully before using the vaccine, because
it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This vaccine has been prescribed for a specific individual. Do not pass it on to others.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

1. What Ty-Szczepionka durowa is and what it is used for

Ty-Szczepionka durowa is an injection suspension containing inactivated Salmonella typhi bacilli. The vaccine induces or enhances immunity against typhoid fever. Salmonella typhi bacilli killed by formaldehyde at elevated temperature retain the antigenic properties of live bacteria, but being non-pathogenic, they elicit a protective immune response. After administration of the vaccine, the human body produces antibodies against typhoid fever and also develops immunological memory mechanisms protecting against disease upon re-exposure to Salmonella typhi bacteria.
Indications for use
Ty-Szczepionka durowa is used for active immunization against typhoid fever according to epidemiological indications:

• for mass vaccination during epidemic threats,
• for individual vaccination in high-risk groups (workers in public services and travelers to countries where typhoid fever is endemic).

2. Important information before using Ty-Typhoid vaccine

When not to use Ty-Typhoid vaccine:

• If the patient is allergic to the active substance or to any of the other components of this vaccine (listed in section 6).
• In case of acute illness with fever. Mild infections are not a contraindication for vaccination.
• In case of chronic diseases during an exacerbation period. Vaccination should be postponed until the exacerbation has resolved.
• In pregnant or breastfeeding women (lactation).
• In children under 5 years of age.
• In adults over 60 years of age.

If any contraindications to vaccination with Ty-Typhoid vaccine exist, the physician should assess the risk of administering the vaccine against the risk of contracting the infection.

Warnings and precautions

Before starting Ty-Typhoid vaccine, discuss with a doctor or nurse if any adverse reactions described in section 4 or any other concerning symptoms occurred after a previous dose of the vaccine.

Vaccination with Ty-Typhoid vaccine should be preceded by a medical examination and a medical history review regarding general health status and previously administered and documented vaccinations. This procedure helps predict the risk of adverse reactions following vaccination.

After injection, remain under medical observation for 30 minutes.

Ty-Typhoid vaccine and other medicines

Ty-Typhoid vaccine may be administered simultaneously with other vaccines, as indicated by the National Immunization Program.

Different vaccines administered at the same time should be injected at different sites of the body, using separate syringes and needles.

In patients undergoing immunosuppressive treatment or suffering from immunodeficiency, the immune response to the vaccine may be reduced. In such cases, it is recommended to postpone vaccination until completion of therapy and to measure antibody levels after vaccination.

Inform the doctor about all medicines currently or recently taken by the patient, as well as any medicines the patient plans to take.

Pregnancy and breastfeeding

Ty-Typhoid vaccine is contraindicated during pregnancy and breastfeeding.

If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult a doctor before using this vaccine.

Driving and operating machinery

There are no data available regarding the influence of Ty-Typhoid vaccine on the ability to drive or operate machinery.

3. How to use Ty-Szczepionka durowa

Ty-Szczepionka durowa will be administered by a doctor/nurse as a deep subcutaneous injection. The vaccine must never be administered intravenously.
Dosage for primary and booster vaccination:
Primary vaccination
The primary vaccination consists of three doses of the vaccine given according to a 0-1-12 month schedule:

• The first and second doses should be given one month apart.
• The third dose should be given 12 months after the first dose.

Booster vaccination
Single booster doses should be administered every 3 to 5 years.
Use of a higher than recommended dose of Ty-Szczepionka durowa
If you have any further questions regarding the use of this vaccine, consult your doctor, pharmacist, or nurse.
Interrupting the use of Ty-Szczepionka durowa
If you have any further questions regarding the use of this vaccine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like any vaccine, this vaccine may cause adverse reactions, although they do not occur in
everyone.
Frequency unknown (cannot be estimated based on available data):

• reactions at the injection site: redness, painful swelling
• general adverse reactions: headache, high temperature, malaise
  These symptoms usually resolve within 24–48 hours.

Reporting adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform a doctor, pharmacist, or nurse.
Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +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 vaccine.

5. How to store Ty-Szczepionka durowa

Store in a refrigerator (2°C - 8°C).
Do not freeze. If the vaccine has been frozen, destroy it.
Keep the vaccine out of sight and reach of children.
Keep the vial in the outer packaging to protect from light.
After the first opening of the vial, the vaccine may be stored for up to 10 days
in the refrigerator (2°C - 8°C) within the vaccine's shelf life.
Do not use this vaccine after the expiry date stated on the carton.
The expiry date refers to the last day of the stated month.
Medicines must 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 packaging and other information

What Ty-Szczepionka durowa contains
The active substance in the vaccine is:
Salmonella typhi bacteria (inactivated), not less than 5x10 and not more than 1x10
Other components are: phenol, sodium chloride, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, water for injections.

What Ty-Szczepionka durowa looks like and contents of the pack
After shaking, the vaccine is a homogeneous, white or almost white or whitish-grey suspension.
During storage, a white sediment forms at the bottom of the vial, with a clear supernatant (liquid) above it.
The vaccine is available in the following packaging:
1 vial of 10 ml (20 doses), closed with a rubber stopper, in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Institute of Biotechnology of Sera and Vaccines BIOMED Joint Stock Company
Al. Sosnowa 8
30-224 Kraków
Tel. +48 12 37 69 200
Fax +48 12 37 69 205
e-mail: [email protected]

Information intended exclusively for healthcare professionals

Administration of Ty-Szczepionka durowa
Shake well before use to obtain a homogeneous suspension.
Visually inspect the vaccine for any foreign particles and (or) changes in appearance.
Do not use the vaccine if any changes are observed.
Check the expiry date on the packaging before administration.
Do not use the vaccine after the expiry date.
Administer a dose of 0.5 ml by deep subcutaneous injection.
The upper arm is recommended as the injection site.
Do not administer intravenously! Ensure that the needle has not entered a blood vessel.
Warning: Due to the risk of anaphylactic shock associated with vaccine administration,
the vaccination room must be equipped with a standard anaphylaxis emergency kit.