Ti-shhepionka durova
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Package Leaflet: Information for the User
Ty - Typhoid Vaccine
suspension for injection
Typhoid vaccine
Not less than 5x10 and not more than 1x10 Salmonella typhibacteria / 0.5 ml;
20-dose vaccine, 1 dose (0.5 ml)
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 for a specific person. Do not pass it on to others.
- If the patient experiences 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 Ty - Typhoid Vaccine and what is it used for
- 2. Important information before using Ty - Typhoid Vaccine
- 3. How to use Ty - Typhoid Vaccine
- 4. Possible side effects
- 5. How to store Ty - Typhoid Vaccine
- 6. Package contents and other information
1. What is Ty - Typhoid Vaccine and what is it used for
Ty - Typhoid Vaccine is a suspension for injection containing inactivated Salmonella typhirods. The vaccine induces or enhances immunity to typhoid fever. The formaldehyde-killed Salmonella typhirods retain the antigenic properties of live bacteria, but are non-pathogenic, inducing a protective immune response. After vaccination, the human body produces antibodies against typhoid fever and develops a mechanism of immunological memory that protects against infection after re-exposure to Salmonella typhirods.
Indications for use
Ty - Typhoid Vaccine is used for active immunization against typhoid fever according to epidemiological indications:
- 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).
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 any of the other ingredients of this vaccine (listed in section 6).
- Acute diseases with fever are present. Mild infections are not a contraindication to vaccination.
- Chronic diseases are present during exacerbation. In these cases, vaccination should be postponed until the exacerbation of the disease has subsided.
- The woman is pregnant or breastfeeding.
- The child is less than 5 years old.
- The adult is over 60 years old.
If there are any contraindications to vaccination with Ty - Typhoid Vaccine, the doctor should assess the risk of vaccination versus the risk of infection.
Warnings and precautions
Before starting to use Ty - Typhoid Vaccine, discuss it with your doctor or nurse if any side effects occurred after the previous dose of the vaccine or any other worrying reactions.
Vaccination with Ty - Typhoid 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 predicting the risk of side effects after vaccination.
After the injection, stay under medical observation for 30 minutes.
Ty - Typhoid Vaccine and other medicines
Ty - Typhoid Vaccine can be administered simultaneously with other vaccines, if it results from the Vaccination Program.
Different vaccines administered at the same time should be injected into different parts of the body, using separate syringes and needles.
In patients undergoing immunosuppressive therapy 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.
Tell your doctor about all medicines the patient is currently taking or has recently taken, as well as medicines the patient plans to take.
Pregnancy and breastfeeding
Ty - Typhoid Vaccine is contraindicated in pregnancy and breastfeeding.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor before using this vaccine.
Driving and using machines
There are no data on the effect of Ty - Typhoid Vaccine on the ability to drive and use machines.
3. How to use Ty - Typhoid Vaccine
Ty - Typhoid Vaccine will be administered by a doctor/nurse as a deep subcutaneous injection. The vaccine must never be administered intravascularly.
Dosing in primary and booster vaccination: Primary vaccination
Primary vaccination consists of three doses of the vaccine in a 0-1-12 month schedule
- The first and second doses of the vaccine should be administered at an interval of 1 month.
- The third dose of the vaccine should be administered 12 months after the first dose.
Booster vaccination
Single doses of the vaccine should be administered at intervals of 3-5 years.
Using a higher dose of Ty - Typhoid Vaccine than recommended
In case of any further doubts about the use of this vaccine, consult a doctor, pharmacist, or nurse.
Stopping the use of Ty - Typhoid Vaccine
In case of any further doubts about the use of this vaccine, consult a doctor, pharmacist, or nurse.
4. Possible side effects
Like all vaccines, this vaccine can cause side effects, although not everybody gets them.
Frequency not known (cannot be estimated from the available data):
- local reactions at the injection site: redness, painful swelling
- general side effects: headache, high temperature, malaise These symptoms usually resolve within 24-48 hours.
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 of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309,
website: https://smz.ezdrowie.gov.pl .
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will allow more information to be collected on the safety of the vaccine.
5. How to store Ty - Typhoid Vaccine
Store in a refrigerator (2°C - 8°C).
Do not freeze. If frozen, the vaccine should be destroyed.
The vaccine should be stored out of sight and reach of children.
Store the vial in the outer packaging to protect from light.
After the first opening of the vial, the vaccine can be stored for a maximum of 10 days in a 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 month.
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. Package contents and other information
What Ty - Typhoid Vaccine contains
The active substance of the vaccine is:
Salmonella typhibacteria (inactivated)
not less than 5x10 and not more than 1x10
The other ingredients are: phenol, sodium chloride, disodium phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, water for injections.
What Ty - Typhoid Vaccine looks like and what the package contains
The vaccine is a homogeneous, white or almost white or greyish-white suspension after shaking.
A white sediment forms at the bottom of the vial during storage, and a clear supernatant (liquid) forms above it.
The vaccine is available in a package:
1 vial of 10 ml (20 doses), closed with a rubber stopper, in a cardboard box.
Marketing authorization holder and manufacturer
Biomed S.A.
Al. Sosnowa 8
- 30-224 Krakow Tel. +48 12 37 69 200 Fax +48 12 37 69 205 e-mail: [email protected]
Date of last revision of the leaflet: -------------------------------------------------------------------------------------------------------------------------
Information intended for healthcare professionals only
Administration of Ty - Typhoid Vaccine
Shake before use to obtain a homogeneous suspension.
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 expiry date of the vaccine on the packaging.
Do not use the vaccine after the expiry date.
Administer 0.5 ml deep subcutaneously.
The recommended injection site is the arm.
Do not administer intravascularly! Ensure the needle is not inserted into a blood vessel.
Note: Due to the risk of anaphylactic shock associated with vaccine administration, the vaccination room should be equipped with a standard emergency kit.
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- ImporterInstytut Biotechnologii Surowic i Szczepionek BIOMED S.A.
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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