Tdap Shhepionka

1. What is Tdap Vaccine and what is it used for

• Tdap Vaccine is used for vaccination of children (4 years or older), adolescents, and adults.
• Tdap Vaccine is a vaccine that provides protection against diphtheria, tetanus, and pertussis.
• Tdap Vaccine stimulates the body to produce antibodies against diphtheria, tetanus, and pertussis bacteria.

The patient should receive Tdap Vaccine only if they have been previously vaccinated against diphtheria, tetanus, and pertussis.

2. Important information before using Tdap Vaccine

Vaccination with Tdap Vaccine should not be performed

• if the patient is allergic to the active substances or any of the other ingredients of this vaccine (listed in section 6) or to formaldehyde, which may be present in very small amounts.
• if the patient has a progressive neurological disease.
• if the patient is ill and has a high fever. In such cases, vaccination should be postponed.
• if the patient has previously experienced problems with the nervous system (encephalopathy) that occurred within 7 days after vaccination with pertussis vaccine.

Warnings and precautions

The doctor or nurse should exercise special caution when vaccinating with Tdap Vaccine.

• if the patient's immune response is weakened or the patient is taking immunosuppressive drugs. In such cases, the patient can still be vaccinated with Tdap Vaccine, but the immune response may be reduced.
• if the patient has a disease or is taking medications that increase the risk of bleeding.
• if the patient has previously experienced one or more of the following side effects after pertussis vaccination:

General:

• if the patient had a fever (temperature above 40°C) within 48 hours after vaccination, which was not caused by any other known reason.

Children:

• if the child experienced collapse or a shock-like state within 48 hours after vaccination.
• if the child had persistent crying lasting more than 3 hours within 48 hours after vaccination.
• if the child had seizures or fever within 3 days after vaccination.

Tdap Vaccine and other medicines

Tell your doctor or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take. Tdap Vaccine can be administered simultaneously with other vaccines, which does not affect the efficacy of Tdap Vaccine.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before being vaccinated with this vaccine.

Driving and using machines

Tdap Vaccine should not affect the ability to drive and use machines.

Tdap Vaccine contains sodium

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

3. How to use Tdap Vaccine

The vaccine should be administered by a doctor or nurse, usually by injection into the muscle (intramuscularly). If there is a risk of bleeding, the vaccine can be administered subcutaneously. The recommended dose for children (4 years or older), adolescents, and adults is 0.5 ml.

Procedure in case of need for vaccination

In case of need for vaccination, consult a doctor or nurse.

4. Possible side effects

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

Severe side effects

Very rare side effects:may affect up to 1 in 10,000 people
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Severe allergic reactions (hypersensitivity reactions occurring within minutes or hours after vaccination), such as skin rash, difficulty breathing, or fainting (anaphylactic reaction). These can be fatal.

Other side effects

Very common side effects:may affect more than 1 in 10 people
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Pain, itching, redness, or swelling at the injection site.
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Headache.
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Fatigue.
Common side effects:may affect up to 1 in 10 people
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General malaise, irritability, and fever (temperature 38°C or higher).
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Redness and swelling of 5 cm or more in diameter at the injection site.
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Muscle pain (myalgia).
Rare side effects:may affect up to 1 in 1,000 people
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High fever (temperature above 40°C).
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Long-lasting itching nodules (granuloma) or sterile abscess at the injection site.
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Urticaria.

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.: +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 vaccine.

5. How to store Tdap Vaccine

Keep the vaccine out of sight and reach of children.
Store in a refrigerator (2°C - 8°C).
Store in the original packaging to protect from light.
Do not freeze.
Discard the vaccine if it has been frozen.
Do not use this vaccine after the expiry date stated on the outer packaging - carton after the words "Expiry date". The expiry date refers to the last day of the month stated.
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 Tdap Vaccine contains

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The active substances per dose are:
Diphtheria toxoid, purified
not less than 2 International Units
Tetanus toxoid, purified
not less than 20 International Units
Pertussis toxoid, purified
20 micrograms
Adsorbed (y) on hydrated aluminium hydroxide, corresponding to 0.5 mg of aluminium. Aluminium serves as an adsorbent in this vaccine. Adsorbents are substances that are part of some vaccines and are intended to accelerate, enhance, and/or prolong the protective effect of the vaccine.
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The other excipients are:
Sodium chloride, sodium hydroxide, and water for injections.

What Tdap Vaccine looks like and contents of the pack

After shaking, Tdap Vaccine is a colorless liquid containing white or gray particles.
Tdap Vaccine is supplied in a pre-filled syringe in packs of:
1 x 0.5 ml, 5 x 0.5 ml, 10 x 0.5 ml, and 20 x 0.5 ml.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

AJ Vaccines A/S
Artillerivej 5
DK-2300 Copenhagen S
Denmark
tel.: +45 7229 7000
e-mail: [email protected]

This vaccine is authorized in the Member States of the European Economic Area under the following names:

AT: dTaP Booster
BE: BoosterTdaP
DE: TdaP-IMMUN
DK, FI, NL, NO, SE: diTekiBooster
IE, IS: TdaPBooster
IT: Tribaccine
PL: Tdap Szczepionka

Date of last revision of the leaflet: July 2024