Package leaflet: Information for the user

Tdap Vaccine
Suspension for injection in pre-filled syringe
Vaccine against diphtheria, tetanus and pertussis (acellular, combined), adsorbed,
with reduced antigen content
Please read all of this leaflet carefully before the vaccine is administered, because
it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

What Tdap Vaccine is and what it is used for
Important information before receiving Tdap Vaccine
How Tdap Vaccine is given
Possible side effects
How to store Tdap Vaccine
Contents of the pack and other information

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

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

You should receive Tdap Vaccine only if you have previously been vaccinated against diphtheria, tetanus and pertussis.

2. Important information before using Tdap Vaccine

Tdap Vaccine should not be used

if the patient is allergic to the active substances or to any of the other ingredients of this medicine (listed in section 6) or to formaldehyde, which may be present in very small amounts.
if the patient suffers from progressive neurological diseases.
if the patient is ill and has a high fever. In such a case, vaccination should be postponed.
if the patient previously experienced neurological problems (encephalopathy) occurring within 7 days after vaccination with a pertussis (whooping cough) vaccine.

Warnings and precautions
The doctor or nurse should exercise special caution when administering Tdap Vaccine.

if the patient has a weakened immune response or is taking immunosuppressive medicines. In such cases, the patient may still be vaccinated with Tdap Vaccine, but the immune response may be reduced.
if the patient suffers from a disease or is taking medicines that increase the risk of bleeding.
if after a previous pertussis vaccination the patient experienced one or more of the following adverse reactions:

General:

if the patient developed fever (temperature above 40°C) within 48 hours of vaccination, not caused by any other identifiable reason.

Children:

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

Tdap Vaccine and other medicines
You should tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Tdap Vaccine can be administered simultaneously with other vaccines, without affecting the effectiveness of Tdap Vaccine.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before receiving this vaccine.
Driving and using machines
Tdap Vaccine is not expected to affect the ability to drive or operate machinery.
Tdap Vaccine contains sodium chloride
The vaccine medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. the medicine is considered "sodium-free".

3. How to use Tdap Szczepionka

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 may be given by subcutaneous
injection.
The recommended dose for children (4 years of age or older), adolescents and adults is 0.5 ml.
Action required if vaccination is necessary
If vaccination becomes necessary, consult a doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Serious side effects
Very rare side effects: may affect up to 1 in 10,000 people

Severe allergic reactions (hypersensitivity reactions occurring within minutes or hours after vaccination), such as skin rash, difficulty breathing, or fainting (anaphylactic reaction). These may be fatal.
Other side effects
Very common side effects: may affect more than 1 in 10 people
Pain, itching, redness or swelling at the injection site.
Headache.
Fatigue.
Common side effects: may affect up to 1 in 10 people
General malaise, irritability and fever (temperature of 38°C or higher).
Redness and swelling of 5 cm or more in diameter at the injection site.
Muscle pain (myalgia).
Rare side effects: may affect up to 1 in 1,000 people
High fever (temperature above 40°C).
Persistent itchy nodules (granuloma) or sterile abscess at the injection site.
Urticaria.
Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, tell your doctor, pharmacist or nurse. Side effects can also be reported directly to the Department of Monitoring of Adverse Drug Reactions of 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).
Side effects can also be reported to the responsible entity.
Reporting side effects helps to provide more information on the safety of this medicine.

5. How to store Tdap Szczepionka

Keep the vaccine out of the sight and reach of children.
Store in the 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—
the cardboard box, after the words "Expiry date". The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Tdap Vaccine contains
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 on aluminium hydroxide, hydrated, corresponding to 0.5 mg of aluminium.
Aluminium acts as an adsorbent in this vaccine. Adsorbents are substances included in
some vaccines to accelerate, enhance and/or prolong the protective effect of the vaccine.
Other excipients:
Sodium chloride, sodium hydroxide and water for injections.

What Tdap Vaccine looks like and contents of the pack
After shaking, Tdap Vaccine is a colourless liquid containing white or grey particles.
Tdap Vaccine is supplied in pre-filled syringes in pack sizes 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 Authorisation Holder and Manufacturer
AJ Vaccines A/S
Artillerivej 5
DK-2300 Copenhagen S
Denmark
Tel.: +45 7229 7000
E-mail: [email protected]

This medicinal product is authorised for marketing in 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