TRIBACCINE

PACKAGE LEAFLET

Package leaflet: information for the user

Tribaccine

Injectable suspension in pre-filled syringe
Vaccine (adsorbed, reduced antigen content) against diphtheria, tetanus and pertussis
(acellular component)
Please read this leaflet carefully before the vaccine is administered to you or your
child, as 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 side effects, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What Tribaccine is and what it is used for
2. What you need to know before vaccination with Tribaccine
3. How vaccination with Tribaccine is administered
4. Possible side effects
5. How to store Tribaccine
6. Contents of the pack and other information

1. What Tribaccine is and what it is used for

• Tribaccine is used to vaccinate children (4 years of age or older), adolescents, and adults.
• Tribaccine is a vaccine that provides protection against diphtheria, tetanus, and pertussis.
• Tribaccine stimulates the body to produce antibodies against the bacteria that cause diphtheria, tetanus, and pertussis. Tribaccine will only be administered if a previous vaccination against diphtheria, tetanus, and pertussis has already been given.

2. What you should know before you or your child are vaccinated with Tribaccine

You or your child must not be vaccinated with Tribaccine

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6) or to formaldehyde, which may be present in extremely small amounts.
• if you have progressive neurological diseases.
• if you have a high fever, vaccination should be postponed.
• if you experienced neurological problems (encephalopathy) within 7 days after a previous vaccination with a pertussis-containing vaccine.

Warnings and precautions
The doctor or nurse will exercise extreme caution when vaccinating you with Tribaccine:

• if your immune response is weakened or if you are taking an immunosuppressive medicine; you may still be vaccinated with Tribaccine, but your immune response could be reduced.
• if you have a disease or are receiving a treatment that increases the risk of bleeding.
• if you experienced one or more of the following adverse reactions after a previous pertussis vaccination:

General:

• if you developed a fever (temperature above 40°C) within 48 hours after a previous vaccination, not attributable to any other identifiable cause.

Children:

• if the child experienced collapse or shock-like state within 48 hours after a previous vaccination.
• if the child cried persistently for more than 3 hours within 48 hours after a previous vaccination.
• if the child had convulsions, with or without fever, within 3 days after a previous vaccination.

Other medicines and Tribaccine
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Tribaccine can be administered simultaneously with other vaccines without reducing its effectiveness.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before being vaccinated with this vaccine.

Driving and using machines
Tribaccine is unlikely to affect the ability to drive vehicles or operate machinery.

Tribaccine contains sodium chloride
This vaccine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially "sodium-free".

3. How your vaccination or your child's vaccination with Tribaccine is administered

The vaccination is usually given by a doctor or nurse as an injection into a muscle (intramuscularly). If there is a risk of bleeding, the vaccine may also be administered by injection under the skin.
The recommended dose is 0.5 ml for children (4 years of age and older), adolescents, and adults.
If you have any doubts, consult your doctor or pharmacist.
If you need a vaccination
If you think you need a vaccination, speak to your 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

• Serious allergic reactions (hypersensitivity reactions occurring within minutes or hours), for example rash, difficulty breathing and fainting (anaphylactic reaction). These can be life-threatening.

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 (feeling unwell), irritability and fever (temperature of 38°C or higher).

• Redness and swelling of 5 cm or more 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).

• Long-lasting itchy nodules (granuloma) or sterile abscess at the injection site.

• Urticaria.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Tribaccine

Keep this medicine out of sight and reach of children.
Store in a refrigerator (2°C – 8°C).
Keep in the original packaging to protect the medicine from light.
Do not freeze.
Discard the vaccine if it has been frozen.
Do not use this medicine after the expiry date stated on the carton after “Expiry”. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Tribaccine contains

• The active substances in each 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 hydrate corresponding to 0.5 mg of aluminium.
Aluminium is added to this vaccine as an adsorbent. Adsorbents are substances added to some vaccines to accelerate, enhance and/or prolong the protective effects of the vaccine.

• Other components are:
  Sodium chloride, sodium hydroxide and water for injections.

Description of the appearance of Tribaccine and package contents
After shaking, Tribaccine is a colourless liquid with white or grey particles.
Tribaccine is supplied in a pre-filled syringe 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
Fax: +45 7229 7999
Email: [email protected]

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Medic Italia S.r.l.
Via Bernardino Telesio, 2
20145 Milan
Italy
Tel.: +39 081 559 7393 – 559 8089 – 559 2582
Fax: +39 081 752 0855
Email: [email protected]
www.medicitaliasrl.it

This medicinal product is authorised 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
PL: Tdap Szczepionka
IT: Tribaccine