Ditebooster solution for injection in single-dose pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

diTeBooster

Injectable suspension, pre-filled single-dose syringe

Injectable suspension, vial

Diphtheria and tetanus vaccine (adsorbed, reduced antigen content)

Read the entire leaflet carefully before receiving this vaccine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Leaflet contents:

1. What diTeBooster is and what it is used for
2. What you need to know before being vaccinated with diTeBooster
3. How to be vaccinated with diTeBooster
4. Possible adverse reactions
5. How to store diTeBooster
6. Contents of the pack and other information

1. What diTeBooster is and what it is used for

diTeBooster is a vaccine that protects against diphtheria and tetanus.

diTeBooster stimulates the body to produce antibodies against diphtheria and tetanus.

This vaccine can be used to revaccinate children (from 5 years of age) and adults who have already received primary vaccination against diphtheria and tetanus.

This vaccine is used to vaccinate children (from 5 years of age) and adults who have missed, not completed, or not received primary vaccination against diphtheria and tetanus.

In the case of deep or potentially contaminated wounds, this vaccine may be used for tetanus prevention and as a booster vaccination against diphtheria.

2. What you need to know before being vaccinated with diTeBooster

You should not be vaccinated with diTeBooster

• if you are allergic to the active substances or to any of the other components of the vaccine (listed in section 6).
• if you have experienced serious adverse reactions after previous vaccinations.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before being vaccinated with diTeBooster:

• if you have any illness. In case of an acute illness with fever, vaccination should be postponed.
• if you are receiving any treatment that reduces the immune response (e.g., corticosteroids) or if you have any disease that increases the risk of bleeding.
• if you have any allergies.
• if you did not feel well after previous vaccinations.
• if you are allergic to formaldehyde. The vaccine may contain traces of formaldehyde used during the manufacturing process.

Children and adolescents

Children under 5 years of age should not be vaccinated with diTeBooster.

Other medicines and diTeBooster

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

diTeBooster may be administered at the same time as other vaccines, but in separate injections.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before being vaccinated with diTeBooster.

Pregnancy

There are insufficient data on the use of diTeBooster in pregnant women. If you are pregnant, your doctor will decide whether the risk of tetanus and diphtheria infection outweighs the potential risk of vaccination to the fetus.

Breastfeeding

There are insufficient data on the use of diTeBooster during breastfeeding; however, no harmful effects of the vaccine transmitted to infants through breast milk have been documented.

Driving and using machines

diTeBooster is unlikely to affect your ability to drive or operate machinery.

diTeBooster contains sodium

diTeBooster contains less than 1 mmol of sodium (23 mg) per dose; essentially "sodium-free".

3. How to be vaccinated with diTeBooster

The doctor or nurse will administer the vaccine intramuscularly.

The recommended dose is 0.5 ml for children (aged 5 years and older) and adults.

If you or your child have not previously been vaccinated against diphtheria and tetanus, you may receive more than one vaccination. Follow your doctor's instructions.

If you have any further questions about the use of this vaccine, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Serious adverse effects

• Severe allergic reactions (for example, difficulty breathing, difficulty swallowing, itching in hands and feet, facial swelling and swelling around the eyes).

If you notice any of these reactions, contact your doctor immediately.

Other adverse effects are:

Very common ( may affect more than 1 in 10 people)

• Slight redness and swelling at the injection site.
• Pain and itching at the injection site.
• Headache and fatigue.

Common ( may affect up to 1 in 10 people)

• General malaise (feeling unwell) and fever (temperature of 38 °C or higher).
• Pronounced redness and swelling of 5 cm or more at the injection site.
• Muscle pain.
• Dizziness.
• Nausea, vomiting and diarrhea.

Uncommon ( may affect up to 1 in 100 people)

• Eczema and skin inflammation (dermatitis).

Rare ( 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.

Very rare ( may affect up to 1 in 10,000 people)

• Fainting.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of diTeBooster

Keep this medicine out of the sight and reach of children.

Store in a refrigerator (between 2 ºC and 8 ºC).

Do not freeze.

Safely discard the vaccine if it has been frozen.

Do not use diTeBooster after the expiry date stated on the packaging after “EXP”. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of diTeBooster

• The active substances are:

1 dose (= 0.5 mL) contains at least 2 International Units of purified diphtheria toxoid and at least 20 International Units of purified tetanus toxoids adsorbed on hydrated aluminium hydroxide, corresponding to 0.5 mg of aluminium.

Aluminium is included in this vaccine as an adsorbent. Adsorbents are substances added to certain vaccines to accelerate, enhance, and/or prolong the protective effects of the vaccine.

• The other excipients are:

Sodium hydroxide, sodium chloride and water for injections.

Appearance of the product and contents of the container

diTeBooster is a colourless or clear yellow liquid with white and grey particles.

Each dose is supplied as a single pre-filled syringe or vial.

Pack sizes: 1 x 0.5 mL, 5 x 0.5 mL, 10 x 0.5 mL and 20 x 0.5 mL.

Vial sizes: 1 x 0.5 mL, 5 x 0.5 mL and 10 x 0.5 mL.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

AJ Vaccines A/S,
5, Artillerivej,
2300 Copenhagen S,
Denmark.
Tel.: +45 7229 7000
Fax: +45 7229 7999
E-mail: [email protected]

Further information about this medicinal product is available from the local representative of the Marketing Authorisation Holder:

MEDICARE PHARMA, S.L.
Pº de la Castellana, 177 3ºB
28046 Madrid, Spain
Tel. 91 3395489

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

AT, DK, EL, ES, FI, IE, PT, NO, SE: diTeBooster
DE: Td-IMMUN

This leaflet has been reviewed in January 2024

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This information is intended for healthcare professionals only:

diTeBooster is used for booster vaccination in children (≥ 5 years of age) and adults who have previously received primary immunisation with at least 3 doses of diphtheria and tetanus vaccine.

diTeBooster is used to vaccinate children (≥ 5 years of age) and adults who have forgotten, not completed, or never received primary vaccination against diphtheria and tetanus.

diTeBooster may be used in cases of deep or potentially contaminated wounds, for tetanus prophylaxis and as a booster against diphtheria.

The use of diTeBooster should follow official local recommendations.

Shake well before use. After thorough resuspension, the vaccine should appear as a colourless or clear yellow suspension with white or grey particles.

The dose is 0.5 mL, administered intramuscularly.

Booster doses of diphtheria and tetanus vaccine should be given according to official recommendations (generally every 10 years). Too frequent administration of booster doses may increase the risk of adverse reactions.

Individuals with unknown immunisation status, or with incomplete primary vaccination, may be vaccinated with diTeBooster. More than one dose may be required to achieve protective immunity against diphtheria and tetanus. National recommendations should be followed.

In individuals with tetanus-prone injuries, diTeBooster may be administered when diphtheria vaccination is also indicated. Tetanus immunoglobulin may be given simultaneously in accordance with national recommendations.

In certain situations (e.g. haemorrhagic diathesis), diTeBooster may be administered by deep subcutaneous route. Clinical studies have shown that local reactions are less frequent after intramuscular injection than after subcutaneous injection.

Appropriate measures for the treatment of anaphylactic reactions should always be readily available.

The final product may contain trace amounts of formaldehyde used during the manufacturing process. Caution should be exercised in individuals with known hypersensitivity to formaldehyde.

Do not mix with other vaccines in the same syringe.

Concomitant administration of diTeBooster with other inactivated vaccines has not been studied. Co-administration is unlikely to interfere with immune responses. If considered necessary, diTeBooster may be administered simultaneously with other vaccines at different injection sites.

Disposal of unused medicinal product and all materials that have come into contact with it should be carried out in accordance with local requirements.