Ditebooster suspension inyectable en jeringa monodosis precargada

Prospect: information for the user

diTeBooster

Injectable suspension, preloaded single-dose syringe

Injectable suspension, vial

Vaccine against diphtheria and tetanus (adsorbed, reduced antigen content)

Read this prospect carefully before receiving this vaccine as it contains important information for you.

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

1. What diTeBooster is and for what it is used.

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

3. How to be vaccinated with diTeBooster

4. Possible adverse effects

5. Storage of diTeBooster

6. Contents of the package and additional information

diTeBooster is a vaccine that protects against diphtheria and tetanus.

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

This vaccine may 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 forgotten, not completed or have not received primary vaccination against diphtheria and tetanus.

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

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 section6).
• if you have experienced severe adverse effects after previous vaccinations.

Warnings and precautions

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

• if you have any disease. In case of acute disease with fever, vaccination should be postponed.
• if you are receiving any treatment that reduces the immune response (for example, corticosteroids) or if you have any disease that increases the risk of bleeding.
• if you have any allergy.
• 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 5years of age should not be vaccinated with diTeBooster.

Other medications and diTeBooster

Inform your doctor or pharmacist if you are taking, have taken recentlyor may have to take anyother medication, including those acquired without a prescription.

diTeBooster can be administered concurrently with other vaccines, but in separate injections.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or intend 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 infection with tetanus and diphtheria is greater than the possible risk to the fetus from vaccination.

Breastfeeding

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

Driving and operating machinery

diTeBooster should not affect your ability to drive vehicles and operate machinery.

diTeBooster contains sodium

diTeBooster contains less than 1mmol of sodium (23mg) per dose; this is, essentially “sodium-free”.

The doctor or nurse will administer the vaccine intramuscularly.

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

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

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

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

Severe side effects

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

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

Other side effects are:

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

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

Common (can affect up to 1 in 10 people)

• General discomfort (feeling unwell) and fever (temperature of 38°C or higher).
• Marked redness and swelling of 5cm or more at the injection site
• Muscle pain.
• Dizziness.

• Nausea, vomiting, and diarrhea.

Uncommon(can affect up to 1in 100people)

• Eczema and skin inflammation (dermatitis).

Rare(can affect up to 1in 1000people)

• High fever (temperature above 40°C).
• Persistent pruritic nodules (granuloma) or sterile abscess at the injection site.
• Urticaria.

Very rare (can affect up to 1in 10000people)

• Weakness.

Reporting of side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Store in refrigerator (between 2°C and 8°C).

Do not freeze.

Dispose of the vaccine safely if it has frozen.

Do not use diTeBooster after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains. Ask your pharmacist how to dispose of the packaging and unused medicines. This will help protect the environment..

Composition of diTeBooster

• The active principles 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 aluminium hydroxide, hydrated, corresponding to 0.5 mg of aluminium.

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

• The other excipients are:

Sodium hydroxide, sodium chloride, and water for injection preparations.

Aspect of the product and content of the packaging

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

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

Packaging sizes: 1 x 0.5 ml, 5 x 0.5 ml, 10 x 0.5 ml, and 20 x 0.5 ml.

Vial size: 1 x 0.5 ml, 5 x 0.5 ml, and 10 x 0.5 ml.

Not all packaging sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

AJ Vaccines A/S,

5, Artillerivej,

2300 Copenhagen S,

Denmark.

tel.: +45 7229 7000

fax: +45 7229 7999

e-mail:[email protected]

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

MEDICARE PHARMA, S.L.

Pº de la Castellana, 177 3ºB

28046 Madrid, Spain

Tel. 91 3395489

This medicinal product is authorized in the member states of the European Economic Area with the following names:

AT, DK, EL, ES, FI, IE, PT, NO, SE: diTeBooster

DE: Td-IMMUN

This leaflet was last revised in January 2024

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This information is intended only for medical professionals or healthcare professionals:

diTeBooster is used for revaccination of children (≥ 5 years of age) and adults who have received primary immunization with at least 3 doses of diphtheria and tetanus vaccine.

diTeBooster is used for vaccination of children (≥ 5 years of age) and adults who have forgotten, not completed, or not received primary vaccination against diphtheria and tetanus.

diTeBooster may be used in case of deep or potentially contaminated wounds, as a preventive measure against tetanus and as a revaccination against diphtheria.

The use of diTeBooster should be carried out in accordance with local official recommendations.

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

The dose is 0.5 ml, which is administered intramuscularly.

The administration of booster doses of diphtheria and tetanus vaccine should be carried out at intervals marked by official recommendations (usually every 10 years). Frequent administration of booster doses increases the risk of adverse reactions.

Individuals with unknown immunization status, or with incomplete primary vaccination, may be vaccinated with diTeBooster. It may be necessary to administer more than one vaccine to achieve protective immunity against diphtheria and tetanus. National recommendations should be followed.

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

In certain situations (e.g. haemorrhagic diathesis) diTeBooster may be administered subcutaneously. Clinical studies have shown that fewer local reactions occur with intramuscular injection than with subcutaneous injection.

Always take necessary precautions for the treatment of anaphylactic reactions.

The final product may contain trace amounts of formaldehyde used during the manufacturing process. Precautions should be taken in subjects with known hypersensitivity to formaldehyde.

Do not mix with other vaccines in the same syringe.

The concomitant administration of diTeBooster with other inactivated vaccines has not been studied. It is unlikely that concurrent administration will interfere with immune responses. If necessary, diTeBooster may be administered simultaneously with other vaccines, in a different injection site.

The disposal of unused medication and all materials that have come into contact with it, should be carried out in accordance with local regulations.