Ditevaksal-T for adults – tetanus and diphtheria (Td) vaccine for children over 7 and adults

DITEVAKSAL-T® for adults is a combined vaccine containing concentrated and purified tetanus and diphtheria toxoids adsorbed on aluminium phosphate. One 0.5 mL dose contains at least 40 IU of tetanus toxoid and not more than 30 IU of diphtheria toxoid. It is produced by the Institute of Virology, Vaccines and Sera "Torlak" in Belgrade.

The vaccine is used for active immunisation of children over 7 years and adults to prevent diphtheria and tetanus – for primary vaccination and for revaccination, in line with current national immunisation regulations. It is administered only in health facilities, under medical supervision.

What is Ditevaksal-T for adults used for and how is it given?

Key facts about the medicine

What is Ditevaksal-T for adults used for?

For active immunisation against diphtheria and tetanus (vaccination and revaccination) in children over 7 years and adults. The vaccine stimulates the production of specific antitoxin antibodies. According to the leaflet, three doses (complete vaccination) provide about 5 years of protection, and a fourth booster dose provides good immunity for the next 10 years in most people.

How is it given and on what schedule?

• Route: one 0.5 mL dose intramuscularly into the deltoid muscle of the upper arm. Shake gently before use and briefly bring to room temperature.
• Primary vaccination (people over 7 who have not received DTP, DTaP or DT vaccine or have no proof of vaccination): three 0.5 mL doses – the second at least one month (4 weeks) after the first, the third 6–12 months after the second.
• Revaccination: in fully vaccinated children, the third revaccination is given as one 0.5 mL booster dose in the final year of primary school or at age 18; it can be given one year after the second revaccination.
• If another intramuscular vaccine is given at the same time, they are injected into opposite sides of the body; the vaccine must not be mixed with other vaccines or medicines in the same syringe.

Special patient groups

• Children under 7 years: this vaccine is intended for children over 7 and adults.
• People with immunodeficiency or on immunosuppressive treatment: can be vaccinated, but the immune response may be reduced.
• People with thrombocytopenia or clotting disorders (e.g. haemophilia): intramuscular administration is contraindicated, so the adsorbed Td vaccine is not used in them.

Contraindications – when the vaccine must not be given

• serious allergic reactions (e.g. anaphylaxis) to vaccine components or after a previous dose of Td vaccine (absolute contraindication);
• moderate to severe acute illness with or without fever – vaccination should be postponed until the condition is stable;
• Guillain-Barré syndrome within 6 weeks after a previous dose of a tetanus toxoid-containing vaccine – the vaccine may be given only if the benefit outweighs the risk.

Warnings and precautions

• Before vaccination, the doctor assesses your health and asks about previous allergic reactions and reactions to earlier vaccine doses.
• Special precautions are taken in people allergic to medicines or food or prone to hypersensitivity reactions; the facility must be ready to treat anaphylactic shock.
• All vaccinated people should be observed by a doctor for at least 30 minutes after administration.
• The vaccine must not be injected into a blood vessel; it is not used if it has been frozen or its appearance has changed (discoloration, particles, sediment that cannot be resuspended).
• The vaccine contains thiomersal (a preservative), which may cause an allergic reaction; it contains less than 1 mmol (23 mg) sodium per dose.

Interactions with other medicines, food and drink

Ditevaksal-T for adults can be given at the same time as other vaccines if injected at different sites. Immunosuppressive medicines (e.g. corticosteroids, corticotropin, alkylating cytostatics, antimetabolites) and radiotherapy may reduce the immune response to the vaccine. There are no data on the effect of food and drink.

Pregnancy and breast-feeding

• Pregnancy: it is not known whether the toxoids can harm the unborn baby, so the vaccine is used in pregnant women only when necessary – in those who have not received all three primary doses, in the second or third trimester.
• Breast-feeding: it is not known whether the vaccine passes into breast milk; special caution is needed.

Driving and using machines

According to the leaflet, the vaccine has no effect on psychophysical abilities.

Possible side effects

• Very common (more than 1 in 10): pain, swelling and redness at the injection site.
• Common (up to 1 in 10): fever of 38 °C or higher, irritability, chills, malaise, headache, general weakness, joint and muscle pain.
• Uncommon (up to 1 in 100): nodular infiltrate at the injection site; loss of appetite, nausea, vomiting.
• Rare (up to 1 in 1,000): sterile abscess (localised collection of pus) at the injection site.
• Very rare (up to 1 in 10,000): allergic reactions (rash, itching, hives), including anaphylaxis; brachial neuritis (inflammation of the nerves of the neck and arm) and Guillain-Barré syndrome.

Overdose, missed dose and stopping

• Overdose: no data.
• Missed dose / stopping: not applicable according to the leaflet; continuation of the vaccination schedule is decided by the doctor in line with national immunisation regulations.

Related information

For information on the vaccination schedule and tetanus and diphtheria boosters, contact your family doctor or the immunisation service at your local health centre.

Composition, pack and manufacturer

• Active substances (per 0.5 mL dose): concentrated and purified tetanus toxoid – not less than 40 IU; concentrated and purified diphtheria toxoid – not more than 30 IU.
• Excipients: aluminium phosphate (up to 1.25 mg Al); thiomersal 0.05 mg; sodium chloride 4.5 mg; sodium hydroxide and sodium hydrogen carbonate q.s.; water for injections to 0.5 mL.
• Appearance and pack: homogeneous whitish suspension that forms a whitish sediment on standing (resuspended by shaking); 5 mL glass vial (10 doses) with rubber stopper and aluminium cap; carton of 10 vials.
• Marketing authorisation holder and manufacturer: Institute of Virology, Vaccines and Sera "Torlak", Vojvode Stepe 458, Belgrade.

Storage

• Store in a refrigerator at 2 °C to 8 °C in the original package. Do not freeze – a frozen vaccine must not be used.
• Use opened multidose vials within 5 days, stored at 2–8 °C. The shelf life of the unopened vaccine is 2 years.
• Keep out of the sight and reach of children; do not use after the expiry date.

Frequently asked questions

How long does protection last after Ditevaksal-T?

According to the leaflet, three doses (complete vaccination) give about 5 years of protection, and a fourth booster dose provides good immunity for the next 10 years in most people.

Can an adult who has never been vaccinated receive Ditevaksal-T?

Yes. People over 7 who have not received DTP, DTaP or DT vaccine or have no proof of vaccination receive three doses: the second at least 4 weeks after the first and the third 6–12 months after the second.

Is it normal for my arm to hurt after the vaccine?

Yes. Pain, swelling and redness at the injection site are very common side effects and usually go away on their own. If a painful, warm, pus-filled swelling or a persistent high fever develops, see a doctor.

Can I receive the vaccine during pregnancy?

In pregnant women the vaccine is used only when necessary; in those who have not received all three primary doses it is given in the second or third trimester. The doctor decides.

Sources

• ALIMS – Summary of Product Characteristics, DITEVAKSAL-T for adults, suspension for injection (SmPC, Serbian)
• ALIMS – Package leaflet, DITEVAKSAL-T for adults, suspension for injection (PIL, Serbian)

Sources checked on: 25 October 2026.