DITEVAKSAL-T vaccine – protecting children against diphtheria and tetanus (DT vaccine)

DITEVAKSAL-T is a combined vaccine against diphtheria and tetanus (DT vaccine). It consists of concentrated and purified diphtheria toxoid and tetanus toxoid, adsorbed on aluminium phosphate. One 0.5 mL dose contains at least 40 IU of tetanus toxoid and at least 30 IU of diphtheria toxoid.

The vaccine is used for active immunisation (primary vaccination and booster doses) against diphtheria and tetanus in children from the age of 2 months up to 7 years. It stimulates the production of specific antitoxin antibodies. It is manufactured by the Torlak Institute in Belgrade and is given only in healthcare facilities, under the supervision of an experienced paediatrician.

Who is DITEVAKSAL-T vaccine for and what is the vaccination schedule?

Key facts about the medicine

What is DITEVAKSAL-T used for?

According to the leaflet, the vaccine is used for active immunisation against diphtheria and tetanus in children from 2 months to 7 years of age:

• primary vaccination in children aged 2 months to 5 years in whom a vaccine with a pertussis (whooping cough) component – DTP or DTaP – is contraindicated (e.g. because of a serious allergic reaction to the pertussis component, coma, reduced consciousness, prolonged seizures or progressive neurological disease);
• primary vaccination of children older than 5 and under 7 years who have not been vaccinated against diphtheria and tetanus or for whom there is no proof of 3 doses of a combined vaccine;
• booster doses up to 7 years of age.

Three doses in childhood provide protection for 3–5 years, and the fourth and fifth doses (boosters) provide adequate protection in adolescence.

How is it given – vaccination schedule?

• Each dose is 0.5 mL and is given intramuscularly into the deltoid muscle of the upper arm.
• The interval between doses must not be shorter than one month (4 weeks).
• If another injectable vaccine is given at the same time, it is injected into the other arm; vaccines are not mixed in the same syringe.
• Before use the vaccine should be brought to room temperature and gently shaken; a separate syringe and needle are used for each child.

Special patient groups

• Age: the vaccine is intended only for children from 2 months up to 7 years.
• Immunodeficiency: children with congenital or acquired immunodeficiency can be vaccinated, but the immune response may be weaker; immunosuppressive medicines also weaken the response.
• Clotting disorders: in thrombocytopenia or haemophilia intramuscular administration is contraindicated, so the adsorbed DT vaccine is not given.

Contraindications – when the medicine must not be used

DITEVAKSAL-T must not be given:

• in case of a serious allergic reaction (e.g. anaphylaxis) to any vaccine component or to a previous dose of DT vaccine – absolute contraindication;
• in moderate to severe acute illness with or without fever – vaccination is postponed until the condition is stable;
• if Guillain-Barré syndrome occurred within 6 weeks of a previous tetanus toxoid vaccine – the vaccine is then given only if the benefit outweighs the risk.

Warnings and precautions

• Before vaccination the doctor assesses the child’s health and obtains information from the parents about illnesses, allergies and reactions to previous doses.
• The facility must be prepared to treat anaphylactic shock; the child is supervised for at least 30 minutes after vaccination.
• The vaccine must not be injected into a blood vessel.
• If the suspension has changed in appearance (colour, visible particles, sediment that does not resuspend) or has been frozen, it must not be used.
• It contains thiomersal (a preservative), which can cause an allergic reaction; it contains less than 1 mmol sodium per dose.

Interactions with other medicines, food and drink

DITEVAKSAL-T can be given at the same time as other vaccines if they are injected at different sites, but it must not be mixed with other vaccines or medicines in the same syringe. Immunosuppressive medicines (corticosteroids, corticotropin, alkylating cytostatics, antimetabolites) and radiotherapy may reduce the immune response to the vaccine – tell the doctor if your child is receiving such treatment.

Pregnancy and breast-feeding

Not applicable – the vaccine is given only to children up to seven years of age.

Driving and using machines

Not applicable – the vaccine is given only to children up to seven years of age.

Possible side effects

Like all vaccines, DITEVAKSAL-T can cause side effects, although not every child gets them. According to the leaflet and the Summary of Product Characteristics:

• Very common and common: pain, swelling and redness at the injection site; irritability, malaise, general weakness; fever of 38 °C and higher, shivering, headache, joint and muscle pain; a nodular infiltrate (lump) at the injection site.
• Uncommon: loss of appetite, nausea, vomiting.
• Very rare: allergic reactions (rash, itching, hives), including anaphylaxis; sterile abscess at the injection site; brachial neuritis (inflammation of nerves in the neck and arm); Guillain-Barré syndrome.

Overdose, missed dose and stopping treatment

• Overdose: no data; the vaccine is given by a healthcare professional at the prescribed dose of 0.5 mL.
• Missed dose: the paediatrician decides how to continue the schedule; the interval between doses must not be shorter than 4 weeks.
• Stopping: not applicable in the usual sense – completing the whole schedule is important for full protection.

Related information

Vaccination against diphtheria and tetanus is carried out by a paediatrician in a healthcare facility according to the immunisation schedule. For questions about your child’s vaccination status, please contact your paediatrician.

Composition, pack and manufacturer

• Active substances (per 0.5 mL): concentrated and purified tetanus toxoid at least 40 IU; concentrated and purified diphtheria toxoid at least 30 IU.
• Excipients (per 0.5 mL): aluminium phosphate (up to 1.25 mg Al); thiomersal 0.05 mg; sodium chloride 4.5 mg; sodium hydroxide; sodium hydrogen carbonate; water for injections.
• Appearance and pack: homogeneous whitish suspension that forms a sediment on standing, which resuspends on shaking; 5 mL glass vial (10 doses) with rubber stopper and aluminium cap; carton with 10 vials.
• Marketing authorisation holder and manufacturer: Institute of Virology, Vaccines and Sera “Torlak”, Vojvode Stepe 458, Belgrade.

Storage

• Store in a refrigerator (2–8 °C) in the original package; do not freeze – a frozen vaccine must not be used.
• An opened multi-dose vial must be used within 5 days if stored at 2–8 °C.
• Shelf life: 2 years; keep out of the sight and reach of children.

Frequently asked questions

When is DITEVAKSAL-T given instead of a whooping cough vaccine?

When a vaccine with a pertussis component (DTP or DTaP) is contraindicated in the child – e.g. after a serious allergic reaction to it or in certain neurological conditions – and in children aged 5 to 7 years who have not been vaccinated against diphtheria and tetanus.

How many doses of DITEVAKSAL-T does a child receive?

Primary vaccination consists of 3 doses of 0.5 mL (from 2 months of age, 4–8 weeks apart), followed by two boosters – one year after primary vaccination and before starting school, by 7 years of age.

Is it normal for a child to have a fever after the vaccine?

Yes, fever, irritability, tiredness and pain, swelling and redness at the injection site are common side effects. If the fever does not go down or the child behaves unusually, contact your paediatrician.

Can DITEVAKSAL-T be given to adults?

No. This vaccine is intended only for children up to 7 years; there is a separate vaccine, DITEVAKSAL-T for adults.

Sources

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

Sources checked on: 25 October 2026.