Dt-diphtheria-tetanus vaccine adsorbed
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Package leaflet: Information for the user
DT - Adsorbed diphtheria-tetanus vaccine
Injection suspension
Diphtheria and tetanus vaccine, adsorbed
Not less than 40 I.U. of tetanus toxoid and not less than 30 I.U. of diphtheria toxoid per 0.5 ml;
1 dose (0.5 ml)
Please read all of this leaflet carefully before this vaccine is administered, because it contains
important information for the patient.
- Keep this leaflet, as you may need to read it again.
- Speak to your doctor, pharmacist or nurse if you have any further doubts or concerns.
- This vaccine has been prescribed for a specific individual only. Do not pass it on to others.
- If any of the adverse effects worsens, or if you notice any adverse effects not listed in this leaflet, inform your doctor, pharmacist or nurse.
Contents of the leaflet:
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What DT - Adsorbed diphtheria-tetanus vaccine is and what it is used for
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Important information before using DT - Adsorbed diphtheria-tetanus vaccine
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How to use DT - Adsorbed diphtheria-tetanus vaccine
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Possible side effects
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How to store DT - Adsorbed diphtheria-tetanus vaccine
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Contents of the pack and other information
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What DT - Adsorbed diphtheria-tetanus vaccine is and what it is used for
DT - Adsorbed diphtheria-tetanus vaccine protects against two diseases: diphtheria and tetanus, caused by Corynebacterium diphtheriae and Clostridium tetani. The active substances of the vaccine are diphtheria toxoid and tetanus toxoid (non-infectious components derived from bacteria). After administration, the child's body produces protective antibodies against the diseases.
The vaccine is intended for active immunisation of children against diphtheria and tetanus.
Primary vaccination
- Children who have not received primary vaccination (i.e. compulsory vaccination consisting of three doses) against diphtheria and tetanus. Primary vaccination with DT vaccine is used in children with contraindications to pertussis vaccination.
Booster vaccination
- Children who have completed the full primary vaccination course against diphtheria and tetanus.
An adequate level of immunity protecting against infection is achieved after administration of all doses according to the National Immunisation Programme, which provides information on these vaccinations.
The vaccine meets the requirements of the European Pharmacopoeia and the World Health Organization.
- Important information before using DT - Adsorbed diphtheria-tetanus vaccine
When not to use DT - Adsorbed diphtheria-tetanus vaccine:
- If the child is allergic to diphtheria toxoid and/or tetanus toxoid or to any of the other components of this vaccine (listed in section 6). Symptoms of allergy may include: itchy rash, difficulty breathing, swelling of the face and tongue.
- If the child has an acute illness with fever. A mild infection, such as a cold, should not prevent vaccination, but the doctor should be informed first.
- If the child has an acute exacerbation of a chronic disease. In such cases, vaccination should be postponed until the exacerbation has resolved.
- If the child has previously experienced thrombocytopenia (reduced platelet count), increasing the risk of bleeding and bruising, or neurological disorders after prior administration of any diphtheria and/or tetanus-containing vaccine.
If there are any contraindications to vaccination with DT - Adsorbed diphtheria-tetanus vaccine, the doctor should assess the risk of administering the vaccine versus the risk of infection.
Warnings and precautions
Before starting vaccination with DT - Adsorbed diphtheria-tetanus vaccine, consult a doctor or nurse if adverse effects described in section 4 or any other worrying reactions occurred after a previous dose of the vaccine.
Vaccination should be preceded by a medical examination and a review of the child's general health status and previous vaccination records. This procedure helps predict the risk of adverse reactions following vaccination.
For safety reasons, remain under medical observation for 30 minutes after vaccination.
The vaccine contains thiomersal as a preservative, therefore allergic reactions may occur in the vaccinated child. Inform the doctor if known allergic reactions have occurred or are present. Also inform the doctor if any health disorders occurred after previous vaccination.
Other medicines and DT - Adsorbed diphtheria-tetanus vaccine
DT - Adsorbed diphtheria-tetanus vaccine may be administered simultaneously with other vaccines, as indicated by the National Immunisation Programme, and with immunoglobulins, if necessary.
Different vaccines and immunoglobulins administered at the same time should be injected at different body sites, using separate syringes and needles.
In children undergoing immunosuppressive treatment (which suppresses the immune system) or in children with immunodeficiency, the immune response to the vaccine may be reduced. In such cases, the doctor may decide to delay vaccination until the end of therapy and to measure antibody levels after vaccination.
Inform the doctor about all medicines currently or recently taken by the child, as well as any medicines the child will be taking.
Pregnancy and breastfeeding
Not applicable. The vaccine is administered only to children.
Driving and using machines
Not applicable. The vaccine is administered only to children.
- How to use DT - Adsorbed diphtheria-tetanus vaccine
The vaccine will be administered by a doctor or nurse as a deep subcutaneous injection.
The vaccine must never be administered intravenously.
Dosage for primary and booster vaccination
Primary vaccination
Primary vaccination consists of three doses of the vaccine:
- First dose – infants at the transition between 3 and 4 months of age
- Second dose – infants at 5 months of age (6 weeks after the first dose)
- Third dose – infants at 16–18 months of age (11–13 months after the second dose)
Booster vaccination
One dose of the vaccine at 6 years of age.
If vaccination at 6 years of age is not possible, the vaccine should be administered at 7 years of age. For children over 7 years of age, a diphtheria-tetanus vaccine with reduced diphtheria toxoid content should be used.
Administration of a higher than recommended dose of DT - Adsorbed diphtheria-tetanus vaccine
Overdose is unlikely, as the packaging is single-dose.
In case of doubt, consult a doctor.
Interrupting the use of DT - Adsorbed diphtheria-tetanus vaccine
If you have any further doubts regarding the use of the vaccine, consult your doctor, pharmacist or nurse.
4. Possible side effects
Like all vaccines, this vaccine may cause side effects, although not everybody gets them:
Frequency unknown (frequency cannot be estimated from the available data):
- Hypersensitivity reactions
- Headache, usually resolving within 24–48 hours
- Gastrointestinal disturbances
- General reaction: excessive sweating, chills, fever, malaise. These symptoms usually resolve within 24–48 hours
- Local reaction: redness, swelling and/or pain, itching at the injection site. A itchy lymphatic infiltration may also occur. Such reactions are most common in individuals who have been vaccinated multiple times. Subcutaneous nodules (granulomas) may also develop, occasionally progressing to aseptic abscesses (1:100,000). Granulomas that do not resolve within 6 weeks may result from hypersensitivity to aluminium. These symptoms usually resolve within 24–48 hours.
In preterm infants (born at 28 weeks of gestation or earlier), prolonged breathing pauses may occur within 2–3 days after vaccination.
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, consult your doctor, pharmacist or nurse.
5. How to store DT-Adsorbed Diphtheria-Tetanus Vaccine
Store in an upright position in a refrigerator (2°C–8°C).
Do not freeze; if the vaccine freezes, it must be discarded.
The vaccine should be stored out of sight and out of reach of children.
Do not use the vaccine after the expiry date stated on the carton.
The expiry date refers to the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer in use. Such practices help protect the environment.
6. Contents of the packaging and other information
What DT-Adsorbed Diphtheria and Tetanus Vaccine contains
The active substances of the vaccine are:
Tetanus toxoid not less than 40 I.U.
Diphtheria toxoid not less than 30 I.U.
adsorbed on aluminium hydroxide, hydrated, not more than 0.7 mg Al
Other vaccine components are: thiomersal, sodium chloride and water for injections.
What DT-Adsorbed Diphtheria and Tetanus Vaccine looks like and contents of the pack
The vaccine is a milky, homogeneous suspension of cream color in glass vials.
During storage, a white sediment may form at the bottom of the vial, with a clear supernatant (liquid) above it.
The pack contains 5 vials.
Marketing Authorisation Holder and Manufacturer
Institute of Serum and Vaccine Biotechnology BIOMED Joint Stock Company
Al. Sosnowa 8
30-224 Kraków
Tel.: +48 12 37 69 200
Fax: +48 12 37 69 205
e-mail: [email protected]
Information intended exclusively for healthcare professionals
Administration of DT-Adsorbed Diphtheria and Tetanus Vaccine
Shake well before use to obtain a homogeneous suspension.
Visually inspect the vaccine for any foreign particles and (or) changes in appearance. Do not use the vaccine if any changes are observed.
Administer 0.5 ml deep subcutaneously (intramuscular administration is also recommended to minimize local reactions associated with the presence of adjuvant).
Recommended injection sites are the deltoid muscle or the anterolateral thigh.
Do not administer intravenously! Ensure that the needle has not entered a blood vessel.
Warning: Due to the risk of anaphylactic shock associated with vaccine administration, the vaccination room must be equipped with a standard anaphylaxis emergency kit.
If contraindications exist for diphtheria vaccination, administer tetanus vaccine (T) only. Monovalent diphtheria vaccine (D) may be used if there are no contraindications to its administration and contraindications exist for tetanus vaccination.