Dt-shhepionka bvoniho-temzhcova adsorbovana

Leaflet included in the packaging: information for the user

DT - Diphtheria and Tetanus Vaccine, Adsorbed

Suspension for injection. Vaccine against diphtheria and tetanus, adsorbed. Not less than 40 IU of tetanus toxoid and not less than 30 IU of diphtheria toxoid/0.5 ml; 1 dose (0.5 ml)

You should read the contents of the leaflet before using the vaccine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• You should consult a doctor, pharmacist, or nurse if you have any further questions.
• This vaccine has been prescribed specifically for you. Do not pass it on to others.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, pharmacist, or nurse.

Table of contents of the leaflet:

• 1. What DT - Diphtheria and Tetanus Vaccine, Adsorbed is and what it is used for
• 2. Important information before using DT - Diphtheria and Tetanus Vaccine, Adsorbed
• 3. How to use DT - Diphtheria and Tetanus Vaccine, Adsorbed
• 4. Possible side effects
• 5. How to store DT - Diphtheria and Tetanus Vaccine, Adsorbed
• 6. Contents of the packaging and other information

1. What DT - Diphtheria and Tetanus Vaccine, Adsorbed is and what it is used for

DT - Diphtheria and Tetanus Vaccine, Adsorbed protects against two diseases: diphtheria (dyphtheria) 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 of the vaccine, the child's body produces antibodies that protect against the disease. The vaccine is used for active immunization of children against diphtheria and tetanus. Primary vaccination

• children who have not received primary vaccination (i.e., mandatory, 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 received a full cycle of primary vaccination against diphtheria and tetanus.

An appropriate level of immunity that protects against infection is achieved after using all doses of vaccination in accordance with the National Vaccination Program, which contains information about these vaccinations. The vaccine meets the requirements of the European Pharmacopoeia and the World Health Organization.

2. Important information before using DT - Diphtheria and Tetanus Vaccine, Adsorbed

When not to use DT - Diphtheria and Tetanus Vaccine, Adsorbed:

• if the child is allergic to diphtheria toxoid and/or tetanus toxoid or to any of the other components of this medicine (listed in section 6). Allergy symptoms may include: rash, difficulty breathing, facial swelling, and tongue swelling,

if the child has acute illnesses with fever. Mild infections, such as a cold, should not be a contraindication to vaccination, but the doctor should be informed about it first, if the child has chronic diseases during exacerbation. In these cases, vaccination should be performed after the exacerbation of the disease has subsided, if the child has had a decrease in platelet count, which increases the risk of bleeding and bruising, or if neurological disorders have occurred after previous administration of any diphtheria and/or tetanus vaccine.

Warnings and precautions

Before starting to use DT - Diphtheria and Tetanus Vaccine, Adsorbed, you should consult a doctor or nurse if any of the side effects described in section 4 occurred after the previous dose of the vaccine or if there were any other worrying reactions. Vaccination should be preceded by a medical examination and a survey of the child's general health and previously performed and recorded vaccinations. This approach allows predicting the risk of side effects after vaccination.

For safety reasons, after vaccination, you should stay under the doctor's observation for 30 minutes.

The vaccine contains thiomersal as a preservative, so allergic reactions may occur in the vaccinated child. You should inform the doctor if there were any known allergic reactions. You should also inform the doctor if there were any health disorders after previous vaccination.

Other medicines and DT - Diphtheria and Tetanus Vaccine, Adsorbed

DT - Diphtheria and Tetanus Vaccine, Adsorbed can be administered at the same time as other vaccines, if it is in accordance with the National Vaccination Program, and with immunoglobulins, if necessary. Different vaccines and immunoglobulins administered at the same time should be injected into different parts of the body, using separate syringes and needles. In children undergoing immunosuppressive therapy (inhibiting the activity of the immune system) or in children with immune deficiencies, the response to the vaccine may be reduced. In such cases, the doctor may decide to postpone vaccinations until the end of therapy and to determine the level of antibodies after vaccination. You should tell the doctor about all medicines that the child is currently taking or has recently taken, as well as about medicines that the child will take.

Pregnancy and breastfeeding

This does not apply. The vaccine is used only in children.

Driving and using machines

This does not apply. The vaccine is used only in children.

3. How to use DT - Diphtheria and Tetanus Vaccine, Adsorbed

The vaccine will be administered by a doctor or nurse as a deep subcutaneous injection. The vaccine must never be administered intravenously.

Dosing for primary and booster vaccination

Primary vaccination The primary vaccination consists of three doses of the vaccine:

• first dose - children at the age of 3-4 months
• second dose - children at the age of 5 months (6 weeks after the first dose)
• third dose - children at the age of 16-18 months (11-13 months after the second dose).

Booster vaccination One dose of the vaccine at the age of 6. If it is not possible to perform the vaccination at the age of 6, the vaccine should be administered at the age of 7. In children over 7 years of age, a tetanus-diphtheria vaccine with reduced diphtheria toxoid content should be used.

Use of a higher dose of DT - Diphtheria and Tetanus Vaccine, Adsorbed than recommended

Overdose is unlikely, as the packaging is single-dose. In case of doubt, you should consult a doctor.

Discontinuation of DT - Diphtheria and Tetanus Vaccine, Adsorbed

In case of any further doubts related to the use of the vaccine, you should consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all vaccines, this vaccine can cause side effects, although not everybody gets them:

Frequency not known (frequency cannot be estimated from the available data):

• allergy symptoms
• headache, this symptom usually disappears after 24-48 hours
• gastrointestinal disorders
• general reaction: excessive sweating, chills, fever, malaise. These symptoms usually disappear after 24-48 hours
• local reaction: redness, swelling and/or pain, itching at the injection site. A painful lymphatic nodule may also appear. This type of reaction occurs most often in people who have been vaccinated multiple times. There may also be subcutaneous nodules - granulomas, which sometimes transform into aseptic abscesses (1:100,000). Granulomas that do not disappear within 6 weeks may be a sign of hypersensitivity to aluminum. These symptoms usually disappear after 24-48 hours.

In premature infants (born at 28 weeks of gestation or earlier), within 2-3 days after vaccination, longer pauses between breaths may occur. If any side effects occur, including any possible side effects not listed in this leaflet, you should consult a doctor, pharmacist, or nurse.

5. How to store DT - Diphtheria and Tetanus Vaccine, Adsorbed

Store upright, in a refrigerator (2°C - 8°C). Do not freeze, in case of freezing, the vaccine should be destroyed. The vaccine should be stored out of the sight and 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 given month. Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What DT - Diphtheria and Tetanus Vaccine, Adsorbed contains

The active substances of the vaccine are: Tetanus toxoid not less than 40 IU Diphtheria toxoid not less than 30 IU adsorbed on hydrated aluminum hydroxide not more than 0.7 mg Al The other ingredients of the vaccine are: thiomersal, sodium chloride, and water for injections.

What DT - Diphtheria and Tetanus Vaccine, Adsorbed looks like and what the packaging contains

The vaccine is a milky, homogeneous suspension with a creamy tint in glass ampoules. During storage, a white sediment forms at the bottom of the ampoule, and a clear supernatant (liquid) forms above it. The packaging contains 5 ampoules.

Responsible entity and manufacturer

Biomed S.A. Al. Sosnowa 8 30-224 Kraków Tel.: +48 12 37 69 200 Fax: +48 12 37 69 205 e-mail: [email protected]

Date of the last update of the leaflet: ---------------------------------------------------------------------------

Information intended exclusively for medical professionals

Administration of DT - Diphtheria and Tetanus Vaccine, Adsorbed

Before use, shake to obtain a homogeneous suspension. You should visually inspect the vaccine for any foreign particles and/or changes in its appearance. If there are any changes, the vaccine should not be used. The dose of 0.5 ml should be administered deep subcutaneously (it is also recommended to administer the vaccine intradermally to minimize local reactions associated with the presence of the adjuvant). The recommended injection site is the deltoid muscle or the anterolateral thigh. Do not administer intravenously! Make sure the needle is not inserted into a blood vessel. Note: due to the risk of anaphylactic shock associated with vaccine administration, the vaccination room should be equipped with a standard anaphylaxis kit. If there are contraindications to the administration of the diphtheria vaccine, only the tetanus vaccine (T) should be administered. A monovalent diphtheria vaccine (D) can be used if there are no contraindications to its administration, and there are contraindications to the administration of the tetanus vaccine.