D-shhepionka bvoniha adsorbovana

Leaflet attached to the packaging: information for the user

D - Diphtheria vaccine adsorbed

Injection suspension
Diphtheria vaccine, adsorbed
Not less than 30 IU of diphtheria toxoid/0.5 ml;
20-dose vaccine

Read the leaflet carefully before using the vaccine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult a doctor, pharmacist, or nurse.
• This vaccine has been prescribed to a specific person. Do not pass it on to others.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is D - Diphtheria vaccine adsorbed and what is it used for
• 2. Important information before using D - Diphtheria vaccine adsorbed
• 3. How to use D - Diphtheria vaccine adsorbed
• 4. Possible side effects
• 5. How to store D - Diphtheria vaccine adsorbed
• 6. Package contents and other information

1. What is D - Diphtheria vaccine adsorbed and what is it used for

• D - Diphtheria vaccine adsorbed protects against diphtheria (caused by Corynebacterium diphtheriae). The active substance of the vaccine is diphtheria toxoid (a non-infectious component derived from bacteria). After administration of the vaccine, the body produces antibodies that protect against the disease. The vaccine is used for active immunization of children against diphtheria, depending on the epidemiological situation.

Primary vaccination

• children under 6 years of age who have not received primary (i.e., mandatory, consisting of three doses) vaccination against diphtheria.

Booster vaccination

• children at the age of 6 who have received a full primary vaccination cycle (provided that the third dose of primary vaccination was given in the second year of life)

An appropriate level of immunity against diphtheria is achieved after using all doses of diphtheria vaccination in accordance with the National Vaccination Program, which contains information about these vaccinations.
The immunizing properties of the vaccine are enhanced by the action of aluminum hydroxide (adjuvant).
The vaccine meets the requirements of the European Pharmacopoeia and the World Health Organization.

2. Important information before using D - Diphtheria vaccine adsorbed

When not to use D - Diphtheria vaccine adsorbed:

• if the child is allergic to diphtheria toxoid or any other component of this vaccine (listed in section 6). Allergy symptoms may include: itching

rash, shortness of breath, swelling of the face and tongue,

• 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 first,
• if the child has chronic diseases during an exacerbation. In such cases, vaccination should be performed after the exacerbation of the disease has subsided.

If there are any contraindications to vaccination with D - Diphtheria vaccine adsorbed, the doctor should assess the risk of administering the vaccine in relation to the risk of infection.

Warnings and precautions

Before starting to use D - Diphtheria vaccine adsorbed, discuss it with your doctor or nurse if any side effects or other worrying reactions occurred after the previous dose of the vaccine.
Vaccination should be preceded by a medical examination and interview about the child's general health and previously performed and recorded vaccinations. This procedure allows for predicting the risk of side effects after administering the vaccine.

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

The vaccine contains thiomersal as a preservative, so allergic reactions may occur in the vaccinated child. Inform your doctor if you have had or have known allergic reactions. You should also inform your doctor if you have had health disorders after previous vaccination.

D - Diphtheria vaccine adsorbed and other medicines

• D - Diphtheria vaccine adsorbed can be administered at the same time as other vaccines, if it results from 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 vaccination until the end of therapy and determine the level of antibodies after vaccination.

Tell your doctor about all medicines your child is taking or has recently taken, as well as any medicines your child will be taking.

Pregnancy and breastfeeding

Not applicable. The vaccine is used only in children.

Driving and operating machinery

Not applicable. The vaccine is used only in children.

3. How to use D - Diphtheria vaccine adsorbed

The vaccine will be administered by a doctor or nurse as a deep subcutaneous injection.
The recommended injection site is the deltoid muscle or the anterolateral part of the thigh.
The vaccine must never be administered intravascularly.

Dosing in primary and booster vaccination

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

• two doses of the vaccine at an interval of 4-6 weeks
• a third dose of the vaccine after 6-12 months from the administration of the second dose.

Dose I
Dose II
Dose III
Children under 2 years
0.5 ml
0.5 ml
0.3 ml
Children aged

• 2 - 6 years 0.3 ml 0.3 ml 0.3 ml

Booster vaccination
One dose of the vaccine 0.2 ml:

• children at the age of 6 who have received a full primary vaccination cycle (provided that the third dose of primary vaccination was given in the second year of life).

The dosing schedule is determined by the doctor after a thorough analysis of the primary and booster vaccination course against diphtheria.

Use of a higher than recommended dose of D - Diphtheria vaccine adsorbed

There are no data on overdose.

Discontinuation of D - Diphtheria vaccine adsorbed

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

4. Possible side effects

Like any vaccine, this vaccine can cause side effects, although not everybody gets them.

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

• headache
• fever
• malaise
• redness, swelling, and/or pain at the injection site. These symptoms usually resolve within 24 - 48 hours.

In preterm infants (born at 28 weeks of gestation or earlier), within 2-3 days after vaccination, longer pauses between breaths may occur.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website:
https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will allow for more information to be collected on the safety of the vaccine.

5. How to store D - Diphtheria vaccine adsorbed

Store 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 sight and reach of children.
Do not use this 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 containers. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What D - Diphtheria vaccine adsorbed contains

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

What D - Diphtheria vaccine adsorbed looks like and what the pack contains

The vaccine is a white or almost white, homogeneous suspension in glass vials. During storage, a white sediment forms at the bottom of the vial, and a clear supernatant (liquid) forms above it.
The package contains 1 vial (10 ml)

20-dose vaccine

Marketing authorization holder and manufacturer

Biomed S.A.
Al. Sosnowa 8
30-224 Krakow
Tel.: +48 12 37 69 200
Fax: +48 12 37 69 205
e-mail: informacjanaukowa@biomed.pl

Date of last revision of the leaflet:

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Information intended for healthcare professionals only

Administration of D - Diphtheria vaccine adsorbed

Before use, shake the vial to obtain a homogeneous suspension.
Visually inspect the vaccine for any foreign particles or changes in appearance. If any changes are observed, do not use the vaccine.
The vaccine should be used within 24 hours after opening the vial.
Administer the vaccine dose deep subcutaneously.
Do not exceed a dose of 0.5 ml.
The recommended injection site is the deltoid muscle or the anterolateral part of the thigh.
Do not administer intravascularly! Ensure that the needle is not inserted into a blood vessel.
Note: due to the risk of anaphylactic shock associated with vaccine administration, the vaccination office should be equipped with a standard anaphylaxis kit.