D-diphtheria vaccine adsorbed

Package leaflet: Information for the user

D - Diphtheria adsorbed vaccine
suspension for injection
Diphtheria vaccine, adsorbed
Not less than 30 I.U. of diphtheria toxoid/0.5 ml;
20-dose vaccine
Please read all of this leaflet carefully before using this vaccine, because
it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This vaccine has been prescribed for a specific individual. Do not pass it on to others.
• If any side effects occur in the patient, including any side effects not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

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

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

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

Primary vaccination

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

Booster vaccination

• Children aged 6 years who have completed the primary vaccination cycle (with the third dose of primary vaccination received in the second year of life)

A protective level of immunity against diphtheria infection is achieved after administration of all doses of diphtheria vaccination according to the National Immunization Program, which provides information on these vaccinations.
The immunogenic properties of the vaccine are enhanced by the presence of aluminium hydroxide (adjuvant).
The vaccine meets the requirements of the European Pharmacopoeia and the World Health Organization.

2. Important information before using Diphtheria Adsorbed Vaccine

When not to use Diphtheria Adsorbed Vaccine:

• if the child is allergic to diphtheria 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 acute illness with fever. A mild infection, such as a common cold, should not prevent vaccination, but the doctor should be informed first,
• if the child has chronic diseases during an exacerbation period. In such cases, vaccination should be performed after the exacerbation has subsided.

If there are any contraindications to vaccination with Diphtheria Adsorbed Vaccine,
the doctor should assess the risk of administering the vaccine against the risk of contracting the infection.
Warnings and precautions
Before starting Diphtheria Adsorbed Vaccine, discuss with the doctor or nurse if any adverse reactions described in section 4 occurred after a previous dose of the vaccine, or any other concerning reactions.
Vaccination should be preceded by a medical examination and a review of the child's general health status and previously administered and recorded vaccinations. 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 vaccinated children. Inform the doctor if there have been or are known allergic reactions. Also inform the doctor if any health disturbances occurred after previous vaccination.
Diphtheria Adsorbed Vaccine and other medicines
Diphtheria Adsorbed Vaccine may be administered at the same time as other vaccines, if indicated by the National Immunization Program, and with immunoglobulins, if necessary.
Different vaccines and immunoglobulins administered simultaneously should be injected at different sites of the body, using separate syringes and needles.
In children undergoing immunosuppressive treatment (which suppresses immune system activity) or in children with immunodeficiency, the response to the vaccine may be reduced. In such cases, the doctor may decide to postpone vaccination until the end of therapy and to measure antibody levels after vaccination.
Inform the doctor about all medicines currently taken or recently taken by the child, as well as any medicines the 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 Diphtheria Adsorbed Vaccine

The vaccine will be administered by a doctor or nurse as a deep subcutaneous injection.
The recommended injection sites are the deltoid muscle or the anterolateral thigh.
The vaccine must never be administered intravenously.

Dosage for primary and booster vaccination
Primary vaccination
Primary vaccination consists of three doses of the vaccine:

• two doses of the vaccine given 4–6 weeks apart
• the third dose of the vaccine administered 6–12 months after the second dose.

Dose I  Dose II  Dose III
Children up to 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 0.2 ml of the vaccine:

• children aged 6 years who have completed the full primary vaccination course (provided that the third dose of the primary vaccination was given during the second year of life).

The physician decides on the dosing schedule after careful evaluation of the individual’s history of primary and booster vaccinations against diphtheria.

Use of a higher than recommended dose of Diphtheria Adsorbed Vaccine
There is no data available on overdose.

Interrupting the use of Diphtheria Adsorbed Vaccine
If you have any further doubts regarding the use of this vaccine, consult a doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like any vaccine, this vaccine may cause adverse reactions, although they do not occur in
everyone.
Frequency unknown (frequency cannot be determined 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 infants born prematurely (at 28 weeks of gestation or earlier), prolonged breathing pauses may occur within 2–3 days after vaccination.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the vaccine.

5. How to store D-Szczepionka błonicza adsorbowana

Store in a refrigerator (2°C - 8°C).
Do not freeze; if frozen, destroy the vaccine.
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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the packaging and other information

What Diphtheria Vaccine Adsorbed contains
The active substance of the vaccine is:
Diphtheria toxoid not less than 30 I.U.
adsorbed on aluminium hydroxide, hydrated, not more than 0.7 mg Al
Other components of the vaccine are: thiomersal, sodium chloride, and water for injections.

What Diphtheria Vaccine Adsorbed looks like and contents of the pack
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, with a clear supernatant (liquid) above it.
Pack size: 1 vial (10 ml)
20-dose vaccine vial

Marketing Authorisation Holder and Manufacturer
BIOMED S.A. Institute of Serum and Vaccine Biotechnology
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 Diphtheria Adsorbed 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.
The vaccine must be used within 24 hours after opening the vial.
Administer the vaccine dose deeply subcutaneously.
Do not exceed the dose of 0.5 ml.
The recommended injection sites are the deltoid muscle or the anterolateral aspect of the 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 should be equipped with a standard anaphylaxis kit.