D-diphtheria adsorbed vaccine

Patient Information Leaflet

d - Diphtheria adsorbed vaccine
injection suspension
Diphtheria vaccine (adsorbed, reduced antigen content)
Not less than 5 I.U. diphtheria toxoid/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 you.

• 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 you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

1. What d - Diphtheria adsorbed vaccine is and what it is used for
2. What you need to know before receiving 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.
This vaccine is used for active immunization of adolescents and adults against diphtheria within the National Immunization Programme, as a booster dose or administered depending on the epidemiological situation.
A booster dose provides protection for 10 years.

2. What you need to know before receiving d - Diphtheria adsorbed vaccine

When d - Diphtheria adsorbed vaccine must not be used:

• if you are allergic to diphtheria toxoid or to any of the other ingredients of this vaccine (listed in section 6). Symptoms of allergy may include itchy rash, difficulty breathing, swelling of the face and tongue,
• if you have an acute illness with fever. A mild infection, such as a cold, should not prevent vaccination, but you should inform your doctor first,
• if you have chronic diseases in an acute exacerbation phase. In such cases, vaccination should be postponed until the exacerbation has resolved.

If there are any contraindications to vaccination with d - Diphtheria adsorbed vaccine, your doctor should assess the risk of administering the vaccine against the risk of contracting the infection.

Warnings and precautions

Talk to your doctor or nurse before receiving d - Diphtheria adsorbed vaccine if you experienced any of the adverse reactions listed in section 4 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 individual's general health status and previous vaccination history. This helps predict the risk of adverse reactions following vaccination.

For safety reasons, you should remain under medical observation for 30 minutes after vaccination.

The vaccine contains thiomersal as a preservative, therefore allergic reactions may occur in vaccinated individuals. Inform your doctor if you have known allergies or allergic reactions. You should also inform your doctor about any health problems experienced after previous vaccinations.

d - Diphtheria adsorbed vaccine and other medicines

d - Diphtheria adsorbed vaccine may be administered at the same time as other vaccines, if required by the National Immunization Programme, and with immunoglobulins, if medically necessary.

Different vaccines and immunoglobulins administered simultaneously should be injected at different sites of the body, using separate syringes and needles.

In patients receiving immunosuppressive therapy (which suppresses the immune system) or in those 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 may measure antibody levels after vaccination.

Tell your doctor about all medicines you are currently taking, have recently taken, or plan to take.

Pregnancy and breastfeeding

The vaccine may be administered only in case of serious risk of diphtheria infection. In such cases, the decision is made by the doctor.

Breastfeeding is not a contraindication to vaccination.

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, you should consult your doctor before receiving this vaccine.

Driving and using machines

The vaccine has no effect or negligible effect on the ability to drive and use machines.

3. How to use d - Adsorbed Diphtheria Vaccine

The vaccine will be administered by a doctor or nurse as a deep subcutaneous injection.
The deltoid muscle is recommended as the injection site.
The vaccine must never be administered intravenously.
Booster vaccination:

• one dose of vaccine 10 years after the last vaccination.

Use of a higher than recommended dose of d - Adsorbed Diphtheria Vaccine
Overdose is unlikely, as the packaging contains a single dose.
In case of doubt, consult your doctor.
Interrupting the use of d - Adsorbed Diphtheria Vaccine
If you have any further questions regarding the use of this vaccine, consult your 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 estimated from available data):

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

Reporting of adverse reactions
If any adverse reactions occur, including any 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 diphtheria adsorbed vaccine

Store in an upright position in a refrigerator (2°C - 8°C).
Do not freeze; if frozen, destroy the vaccine.
Keep the vaccine out of 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 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 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 5 IU
adsorbed on aluminium hydroxide, hydrated, not more than 0.5 mg Al

The 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 ampoules. During storage, a white sediment may form at the bottom of the ampoule, with a clear supernatant (liquid) above it.
The pack contains 5 or 15 ampoules.
Not all pack sizes may be marketed.

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 d-Diphtheria adsorbed vaccine
Shake well before use to obtain a uniform 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 a 0.5 ml dose deeply subcutaneously.
The deltoid muscle is recommended as the injection site.
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 emergency kit.