d-shhepionka bvoniha adsorbovana

Leaflet attached to the packaging: information for the user

• d - Diphtheria vaccine adsorbedsuspension for injection Diphtheria vaccine, adsorbed, with reduced antigen content Not less than 5 IU of diphtheria toxoid/0.5 ml; 1 dose (0.5 ml)

You should carefully read the contents of the leaflet before using the vaccine, because

it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This vaccine has been prescribed to a specific person. It should not be given to others.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their 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. Contents of the packaging 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 adolescents and adults against diphtheria as part of the Immunization Program, as a booster dose or administered depending on the epidemiological situation. The booster dose provides immunity for 10 years.

2. Important information before using d - Diphtheria vaccine adsorbed

When not to use d - Diphtheria vaccine adsorbed:

• if the patient is allergic to diphtheria toxoid or any of the other components of this vaccine (listed in section 6). Allergy symptoms may include: itching rash, shortness of breath, swelling of the face and tongue,
• if the patient 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 patient has chronic diseases during 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, you should discuss it with your doctor or nurse if any side effects described in section 4 occurred after the previous dose of the vaccine or any other worrying reactions. Vaccination should be preceded by a medical examination and interview on the overall health condition and previously performed and recorded vaccinations. This procedure allows for predicting the risk of side effects after vaccination.

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

The vaccine contains thiomersal as a preservative, so allergic reactions may occur in the vaccinated person. You should inform your doctor if you have had or have known allergic reactions. You should also inform your doctor if you have had any 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 this results from the Immunization 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 patients undergoing immunosuppressive treatment (inhibiting the activity of the immune system) or 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.

You should tell your doctor about all medicines that the patient is currently taking or has recently taken, as well as medicines that the patient plans to take.

Pregnancy and breastfeeding

The vaccine can only be administered in the event of a serious risk of diphtheria infection. In such a case, the decision is made by the doctor. Breastfeeding is not a contraindication to vaccination. If the patient is pregnant or breastfeeding, suspects that she may be pregnant, or plans to have a child, she should consult her doctor before using this vaccine.

Driving and operating machinery

The vaccine has no influence or has a negligible influence on the ability to drive and operate machinery.

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. The vaccine should never be administered intravascularly. Booster vaccination

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

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

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

Discontinuation of d - Diphtheria 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 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.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should inform 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. By reporting side effects, you can help provide more information on the safety of the vaccine.

5. How to store d - Diphtheria 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 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 d - Diphtheria vaccine adsorbed contains

The active substance of the vaccine is: Diphtheria toxoid not less than 5 IU adsorbed on hydrated aluminum hydroxide not more than 0.5 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 packaging contains

The vaccine is a white or almost white, homogeneous suspension 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 or 15 ampoules. Not all pack sizes may be marketed.

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: [email protected]

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

Information intended only for healthcare professionals

Administration of d - Diphtheria 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 any changes are observed, the vaccine should not be used. The dose of 0.5 ml should be administered deep subcutaneously. The recommended injection site is the deltoid muscle. Do not administer intravascularly! Make sure the needle is not inserted into a blood vessel. Note: due to the risk of anaphylactic shock associated with vaccination, the vaccination room should be equipped with a standard anaphylaxis kit.