Shhepionka temzhcova adsorbovana (t)

Leaflet included in the packaging: information for the user

Tetanus vaccine adsorbed (T)

Tetanus vaccine, adsorbed
Suspension for injection

It is necessary to carefully read the contents of the leaflet before using the vaccine, as it contains important information for the patient.

• It is necessary to keep this leaflet, so that it can be re-read if necessary.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• If the patient experiences any adverse reactions, including any adverse reactions 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 Tetanus vaccine adsorbed (T) and what is it used for
• 2. Important information before using Tetanus vaccine adsorbed (T)
• 3. How to use Tetanus vaccine adsorbed (T)
• 4. Possible adverse reactions
• 5. How to store Tetanus vaccine adsorbed (T)
• 6. Contents of the packaging and other information

1. What is Tetanus vaccine adsorbed (T) and what is it used for

Tetanus vaccine adsorbed (T) is an injectable suspension that induces active immunity against tetanus.
Tetanusis a bacterial infectious disease caused by the presence of tetanus bacilli in the soil and dust, which, when they enter a wound, multiply in anaerobic conditions and produce a very potent toxin called tetanospasmin. Tetanospasmin is a potent and dangerous toxin for health and life, as it binds irreversibly to motor nerve cells, causing tonic muscle contraction of the face, limbs, neck, back, and abdomen. At the same time, there is difficulty breathing, frequent muscle spasms, and irregular heart rhythm, excessive sweating, and salivation.
Treatment involves maintaining basic life functions, using anti-spasmodic agents to relieve muscle tension, painkillers, and the administration of passive-active immunization by injecting tetanus toxoid (Tetanus vaccine adsorbed (T)) and human tetanus immunoglobulin (a substance that binds to tetanus toxin). Recovering from the disease does not provide immunity to re-infection. There is also no natural immunity to tetanus.
The most effective way to prevent tetanus is protective vaccinations in a full cycle, which guarantee the production of long-term immunity.

Tetanus vaccine adsorbed (T) is administered:

• to adults and children who have not been vaccinated against tetanus,
• to adults as a booster dose, after a period of 10 years from the last vaccination cycle or the last booster dose,
• to adults who have not received all doses of primary vaccination,
• to children if there are contraindications to vaccinations with diphtheria and/or pertussis vaccines,
• to injured persons exposed to tetanus bacilli infection, with active-passive immunization against tetanus, or in the early stages of the disease, and in cases of incomplete vaccinations or lack of vaccination documentation.

2. Important information before using Tetanus vaccine adsorbed (T)

When not to use Tetanus vaccine adsorbed (T)

• if the patient is allergic to the active substance or any of the other ingredients of this vaccine (listed in section 6),
• if the patient has acute illnesses with fever,
• if the patient has severe symptoms of chronic diseases,
• if the patient is being treated with high doses of corticosteroids.

Vaccination can be performed after the acute symptoms of the disease have subsided and after the treatment with corticosteroids has been completed.

Warnings and precautions

Before starting the use of Tetanus vaccine adsorbed (T), it is necessary to discuss it with a doctor or nurse if adverse reactions occurred after the previous dose of the vaccine, as described in section 4.
Vaccination should be preceded by a medical examination and a survey of the patient's allergic conditions, especially reactions to protective vaccinations.

Tetanus vaccine adsorbed (T) and other medicines

It is necessary to inform the doctor about all medicines used by the patient currently or recently, as well as about medicines that the patient plans to use.
Chloramphenicol should not be administered simultaneously with Tetanus vaccine adsorbed (T), as it inhibits the immune system response.
In the case of necessary treatment with cyclosporine, vaccination should be performed 2 to 4 weeks before the start of treatment.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, or suspects that she may be pregnant, she should consult a doctor before using this medicine.
Tetanus vaccine adsorbed (T) can be used during pregnancy (after 28 weeks of pregnancy).
There is insufficient data on the penetration of the active substance into breast milk.
Tetanus vaccine adsorbed (T) has not been evaluated in fertility studies.

Driving and using machines

Tetanus vaccine adsorbed (T) has no influence or has a negligible influence on the ability to drive and use machines.

Tetanus vaccine adsorbed (T) contains thiomersal

Tetanus vaccine adsorbed (T) contains thiomersal as a preservative, which may cause allergic reactions. The doctor should be informed if significant allergic reactions have occurred or are occurring. The doctor should be informed if there have been any health disorders after previous vaccination.

3. How to use Tetanus vaccine adsorbed (T)

The vaccine is administered by medical personnel as a deep subcutaneous or intramuscular injection. The vaccine cannot be administered intravenously.
The recommended injection site is the deltoid muscle or the anterolateral thigh.
Dosage

• Primary vaccinations (full vaccination cycle according to the 0; 1; 6-12 months schedule): the first two doses at an interval of not less than 4 to 6 weeks; the third dose after 6 months to 1 year from the second vaccination,
• Booster vaccinations: one dose every 10 years from the last vaccination,
• Vaccination of injured persons (active-passive immunization). Detailed information can be found at the end of the leaflet "Information intended exclusively for healthcare professionals".

Use of a higher dose of Tetanus vaccine adsorbed (T)

General reactions have been observed in individuals who have been over-immunized, who have received too many doses in shorter intervals than recommended. In these individuals, there is still a high level of antibodies. General reactions are caused by antibodies that form complexes with an excessive amount of antigen (tetanus toxoid).
These complexes inactivate complement and leukocytes, causing local edema, pain, and malaise.
Overdose of tetanus toxoid can also lead to polyneuropathy.
Overdose is unlikely, as the immediate packaging is single-dose.

4. Possible adverse reactions

Like all medicines, this vaccine can cause adverse reactions, although not everybody gets them.
The frequency of possible adverse reactions listed below is defined as follows:

• Very common: (occurring in 1 or more people out of 10);
• Common: (occurring in 1 or more people out of 100 and less than 1 person out of 10);
• Uncommon: (occurring in 1 or more people out of 1,000 and less than 1 person out of 100);
• Rare: (occurring in 1 or more people out of 10,000 and less than 1 person out of 1,000);
• Very rare: (occurring in less than 1 person out of 10,000);
• Frequency not known: (frequency cannot be estimated from the available data).

General disorders and administration site conditions

Very rarely, adverse reactions may occur at the injection site: redness, swelling, pain.
These symptoms disappear within 24 hours.
Very rarely, general adverse reactions may occur: elevated body temperature, malaise. The cause may be too short intervals between consecutive doses or hypersensitivity (allergy) to thiomersal or aluminum.

Reporting adverse reactions

If any adverse reactions occur, including any adverse reactions not listed in the leaflet, the doctor or nurse should be informed. Adverse reactions can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: [email protected]
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to gather more information on the safety of the medicine.

5. How to store Tetanus vaccine adsorbed (T)

The vaccine should be stored out of sight and reach of children.
Store in a refrigerator (2°C – 8°C). Do not freeze.
Store in the outer packaging to protect from light.
Do not use this vaccine after the expiry date stated on the packaging after:
Expiry date. The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste containers. The pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What Tetanus vaccine adsorbed (T) contains

• The active substance of the vaccine contained in 1 dose (0.5 ml) is: tetanus toxoid not less than 40 IU adsorbed on aluminum hydroxide, hydrated, not more than 1.25 mg Al
• Other ingredients are: thiomersal, sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, sodium chloride, water for injections.

What Tetanus vaccine adsorbed (T) looks like and what the packaging contains

Tetanus vaccine adsorbed (T) is a homogeneous, milky suspension with a white tint after mixing.
The vaccine is available in ampoules containing 0.5 ml of suspension for injection, packaged in 3 units.

Marketing authorization holder and manufacturer

Biomed Serum and Vaccine Plant Ltd.
Chełmska 30/34 Street
00-725 Warsaw
phone: 22 841 40 71
(logo)

Date of the last update of the leaflet:

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Information intended exclusively for healthcare professionals:

Method of administration

Before using the vaccine, the ampoule should be shaken vigorously to obtain a uniform suspension. The uniformity of the suspension ensures proper absorption of the vaccine from the injection site.
Single-use needles and syringes should be used.
The dose of 0.5 ml should be administered deep subcutaneously or intramuscularly. Do not administer intravenously!
The recommended injection site is the deltoid muscle or the anterolateral thigh.
When administering subcutaneously, it should be remembered that it should be deep, as too shallow administration of the vaccine may cause the formation of a sterile abscess, and the absorption of the toxoid may be insufficient.

Guidelines for specific prevention of tetanus in injured persons