Tetanus vaccine adsorbed (t)

Package leaflet: Information for the user

Tetanus vaccine adsorbed (T)
Tetanus vaccine, adsorbed
Injection suspension
It is important to read this leaflet before using the vaccine, as it contains important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• If you experience any adverse reactions after vaccination, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Leaflet contents

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 side effects
5. How to store Tetanus vaccine adsorbed (T)
6. Contents of the pack and other information

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

Tetanus vaccine adsorbed (T) is a suspension for injection that induces immunity against tetanus.
Tetanus is a bacterial infectious disease caused by Clostridium tetani bacteria present in soil and dust. When these bacteria enter a wound, they multiply under anaerobic conditions and produce a highly potent toxin called tetanospasmin. Tetanospasmin is a powerful and dangerous poison that irreversibly binds to motor nerve cells, causing tonic muscle spasms of the face, limbs, neck, back, and abdomen. Concurrently, breathing difficulties, increased heart rate, arrhythmia, excessive sweating, and salivation may occur.
Treatment involves maintaining vital functions, administering anticonvulsant drugs to relieve muscle tension, analgesics, and applying passive-active immunization by injecting tetanus toxoid (the medicinal product Tetanus vaccine adsorbed (T)) and human tetanus immunoglobulin (a substance that binds tetanus toxin). Recovery from tetanus does not confer immunity against reinfection. There is also no natural immunity against tetanus.
The most effective way to prevent tetanus is through complete primary vaccination series, which ensures long-lasting immunity.
Tetanus vaccine adsorbed (T) is administered to:

• adults and children who have not been vaccinated against tetanus,
• adults, as a booster dose, 10 years after the last vaccination series or the last booster dose,
• adults who have not received all doses of the primary vaccination series,
• children, if contraindications exist for combined diphtheria and/or pertussis vaccines,
• injured individuals at risk of infection with Clostridium tetani, for passive-active immunization against tetanus or in the early stages of the disease, as well as in cases of incomplete or undocumented vaccination history.

2. 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 to any of the other components of this vaccine (listed in section 6),
• if the patient has acute illnesses with feverish conditions,
• if the patient has severe symptoms of chronic diseases,
• if the patient is being treated with high doses of corticosteroids.

Vaccination may be carried out after the acute symptoms have subsided and after completion of corticosteroid treatment.

Warnings and precautions

Before starting administration of Tetanus Vaccine Adsorbed (T), discuss with a doctor or nurse if adverse reactions described in section 4 occurred after a previous dose of the vaccine.

Vaccination should be preceded by a medical examination and a medical history regarding the patient's allergic conditions, especially reactions to previous vaccinations.

Tetanus Vaccine Adsorbed (T) and other medicines

Inform the doctor about all medicines currently used or recently used, as well as any medicines the patient plans to use.

Do not administer chloramphenicol simultaneously with Tetanus Vaccine Adsorbed (T), as it may suppress the immune response.

If treatment with cyclosporines is necessary, vaccination should be performed 2 to 4 weeks before starting such treatment.

Pregnancy, breastfeeding and fertility

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicinal product.

Tetanus Vaccine Adsorbed (T) may be used during pregnancy (after the 28th week of pregnancy).

There are insufficient data on the passage of the active substance into human milk.

Tetanus Vaccine Adsorbed (T) has not been evaluated in fertility studies.

Driving and operating machinery

Tetanus Vaccine Adsorbed (T) has no effect or has a negligible effect on the ability to drive and operate machinery.

Tetanus Vaccine Adsorbed (T) contains thiomersal

Tetanus Vaccine Adsorbed (T) contains thiomersal as a preservative, which may cause allergic reactions. Inform the doctor if significant allergic reactions have occurred or are present. Inform the doctor if any health disorders occurred after previous administration of the vaccine.

3. How to use Adsorbed Tetanus Vaccine (T)

The vaccine is administered by trained medical personnel as a deep subcutaneous or intramuscular injection. The vaccine must not be administered intravenously.
Recommended injection sites are the deltoid muscle or the anterolateral thigh muscle.

Dosage

• Primary vaccination (complete vaccination schedule according to the 0; 1; 6–12 months scheme): the first two doses administered at intervals of not less than 4 to 6 weeks; the third booster dose given 6 months to 1 year after the second vaccination,
• Booster vaccinations: one dose every 10 years after the last vaccination,
• Vaccination of injured persons (active-passive immunization). Detailed information is provided at the end of the leaflet “Information intended exclusively for healthcare professionals”.

Administration of a higher than recommended dose of Adsorbed Tetanus Vaccine (T)
General reactions have been observed in individuals who were over-immunized in the past with excessive doses administered at intervals shorter than recommended. In such individuals, antibody levels were still high. General reactions are caused by antibodies forming complexes with an excess of antigen (tetanus toxoid).
These complexes inactivate complement and leukocytes, leading to local swelling, pain, and malaise.
Overdosing with tetanus toxoid may also lead to polyneuropathy.
Overdose is unlikely because the immediate packaging is single-dose.

4. Possible adverse reactions

Like any medicinal product, this vaccine may cause adverse reactions, although they do not occur in everyone.

The frequency of the possible adverse reactions listed below is defined as follows:

• Very common: occurs in 1 or more out of 10 individuals;
• Common: occurs in 1 or more out of 100 individuals, but less than 1 out of 10;
• Uncommon: occurs in 1 or more out of 1,000 individuals, but less than 1 out of 100;
• Rare: occurs in 1 or more out of 10,000 individuals, but less than 1 out of 1,000;
• Very rare: occurs in less than 1 out of 10,000 individuals;
• Frequency not known: frequency cannot be estimated based on available data.

General disorders and administration site conditions
Very rare adverse reactions at the injection site may occur: redness, swelling, pain.
These symptoms resolve within 24 hours.
Very rare general adverse reactions may include: increased body temperature, malaise. These may be caused by too short intervals between consecutive doses or hypersensitivity to thiomersal or aluminium.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or nurse. Adverse reactions can also 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.: +48 22 4921 301
Fax: +48 22 4921 309
e-mail: [email protected]

Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to collect more information on the safety of the medicinal product.

5. How to store Adsorbed Tetanus Vaccine (T)

The vaccine should be stored in a place 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 following:
Expiry date. 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. This will help protect the environment.

6. Contents of the packaging and other information

What Szczepionka tężcowa adsorbowana (T) contains

• The active substance in 1 dose (0.5 ml) is: tetanus toxoid, not less than 40 I.U., adsorbed on aluminium hydroxide, hydrated, not more than 1.25 mg Al.
• The other ingredients are: thiomersal, disodium hydrogen phosphate dodecahydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, water for injections.

What Szczepionka tężcowa adsorbowana (T) looks like and contents of the pack
After mixing, Szczepionka tężcowa adsorbowana (T) is a homogeneous, milky, white suspension for injection.
The vaccine is available in ampoules containing 0.5 ml of suspension for injection, packed in packs of 3.

Marketing Authorisation Holder and Manufacturer
BIOMED Sera and Vaccines Manufacturing Company Ltd.
ul. Chełmska 30/34
00-725 Warsaw
tel. 22 841 40 71
(logo)

Information intended exclusively for medical professionals:

Method of administration
Before administration, the ampoule must be shaken vigorously to obtain a uniform
suspension. Homogeneity of the suspension ensures proper absorption of the vaccine from the injection site.
Use disposable needles and syringes.
The dose of 0.5 ml should be administered deep subcutaneously or intramuscularly. Do not administer intravenously!
Recommended injection sites are the deltoid muscle or the anterolateral thigh.
For subcutaneous administration, deep injection is recommended, as too superficial administration of the vaccine may lead to the formation of a sterile abscess and inadequate absorption of the toxoid.

Guidelines for specific tetanus prophylaxis in injured persons