Tetana

Package Leaflet: Information for the User

Tetana, suspension for injection
Tetanus vaccine, adsorbed
Not less than 40 IU of tetanus toxoid/0.5 ml; 1 dose (0.5 ml)

Read the package leaflet carefully before using the vaccine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This vaccine has been prescribed for a specific person. 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.

Table of Contents of the Leaflet

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

1. What is Tetana vaccine and what is it used for

Tetana is a vaccine that protects against tetanus, a disease caused by
Clostridium tetani. The active substance of the vaccine is tetanus toxoid (a non-infectious component derived from bacteria). After vaccination, the body produces antibodies that protect against the disease. The vaccine is used for active immunization of children, adolescents, and adults against tetanus, in accordance with the National Immunization Program.
Primary vaccination

• if there are contraindications to the use of combined vaccines containing, in addition to the tetanus component, a diphtheria or diphtheria and pertussis component.

Booster vaccination

• persons who have received a full primary vaccination cycle against tetanus.

Both primary and booster vaccinations may also include pregnant women who expect to give birth in unhygienic conditions.
Tetanus vaccination in injured persons
Tetana vaccine is used in tetanus prophylaxis in persons with contaminated wounds, with a high probability of the presence of tetanus bacilli in the wound.
A single dose of Tetana vaccine does not protect against tetanus. An adequate level of immunity, which protects against infection, is achieved after all doses of primary vaccination against tetanus, in accordance with the National Immunization Program, which contains information about these vaccinations. Each subsequent booster dose provides long-term protection against the disease, lasting about 10 years.
Tetana vaccine meets the requirements of the European Pharmacopoeia and the World Health Organization (WHO).
Persons with AIDS or HIV virus carriers should be vaccinated according to the standard schedule, and in the event of injury, they should always receive human tetanus immunoglobulin (immunoglobulin with a high titre of tetanus antibodies), regardless of their tetanus vaccination history.

2. Important information before using Tetana vaccine

When not to use Tetana vaccine:

• if the patient is hypersensitive to tetanus toxoid or any of the other components of this vaccine (listed in section 6). Hypersensitivity 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 an exacerbation. In such cases, vaccination should be performed after the exacerbation of the disease has subsided,
• if the patient has a suspected infection (other than tetanus) during the incubation period,
• if the patient has a decreased platelet count, causing an increased risk of bleeding and bruising, or has experienced neurological disorders after previous tetanus vaccination.

If there are any contraindications to vaccination with Tetana vaccine, the doctor should assess the risk of vaccination in relation to the risk of infection.

Warnings and precautions

Before starting vaccination with Tetana vaccine, discuss it with your doctor or nurse,
if after the previous dose of the vaccine, side effects described in section 4 occurred
or any other worrying reactions.
Vaccination should be preceded by a medical examination and a survey of the overall health status and previously performed and recorded vaccinations. This approach allows for predicting the risk of side effects after vaccination.

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

Tetana vaccine and other medicines

Tetana vaccine can be administered at the same time as other vaccines, if it is part of the National 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 therapy (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 vaccinations until the end of therapy and to determine the level of antibodies after vaccination.
Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Pregnancy and breastfeeding

The vaccine can be used during pregnancy if necessary. In such a case, the decision is made by the doctor. Dosage during pregnancy is described in section 3.
There is no data on the administration of the vaccine during breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this vaccine.

Driving and using machines

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

3. How to use Tetana vaccine

Tetana vaccine will be administered by a doctor or nurse as a deep subcutaneous injection. The vaccine should never be administered intravenously.

Dosage in primary and booster vaccination

Primary vaccination
Primary vaccination consists of three doses of the vaccine:

• two doses of the vaccine at an interval of 4-6 weeks (primary vaccination)
• a third dose of the vaccine after 6-12 months from the administration of the second dose (booster vaccination). This dose provides immunity that lasts from 5 to 10 years.

Booster vaccination
One dose of the vaccine 10 years after the last tetanus vaccination.

Dosage in case of injury

In case of injury, the doctor decides on the administration of the vaccine and the dosage method.
Detailed information can be found at the end of the leaflet in the section "Information intended exclusively for healthcare professionals".

Dosage during pregnancy

Unvaccinated or partially vaccinated women who are at risk of giving birth in unhygienic conditions should be vaccinated in the second trimester of pregnancy.
Women who received one or two doses of the vaccine before pregnancy was confirmed should complete the vaccination during pregnancy. Pregnant women who were vaccinated more than 10 years ago should receive a booster dose in the second trimester of pregnancy.

Use of a higher than recommended dose of Tetana vaccine

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

Discontinuation of Tetana vaccine

In case of any further doubts related to the use of this vaccine, consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all vaccines, this vaccine can cause side effects, although not everyone will experience them.

Frequency not known (frequency cannot be estimated from the available data):

• decreased platelet count, causing an increased risk of bleeding and bruising; lymph node enlargement and/or tenderness
• common cold
• allergic reactions (including urticaria, rash, e.g. nodular, swelling of the eyelids, face, submandibular area, lips, forehead) up to anaphylactic shock
• headache, dizziness, fainting, loss of consciousness
• hypotonic-hyporesponsive episode, characterized by limpness or decreased muscle tone, skin discoloration (pallor or cyanosis), reduced and weakened response to external stimuli, occurring in children under 10 years of age within 48 hours of vaccination
• nervous system disorders, tremors
• lacrimation
• hearing impairment
• low blood pressure, pallor
• gastrointestinal disorders (nausea, vomiting, dry mouth)
• petechiae (small subcutaneous bleeding), erythema nodosum (painful, bright red nodules usually located on the anterior surface of the legs, resolving spontaneously)
• limb pain, in which the vaccine was administered, arm pain, in which the vaccine was administered, joint pain
• renal failure
• low body temperature
• generalized reaction: subfebrile state, fever, chills, feeling of cold, excessive sweating, weakness, malaise. These symptoms usually resolve within 24-48 hours
• local reaction: redness, rash, pain, swelling, swelling of the entire limb, limited mobility of the limb, rash, itching, burning, inflammation, bruising, hematoma (probably due to improper vaccination), induration, warmth in the area of the injection site. A pruritic lymphatic infiltrate may also appear. Such reactions occur most frequently in persons vaccinated multiple times. There may be the formation of subcutaneous nodules-granulomas, which sometimes transform into aseptic abscesses (1:100,000). Granulomas that do not resolve within 6 weeks may be a result of hypersensitivity to aluminium.

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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.
Reporting side effects will help to gather more information on the safety of the vaccine.

5. How to store Tetana vaccine

Store upright, in a refrigerator (2°C - 8°C). Do not freeze, in case of freezing, destroy the vaccine.
Store the vaccine 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 month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Tetana vaccine contains

The active substance of the vaccine is:
Tetanus toxoid
not less than 40 IU
adsorbed on aluminium hydroxide, hydrated
not more than 0.7 milligrams of Al
The other ingredients are: sodium chloride and water for injections.

What Tetana vaccine 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 forms at the bottom of the ampoule, and above it, a clear supernatant (liquid).
The pack contains 1, 5 or 10 ampoules of 0.5 ml in a cardboard box.
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 revision of the leaflet: ---------------------------------------------------------------------------------------------------------------------------

Information intended exclusively for healthcare professionals:

Administration of Tetana vaccine

Before use, shake to obtain a homogeneous suspension. Visually inspect the vaccine for any foreign particles and/or changes in appearance. If any changes are observed, do not use the vaccine.
Measure the dose of 0.5 ml and administer deep subcutaneously.
The recommended injection site is the deltoid muscle or the anterolateral part of the thigh.
Do not administer intravenously! Ensure that the needle is not inserted into a blood vessel.
Note: Due to the risk of anaphylactic shock associated with vaccination, the vaccination office should be equipped with a standard emergency kit.

Guidelines for specific tetanus prevention in injured persons

*LIT - Human Tetanus Immunoglobulin
In case of injury and contraindications to tetanus vaccination, human tetanus immunoglobulin should be administered immediately.