Tetana Pro

Leaflet attached to the packaging: information for the user

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

You should carefully read the contents of the leaflet before using the vaccine, as 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 specifically for you. Do not pass it on to others.
• If you experience any side effects, including any not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

Tetana PRO is a vaccine that protects against tetanus, a disease caused by tetanus bacteria. These bacteria can enter the body through cuts, scratches, or wounds on the skin. The bacteria produce a toxin. Tetanus causes painful muscle stiffness. Tetanus can lead to serious health problems, including inability to open the mouth, swallowing and breathing problems, and even death.
The active substance of the vaccine is tetanus 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 indicated for active immunization of children (from the second month of life), adolescents, and adults against tetanus:

• as part of primary and booster vaccination
• for individuals who have been injured and are unvaccinated or not fully vaccinated, or have an uncertain vaccination history, in accordance with official recommendations.

A single dose of Tetana PRO vaccine does not protect against tetanus. According to official recommendations, which contain information about these vaccinations, an appropriate level of immunity that protects against infection is achieved after administration of all doses of primary vaccination against tetanus. Each subsequent booster dose provides long-term protection against the disease, lasting about 10 years.

2. Important information before using Tetana PRO vaccine

When not to use Tetana PRO vaccine:

• if the patient is allergic to tetanus toxoid or any of the other ingredients of this medicine (listed in section 6). Allergy symptoms may include: itching rash, shortness of breath, face and tongue swelling,
• 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 these 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, which increases the risk of bleeding and bruising, or has experienced neurological disorders after previous administration of tetanus vaccine.

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

Warnings and precautions

Before starting to use Tetana PRO vaccine, you should discuss it with your doctor or nurse if you have experienced any side effects or other worrying reactions after the previous dose of the vaccine, as described in section 4.
Vaccination should be preceded by a medical examination and a medical history, including previous vaccinations. This approach allows for predicting the risk of side effects after administration of the vaccine.

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

Tetana PRO vaccine and other medicines

Tetana PRO vaccine can be administered at the same time as other vaccines, if this is in accordance with the National Vaccination 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 determine the level of antibodies after vaccination.
You should 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 this case, the decision is made by the doctor. Dosing during pregnancy will be performed in accordance with official guidelines.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before using this medicine.

Driving and using machines

The vaccine has no influence or insignificant influence on the ability to drive and use machines.
The vaccine contains less than 1 mmol (23 mg) of sodium per dose, which means the vaccine is considered "sodium-free".

3. How to use Tetana PRO vaccine

Tetana PRO vaccine will be administered by a doctor or nurse, as an intramuscular injection. The vaccine must never be administered intravenously.
In the case of patients with bleeding disorders, the doctor will consider administering the Tetana PRO vaccine subcutaneously.

Dosing for 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
• a third dose of the vaccine after 6-12 months from the administration of the second dose. This dose ensures the development of immunity, which lasts from 5 to 10 years.

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

Dosing in case of injury

In the event of an injury, the doctor decides on the administration of the vaccine and the dosing regimen in accordance with official guidelines.

Dosing during pregnancy

Unvaccinated or partially vaccinated women should be vaccinated in accordance with official recommendations.

Use of a higher dose of Tetana PRO vaccine than recommended

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

Discontinuation of Tetana PRO vaccine

If you have any further doubts about the use of this vaccine, you should consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all vaccines, this vaccine can cause side effects, although not everybody gets them.

Side effects that occurred during clinical trials in adults:

Very common (may occur more often than 1 in 10 doses of the vaccine):

• pain at the injection site

Common (may occur no more often than 1 in 10 doses of the vaccine):

• redness, swelling, induration at the injection site
• warmth in the area of the injection site
• weakness
• headache
• hearing impairment
• tinnitus
• exacerbation of eczema.

Side effects that occurred during spontaneous monitoring after the product was placed on the market:

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

• decreased platelet count, which increases the risk of bleeding and bruising; lymph node enlargement and/or tenderness
• rhinitis
• allergy symptoms (including urticaria, rash, e.g. nodular, swelling of the eyelids, face, and lips) up to anaphylactic shock
• headache, dizziness, fainting, loss of consciousness
• hypotonic-hyporesponsive syndrome, 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
• decreased blood pressure, pallor
• gastrointestinal disorders (nausea, vomiting, dry mouth)
• petechiae (small subcutaneous bleeding), erythema nodosum (painful, bright red nodules, usually on the anterior surface of the legs, resolving on their own)
• limb pain, in which the vaccine was administered, arm pain, in which the vaccine was administered, joint pain
• renal failure
• decreased 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, erythema, 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 prickly lymphatic infiltrate may also appear. This type of reaction occurs most often in individuals who have been 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 disappear within 6 weeks may be a sign of hypersensitivity to aluminum.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell 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,
Jerozolimskie Avenue 181C,
02-222 Warsaw,
phone: 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 gather more information on the safety of the vaccine.

5. How to store Tetana PRO vaccine

Store and transport in an upright position, in a refrigerator (2°C - 8°C). Do not freeze; if frozen, the vaccine should be destroyed.
Store the ampoules in the outer packaging to protect them from light.
The vaccine should be stored out of the 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. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Tetana PRO vaccine contains

The active substance of the vaccine is:
Tetanus toxoid
not less than 40 International Units (IU)
adsorbed on hydrated aluminum hydroxide
0.5 milligrams of Al
The other ingredients are: sodium chloride and water for injections.

What Tetana PRO vaccine looks like and what the pack 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.
Tetana PRO may be available in packs containing 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

IBSS BIOMED S.A.
Sosnowa Avenue 8
30-224 Krakow
phone: +48 12 37 69 200
e-mail: [email protected]

Date of last revision of the leaflet: ---------------------------------------------------------------------------------------------------------------------------

Information intended for healthcare professionals only:

Tetana PRO should be used in accordance with official recommendations for tetanus vaccines.

Administration of Tetana PRO vaccine

Before use, shake the vaccine to obtain a homogeneous suspension. You should visually inspect the vaccine for any foreign particles and/or changes in appearance.
If there are any changes, do not use the vaccine.
Measure the dose of 0.5 ml and administer intramuscularly.
The recommended injection site is the deltoid muscle or the anterolateral thigh.
Do not administer intravenously! Make sure the needle is not inserted into a blood vessel.
Note: Due to the risk of anaphylactic shock associated with vaccine administration, the vaccination office should be equipped with a standard anaphylaxis kit.
Identifiability
To improve the identifiability of biological medicinal products, the name and batch number of the administered product should be clearly recorded.