Tetana pro

Package leaflet: Information for the user

Tetana PRO, injection suspension
Tetanus vaccine, adsorbed
Not less than 40 I.U. of tetanus toxoid/0.5 ml; 1 dose (0.5 ml)
Please read all of this leaflet carefully before the vaccine is administered, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist or nurse.
• This vaccine has been prescribed for a specific individual. Do not pass it on to others.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Table of contents

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

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

Tetana PRO is a vaccine that protects against tetanus, a disease caused by Clostridium tetani bacteria. These bacteria can enter the body through cuts, scratches or wounds in 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, difficulty swallowing and breathing, and even death.
The active substance of the vaccine is tetanus toxoid (a non-infectious component derived from the bacteria). After vaccination, the body produces antibodies that protect against the disease.
The vaccine is indicated for active immunisation of children (from the age of two months), adolescents and adults against tetanus:

• as part of primary and booster vaccination schedules
• in injured persons who are unvaccinated or incompletely vaccinated, or with uncertain vaccination history, in accordance with official recommendations.

One dose of Tetana PRO vaccine does not protect against tetanus. According to official recommendations, adequate immunity protecting against infection is achieved after administration of all doses of the primary tetanus vaccination series. Each subsequent booster dose provides long-lasting protection against tetanus, lasting approximately 10 years.

2. Important information before administering Tetana PRO vaccine

When not to use Tetana PRO vaccine:

• if the patient is allergic to tetanus toxoid or to any of the other components of this medicine (listed in section 6). Symptoms of allergy may include itching rash, difficulty breathing, swelling of the face and tongue,
• if the patient has acute illness with fever. A mild infection, such as a cold, should not be a reason to delay vaccination, but the doctor should be informed about it first,
• if the patient has chronic diseases during an exacerbation period. In such cases, vaccination should be performed after the exacerbation has subsided,
• if there is suspicion of an infection (other than tetanus) during its incubation period,
• if the patient has experienced a decrease in platelet count leading to increased risk of bleeding and bruising, or if neurological disorders occurred after previous administration of tetanus vaccine.

If there are any contraindications to vaccination with Tetana PRO, the doctor should evaluate the risk of administering the vaccine against the risk of acquiring tetanus infection.

Warnings and precautions

Before starting vaccination with Tetana PRO, discuss with a doctor or nurse if any adverse reactions described in section 4 occurred after a previous dose of the vaccine, or if any other worrying reactions have occurred.

Vaccination should be preceded by a medical examination and a review of the patient’s general health status and previously administered and documented vaccinations. This procedure helps predict the risk of adverse reactions following vaccination.

For safety reasons, patients should remain under medical supervision for 30 minutes after vaccination.

Tetana PRO vaccine and other medicines

Tetana PRO vaccine may be administered simultaneously with other vaccines, as indicated in the National Immunization Program, and with immunoglobulins, if necessary.

Different vaccines and immunoglobulins administered at the same time should be injected at different sites of the body, using separate syringes and needles.

In patients undergoing immunosuppressive treatment (which suppresses immune system activity) or in patients with immunodeficiency, the immune response to the vaccine may be reduced. In such cases, the doctor may decide to postpone vaccination until the end of therapy and may measure antibody levels after vaccination.

Inform the doctor about all medicines currently or recently taken by the patient, as well as any medicines the patient plans to take.

Pregnancy and breastfeeding

The vaccine may be used during pregnancy if there is a medical indication. In such cases, the decision is made by the doctor. The dosing schedule during pregnancy will follow official guidelines.

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

Driving and operating machinery

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

The vaccine contains less than 1 mmol (23 mg) of sodium per dose; therefore, the vaccine is considered "sodium-free".

3. How to use Tetana PRO vaccine

The Tetana PRO vaccine will be administered by a doctor or nurse as an intramuscular injection. The vaccine must never be given intravenously.
For individuals with coagulation disorders, the doctor may consider subcutaneous administration of the Tetana PRO vaccine.
Primary and booster vaccination dosing
Primary vaccination
The primary vaccination consists of three doses of the vaccine:

• two doses of the vaccine given 4-6 weeks apart
• the third dose administered 6-12 months after the second dose. This dose provides immunity lasting 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 case of injury, the decision on administering the vaccine and the dosing schedule will be made by the doctor according to official guidelines.
Dosing during pregnancy
Unvaccinated women or those with incomplete vaccination should be vaccinated according to official recommendations.
Administration of a higher than recommended dose of Tetana PRO vaccine
Overdose is unlikely because the packaging contains a single dose.
If in doubt, consult a doctor.
Discontinuation of Tetana PRO vaccine
If you have any further questions regarding the use of this vaccine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like any vaccine, this vaccine may cause adverse reactions, although they do not occur in
everyone.
Adverse reactions observed during clinical trials in adults:
Very common (may occur in more than 1 in 10 vaccine doses):

• pain at the injection site

Common (may occur in not more than 1 in 10 vaccine doses):

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

Adverse reactions reported during spontaneous monitoring after
product release to market:
Frequency unknown (frequency cannot be estimated from available data):

• decreased platelet count, leading to increased risk of bleeding and bruising; enlargement and/or tenderness of lymph nodes
• rhinitis
• allergic reactions (including urticaria, rash, e.g. nodular, eyelid, facial, submandibular, lip or forehead swelling), up to and including anaphylactic shock
• headache, dizziness, fainting, loss of consciousness
• hypotonic-hyporesponsive episode, characterized by limpness or reduced muscle tone, skin colour disturbances (pallor or cyanosis), reduced and weakened response to external stimuli, occurring in children under 10 years of age within 48 hours after 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 typically located on the anterior surface of the lower legs, resolving spontaneously)
• pain in the limb into which the vaccine was administered, shoulder pain, joint pain
• renal failure
• decreased body temperature
• systemic reactions: feeling unwell, feverishness, fever, chills, feeling cold, excessive sweating, fatigue, malaise. These symptoms usually resolve within 24–48 hours
• local reactions: redness, erythema, pain, swelling, swelling of the entire limb, limited mobility of the limb, rash, itching, burning sensation, inflammation, bruising, haematoma (likely due to incorrect administration technique), induration, warmth around the injection site. Itchy lymphatic streaking may also occur. Such reactions are most commonly observed in repeatedly vaccinated individuals. Subcutaneous nodules (granulomas) may develop, occasionally progressing to aseptic abscesses (1:100,000). Granulomas that do not resolve within 6 weeks may result from hypersensitivity to aluminium.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, inform a doctor, pharmacist, or nurse. Adverse reactions
can be reported directly to the Department of Monitoring of Adverse Drug Reactions 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.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to gather more information on the safety of the medicinal product.

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 must be destroyed.
Keep vials in the outer packaging to protect from light.
The vaccine should be stored 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 indicated.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the package and other information

What Tetana PRO vaccine contains
The active substance in the vaccine is:
Tetanus toxoid not less than 40 International Units (IU)
adsorbed on aluminium hydroxide, hydrated, 0.5 milligrams Al
The other components are: sodium chloride and water for injections.

What Tetana PRO vaccine looks like and contents of the pack
After shaking, the vaccine is a white or almost white, homogeneous suspension in glass vials.
During storage, a white sediment may form at the bottom of the vial, with a clear supernatant (liquid) above it.
Tetana PRO may be available in packs containing 1, 5 or 10 vials of 0.5 ml each, in a cardboard carton.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
IBSS BIOMED S.A.
Al. Sosnowa 8
30-224 Kraków
tel. +48 12 37 69 200
e-mail: [email protected]

Information intended exclusively for healthcare professionals:

Tetana PRO should be used in accordance with official recommendations for tetanus vaccines.
Administration of Tetana PRO vaccine
Shake well before use to obtain a uniform suspension. Visually inspect the vaccine for any foreign particles and/or changes in appearance. Do not use the vaccine if any changes are observed.
Measure a 0.5 mL dose and administer intramuscularly.
The recommended injection sites are the deltoid muscle or the anterolateral thigh.
Do not administer intravenously! Ensure that the needle has not entered a blood vessel.
Warning: Due to the risk of anaphylactic shock associated with vaccine administration, the vaccination room should be equipped with a standard anaphylaxis emergency kit.
Traceability
To improve traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded.