Tetraxim

Package Leaflet: Information for the User

Vaccine suspension for injection in a pre-filled syringe

Diphtheria, Tetanus, Pertussis (acellular, component) and Poliomyelitis (inactivated) vaccine, adsorbed

Read the package leaflet carefully before your child is vaccinated, as it contains important information for them.

• You should 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 child. Do not pass it on to others.
• If your child experiences any side effects, including any not listed in this leaflet, please inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

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

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

(DTaP-IPV) is a vaccine used to protect against infectious diseases.
It helps protect your child against diphtheria, tetanus, pertussis, and poliomyelitis.
This vaccine is used for primary vaccination in children from 2 months of age
and as a booster in children who have previously received this or a similar vaccine.
After vaccination, the body's natural defense mechanisms will provide protection against these diseases.

• Diphtheria is an infectious disease that usually starts with a sore throat. The infection in the throat can cause pain and swelling, which can lead to suffocation. The bacteria that cause this disease also produce a toxin that can damage the heart, kidneys, and nerves.
• Tetanus (often called lockjaw) is caused by the tetanus bacteria entering deep wounds. The bacteria produce a toxin that causes muscle spasms leading to difficulty breathing and possible suffocation.
• Pertussis (often called whooping cough) is a respiratory infection that can occur at any age, but most commonly affects infants and young children. Characteristic of this disease are increasingly severe coughing fits, which can last for several weeks. The cough may be accompanied by a "strong inspiratory whoop" sound.
• Poliomyelitis (often simply called polio) is caused by viruses that attack the nerves. The disease can lead to muscle weakness or paralysis, most commonly of the legs. Muscle weakness affecting breathing and swallowing can be fatal.

Important

The vaccine only helps prevent diseases caused by the bacteria or viruses it is directed against. Your child can still get infectious diseases caused by other bacteria or viruses.

2. Important information before vaccination

To ensure the vaccine is suitable for your child, it is important to inform your doctor, pharmacist, or nurse if any of the following apply to your child.

When not to use the vaccine

• if your child is allergic to:
• the active substance of the vaccine or any of the other ingredients of the vaccine (listed in section 6);
• other vaccines containing any of the substances listed in section 6;
• any pertussis vaccine;
• if your child has any active brain disease (progressive encephalopathy),
• if your child has had a severe reaction involving the brain after receiving any pertussis vaccine.

Warnings and precautions

Before administering the vaccine, inform your doctor or nurse:

• if your child has a fever or acute illness (e.g., fever, sore throat, cough, cold, or flu). Vaccination may need to be postponed until your child's condition improves.
• if any of the following symptoms occurred after a previous pertussis vaccination:
• fever over 40°C within 48 hours not caused by another identified reason;
• collapse or a shock-like state with a hypotensive-hyporeactive episode within 48 hours of vaccination;
• prolonged, uncontrolled crying lasting 3 hours or more, occurring within 48 hours of vaccination;
• seizures with or without fever, occurring within 3 days of vaccination.
• if your child is allergic (hypersensitive) to glutaraldehyde, neomycin, streptomycin, and polymyxin B. These substances are used in the manufacturing process of the vaccine and may be present in the vaccine in undetectable trace amounts.
• if your child has had febrile seizures in the past, not related to previous vaccination, it is especially important to monitor body temperature within 48 hours of vaccination and administer antipyretic medication during this period.
• if your child has had a temporary loss of ability to move or feel (Guillain-Barré syndrome) or loss of ability to move, pain, and numbness of the arm and shoulder (brachial neuritis) after a previous tetanus vaccination. The doctor or nurse will decide whether to administer the vaccine.
• if your child has immune system deficiencies or is undergoing immunosuppressive treatment, as the immune response to the vaccine may be weakened. In such cases, it is recommended to postpone vaccination until treatment is completed or recovery occurs. However, administering the vaccine to children with chronic immune system deficiencies (including HIV infection) is recommended, even if the immune response may be limited.
• if your child has thrombocytopenia (low platelet count) or bleeding disorders (such as hemophilia), as bleeding may occur at the injection site.

Fainting can occur after, or even before, any needle injection. Therefore, inform your doctor or nurse if your child has fainted during previous injections.
and other medicines/vaccines
The vaccine can be administered at the same time as vaccines:

• Act-HIB (Haemophilus type b conjugate vaccine),
• measles, mumps, and rubella, and varicella vaccines,
• hepatitis B vaccine, but in different parts of the body.

If your child is to receive the vaccine at the same time as other vaccines not listed above, ask your doctor or pharmacist for additional information.
Tell your doctor or pharmacist about all medicines your child is taking or has recently taken, as well as any medicines planned for use in your child.

Pregnancy and breastfeeding

Not applicable. The vaccine is intended for use in children only.

The vaccine contains phenylalanine, ethanol, and sodium

The vaccine contains 12.5 micrograms of phenylalanine per 0.5 ml dose.
Phenylalanine may be harmful to patients with phenylketonuria, a rare genetic disorder in which phenylalanine accumulates in the body because the body does not eliminate it properly.
The vaccine contains 2 mg of ethanol per 0.5 ml dose. The small amount of ethanol in this vaccine will not produce noticeable effects.
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 the vaccine

The vaccine should always be used in accordance with the doctor's recommendations. If in doubt, consult your doctor.

Dosage:

Primary vaccination and booster dose:
Primary vaccination schedules include:

• two injections (given at least 2 months apart),
• or three injections (given at least 1 month apart), followed by a booster dose from 12 months of age.

Booster vaccinations:
A booster dose is recommended between 4 and 13 years of age.
The vaccine should be used in accordance with official recommendations.

Method of administration:

The vaccine should be administered by a healthcare professional trained in vaccine administration and equipped to handle rare, severe allergic reactions to the vaccine.
The vaccine is administered as an intramuscular injection (i.m.) into the upper thigh or arm of the child. The vaccine is never administered into a blood vessel.

Missed dose of the vaccine

If a dose of the vaccine is missed, the doctor will decide when to administer the missed dose.

Administration of a higher dose of the vaccine than recommended

Since the vaccine is administered by a doctor or nurse, administration of a higher dose than recommended is unlikely. If a parent/caregiver believes the child has received too much vaccine or that the time between two injections was too short, they should inform the doctor or nurse.
In case of any further doubts about the use of this vaccine, consult your doctor, nurse, or pharmacist.

4. Possible side effects

Like all medicines, the vaccine can cause side effects, although not everybody gets them.

Severe allergic reactions

If any of these symptoms occur after leaving the vaccination site, seek medical attention IMMEDIATELY.

After administration of any vaccine, there is a possibility of severe allergic reactions (of unknown frequency). These include:

• difficulty breathing
• swelling of the tongue or lips
• rash
• swelling of the face, throat, or other parts of the body
• low blood pressure causing dizziness or fainting.

These symptoms usually occur very soon after injection, while the child is still in the clinic or doctor's office.

Other side effects

If your child experiences any of the following side effects, or if they worsen, or if you notice any side effects not listed in this leaflet, inform your doctor, nurse, or pharmacist.

• Very common reactions(may affect more than 1 in 10 people):
• vomiting
• loss of appetite (feeding problems)
• sleepiness
• headache
• irritability (restlessness)
• unusual crying
• muscle pain
• redness at the injection site
• pain at the injection site
• swelling at the injection site
• fever over 38°C
• feeling unwell.
• Common reactions(may affect 1 to 10 people in 100):
• diarrhea
• sleep disturbances (insomnia)
• hardening of the skin at the injection site.
• Uncommon reactions(may affect 1 to 10 people in 1,000):
• prolonged, uncontrolled crying
• redness and swelling larger than 5 cm at the injection site
• fever over 39°C.
• Rare reactions(may affect 1 to 10 people in 10,000):
• fever over 40°C.
• Side effects of unknown frequency(frequency cannot be estimated from available data)
• seizures with or without fever
• loss of consciousness (fainting)
• rash, redness, and itching of the skin (erythema and urticaria)
• large reactions at the injection site (larger than 5 cm), including extensive limb swelling from the injection site beyond one or both joints. These reactions occur within 24 to 72 hours of vaccination and may be accompanied by symptoms such as redness (erythema), warmth, tenderness, or pain at the injection site, resolving without treatment within 3 to 5 days. The risk of occurrence appears to be related to the number of previous doses of vaccine containing acellular pertussis components, with greater risk after the fourth and fifth doses.
• enlargement of lymph nodes in the neck, armpits, or groin (lymphadenopathy).

Other reactions that may occur when the vaccine is administered at the same time as, and separately from, the Haemophilus type b vaccine:

• swelling of one or both lower limbs, which may occur with a bluish discoloration of the skin (cyanosis), redness, a small area of bleeding under the skin (transient purpura), and severe crying. If such a reaction occurs, it can usually be observed mainly after the first injections (primary vaccination) within the first few hours of vaccination. All symptoms resolve within 24 hours without treatment.

Possible side effects(i.e., not reported directly after vaccination, but after other vaccines containing one or more antigenic components of the vaccine) include:

• temporary loss of ability to move or feel (Guillain-Barré syndrome) and loss of ability to move, pain, and numbness of the arm and shoulder (brachial neuritis),
• episodes where the child becomes pale, floppy, and unresponsive for a period (hypotensive-hyporeactive episodes),
• in premature infants (born at 28 weeks of gestation or earlier), within 2-3 days of vaccination, longer pauses between breaths may occur.

Reporting side effects

If your child experiences any side effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store the vaccine

Store the vaccine out of sight and reach of children.
Store in a refrigerator (2°C – 8°C).
Do not freeze.
Do not use this vaccine after the expiry date stated on the label and carton after:
(EXP).
The expiry date refers to the last day of the month stated.
Medicines should 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 pack and other information

What it contains

• The active substances are: One dose (0.5 ml) contains: Diphtheria toxoid ..................................................................... at least 20 IU (30 Lf) Tetanus toxoid ...................................................................... at least 40 IU (10 Lf) Bordetella pertussisantigens Pertussis toxoid 25 micrograms Filamentous hemagglutinin 25 micrograms Inactivated poliovirus Type 1 (Mahoney) 29 antigen units D Type 2 (MEF-1) 7 antigen units D Type 3 (Saukett) 26 antigen units D

Adsorbed on hydrated aluminium hydroxide (0.3 milligrams Al)
Lower limit of the confidence interval (p = 0.95) and not less than 30 IU as the mean value
Or equivalent activity determined by immunogenicity assessment
Lower limit of the confidence interval (p = 0.95)
Propagated in Vero cells
These antigen amounts are exactly the same as previously expressed as 40-8-32 antigen units D, respectively for virus types 1, 2, and 3, measured by another appropriate immunochemical method
Aluminium hydroxide is contained in this vaccine as an adjuvant. Adjuvants are substances contained in some vaccines to accelerate, improve, and (or) prolong the protective effect of the vaccine.

• The other ingredients are: Hanks' 199 medium without phenol red (a complex mixture of amino acids, including phenylalanine, mineral salts, vitamins, and other substances such as glucose), formaldehyde, glacial acetic acid, and (or) sodium hydroxide to adjust pH, phenoxylethanol, anhydrous ethanol, and water for injections.

The vaccine may contain trace amounts of glutaraldehyde, neomycin, streptomycin, and polymyxin B, which are used in the production process of the vaccine.

What the pack contains and what it looks like

The vaccine suspension for injection is available in a pre-filled syringe containing a single dose (0.5 ml).
Pack sizes of 1 and 10, without a needle, with an attached needle, with 1 separate needle, or with 2 separate needles.
Not all pack sizes may be marketed.

Marketing authorization holder

Sanofi Winthrop Industrie - 82 Avenue Raspail - 94250 Gentilly - France

Manufacturer

Sanofi Winthrop Industrie
1541 avenue Marcel Mérieux
69280 Marcy l’Etoile
France
Sanofi Winthrop Industrie
Voie de l’Institut - Parc Industriel d’Incarville
B.P 101
27100 Val de Reuil
France
SANOFI-AVENTIS Zrt.
1225 Budapest
Campona u. 1 (Harbor Park)
Hungary

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Tetraxim: Croatia, Czech Republic, Hungary, Poland, Slovakia, Spain.
Tetravac: Cyprus.
Date of last revision of the leaflet:May 2025
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Information intended for healthcare professionals only:

Instructions for preparation for administration – vaccine suspension for injection in a pre-filled syringe
Diphtheria, Tetanus, Pertussis (acellular, component) and Poliomyelitis (inactivated) vaccine, adsorbed
In the case of syringes without attached needles, a separate needle must be firmly attached to the syringe by twisting it a quarter turn.
Before administration, shake the pre-filled syringe to obtain a homogeneous, whitish, cloudy suspension.
Inspect the suspension visually before administration. If any foreign particles or changes in physical properties are observed, discard the pre-filled syringe.
The vaccine can be administered by reconstituting the Act-HIB vaccine (Haemophilus type b conjugate vaccine) as follows:
Shake the pre-filled syringe until the contents are homogeneous and reconstitute the vaccine by injecting the combined diphtheria, tetanus, pertussis (acellular), and poliomyelitis vaccine suspension into the vial containing the Haemophilus type b conjugate vaccine powder.

• Gently shake the vial until the powder is completely dissolved. After reconstitution, the appearance of a whitish, cloudy suspension is normal.
• Immediately withdraw the suspension into the syringe after reconstitution.
• The whitish, cloudy suspension must be used immediately after reconstitution and shaken before injection.
• After reconstitution and withdrawal into the syringe, a separation of the suspension into a clear phase and a gel-like phase may occur. In such cases, the syringe should be shaken vigorously before administration.

The vaccine should be administered intramuscularly. The recommended injection site is the anterolateral aspect of the upper thigh in infants and the deltoid muscle in older children.