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TRIAXIS POLIO INJECTABLE SUSPENSION IN PRE-FILLED SYRINGE

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About the medicine

How to use TRIAXIS POLIO INJECTABLE SUSPENSION IN PRE-FILLED SYRINGE

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the User

TRIAXIS POLIO, injectable suspension in a pre-filled syringe

Vaccine against diphtheria, tetanus, pertussis (acellular component) and poliomyelitis (inactivated, reduced antigen content)

Read all of this leaflet carefully before you or your child are vaccinated because it contains important information for you.

  • Keep this leaflet, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you or your child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
  • If you or your child experience any side effects, consult your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

  1. What is Triaxis Polio and what is it used for
  2. What you need to know before you or your child receive Triaxis Polio
  3. How to use Triaxis Polio
  4. Possible side effects
  5. Storage of Triaxis Polio
  6. Contents of the pack and further information

1. What is Triaxis Polio and what is it used for

Triaxis Polio (Tdap-IPV) is a vaccine. Vaccines are used to protect against infectious diseases. Vaccines make the body produce its own protection against the bacteria and viruses that cause these infectious diseases.

This vaccine is used as a booster to protect against diphtheria, tetanus, pertussis (whooping cough), and poliomyelitis (polio) in children from 3 years of age, adolescents, and adults after completing the primary vaccination schedule.

The use of Triaxis Polio during pregnancy allows the protection to be transferred to the child in the womb against whooping cough during the first months of life.

Limitations of the protection provided

Triaxis Polio will only prevent these diseases if they are caused by the bacteria or viruses used to produce the vaccine. It is possible that you or your child may suffer from similar diseases that are caused by other bacteria or viruses.

Triaxis Polio does not contain any live bacteria or viruses and cannot cause any of the infectious diseases it protects against.

Remember that no vaccine can offer complete and long-lasting protection to all people who are vaccinated.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. What you need to know before you or your child receive Triaxis Polio

To ensure that Triaxis Polio is suitable for you or your child, it is important that you tell your doctor or nurse if any of the following apply to you or your child. If there is anything you do not understand, ask your doctor or nurse.

Do not use Triaxis Polio if you or your child

  • have had an allergic reaction:
  • to diphtheria, tetanus, pertussis (whooping cough), or poliomyelitis vaccines
  • to any other component (listed in section 6)
  • to any residual component transferred during manufacturing (formaldehyde, glutaraldehyde, streptomycin, neomycin, polymyxin B, and bovine serum albumin) that may be present in small quantities.
  • have ever had a severe reaction that affected the brain within one week of a previous dose of a pertussis vaccine.
  • have a severe acute febrile illness. Vaccination should be postponed until you or your child have recovered. A minor illness without fever is usually not a reason to postpone vaccination. Your doctor will decide whether you or your child should receive Triaxis Polio.

Warnings and precautions

Consult your doctor or nurse before vaccination if you or your child:

  • have received a booster dose of a diphtheria and tetanus vaccine in the last 4 weeks. In this case, you or your child should not receive Triaxis Polio, and your doctor will decide, according to official recommendations, whether you or your child can receive another injection.
  • have had Guillain-Barré syndrome (temporary loss of mobility and sensitivity in the whole body or part of it) within 6 weeks of receiving a previous dose of a tetanus antigen-containing vaccine. Your doctor will decide whether you or your child should receive Triaxis Polio.
  • have a progressive disease that affects the brain/nerves or uncontrolled seizures. Your doctor will start treatment and perform vaccination when the condition has stabilized.
  • have a reduced or deficient immune system due to:
    • medicines (e.g., steroids, chemotherapy, or radiotherapy).
    • HIV or AIDS infection.
    • any other disease.

It is possible that the vaccine may not protect these individuals in the same way as it protects people with a healthy immune system. If possible, vaccination should be postponed until the end of such illness or treatment.

  • have blood problems that cause easy bruising or prolonged bleeding after minor cuts (e.g., due to a blood disorder such as hemophilia, thrombocytopenia, or treatment with anticoagulant medicines).

After any injection with a needle, or even before, fainting can occur. Therefore, inform your doctor or nurse if you or your child have fainted with any previous injection.

Other medicines or vaccines and Triaxis Polio

Tell your doctor or pharmacist if you or your child are using or have recently used any other medicines.

Since Triaxis Polio does not contain any live bacteria or viruses, it can be administered at the same time as other vaccines or immunoglobulins, although in a different injection site. There are studies that have shown that Triaxis Polio can be used at the same time as some of the following vaccines: inactivated influenza vaccine, hepatitis B vaccine, and human papillomavirus vaccine, respectively. Injections of more than one vaccine at the same time will be given in different limbs.

If you or your child are receiving medical treatment that affects your blood or immune system (such as anticoagulants, steroids, or chemotherapy), consult the previous section "Warnings and precautions".

Pregnancy, breastfeeding, and fertility

Consult your doctor or nurse if you are pregnant, think you may be pregnant, or are planning to become pregnant or are breastfeeding. Your doctor or nurse will help you decide whether you should receive Triaxis Polio during pregnancy.

Driving and using machines

No studies have been performed on the effects on the ability to drive and use machines. The vaccine has a negligible influence on the ability to drive and use machines.

Triaxis Polio contains Ethanol

Triaxis Polio contains 1.01 milligrams of alcohol (ethanol) per 0.5 ml dose. The small amount of alcohol in this medicine will not produce noticeable effects.

3. How to use Triaxis Polio

When will you or your child receive the vaccine

Your doctor will decide whether Triaxis Polio should be administered to you or your child, based on:

  • which vaccines you or your child have received in the past
  • how many doses of similar vaccines you or your child have received in the past
  • when you or your child last received a dose of a similar vaccine

Your doctor will decide what period to wait between vaccinations.

If you are pregnant, your doctor will help you decide whether you should receive Triaxis Polio during pregnancy.

Dosage and administration

Who will administer Triaxis Polio to you?

Triaxis Polio should be administered by trained healthcare professionals in the use of vaccines and in a clinic or outpatient setting with the necessary equipment to treat any severe allergic reaction to the vaccine.

Dosage

All age groups for which Triaxis Polio is indicated will receive one injection (0.5 ml).

In case you or your child experience an injury that requires preventive action against tetanus, your doctor may decide to give you Triaxis Polio with or without tetanus immunoglobulin.

Triaxis Polio can be used for booster vaccination. Your doctor will recommend repeating the vaccination.

Administration

The doctor or nurse will administer the vaccine into a muscle in the upper outer part of the arm (deltoid muscle).

The doctor or nurse will notadminister the vaccine into a blood vessel, buttocks, or under the skin. In case of blood coagulation disorders, they may decide to inject under the skin, although this may cause more local side effects, including a small lump under the skin.

If you have any doubts about the use of this medicine, consult your doctor or pharmacist or nurse.

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

Like all medicines, Triaxis Polio can cause side effects, although not everybody gets them.

Severe allergic reactions

If any of the following symptoms occur after leaving the place where you or your child received the injection, you must consult a doctor IMMEDIATELY.

  • difficulty breathing
  • blue discoloration of the tongue or lips
  • a rash
  • swelling of the face or throat
  • low blood pressure causing dizziness or fainting (collapse)

When these signs or symptoms occur, they usually develop very quickly after the injection and while you or your child are still in the doctor's office. Severe allergic reactions are a very rare possibility (may affect up to 1 in 10,000 people) after receiving any vaccine.

Other side effects

The following side effects were observed during clinical studies conducted in specific age groups.

In children between 3 and 6 years of age

Very common (may occur in more than 1 in 10 people):

  • pain
  • swelling and redness at the injection site
  • fatigue
  • fever (a temperature of or above 37.5°C)
  • diarrhea

Common (may occur in up to 1 in 10 people):

  • bruising
  • itching and inflammation of the skin at the injection site
  • headache
  • nausea
  • vomiting
  • rash
  • joint pain or swelling
  • irritability

In adolescents (11 years of age or older) and adults

Adolescents are slightly more likely than adults to experience side effects. Most side effects occur within the first 3 days after vaccination.

Very common (may occur in more than 1 in 10 people):

  • pain
  • redness and swelling at the injection site
  • headache
  • nausea
  • joint pain or swelling
  • muscle pain
  • weakness
  • chills

Common (may occur in up to 1 in 10 people):

  • vomiting
  • diarrhea
  • fever (a temperature of or above 38°C)

The following additional adverse events have been reported in the recommended age groups during commercial use of Triaxis Polio. It is not possible to calculate the frequency of these adverse events with precision, as they are based on voluntary reports of notification in relation to the estimated number of people vaccinated.

Lymph node disorder, allergic reactions/severe allergic reactions, seizures (convulsions), fainting, paralysis of part or all of the body (Guillain-Barré syndrome), facial paralysis, spinal cord inflammation, arm nerve inflammation (brachial neuritis), temporary or altered sensation in the vaccinated limb, dizziness, pain in the vaccinated limb, extensive swelling of the limbs (often associated with redness and sometimes with blisters), feeling unwell, pale skin, lump (induration) at the injection site, abdominal pain.

Reporting of side effects

If you or your child experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Triaxis Polio

Keep this medicine out of the sight and reach of children.

Do not use Triaxis Polio after the expiry date stated on the packaging and label after EXP. The expiry date is the last day of the month stated.

Store in a refrigerator (between 2°C and 8°C). Do not freeze. Discard the vaccine if it freezes.

Keep the syringe in the outer packaging to protect it from light.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition of Triaxis Polio

The active substances of each dose (0.5 ml) of vaccine are:

Diphtheria toxoid not less than 2 international units (2 Lf)Tetanus toxoid not less than 20 international units (5 Lf)Pertussis antigens: Pertussis toxoid 2.5 micrograms Filamentous hemagglutinin 5 micrograms Pertactin 3 micrograms Fimbriae types 2 and 3 5 micrograms

Inactivated Poliovirus (grown in Vero cells):

Type 1 (Mahoney) 29 units of antigen D1

Type 2 (MEF1) 7 units of antigen D1

Type 3 (Saukett) 26 units of antigen D1

Adsorbed on aluminum phosphate 1.5 mg (0.33 mg of Al3+)

1 These antigen quantities are strictly the same as those previously expressed as 40-8-32 units of antigen D, for virus types 1, 2, and 3, respectively, when measured by another suitable immunochemical method.

The aluminum phosphate in the vaccine is an adjuvant. Adjuvants are substances included in some vaccines to accelerate, enhance, or prolong the protective effects of the vaccine.

The other ingredients are: phenoxylethanol, ethanol, polysorbate 80, water for injections.

Appearance of the product and pack contents

Triaxis Polio is presented as an injectable suspension in a pre-filled syringe (0.5 ml):

  • without needle - pack of 1, 10, or 20
  • with 1 or 2 separate needles - pack of 1 or 10

Not all pack sizes may be marketed.

The normal appearance of the vaccine is a white and turbid suspension, which may sediment during storage. After correct shaking, the liquid has a uniform white appearance.

Marketing authorization holder and manufacturer

The marketing authorization holder is:

Sanofi Winthrop Industrie

82 avenue Raspail

94250 Gentilly

France

The manufacturer is:

Sanofi Winthrop Industrie

1541 avenue Marcel Mérieux

69280 Marcy l’Etoile

France

or

Sanofi Winthrop Industrie

Voie de l’Institut – Parc Industriel d’Incarville

B.P 101

27100 Val de Reuil

France

or

Sanofi-Aventis Zrt.

Campona Utca. 1 (Harbor Park)

H-1225 Budapest

Hungary

Local representative

sanofi-aventis, S.A.

C/ Rosselló i Porcel, 21

08016 Barcelona - Spain

Tel: +34 93 485 94 00

This medicine has been authorized in the EEA Member States under the following names:

Austria, Germany, Denmark, Finland, France, Greece, Ireland, Iceland, Norway, Portugal, Sweden, United Kingdom (Northern Ireland):

REPEVAX

Belgium, Italy, Luxembourg, Netherlands, Spain:

TRIAXIS POLIO

Bulgaria, Croatia, Slovakia, Slovenia, Hungary, Poland, Czech Republic, Romania:

ADACEL POLIO

Date of last revision of this leaflet:February 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/

This information is intended only for healthcare professionals:

Instructions for use

In the absence of compatibility studies, Triaxis Polio should not be mixed with other medicines.

Parenteral biological products should be inspected visually for particulate matter and/or discoloration before administration. If these conditions occur, the product should not be administered.

For products without a needle, the needle should be firmly attached to the end of the pre-filled syringe by a 90-degree turn.

Do not replace the needle cap.

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Hocine Lokchiri

General medicine 21 years exp.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

Online consultations with Dr. Lokchiri are suitable for many situations when someone needs quick medical guidance, reassurance or a clear next step. Common reasons for booking include:

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Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques.

For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance.

Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults.

In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions.

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Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.
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Lina Travkina

Family medicine 13 years exp.

Dr. Lina Travkina is a licensed family and preventive medicine doctor based in Italy. She provides online consultations for adults and children, supporting patients across all stages of care – from acute symptom management to long-term health monitoring and prevention.

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Alina Tsurkan

Family medicine 13 years exp.

Dr. Alina Tsurkan is a licensed family medicine physician based in Portugal, offering online consultations for adults and children. She provides professional primary care, with a focus on prevention, accurate diagnosis, and long-term management of acute and chronic conditions.

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Yevgen Yakovenko

General surgery 12 years exp.

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

Areas of medical expertise:

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Frequently Asked Questions

Is a prescription required for TRIAXIS POLIO INJECTABLE SUSPENSION IN PRE-FILLED SYRINGE?
TRIAXIS POLIO INJECTABLE SUSPENSION IN PRE-FILLED SYRINGE requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in TRIAXIS POLIO INJECTABLE SUSPENSION IN PRE-FILLED SYRINGE?
The active ingredient in TRIAXIS POLIO INJECTABLE SUSPENSION IN PRE-FILLED SYRINGE is diphtheria-pertussis-poliomyelitis-tetanus. This information helps identify medicines with the same composition but different brand names.
Who manufactures TRIAXIS POLIO INJECTABLE SUSPENSION IN PRE-FILLED SYRINGE?
TRIAXIS POLIO INJECTABLE SUSPENSION IN PRE-FILLED SYRINGE is manufactured by Sanofi Winthrop Industrie. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of TRIAXIS POLIO INJECTABLE SUSPENSION IN PRE-FILLED SYRINGE online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether TRIAXIS POLIO INJECTABLE SUSPENSION IN PRE-FILLED SYRINGE is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to TRIAXIS POLIO INJECTABLE SUSPENSION IN PRE-FILLED SYRINGE?
Other medicines with the same active substance (diphtheria-pertussis-poliomyelitis-tetanus) include BOOSTRIX POLIO Injectable Suspension in Pre-filled Syringe, INFANRIX-IPV PRE-FILLED SYRINGE SUSPENSION FOR INJECTION, TETRAXIM SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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