TRIAXIS POLIO INJECTABLE SUSPENSION IN PRE-FILLED SYRINGE

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.

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:

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.