Prospect: information for the user

TRIAXIS suspension for injection in preloaded syringe

Diphtheria, tetanus, and pertussis (acellular component) vaccine

(adsorbed, reduced antigen content)

Read this prospect carefully before you or your child are vaccinated, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you or your child and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you or your child experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

1. What is Triaxis and how is it used

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

3. How to use Triaxis

4. Possible adverse effects

5. Storage of Triaxis

6. Contents of the package and additional information

Triaxis (Tdap) is a vaccine. Vaccines are used to protect against infectious diseases.Vaccines cause the body to generate its own protection against the bacteria that causethese infectious diseases.

This vaccine is used as a booster for protection against diphtheria, tetanus, and pertussis (whooping cough) in children from four years old,adolescents, and adults after completing the primary vaccination schedule.

The use of Triaxis during pregnancy allows the protection to be transmitted to the baby through the mother's milk against whooping cough during the first months of life.

Limits of the protection provided

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

Triaxis 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 individuals who are vaccinated.

To ensure that Triaxis is suitable for you or your child, it is essential to inform your doctor or nurse if any of the following points apply to you or your child. If you do not understand something, consult with your doctor or nurse.

Do not use Triaxis if you or your child

• have had an allergic reaction:

• to diphtheria, tetanus, or pertussis (whooping cough) vaccines
• to any other component (listed in section 6)

• to any residual component transferred during manufacturing (formaldehyde, glutaraldehyde) that may be present in small quantities.

• have had a severe reaction that affected the brain within one week after a previous dose of a pertussis vaccine.

• have a severe acute illness. Vaccination should be postponed until you or your child have recovered.A minor illness without fever usually does not warrant postponing vaccination. Your doctor will determine if you or your child should receive Triaxis.

Warnings and precautions

Consult your doctor or nurse before vaccinating 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 and your doctor will decide in accordance with official recommendations when 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 after receiving a previous dose of a tetanus vaccine. Your doctor will decide if you or your child should receive Triaxis.
• have a progressive brain/nervous system disease or uncontrolled seizures. Your doctor will initiate treatment and perform vaccination when the condition has stabilized.
• have a reduced or deficient immune system, due to

• • medications (e.g., steroids, chemotherapy, or radiation therapy).
  • infection with HIV or AIDS.
  • any other disease.

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

• have bleeding disorders that cause easy bruising or prolonged bleeding after minor cuts (e.g., due to a bleeding disorder such as hemophilia, thrombocytopenia, or anticoagulant medication).

After any injection with a needle, or even before, dizziness may occur. Therefore, inform your doctor or nurse if you or your child have experienced dizziness with any previous injection.

Consult your doctor, pharmacist, or nurse before starting to use Triaxis, if you or your child have had any allergic reaction to latex. The pre-filled syringes (1.5 ml) with soft rubber stopper contain a natural latex derivative (latex rubber) that may cause an allergic reaction.

Other medications or vaccines and Triaxis

Inform your doctor, nurse, or pharmacist if you or your child are using or have used recently or may need to use any other medication.

Since Triaxis does not contain any live bacteria, it is possible to administer it at the same time as other vaccines or immunoglobulins, although in a different injection site.There arestudies that have demonstrated that Triaxis can be used at the same time as some of the following vaccines: hepatitis B vaccine, polio virus vaccine (oral or injectable), inactivated influenza vaccine, and human papillomavirus recombinant vaccine, respectively. Multiple injections of more than one vaccine at the same time will be administered in different limbs.

If you or your child are receiving medical treatment that affects the 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 nurseif you are pregnant, think you may be pregnant, or intend to become pregnant or are breastfeeding. Your doctor will help you decide if you should receive Triaxis during pregnancy.

Driving and operating machinery

No studies have been conducted on the effects on the ability to drive and operate machinery. The vaccine has no or insignificant effect on the ability to drive and operate machinery.

When You or Your Child Will Receive the Vaccine

The doctor will determine if Triaxis should be administered to you or your child, based on:

• the vaccines that have been administered to you or your child in the past.
• the number of doses of similar vaccines that have been administered to you or your child in the past.
• when the last dose of a similar vaccine was administered to you or your child.

The doctor will decide what interval should be waited between vaccinations.

If you are pregnant, the doctor will help you decide if you should receive Triaxis during pregnancy.

Dosage and Administration

Who Will Administer Triaxis?

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

Dosage

All age groups for which it is indicated will receive an injection (0.5 milliliters).

If you or your child experience an injury that requires preventive action for tetanus disease, your doctor may decide to give you Triaxis with or without tetanus immunoglobulin.

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

Administration

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

The doctor or nurse will not administer the vaccine in a vein, in the buttocks, or under the skin.In the case of blood clotting 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 medication, consult your doctor or pharmacist or nurse.

Like all medicines, Triaxis can cause side effects, although not everyone will experience them.

Severe allergic reactions

If any of these symptoms appear 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
• 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 consultation. Severe allergic reactions are a very rare possibility (they can affect 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 aged 4 to 6 years

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

• Loss of appetite
• Headache
• Diarrhea
• Fatigue
• Pain
• Redness
• Swelling at the injection site

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

• Nausea
• Vomiting
• Rash
• Pain (in the whole body) or muscle weakness
• Joint pain or swelling
• Fever
• Chills
• Lymph node disorder in the armpit

In adolescents aged 11 to 17 years

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

• Headache
• Diarrhea
• Nausea
• Pain (in the whole body) or muscle weakness
• Joint pain or swelling
• Fatigue/weakness
• Malaise
• Chills
• Pain
• Redness and swelling at the injection site

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

• Vomiting
• Skin rash
• Fever
• Lymph node disorder in the armpit

In adults aged 18 to 64 years

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

• Headache
• Diarrhea
• Pain (in the whole body) or muscle weakness
• Fatigue/weakness
• Malaise
• Pain
• Redness and swelling at the injection site

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

• Nausea
• Vomiting
• Skin rash
• Pain or joint swelling
• Fever
• Chills
• Lymph node disorder in the armpit

The following additional adverse events have been reported in the recommended age groups during the commercial use of Triaxis.It is not possible to calculate the frequency of these adverse events with precision, as it would be based on voluntary reporting of notifications in relation to the estimated number of people vaccinated.

-Severe allergic reactions/allergic reactions (for information on how to recognize this type of reaction, see the beginning of section 4), muscle crampsor numbness, paralysis of part or all of the body (Guillain-Barré syndrome), inflammation of the nerves of the arm (brachial neuritis), loss of function in the nerve that transmits the impulse to the facial muscles (facial paralysis), seizures (convulsions), fainting, inflammation of the spinal cord (myelitis), inflammation of the muscular part of the heart (myocarditis), itching (pruritus), urticaria, inflammation of a muscle (myositis), extensive swelling of the limbs associated with redness, heat, pain on palpation or pain at the injection site, bruising, swelling or a small lump at the injection site.

Reporting of side effects

If you or your child experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use Triaxis after the expiration date that appears on the packaging and label after CAD/EXP. The expiration date is the last day of the month indicated.

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

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

Medicines should not be thrown down the drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Triaxis

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

Diphtheria toxoid no less than 2 international units (2 Lf)
Tetanus toxoid no 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
It is adsorbed on aluminium phosphate 1.5 mg (0.33 mg of Al3+)

Aluminium phosphate is included in the vaccine as an adjuvant. Adjuvants are substances included in certain vaccines to accelerate, improve and/or prolong the protective effects of the vaccines.

The other components are:phenol, water for injection.

Appearance of the product and contents of the package

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

• without needle -package of 1 or 10
• with 1 or 2 separate needles -package of 1 or 10

It contains a natural rubber latex derivative (latex) in the stopper at the end of the pre-filled syringe.

Only some package sizes may be marketed.

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

Holder of the marketing authorization and manufacturer responsible

The holder of the marketing authorization is:

Sanofi Winthrop Industrie

82 avenue Raspail

94250 Gentilly

France

The manufacturer responsible 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 U.1 (Harbor Park ) - Budapest - 1225 - Hungary

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

Date of the last review of this leaflet:March 2023

The detailed information of this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

This information is intended solely for healthcare professionals:

Instructions for use

In the absence of compatibility studies, Triaxis should not be mixed with other medicinal products.

Biological parenteral products must be visually inspected to detect foreign particles and/or discoloration before administration. If these conditions occur, the product should not be administered.

The needle should be tightened firmly in the end of the pre-filled syringe by a 90-degree turn.

The stopper should not be replaced on the needles.