TRIAXIS SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE

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

To ensure that Triaxis 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 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 amounts.

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

• have a severe acute illness. Vaccination should be delayed until you or your child have recovered. A minor illness without fever is not usually a reason to delay vaccination. Your doctor will decide if you or your child should receive Triaxis.

Warnings and precautions

Tell 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 and your doctor will decide when you or your child can receive another injection according to official recommendations.
• 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 vaccine containing tetanus antigen. Your doctor will decide if you or your child should receive Triaxis.
• 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 bleeding disorders that cause easy bruising or prolonged bleeding after minor cuts (e.g., due to a bleeding disorder such as hemophilia, thrombocytopenia, or treatment with anticoagulant medicines).

Fainting can occur after any injection with a needle, even before. Tell your doctor or nurse if you or your child have fainted after a previous injection.

Tell 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 a soft stopper contain a derivative of natural rubber latex (latex) that may cause an allergic reaction.

Other medicines or vaccines and Triaxis

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

Since Triaxis does not contain any live bacteria, 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 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 vaccine, respectively. Injections of more than one vaccine at the same time will be performed 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), see the previous section "Warnings and precautions".

Pregnancy, breastfeeding, and fertility

Ask your doctor or nurse if you are pregnant, think you may be pregnant, or plan to become pregnant or are breastfeeding. Your doctor will help you decide if you should receive Triaxis 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 effect on the ability to drive and use machines.

3. How to use Triaxis

When will you or your child receive the vaccine

Your doctor will decide if Triaxis 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 received the last 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 if you should receive Triaxis during pregnancy.

Dosage and administration

Who will administer Triaxis to you?

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 severe allergic reaction to the vaccine.

Dosage

All age groups for which it is indicated will receive an 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 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 blood vessel, buttocks, or under the skin. In case of bleeding 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, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

Severe allergic reactions

If any of these symptoms occur after leaving the place where you or your child received the injection, see 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 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 from 4 to 6 years of age

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

• loss of appetite
• headache
• diarrhea
• fatigue
• pain
• redness
• swelling at the injection site

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

• nausea
• vomiting
• rash
• body pain or muscle weakness
• joint pain or swelling
• fever
• chills
• lymph node disorder in the armpit

In adolescents from 11 to 17 years of age

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

• headache
• diarrhea
• nausea
• body pain or muscle weakness
• joint pain or swelling
• fatigue/weakness
• malaise
• chills
• pain
• redness and swelling at the injection site

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

• vomiting
• skin rash
• fever
• lymph node disorder in the armpit

In adults from 18 to 64 years of age

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

• headache
• diarrhea
• body pain or muscle weakness
• fatigue/weakness
• malaise
• pain
• redness and swelling at the injection site

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

• nausea
• vomiting
• skin rash
• joint pain or swelling
• fever
• chills
• lymph node disorder in the armpit

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

• allergic reactions/severe allergic reactions (for information on how to recognize such a reaction, see the beginning of section 4), muscle aches or numbness, paralysis of part or all of the body (Guillain-Barré syndrome), inflammation of the nerves in the arm (brachial neuritis), loss of function in the nerve that transmits the impulse to the facial muscles (facial paralysis), seizures, fainting, inflammation of the spinal cord (myelitis), inflammation of the muscular part of the heart (myocarditis), itching (pruritus), hives, inflammation of a muscle (myositis), extensive swelling of the limbs associated with redness, heat, pain to the touch, 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 side effects, talk to your doctor, pharmacist, or nurse, even if it is possible that they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Triaxis

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

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

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

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container Contents and Additional Information

Composition of Triaxis

The active principles of each dose (0.5 ml) of the 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 It is adsorbed on aluminum phosphate 1.5 mg (0.33 mg of Al3+)

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

The other components are: phenoxylethanol, water for injectable preparations.

Appearance of the Product and Container Contents

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

• without needle - packaging of 1 or 10
• with 1 or 2 separate needles - packaging of 1 or 10
• with separate safety needle – packaging of 1 or 10

It contains a derivative of natural rubber latex (latex rubber) in the plug 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 and form lumpy or scaly aggregates. After correct agitation, the liquid has a uniform white appearance. If there are aggregates, the product can be shaken again until a uniform suspension is obtained.

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

Marcy l'Etoile - 69280 - 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

Local Representative

sanofi-aventis, S.A.

C/ Rosselló i Porcel, 21

08016 Barcelona

Spain

Tel: +34 93 485 94 00

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

Date of the Last Revision of this Leaflet:March 2023

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

This information is intended only for healthcare professionals:

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

Preparation for Administration

The pre-filled syringe may be supplied with a Luer Lock closure with a soft tip cap (Image A) or with a rigid tip cap (Image B). The syringe with the injectable suspension should be visually inspected before administration. In case of foreign particles, leaks, premature plunger activation, or defective tip sealing, discard the pre-filled syringe. The syringe is for single use and should not be reused.

Instructions for use of the Luer Lock pre-filled syringe:

Image A: Luer Lock Syringe with Soft Tip Cap

Image B: Luer Lock Syringe with Rigid Tip Cap

Instructions for use of the safety needle with the Luer Lock pre-filled syringe:

Follow steps 1 and 2 above to prepare the Luer Lock syringe and needle for placement.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

The cap should not be replaced on the needles.