DIFTAVAX SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE

Introduction

Leaflet: information for the user

DIFTAVAX injectable suspension in pre-filled syringe

Diphtheria and tetanus vaccine (adsorbed) for adults and adolescents.

Read the entire leaflet carefully before you or your child is vaccinated because it contains important information for you or your child.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Diftavax is and what it is used for
2. What you need to know before you or your child use Diftavax
3. How to use Diftavax
4. Possible side effects

5 Conservation of Diftavax

1. Package contents and additional information

1. What Diftavax is and what it is used for

Diftavax (Td) is a vaccine. Vaccines are used to protect against infectious diseases.

Diftavax is indicated for active immunization against tetanus and diphtheria in children from 7 years of age and in adults, in the following situations:

• For primary vaccination in individuals who have not been previously vaccinated against tetanus and diphtheria.
• To complete the primary vaccination cycle in individuals who did not complete it before the age of 7.
• As a booster dose in cases where the primary vaccination cycle has been completed.
• In the case of wounds, as prevention against tetanus and as a booster dose against diphtheria.

2. What you need to know before you or your child use Diftavax

Do not use Diftavax:

• if you/your child is allergic to the active substance(s) or to any of the other components of this vaccine (listed in section 6).
• if you/your child has suffered severe adverse reactions after previous vaccinations against tetanus and/or diphtheria.
• in cases of wounds in immunodeficient individuals. In these cases, only the tetanus vaccine should be administered, and not accompanied by the diphtheria component. Therefore, Diftavax is not indicated in these patients.
• in cases of wounds when there is an absolute contraindication to the tetanus vaccine. In these cases, tetanus immunoglobulin (2 x 250 IU at intervals of 4 weeks) should be administered. Therefore, Diftavax is not indicated in these patients.
• if you/your child has a high fever, acute infection, or is in the incubation period of an infection. In these cases, administration of Diftavax should be postponed. However, moderate fever or mild infection does not contraindicate vaccination.
• it should not be administered to individuals with a history of thrombocytopenia (decrease in platelet count), allergic reactions (hypersensitivity), or neurological complications after a previous vaccination against tetanus and/or diphtheria.
• when, at the time of vaccination, there is an allergic reaction or complication of the central and/or peripheral nervous system. Your doctor will assess the risk of immunization versus the risk of contracting tetanus or diphtheria.

Warnings and precautions

Do not administer by intravascular injection: ensure that the needle does not penetrate a blood vessel.

Consult your doctor or pharmacist before starting to use Diftavax:

• if you/your child has been vaccinated against tetanus and/or diphtheria in the last 5 years. To prevent hypersensitivity reactions (allergy), avoid injection in the 5 years following vaccination in individuals who have completed a primary vaccination cycle and in those who have received a booster dose.

• if you/your child is receiving simultaneous immunosuppressive treatment (which suppresses the body's immune response). In such cases, it is recommended to delay vaccination until the end of treatment or to check the protective levels of the subject. However, vaccination of subjects with chronic immunosuppression, such as HIV infection, is recommended if the disease allows the induction of an antibody response, even if limited.

• if you/your child has had problems with previous vaccinations, such as weakness and numbness of the limbs (Guillain-Barré syndrome) or decreased movement or sensitivity in the arm and shoulder due to a nerve problem (brachial neuritis). In these cases, the decision to administer any vaccine containing tetanus toxoid should be based on a careful consideration of the potential benefits and risks, both if the primary immunization schedule is completed and if not. Vaccination is usually justified when the primary immunization schedule is incomplete (e.g., if fewer than three doses have been received).

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

Use of Diftavax with other vaccines or medicines

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

There is no evidence of any interaction with other medicines, and no interaction studies have been conducted with diagnostic tests and/or laboratory tests.

No contraindication has been reported for the administration of Diftavax during a vaccination session with other common vaccines.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this vaccine.

For many years, clinical experience has not indicated any harmful effects on embryonic and/or fetal development.

Unvaccinated or insufficiently vaccinated pregnant women may be vaccinated during the second and third trimester of pregnancy, especially in cases of travel to countries with endemic diphtheria or suspected exposure.

Breastfeeding is not a contraindication.

Driving and using machines

No studies have been conducted on the effects on the ability to drive and use machines.

DIFTAVAX, injectable suspension in pre-filled syringe contains:

Potassium and sodium

DIFTAVAX contains less than 1 mmol of potassium (39 mg) and sodium (23 mg) per dose, so it is considered essentially "potassium-free" and "sodium-free".

3. How to use Diftavax

Follow the administration instructions of this vaccine exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

• For primary vaccination, the following schedule is recommended:

1st dose on the chosen date.

2nd dose 1-2 months after the 1st dose

3rd dose 6-12 months after the 2nd dose

• After completing the primary vaccination cycle, a single dose of 0.5 ml is recommended as a booster dose every 5 to 10 years
• In vaccination associated with wounds, it will be taken into account that the need for active immunization with or without passive immunization (tetanus immunoglobulin) will depend on the type of wound and the patient's vaccination history. Tetanus immunoglobulin should be administered at a different injection site than the one used for the vaccine.

MINOR OR CLEAN WOUNDS

When it is known that the person has completed their primary tetanus vaccination cycle and has received their last booster dose within the last 10 years, revaccination and the use of tetanus immunoglobulin are not recommended.

When the person has completed their primary vaccination cycle but more than 10 years have passed since the last booster dose, a dose of the vaccine will be administered, and after 10 years, the corresponding booster dose will be indicated. In these cases, administration of tetanus immunoglobulin is not necessary.

In individuals who have not completed the primary vaccination cycle, or in individuals whose vaccination status is unknown or uncertain, vaccination is recommended (according to the primary vaccination schedule). In all these cases, administration of tetanus immunoglobulin is not necessary.

OTHER TYPES OF WOUNDS, SUCH AS MAJOR AND DIRTY

Vaccination will always be performed, unless the person has completed their primary tetanus vaccination cycle and has received their last booster dose within the last 5 years. In individuals who have not completed their primary tetanus vaccination cycle or whose vaccination status is unknown or uncertain, in addition to the vaccine, tetanus immunoglobulin will be administered.

Method of administration

The contents of 0.5 ml should be injected intramuscularly. The recommended injection site is the deltoid area - upper arm (except in small children).

Individuals with bleeding disorders should be vaccinated subcutaneously.

It should never be administered intravenously.

The vaccine should not be administered intradermally.

This medicine will always be administered by a healthcare professional.

4. Possible side effects

Like all medicines, this vaccine can cause side effects, although not everyone gets them.

Based on spontaneous reporting, the following adverse reactions have been reported during the commercial use of Diftavax. These reactions have been reported with a very rare frequency (up to one in 10,000 patients).

Brachial neuritis (decreased movement or sensitivity in the arm and shoulder due to a nerve problem) and Guillain-Barré syndrome (weakness and numbness of the limbs) have also been reported after administration of other vaccines containing tetanus toxoid.

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. You can also report them 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. Conservation of Diftavax

Keep in the refrigerator (between 2°C and 8°C). Do not freeze.

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

Do not use this medicine after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

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 in doubt, ask your pharmacist how to dispose of the packaging and any unused medicine.

In this way, you will help protect the environment.

6. Package contents and additional information

Composition of Diftavax

The active ingredients are:

• Purified diphtheria toxoid………………………………………………………at least 2 IU
• Purified tetanus toxoid…………………………………………………………at least 20 IU
• Aluminum hydroxide (expressed as Al)…………………………………………0.6 mg

The other ingredients are:

Acetic acid (for pH adjustment), sodium hydroxide (for pH adjustment), and a buffer solution containing sodium chloride, disodium phosphate dihydrate, monopotassium phosphate, hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), and water for injectable preparations.

Appearance of the product and package contents

Package with 1 pre-filled syringe of 0.5 ml

Marketing authorization holder and manufacturer

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

or

Sanofi Winthrop Industrie

Voie de l’Institut – Parc Industriel

d’Incarville

B.P 101

27100 Val de Reuil

France

Local representative

sanofi-aventis, S.A.

C/ Rosselló i Porcel, 21

08016 Barcelona

Spain

Tel: +34 93 485 94 00

Date of the last revision of this leaflet: June 2022

Detailed information on this medicine 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:

Before proceeding with vaccination, the vaccine will be shaken well and visually inspected to confirm that its appearance is normal and does not contain any foreign particles.

Disposal of unused medicine and all materials that have come into contact with it will be carried out in accordance with local regulations.