Product Informationfor the User

DIFTAVAX Injectable Suspension in Pre-filled Syringe

Diphtheria and Tetanus Toxoid Vaccine (adsorbed) for Adults and Adolescents.

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

• Keep this product information, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• Ifyou experience any adverse effects, consult your doctor or pharmacist even if they are not listed in this product information. See section4.

1.What is Diftavax and how is it used

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

3.How to use Diftavax

4.Possible adverse effects

5Storage of Diftavax

6. Contents of the container and additional information

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 7 years of age and older and in adults, in the following situations:

- For primary vaccination in individuals not 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 a preventive measure against tetanus and as a booster dose against diphtheria.

Do not use Diftavax:

• If you or your child is allergic to the active principle(s) or to any of the other components of this vaccine (listed in section 6).
• If you or your child has had 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 the diphtheria component should not be given. Therefore, Diftavax is not indicated in these patients.
• In cases of wounds when there is an absolute contraindication for the tetanus vaccine. In these cases, tetanus immunoglobulin (2 x 250 U.I. at intervals of 4 weeks) should be administered. Therefore, Diftavax is not indicated in these patients.
• If you or your child has a disease with high fever, acute infection, or in individuals who, due to a history of exposure, may be in the incubation period of an infection. In these cases, the administration of Diftavax should be postponed. However, moderate fever or mild infection does not contraindicate vaccination.
• Do not administer to individuals with a history of thrombocytopenia (decrease in the number of platelets in the blood), allergic reactions (hypersensitivity), or neurological complications after a previous vaccination against tetanus and/or diphtheria.
• If, at the time of vaccination, you or your child presents any allergic reaction or complication of the Central and/or peripheral nervous system. Your doctor will evaluate the risk of immunization against 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 or 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 or your child is receiving immunosuppressive treatment (anuls the body's immune response) simultaneously. In such cases, it is recommended that vaccination be delayed until the end of treatment or that protective levels of the subject be checked. However, vaccination of subjects with chronic immunodepression, such as HIV infection, is recommended if the disease allows the induction of antibody response, even if it is limited.

• If you or your child has had problems with previous vaccinations, such asweakness and numbness of the limbs (Guillain-Barré syndrome)or decreased movement or sensitivity in the arm and shoulder due to a nervous 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 vaccination schedule has been completed and if not. Vaccination is normally justified when the primary vaccination schedule is incomplete (for example, if fewer than three doses have been received).

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

Use of Diftavaxwith other vaccines or medications

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

No interactions with other medications have been reported, nor have studies of interactions with diagnostic tests and/or laboratory tests been conducted.

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

Pregnancy, breastfeeding, and fertility

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

For numerous years, clinical experiences have not indicated any kind of harmful influence on embryonic and/or fetal development.

Pregnant women who are not immunized or insufficiently immunized may be vaccinated during the second and third trimesters of pregnancy, especially in cases of travel to countries with endemic diphtheria or in suspected exposure.

Breastfeeding is not a contraindication.

Driving and operating machinery

No studies have been conducted on the effects on the ability to drive and operate machinery.

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".

Follow exactly the administration instructions for this vaccine as indicated by your doctor. In case of 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 every five to ten years.

- In wound-associated vaccination, 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 in a different injection site from 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, it is not recommended to revaccinate or use tetanus immunoglobulin.

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

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

Other types of wounds, such as LARGER AND DIRTY WOUNDS

Always vaccinate, except in individuals who have completed their primary tetanus vaccination cycle and have 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, both the vaccine and tetanus immunoglobulin will be administered.

Administration form

The 0.5 ml content must be injected intramuscularly. The recommended injection site is the deltoid area - upper arm (except in young children).

Individuals with bleeding disorders should be vaccinated by deep subcutaneous injection.

This vaccine should never be administered intravenously.

The vaccine should not be administered intradermally.

This medication will always be administered by a healthcare professional.

Like all medicines, this vaccine may cause side effects, although not everyone will experience 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 (decrease in movement or sensitivity in the arm and shoulder due to a nervous problem) and Guillain-Barré Syndrome (weakness and numbness of the extremities) have also been reported after administration of other vaccines containing tetanus toxoid.

Reporting of Adverse Reactions

If you experienceany type of adverse reaction, consult your doctor or pharmacist, even if it is apossibleadverse reaction that does not appear in this prospectus.You can also report them directly to theSpanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaRAM.es.

By reporting adverse reactions, you can contribute to providing more information on the safety of this medicine.

Store in refrigerator (between2°Cand8°C). Do not freeze.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash.Deposit the containers and medications you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need.

By doing so, you will help protect the environment.

Composition of Diftavax

The active principles are:

- Purified diphtheria toxoid………………………………………………………no less than 2 U.I.

- Purified tetanus toxoid……………………………………………………….no less than 20 U.I.

- Aluminium hydroxide (expressed as Al)…………………………………………0.6 mg

The other components are:

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

Appearance of the product and contents of the packaging

Packaging with 1 pre-filled syringe of 0.5 ml

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Sanofi Winthrop Industrie

82 avenue Raspail

94250 Gentilly

France

Responsible for manufacturing:

Sanofi Winthrop Industrie

1541 avenue Marcel Mérieux

69280 Marcy l’Etoile

France

or

Sanofi Winthrop Industrie

Voie de l’Institut – Industrial Park

d’Incarville

B.P 101

27100 Val de Reuil

France

Phone: +34 93 485 94 00

Last review date of this leaflet: June 2022

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/
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This information is intended solely for healthcare professionals:

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

The elimination of unused medication and all materials that have been in contact with it, will be carried out in accordance with local regulations