Prospect: information for the user

Typhim Vi, injectable solution

Polysaccharide typhoid vaccine

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

• 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/your child and must not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.

Typhim Vi is a capsular polysaccharide Vi vaccine, used for the prevention of typhoid fever caused bySalmonella enterica serovar typhi, S.typhi in adults and children aged 2 years and older.

It is not recommended for routine vaccination against typhoid fever in Spain. Vaccination is indicated in the following cases:

-Travelers to endemic areas.It should be noted that vaccination is not a substitute for hygienic and sanitary prevention of food and beverages.

-Individuals in contact with documented carriers of typhoid fever.

-Microbiology laboratory personnel working withSalmonella typhi.

Do not use Typhim Vi if the person to be vaccinated:

• is allergic to the active ingredient or to any of the other components of this vaccine (listed in section 6).
• has had a life-threatening reaction after previous administration of the vaccine or of a vaccine containing the same substances.
• has a fever or acute illness. Postpone vaccination in these situations.

Warnings and precautions

Consult a doctor or pharmacist before starting to use Typhim Vi:

• If you are allergic to formaldehyde or casein.

Each dose may contain traces of formaldehyde and casein, used during the production of the vaccine. Therefore, caution should be exercised when administering to individuals with hypersensitivity to these substances.

• If you are being treated with immunosuppressants (medicines that reduce the body's defenses). The immunogenicity (efficacy) of Typhim Vi may be reduced by immunosuppressive treatment or immunodeficiency. In these cases, it is recommended to postpone vaccination until the end of the disease or treatment. However, vaccination of individuals with chronic immunodeficiency such as HIV infection is recommended even if the antibody response is limited.

• If you are less than two years old.

As with other polysaccharide vaccines, the antibody response may be inadequate in children under 2 years old.

• If you have any blood disorder. As with all injectable vaccines, the vaccine should be administered with caution to individuals with thrombocytopenia or blood disorders, as bleeding may occur after an intramuscular injection in these individuals.

• If you have had a severe reaction within 48 hours following a previous injection with a vaccine containing similar components. In these cases, vaccination should be considered carefully.

The vaccine provides protection against the risk of infection related to Salmonella typhi, but does not provide protection against Salmonella paratyphi A or B or against non-typhoid Salmonella.

As with any vaccine, vaccination with Typhim Vi may not protect 100% of susceptible individuals.

Vaccination should occur at least 2 weeks before potential exposure to infection with Salmonella typhi.

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

Before administering any biological product, the person responsible for administration should take all known precautions to prevent allergic reactions or any other reaction.

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

Use of Typhim Vi with other vaccines or medications

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

Typhim Vi may be administered together with other common vaccines during the same vaccination session (yellow fever, diphtheria, tetanus, poliomyelitis, rabies prepared in Vero cells, meningitis A+C, hepatitis A, and hepatitis B).

In case of administration with other medications or vaccines, different injection sites should be used.

No interference with laboratory tests or diagnostic tests has been studied.

Pregnancy, breastfeeding, and fertility

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

Typhim Vi is not recommended during pregnancy due to a lack of sufficient data on the use of this vaccine during pregnancy. Typhim Vi may be administered to pregnant women if it is really necessary and after an evaluation of the risks and benefits.

Caution should be exercised when administering Typhim Vi to women who are breastfeeding, as it is unknown whether this vaccine is excreted in breast milk.

Driving and operating machinery

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

Typhim Vi contains sodium

Typhim Vi contains less than 1 mmol of sodium (23 mg) per dose, i.e., it is essentially "sodium-free".

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

The immune response appears during the 1-3 weeks following vaccination and the protection lasts for around 3 years.

Adults and children over 2 years of age

The recommended dose is a single injection of 0.5ml.

Boosters

If the individual continues to be at risk of exposure to the disease, a booster should be administered every 3 years.

The preferred route of administration for this vaccine is intramuscular, although it may also be administered subcutaneously.

Like all medicines, this vaccine may cause side effects, although not everyone will experience them.

The following side effects may occur with this vaccine:

Severe allergic reactions

Anaphylactic, anaphylactoid reactions, including shock, which may include one or more of the following symptoms:

• Red itchy patches on the skin (urticaria), skin rash,
• Swelling of the face and/or neck,
• Difficulty breathing, blue discoloration of the tongue or lips,
• Low blood pressure, rapid heart rate, and weak pulse, cold skin, dizziness, and potentially fainting.

When these symptoms or signs appear, they usually develop very quickly after the injection, while the affected person is still in the doctor's consultation.

If any of these symptoms appear after leaving the place where the injection was administered, you must consult a doctor IMMEDIATELY.

Other side effects

Most side effects appeared within 3 days of vaccination and resolved spontaneously within 1 to 3 days after onset.

The side effects were reported with the following frequencies:

Very common: may affect more than 1 in 10 people

• Dullness or pain at the injection site, redness at the injection site (erythema)(1), swelling/edema at the injection site(1), hardness (induration) at the injection site(1),
• Headache(1),
• Muscle pain (myalgia),
• General feeling of being unwell (malaise)(2),
• Fatigue(2), unusual weakness (asthenia)(2)

Common: may affect up to 1 in 10 people

• Fever(3)

Uncommon: may affect up to 1 in 100 people

• Itching (pruritus) at the injection site(4)

Frequency not known: cannot be estimated from available data

• Serum sickness: joint pain, skin rash, swollen lymph nodes, and general feeling of being unwell.

When these symptoms appear, they usually occur 2-4 weeks after vaccination,

• Fainting as a response to the injection (vasovagal syncope),
• Cough, wheezing, respiratory discomfort (asthma),
• Nausea, vomiting, diarrhea, abdominal pain,
• Rash, sometimes accompanied by inflammation and itching (pruritus, skin rash, red patches on the skin)
• Joint pain (arthralgia)

(1)“Common” in adults,

(2)“common” in children and adolescents (2 to 17 years old),

(3)Not reported in adults,

(4)Not reported in children and adolescents (2 to 17 years old).

Reporting of side effects

If you experienceany type of side effect, consult your doctor or pharmacist, even if it is apossibleside effect that does not appear in this prospectus.You can also report them directly through theSpanish System for 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.

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

Do not use this vaccine 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. Dispose of packaging and unused medicines at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

Composition of Typhim Vi

• The active principle isPolysaccharide capsular Vi

Purified fromSalmonella typhi................................................25 micrograms

• The other components arephenol and isotonic buffer solution (sodium chloride,disodium dihydrogen phosphate dihydrate, sodium dihydrogen phosphate dihydrate, water for injectable preparations).

Appearance of the product and contents of the package

Pre-filled syringe of single dose of 0.5 ml (Type I glass) with piston plug (chlorobutyl elastomer) and plug at the tip (synthetic isoprene-bromobutyl elastomer), without needle.

Pre-filled syringe of single dose of 0.5 ml (Type I glass) with piston plug (chlorobutyl elastomer) and plug at the tip (synthetic isoprene-bromobutyl elastomer), with 1 separate needle (per syringe).

Pre-filled syringe of single dose of 0.5 ml (Type I glass) with piston plug (chlorobutyl elastomer) and plug at the tip (synthetic isoprene-bromobutyl elastomer), with 2 separate needles (per syringe).

Package of 1 dose.

Only some package sizes may be commercially available.

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

Sanofi Winthrop Industrie-Voie de l’Institut- Industrial Park of Incarville B.P 101 - 27100

Val de Reuil – France

Sanofi-Aventis Zrt. Bdg. DC5 - Campona Utca 1.Budapest XXII - 1225 Budapest – Hungary

Tel: +34 93 485 94 00

Date of the last review of this prospectus:April 2019

This information is intended solely for healthcare professionals:

The vaccine should be visually inspected before administration for the observation of discoloration or any small particle.

The vaccine should be placed at room temperature for a few minutes before injection.

Shake well immediately before use.

In pre-filled syringes without needles, the needle should be securely attached to the end of the pre-filled syringe by a 90° turn.

As with all injectable vaccines, medical treatment and adequate supervision should always be available in case of rare anaphylactic events following administration of the vaccine.

As a precaution, an injection of epinephrine (1:1000) should be available for immediate administration in case of severe or unexpected anaphylactic reaction.