TYPHIM VI INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Typhim Vi, injectable solution

Typhoid polysaccharide vaccine

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you or your child only. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What Typhim Vi is and what it is used for
2. What you need to know before you or your child uses Typhim Vi
3. How to use Typhim Vi
4. Possible side effects
5. Storage of Typhim Vi
6. Contents of the pack and further information

1. What Typhim Vi is and what it is used for

Typhim Vi is a Vi capsular polysaccharide vaccine used for the prevention of typhoid fever caused by Salmonella enterica serovar Typhi, S. Typhi in adults and children from 2 years of age.

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

• Travelers to endemic areas. It should be noted that vaccination is not a substitute for hygiene and sanitation prevention of food and drinks.

• People in contact with documented typhoid fever carriers.

• Laboratory microbiology personnel working with Salmonella Typhi.

2. What you need to know before you or your child uses Typhim Vi

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

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

Warnings and precautions

Consult your 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 vaccine production. 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, vaccination should be postponed 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 under 2 years of age.

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

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

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

The vaccine provides protection against the risk of infection related to Salmonella Typhi, but does not confer protection against Salmonella Paratyphi A or Bor 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 Salmonella Typhiinfection.

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

Before injecting 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, fainting may occur, mainly in adolescents. Therefore, inform your doctor or nurse if you or your child have fainted with any previous injection.

Using Typhim Vi with other vaccines or medicines

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

Typhim Vi can be administered 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 the case of administration with other medicines or vaccines, different injection sites should be used.

There have been no studies on the interference of Typhim Vi with laboratory tests or diagnostic tests.

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.

Typhim Vi is not recommended during pregnancy due to insufficient data on the use of this vaccine during pregnancy. Typhim Vi may be administered to pregnant women if it is really necessary and after a risk-benefit assessment.

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

Driving and using machines

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

Typhim Vi contains sodium

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

3. How to use Typhim Vi

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

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

Adults and children over 2 years of age

The recommended dose is a single injection of 0.5 ml.

Revaccination

If the individual continues to be at risk of exposure to the disease, revaccination should be performed every 3 years.

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

4. Possible side effects

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

The following side effects may occur with this vaccine:

Severe allergic reactions

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

• Red rash 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, cool skin, dizziness, and potentially fainting.

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

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

Other side effects

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

Side effects were reported with the following frequencies:

Very common: may affect more than 1 in 10 people

• Pain at the injection site, redness at the injection site (erythema)(1), swelling/edema at the injection site(1), hardening (induration) at the injection site(1),
• Headache(1),
• Muscle pain (myalgia),
• General malaise (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 at the injection site (pruritus)(4)

Frequency not known: cannot be estimated from the available data

• Serum sickness: joint pain, skin rash, swollen lymph nodes, and general malaise.

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

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

(1) "Common" in adults,

(2) "common" in children and adolescents (from 2 to 17 years of age),

(3) not reported in adults,

(4) not reported in children and adolescents (from 2 to 17 years of age).

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Surveillance System for Human Use: https://www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Typhim Vi

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

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

Do not use this vaccine after the expiry date stated on the carton after EXP. The expiry date is the last day of the month stated.

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

6. Contents of the pack and further information

Composition of Typhim Vi

• The active substance is Vi capsular polysaccharide

purified from Salmonella Typhi................................................25 micrograms

• The other components are phenol and isotonic buffer solution (sodium chloride, disodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate dihydrate, water for injections).

Appearance and pack contents

Single-dose prefilled syringe of 0.5 ml (Type I glass) with plunger stopper (chlorobutyl rubber) and tip cap (isoprene-bromobutyl synthetic rubber), without needle.

Single-dose prefilled syringe of 0.5 ml (Type I glass) with plunger stopper (chlorobutyl rubber) and tip cap (isoprene-bromobutyl synthetic rubber), with 1 separate needle (per syringe).

Single-dose prefilled syringe of 0.5 ml (Type I glass) with plunger stopper (chlorobutyl rubber) and tip cap (isoprene-bromobutyl synthetic rubber), with 2 separate needles (per syringe).

Packs of 1 dose.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Sanofi Winthrop Industrie

82 avenue Raspail

94250 Gentilly

France

Manufacturer

Sanofi Winthrop Industrie - 1541 avenue Marcel Mérieux - 69280 Marcy l'Etoile - France

Sanofi Winthrop Industrie - Voie de l’Institut - Parc Industriel d'Incarville B.P 101 - 27100

Val de Reuil – France

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

Local representative

sanofi-aventis, S.A.

C/ Rosselló i Porcel, 21

08016 Barcelona

Spain

Tel: +34 93 485 94 00

Date of last revision of this leaflet:April 2019

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:

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

The vaccine should be brought to room temperature a few minutes before injection.

Shake well immediately before use.

In prefilled syringes without a needle, the needle should be firmly attached to the end of the prefilled syringe by a 90-degree turn.

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

As a precautionary measure, an injection of epinephrine (1:1000) should be available for immediate administration in the event of a severe allergic or anaphylactic reaction.