Typhim Vi solution for injection
Spain
Table of Contents
Package leaflet: Information for the user
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 are 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, consult your doctor, pharmacist, or nurse.
- This medicine has been prescribed for you/your child only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.
Contents of the leaflet
- What Typhim Vi is and what it is used for
- What you need to know before you or your child use Typhim Vi
- How to use Typhim Vi
- Possible side effects
- How to store Typhim Vi
- Contents of the pack and other information
1. What Typhim Vi is and what it is used for
Typhim Vi is a Vi capsular polysaccharide vaccine used to prevent 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:
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Travelers to endemic areas. It should be noted that vaccination does not replace hygienic-sanitary precautions regarding food and drink.
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Individuals in contact with documented typhoid carriers.
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Microbiology laboratory personnel who work with Salmonella typhi.
2. What you need to know before you or your child are given Typhim Vi
Do not use Typhim Vi if the person to be vaccinated:
- is allergic to the active substance or to any of the other components of this vaccine (listed in section 6).
- has experienced a life-threatening reaction after previous administration of the vaccine or of 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 the production of the vaccine. Therefore, caution should be exercised when administering the vaccine to individuals with hypersensitivity to these substances.
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If you are being treated with immunosuppressive agents (medications that reduce the body's defenses). The immunogenicity (effectiveness) of Typhim Vi may be reduced by immunosuppressive therapy or immunodeficiency. In these cases, vaccination is recommended to be postponed until the end of the illness or treatment. However, vaccination of individuals with chronic immunodeficiency, such as HIV infection, is recommended even if the antibody response may be limited.
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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.
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If you have a 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 following intramuscular injection in these individuals.
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If you have experienced a severe reaction within 48 hours following a previous injection with a vaccine containing similar components. In such cases, vaccination should be carefully considered.
The vaccine provides protection against the risk of infection caused by Salmonella typhi, but does not confer protection against Salmonella paratyphi A or B or against non-typhoidal 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 typhi infection.
Do not administer by intravascular injection. Ensure that the needle does not enter a blood vessel.
Prior to the injection of any biological product, the person responsible for administration must take all known precautions to prevent allergic reactions or any other adverse reactions.
Fainting may occur after any needle injection, or even before, particularly in adolescents. Therefore, inform your doctor or nurse if you or your child has previously experienced fainting after an injection.
Use of Typhim Vi with other vaccines or medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Typhim Vi may be administered simultaneously with other common vaccines during the same vaccination session (yellow fever, diphtheria, tetanus, poliomyelitis, Vero cell rabies, meningitis A+C, hepatitis A and hepatitis B).
When administered with other medicines or vaccines, different injection sites must be used.
Interference of Typhim Vi with laboratory tests or diagnostic tests has not been studied.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 clearly needed and after careful assessment of risks and benefits.
Caution should be exercised when administering Typhim Vi to breastfeeding women, as it is unknown whether this vaccine is excreted in human milk.
Driving and use of 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., essentially “sodium-free”.
3. How to use Typhim Vi
Follow exactly the administration instructions for this vaccine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The immune response occurs within 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 0.5 ml injection.
Revaccination
If the individual remains at risk of exposure to the disease, revaccination should be carried out every 3 years.
The preferred route of administration for this vaccine is intramuscular, although it may also be administered subcutaneously.
4. Possible adverse effects
Like all medicines, this vaccine may cause adverse effects, although not everyone experiences them.
The following adverse 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 skin rashes (urticaria), skin rash,
- Swelling of the face and/or neck,
- Difficulty breathing, bluish discoloration of the tongue or lips,
- Low blood pressure, rapid heartbeat and weak pulse, cold skin, dizziness and potentially fainting.
When these symptoms or signs occur, they usually develop very quickly after the injection, while the affected person is still in the doctor's office.
If any of these symptoms occur after leaving the place where the injection was administered, you must consult a doctor IMMEDIATELY.
Other adverse effects
Most adverse effects occurred within 3 days following vaccination and resolved spontaneously within 1 to 3 days after onset.
Adverse 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 (pruritus) at the injection site(4)
Frequency not known: cannot be estimated from available data
- Serum sickness: joint pain, skin rash, enlarged lymph nodes and general malaise.
When these symptoms occur, they generally appear 2–4 weeks after vaccination,
- Fainting as a response to injection (vasovagal syncope),
- Cough, wheezing, breathing discomfort (asthma),
- Nausea, vomiting, diarrhea, stomach ache (abdominal pain),
- Rash, sometimes accompanied by swelling and itching (pruritus, skin rash, red, itchy skin patches),
- Joint pain (arthralgia)
(1) “Common” in adults,
(2) “Common” in children and adolescents (aged 2 to 17 years),
(3) not reported in adults,
(4) not reported in children and adolescents (aged 2 to 17 years).
Reporting of adverse effects
If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es.
By reporting adverse 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 packaging after EXP. The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Typhim Vi
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The active substance is purified Vi capsular polysaccharide from Salmonella typhi ................................................25 micrograms
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The other components are phenol and isotonic buffer solution (sodium chloride, disodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate dihydrate, water for injections).
Presentation of the product and contents of the pack
Single-dose 0.5 ml pre-filled syringe (type I glass) with plunger stopper (chlorobutyl rubber) and tip cap (synthetic isoprene-bromobutyl rubber), without needle.
Single-dose 0.5 ml pre-filled syringe (type I glass) with plunger stopper (chlorobutyl rubber) and tip cap (synthetic isoprene-bromobutyl rubber), with 1 separate needle (per syringe).
Single-dose 0.5 ml pre-filled syringe (type I glass) with plunger stopper (chlorobutyl rubber) and tip cap (synthetic isoprene-bromobutyl rubber), with 2 separate needles (per syringe).
Pack sizes of 1 dose.
Only some 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 the most recent review of this leaflet: April 2019
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/
This information is intended for healthcare professionals only:
The vaccine should be inspected visually before administration for discoloration or any particulate matter.
The vaccine should be allowed to reach room temperature for a few minutes before injection.
Shake well immediately before use.
For pre-filled syringes without needle, the needle must be firmly attached to the syringe tip by turning 90 degrees.
As with all injectable vaccines, appropriate medical treatment and supervision must be readily available in case of rare anaphylactic reactions following vaccine administration.
As a precautionary measure, epinephrine (1:1000) injection should be readily available for immediate administration in case of unexpected severe allergic or anaphylactic reactions.