Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Typhoid vaccine may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
FOR
Typhim Vi is a vaccine. Vaccines are used to protect against infectious diseases. This vaccine helps to protect adults and children who are aged 2 years and over against typhoid fever. It may not be effective in children under 2. When the vaccine is given to you or your child, the body's natural defences will produce protection against typhoid fever. Typhoid fever is an infectious disease. Symptoms are a headache with a fever that gets worse over three to four days. Additional symptoms include cough, sore throat and altered behaviour. This vaccine will only protect against typhoid fever. It will not work against any other disease, such as paratyphoid fever or food poisoning. It cannot cause typhoid fever. As with any vaccine, not everyone who receives this vaccine will definitely be protected against typhoid fever.
2.
BEFORE TYPHIM Vi IS GIVEN
To make sure that this vaccine is suitable for you or your child, it is important to tell your doctor or nurse if any of the points below apply to you or your child. If there is anything you do not understand, ask your doctor or nurse to explain. Do not use this vaccine if you or your child is:
Take special care with this vaccine Tell your doctor or nurse if you or your child has:
The vaccine will be given by a doctor or nurse who has been trained in the use of vaccines and who is equipped to deal with any uncommon severe allergic reaction to the injection. Dosage Typhim Vi is given as a single injection of half a millilitre of the vaccine to adults and children aged 2 years and over. The vaccine should be given at least 2 weeks before protection against typhoid fever is required. Protection lasts for 3 years so you or your child may need another dose after this time. How the vaccine is administered The doctor or nurse will shake the syringe immediately before use and check that the liquid is not discoloured and has no unexpected particles in it. 2
The vaccine is given as an injection into a muscle or deep under the skin, in the outer part of the upper arm or leg. They will avoid giving the injection into a blood vessel. Your doctor or nurse will make a note of the details of the injection. If you have any further questions on the use of this vaccine, ask your doctor, nurse or pharmacist.
4.
Like all medicines, this vaccine can cause side effects, although not everybody gets them. Serious allergic reactions: Anaphylactic, anaphylactoid reactions, including shock which can include one or several of the following symptoms: o urticaria, skin rash, o swelling of face and/or neck, o breathing difficulties, bluish discoloration of the tongue or lips, o low blood pressure, rapid heart rate and weak pulse, skin coldness, dizziness and potentially fainting. When these signs or symptoms appear, it is usually very soon after the injection, while the person affected is still at the clinic or at the doctor's surgery. If one of these symptoms occurs after you have left the place where the injection was administered, you must consult a doctor IMMEDIATELY. Other side effects Most side effects appeared within 3 days after vaccination. Most reactions resolved spontaneously within 1 to 3 days after onset. They were reported with the following frequencies: Very common: may affect more than 1 in 10 people Common: may affect up to 1 in 10 people Uncommon: may affect up to 1 in 100 people Not known: frequency cannot be estimated from the available data Adverse Reactions Experienced
Serum sickness disease: joint pain, skin rash, enlarged lymph nodes and generally feeling unwell.* Fainting in response to injection (vasovagal syncope) Headache Cough, wheezing, respiratory discomfort (asthma) Nausea, vomiting, diarrhoea, stomach pain (abdominal pain) Rash, sometimes swollen and itchy (pruritus, skin rash, urticaria) Joint pain (arthralgia) Muscle pain (myalgia)
Children and Adolescents 2-17 years
Adults ≥ 18 years
Frequency
Frequency Not known
Not known Very common
Common Not known Not known Not known Not known Very common
3
Adverse Reactions Experienced
Children and Adolescents 2-17 years
Adults ≥ 18 years
Frequency
Frequency
Injection site pain Very common Itching at the injection site Uncommon (injection site pruritus) Injection site redness (erythema), Very common Common injection site swelling/oedema, injection site hardening (induratio n) Generally feeling unwell (malaise) Common Very common Fever Common Fatigue, unusual weakness Common Very common (asthenia) *When these symptoms appear, it is generally 2-4 weeks after vaccination
Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5.
TYPHIM Vi
6.
FURTHER INFORMATION
What Typhim Vi contains The active substance is purified Vi capsular polysaccharide of Salmonella typhi (Ty 2 strain). Each 0.5 millilitre dose of Typhim Vi contains 25 micrograms of the active substance. The other ingredients are phenol, sodium chloride, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate and Water for injections. What Typhim Vi looks like and contents of the pack Typhim Vi is provided as a solution for injection. The solution is a clear colourless liquid. The vaccine comes in a prefilled glass syringe (without an attached needle) which contains a single 0.5 millilitre injection. The syringes are available as a single unit pack or as a pack of ten. Not all pack sizes may be marketed Marketing Authorisation Holder and Manufacturer The manufacturer responsible for batch release is one of the following manufacturing sites: Sanofi Winthrop Industrie – 1541 avenue Marcel Mérieux – 69280 Marcy l'Etoile – France 4
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
The Marketing Authorisation Holder is: Sanofi Winthrop Industrie 82 avenue Raspail 94250 Gentilly France Distributed by: Sanofi 410 Thames Valley Park Drive Reading Berkshire RG6 1PT UK Tel: 0800 035 2525
This leaflet was last revised in 01/2025.
5
TYPHIM Vi Solution for Injection comes as injection. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in TYPHIM Vi Solution for Injection is typhoid vaccine.
This leaflet reproduces the patient information leaflet approved for TYPHIM Vi Solution for Injection, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
TYPHIM Vi is indicated for active immunisation against typhoid fever caused by Salmonella enterica serovar typhi, S.typhi in adults and children 2 years of age or older.
Adults and Children over 2 years of age: A single dose of 0.5 millilitre.
The preferred route of administration for this vaccine is intramuscular although it may be given subcutaneously.
Do not administer by intravascular injection. Ensure that the vaccine does not penetrate a blood vessel.
Vaccination should occur at least 2 weeks prior to potential exposure to infection with Salmonella typhi (see section 5.1)
Children under 2 years of age: As with other polysaccharide vaccines, the antibody response may be inadequate in children under 2 years of age.
Elderly: As for adults and children over 2 years of age.
Revaccination: A single dose at 3 yearly intervals in subjects who remain at risk from typhoid fever.
Hypersensitivity to the active substance, to any of the excipients listed in section 6.1 or to any residual substances that may be present as traces such as formaldehyde or casein.
Vaccination must be postponed in case of febrile or acute disease.
This vaccine provides protection against the risk of infection related to Salmonella typhi but gives no protection against Salmonella paratyphi A or B or against non-typhoidal Salmonellae.
Prior to administration of TYPHIM Vi, the recipient or their guardian must be asked about the recipient's personal history, current health status and any adverse event after previous immunisations. In subjects who have a history of serious or severe reaction within 48 hours of a previous injection with a vaccine containing similar components, the need for the vaccination must be carefully considered, following a risk-benefit assessment.
As with all vaccines, facilities for the management of anaphylaxis should always be available during vaccination. As a precautionary measure, epinephrine injection (1:1000) must be immediately available in case of unexpected anaphylactic or serious allergic reactions.
Syncope (fainting) can occur following, or even before, any vaccination especially in adolescents as a psychogenic response to the needle injection. This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. It is important that procedures are in place to avoid injury from faints.
As with all injectable vaccines, TYPHIM Vi must be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following intramuscular administration to these subjects.
As with any vaccine, vaccination with TYPHIM Vi may not result in protection in all vaccine recipients.
The immunogenicity of TYPHIM Vi may be reduced by immunosuppressive treatment or immunodeficiency. In such cases it is recommended to postpone vaccination until the end of the disease or treatment. Nevertheless, vaccination of subjects with chronic immunodeficiency such as HIV infection is recommended even if the antibody response might be limited.
TYPHIM Vi contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'.
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Separate injection sites must be used in case of concomitant vaccine administration.
TYPHIM Vi may be administered during the same vaccination session with other common vaccines (yellow fever, diphtheria, tetanus, poliomyelitis, rabies prepared on Vero cells, meningitis A+C, hepatitis A and hepatitis B).
Pregnancy
Animal reproduction studies have not been conducted with TYPHIM Vi.
Data on the use of this vaccine in pregnant women are limited. Therefore the administration of the vaccine during pregnancy is not recommended. TYPHIM Vi should be given to pregnant women only if clearly needed and following an assessment of the risks and benefits
Lactation
It is not known whether this vaccine is excreted in human milk. Caution must be exercised when TYPHIM Vi is administered to a nursing mother.
No studies on the effects on the ability to drive and use machines have been performed. Tiredness has been observed as a very rare reaction following administration of this vaccine (see section 4.8).
a. Summary of the safety profile
During clinical development, more than 15,000 people received TYPHIM Vi (first or second injection).
The most common adverse reactions, in all age groups, were injection site pain. In adults from 18 years of age, myalgia and fatigue were the most frequently reported systemic reactions. In children and adolescents (from 2 to 17 years of age), myalgia and headache were the most frequently reported systemic reactions.
Most adverse reactions appeared within 3 days after vaccination. Most reactions resolved spontaneously within 1 to 3 days after onset.
b. Tabulated list of adverse reactions
The adverse reactions come from clinical studies (pooled analysis) and worldwide post-marketing experience. The pooled analysis has been performed on 6 recent studies sharing the same safety standard integrating data from 1532 subjects (97 children and adolescents from 2 to 17 years of age and 1435 adults).
In each System Organ Class, the adverse reactions are ranked under headings of frequency, the most common reactions coming first, using the following convention:
Very common (≥1/10)Common (≥1/100 to <1/10)Uncommon (≥1/1000 to <1/100)Rare (≥1/10 000 to <1/1000)Very rare (<1/10 000) including isolated casesNot known (cannot be estimated from the available data).
The table below summarizes the frequencies of the adverse reactions that were recorded after any dose of TYPHIM Vi in children and adolescents from 2 to 17 years of age and adults.
Adverse Reactions Experienced
Children and Adolescents
2-17 years
Adults
≥ 18 years
Frequency
Frequency
Immune system disorders
Anaphylactic, anaphylactoid reactions, including shock
Not known*
Serum sickness disease
Not known*
Nervous system disorders
Vasovagal syncope in response to injection
Not known*
Headache
Very common
Common
Respiratory, thoracic and mediastinal disorders
Asthma
Not known*
Gastrointestinal disorders
Nausea
Not known*
Vomiting
Not known*
Diarrhoea
Not known*
Abdominal pain
Not known*
Skin and subcutaneous tissue disorders
Allergic type reactions such as pruritus, rash, urticaria
Not known*
Musculoskeletal and connective tissue disorders
Arthralgia
Not known*
Myalgia
Very common
Very common
General disorders and administration site condition
Injection site pain
Very common
Injection site erythema
Very common
Common
Injection site pruritus
-
Uncommon
Injection site swelling/oedema/ induration
Very common
Common
Malaise
Common
Very common
Fever
Common
-
Fatigue/asthenia
Common
Very common
* reported during postmarketing surveillance
The most frequently reported adverse reactions in children and adolescents (from 2 to17 years of age) were injection site reactions: pain (52.6%), swelling/oedema/ induration (16.5%) and erythema (14.4%). The most frequently reported systemic reactions were myalgia (14.6%) and headache (13.5%).
In adults from 18 years of age, the most frequently reported adverse reaction were injection site pain (75.6%), myalgia (47.1%) and fatigue/asthenia (25.0%).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Not applicable.
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Not the same combination. This medicine contains Typhoid vaccine. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Not the same combination. This medicine contains Typhoid vaccine. The products below do not contain exactly the same set of active substances — they are not direct substitutes.
Some of these do not contain exactly the same active substances — check each one. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
Ask anything about TYPHIM Vi Solution for Injection. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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