25 micrograms/0.5 ml solution for injection in a pre-filled syringe
What Typhim Vi is and what it is used for
Typhim Vi is a vaccine used to protect against typhoid fever .
Typhim Vi is used to vaccinate people traveling to areas where there is a high risk of contracting typhoid fever caused by Salmonella typhi – bacteria.
When vaccinated, the immune system (the body’s natural defense system) produces protection against typhoid fever .
Limitations in the vaccine’s protection
Please note that Typhim Vi only protects against this disease if it has been caused by the same bacteria that has been used to make the vaccine. You or your child can still get an infectious disease if it is caused by other bacteria.
What you need to know before using Typhim Vi
Do not use Typhim Vi
- if you or your child are allergic to the active substance or any other ingredient in this vaccine (listed in section 6)
- if you or your child has a high fever or an acute infection . Vaccination with Typhim We must be postponed until after you or your child has recovered.
Warnings and precautions
Talk to your doctor or pharmacist or nurse before you are vaccinated with Typhim Vi.
Talk to your doctor before vaccination about:
- you or your child is allergic (hypersensitive) to formaldehyde or casein. Formaldehyde and casein are used during the production of Typhim Vi and there may be traces of these substances in the vaccine.
- you or your child have problems with the immune system or you or your child is receiving immunosuppressive treatment. It is recommended to postpone vaccination until such illness or treatment is over. It is recommended to give Typhim Vi to people who have chronic problems with their immune system (including HIV infection ), but protection against infection after vaccination may not be as good in people with good immunity against infection .
- you or your child have thrombocytopenia (reduced number of blood platelets ) or a bleeding disorder as bleeding may occur at the injection site.
Fainting can occur (mainly in young people) after, or even before, a needle stick. Therefore, tell the doctor or nurse if your child has fainted during a previous injection .
Typhim We contain sodium
Typhim Vi contains less than 1 mmol (23 mg) of sodium per dose , i.e. is almost ‘sodium-free’.
Other medicines and Typhim Vi
Tell the doctor or pharmacist if you or your child are taking, have recently taken or might take other medicines or receive other vaccines.
Typhim Vi can be given at the same time as other common vaccines such as vaccines against yellow fever, diphtheria , tetanus, poliomyelitis, rabies produced on vero cells, meningitis A+C, hepatitis A and B, if they are given in different parts of the body (e.g. the other arm or the leg).
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this vaccine.
Typhim Vi should only be used by pregnant women when absolutely necessary, and after the risks to the fetus have been weighed against the benefits to the mother.
As it is not known whether the vaccine is excreted in human milk, caution should be exercised when Typhim Vi is administered to lactating women.
Driving ability and use of machinery
Typhim We contain polysaccharide vaccine against typhoid fever
How to use Typhim Vi
Dosage :
Adults and children from 2 years of age receive a dose of 0.5 ml.
Children under 2 years of age: As with other polysaccharide vaccines, the antibody response may be insufficient in children under 2 years of age.
Vaccination should be done at least two weeks before potential exposure to Salmonella typhi .
Renewed vaccination is recommended after 3 years if there is a risk of exposure to infection.
Method of administration and route of administration
Typhim Vi is given as an injection into a muscle or deep under the skin.
Possible side effects
Like all medicines, this vaccine can cause side effects , although not everybody gets them.
Serious allergic reactions:
Anaphylactic and anaphylactoid reactions, including anaphylactic shock , which may be associated with one or more of the following symptoms:
- hives , skin rash
- swelling of the face or neck
- difficulty breathing, bluish tongue or bluish lips
- low blood pressure , rapid heartbeat and weak pulse , cold skin, dizziness and possible fainting.
When such signs or symptoms occur, it is usually very soon after an injection is given, while the person is still in the clinic or doctor’s office. If you observe any of these symptoms after leaving the clinic or reception where an injection was given, you must contact a doctor IMMEDIATELY.
Other side effects ar
Most side effects occur within 3 days after the vaccination. Most side effects disappear by themselves within 1–3 days after they appear. Side effects have been reported with the following frequency of occurrence ( side effects apply to both adults and children from the age of 2 with some exceptions, see footnotes):
Very common: may affect more than 1 in 10 users
- Pain at the injection site, redness at the injection site 1 , swelling at the injection site 1 , induration at the injection site 1
- Headache 1
- Muscle pain
- General malaise (nausea) 2
- Fatigue 2 , abnormal weakness 2 .
Common: may affect up to 1 in 10 users
- Fever 3
Uncommon: may affect up to 1 in 100 users
- Itching at the injection site 4
Has been reported (occurring in an unknown number of users)
- Serum sickness: joint pain, skin rash, enlarged lymph nodes and general malaise. If these symptoms occur, this usually occurs within 2-4 weeks after vaccination.
- Fainting as a result of injection (vasovagal syncope)
- Cough, wheezing, difficulty breathing ( asthma )
- Nausea, vomiting, diarrhoea, stomach pain
- Skin rash, sometimes with swelling and itching ( pruritus , rash, hives )
- Joint pain.
1) common side effects in adults
2) common side effects in children and adolescents (2–17 years of age)
3) has not been reported in adults
4) has not been reported in children and adolescents (2–17 years of age).
How Typhim Vi should be stored
Store out of sight and reach of children.
Store in a refrigerator (2 °C–8 °C). Do not freeze. Store the syringe in the outer carton. Light sensitive.
Use before the expiry date which is stated on the carton and on the syringe label after EXP.
The expiration date is the last day of the specified month.
The medicine must not be thrown into the drain or among household waste. Ask the pharmacist how to deal with medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is purified Vi capsular polysaccharide of Salmonella typhi (Ty2 strain). Each dose (0.5 ml) contains 25 micrograms Vi polysaccharide of Salmonella typhi (Ty2 strain).
- Other ingredients are phenol, sodium chloride, disodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate dihydrate and water for injection .
Appearance and package sizes of the medicine
Typhim Vi is a clear, colorless solution.
Package sizes:
1 and 10 pre-filled syringes with attached or separate injection needle.
1 and 10 pre-filled syringes without injection needle.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sanofi Pasteur Europe
14 Espace Henry Vallée
69007 Lyon
France
Manufacturer :
Sanofi Pasteur
1541 Avenue Marcel Mérieux
69280 Marcy L’Étoile
France
Sanofi Pasteur
Incarville Industrial Park
27100 Val de Reuil
France
Local representative:
Sanofi AB
Box 30052
104 25 Stockholm
Phone: +46 8-634 50 00