Typhim Vi

The solution is clear and colourless.
The active substance is: Polysaccharides of Salmonella typhi (Ty2 strain) 25 micrograms for one 0.5-ml dose.
Excipients/Inactive Ingredients: The other components are: phenol and a buffer solution containing sodium chloride, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate and water for injections.

This medicinal product is a vaccine.
Vaccines are used to protect against infectious diseases.
Typhoid fever is caused by a bacterium called Salmonella typhi. The main symptoms include high fever (40°C), headache, insomnia, dizziness, epistaxis (nose bleeding), anorexia (loss of appetite), nausea, diarrhoea and consciousness disorders.
When the patient or the child receive an injection of TYPHIM Vi, the body's natural defences elaborate a protection against the infection caused by this bacterium.

This vaccine helps protect adults and children over 2 years of age against typhoid fever.
TYPHIM Vi is intended for travellers to endemic areas (areas where the disease is present and affects a large part of the population), migrants, healthcare professionals and military personnel.

Dosage: RESTRICTED TO ADULTS AND CHILDREN OVER 2 YEARS OF AGE.
A single dose (0.5 ml) is enough.
If exposure to risk continues, revaccination should be performed every 3 years.
The vaccination schedule is the same for children and for adults.
Method of administration: This vaccine will be administered in a muscle or under the skin by a healthcare professional.
This vaccine should never be administered into a blood vessel.
If the patient has any further questions on the use of this medicine, advise the patient to ask the doctor or pharmacist.

Do not use TYPHIM Vi: if the patient or the child is allergic (hypersensitive) to the active substance, to any of the other components of TYPHIM Vi (listed in Description), to formaldehyde or to casein (used during the production of the vaccine and which may be present in it in small amounts); if the patient or the child is ill with a high temperature. Vaccination must be postponed until after the patient has recovered.

Advise the patient to talk to the doctor, pharmacist or nurse before using TYPHIM Vi, solution for injection in prefilled syringe.
This vaccine protects against the typhoid fever bacterium (Salmonella typhi), but not against the related bacteria (Salmonella paratyphi A or B) or non-typhoidal salmonella.
This vaccine is not indicated in children less than 2 years of age because it is not efficient enough.
If the patient or the child has a weak immune system, due to: Corticosteroid drugs, cytotoxic medicines, radiotherapy or other treatments likely to weaken the immune system. The doctor may wait until the end of treatment; HIV (Human Immunodeficiency Virus) infection or any other diseases which weaken the immune system. It is recommended to administer the vaccine although it may not protect the patient as well as it would in a person with a normal immune system.
If the patient or the child suffers from haemophilia or if the patient is easily prone to bruising or bleeding.
Fainting can occur (mostly in adolescents) following, or even before, any needle injection. Therefore, advise the patient to inform the doctor or nurse if the patient fainted with a previous injection.
TYPHIM Vi contains sodium: TYPHIM Vi contains less than 1 mmol (23 mg) sodium per dose, that is to say essentially 'sodium-free'.
Driving and using machines: The effects on the ability to drive and use machines have not been studied.
Use in Children: This vaccine is not indicated in children less than 2 years of age because it is not efficient enough.

Because of the seriousness of the disease, and in case of high risk of exposure to typhoid fever, pregnancy is not an obstacle to vaccination.
This vaccine will be used during pregnancy only if advised by the doctor.
This vaccine can be used during breast-feeding.
Advise the patient to ask the doctor or pharmacist for advice before taking any medicines.

Like all medicines, TYPHIM Vi can cause side effects, although not everybody gets them.
Severe allergic reactions: Anaphylactic, anaphylactoid reactions, including shock which can include one or several of the following symptoms: urticaria, skin rash, swelling of face and/or neck, breathing difficulties, bluish discoloration of the tongue or lips, 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 medical centre or at the doctor's surgery. If one of these symptoms occurs after leaving the place where the injection was administered, the patient must consult a doctor IMMEDIATELY.
Other side effects: Most side effects occurred within 3 days after vaccination. Most effects 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: Injection site pain, injection site redness (erythema)⁽¹⁾, injection site swelling/oedema⁽¹⁾, injection site hardening (induration)⁽¹⁾, Headache (cephalalgia)⁽¹⁾, Muscle pain (myalgia), Generally feeling unwell, Fatigue, unusual weakness (asthenia)⁽²⁾.
Common: may affect up to one in 10 people: Fever⁽³⁾.
Uncommon: may affect up to one in 100 people: Injection site itching (injection site pruritus)⁽⁴⁾.
Not known: cannot be estimated from available data: Serum sickness disease: joint pain, skin rash, swelling of lymph nodes and generally feeling unwell. When these symptoms appear, it is generally within 2-4 weeks after vaccination; Fainting in response to an injection (vasovagal syncope); Cough, wheezing, respiratory discomfort (asthma); Nausea, vomiting, diarrhoea, stomach pain (abdominal pain); Rash, sometimes swollen and itchy (pruritus, skin rash, urticaria); Joint (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 the patient or the child gets any side effects, advise the patient/parent to talk to the doctor, pharmacist or nurse. This includes any possible side effects not listed in this monograph.
By reporting side effects, the patient can help provide more information on the safety of this medicine.

TYPHIM Vi can be associated with other vaccines (hepatitis A, yellow fever, diphtheria, tetanus, poliomyelitis, rabies, meningitis A + C and hepatitis B) during the same vaccination session. However injections must be performed in separate injection sites, i.e. in another part of the body such as the other arm or the other leg, and the vaccines must not be mixed in the same syringe. Inform the doctor or pharmacist if the patient or the child takes or has recently taken any other medicines, even those not prescribed.

This vaccine must not be used if the doctor or nurse notices foreign particles in the syringe or in the vial.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
The following information is intended for healthcare professionals only: This vaccine must not be mixed with other vaccines in the same syringe.
For syringes without attached needles, the needle must be fitted firmly to the syringe, rotating it by a one quarter turn.

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

Vaccines, Antisera & Immunologicals

J07AP03 - typhoid, purified polysaccharide antigen ; Belongs to the class of typhoid bacterial vaccines.

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