Typhim Vi

Typhim Vi

Manufacturer:

Sanofi Pasteur

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Purified Vi capsular polysaccharide of Salmonella typhi.
Description
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 buffer solution containing sodium chloride, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate and water for injections.
Action
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 receives an injection of TYPHIM Vi, the body's natural defences elaborate a protection against the infection caused by this bacterium.
Indications/Uses
This medicinal product is a vaccine.
Vaccines are used to protect against infectious diseases.
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, health care professionals and military personnel.
Dosage/Direction for Use
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 will 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.
For any further questions on the use of this medicine, ask the doctor or pharmacist.
Contraindications
Do not use TYPHIM Vi: if the patient is allergic (hypersensitive) to the active substance, to any of the other components of TYPHIM Vi (listed in Description), to formaldehyde (used during the production of the vaccine and which may be present in it in small amounts).
If the patient is ill with a high temperature. Vaccination must be postponed until after the patient has recovered.
Special Precautions
Take special care with TYPHIM Vi: 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.
If the patient 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 suffers from haemophilia or is easily prone to bruising or bleeding.
Fainting can occur (mostly in adolescents) following, or even before, any needle injection. Therefore tell the doctor or nurse if the patient fainted with a previous injection.
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.
Use In Pregnancy & Lactation
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.
Ask the doctor or pharmacist for advice before taking any medicines.
Side Effects
Like all medicines, TYPHIM Vi can cause side effects, although not everybody gets them.
Very common reactions (reported by more than 1 in 10 persons): Injection site pain, injection site hardening (induration), injection site redness (erythema).
Common reactions (reported by less than 1 in 10 persons but more than 1 in 100 persons): Fever.
Very rare reactions (reported by less than 1 in 10 000 persons): Serious allergic reactions: 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 or 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 clinic or at the doctor's surgery. If one of these symptoms occurs after the patient has left the place where the injection was administered, the patient must consult a doctor IMMEDIATELY.
Serum sickness disease: joint pain, skin rash, enlarged lymph nodes and generally feeling unwell. When these symptoms appear, it is generally 2-4 weeks after vaccination.
Fainting in response to injection.
Headache (cephalalgia).
Cough, wheezing, respiratory discomfort (asthma).
Nausea, vomiting, diarrhoea, stomach pain (abdominal pain).
Rash, sometimes swollen and itchy (pruritus, skin rash, urticaria).
Joint and muscle pain.
Fatigue, generally feeling unwell.
Reporting of side effects: If the patient gets any side effects, talk to the doctor, pharmacist or nurse. This includes any possible side effects not listed.
By reporting side effects, the patient can help provide more information on the safety of this medicine.
Drug Interactions
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 patient has recently taken any other medicines, even those not prescribed.
Caution For Usage
The vaccine must not be used if the doctor or nurse notices foreign particles in the syringe or vial.
For syringes without attached needles, the needle must be fitted firmly to the syringe, rotating it by a one quarter turn.
Medicines should not be disposed of via wastewater or household waste.
Ask the pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Storage
Store in a refrigerator (2°C-8°C).
Do not freeze.
ATC Classification
J07AP03 - typhoid, purified polysaccharide antigen ; Belongs to the class of typhoid bacterial vaccines.
Presentation/Packing
Inj (single-dose disposable syringe) 0.025 mg/0.5 mL (clear and colorless solution) x 0.5 mL x 1's.
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