TYPHIM Vi

Abbreviated Prescribing Information

See local Prescribing Information for full details prior to prescribing

1. TRADE NAME OF THE MEDICINAL PRODUCT AND PRESENTATION

Typhim Vi is a clear colorless solution for injection of polysaccharide typhoid vaccine is available in a single-dose, 0.5 ml syringe. It contains Purified Vi capsular polysaccharide of Salmonella typhi, phenol, isotonic buffer solution.

2. THERAPEUTIC INDICATIONS

This vaccine is based on a constituent (capsular antigen) of the bacteria which cause typhoid fever for person two years of age or older.

Typhoid fever prevention becomes effective approximately 2 to 3 weeks after injection and protection lasts around 3 years.

3. POSOLOGY AND METHOD OF ADMINISTRATION

Posology

RESTRICTED TO ADULTS AND CHILDREN OVER 2 YEARS OF AGE.

A single injection (0,5 ml) by the intramuscular or subcutaneous route with protection lasts around 3 years.

If exposure to risk continues, revaccination will be performed every 3 years

Vaccination schedule is the same for children and for adults.

A successful extraction operation for one or more vaccine doses from a multidose vial depends essentially on the quality of the handling.

Method of administration

If the vaccine is an adsorbed vaccine, the vial must first of all be shaken gently, to avoid foaming, but sufficiently to obtain a homogenous mixture of the contents. Then, using a sterile syringe fitted with a sterile needle, a single dose is withdrawn from the multidose vial, after disinfecting the outer surface of the vial stopper using a disinfectant.

For the subsequent dose(s), the same operation should be repeated.

Between the different withdrawal operations and, in any case, within not more than five minutes after the last dose withdrawn, the vial should be replaced in a refrigerator to keep the product at its normal storage temperature, i.e., between +2°C and +8°C (never place it in a freezer).

The manufacturer’s legal liability covers the product up until its use.

The quality of the handling performed by the user to withdraw vaccine doses can affect the quality of a product packaged in a multidose vial. For this reason, the manufacturer cannot assume responsibility for the product over 24 hours after the first extraction operation unless the vial has been stored, in compliance with the manufacturer’s recommendations, at a normal refrigerator temperature.

Thereafter, follow the W.H.O. recommendations which, may be found in UNICEF or PAHO brochures

4. CONTRA-INDICATIONS

The vaccination should not be administered, if the patient is known to be hypersensitive to one of the vaccine components or formaldehyde or to casein (which may be present as traces in each dose, owing to its use during the manufacturing process).

- Pregnancy: inform local doctor. See pregnancy section below.

- Children under 2 years old:

• Typhoid fever is extremely rare in infants.

• This vaccine is not indicated in children under 2 years of age because of the risk of insufficient antibody response.

Vaccination should be postponed in case of acute febrile disease.

5. SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE

Postpone vaccination in the event of fever or severe infection.

As with all injectable vaccines, appropriate medical treatment and supervision must always be readily available, in the event of a rare anaphylactic reaction following administration of the vaccine.

Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection, especially in adolescents. This may be accompanied by several neurological signs such as transient sight disorders, paraesthesia and tonic-clonic limb movements during the recovery phase. It is important that procedures be in place to avoid any injury from faints.

Do not inject by the intravascular route.

This vaccine protects against the risks of infection by Salmonella typhi but not against Salmonella paratyphi A or B or non-typhoidal salmonella.

The immunogenicity of TYPHIM Vi may be reduced by immunosuppressive treatment or immunodeficiency. It is then recommended to wait until the end of the treatment or disease before vaccinating. Nevertheless, vaccination of subjects with chronic immunodeficiency such as HIV infection is recommended even if the immune response may be limited.

Injection must be performed via the subcutaneous route in subjects with thrombocytopenia or bleeding disorders.

TYPHIM Vi contains less than 1 mmol (23 mg) sodium per dose, that is to say essentially ‘sodium-free’.

6. INTERACTION

This vaccine can be associated with other common vaccines (hepatitis A, yellow fever, diphtheria, tetanus, poliomyelitis, rabies, meningitis A + C and hepatitis B) during the same vaccination session, using separate injection sites.

7. EFFECT ON ABILITY TO DRIVE AND USE MACHINES

The effects on the ability to drive and use machines have not been studied.

8. UNDESIRABLE EFFECTS

a. Summary of the safety profile

More than 15,000 subjects received TYPHIM Vi (either in a single injection or as a second injection) in clinical studies.The most common adverse reaction, in all age groups, was 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 cephalalgia were the most frequently reported systemic reactions.

Most adverse reactions occurred within three days of vaccination. Most reactions resolved spontaneously within 1 to 3 days after onset.

b. Tabulated list of adverse reactions

The adverse reactions listed below come from clinical studies (pooled analysis) and worldwide post-marketing experience.

Very common (≥1/10)

Common (≥1/100, <1/10)

Uncommon (≥1/1000, <1/100)

Rare (≥1/10 000, <1/1000)

Very rare (<1/10 000) including isolated cases.

Not known: cannot be estimated from available data.

The most frequently reported adverse reactions in children and adolescents (from 2 to 17 years of age) were injection site reactions: pain (52.6%), swelling / œdema / induration (16.5%) and erythema (14.4%). In adults from 18 years of age, the most frequently reported adverse reactions were injection site pain (75.6%), myalgia (47.1%) and fatigue / asthenia (25.0%).

9. SHELF LIFE

3 years.

10. STORAGE

Do not exceed the expiry date stated on the external packaging.

11. SPECIAL PRECAUTIONS FOR STORAGE

Store between +2°C and +8°C (in a refrigerator). Do not freeze

12. PHARMACODYNAMIC PROPERTIES

ATC Code: J07AP03.

Date of revision : 30 March 2023 (based on BPOM approval on 24 March 2023)

This information is intended for Health Care Professional only. See local product information for full details information

TYPHIM VI