TYPHIM Vi Solution for Injection

Typhoid Polysaccharide Vaccine

Each dose of 0.5 ml contains:

Purified Vi capsular polysaccharide of Salmonella typhi (Ty2 strain) - 25 micrograms

For a full list of excipients, see section 6.1.

Solution for injection

TYPHIM Vi is a clear, colourless solution.

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.

Known systemic hypersensitivity reaction to any component of TYPHIM Vi or a life-threatening reaction after previous administration of the vaccine or a vaccine containing the same substances

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.

The vaccine may contain traces of formaldehyde which is used during the manufacturing process. Caution should be exercised when the vaccine is administered to subjects with hypersensitivity to formaldehyde.

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.

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).

Adverse reaction information is derived from clinical trials and worldwide post marketing experience.

Within each system organ class the adverse reactions are ranked under headings of frequency using the following convention:

Very common: > 10%

Common: > 1% and < 10%

Uncommon: > 0.1% and < 1%

Rare: > 0.01% and <0.1%

Very rare: <0.01%

Data from clinical studies

In controlled clinical studies involving more than 10,000 subjects, TYPHIM Vi was administered either in a single injection or as a second injection. The most frequently reported adverse events after administration of TYPHIM Vi were mild injection site reactions, with onset usually within the 48 hours following vaccination and disappearing within 2 days

General disorders and administration site conditions

• Very common: injection site pain, injection site induration, injection site erythema

• Common: fever

Data from post marketing experience

Based on spontaneous reporting, the following additional adverse events have been reported during the commercial use of TYPHIM Vi. Incidence rates cannot be calculated.

Immune system disorders

• Anaphylactic/anaphylactoid reactions, including shock; serum sickness

Nervous system disorders

• Headache

Respiratory, thoracic and mediastinal disoders

• Asthma

Gastrointestinal disorders

• Nausea, vomiting, diarrhoea, abdominal pain

Skin and subcutaneous tissue disorders

• Allergic type reactions such as pruritus, rash, urticaria

Musculoskeletal and connective tissue disorders

• Arthralgia, myalgia

General disorders and administrative site conditions

• Fatigue, malaise

Not applicable.

Pharmacotherapeutic group: Typhoid vaccines, ATC code: J07AP03

This vaccine contains purified Vi capsular polysaccharide of Salmonella typhi (Ty 2 strain). Immunity appears within 2-3 weeks after injection and lasts around 3 years.

In the two clinical efficacy trials performed in highly endemic areas, the level of protection conferred (against typhoid fever) by a single dose of the vaccine has been observed as 77% in Nepal and 55% in South Africa. In non endemic countries, seroconversion is obtained in more than 90% of subjects after a single injection.

Not applicable.

Not applicable.

Phenol (preservative)

Isotonic buffer solution*

*Composition of the isotonic buffer solution:

Sodium Chloride

Disodium phosphate dihydrate

Sodium dihydrogen phosphate dihydrate

Water for Injections

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

3 years

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

Keep the syringe in the outer carton in order to protect from light.

0.5 ml single dose prefilled syringe (type I glass) with plunger (chlorobromobutyl, bromobutyl or chlorobutyl elastomer), attached needle and needle shield (natural rubber or polyisoprene elastomer).

0.5 ml single dose prefilled syringe (type I glass) with plunger (chlorobromobutyl, bromobutyl or chlorobutyl elastomer) and tip cap (chlorobromobutyl elastomer), without needle.

0.5 ml single dose prefilled syringe (type I glass) with plunger (chlorobromobutyl, bromobutyl or chlorobutyl elastomer) and tip cap (chlorobromobutyl elastomer), with 1 or 2 separate needles (for each syringe).

Packs of 1 or 10.

Not all pack sizes and presentations may be marketed.

The vaccine should be visually inspected before administration for discolouration or any particulate matter.

Shake well immediately before use.

For needle free syringes, the needle should be pushed firmly on to the end of the pre-filled syringe and rotated through 90 degrees.

Any unused product or waste material should be disposed of in accordance with local requirements.

Sanofi Pasteur MSD Ltd

Mallards Reach

Bridge Avenue

Maidenhead

Berkshire

SL6 1QP

PL 06745/0039

5^th May 1992

7^th April 2011