Prevention of typhoid fever in adults and in children over 2 years of age, and especially: travellers to endemic areas, migrants, health care professionals and military personnel.

Posology
RESTRICTED TO ADULTS AND CHILDREN OVER TWO YEARS OF AGE.
A single injection ensures protection. Revaccination should be performed every 3 years if the risk of exposure continues.
The vaccination schedule is the same for children and for adults.
Method of administration
Intramuscular or subcutaneous route

Do not inject by the intravascular route: make sure the needle does not penetrate a blood vessel.
This vaccine protects against the risks of infection by Salmonella typhi but not against Salmonella paratyphi A or B.
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 fever, acute disease or progressive chronic disease.
This vaccine provides no protection 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 immunizations. 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.
• Syncope (fainting) can occur following, or even before, any vaccination especially in adolescents as a psychogenic response to the needle injection. This can be accompanied by several neurological signs such as transient visual disturbance, paranesthesia and tonic-clonic limb movements during recovery. It is important that procedures are in place to avoid injury from faints.
• 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.

This vaccine may be given together with other common vaccines (hepatitis A, yellow fever, diphtheria, tetanus, poliomyelitis, rabies, meningitis A + C and hepatitis B) during the same vaccination session. Separate injection sites must be used in case of concomitant vaccine administration.

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
• Vasovagal syncope in response to injection, 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
To report any side effects:
The National Pharmacovigilance and Drug Safety Centre (NPC)
• Fax: +966-11-205-7662
• Call NPC at +966-11-203-20-38222, Exts: 2317-2356-2353-2354-2334-2340.
• Toll free phone: 8002490000
• E-mail: npc.dru@sfda.gov.sa
• Website: WWW.sfda.gov.sa/npc

Not applicable

ANTI-TYPHOID VACCINE
(ATC code: J07AP)
Vaccine prepared from purified Vi capsular polysaccharides of Salmonella typhi. Immunity appears about 15 days to 3 weeks after the injection. Protection lasts at least 3 years.
During studies carried out in highly endemic areas, a seroprotection rate (for typhoid fever) of 77% in Nepal and 55% in South Africa has been observed after one vaccine injection. In industrialized countries, seroconversion is observed in more than 90% of subjects after a single injection.

Not applicable

Not applicable

Phenol and a buffer solution containing sodium chloride, disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate and water for injections.

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

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

0.5 ml of solution in prefilled syringe (type I glass) with a plunger stopper (chlorobromobutyl or chlorobutyl or bromobutyl). Box of 1 and 20.
0.5 ml of solution in prefilled syringe (type I glass) with a plunger stopper (chlorobromobutyl or chlorobutyl or bromobutyl), a tip-cap (chlorobromobutyl), without needle. Box of 1.
0.5 ml of solution in prefilled syringe (type I glass) with a plunger stopper (chlorobromobutyl or chlorobutyl or bromobutyl), a tip-cap (chlorobromobutyl), with 1 or 2 separate needles. Box of 1.
Not all pack sizes may be marketed.

The vaccine should be kept at room temperature for a few minutes before use.
For syringes without attached needles, the separate needle must be fitted firmly to the syringe, rotating it by a one quarter turn.
Any unused product or waste material should be disposed of in accordance with local requirements.