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TYPHIM VI. TYPHOID POLYSACCHARIDE VACCINE SOLUTION FOR INJECTION

Active substance(s): SALMONELLA TYPHI VI CAPSULAR POLYSACCHARIDE / SALMONELLA TYPHI VI CAPSULAR POLYSACCHARIDE / SALMONELLA TYPHI VI CAPSULAR POLYSACCHARIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
TYPHIM Vi®. Typhoid Polysaccharide Vaccine
Solution for Injection

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
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.

3

PHARMACEUTICAL FORM
Solution for injection
Typhim Vi is a clear colourless solution.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Typhim 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.

4.2

Posology and method of administration
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.
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.

4.3

Contraindications
Known systemic hypersensitivity reaction to any component of Typhim Vi or a lifethreatening 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.

4.4

Special warnings and precautions for use
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.
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, paraesthesia 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.

4.5

Interaction with other medicinal products and other forms of interaction
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).

4.6

Fertility, Pregnancy and lactation
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

4.7

Effects on ability to drive and use machines
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)

4.8

Undesirable effects
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
Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal
product is important. It allows continued monitoring of the benefit/risk balance
of the medicinal product. Healthcare professionals are asked to report any
suspected adverse reactions via the Yellow Card Scheme at:
https://yellowcard.mhra.gov.uk/.

4.9

Overdose
Not applicable.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic group: Typhoid vaccines, ATC code: J07AP
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 (versus 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.

5.2

Pharmacokinetic properties
Not applicable.

5.3

Preclinical safety data
Not applicable.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Phenol (preservative)
Isotonic buffer solution*

*Composition of the isotonic buffer solution:
Sodium Chloride
Disodium phosphate dihydrate
Sodium dihydrogen phosphate dihydrate
Water for Injections

6.2

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

6.3

Shelf life
3 years

6.4

Special precautions for storage
Store in a refrigerator (2ºC -8ºC). Do not freeze.
Keep the syringe in the outer carton in order to protect from light.

6.5

Nature and contents of container
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.

6.6

Special precautions for disposal
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 prefilled syringe and rotated through 90 degrees.
Any unused product or waste material should be disposed of in accordance with local
requirements.

7

MARKETING AUTHORISATION HOLDER
Sanofi Pasteur Europe
2 Avenue Pont Pasteur
69007 Lyon
FRANCE

8

MARKETING AUTHORISATION NUMBER(S)
PL 46602/0008

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
05/05/1992

10

DATE OF REVISION OF THE TEXT
30/11/2016

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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