Typherix, solution for injection in a pre-filled syringe Typhoid Polysaccharide vaccine

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

VI POLYSACCHARIDE, OF SALMONELLA, TYPHI

Available from:

Smithkline Beecham Limited 980, Great West Road, Brentford Middlesex TW8 9GS, United Kingdom

ATC code:

J07AP03

INN (International Name):

VI POLYSACCHARIDE OF SALMONELLA TYPHI 1 µg

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

VI POLYSACCHARIDE OF SALMONELLA TYPHI 1 µg

Prescription type:

POM

Therapeutic area:

VACCINES

Authorization status:

Withdrawn

Authorization date:

2006-08-14

Patient Information leaflet

Reason for update: QRD update
Agency approval Date:
Text Date: 5 December 2014
Text Issue and Draft No: Issue 3 draft 1
SPC Issue and Draft No: Issue 6 draft 1
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
TYPHERIX, SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE
Typhoid Polysaccharide vaccine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START RECEIVING THIS
VACCINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This vaccine has been prescribed for you only. Do not pass it on to
others.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1 What Typherix is and what it is used for
2 What you need to know before you receive Typherix
3 How Typherix is given
4 Possible side effects
5 How to store Typherix
6 Contents of the pack and other information
1
WHAT TYPHERIX IS AND WHAT IT IS USED FOR
Typherix is a vaccine which helps prevent typhoid fever, an infectious
illness caused by a
type of bacteria called _Salmonella typhi_.
This vaccine can be given to both adults and children aged 2 years and
over. In this leaflet,
any reference to ‘you’ can also mean ‘your child’.
HOW TYPHERIX WORKS
Typherix contains a small part of the bacterium which causes typhoid
fever. This is not
infectious and cannot make you ill.
•
When you are given the vaccine it will trigger the body’s immune
system to prepare itself
to protect against typhoid fever in the future.
•
Typherix will only prevent disease caused by the bacterium _Salmonella
typhi_ and not
against salmonella bacteria that can cause food poisoning or
gastroenteritis.
Typhoid fever is an infectious illness caused by a bacterium,
_Salmonella typhi_. It is caused
and spread by eating or drinking contaminated food or water. Since the
bacterium is present
in the bowel movement (motion), the infection can occur in any
co

Summary of Product characteristics

Page 1 of 6
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 6
1.
NAME OF THE MEDICINAL PRODUCT
Typherix, solution for injection in a pre-filled syringe
Typhoid Polysaccharide vaccine.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.5 ml dose of vaccine contains:
Vi polysaccharide of _Salmonella typhi (Ty2 strain)_
25 micrograms
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection in a pre-filled syringe.
Clear isotonic colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Typherix is indicated for active immunisation against typhoid fever in
both adults and children
two years of age and older.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology _
A single dose of 0.5 ml is recommended for both adults and children
two years of age and older.
The vaccine should be administered at least two weeks prior to risk of
exposure to typhoid
fever.
Subjects who remain at risk of typhoid fever should be revaccinated
using a single dose of
vaccine with an interval of not more than 3 years.
_Paediatric population _
_ _
The safety and efficacy of Typherix in children under 2 years of age
has not been established._ _
_ _
Method of administration
Typherix is for INTRAMUSCULAR injection.
Typherix should under no circumstances be administered
intravascularly.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients
listed in section
6.1
Hypersensitivity after previous administration.
Page 3 of 6
As with other vaccines, the administration of Typherix should be
postponed in subjects
suffering from acute febrile illness. The presence of a minor
infection, however, is not a
contraindication for vaccination.
4.4
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
As with all injectable vaccines, appropriate medical treatment and
supervision should always be
readily available in case of a rare anaphylactic reaction following
administration of the vaccine.
The vaccine protects against typhoid fever caused by _Salmonella
typhi_. Protection