Typherix

Maa: Uusi-Seelanti

Kieli: englanti

Lähde: Medsafe (Medicines Safety Authority)

Aktiivinen ainesosa:

Vi capsular polysaccharide of S. typhi ty2 25ug;  

Saatavilla:

GlaxoSmithKline NZ Limited

INN (Kansainvälinen yleisnimi):

Vi capsular polysaccharide of S. typhi ty2 25 µg

Annos:

25 mcg/0.5mL

Lääkemuoto:

Solution for injection

Koostumus:

Active: Vi capsular polysaccharide of S. typhi ty2 25ug   Excipient: Dibasic sodium phosphate dihydrate Monobasic sodium phosphate dihydrate Phenol Sodium chloride Water for injection

Kpl paketissa:

Syringe, glass, Monodose, 0.5 mL

luokka:

Prescription

Prescription tyyppi:

Prescription

Valmistaja:

GlaxoSmithKline Biologicals SA

Käyttöaiheet:

Active immunisation against typhoid fever for adults and children older than two years of age.

Tuoteyhteenveto:

Package - Contents - Shelf Life: Syringe, glass, Monodose - 0.5 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Valtuutus päivämäärä:

1997-12-01

Pakkausseloste

 
1 
TYPHERIX
®

(Typhoid Vaccine) 
CONSUMER MEDICINE INFORMATION LEAFLET 

WHAT IS IN THIS LEAFLET 

This leaflet answers some of the common questions about
TYPHERIX vaccine.  It does not contain all the available 
information.  It does not
take the place of talking to your doctor or pharmacist. 

All medicines
and vaccines have risks and benefits.  Your doctor has weighed the possible risks of you or your child having 
TYPHERIX against the expected benefits. 

IF YOU HAVE ANY CONCERNS ABOUT RECEIVING TYPHERIX
TALK TO YOUR DOCTOR, NURSE OR PHARMACIST. 

KEEP THIS LEAFLET WITH
THIS VACCINE.  You may need to read it again. 

WHAT TYPHERIX IS USED FOR 

TYPHERIX is a vaccine used to prevent
typhoid fever in adults and children aged two and above.  The vaccine works by 
causing the body to produce its own protection (antibodies) against
this disease.  

Typhoid fever is caused by bacteria called _Salmonella typhi_.  Typhoid fever can cause persistent
high fever which may last for 
10-14 days, tiredness, headache, stomach pains and a rose coloured rash.  In severe cases, it may cause tears and bleeding in 
the intestines.  The death rate can be as high as 12%
if left untreated. 

SOME ANTIBIOTICS CAN BE USED TO TREAT TYPHOID
FEVER.  HOWEVER, VACCINATION
IS THE BEST WAY TO PROTECT AGAINST INFECTION. 

BEFORE RECEIVING TYPHERIX 

WHEN YOU MUST NOT HAVE TYPHERIX 

TELL YOUR DOCTOR IF: 

you have/ your child has had an allergic reaction to TYPHERIX, or any ingredient
contained in this vaccine.  The 
ingredients are listed at the end of this leaflet.  Signs of an allergic reaction may include an itchy skin rash, shortness of 
breath and swelling of the face or tongue. 

you have/ your child has had an allergic reaction to any other 

Valmisteyhteenveto

1
DATA SHEET
_NAME OF MEDICINAL PRODUCT_
_ _
TYPHERIX
TM
Vi polysaccharide typhoid vaccine.
_PRESENTATION_
_ _
Typherix is a clear colourless solution containing the cell surface Vi
polysaccharide extracted from
_Salmonella typhi_ Ty2 strain.
Typherix meets the WHO requirements for manufacture of biological
substances and complies with the
European Pharmacopeia monograph on Vi polysaccharide typhoid vaccines.
Each 0.5 ml dose of vaccine contains 25 µg of the Vi polysaccharide
of _Salmonella typhi_.
_PHARMACEUTICAL FORM_
_ _
Solution for injection.
_CLINICAL PARTICULARS_
_ _
_THERAPEUTIC INDICATIONS _
Active immunisation against typhoid fever for adults and children
older than two years of age.
_POSOLOGY AND METHOD OF ADMINISTRATION_
_ _
_POSOLOGY _
A single dose of 0.5 ml containing 25µg of the Vi polysaccharide of
_Salmonella typhi_ is recommended
for both children and adults.
Subjects who remain at risk of typhoid fever should be revaccinated
using a single dose of vaccine
every 3 years.
The vaccine should be administered at least 2 weeks prior to potential
exposure with _Salmonella typhi_.
_METHOD OF ADMINISTRATION _
Typherix is for INTRAMUSCULAR injection.
Typherix
should under no circumstances be administered intravascularly.
2
Typherix should be administered with caution to subjects with
thrombocytopenia or bleeding disorders
since bleeding may occur following an intramuscular administration to
these subjects: following injection,
firm pressure should be applied to the site (without rubbing) for at
least two minutes.
_CONTRA-INDICATIONS _
Typherix should not be administered to subjects with known
hypersensitivity to any component of the
vaccine or to subjects having shown signs of hypersensitivity after
previous Typherix administration,
or after any other vaccine containing Vi polysaccharide _Salmonella
typhi_ antigens.
As with other vaccines, the administration of Typherix should be
postponed in subjects suffering from
acute severe febrile illness.
_SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE_
_ _
T