TYPHIM Vi 0.025mg/0.5mL injection syringe

Страна: Австралия

Език: английски

Източник: Department of Health (Therapeutic Goods Administration)

Активна съставка:

Salmonella typhi Vi polysaccharide, Quantity: 0.025 mg

Предлага се от:

Sanofi-Aventis Australia Pty Ltd

Лекарствена форма:

Injection, solution

Композиция:

Excipient Ingredients: monobasic sodium phosphate; phenol; water for injections; sodium chloride; dibasic sodium phosphate dihydrate

Начин на приложение:

Intramuscular

Броя в опаковка:

1 x 0.5mL (single dose)

Вид предписание :

(S4) Prescription Only Medicine

Терапевтични показания:

For the active immunisation against typhoid fever, in subjects over 5 years of age. INDICATIONS AS AT 9 OCTOBER 2000: TYPHIM Vi is indicated for active immunisation against typhoid fever in subjects 2 years of age and over.

Каталог на резюме:

Visual Identification: Clear colourless solution.; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Статус Оторизация:

Registered

Дата Оторизация:

1993-12-13

Листовка

TYPHIM VI™
_Salmonella typhi Vi polysaccharide vaccine_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Typhim Vi.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines, including vaccines,
have risks and benefits. Your doctor
has weighed the risks of you or your
child having Typhim Vi against the
benefits they expect it will have.
IF YOU HAVE ANY CONCERNS ABOUT THIS
VACCINE, ASK YOUR DOCTOR, NURSE OR
PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT TYPHIM VI IS
USED FOR
Typhim Vi is a vaccine used to help
prevent typhoid fever, which is
caused by a bacterium called
Salmonella typhi.
The organism which causes typhoid
fever can be passed on through
contaminated food or water. If you
are in an area where there is a risk of
getting typhoid fever, in addition to
having Typhim Vi, it is also very
important to be careful with your
personal, food and water hygiene.
Hygiene will also help avoid illness
caused by other bacteria in the water.
Typhim Vi may be given to people
aged 2 years and older.
IF YOU WANT MORE INFORMATION ON
PERSONAL CARE IN AREAS WHERE THERE
IS A RISK OF GETTING TYPHOID FEVER,
TALK TO YOUR DOCTOR, NURSE OR
PHARMACIST.
HOW TYPHIM VI WORKS
Typhim Vi works by causing your
body to produce its own protection
against typhoid fever. It does this by
making substances, called antibodies,
which destroy the Salmonella typhi
organism. If you have been
vaccinated against Salmonella typhi,
your body is able to attack that
organism if you come in contact with
it.
Your body usually takes several
weeks after vaccination to fully
develop this protection against
typhoid fever.
You must have one dose at least 2
weeks before you may be exposed to
typhoid fever.
If you are continually or repeatedly
exposed to the Salmonella typhi
organism, it is recommended that you
have an injection of Typhim Vi every
3 years.
Most people will make enough
antibodies against Salmonella t

Данни за продукта

typhim-ccdsv11-piv3-20jul20
Page 1 of 11
AUSTRALIAN PRODUCT INFORMATION – TYPHIM VI™,
SALMONELLA TYPHI VI POLYSACCHARIDE
1
NAME OF THE MEDICINE
Typhim VI ™
_Salmonella typhi_
VI polysaccharide vaccine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.5 mL dose contains:
Salmonella typhi Vi polysaccharide
…………………………………….25 micrograms
Typhim Vi is a sterile solution, prepared from the purified Vi
capsular polysaccharide of
_Salmonella typhi_
(Ty 2 strain). The purified Vi capsular polysaccharide is diluted in
isotonic
buffer solution which contains phenol as preservative.
For the full list of excipients, see Section 6.1 List of excipients.
The manufacture of this product includes exposure to bovine materials.
No evidence exists that
any case of vCJD (considered to be the human form of bovine spongiform
encephalopathy) has
resulted from the administration of any vaccine product.
3
PHARMACEUTICAL FORM
Solution for injection
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Typhim Vi is indicated for active immunisation against typhoid fever
caused by
_Salmonella _
_typhi_
in individuals 2 years of age and over.
4.2
DOSE AND METHOD OF ADMINISTRATION
A single dose of 0.5 mL for adults is given intramuscularly in the
deltoid, and the dose for
children is given intramuscularly either in the deltoid or the vastus
lateralis. The vaccine
should not be injected into the gluteal area or areas where there may
be a nerve trunk.
The vaccination dose is the same for adults and children.
TyphimVi should be administered at least 14 days prior to potential
exposure to infection
with
_Salmonella typhi_
.
typhim-ccdsv11-piv3-20jul20
Page 2 of 11
An optimal revaccination schedule has not been established.
Revaccination consisting of a
single dose every three years for individuals under conditions of
repeated or continued
exposure to the
_Salmonella typhi _
organism is recommended at this time.
Product is for single use only and must not be used in more than one
individual. Discard any
remaining unused