Typhim Vi vaccine

Valsts: Jaunzēlande

Valoda: angļu

Klimata pārmaiņas: Medsafe (Medicines Safety Authority)

Aktīvā sastāvdaļa:

Salmonella typhi Vi polysaccharide 25ug

Pieejams no:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

SNN (starptautisko nepatentēto nosaukumu):

Salmonella typhi Vi polysaccharide 0.025 mg

Deva:

25µg/0.5mL

Zāļu forma:

Solution for injection

Kompozīcija:

Active: Salmonella typhi Vi polysaccharide 25ug Excipient: Dibasic sodium phosphate Hydrochloric acid Monobasic sodium phosphate dihydrate Phenol Sodium chloride Sodium hydroxide Water for injection

Vienības iepakojumā:

Syringe, single dose prefilled, 0.5mL, 1 dose unit

Klase:

Prescription

Receptes veids:

Prescription

Ražojis:

Sanofi Pasteur SA

Ārstēšanas norādes:

TYPHIM Vi™ is indicated for active immunisation against typhoid fever caused by Salmonella typhi in individuals 2 years of age and over.

Produktu pārskats:

Package - Contents - Shelf Life: Syringe, single dose prefilled, 0.5mL - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Autorizācija datums:

1994-02-14

Lietošanas instrukcija

TYPHIM VI™
1
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 agai

Produkta apraksts

typhim-ccdsv11.1-dsv7-20jun22
Page 1 of 11
NEW ZEALAND DATA SHEET
1
TYPHIM VI 25 MICROGRAMS SOLUTION FOR INJECTION
Typhim Vi™ 25 micrograms solution for injection
_Salmonella typhi Vi _
polysaccharide vaccine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 0.5 mL 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.
The vaccine is a clear, colourless solution.
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.
typhim-ccdsv11.1-dsv7-20jun22
Page 2 of 11
Typhim Vi should be administered at least 14 days prior to potential
exposure to infection
with
_Salmonella typhi_
.
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
_S. typhi_
organism is recommended at this time.
Product is for single use only and must not be used in