VIVOTIF ORAL oral typhoid vaccine capsule blister pack

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

Salmonella typhi

Prieinama:

Biocelect Pty Ltd

INN (Tarptautinis Pavadinimas):

Salmonella typhi

Autorizacija statusas:

Registered

Pakuotės lapelis

Vivotif Oral_Capsule_CMI_annotated
Page 1 of 3
VIVOTIF
®
ORAL
_Oral Typhoid Vaccine _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Vivotif
®
Oral.
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 Vivotif
®
Oral against the
benefits expected.
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 VIVOTIF
®
ORAL IS
USED FOR
Vivotif
®
Oral is a vaccine used to
prevent typhoid fever. Typhoid fever
is a severe form of infection caused
by a type of Salmonella bacteria.
Vaccination with Vivotif
®
Oral is
recommended for adults and children
over 6 years of age who live in or
travel through areas where typhoid
fever occurs.
_HOW IT WORKS _
Vivotif
®
Oral contains live bacteria
called
_Salmonella typhi_
strain Ty21a,
which do not cause typhoid fever.
Vivotif
®
Oral works by causing your
body to produce its own protection
against the bacteria (germs) which
cause typhoid fever. The body makes
substances, called antibodies, which
destroy the
_Salmonella typhi _
bacteria.
If you have been vaccinated against
_Salmonella typhi_
, your body is able
to attack the bacteria if you come in
contact with it.
Protection with Vivotif
®
Oral
requires a full course of 3 doses.
After a full course most people will
produce enough antibodies to prevent
typhoid fever. However, as with all
vaccines, 100% protection cannot be
guaranteed.
The vaccine cannot give you or your
child typhoid fever.
The chance of a severe reaction from
Vivotif
®
Oral is very small, but the
risks from not being vaccinated
against typhoid fever may be very
serious.
BEFORE YOU TAKE
VIVOTIF
®
ORAL
_WHEN YOU OR YOUR CHILD _
_MUST NOT TAKE VIVOTIF_
_® _
_ORAL _
DO NOT TAKE VIVOTIF
®
ORAL IF YOU
HAVE AN ALLERGY TO:
•
Vivotif
®
Oral

Prekės savybės

AUSTRALIAN PRODUCT INFORMATION – VIVOTIF ORAL (SALMONELLA TYPHI)
CAPSULE
1
NAME OF THE MEDICINE
Oral Typhoid Vaccine _Salmonella typhi_ strain Ty21a (live,
attenuated)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vivotif
®
Oral is an oral, live, attenuated typhoid vaccine for active
immunisation against
typhoid and contains _Salmonella typhi _strain Ty21a. Each enteric
coated capsule contains
not fewer than 2 x 10
9
viable organisms.
Excipients with known effect: Vivotif® Oral contains sucrose and
lactose. It may also
contain traces of sulfites and milk products.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Vivotif
®
Oral capsules are enteric-coated capsules, salmon-pink and white in
colour.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Vivotif
®
Oral is indicated for active immunisation against typhoid in adults
and children
above 6 years of age. Effectiveness in children below 6 years of age
is not known at
present.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The complete immunisation schedule, irrespective of age, for adults
and children above 6
years of age, is the ingestion of one capsule on each of days 1, 3 and
5.
The Vivotif
®
Oral Typhoid Vaccine capsule should be swallowed whole and must not be
chewed. The capsule should be taken approximately one hour before a
meal, with a cold or
lukewarm drink (temperature not to exceed body temperature i.e.
37ºC).
RE-IMMUNISATION
An optimal booster schedule for Vivotif
®
Oral Typhoid Vaccine has not been determined.
Re-immunisation, consisting of 3 capsules, one taken on each of Days
1, 3 and 5 is
recommended every 3 years.
See also Section 4.5 Interaction with other medicines and other forms
of interaction.
4.3
C
ONTRAINDICATIONS
Primary and acquired immunodeficiency, including that from treatment
with
immunosuppressive and antimitotic drugs, acute febrile illness: acute
intestinal infection,
allergic reaction to a previous dose, and hypersensitivity to the
vaccine or to any of the
inactive components.
4.4
S
PEC