JESPECT Japanese encephalitis virus purified inactivated vaccine 0.5mL suspension for injection syringe

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Toimeaine:

Japanese encephalitis virus, Quantity: 6 AgU

Saadav alates:

Seqirus Pty Ltd

INN (Rahvusvaheline Nimetus):

Japanese encephalitis virus

Ravimvorm:

Injection, suspension

Koostis:

Excipient Ingredients: aluminium hydroxide hydrate; sodium chloride; monobasic potassium phosphate; dibasic sodium phosphate; water for injections

Manustamisviis:

Intramuscular

Ühikuid pakis:

single pre-filled syringe 0.5 mL dose

Retsepti tüüp:

(S4) Prescription Only Medicine

Näidustused:

JESPECT is indicated for active immunisation against Japanese Encephalitis (JE) virus for persons 18 years of age and older. JESPECT should be considered for use in persons who plan to reside in or travel to areas where JE is endemic (common) or epidemic (seasonal), especially during the transmission season. JESPECT is indicated for persons who work with JE virus in laboratories and in industry.

Toote kokkuvõte:

Visual Identification: clear liquid with a white precipitate. A white/cloudy liquid/suspension forms upon agitation; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Volitamisolek:

Licence status A

Loa andmise kuupäev:

2009-01-30

Infovoldik

Jespect
®
Consumer Medicine Information
Page 1 of 4
JESPECT
®
_(jess-pect)_
INACTIVATED JAPANESE ENCEPHALITIS VACCINE (ADSORBED)
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
JESPECT
®
.
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
having JESPECT
®
against
the benefits they expect it will
have.
IF YOU HAVE ANY CONCERNS
ABOUT THIS VACCINE, TALK TO
YOUR DOCTOR, NURSE OR
PHARMACIST.
KEEP THIS LEAFLET. YOU MIGHT
NEED TO READ IT AGAIN.
WHAT JESPECT
®
IS
USED FOR
JESPECT
®
is a vaccine. It
helps prevent Japanese
encephalitis _(en-kef-al-i-tis)_, a
severe and often fatal
infection of the brain. Some
of those who recover from
the disease are often left with
brain damage.
Japanese encephalitis is
caused by the Japanese
encephalitis virus that mainly
occurs in Asia. The virus is
transmitted to humans by
infected mosquitoes that feed
on human blood.
JESPECT
®
is used to
vaccinate persons 18 years
and older who:
•
plan to live in or travel to
areas where Japanese
encephalitis is common
or seasonal. Your doctor
will explain your
individual risk of catching
the disease
•
work with Japanese
encephalitis virus.
JESPECT
®
is given as two
injections 28 days apart. The
vaccination course should be
completed at least one week
before potential exposure to
the Japanese encephalitis
virus.
_HOW JESPECT_
_®_
_ WORKS _
JESPECT
_®_
_ _works by getting
your body to produce its own
protection against the
Japanese encephalitis virus.
The vaccine does not contain
live virus and cannot give you
the illness.
After you have been given
JESPECT
®
, your body makes
substances called antibodies.
These antibodies fight the
Japanese encephalitis virus.
When you come into contact
with the virus, your body is
usually ready to destroy it.
Most people who receive
both doses of the vaccine will
produce enough anti

Toote omadused

JESPECT
®
Product Information
Page 1
AUSTRALIAN PRODUCT INFORMATION – JESPECT

[INACTIVATED JAPANESE ENCEPHALITIS VACCINE (ADSORDED)]
SUSPENSION FOR INJECTION
1
NAME OF THE MEDICINE
Inactivated Japanese Encephalitis Vaccine (adsorbed).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
JESPECT
®
Japanese Encephalitis (JE) Virus, purified inactivated vaccine is a
sterile, ready to
use suspension for intramuscular (IM) injection. The vaccine is
prepared by propagating
Japanese encephalitis virus strain (SA
14
-14-2) in Vero cells. No preservatives or antibiotics
are added to the formulation.
JESPECT
®
is a clear liquid with white precipitate and when shaken before use a
white/cloudy
suspension forms. JESPECT
®
is supplied in pre-filled syringes without needles. Each 0.5
mL dose of vaccine contains 6 antigen units (AgU) of purified,
inactivated JE virus. Each
dose of vaccine also contains the following excipients: 0.1% aluminium
hydroxide, hydrated
corresponding to 0.25 mg aluminium, and Phosphate Buffered Saline.
3
PHARMACEUTICAL FORM
JESPECT
®
is supplied as a 0.5 mL suspension in a pre-filled syringe (Type I
glass) with a
plunger stopper (chlorobutyl elastomer) in a pack size of 1
needle-less syringe.
To attach needle, remove the syringe cap by gently twisting it. Do not
attempt to snap or pull
the tip off as this may damage the syringe.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
JESPECT
®
is indicated for active immunisation against Japanese Encephalitis
(JE) virus for
persons 18 years of age and older.
JESPECT
®
should be considered for use in persons who plan to reside in or
travel to areas
where JE is endemic (common) or epidemic (seasonal), especially during
the transmission
season.
JESPECT
®
is indicated for persons who work with JE virus in laboratories and in
industry.
JESPECT
®
Product Information
Page 2
4.2
DOSE AND METHOD OF ADMINISTRATION
PRIMARY VACCINATION
The primary vaccination series consists of a total of two doses of 0.5
mL each according to
the following schedule:

First dose