Jespect

País: Nova Zelanda

Idioma: anglès

Font: Medsafe (Medicines Safety Authority)

ingredients actius:

Japanese encephalitis vaccine 6 Units

Disponible des:

Seqirus (NZ) Ltd

Designació comuna internacional (DCI):

Japanese encephalitis vaccine 6 Units

Dosis:

6 U/dose

formulario farmacéutico:

Suspension for injection

Composición:

Active: Japanese encephalitis vaccine 6 Units Excipient: Aluminium hydroxide gel Dibasic sodium phosphate Monobasic potassium phosphate Sodium chloride

Unidades en paquete:

Syringe, glass, 0.5 mL

clase:

Prescription

tipo de receta:

Prescription

Fabricat per:

Valneva Scotland Ltd

indicaciones terapéuticas:

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.

Resumen del producto:

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

Data d'autorització:

2012-04-02

Informació per a l'usuari

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

Fitxa tècnica

NEW ZEALAND DATA SHEET
Page 1 of 12
1.
PRODUCT NAME
JESPECT
®
. Inactivated Japanese Encephalitis Vaccine (adsorbed), suspension for
injection.
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 hydrate
corresponding to 0.25 mg
aluminium, and Phosphate Buffered Saline. Refer section 6.1 – List
of excipients.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Clear liquid with a white precipitate.
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.
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 at Day 0 (elected date).
•
Second dose: 28 days after first dose.
It is recommended that persons who receive the first dose of JESPECT
®
complete the 2-dose primary
vaccination course.
If the primary immunisation schedule of 2 doses is not completed,
sufficient protection against
Japanese encephalitis virus might not be achieved. Clin