RABIPUR rabies virus vaccine (Inactivated) 2.5 IU powder for injection vial with diluent pre-filled syringe

Country: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

Rabies virus, Quantity: 2.5 IU

Доступно од:

Seqirus Pty Ltd

Фармацеутски облик:

Injection, powder for

Састав:

Excipient Ingredients: monopotassium glutamate; trometamol; sodium chloride; disodium edetate; polygeline; sucrose

Пут администрације:

Intramuscular

Јединице у пакету:

1 single dose vial with 1 pre-filled syringe of diluent, 5 single dose vials with 5 pre-filled syringes of diluent

Тип рецептора:

(S4) Prescription Only Medicine

Терапеутске индикације:

Active immunisation against rabies virus, including a) Pre-exposure immunisation b) Post-exposure treatment following exposure to rabies virus.

Резиме производа:

Visual Identification: A white freeze dried powder that upon reconstitution is clear to slightly opalescent and colourless to slightly pink.; Container Type: Multiple containers; Container Material: Glass Type I Clear; Container Life Time: 48 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Статус ауторизације:

Registered

Датум одобрења:

2018-04-17

Информативни летак

1
RABIPUR
_(Rab-ee-per)_
Inactivated Rabies Virus Vaccine
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about RABIPUR
(Inactivated Rabies Virus Vaccine).
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 RABIPUR
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 RABIPUR IS USED
FOR
RABIPUR is a vaccine used to help
prevent rabies infection in people
who either:
•
have been; or
•
are at risk of being
bitten, licked or
scratched by an animal
infected with rabies
virus.
Rabies is a very serious infection.
The rabies virus attacks the nerves
and the brain. Rabies infection can
be fatal if not treated as early as
possible.
_HOW IT WORKS_
RABIPUR works by encouraging
your body to protect itself against
rabies. The body makes
substances called antibodies that
fight the rabies virus.
If the rabies virus gets into
someone who has been
vaccinated against rabies, the
antibodies kill the virus before it
can cause damage.
After vaccination your body
takes several weeks to develop
enough antibodies to
successfully fight rabies_._
For vaccination against rabies
you need a course of 3 to 5
injections.
After this course, most people
produce enough antibodies
against rabies_. _ However, as
with all vaccines, RABIPUR may
not fully protect all people who are
vaccinated.
For people at risk, further
booster injections of rabies
vaccine may be needed every
few years to ensure enough
antibodies are present.
The vaccine will not give you or
your child rabies.
The chance of a severe
reaction from RABIPUR is very
small,
but the
risks from not
being vaccinated against rabies
may be very serious.
BEFORE YOU ARE GIVEN
RABIPUR
_WHEN YOU OR YOUR CHILD _
_MUST NOT BE GIVEN

Карактеристике производа

1
AUSTRALIAN PRODUCT INFORMATION
RABIPUR (INACTIVATED RABIES VIRUS VACCINE) POWDER FOR
INJECTION
1
NAME OF THE MEDICINE
Inactivated Rabies Virus Vaccine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
RABIPUR is an inactivated rabies virus vaccine, derived from the
fixed-virus strain, Flury
LEP. The virus is propagated in a Purified Chick Embryo Cell (PCEC)
culture, inactivated
using
β
-propiolactone and purified via centrifugation.
Each 1.0 mL dose of the reconstituted vaccine contains no less than
2.5 IU of inactivated
rabies virus, in accordance with the World Health Organization
requirements.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Powder and diluent for injection.
The reconstituted vaccine is clear to slightly opalescent and
colourless to slightly pink.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For active immunisation against rabies virus, including:
a)
Pre-exposure immunisation,
b)
Post-exposure treatment following exposure to rabies virus.
4.2
DOSE AND METHOD OF ADMINISTRATION
Recommended dosages, as outlined below, are the same for children,
adolescents and
adults.
DOSAGE
Pre-exposure Prophylaxis
_Primary immunisation _
In previously unvaccinated persons, an initial course of pre-exposure
prophylaxis consists of
three doses (each of 1.0 mL) administered on days 0, 7 and 21 _or_ 28.
2
_Booster doses _
In persons with ongoing risk of exposure to rabies virus, the
following general guidance is
provided:
•
Testing for neutralising antibodies by the Rapid Focus-Fluorescent
Inhibition Test
(RFFIT) at 6-month intervals is usually recommended if the risk of
exposure to rabies
virus is high (e. g. Laboratory staff working with rabies virus).
•
In persons who are considered to be at continuing risk of exposure to
rabies (e.g.
veterinarians and their assistants, wildlife workers, hunters), a
serological test should
usually be performed at least every 2 years, with shorter intervals if
appropriate to the
perceived degree of risk.
•
In above mentioned cases