RABIPUR rabies virus vaccine (Inactivated) 2.5 IU powder for injection vial with diluent ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Rabies virus

Available from:

GlaxoSmithKline Australia Pty Ltd

INN (International Name):

Rabies virus

Authorization status:

Registered

Patient Information leaflet

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 causing your
body to protect itself against rabies.
The body makes substances that fight
the rabies virus. They are called
antibodies and circulate in the blood.
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,
100% protection cannot be
guaranteed.
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 RABIPUR_
DO NOT HA

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
RABIPUR (INACTIVATED RABIES VIRUS VACCINE) POWDER FOR
INJECTION
1
NAME OF THE MEDICINE
Inactivated Rabies Virus
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

-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 Organisation
requirements.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Powder 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, a booster dose sh