Merieux Inactivated Rabies Vaccine

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

Rabies virus

Tillgänglig från:

Sanofi-Aventis Australia Pty Ltd

Klass:

Medicine Registered

Bipacksedel

MERIEUX
INACTIVATED RABIES
VACCINE (MIRV)

_Rabies Vaccine_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Merieux Inactivated
Rabies Vaccine (MIRV).
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 MIRV 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 MIRV IS USED FOR
MIRV is a vaccine used to help
prevent rabies infection in people
who have been, or are likely to be,
bitten, licked or scratched by an
animal that has rabies.
Rabies is a serious infection caused
by a virus. The virus affects the
brain. Rabies is fatal if not treated
early.
_HOW IT WORKS_
MIRV works by causing your body
to protect itself against rabies. The
body makes substances which fight
the rabies virus. They are called
antibodies and circulate in the blood.
If the rabies virus gets into a
vaccinated person, the antibodies
destroy the virus before it can cause
damage. After vaccination your body
takes several weeks to develop
adequate antibodies against rabies.
For vaccination against rabies you
need a course of 3 injections. After 1
year another (booster) injection may
also be required. Further booster
injections may be needed every few
years.
After this course, most people
produce enough antibodies against
rabies. However, as with all vaccines,
100% protection cannot be
guaranteed.
The vaccine will not give you or your
child rabies.
The chance of a severe reaction from
MIRV is very small, but the risks
from not being vaccinated against
rabies may be very serious.
BEFORE YOU ARE GIVEN
MIRV
_WHEN YOU OR YOUR CHILD_
_MUST NOT BE GIVEN IT_
DO NOT HAVE MIRV IF YOU HAVE AN
ALLERGY TO:
•
MIRV or any of the ingredients
listed at the end of this leaflet
UNL

Produktens egenskaper

SANOFI PASTEUR 
MIRV MERIEUX INACTIVATED RABIES VACCINE 

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MERIEUX INACTIVATED RABIES VACCINE 

PRODUCT INFORMATION 

COMPOSITION 

Inactivated Rabies Vaccine 

DESCRIPTION 

The  vaccine  is  lyophilised,  stabilised  suspension  of  inactivated  Wistar  rabies  virus  strain 
PM/W1381503-3M,  cultured  on  human  diploid  cells  and  inactivated  by  ß-propiolactone.  These 
human diploid cells are a cell line derived from human embryonic
lung tissue in the 1960s. 

The  dry  vaccine  is  coloured  off  white  but  after  reconstitution  with  the  diluent  supplied  it  turns  a 
pinkish colour due to the presence of phenol red. 

The potency of the reconstituted vaccine is not less than 2.5 IU,
the WHO International Standard per 
dose (1 mL). Each vial contains, in addition, between 100 and 150 microgram of neomycin and up 
to 70 mg of human serum albumin. 

The manufacture of this product includes exposure to bovine materials. No evidence exists that any 
case of vCJD (considered to be the human form of bovine spongiform encephalopathy) has resulted 
from the administration of any vaccine product. 

PHARMACOLOGY 

Following  a  single  deep  subcutaneous  injection,  an  antibody  response  can  be  detected  after  a 
variable period of up to 7 days, in all subjects. Peak
antibody levels are reached at about 30 days and 
then start to decline. 

In  order  to  maintain  the  antibody  response  multiple  doses  are  necessary,  in  particular  the  booster 
doses  on  days  30  and  90  of  the  recommended  immunisation  schedule  (see  dosage  and 
administration).  Antibody  titres  of  more  than  the  minimum  desirable  value  of  0.5  IU/mL  are 
achieved in the plasma in