Imogam

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Immunoglobulin - rabies

Available from:

Sanofi-Aventis Australia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

IMOGAM RABIES
PASTEURIZED
®

_Human rabies immunoglobulin_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about IMOGAM RABIES
pasteurized (IMOGAM). It does not
contain all the available information.
It does not take the place of talking to
your doctor.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking IMOGAM
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT IMOGAM IS USED
FOR
IMOGAM is used to help prevent
rabies infection in people who have
been bitten, licked or scratched by a
rabies-infected animal.
Rabies is an infection caused by a
virus which affects the brain and is
fatal if not treated early.
IMOGAM is prepared from blood
obtained from voluntary donors. It
contains protein substances called
antibodies, which can provide
protection against rabies.
BEFORE IMOGAM IS
USED
_SPECIAL WARNING_
This product is made from human
plasma obtained from voluntary
donors immunized against rabies.
When products are made from
human blood and injected into you, it
is possible that viruses or other
substances could be present in the
product and cause an illness. These
could be viruses such as hepatitis,
HIV (human immunodeficiency
virus), or parvovirus B19. There
could also be other infectious agents
some of which may not yet have
been discovered.
To reduce the risk of this happening,
extra steps are taken when
manufacturing this product. Strict
controls are applied to the selection
of blood donors and donations. The
product is specially treated to remove
and kill certain viruses. This special
treatment is considered effective
against viruses known as enveloped
viruses such as HIV and hepatitis B
and C viruses, and the non-enveloped
virus, hepatitis A. The effect against
the non-enveloped virus, human
parvovirus B19 is limited. However,
the product contains specific
antibodies which can provide so

Summary of Product characteristics

IMOGAM Product Information 
Approved: 01 Feb 2000 

Page 1 of 5 
Last RA Notification: 23 Jul 2007 
Last revised: 08 Aug 2007 

IMOGAM RABIES PASTEURIZED - HUMAN RABIES IMMUNOGLOBULIN 

COMPOSITION 

1 ml of human rabies immunoglobulin contains: 

Active ingredient: 

  Human proteins   

100 
–180 mg 

containing (IgG class) human rabies immunoglobulins with
a minimum titre of 150 I.U. 

Other ingredients: 

  Glycine   

22.5 mg 

  Sodium chloride  

1 mg 

  Water for injections 

up to 1 mL 

PHARMACEUTICAL DOSAGE FORM 

Injectable solution. 

  Vial of 2 ml containing at least 300 I.U. human rabies
immunoglobulins. 

  Vial of 10 ml containing at least 1500 I.U. human rabies
immunoglobulins. 

INDICATIONS 

IMOGAM RABIES PASTEURIZED is indicated in subjects who are thought to have been exposed 
to rabies virus, especially cases of major exposure, in
accordance with W.H.O. recommendations. 

CATEGORY 
TYPE OF CONTACT WITH A SUSPECT OR 
CONFIRMED RABID DOMESTIC OR WILD 
ANIMAL, OR ANIMAL UNAVAILABLE FOR 
OBSERVATION 
RECOMMENDED TREATMENT 
I 
Touching or feeding of animals. 
Licks on intact skin. 
None if reliable case history is available. 
II 
Nibbling of uncovered skin. 
Minor scratches or abrasions without 
bleeding. 
Licks on broken skin. 
Administer vaccine immediately. Stop 
treatment if animal remains healthy 
throughout an observation period of 10 
days or if animal is killed humanely and 
found to be negative for rabies by 
appropriate laboratory techniques. 
III 
Single or multiple transdermal bites or 
scratches. 
Contamination of mucous membrane 
with saliva (i.e. licks). 
Administer rabies immunoglobulin and 
vaccine immediately. Stop treatment if 
animal remains healthy