IMOGAM RABIES PASTEURIZED human rabies immunoglobulin 150 IU/mL injection vial

国: オーストラリア

言語: 英語

ソース: Department of Health (Therapeutic Goods Administration)

有効成分:

rabies immunoglobulin, Quantity: 150 IU/mL

から入手可能:

Sanofi-Aventis Australia Pty Ltd

医薬品形態:

Injection

構図:

Excipient Ingredients: glycine; sodium chloride; water for injections

投与経路:

Intramuscular

パッケージ内のユニット:

2mL vial, 10mL vial

処方タイプ:

(S4) Prescription Only Medicine

適応症:

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 as specified in the International Product Information.

製品概要:

Visual Identification: Clear, pale yellow to light brown liquid. During storage it may show formation of slight turbidity or a small amount of particulate matter.; Container Type: Vial; Container Material: Al; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

認証ステータス:

Licence status A

承認日:

2000-02-24

情報リーフレット

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 some
protection ag

製品の特徴

SANOFI PASTEUR, SA
194 IMOGAM
® RABIES – HT
CONFIDENTIAL/PROPRIETARY INFORMATION
1
AHFS Category: 80:04 RIG
RABIES IMMUNE GLOBULIN
(HUMAN) USP, HEAT TREATED
IMOGAM
®
RABIES – HT
FOR WOUND INFILTRATION AND INTRAMUSCULAR USE ONLY
DESCRIPTION
Rabies Immune Globulin (Human) USP, Heat Treated, Imogam
®
Rabies – HT, is a sterile solution
of
antirabies
immunoglobulin
(10-16%
protein)
for
wound
infiltration
and
intramuscular
administration. Rabies immune globulin (RIG) is prepared by cold
alcohol fractionation from
pooled venous plasma of individuals immunized with Rabies Vaccine
prepared from human
diploid cells (HDCV). The product is stabilized with 0.3 M glycine.
The immune globulin
solution has a pH of 6.8 ± 0.4 adjusted with sodium hydroxide or
hydrochloric acid. No
preservatives are added. Imogam Rabies – HT is a clear or slightly
opalescent, colorless or pale-
yellow or light-brown liquid. During storage it may show formation of
slight turbidity or a small
amount of visible particulate matter.
A heat-treatment process step (58° to 60°C, 10 hours) to inactivate
viruses is used to further
reduce any risk of blood-borne viral transmission. The inactivation
and removal of model
laboratory strains of enveloped and non-enveloped viruses during the
manufacturing and heat
treatment processes for Imogam Rabies – HT have been validated by
spiking experiments.
Human immunodeficiency virus, type 1 (HIV-1) and type 2 (HIV-2) were
selected as relevant
viruses for plasma derived products. Bovine viral diarrhea virus and
Sindbis virus were chosen to
model hepatitis C virus. Porcine pseudorabies virus was selected to
model hepatitis B virus and
herpes virus. Avian reovirus was used to model non-enveloped RNA
viruses and for its relative
resistance to inactivation by chemical and physical methods. Finally,
porcine parvovirus was
selected to model human parvovirus B19 and its notable resistance to
inactivation by heat
treatment.
Removal and/or inactivation of the spiked model viruses was
demonstrated at the precipita