REOPRO abciximab 10mg/5mL injection vial

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

Abciximab

Tilgjengelig fra:

Janssen-Cilag Pty Ltd

Autorisasjon status:

Registered

Informasjon til brukeren

REOPRO
(170213) ACMI
1
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about REOPRO. It does not
contain all the available information. It
does not take the place of talking with
your doctor or nurse.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you being given REOPRO against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT BEING
GIVEN THIS MEDICINE, ASK YOUR DOCTOR
OR NURSE.
KEEP THIS LEAFLET.
You may need to
read it again.
WHAT REOPRO IS USED
FOR
REOPRO belongs to a class of
medicines called antithrombotics which
help to prevent blood clots.
REOPRO inhibits the aggregation of
blood-clotting cells (called platelets) in
the blood.
REOPRO is used in patients with heart
disease caused by poor blood flow in
the arteries of the heart (known as
ischaemic cardiac complications).
REOPRO prevents the formation of
blood clots in the heart that may occur
during procedures to open blocked
arteries in the heart (known as
percutaneous
coronary intervention).
Examples of percutaneous
coronary
intervention procedures include balloon
angioplasty, atherectomy and stent
placement.
REOPRO is also used in patients who
have severe chest pain with heart
disease (known as unstable angina),
when percutaneous coronary
intervention is planned. REOPRO may
be started 18 to 24 hours prior to the
planned intervention.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU. YOUR
DOCTOR MAY HAVE PRESCRIBED IT FOR
ANOTHER REASON.
There is not enough information to
recommend the use of this medicine in
children under the age of 18 years.
BEFORE YOU HAVE REOPRO
_WHEN YOU MUST NOT HAVE IT _
_ _
DO NOT HAVE REOPRO IF YOU HAVE AN
ALLERGY TO:

any medicine containing abciximab

any of the ingredients listed at the
end of this leaflet

specific disease-fighting protein
substances (called murine
proteins).
_ _
Some of the symptoms of an allergic
reaction may include shortness of
breath, wheezing or difficulty
breathing; swelling

Preparatomtale

CCDS181029v10.0
Page 1 of 15
ReoPro(190405)API
REOPRO
®
(ABCIXIMAB RMC)
NAME OF THE MEDICINE
ReoPro
®
(abciximab)
The active ingredient is abciximab.
DESCRIPTION
ReoPro (abciximab rmc) is the Fab fragment of the chimeric monoclonal
antibody 7E3 (c7E3
Fab). The chemical description of abciximab is:
Immunoglobulin G (human-mouse monoclonal c7E3 clone p7E3V
H
hC
H
Fab
fragment anti-human glycoprotein IIb/IIIa receptor), disulfide with
human-
mouse monoclonal c7E3 clone p7E3V
_K_
hC
_K_
light chain.
The chimeric 7E3 antibody is produced by continuous perfusion in
mammalian cell culture.
The 47,615 dalton Fab fragment is purified from cell culture
supernatant by a series of steps
involving specific viral inactivation and removal procedures,
digestion with papain and column
chromatography.
Each 5 mL single-use vial contains 10 mg abciximab, 6.75 mg dibasic
sodium phosphate
dihydrate, 1.65 mg monobasic sodium phosphate (monohydrate), 43.85 mg
sodium chloride,
0.05 mg polysorbate 80 and water for injections, qs to 5.0 mL. No
preservatives are added.
PHARMACOLOGY
ReoPro binds to the intact platelet GPIIb/IIIa receptor, which is a
member of the integrin family
of adhesion receptors and the major platelet surface receptor involved
in platelet aggregation.
ReoPro inhibits platelet aggregation by preventing the binding of
fibrinogen, von Willebrand
factor and other adhesive molecules to GPIIb/IIIa receptor sites on
activated platelets. The
mechanism of action is thought to involve steric hindrance and/or
conformational effects to
block access of large molecules to the receptor rather than direct
interaction with the RGD
(arginine-glycine-aspartic acid) binding site of GPIIb/IIIa.
ReoPro binds with similar affinity to the related integrin,
α
v
ß
3
, also known as the vitronectin
receptor. The
α
v
ß
3
receptor is present on a wide variety of cell types including
platelets and
vessel wall endothelial and smooth muscle cells. ReoPro effectively
blocks
α
v
ß
3
-mediated
effects including cell adhesion (IC
50
= 0.34 mcg/mL)