Bydureon

Maa: Australia

Kieli: englanti

Lähde: Department of Health (Therapeutic Goods Administration)

Aktiivinen ainesosa:

Exenatide

Saatavilla:

Bristol-Myers Squibb Australia Pty Ltd

luokka:

Medicine Registered

Pakkausseloste

BYDUREON
®

_exenatide_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about BYDUREON.
It does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
The information in this leaflet was
last updated on the date shown on the
final page. More recent information
on this medicine may be available.
Make sure you speak to your
pharmacist, nurse or doctor to obtain
the most up to date information on
this medicine.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking BYDUREON
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, CONSULT YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT BYDUREON IS
USED FOR
BYDUREON is an injectable
medicine used to improve blood
sugar control in adults with type 2
diabetes mellitus.
It is used with metformin or
sulfonylureas. It may also be used
with a combination of metformin and
sulfonylureas.
ASK YOUR DOCTOR OR HEALTHCARE
PROFESSIONAL IF YOU ARE NOT SURE
WHETHER YOUR ANTIDIABETIC
MEDICINE CONTAINS SULFONYLUREA.
Diabetes mellitus is a condition in
which your pancreas does not
produce enough insulin to control
your blood sugar level. BYDUREON
helps your body to increase
production of insulin when your
blood sugar is high.
BYDUREON is not a substitute for
insulin in patients who require
insulin treatments for their diabetes.
This medicine has not been studied in
children.
This medicine is only available with
a doctor's prescription.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
BEFORE YOU USE
BYDUREON
_WHEN YOU MUST NOT USE IT_
DO NOT USE BYDUREON IF:
•
you have type 1 diabetes or
diabetic ketoacidosis (often
caused by very high blood
glucose levels).
•
you are allergic to exenatide or
any of the ingredients listed at the
end of this leaflet
•
you have severe kidney problems
or

Valmisteyhteenveto

BYDUREON
®
 Product Information 
CV.000-757-447.3.0 
1(23) 
BYDUREON
®

(exenatide) 
PRODUCT INFORMATION 
NAME OF THE MEDICINE 
BYDUREON (exenatide) powder for
injection vial with diluent syringe. 
The active ingredient in BYDUREON is exenatide. Exenatide is
a 39-amino acid 
peptide amide. It has the empirical formula C
184
H
282
N
50
O
60
S and molecular weight 
of 4186.6 Daltons. The amino acid sequence for exenatide is
shown below. 
H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-
Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-
Pro-Ser-NH
2
. 
The CAS number for exenatide is 141732-76-5. 
DESCRIPTION 
BYDUREON is
an extended release microspheres formulation of exenatide. 
BYDUREON is supplied in a single dose kit containing a vial
of powder, a prefilled 
syringe of diluent, a vial connector
and two needles (one spare). BYDUREON is a 
sterile, white to off-white powder
in a glass vial. The active ingredient in 
BYDUREON is exenatide. The powder is
suspended using the diluent supplied. 
The diluent is a clear, colourless
to pale yellow to pale brown solution. When the 
product is
prepared as instructed, the resulting suspension contains 2 mg 
exenatide. The suspension is intended for subcutaneous
use only, once per week. 
Bydureon consists of exenatide (5%) and sucrose (2%)
encapsulated within 
biodegradable polyglactin microspheres that are
designed to release exenatide 
over
an extended period of time. During dose preparation, a custom diluent is 
added to these microspheres, which are
dispersed into the diluent to create a 
suspension. Following administration of the suspension, the polymer
biodegrades 
over
time, providing extended release of exenatide into the circulation. The diluent 
contains
carmellose sodium, sodium chloride, polysorbate 20, sodium phosph