BYDUREON 2 mg powder and solvent for prolonged-release suspension for injection

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

EXENATIDE

Boleh didapati daripada:

ASTRAZENECA SDN. BHD.

INN (Nama Antarabangsa):

EXENATIDE

Unit dalam pakej:

4units Units; 4units Units; 4units Units; 4units Units

Dikeluarkan oleh:

Amylin Ohio LLC

Risalah maklumat

BYDUREON
®
POWDER AND SOLVENT FOR PROLONGED-RELEASE SUSPENSION FOR INJECTION
EXENATIDE 2 MG
_CONSUMER MEDICATION INFORMATION _
_LEAFLET (RIMUP)_
1
WHAT IS IN THIS LEAFLET
1.
What BYDUREON is used
for
2.
How BYDUREON works
3.
Before you use BYDUREON
4.
How to use BYDUREON
5.
While you are using it
6.
Side effects
7.
Storage and disposal of
BYDUREON
8.
Product description
9.
Manufacturer
10.
Product Registration Holder
11.
Date of revision
12.
Serial number
WHAT BYDUREON IS USED FOR
BYDUREON contains the active
substance exenatide. It is an
injectable medicine used to
improve blood sugar control in
adults with type 2
diabetes
mellitus.
This medicine is used in
combination with the following
diabetes medicines: metformin,
sulphonylureas, thiazolidinediones
and SGLT2 inhibitors. Your doctor
is now prescribing this medicine as
an additional
medicine to help
control your blood sugar. Continue
to follow your food and exercise
plan.
HOW BYDUREON WORKS
You have diabetes because your
body does not make enough insulin
to control the level of sugar in
your
blood or your body is not able to
use the insulin properly. The active
substance in this medicine helps
your body to
increase the
production of insulin when your
blood sugar is high.
BEFORE YOU USE BYDUREON
-
_When you must not use it _
_ _
_DO NOT USE BYDUREON _
•
If you are allergic
(hypersensitive) to exenatide or
any of the other ingredients of
this medicine (listed in section
“Product description”).
-
_Before you start to use it _
_ _
_TALK TO YOUR DOCTOR, PHARMACIST, _
_OR DIABETES NURSE BEFORE USING _
_BYDUREON ABOUT THE FOLLOWING: _
•
Using this medicine in
combination with a
sulphonylurea, as low blood
sugar (hypoglycaemia) can
occur. Test your blood glucose
levels regularly. Ask your
doctor, pharmacist or diabetes
nurse if you are not
sure if any
of your other medicines contain
a sulphonylurea.
•
If you have type 1 diabetes or
diabetic ketoacidosis, as this
medicine should not be used.
•
If you have severe problems
with your stomach emptying
(includi

Ciri produk

INSTRUCTIONS FOR THE USER
READ THESE INSTRUCTIONS CAREFULLY BEFORE USE
BYDUREON 2 MG POWDER AND SOLVENT FOR PROLONGED-RELEASE SUSPENSION FOR
INJECTION IN
PRE-FILLED PEN
HOW TO USE BYDUREON PRE-FILLED PEN
COVER
KNOB
ORANGE LABEL
STRIPED LABEL
NEEDLE
TOP OF PEN
MIXING WINDOW
INSPECTION WINDOW
GREEN LABEL
Prior to use of the pen, it is recommended that you should be trained
by a doctor or diabetes
nurse on its proper use.
Unless a trained person can help to inject this medicine it is not
recommended for people who
are blind or cannot see well.
STEP 1: PREPARE YOUR PEN
LET YOUR PEN WARM UP. Remove one pen from the
refrigerator and let it stand at room temperature for at
least 15 minutes. DO NOT use a pen past its
expiration date.
WAIT
15
MINUTES
WASH YOUR HANDS WHILE THE PEN IS WARMING UP.
OPEN THE TRAY by pulling on the corner tab. Then
remove the pen and needle. DO NOT use your pen or
needle if any parts are broken or missing.
CHECK THE LIQUID inside the inspection window. It
should be clear and free of particles. It’s normal if you
see air bubbles in the liquid.
PEEL OFF THE PAPER TAB from the needle cover.
ATTACH THE NEEDLE TO THE PEN by pushing and
screwing it onto the top of the pen until it is tight. DO
NOT remove the needle cover yet.
STEP 2: MIX YOUR DOSE
COMBINE THE MEDICINE. While holding the pen
upright with the needle cover uppermost, SLOWLY turn
the knob anticlockwise. STOP when you hear the
click and the green label disappears.
HOLD UPRIGHT
FIRMLY TAP THE PEN TO MIX. Hold the pen by the end
with the orange label and TAP THE PEN FIRMLY AGAINST
THE PALM OF YOUR HAND. WITHOUT twisting the knob,
ROTATE the pen every few taps. Tap the prefilled
pen firmly until a uniformly cloudy suspension with no
clumps is obtained. You may need to tap 80 times or
more.
CHECK THE SUSPENSION. HOLD THE PEN UP TO THE LIGHT AND LOOK THROUGH
BOTH SIDES OF
THE MIXING WINDOW. The solution should have NO CLUMPS and be uniformly
cloudy.
NOT MIXED
WELL
CLUMPS,
non
-
uniform solution
MIXED WELL
NO CLUMPS, UNIFORMLY CLOUDY SOLUTION