Bydureon 2mg powder and solvent for prolonged-release suspension for injection pre-filled pen

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

유효 성분:

Exenatide

제공처:

AstraZeneca UK Ltd

ATC 코드:

A10BJ01

INN (국제 이름):

Exenatide

복용량:

2mg

약제 형태:

Powder and solvent for prolonged-release suspension for inj

관리 경로:

Subcutaneous

수업:

No Controlled Drug Status

처방전 유형:

Valid as a prescribable product

제품 요약:

BNF: 06010203; GTIN: 5000456007191

환자 정보 전단

User manual
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.
User manual
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
CLUMPS,
non
-
uniform solution
MIXED
NO CLUMPS, UNIFORMLY C

제품 특성 요약

OBJECT 1
BYDUREON 2 MG POWDER AND SOLVENT FOR
PROLONGED-RELEASE SUSPENSION FOR INJECTION IN PRE-
FILLED PEN
Summary of Product Characteristics Updated 27-Nov-2017 | AstraZeneca
UK Limited
1. Name of the medicinal product
Bydureon 2 mg powder and solvent for prolonged-release suspension for
injection in pre-filled pen
2. Qualitative and quantitative composition
Each pre-filled pen contains 2 mg of exenatide. After suspension, each
pen delivers a dose of 2 mg in
0.65 ml.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder and solvent for prolonged-release suspension for injection.
Powder: white to off-white powder.
Solvent: clear, colourless to pale yellow to pale brown solution.
4. Clinical particulars
4.1 Therapeutic indications
Bydureon is indicated in adults 18 years and older with type 2
diabetes mellitus to improve glycaemic
control in combination with other glucose-lowering medicinal products
including basal insulin, when the
therapy in use, together with diet and exercise, does not provide
adequate glycaemic control (see section
4.4, 4.5 and 5.1 for available data on different combinations).
4.2 Posology and method of administration
Posology
The recommended dose is 2 mg exenatide once weekly.
Patients switching from immediate-release (Byetta) to
prolonged-release exenatide may experience
transient elevations in blood glucose concentrations, which generally
improve within the first two weeks
after initiation of therapy.
When prolonged-release exenatide is added to existing metformin and/or
thiazolidinedione therapy, the
current dose of metformin and/or thiazolidinedione can be continued.
When prolonged-release exenatide
is added to sulphonylurea therapy, a reduction in the dose of
sulphonylurea should be considered to
reduce the risk of hypoglycaemia (see section 4.4).
Prolonged-release exenatide should be administered once a week on the
same day each week. The day of
weekly administration can be changed if necessary as long as the next
dose is administered at least one
day (24 ho