What BYDUREON contains:
- The active substance is exenatide. Each vial contains 2 mg of exenatide.
- The other ingredients are:
- In the powder: poly (D,L-lactide-co-glycolide) and sucrose.
- In the solvent: carmellose sodium, sodium chloride, polysorbate 20, monobasic sodium phosphate monohydrate, dibasic sodium phosphate heptahydrate and water for injections.
What BYDUREON looks like and contents of the pack:
Powder and solvent for prolonged-release suspension for injection.
The powder is white to off-white and the solvent is a clear, colourless to pale yellow to pale brown solution.
Each single-dose kit consists of one vial containing 2 mg exenatide powder, one pre-filled syringe containing 0.65 ml solvent, one vial connector, and two injection needles. One needle is a spare.
It is available in pack sizes of 4 single dose kits and 3 packs of 4 single-dose kits. Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Eli Lilly Nederland B.V., Grootslag 1-5, NL-3991 RA Houten, The Netherlands.
Manufacturer:
Lilly Pharma Fertigung und Distribution GmbH & Co. KG, Teichweg 3, D - 35396 Giessen, Germany.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
BelgiqueBelgiëBelgien Eli Lilly Benelux S.AN.V. TélTel 32-0 2 548 84 84 LuxembourgLuxemburg Eli Lilly Benelux S.AN.V. TélTel 32-0 2 548 84 84
.. - . 359 2 491 41 40 Magyarország Lilly Hungária Kft. Tel 36 1 328 5100
eská republika Eli Lilly R, s.r.o. Tel 420 234 664 111 Malta Charles de Giorgio Ltd. Tel 356 25600 500
Danmark Eli Lilly Danmark AS Tlf 45 45 26 60 00 Nederland Eli Lilly Nederland B.V. Tel 31-0 30 60 25 800
Deutschland Lilly Deutschland GmbH Tel. 49-0 6172 273 2222 Norge Eli Lilly Norge A.S Tlf 47 22 88 18 00
Eesti Eli Lilly Holdings Limited Eesti filiaal Tel 372 6 817 280 Österreich Eli Lilly Ges.m.b.H Tel 43-0 1 711 780
- ... 30 210 629 4600 Polska Eli Lilly Polska Sp. z o.o. Tel. 48 0 22 440 33 00
España Lilly S.A. Tel 34 91 663 50 00 Portugal Lilly Portugal - Produtos Farmacêuticos, Lda Tel 351 21 4126600
France Lilly France SAS Tél. 33-01 55 49 34 34 România Eli Lilly România S.R.L. Tel 40 21 4023000
Ireland Eli Lilly and Co. Ireland Limited, Tel 353-0 1 661 4377 Slovenija Eli Lilly farmacevtska druba, d.o.o. Tel 386 01 580 00 10
Ísland Icepharma hf. Sími 354 540 8000 Slovenská republika Eli Lilly Slovakia, s.r.o. Tel 421 220 663 111
Italia Eli Lilly Italia S.p.A. Tel 39-055 42571 SuomiFinland Oy Eli Lilly Finland Ab PuhTel 358-0 9 85 45 250
Phadisco Ltd 357 22 715000 Sverige Eli Lilly Sweden AB Tel 46 0 8 737 88 00
Latvija Eli Lilly Holdings Limited prstvniecba Latvij Tel 371 67364000 United Kingdom Eli Lilly and Company Limited Tel 44-0 1256 315000
Lietuva
Eli Lilly Holdings Limited atstovyb-
Tel. +370 (5) 2649600
This leaflet was last approved in
INSTRUCTIONS FOR THE USER
Your Step by Step Guide
BYDUREON 2 mg powder and solvent for prolonged-release suspension for injection
If you have questions about taking BYDUREON
- Refer to the Common Questions and Answers
Helpful Hints
- Take your time.
- Follow these instructions step by step.
- You will need enough time to complete all the steps without stopping.
- You will probably need less time as you get used to giving yourself injections.
IMPORTANT:
Read and follow each step in these instructions carefullyevery timeyou take BYDUREON. Do not skip steps. Also read thePackage Leafletin your carton.
Your guide to the parts
Lift here for a closer look at the parts
Keep this flap open so you can refer to it as you go through the steps
Plunger LiquidsolventinsideWhiteCapSyringe DoseLine Vial Vialconnector Greencap Papercover Thepowderinsideisyourmedicine Vialconnectorpackage OrangeconnectorNeedlemonojectThesingledosekithasaspareneedlenotshownincaseyouneedit. Bluecap Needle NeedleCove
Your guide to the parts
Single-dose kit
Syringe Needles2 Vial Vial connector vial connector
What?s inside
To take the correct dose, read each section so that you do every step in order.
This guide is divided into sections:
1 2 3 4 Getting started Connecting the parts Mixing the medicine and filling the syringe Injecting the medicine Common Questions and Answers.
1. Getting Started
1a Take a single-dose kit from the refrigerator.
Prepare to safely dispose of used needles and syringes. Have what you need ready in order to safely dispose of used needles and syringes.
1b Wash your hands.
1c
Peel back the cover to open.
Remove the syringe. The liquid in the syringe should be clear and free of particles. It is okay if there are air bubbles.
Place the needle, vial connector package, vial, and syringe on a clean, flat surface.
1d
Pick up the needle, and twist off the blue cap.
Put the covered needle down. The needle is now prepared. You will need it later.
There is a spare needle in case you need it.
1e
Tap!
Pick up the vial.
Tap the vial several times against a hard surface to loosen the powder.
1f
Use your thumb to remove the green cap.
Put the vial down.
2. Connecting the Parts
2a
Pick up the vial connector package and peel off the paper cover. Do not touch the orange connector inside.
2b
Hold the vial connector package.
In your other hand, hold the vial.
2c
Press the top of the vial firmly into the orange connector.
2d
Lift the vial with the orange connector now attached out of its package.
2e
This is what the vial should now look like.
Put it down for later.
2f
Pick up the syringe.
With your other hand, firmly hold the 2 grey squares on the white cap.
2gSnap Break off the cap
Be careful not to push in the plunger.
Just like you might break a stick, you are breaking off the cap.
2h
This is what the broken-off cap looks like.
You will not need the cap and can throw it away.
2i
This is what the syringe should now look like.
2j
Now, pick up the vial with the orange connector attached.
Twist the orange connector onto the syringe until snug. While twisting, be sure to hold the orange connector. Do not over tighten. Be careful not to push in the plunger.
2k
This is how the parts should now look when they are connected.
3.Mixing the Medicine and Filling the Syringe
IMPORTANT:
During these next steps, you will be mixing the medicine and filling the syringe. Once you mix the medicine, you must inject it immediately. You must not save the mixed medicine to inject at a later time.
3a
With your thumb, push down the plunger until it stops and hold your thumb in place.
The plunger may feel like it is springing back a little.
3b
Keep pushing down on the plunger with your thumb and shake vigorously. Keep shaking until the liquid and powder are mixed well.
Do not worry that the vial might come off. The orange connector will keep it attached to the syringe.
Shake vigorously like you would shake a bottle of oil-and-vinegar salad dressing.
3c
When the medicine is mixed well, it should look cloudy.
If you see clumps of dry powder on the sides or bottom of the vial, the medicine is NOT mixed well.
Shake vigorously again until well mixed.
Keep pushing on the plunger with your thumb while shaking.
3e
Now, hold the vial so the syringe is pointing up. Keep pushing on the plunger with your thumb until it stops, and hold it in place.
3f
Gently tap the vial with the other hand. Keep pushing on the plunger with your thumb to keep the plunger in place.
The tapping helps the medicine drip down along the sides of the vial. It is okay if there are air bubbles.
3g
Pull the plunger down beyond the black dashed Dose Line.
This draws the medicine from the vial into the syringe. You may see air bubbles. This is normal.
A little bit of liquid may cling to the sides of the vial. This is also normal.
3h
With one hand, hold the plunger in place so it does not move.
3i
With the other hand, twist the orange connector to remove.
After removing the connector be careful not to push in the plunger.
3j
This is what the syringe should now look like.
4. Injecting the Medicine
IMPORTANT:
Read the next steps carefully and look closely at the pictures.
This helps you get the correct dose of medicine.
4a
Twist the needle onto the syringe until snug. Do not remove the needle cover yet. Be careful not to push in the plunger.
4bSlowlypush Topofplunger
Slowly push in the plunger so the top of the plunger lines up with the black dashed Dose Line. Then, take your thumb off the plunger.
It is important to stop pushing at this point, or you will waste your medicine and you will not get the
correct dose.
4c
The top of the plunger must stay lined up with the black dashed Dose Line as you go through the next steps. This will help you get the correct dose of medicine.
IMPORTANT:
It is normal to see a few air bubbles in the mixture.
The air bubbles will not harm you or affect your dose.
4dBackofupperarm StomachThighFront Back Areasonbodyforinjection You can inject each dose of the medicine in your stomach area abdomen, your thigh, or the back of your upper arm.
Each week you can use the same area of your body. But be sure to choose a different injection site in that area.
4e
Hold the syringe near the black dashed Dose Line.
4f
Pull
Pull the needle cover straight off.
Do not twist.
Be careful not to push in the plunger.
When you remove the cover, you may see 1 or 2 drops of liquid. This is normal.
4g
Be sure to use the injection technique recommended by your healthcare professional. Remember: You must take your injection of BYDUREON immediately after mixing it
Insert the needle into your skin (subcutaneously). To inject your full dose, push down on the plunger with your thumb until it stops.
Withdraw the needle.
Refer to the package leaflet (section 3) on what to do if you are not sure if you have received a complete dose.
4h. Put the cover back on the needle. Dispose of the syringe with the covered needle still attached as instructed by your healthcare professional.
You do not have to save any parts. Each single-dose kit has everything you need for your weekly dose of BYDUREON.
Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
When it is time for your next weekly dose, start again at step 1.
Common Questions and Answers
If your question is about How soon to inject after mixing Mixing the medicine Air bubbles in syringe Attaching the needle Removing the needle cover Plunger not lining up with black dashed Dose Line Being unable to push the plunger down when injecting See question number 1 2 3 4 5 6 7
Common Questions and Answers
1. After I mix the medicine, how long can I wait before taking the injection?
You must take your injection of BYDUREON immediately after mixing it. If you do not inject BYDUREON immediately, the medicine will start to form small clumps in the syringe. These clumps could clog the needle when you take the injection (see question 7).
2. How do I know that the medicine is mixed well?
When the medicine is mixed well, it should look cloudy. There should not be any dry powder on the sides or bottom of the vial. If you do see any dry powder, shake vigorously while continuing to push
down on the plunger with your thumb. (This question relates to the steps shown on page X, Section 3a to 3d).
3. I?m ready to take the injection. What should I do if I see air bubbles in the syringe?
It is normal for air bubbles to be in the syringe. The air bubbles will not harm you or affect your dose. BYDUREON is injected into your skin (subcutaneously). Air bubbles are not a problem with this type of injection.
4. What should I do if I have trouble attaching the needle?
First, be sure you have removed the blue cap. Then, twist the needle onto the syringe until snug. To prevent losing medicine, do not push in the plunger while attaching the needle. For more information on injection techniques talk with your health care professional.
(This question relates to step 4a.)
5. What should I do if I have trouble removing the needle cover?
With one hand, hold the syringe near the black dashed Dose Line. With your other hand, hold the needle cover. Pull the needle cover straight off. Do not twist it. (This question relates to step 4f page X.)
6. I am at step 4c. What should I do if the top of the plunger has been pushed past the black
dashed Dose Line?
The black dashed Dose Line shows the correct dose. If the top of the plunger has been pushed past the line, you should continue from step 4d and take the injection. Before your next injection in 1 week, carefully review the instructions for steps 3a to 4h.
7. When I inject, what should I do if I cannot push the plunger all the way down?
This means the needle has become clogged. Remove the needle and replace it with the spare needle from your kit. Then choose a different injection site and finish taking the injection.
To review how to:
- Remove the blue cap of the needle, see page X (step 1d)
- Attach the needle, see page X (step 4a)
- Remove the needle cover and give the injection, see page X (steps 4e to 4g)
If you still cannot push the plunger all the way down, withdraw the needle. Carefully put the needle cover back on the needle. Refer to the package leaflet (section 3) on what to do if you are not sure if you have received a complete dose.
To prevent a clogged needle, always mix the medicine very well, and inject immediately after mixing.
BYDUREON only needs to be taken once a week.
Make a note that you have taken your BYDUREON today and mark your calendar for when you are due for your next injection.
Where to learn more about BYDUREON
- Talk with your healthcare professional Read the Package Leaflet carefully
Instructions for the User was last approved in