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What is Bydureon and what it is used for
Bydureon contains the active substance exenatide. It is an injectable medicine used to improve blood glucose control in adults with type 2 diabetes mellitus.
Bydureon is used in combination with the following medicines to treat diabetes: metformin, sulfonylureas, thiazolidinediones. Your doctor now appoints you Bydureon as an additional medicine to help control your blood sugar. Continue to follow your diet and exercise schedule.
You have diabetes because your body does not produce enough insulin to control the level of sugar in your blood or your body can not properly use insulin. The drug in Bydureon helps your body increase insulin production when your blood sugar is high.
2. What you need to know before using Bydureon
Do not use Bydureon:
If you are allergic to exenatide or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Before using Bydureon, talk to your doctor, pharmacist or diabetes nurse about the following:
When used in combination with a sulphonylurea as there may be more than the necessary reduction in blood glucose (hypoglycaemia). Check your blood sugar levels regularly. Ask your doctor, pharmacist or diabetes nurse if you are not sure if any of your other medicines is a sulphonylurea;
Bydureon should not be used if you have type 1 diabetes or diabetic ketoacidosis;
Bydureon should be injected into the skin rather than in a vein or muscle;
If you have severe problems with your stomach emptying (including gastroparesis) or digestion, the use of Bydureon is not recommended. Drug in Bydureon slows stomach emptying so that food passes more slowly through your stomach;
Tell your doctor if you have ever had a pancreatitis (see section 4);
If you lose weight too fast (more than 1.5 kg per week) tell your doctor as this may not be good for you;
He has little experience with Bydureon in patients with kidney problems. The use of Bydureon is not recommended if you have severe kidney disease or are on dialysis.
Children and adolescents
There is no experience with Bydureon in children and adolescents under 18 years of age and therefore the use of Bydureon in this age group is not recommended.
Other Drugs and Bydureon
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including warfarin and non-prescription medicines.
The use of Bydureon with insulins and other medicines used to treat type 2 diabetes that is similar to Bydureon (for example: liraglutide and Byetta [exenatide twice daily] is not recommended).
Pregnancy and breastfeeding
Women of childbearing potential should use contraception while being treated with Bydureon. It is not known if Bydureon can harm your unborn child. If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine because Bydureon should not be used during pregnancy and for at least three months before Pregnancy.
It is not known whether the drug in Bydureon passes into breast milk. Bydureon should not be used during breast-feeding.
Driving and using machines
If you use Bydureon in combination with a sulphonylurea, a decrease in blood glucose (hypoglycaemia) may occur. Hypoglycaemia may reduce your ability to concentrate. Please keep in mind this possible problem in all situations where you may expose yourself and others to risk (eg driving or using machines).
Important information about some of the ingredients of Bydureon
This medicine contains less than 1 mmol sodium (23 mg) per dose, ie. Practically does not contain sodium.
How to use Bydureon
Always use this medicine exactly as your doctor, pharmacist or diabetes nurse has told you. If you are not sure, ask your doctor, pharmacist or diabetes nurse.
Bydureon 2 mg should be injected once a week, at any time of the day, with or without food.
Bydureon is injected into the skin (subcutaneous injection) in the abdomen, upper leg (thigh) or back of the arm (arm).
Every week you can use the same area of your body. Make sure you have chosen a different injection site in the same area.
Check your blood sugar regularly, this is especially important if you also use a sulphonylurea.
See the User Guides provided in the carton to inject Bydureon.
It is recommended that your healthcare professional teach you how to inject Bydureon before using it for the first time. You should carefully observe the "User Guides" provided in the carton.
Before you start, check that the liquid in the pen is clear and free of particles. After mixing the liquid with the powder, use the suspension only if the mixture is white to off-white and cloudy. If you see lumps of dry powder on the walls of the pen, the medicine is NOT mixed well. Kneep again vigorously until it blends well.
Bydureon should be injected immediately after mixing the powder and solvent.
For each injection, use a new pen and discard it after each use.
If you have taken more than the required dose of Bydureon
If you have taken more than the required dose of Bydureon, you may need medical treatment. More than the required dose of Bydureon may cause nausea, vomiting, dizziness, or symptoms of low blood sugar (see section 4).
If you forget to use Bydureon
You may have chosen the day you are planning to inject Bydureon. If a missed dose is given, it should be given as soon as practicable. For the next injection, you can go back to your chosen injection day. However, it should be borne in mind that within 24 hours you can only inject once. You can also change the selected injection day. Do not take two injections on the same day.
If you are not sure that you have received the entire dose of Bydureon
If you are not sure whether you have taken your entire dose, do not inject another dose of Bidireon, just apply it the next week as planned.
If you stop using Bydureon
If you have the feeling that you should stop using Bydureon, please ask your doctor first. If you stop using Bydureon, it may affect your blood sugar levels.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or diabetes nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone gets them.
Severe allergic reactions (anaphylaxis) have been reported (frequency not known: can not be estimated from the available data).
You should immediately consult your doctor if you experience symptoms such as:
Swelling of the face, tongue or throat;
Urticaria and difficulty breathing.
Cases of inflammation of the pancreas (pancreatitis) have been reported with an unknown incidence in patients using Bydureon. Pancreatitis may be a serious, potentially life-threatening disease.
Tell your doctor if you have had pancreatitis, gallstones, alcoholism or very high triglycerides. These diseases may increase your risk of developing pancreatitis or develop it again, whether or not you are using Bydureon;
Stop taking Bydureon and contact your doctor immediately if you experience severe and permanent abdominal pain with or without vomiting because you may have an inflamed pancreas (pancreatitis).
Very common side effects of Bydureon (may affect more than 1 in 10 people):
Nausea (nausea is most common when you first start Bydureon, but most patients decrease over time);
Diarrhea or constipation;
Injection site reactions - If you have a reaction at the injection site (redness, rash or itching), you may ask your doctor for something to help relieve signs or symptoms. You may see or feel a small lump under the skin after the injection, it will disappear after 4 to 8 weeks. You should not stop your treatment;
Hypoglycaemia - When Bydureon is used with a medicinal product that contains a sulphonylurea, blood glucose lowering episodes (hypoglycaemia, usually mild to moderate) may occur. When using Bydureon, the dose of your sulphonylurea may need to be reduced. Signs and symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, wheezing, sweating, and nervousness. Your doctor will advise you on how to act in case of low blood sugar.
Common side effects of Bydureon (may affect up to 1 in 10 people):
Reduced appetite - Bydureon may reduce your appetite, the amount of food you take and your body weight. If you lose too quickly (more than 1.5 kg per week) tell your doctor as this may not be good for you.
Uncommon side effects of Bydureon or those with an unknown frequency (may affect up to 1 in 100 people):
Angioedema (swelling of the face and throat);
Decreased kidney function;
Hypersensitivity (rash, pruritus and swelling of the tissues of the neck, face, mouth or throat);
Intestinal obstruction (bowel obstruction);
Injection site reactions. Skin reactions at the injection site were reported after injection of exenatide. These include: a cavity filled with pus (abscess) and a swollen, red area of the skin that feels burning and is painful (cellulite).
In addition, some other side effects have been observed in patients using Bydureon or a product that has the same active ingredient as Bydureon:
Unusual taste in the mouth.
Rare (may affect up to 1 in 1,000 people):
Dehydration, sometimes with reduced kidney function;
Changes in INR (blood clotting study) have been reported with concomitant use of warfarin.
Reporting of side effects
If any of the side effects gets serious, tell your doctor, pharmacist or diabetes nurse. This includes all possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system. As you report side effects, you can contribute to getting more information about the safety of this medicine.
5. How to store Bydureon
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2 ° C to 8 ° C). Do not freeze.
The pen may be stored for up to 4 weeks below 30 ° C before use.
Store in the original package in order to protect from light.
Discard any Bydureon pen that is frozen.
Do not dispose of medicines in the sewers or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Package Contents and Additional Information
What Bydureon Contains:
The active ingredient is exenatide. Each pre-filled pen contains 2 mg of exenatide. After the suspension, the dose delivered is 2 mg / 0.65 ml.
The other ingredients are:
Powder: poly (D, L-lactide-co-glycolide) and sucrose;
In the solvent: carmellose sodium, sodium chloride, polysorbate 20, sodium dihydrogenphosphate monohydrate, disodium hydrogen phosphate heptahydrate, water for injection and sodium hydroxide (for pH adjustment).
What Bydureon looks like and contents of the pack:
This drug is available as a powder and solvent for suspension for injection in a pre-filled pen.
The powder (2 mg) in one chamber is white to off-white and the solvent (0.65 ml) is a clear, colorless to pale yellow or pale brown solution.
Each single-dose pen is provided with one injection needle. Each package also contains a spare needle.
Bydureon is available in a pack of 4 single-dose pre-filled pens and a pack containing 12 (3 packs of 4) single-dose pre-filled pens.
Not all pack sizes may be marketed.
Your step-by-step guide
Bydureon 2 mg powder and solvent for prolonged-release suspension for injection.
If you have any questions about the use of Bydureon:
See Frequently Asked Questions and Answers.
Do not hurry.
Follow these instructions step by step.
You will need plenty of time to complete all the steps without stopping.
You may need less time when you get used to your own injections.
Read and follow each step of these instructions carefully each time you apply Bydureon. Do not miss the steps. Also read the Package Leaflet in your cardboard box.
Your parts manual
To apply the exact dose, read each point so you can perform each step according to the established order.
This handbook is divided into the following points:
2. Joining parts
3. Mixing the drug and filling the syringe
4. Injecting the medicine
Frequently asked questions and answers.
1a) Remove the single-dose kit from the refrigerator.
Prepare to safely dispose of used needles and syringes. Prepare what you need to dispose of safely used needles and syringes.
1b) Wash your hands.
1c) To open, remove the cover.
Remove the syringe. The solution in the syringe should be clear and free of particles. It is normal if there are bubbles of air.
Put the needle, the vial connector and the syringe on a clean, even surface.
1d) Take the needle and rotate until you remove the blue cap.
Leave the covered needle. The needle is now ready. You will need it later. There is a spare needle in case you need it.
1e) Take the vial.
Tap the vial several times on a hard surface to loosen the powder.
1f) Use your thumb to remove the green cap.
Leave the vial.
2. Joining parts
2a) Lift the container with the vial connector and remove the paper cover. Do not touch the orange connector that is inside.
2b) Keep the container with the vial connector. With the other hand, grasp the vial.
2c) Firmly press the top of the vial into the orange connector.
2d) Remove the vial, with the already attached orange connector, from a pack.
2e) So it should look like the vial now.
Leave it for later.
2f) Take the syringe.
With the other hand, grasp the two gray squares on the white cap.
2g) Break it down!
Break the cap.
Be careful not to push the plunger.
The cap breaks just like a stick breaks.
2h) You will not need the cap and you can throw it away.
2i) Now lift the vial with the orange connector attached to it.
Screw the orange connector onto the syringe until it snaps tight. Keep the orange connector while turning. Do not over-tighten. Be careful not to push the plunger.
3. Mixing the drug and filling the syringe
In the next steps, you will mix the medicine and fill the syringe. Once you mix the medicine, you need to inject it immediately. You should not keep the mixed medicine to inject it later.
3a) With your thumb press down on the plunger all the way down and hold.
You may feel that the piston seems to bounce back a little.
3b) Hold the pressure on the plunger with your thumb and shake vigorously. Continue to shake until the liquid and the powder blend well.
Do not worry that the vial may crash. The orange connector will keep it attached to the syringe.
Shake vigorously as you shake the yoghurt container.
3c) When the medicine is mixed well, it should look muddy.
If you see clumps of dry powder on the walls or the bottom of the vial, the medicine is NOT mixed well.
Shake vigorously again until it blends well.
Hold the plunger with your thumb while shaking.
3e) Now hold the vial so that the syringe is pointing upwards. Hold down the plunger with your thumb until it stops and holds.
3f) Carefully tap the vial
You can inject each dose of the medicine into the abdomen, thigh or back of your arm.
Every week you can use the same area of your body, but make sure you use a different injection site in this area.
4e) Keep the syringe near the black dashed line of the dose.
Directly pull the needle cap.
Do not turn around.
Be careful not to push the plunger.
When you remove the cap, you may see 1 or 2 drops of liquid. This is normal.
4g) Make sure you are using the injection technique recommended by your healthcare professional.
Remember: You must administer your Bydureon injection immediately after mixing.
Put the needle in your skin (subcutaneously). To inject your entire dose, press the plunger fully with your thumb.
Pull the needle.
Refer to the package leaflet (section 3) for what to do if you are not sure whether you have received the entire dose.
4h) Put the cap back on the needle. Discard the syringe with the needle still attached and covered as instructed by your healthcare professional.
There is no need to keep any parts. Each single dose kit contains everything you need for your weekly dose of Bydureon.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of your unnecessary medicines. These measures will help to protect the environment.
When it comes to your next weekly dose, start over again from step 1.
Frequently Asked Questions and Answers
1. After mixing the medicine, how long can I wait before I make the injection?
You should make your Bydureon injection immediately after mixing. If you do not inject Bydureon immediately, the medicine will start to form small lumps in the syringe. These lumps could block the needle when you inject (see question 7).
2. How do I know that the drug is mixed well?
When the medicine is mixed well, it should look muddy. There should be no dry powder on the walls or bottom of the vial. If you see some dry powder, shake vigorously while you press the plunger with your thumb. (This question relates to the steps outlined in points 3a to 3d).
3. I'm ready to get an injection. What should I do if I see air bubbles in the syringe?
It is normal for air bubbles to be present in the syringe. Air bubbles will not hurt or affect your dose. Bydureon is injected into the skin (subcutaneously). Air bubbles are not a problem with this type of injection.
4. What should I do if I pinch the needle with difficulty?
First, make sure you've removed the blue cap. Then, rotate the needle on the syringe until it snaps tight. To prevent drug loss, do not push the plunger until you attach the needle. For more information about the injection technique, talk to your healthcare professional. (This question relates to step 4a)
5. What should I do if I have a problem removing the needle cap?
With one hand, hold the syringe near the black line of the Dose Line. With the other hand, hold the needle cap. Directly pull the needle cap. Do not rotate it. (This question relates to step 4f.)
6. I am in step 4c) What should I do if the tip of the plunger is pushed behind the black line of the Dose Line?
The black line of the Dose Line shows the exact dose. If the tip of the plunger is pushed past the line, you should proceed from step 4d) and make the injection. Before your next injection after 1 week, carefully review the instructions for steps 3a to 4h).
7. When I inject, what should I do if I can not push the plunger all the way?
This means that the needle is clogged. Remove the needle and replace it with the spare needle from your kit. Then choose another injection site and complete the injection.
To see how to:
Remove the blue needle cap, see step 1d);
Attach the needle, see step 4a);
Remove the needle cap and make the injection, see steps 4e) to 4g).
If you still can not press the plunger fully, remove the needle. Carefully replace the needle cap. See the package leaflet (section 3) about what to do if you are not sure whether you have received the full dose.
To prevent clogging of the needle, always mix the medicine very well and inject immediately after mixing.
Bydureon should only be administered once a week.
Note that you have used Bydureon today and save on your calendar when you need to take another injection.
Where To Learn About Bydureon:
Talk to your healthcare professional;
Read the Patient Leaflet carefully.
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