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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 Bydureon is used in combination with a sulphonylurea as there may be more than the necessary reduction in blood sugar (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 plan 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 of sodium (23 mg) per dose, ie. Practically does not contain sodium.
3. 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 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.
Your healthcare professional should teach you how to inject Bydureon before using it for the first time.
Before starting, check that the liquid in the syringe is clear and free of particles. After mixing, use the suspension only if the mixture is white to off-white and cloudy. If you see lumps of dry powder on the walls or bottom of the vial, the medicine is NOT mixed well. Shake vigorously again until it blends well.
Bydureon should be injected immediately after mixing the powder and solvent.
For each injection, use a new injection needle and dispose of 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) (not known) have been reported.
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 frequency 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);
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 kit can 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 kit that is frozen.
Do not dispose of medicines in the sewer 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 vial contains 2 mg of exenatide.
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 and water for injection.
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 solution is clear, colorless to pale yellow or pale brown solution.
Each single unit kit consists of one vial containing 2 mg of exenatide powder, one pre-filled syringe containing 0.65 ml of solvent, one vial connector and two injection needles. One needle is a backup.
There is a pack of 4 single-dose sets and a pack of 3 packs with 4 single-dose sets.
Not all pack sizes may be marketed.
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