Land: Malaysia
Språk: engelsk
Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
EXENATIDE
ASTRAZENECA SDN. BHD.
EXENATIDE
4units Units; 4units Units; 4units Units; 4units Units
Amylin Ohio LLC
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 Les hele dokumentet
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 Les hele dokumentet