Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
dulaglutide
Eli Lilly Nederland B.V.
A10BJ05
dulaglutide
Drugs used in diabetes, Blood glucose lowering drugs, excl. insulins
Diabetes Mellitus, Type 2
Trulicity is indicated for the treatment of patients 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance or contraindicationsin addition to other medicinal products for the treatment of diabetes.For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.
Revision: 17
Authorised
2014-11-21
72 B. PACKAGE LEAFLET 73 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TRULICITY 0.75 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN TRULICITY 1.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN TRULICITY 3 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN TRULICITY 4.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN dulaglutide READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Trulicity is and what it is used for 2. What you need to know before you use Trulicity 3. How to use Trulicity 4. Possible side effects 5. How to store Trulicity 6. Contents of the pack and other information 1. WHAT TRULICITY IS AND WHAT IT IS USED FOR Trulicity contains an active substance called dulaglutide and is used to lower blood sugar (glucose) in adults and children aged 10 years and above, with type 2 diabetes mellitus and can help prevent heart disease. Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should. When this happens, sugar (glucose) builds up in the blood. Trulicity is used: - on its own if your blood sugar is not properly controlled by diet and exercise alone, and you can’t take metformin (another diabetes medicine). - or with other medicines for diabetes when they are not enough to control your blood sugar levels. These other medicines may be medicines taken by mouth and/or insulin given by injection. It is important to continue to follow the advice on diet and exercise given to you by your doctor, pharmac Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Trulicity 0.75 mg solution for injection in pre-filled pen Trulicity 1.5 mg solution for injection in pre-filled pen Trulicity 3 mg solution for injection in pre-filled pen Trulicity 4.5 mg solution for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Trulicity 0.75 mg solution for injection in pre-filled pen Each pre-filled pen contains 0.75 mg of dulaglutide* in 0.5 ml solution. Trulicity 1.5 mg solution for injection in pre-filled pen Each pre-filled pen contains 1.5 mg of dulaglutide* in 0.5 ml solution. Trulicity 3 mg solution for injection in pre-filled pen Each pre-filled pen contains 3 mg of dulaglutide* in 0.5 ml solution. Trulicity 4.5 mg solution for injection in pre-filled pen Each pre-filled pen contains 4.5 mg of dulaglutide* in 0.5 ml solution. *produced in CHO cells by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Type 2 Diabetes Mellitus Trulicity is indicated for the treatment of patients 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise • as monotherapy when metformin is considered inappropriate due to intolerance or contraindications • in addition to other medicinal products for the treatment of diabetes. For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1. 3 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ _ Posology _Adults _ _ _ _Monotherapy _ The recommended dose is 0.75 mg once weekly. _Add-on therapy_ The recommended dose is 1.5 mg once weekly. If needed, • the 1.5 mg dose can be increased after at least 4 weeks to 3 mg once weekly. • the 3 mg dose can be increased after at least 4 weeks to 4.5 mg once weekly. The maximum dose is 4.5 mg once weekly. _Paediatri Aqra d-dokument sħiħ