Ország: Malajzia
Nyelv: angol
Forrás: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
dulaglutide
ZUELLIG PHARMA SDN BHD
dulaglutide
4pieces mL
ELI LILLY & CO
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ TRULICITY SOLUTION FOR INJECTION IN PRE-FILLED PEN Dulaglutide (0.75 mg, 1.5 mg) WHAT IS IN THIS LEAFLET 1. What Trulicity is used for 2. How Trulicity works 3. Before you use Trulicity 4. How to use Trulicity 5. While you are using Trulicity 6. Side effects 7. Storage and Disposal of Trulicity 8. Product Description 9. Manufacture and Product Registration Holder 10. Date of revision WHAT TRULICITY IS USED FOR 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 mealtime insulin given by injection HOW TRULICITY WORKS Trulicity contains an active substance called dulaglutide and is used to lower blood sugar (glucose) in adults with type 2 diabetes mellitus. 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. Your body can also make too much sugar. When this happens, sugar (glucose) builds up in the blood. BEFORE YOU USE TRULICITY _- When you must not use it _ DO NOT USE TRULICITY if you are allergic to dulaglutide or any of the other ingredients of this medicine (see section PRODUCT DESCRIPTION ). _Pregnancy and breast-feeding _ It is not known if dulaglutide could harm your unborn child. Women who could become pregnant should use contraception during treatment with dulaglutide. Tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby, as Trulicity should not be used during pregnancy. Talk to your doctor about the best way to control your blood sugar while you are pregnant. Talk to your doctor if you would like to or are breast-feeding before taking this medicine. Do not use Trulicity if you are breast-feeding. It is not known if dulaglutide passes int Olvassa el a teljes dokumentumot
TRULICITY 0.75 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN TRULICITY 1.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN TRULICITY 0.75 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN TRULICITY 1.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN NL033DAEN00 NL033DAEN00 EUSPC17JUN2021 TRULICITY ™ 0.75 MG OR 1.5 MG SOLUTION FOR INJECTION IN PRE-FILLED PEN Prescription only. 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 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. Not all strengths, pack sizes, or presentations may be marketed. *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 adults 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. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Monotherapy_ The recommended dose is 0.75 mg once weekly. _Add-on therapy_ The recommended dose is 1.5 mg once weekly. For potentially vulnerable populations 0.75 mg once weekly can be considered as a starting dose. When Trulicity is added to existing metformin and/or pioglitazone therapy, the current dose of metformin and/or pioglitazone can be continued. When Trulici Olvassa el a teljes dokumentumot