Country: Европска Унија
Језик: Енглески
Извор: EMA (European Medicines Agency)
insulin glargine, lixisenatide
Sanofi Winthrop Industrie
A10AE
insulin glargine, lixisenatide
Drugs used in diabetes
Diabetes Mellitus, Type 2
Suliqua is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise in addition to metformin with or without SGLT-2 inhibitors.,
Revision: 12
Authorised
2017-01-11
39 B. PACKAGE LEAFLET 40 PACKAGE LEAFLET: INFORMATION FOR THE USER SULIQUA 100 UNITS/ML + 50 MICROGRAMS/ML SOLUTION FOR INJECTION IN PRE-FILLED PEN Insulin glargine + lixisenatide READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 or 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Suliqua is and what it is used for 2. What you need to know before you use Suliqua 3. How to use Suliqua 4. Possible side effects 5. How to store Suliqua 6. Contents of the pack and other information 1. WHAT SULIQUA IS AND WHAT IT IS USED FOR Suliqua is an injectable diabetes medicine that contains two active substances: • insulin glargine: a long-acting type of insulin which helps control blood sugar (glucose) throughout the day. • lixisenatide: a “GLP-1 analogue” that helps the body produce its own additional insulin in response to increases in blood sugar, and slows the absorption of sugar from foods. Suliqua is used to treat adults with type 2 diabetes, to help control blood sugar levels when they are too high, it is an adjunct to diet and exercise. It is given, with metformin with or without sodium- glucose co-transporter-2 (SGLT2) inhibitors (gliflozin products), when other medicines are not enough on their own to control your blood sugar levels. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE SULIQUA DO NOT USE SULIQUA: • if you are allergic to insulin glargine or lixisenatide or to any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your doctor, pharmacist or nurse before using Suliqua if: • you have ty Прочитајте комплетан документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Suliqua 100 units/ml + 50 micrograms/ml solution for injection in pre-filled pen Suliqua 100 units/ml + 33 micrograms/ml solution for injection in pre-filled pen 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Suliqua 100 units/ml + 50 microgram/ml solution for injection in pre-filled pen Each pre-filled pen contains 300 units of insulin glargine* and 150 micrograms lixisenatide in 3 ml solution. Each ml contains 100 units of insulin glargine and 50 micrograms of lixisenatide. Each dose step contains 1 unit of insulin glargine and 0.5 micrograms of lixisenatide Suliqua 100 units/ml + 33 microgram/ml solution for injection in pre-filled pen Each pre-filled pen contains 300 units of insulin glargine and 100 micrograms of lixisenatide in 3 ml solution. Each ml contains 100 units of insulin glargine and 33 micrograms of lixisenatide. Each dose step contains 1 unit of insulin glargine and 0.33 micrograms of lixisenatide *Insulin glargine is produced by recombinant DNA technology in _Escherichia coli_ . The dose window on the pen shows the number of dose steps. Excipient(s) with known effects Each ml contains 2.7 milligrams of metacresol. For the full list of excipients, see section 6.1. _ _ 3. PHARMACEUTICAL FORM Solution for injection in pre-filled pen (SoloStar) Clear colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Suliqua is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise in addition to metformin with or without sodium-glucose co-transporter-2 (SGLT-2) inhibitors. For study results with respect to effect on glycaemic control, and the populations studied, see section 4.4 and 5.1. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Suliqua is available in two pre-filled pens, providing different dosing options, i.e., Suliqua (10-40) pen, Suliqua (30-60) pen respectively. The differentiation between the pen strengths is Прочитајте комплетан документ