国家: 欧盟
语言: 英文
来源: EMA (European Medicines Agency)
Saxagliptin
AstraZeneca AB
A10BH03
saxagliptin
Drugs used in diabetes
Diabetes Mellitus, Type 2
Add-on combination therapyOnglyza is indicated in adult patients aged 18 years and older with type-2 diabetes mellitus to improve glycaemic control:as monotherapy:in patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to contraindications or intolerance;as dual oral therapy:in combination with metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control;in combination with a sulphonylurea, when the sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate;in combination with a thiazolidinedione, when the thiazolidinedione alone with diet and exercise, does not provide adequate glycaemic control in patients for whom use of a thiazolidinedione is considered appropriate;as triple oral therapy:in combination with metformin plus a sulphonylurea when this regimen alone, with diet and exercise, does not provide adequate glycaemic control;as combination therapy with insulin (with or without metformin), when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.
Revision: 22
Authorised
2009-09-30
34 B. PACKAGE LEAFLET 35 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ONGLYZA 2.5 MG FILM-COATED TABLETS Saxagliptin 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 Onglyza is and what it is used for 2. What you need to know before you take Onglyza 3. How to take Onglyza 4. Possible side effects 5. How to store Onglyza 6. Contents of the pack and other information 1. WHAT ONGLYZA IS AND WHAT IT IS USED FOR Onglyza contains the active substance saxagliptin, which belongs to a group of medicines called ‘oral anti-diabetics’. They work by helping to control the level of sugar in your blood. Onglyza is used for adult patients aged 18 years and older with ‘type 2 diabetes’, if the disease cannot be adequately controlled with one oral anti-diabetic medicine, diet and exercise. Onglyza is used alone or together with insulin or other anti-diabetic medicines. It is important to keep following the advice about diet and exercise that you have been given by your doctor or nurse. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ONGLYZA DO NOT TAKE ONGLYZA if you are allergic to saxagliptin or any of the other ingredients of this medicine (listed in section 6). if you have had a serious allergic reaction to any other similar medicines that you take to control your blood sugar. See section 4. WARNINGS AND PRECAUTIONS: Talk to your doctor or pharmacist before taking Onglyza: if you are taking insulin. Onglyza should not be used in place of insulin; if you have type 1 diabetes (your 阅读完整的文件
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Onglyza 2.5 mg film-coated tablets Onglyza 5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Onglyza 2.5 mg film-coated tablets Each tablet contains 2.5 mg saxagliptin (as hydrochloride). Onglyza 5 mg film-coated tablets Each tablet contains 5 mg saxagliptin (as hydrochloride). Excipient(s) with known effect: Each tablet contains 99 mg lactose (as monohydrate). Onglyza contains less than 1 mmol sodium (23 mg) per dose, i.e. is essentially ‘sodium-free’. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Onglyza 2.5 mg film-coated tablets Onglyza 2.5 mg tablets are pale yellow to light yellow, biconvex, round, film-coated tablets, with “2.5” printed on one side and “4214” printed on the other side, in blue ink. Onglyza 5 mg film-coated tablets Onglyza 5 mg tablets are pink, biconvex, round, film-coated tablets, with “5” printed on one side and “4215” printed on the other side, in blue ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Onglyza is indicated in adult patients with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control: as monotherapy when metformin is inappropriate due to intolerance or contraindications in combination with other medicinal products for the treatment of diabetes, including insulin, when these do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose of Onglyza is 5 mg once daily. When Onglyza is used in combination with insulin or a sulphonylurea, a lower dose of the insulin or sulphonylurea may be required to reduce the risk of hypoglycaemia (see section 4.4). The safety and efficacy of saxagliptin as triple oral therapy in combination with metformin and a thiazolidinedione have not been established. 3 Special populations Elderly (≥ 65 阅读完整的文件