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  药店国别: 英国药房
产地国家: 英国
所属类别: 糖尿病->2型糖尿病
处方药:处方药
包装规格: 5毫克/1000毫完 56片/盒
计价单位:
   
生产厂家中文参考译名:
施贵宝-阿斯利康
生产厂家英文名:
Bristol Myers Squibb
该药品相关信息网址1:
http://www.astrazeneca.com/Media/Press-releases/Article/20142101--xigduo-dapagliflozin-and-metformin-hydrochloride
原产地英文商品名:
Xigduo 5mg/1000mg 56 Tablets (Minimum order qty: 10)
原产地英文药品名:
Dapagliflozin and Metformin HCL
中文参考商品译名:
达格列净 5毫克/1000毫完 56片/盒 (最低订货量:10)
中文参考药品译名:
盐酸二甲双胍复方片
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Type 2 Diabetes
临床试验期:
完成
中文适应病症参考翻译1:
2型糖尿病
药品信息:
英文药名:Xigduo(dapagliflozin+metformin)Tablet 中文药名:达格列净/盐酸二甲双胍复方片 生产厂家:阿斯利康和百时美施贵宝 药品介绍: 名称:达格列净+二甲双胍片 英文名:dapagliflozin/metformin 商品名:Xigduo 规格:5mg/850mg 5mg/1000 mg 厂家:施贵宝-阿斯利康 Xigduo (dapagliflozin + metformin): first SGLT2 inhibitor combination tablet Xigduo (dapagliflozin + metformin) has been launched for the treatment of type II diabetes. The twice-daily combination tablet, launched by Bristol-Myers Squibb and AstraZeneca, contains the sodium-glucose cotransporter 2 (SGLT2) inhibitor, dapagliflozin, and the biguanide, metformin. Xigduo is licensed for use alongside diet and exercise to treat type II diabetes in adults who are inadequately controlled on metformin alone, inadequately controlled on other hypoglycaemic agents (including insulin) plus metformin, or currently taking the combination as separate tablets. Xigduo is given as a single tablet twice daily and is available in two strengths: dapagliflozin 5mg/metformin 850mg and dapagliflozin 5mg/metformin 1g. Prescribers should select the initial dose of Xigduo based on the patient's current metformin dose. Both strengths cost £36.59 for 56 tablets. If Xigduo is to be added to a regimen containing insulin or a sulfonylurea, prescribers should consider reducing the dose of insulin and/or sulfonylurea to reduce the risk of hypoglycaemia. Xigduo 5 mg/850 mg & 5 mg/1,000 mg film coated tablets 1. Name of the medicinal product Xigduo 5 mg/850 mg film-coated tablets Xigduo 5 mg/1,000 mg film-coated tablets 2. Qualitative and quantitative composition 5 mg/850 mg: Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 850 mg of metformin hydrochloride. For the full list of excipients, see section 6.1. 5 mg/1,000 mg: Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 1,000 mg of metformin hydrochloride. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet (tablet). 5 mg/850 mg: Brown, biconvex, 9.5 x 20 mm oval, film-coated tablets engraved with “5/850” on one side and “1067” engraved on the other side. 5 mg/1,000 mg: Yellow, biconvex, 10.5 x 21.5 mm oval, film-coated tablets engraved with “5/1000” on one side and “1069” engraved on the other side. 4. Clinical particulars 4.1 Therapeutic indications Xigduo is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control • in patients inadequately controlled on their maximally tolerated dose of metformin alone • in combination with other glucose-lowering medicinal products, including insulin, in patients inadequately controlled with metformin and these medicinal products (see sections 4.4, 4.5 and 5.1 for available data on different combinations) • in patients already being treated with the combination of dapagliflozin and metformin as separate tablets. 4.2 Posology and method of administration Posology For patients inadequately controlled on metformin monotherapy or metformin in combination with other glucose-lowering medicinal products including insulin The recommended dose is one tablet twice daily. Each tablet contains a fixed dose of dapagliflozin and metformin (see section 2). Patients not adequately controlled on metformin alone or in combination with other glucose-lowering medicinal products, including insulin, should receive a total daily dose of Xigduo equivalent to dapagliflozin 10 mg, plus the total daily dose of metformin, or the nearest therapeutically appropriate dose, already being taken. When Xigduo is used in combination with insulin or an insulin secretagogue such as sulphonylurea, a lower dose of insulin or sulphonylurea may be considered to reduce the risk of hypoglycaemia (see sections 4.5 and 4.8). For patients switching from separate tablets of dapagliflozin and metformin Patients switching from separate tablets of dapagliflozin (10 mg total daily dose) and metformin to Xigduo should receive the same daily dose of dapagliflozin and metformin already being taken or the nearest therapeutically appropriate dose of metformin. Special populations Renal impairment No dose adjustment is recommended for patients with mild renal impairment. This medicinal product must not be used in patients with moderate to severe renal impairment (patients with creatinine clearance [CrCl] < 60 ml/min or estimated glomerular filtration rate [eGFR] < 60 ml/min/1.73 m2, see sections 4.3, 4.4, 4.8, 5.1 and 5.2). Hepatic impairment This medicinal product must not be used in patients with hepatic impairment (see sections 4.3, 4.4 and 5.2). Elderly patients (≥ 65 years) Because metformin is eliminated in part by the kidney, and because elderly patients are more likely to have decreased renal function, this medicinal product should be used with caution as age increases. Monitoring of renal function is necessary to aid in prevention of metformin-associated lactic acidosis, particularly in elderly patients (see sections 4.3 and 4.4). Risk of volume depletion with dapagliflozin should also be taken into account (see sections 4.4 and 5.2). Due to the limited therapeutic experience with dapagliflozin in patients 75 years and older, initiation of therapy in this population is not recommended. Paediatric population The safety and efficacy of Xigduo in children and adolescents aged 0 to < 18 years have not yet been established. No data are available. Method of administration Xigduo should be given twice daily with meals to redu
更新日期: 2014-11-06
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