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 详细处方信息以本药内容附件PDF文件（20127522270516.PDF）的“原文Priscribing Information”为准
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 部分中文Kombiglyze XR处方资料（仅供参考）

阿斯利康和施贵宝糖尿病药Kombiglyze XR获FDA批准
    近日，阿斯利康和百时美-施贵宝共同推出的药物Kombiglyze XR已获得FDA批准用于治疗2型糖尿病成人患者。
　　Kombiglyze XR每日用药一次，是一种复方制剂，同时含有缓释型甲福明二甲双胍和DPP-4抑制剂两种成分，可以控制血糖水平——包括糖化血蛋白水平(HbA1c)、空腹血糖水平和饭后血糖水平。
　　Kombiglyze XR主要是作为一种辅助药物，用于那些适合同时采用saxagliptin(商品名为Onglyza)和甲福明二甲双胍治疗的2型糖尿病患者，再结合饮食和运动帮助他们控制血糖水平。
　　这次获准的依据是该药在一系列临床实验中获取的数据，其中包括两项III期临床实验和一项生物等效性实验，后者从疗效和安全性对saxagliptin和甲福明二甲双胍IR两种单独药物合用和安慰剂+甲福明二甲双胍IR进行了检测。
　　Kombiglyze XR和saxagliptin+甲福明二甲双胍XR(两种单独药物联用)的生物等效性也在实验中得到了证实。
　　2007年1月份，百时美-施贵宝和阿斯利康达就达成了一份合作协议，双方将联手研究、开发并推广2型糖尿病治疗药。

Kombiglyze^TM被建议在欧盟获批
    欧洲人用医疗产品委员会对批准Kombiglyze^TM的上市授权持积极意见。本品是一种含有saxagliptin和缓释盐酸二甲双胍（2．5／850m和2．5／1000mg）的膜衣片，计划用于治疗2型糖尿病患者。

WHAT IS KOMBIGLYZE XR?
KOMBIGLYZE XR is a prescription medicine that contains saxagliptin and metformin hydrochloride. KOMBIGLYZE XR is used with diet and exercise to help control high blood sugar (hyperglycemia) in adults with type 2 diabetes. Your doctor will decide if treatment with both saxagliptin and metformin is right for you.

KOMBIGLYZE XR should not be used to treat people with type 1 diabetes or diabetic ketoacidosis (increased ketones in the blood or urine).

If you have had inflammation of the pancreas (pancreatitis), it is not known if you have a higher chance of getting pancreatitis while taking KOMBIGLYZE XR.

IMPORTANT SAFETY INFORMATION for KOMBIGLYZE XR (saxagliptin and metformin HCI extended-release) tablets
Lactic Acidosis: Metformin hydrochloride, one of the medicines in KOMBIGLYZE XR, can cause a rare, but serious, side effect called lactic acidosis (a build-up of lactic acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital. Stop taking KOMBIGLYZE XR and call your doctor right away if you get any of the following symptoms of lactic acidosis: feel very weak and tired, unusual (not normal) muscle pain, trouble breathing, unusual sleepiness or sleep longer than usual, unexplained stomach or intestinal problems with nausea and vomiting or diarrhea, feel cold (especially in your arms and legs), dizzy or lightheaded, or have a slow or irregular heartbeat.

You have a higher chance of getting lactic acidosis if you have kidney or liver problems, have congestive heart failure that requires treatment with medicines, drink a lot of alcohol (very often or short-term “binge” drinking), get dehydrated (lose a large amount of body fluids), have certain x-ray tests with injectable dyes or contrast agents, have surgery, have a heart attack, severe infection, or stroke, or are 80 years of age or older and have not had your kidney function tested.

Do not take KOMBIGLYZE XR if you have kidney problems, have a condition called metabolic acidosis or diabetic ketoacidosis (increased ketones in the blood or urine), or are allergic to metformin hydrochloride, saxagliptin, or any of the ingredients in KOMBIGLYZE XR. Serious allergic reactions can occur with KOMBIGLYZE XR and may include swelling of the face, lips or throat, difficulty swallowing or breathing, swelling of the skin, hives, rash, itching, flaking, or peeling. If you have these symptoms, stop taking KOMBIGLYZE XR and contact your doctor right away.

Serious side effects can happen to people taking KOMBIGLYZE XR, including inflammation of the pancreas (pancreatitis) which may be severe and lead to death. Before taking KOMBIGLYZE XR, tell your doctor if you ever had pancreatitis, gallstones, history of alcoholism, or high triglyceride levels. Stop taking KOMBIGLYZE XR and contact your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis.

Your doctor should do blood tests to check how well your kidneys are working before and during your treatment with KOMBIGLYZE XR.

If you take KOMBIGLYZE XR with another medicine that can cause low blood sugar (hypoglycemia), such as sulfonylureas or insulin, you have a higher risk of having low blood sugar. Symptoms of low blood sugar include, shaking, sweating, rapid heartbeat, change in vision, hunger, headache and change in mood. Follow your doctor's instructions for treating low blood sugar.

The most common side effects of KOMBIGLYZE XR include upper respiratory tract infection, stuffy or runny nose and sore throat, urinary tract infection, headache, diarrhea, and nausea and vomiting.

Tell your doctor if you will be starting or stopping certain other types of medicines, such as antibiotics, or medicines that treat fungus or HIV/AIDS, as your doctor may need to change your dose of KOMBIGLYZE XR.

Tell your doctor if you are pregnant, breast-feeding, or plan to become pregnant or breast-feed.

Swallow KOMBIGLYZE XR whole; do not crush, cut, or chew.

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 详细处方信息以本药内容附件PDF文件（20127522270516.PDF）的“原文Priscribing Information”为准
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