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--------------------------------------------------------------- 详细处方信息以本药内容附件PDF文件(201412119241519.pdf)的“原文Priscribing Information”为准 --------------------------------------------------------------- 部分中文Forxiga处方资料(仅供参考)
AstraZeneca (NYSE : AZN) 和百時美施貴寶公司 (NYSE : ) 今天宣佈的 BMY 美國食品藥品監督管理局 (FDA)承認了新的藥物應用重新提交的收貨 (NDA)調查藥物 dapagliflozin 的成人的處理的與第二類型糖尿病的。 糧食與藥物管理局分配了一個新的處方藥用戶費操作 (PDUFA)目標日期 2014年 1月 11日。
dapagliflozin 第2/3階段臨床發展方案在 26 次臨床試驗包括了超過有糖尿病 (超過 8,000 名患者被接受的 dapagliflozin) 的 12,000 名成人病人。 以回應請求糧食與藥物管理局的 1月 2012 完全回應的信函另外的數據允許對 dapagliflozin 福利風險配置文件的一個更好的鑒定, NDA 重新提交包括幾個新的研究和另外的長期數據 (四年的期限) 從以前被提交的研究,造成一名整體增量患者 - 幾年暴露對超過 50% dapagliflozin。
Dapagliflozin,一種調查化合物,是一種有選擇性和可逆抗化劑鈉葡萄糖 cotransporter 2 (SGLT2),獨立胰島素運作。 它為第二類型糖尿病的處理當前被審批在歐盟、澳大利亞、巴西、墨西哥和新西蘭。
WHAT IS FARXIGA (dapagliflozin)?
FARXIGA is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
FARXIGA should not be used to treat people with type 1 diabetes or diabetic ketoacidosis (increased ketones in your blood or urine).
IMPORTANT SAFETY INFORMATION FOR FARXIGA
Do not take FARXIGA if you are allergic to dapagliflozin or any of the ingredients in FARXIGA. Symptoms of a serious allergic reaction to FARXIGA may include: skin rash, raised red patches on your skin (hives), swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing. If you have any of these symptoms, stop taking FARXIGA and contact your healthcare provider or go to the nearest hospital emergency room right away.
Do not take FARXIGA if you have severe kidney problems or are on dialysis. Your healthcare provider should do blood tests to check how well your kidneys are working before and during your treatment with FARXIGA.
Serious side effects can happen in people who take FARXIGA, including:
Dehydration (the loss of body water and salt) which may cause you to feel dizzy, faint, lightheaded, or weak, especially when you stand up (orthostatic hypotension). You may be at a higher risk of dehydration if you have low blood pressure, take medicines to lower your blood pressure, including water pills (diuretics), are 65 years of age or older, are on a low salt diet, or have kidney problems.
Low blood sugar (hypoglycemia) can occur if you take FARXIGA with another medicine that can cause low blood sugar, such as sulfonylureas or insulin. Symptoms of low blood sugar include, shaking, sweating, fast heartbeat, dizziness, hunger, headache and irritability. Follow your healthcare provider's instructions for treating low blood sugar.
Vaginal yeast infections in women who take FARXIGA. Talk to your healthcare provider if you experience vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese), or vaginal itching.
Yeast infection of skin around the penis (balanitis) in men who take FARXIGA. Talk to your healthcare provider if you experience redness, itching, or swelling of the penis; rash of the penis; foul smelling discharge from the penis; or pain in the skin around penis. Certain uncircumcised men may have swelling of the penis that makes it difficult to pull back the skin around the tip of the penis.
Increase in bad cholesterol (LDL-C). Your healthcare provider should check your LDL-C during treatment with FARXIGA.
Bladder cancer. In studies of FARXIGA in people with diabetes, bladder cancer occurred in a few more people who were taking FARXIGA than in people who were taking other diabetes medications. There were too few cases of bladder cancer to know if bladder cancer was related to FARXIGA. Tell your healthcare provider right away if you have blood or a red color in your urine or pain while you urinate.
Kidney problems |