| 查看: 578 | 回复: 3 | |||
[交流]
求高人帮翻译一段说明书 急~
|
|||
|
1 General Responding patients may not experience an improvement in performance status on therapy and may experience worsening. The relationship between changes in performance status, response to therapy, and treatment-related side effects has not been established. 2 Cutaneous Localized erythema of the extremities with edema followed by desquamation has been observed. In case of severe skin toxicity, an adjustment in dosage is recommended [see Dose Adjustments During Treatment (2.7)]. The discontinuation rate due to skin toxicity was 1.6% (15/965) for metastatic breast cancer patients. Among 92 breast cancer patients premedicated with 3-day corticosteroids, there were no cases of severe skin toxicity reported and no patient discontinued TAXOTERE due to skin toxicity. 3 Fluid Retention Severe fluid retention has been reported following TAXOTERE therapy [see Boxed Warning, Premedication Regimen (2.6)]. Patients should be premedicated with oral corticosteroids prior to each TAXOTERE administration to reduce the incidence and severity of fluid retention [see Premedication Regimen (2.6)]. Patients with pre-existing effusions should be closely monitored from the first dose for the possible exacerbation of the effusions. When fluid retention occurs, peripheral edema usually starts in the lower extremities and may become generalized with a median weight gain of 2 kg. Among 92 breast cancer patients premedicated with 3-day corticosteroids, moderate fluid retention occurred in 27.2% and severe fluid retention in 6.5%. The median cumulative dose to onset of moderate or severe fluid retention was 819 mg/m2. 9.8% (9/92) of patients discontinued treatment due to fluid retention: 4 patients discontinued with severe fluid retention; the remaining 5 had mild or moderate fluid retention. The median cumulative dose to treatment discontinuation due to fluid retention was 1021 mg/m2. Fluid retention was completely, but sometimes slowly, reversible with a median of 16 weeks from the last infusion of TAXOTERE to resolution (range: 0 to 42+ weeks). Patients developing peripheral edema may be treated with standard measures, e.g., salt restriction, oral diuretic(s). 4 Neurologic Severe neurosensory symptoms (paresthesia, dysesthesia, pain) were observed in 5.5% (53/965) of metastatic breast cancer patients, and resulted in treatment discontinuation in 6.1%. When these symptoms occur, dosage must be adjusted. If symptoms persist, treatment should be discontinued [see Dose Adjustments During Treatment (2.7)]. Patients who experienced neurotoxicity in clinical trials and for whom follow-up information on the complete resolution of the event was available had spontaneous reversal of symptoms with a median of 9 weeks from onset (range: 0 to 106 weeks). Severe peripheral motor neuropathy mainly manifested as distal extremity weakness occurred in 4.4% (42/965). 5 Asthenia Severe asthenia has been reported in 14.9% (144/965) of metastatic breast cancer patients but has led to treatment discontinuation in only 1.8%. Symptoms of fatigue and weakness may last a few days up to several weeks and may be associated with deterioration of performance status in patients with progressive disease. 6. ADVERSE REACTIONS Adverse reactions are described for TAXOTERE according to indication. 6.1 Clinical Trial Experience • Breast Cancer Monotherapy with TAXOTERE for locally advanced or metastatic breast cancer after failure of prior chemotherapy TAXOTERE 100 mg/m2: Adverse drug reactions occurring in at least 5% of patients are compared for three populations who received TAXOTERE administered at 100 mg/m2 as a 1-hour infusion every 3 weeks: 2045 patients with various tumor types and normal baseline liver function tests; the subset of 965 patients with locally advanced or metastatic breast cancer, both previously treated and untreated with chemotherapy, who had normal baseline liver function tests; and an additional 61 patients with various tumor types who had abnormal liver function tests at baseline. These reactions were described using COSTART terms and were considered possibly or probably related to TAXOTERE. At least 95% of these patients did not receive hematopoietic support. The safety profile is generally similar in patients receiving TAXOTERE for the treatment of breast cancer and in patients with other tumor types (See Table 4). |
回复此楼» 猜你喜欢
求调剂
已经有3人回复
-
324求调剂
已经有14人回复
-
求调剂
已经有11人回复
-
软件工程求调剂22软工296分求调剂，接受跨调
已经有3人回复
-
考研调剂
已经有10人回复
-
278求调剂
已经有18人回复
-
化工学硕 285求调剂
已经有26人回复
-
一志愿0703化学招61最终排名62化学求调剂
已经有12人回复
-
本科211，293分请求调剂
已经有10人回复
-
285求调剂
已经有10人回复
» 抢金币啦！回帖就可以得到:
-
想做生物创新药的有福啦—南昌大学生物医学创新研究院/药学院陈川课题组招收博士生
+1/193
-
★★精品★★0860生物与医药还有调剂指标，最后的机会，捡漏上岸
+1/145
-
河北大学分析化学招收多名调剂考生
+2/112
-
华北理工大学 矿业工程 研究生调剂
+3/100
-
江西科技师范大学 材料与能源招收调剂研究生
+1/92
-
西安石油大学新能源学院接收材料类、能源动力类、机械类、计算机类等专业专硕调剂生！
+1/87
-
材料与化工专业有大量调剂指标
+1/50
-
北方民族大学085602化学工程有调剂名额58个，欢迎调剂！4月11日报到，12日现场复试
+1/47
-
延安大学长江学者团队招收材料、化工相关领域的调剂研究生数名
+1/42
-
河南工业大学化学化工学院 2026 年硕士调剂火热正在进行中
+1/41
-
河南工业大学化学化工学院 2026 年硕士调剂正在进行！
+1/32
-
汕头大学与化学与精细化工广东省实验室联合培养研究生
+5/20
-
UJN物理学专业调剂
+1/18
-
药物化学、材料与化工专业还有大量名额，速报名！！！
+1/15
-
北京石油化工学院天然高分子与生物材料组招收0817化学工程与技术及0856材料与化工调剂
+1/11
-
武汉纺织大学全国重点实验室吕永钢教授课题组招收材料、化学、生物相关专业硕士研究生
+1/5
-
0854,0858调剂招生
+1/5
-
杭州师范大学-浙江省湿地智慧监测与生态修复重点实验室团队硕士调剂公告
+1/4
-
热门免疫因子研究：分类与检测技术
+1/2
-
太原科技大学材料科学与工程学院学硕、专硕调剂
+1/1
3楼2011-04-06 14:46:32
这么长 4楼2011-04-06 15:01:20
简单回复
Mally892楼
2011-04-01 16:57
回复
suibowen2010(金币+1, 翻译EPI+1): 嘿嘿 没有办法啊 任务...看的不是很到位 很多话不知道怎么说 所以才来这求助高人啊~ 2011-04-01 19:48:04
ringzhu(翻译EPI-1): 无效应助 2011-04-06 12:41:16
哇！ringzhu(翻译EPI-1): 无效应助 2011-04-06 12:41:16
