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資料提供:三軍總醫院臨床藥學部
1.Lialda Approved for Ulcerative Colitis
美國藥物食品管理局核准治療輕度到中度潰瘍性結腸炎的藥物Lialda (mesalamine),此藥物的特點為一天一次,預計在今年第一季上市。
The FDA has approved Shire plc's Lialda (mesalamine) once-daily tablets for the induction of remission in patients with active mild to moderate ulcerative colitis. Shire will launch Lialda in the US in the first quarter of 2007.
Ref : http://www.factsandcomparisons.com
2.New Dosage Strength and Revised Information for Activella
美國藥物食品管理局核准藥物Activella (estradiol/norethindrone acetate)新的劑量,此藥物用來治療與停經有關血管性症狀,並同時修正藥物仿單中有關非避孕使用的雌(性)激素產品在治療血管性和外陰部/陰道萎縮症狀上。此藥物台灣的核准適應症為停經超過一年以上婦女之雌激素缺乏引起的症狀、停經婦女骨質疏鬆症之預防。
The FDA has approved SNDAs for Novo Nordisk's Activella (estradiol/norethindrone acetate) tablets, which include a new dosage (0.5 mg/0.1 mg) for the treatment of moderate to severe vasomotor symptoms associated with menopause in women who have a uterus. There are revisions to the patient leaflet and prescribing information related to the use of noncontraceptive estrogen drug products for treating vasomotor and vulvar/vaginal atrophy symptoms.
Ref : http://www.factsandcomparisons.com
3.Byetta Approved for Expanded Combination Use
美國藥物食品管理局核准注射藥物exenatide的合併治療使用方式,exenatide可以改善並控制第二型糖尿病病人的血醣高低,而且是同時在病人有服用新一代降血醣藥物TZD的情形下。此藥物也同樣被核准用在病人已服用傳統治療糖尿病藥物metformin和sulfonylurea等的合併治療上,最常見的副作用是輕或中度的噁心。
The FDA has approved Amylin Pharmaceuticals' and Eli Lilly and Company's Byetta (exenatide) injection as add-on therapy to improve glycemic control in people with type 2 diabetes who have not achieved adequate control while taking a thiazolidinedione. Byetta is also indicated for this patient population as add-on therapy to metformin, a sulfonylurea, or a combination of the two.
Ref : http://www.factsandcomparisons.com
4.New Claritin RediTabs Dose Strength
美國藥物食品管理局核准Claritin RediTabs 12-Hour (loratadine)5mg的口溶錠。衛生署核准此藥物用來治療緩解過敏性鼻炎的相關症狀,如流鼻水、鼻塞、搔癢及眼睛搔癢和灼熱感及緩解因慢性蕁痲疹及週敏性皮膚病所引起的症狀。
The FDA has approved Schering-Plough Healthcare's NDA for Claritin RediTabs 12-Hour (loratadine) 5 mg orally disintegrating tablets for the temporary relief of symptoms due to hay fever or other upper respiratory allergies, including runny nose, sneezing, itchy/watery eyes, and itching of the nose or throat. Claritin RediTabs are also available in 10 mg strength.
Ref : http://www.factsandcomparisons.com
5.Study: Brain bleeding from blood thinner on rise
美國研究學者表示使用抗凝血藥物warfarin所增加腦部出血的比率在1990年代時就有5倍之多,在年齡超過80歲以上的老人更高達10倍以上。此研究團隊表示必需進行更多的研究去找出安全替代warfarin的藥物來預防那些有心房纖維顫動病人可能引起的缺血性中風。
U.S. researchers say the rate of bleeding in the brain linked to the blood-thinning drug warfarin quintupled in the 1990s and increased more than tenfold in people over 80. The lead author says more research is needed to find a safer alternative to warfarin, which currently is the best available drug for preventing ischemic strokes in patients who have atrial fibrillation.
Ref : Forbes/HealthDay News
6.New HIV test detects small amounts of drug-resistant virus
杜克大學學者報告已經研發出新的HIV檢測器,這種檢測器可以偵測到很少量對藥物有抗藥性的病毒。他們希望可以更準確預測每一個病人的治療方式,如此將可以提供有效且價格低的治療方法。
Duke University researchers report development of a new HIV test that is able to detect even small amounts of drug-resistant forms of the virus. Their hope is that the test will allow more accurate prediction of which therapies will work best in individual patients, thus providing more effective and less costly treatment
Ref : The News & Observer
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