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【drug-news】FDA批准小剂量Tamiflu用于儿童
NEW YORK (Reuters) Jul 03 - Swiss drugmakerRoche Holding Ag said on Monday that U.S. health regulators approved its Tamiflu influenza treatment at two lower doses for children in a form with a longer shelf life that could be an advantage for use in stockpiling against a flu pandemic.
The U.S. Food and Drug Administration approved Tamiflu capsules for sale at 30 milligram and 45 mg doses for the treatment and prevention of influenza types A and B in patients one year and older, Roche said.
The shelf life of the capsules is five years, the company said, considerably longer than that of the 24-month shelf life of the standard liquid suspension formulation.
Many countries are stockpiling the anti-viral drug with the hope that it will be able to lessen the effects of an influenza pandemic if and when one strikes.
The 30 mg and 45 mg capsules will be available nationwide and for government stockpiling in time for the 2007-2008 flu season, Roche said.
"Roche continues to take steps to facilitate the use of antivirals in pandemic preparedness and response," Dominick Iacuzio, medical director at Roche, said in a statement.
"These lower dose capsules not only provide governments with a new option for pandemic stockpiling, but also give prescribing physicians an alternative for patients who prefer a capsule formulation," he said.
Roche has received Tamiflu orders totaling 215 million treatment courses from more than 75 countries. It has also donated 5.1 million Tamiflu treatment courses to the World Health Organization to help contain any initial pandemic outbreak.
Roche said it has filled orders from the U.S. government and states for 43.7 million Tamiflu treatment courses so far.
Tamiflu will continue to be available in a 75 mg capsule for adults as well as liquid suspension formulation for children, the company said.
http://www.medscape.com/viewarticle/559222 FDA Approves Roche's Low Dose Tamiflu for Children
FDA批准小剂量Tamiflu用于儿童流感的治疗
NEW YORK (Reuters) Jul 03 - Swiss drugmakerRoche Holding Ag said on Monday that U.S. health regulators approved its Tamiflu influenza treatment at two lower doses for children in a form with a longer shelf life that could be an advantage for use in stockpiling against a flu pandemic.
纽约（路透社）7月3日——瑞士制药企业罗氏公司公布：周一，美国食品药品管理局（FDA）批准了两种小剂量Tamiflu胶囊用于儿童流感的治疗，该剂型具备长有效期的特点，有利于流感大面积流行抗病毒药物的储备。
The U.S. Food and Drug Administration approved Tamiflu capsules for sale at 30 milligram and 45 mg doses for the treatment and prevention of influenza types A and B in patients one year and older, Roche said.
FDA批准的两种小剂量Tamiflu胶囊的适应症为用于预防及治疗A、B 两型流感病毒引起的流行性感冒，规格为每粒含Tamiflu30mg和45mg，适用人群为一岁以上的儿童。
The shelf life of the capsules is five years, the company said, considerably longer than that of the 24-month shelf life of the standard liquid suspension formulation.
本次批准的两种小剂量Tamiflu胶囊有效期为5年，远远长于Tamiflu混悬液两年有效期的标准。
Many countries are stockpiling the anti-viral drug with the hope that it will be able to lessen the effects of an influenza pandemic if and when one strikes.
目前，许多国家都在储备抗病毒药物，以降低流感大面积流行或他国病毒攻击带来的危害。
The 30 mg and 45 mg capsules will be available nationwide and for government stockpiling in time for the 2007-2008 flu season, Roche said.
不久，人们在全国范围内将均可购买到30mg和45mg规格的Tamiflu胶囊，政府在及时储备2007-2008流感季节的抗病毒药物时，亦可购得上述Tamiflu胶囊，罗氏公司提到。
"Roche continues to take steps to facilitate the use of antivirals in pandemic preparedness and response," Dominick Iacuzio, medical director at Roche, said in a statement.
“罗氏还在进步研究，如何在流感预防及反应中更便利地使用抗病毒药物。”罗氏医学总监Dominick Iacuzio表示。
"These lower dose capsules not only provide governments with a new option for pandemic stockpiling, but also give prescribing physicians an alternative for patients who prefer a capsule formulation," he said.
此两种小剂量Tamiflu胶囊，不仅为流感大面积流行抗病毒药物的储备提供了新选择，而且对于一些偏好胶囊剂型的病人，也为医生提供了替代处方选择。
Roche has received Tamiflu orders totaling 215 million treatment courses from more than 75 countries. It has also donated 5.1 million Tamiflu treatment courses to the World Health Organization to help contain any initial pandemic outbreak.
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作者:admin@医学,生命科学 2011-02-18 05:11
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