药品信息:
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部分中文 Ellaone 处方资料(仅供参考)
Ellaone is a medicine that contains the active substance ulipristal acetate. It is available as white tablets (30 mg).
Ellaone is a medicine that contains the active substance ulipristal acetate. It is available as whitetablets (30 mg).
What is Ellaone used for? Ellaone is a female emergency contraceptive to be taken within five days of unprotected sex or contraceptive failure (such as a tear in a condom during sex). The medicine can only be obtained with a prescription.
How is Ellaone used? Ellaone is taken as one tablet as soon as possible but no later than five days after unprotected sex or contraceptive failure. The tablet can be taken with or without food. If the woman vomits within three hours of taking the medicine she should take another tablet. Ellaone can be taken at anytime during the menstrual cycle.
How does Ellaone work? For pregnancy to occur there has to be ovulation (release of eggs) followed by the fertilisation of the egg (fusion with a sperm) and implantation in the womb. The sex hormone progesterone stimulates the production of the proteins that play a role in the timing of ovulation and in preparing the lining of womb to receive the fertilised egg. The active substance in Ellaone, ulipristal acetate, acts as a progesterone receptor modulator. This means that it attaches to the receptors that progesterone normally attaches to, preventing the hormone from having its effect. Through its actions on the progesterone receptors, Ellaone prevents pregnancies by interfering with ovulation and it may also lead to changes in the lining of the womb.
How has Ellaone been studied? The effects of Ellaone were first tested in experimental models before being studied in humans. In one main study, Ellaone was given to 1,533 women (aged on average 24 years) who had requested emergency contraception between two and five days after unprotected sex or contraceptive failure. The main measure of effectiveness was the number of women who did not become pregnant. This was then compared with the number of women who would have been expected to become pregnant if they had not taken any contraceptive, calculated from published rates.
房事后五天内仍有效 新一代避孕药将上市
新一代取名为EllaOne“事后丸”,号称在无避孕性交5天之内仍然有效而引起关注。这种紧急避孕药即将在欧洲行销。
这种事后丸的生产厂家HRAPharma制药厂将于本周末在罗马欧洲妇科协会代表大会上介绍这种紧急避孕药。事后丸Norlevo也是这家药厂销售的。此药1999年以来投放市场,在法国自由销售。总部设在法国的HRAPharma总裁盖纳医生说:“EllaOne是用新分子ulipristal制作的,此前从未销售过,必须凭医生处方才能购买。”由于EllaOne是新药,它的售后监督计划还必须获得欧洲药品管理局(EMEA)的同意。欧洲药品管理局应于9月24日对这个问题表态。盖纳医生进而指明:如果到这个日期,药品管理局开绿灯,“我们9月就可以销售EllaOne,而无需等待社会保险局是否同意报销。”药厂“希望2009年底或2010年初能够销售可在法国报销的事后丸EllaOne”,药厂已经在法国和欧洲大多数国家递交了报销申请材料。
EllaOne的价格将比Norlevo高(依国家不同,价格低则为7.5欧元,高则达30欧元),但“低于50欧元”。药厂总裁声称“将在国际范围内寻求统一价”。依据对4000名妇女做的临床研究资料看,EllaOne耐受性好,药效看来高于Norlevo的成分左炔诺孕酮(levonorgestrel)。
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