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 详细处方信息以本药内容附件PDF文件（201251801332311.PDF,201251801331629.PDF）的“原文Priscribing Information”为准
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部分中文阿托西班处方资料（仅供参考）

中文名：阿托西班

中文别名：醋酸阿托西班

英文名称：Atosiban

英文别名：Oxytocin,1-(3-mercaptopropanoicacid)-2-(O-ethyl-D-tyrosine)-4-L-threonine-8-L-ornithine-;Antocile;Antocin;Antocin II;CAP 449;CAP 476;CAP 581;F 314;ORF 22164;RW22164;RWJ 22164;Tractocil;Tractocile;Atosiban Acetate;

阿托西班物化性质       
储存条件：20℃；
溶解度：H2O：≤100mg/mL。

阿托西班用途：其主要用于推迟孕妇早产。是一种后叶催产素拮抗剂，通过阻断催产素同子宫上的受体结合而抑制产前子宫收缩。用于18岁以上，孕龄24～33周，胎儿心率正常的孕妇，在其规则性宫缩达每30分钟4次以上，每次持续至少30秒，并伴宫颈扩张1～3cm(初产妇0～3cm)、宫颈消失50%以上的时候，推迟其即将出现的早产。

阿托西班(90779-69-4)的制备方法：先从芴基甲基氧羰基和叔丁基保护的氨基酸通过固相法制得β-乙酰胺基甲基－巯基丙酰基-D-Tyr(Et)-Ile-Thr(tBu)-Asn-Cys-(s-乙酰胺基甲基)-Pro-Orn(Boc)-Gly-NH-树脂，和三氟乙酸的水溶液在室温反应2h，使其从树脂上脱下来，并脱去部分保护基。然后加入乙醚浸渍，过滤，用乙醚洗。得到的白色粉末溶于10%乙酸水溶液，在室温和搅拌下，滴加碘的乙醇溶液，加毕再搅拌过夜。反应液进行柱层析分离，得产物。

用法用量：初始剂量为6.75mg，采用本品7.5mg/ml注射液注射给药；紧接着用本品7.5mg/ml浓缩持续3小时大剂量(每分钟300μg)输注；然后以本品7.5mg/ml浓缩液低剂量(每分钟100μg)输注，最多达45小时。持续治疗应不超过48小时。整个疗程中，总剂量不宜超过330mg。 治疗应在确诊早产后尽快开始。宫缩持续存在时，应考虑替换疗法。

注意事项：本品禁用于下列孕妇：孕龄少于24周或超过33周者，孕龄超过30周胎膜早破者，宫内胎儿生长迟缓和胎儿心率异常者，产前子宫出血须立即分娩者，子痫和重度先兆子痫须分娩者，宫内胎儿死亡者，宫内感染可疑者，前置胎盘者，胎盘分离者，继续怀孕对母亲或胎儿有危险者，已知对本品的活性成分或辅料过敏者。当无法排除胎膜早破的病人使用时，应该衡量延迟分娩的益处与潜在的绒膜羊膜炎的危险。本品用于多胎妊娠或孕龄在24～27周的疗效尚未确定。给药时应监督宫缩和胎儿心率，应考虑到出现持续宫缩的情况，并应监测产后失血。过量使用的病例较少，亦未见异常症状的报道。最常见的不良反应(发生率大于10%)为恶心。常见的(发生率为1%～10%)有头痛、头晕、潮红、呕吐、心悸亢进、低血压、注射部位反应和高血糖症。少见的(发生率为0.1%～1%)有发烧、失眠、瘙痒和出疹。

Tractocile：atosiban
What is Tractocile?
Tractocile is a solution for injection, and a concentrate that is made up into a solution for infusion (drip into a vein). Both contain the active substance atosiban (7.5 mg per millilitre).

What is Tractocile used for?
Tractocile is used to delay birth in adult women who are 24 to 33 weeks pregnant, when they show signs that they may give birth pre-term (prematurely). These signs include:
regular contractions lasting at least 30 seconds at a rate of at least four every 30 minutes;
dilation of the cervix (the neck of the womb) of 1 to 3 cm and an effacement (a measure of the thinness of the cervix) of 50% or more.

In addition, the baby must have a normal heart rate.

The medicine can only be obtained with a prescription.

How is Tractocile used?
Treatment with Tractocile should be carried out by a doctor who has experience in the treatment of pre-term labour.

Treatment should be started as soon as possible after diagnosis of pre-term labour. Tractocile is given into a vein in three stages, over a maximum of 48 hours: an initial injection into a vein (6.75 mg), followed by a high-dose infusion (18 mg per hour) over three hours, then a lower dose infusion (6 mg per hour) lasting up to 45 hours. If contractions come back, treatment with Tractocile can be repeated up to three more times during the pregnancy.

How does Tractocile work?
The active substance in Tractocile, atosiban, is an antagonist of the natural hormone oxytocin. This means that atosiban blocks the action of oxytocin. Oxytocin is the hormone involved in starting contractions of the womb. By blocking the action of oxytocin, Tractocile prevents contractions and causes the womb to relax, helping to delay birth.

How has Tractocile been studied?
The ability of Tractocile to delay pre-term birth was studied in 742 women who were 23 to 33 weeks pregnant in three main studies. Tractocile was compared with ritodine, terbutaline and salbutamol (all from a different class of medicines used in pre-term labour called beta-agonists). The main measure of effectiveness was whether the treatment had worked after a week.

What benefit has Tractocile shown during the studies?
Looking at the results of the three main studies together, 60% of the women treated with Tractocile were still pregnant one week after treatment (201 out of 337) compared with 48% of the women treated with the comparator medicines (163 out of 342). There were too few women with a pregnancy at less than 28 weeks for the effectiveness of Tractocile in comparison to beta-agonists to be established in this group. The better result with Tractocile over the beta-agonists might have been because it caused fewer side effects, thereby allowing the patients to receive a full course of treatment.

What is the risk associated with Tractocile?
The most common side effect with Tractocile (seen in more than 1 patient in 10) is nausea (feeling sick). No side effects have been noted in the newborn baby. For the full list of all side effects reported with Tractocile, see the Package Leaflet.

Tractocile should not be used in people who may be hypersensitive (allergic) to atosiban or any of the other ingredients. It must not be used in women whose pregnancy is less than 24 weeks or more than 33 weeks, in women who have premature rupture of the membranes (when the waters break early) after 30 weeks of pregnancy, bleeding from the womb, eclampsia (a dangerous condition at the end of pregnancy caused by toxins in the blood), pre-eclampsia (a condition that can lead to eclampsia) or problems with the baby or placenta, or when continuing the pregnancy could be dangerous for the mother or baby. For the full list of restrictions, see the Package Leaflet.

Why has Tractocile been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that Tractocile has shown an effectiveness in delaying pre-term birth that is the same as seen with beta-agonists, and that the better outcome with Tractocile was due to the medicine being better tolerated. The Committee decided that Tractocile’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Tractocile
The European Commission granted a marketing authorisation valid throughout the European Union for Tractocile on 20 January 2000. The marketing authorisation holder is Ferring Pharmaceuticals A/S. The marketing authorisation is valid for an unlimited period.

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 详细处方信息以本药内容附件PDF文件（201251801332311.PDF,201251801331629.PDF）的“原文Priscribing Information”为准
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