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醋酸乌利司他片ELLAONE(ulipristal acetate Tablets)

2013-07-29 13:47:47  作者:新特药房  来源:互联网  浏览次数:1100  文字大小:【】【】【
简介:Generic Name for ELLAUlipristal acetate 30mg; tab. Legal Classification:Rx Pharmacological Class for ELLAProgesterone agonist/antagonist. Manufacturer of ELLAWatson Pharmaceuticals, Inc. Indi ...

英文药名:ELLAONE(ulipristal acetate)
中文药名:醋酸乌利司他片
分子式:C30H37NO4
分子量:475.62
别名:(11β)-17α-(乙酰氧基)-11-[4-(二甲基氨基)苯基]-19-去甲孕甾-4,9-二烯-3,20-二酮;CDB2914;醋酸乌利司他
剂型及规格:
片剂,每片含30mg醋酸优力司特。
适应症:
无防护性交或避孕失败120h(5天)内紧急避孕。
作用机制:
乌利司他可以推迟卵泡的破裂,排卵前立即服用。所以乌利司他的主要作用机制可能是抑制或延迟排卵;然而,子宫内膜的改变可能影响植入也许是发生疗效的原因。
醋酸乌利司他由HRA制药公司开发,醋酸乌利司他(ulipristal acetate)是一种孕酮激动剂/拮抗剂,主作用是抑制或延迟排卵。 有关研究发现,当在接近排卵日(受孕机会最高)给药后,醋酸乌利司他能较左炔诺孕酮更有效地抑制排卵,从而提示醋酸乌利司他可能具有更强的紧急避孕效力。
醋酸乌利司他是首个批准可用于无防护性交后0-120h(5天)内紧急避孕的孕激素受体调节剂,以往的紧急避孕药都仅限用于无防护性交后72h(3天)内,故醋酸乌利司他使紧急避孕药的服药时间窗延长了2天,显著增加防止非意愿妊娠的机会。醋酸乌利司他30mg片剂的紧急避孕效果至少不劣于左炔诺孕酮1.5mg,耐受性良好,安全性特征总体与左炔诺孕酮相似。
2009年5月,欧盟首次经集中审批程序批准法国Laboratoire HRA Pharma的口服醋酸乌利司他30mg片剂用于无防护性交或避孕失败后120h(5天)内紧急避孕。
目前,临床应用最广泛的紧急避孕药为左炔诺孕酮(1evonorgestre1),以间隔12 h各服1片(0.75 mg)或单次服用2片(1.5 mg)方案用药。不过,左炔诺孕酮仅被批准在无保护性交或避孕失败后72 h(3 d)内用作紧急避孕药。即使如此,左炔诺孕酮的紧急避孕效力也会随用药时间延迟而明显下降,故被推荐最好在无保护性交或避孕失败后12 h内开始服药。
作为一种新型口服紧急避孕药,醋酸乌利司他不仅能在妇女无保护性交后长达120h内用药,且紧急避孕效力不会随用药时间延迟而下降,同时安全性和耐受性均很好。与目前最常用的紧急避孕药左炔诺孕酮相比,醋酸乌利司他的临床适用性更广,具有能够预防更多意外妊娠的潜力。
ellaOne 30 mg
1. Name of the medicinal product
ellaOne 30 mg tablet
2. Qualitative and quantitative composition
Each tablet contains 30 mg ulipristal acetate.
Excipients with known effect: each tablet contains 237 mg lactose monohydrate.
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Tablet
White to off-white, round curved tablet engraved with code “еllа” on both faces
4. Clinical particulars
4.1 Therapeutic indications
Emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure
4.2 Posology and method of administration
The treatment consists of one tablet to be taken orally as soon as possible, but no later than 120 hours (5 days) after unprotected intercourse or contraceptive failure.
The tablet can be taken with or without food.
If vomiting occurs within 3 hours of ellaOne intake, another tablet should be taken.
ellaOne can be taken at any moment during the menstrual cycle.
Pregnancy should be excluded before ellaOne is administered.
Renal or hepatic impairment: In the absence of specific studies, no specific dose recommendations for ellaOne can be made.
Severe hepatic impairment: In the absence of specific studies, ellaOne is not recommended.
Children and adolescents: A limited number of women under 18 years were included in clinical trials of ellaOne.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Pregnancy.
4.4 Special warnings and precautions for use
Concomitant use with an emergency contraceptive containing levonorgestrel is not recommended (see section 4.5).
Use in women with severe asthma insufficiently controlled by oral glucocorticoid is not recommended.
Emergency contraception with ellaOne is an occasional method. It should in no instance replace a regular contraceptive method. In any case, women should be advised to adopt a regular method of contraception.
Although the use of ellaOne does not contraindicate the continued use of regular hormonal contraception, ellaOne may reduce its contraceptive action (see section 4.5). Therefore, after using emergency contraception, it is recommended that subsequent acts of intercourse be protected by a reliable barrier method until the next menstrual period starts. If a woman wishes to initiate hormonal contraception as a regular contraception method, she can do so immediately after using ellaOne, but the woman should use a reliable barrier method until the next menstrual period.
Repeated administration of ellaOne within the same menstrual cycle is not advisable, as safety and efficacy of ellaOne after repeated administration within the same menstrual cycle has not been investigated.
Emergency contraception with ellaOne does not prevent pregnancy in every case. No data is available on the efficacy of ellaOne for women who have had unprotected intercourse more than 120 hours before ellaOne intake. In case of doubt, delay of more than 7 days in next menstrual period, abnormal bleeding at the expected date of menses, or symptoms of pregnancy, pregnancy should be excluded by a pregnancy test.
If pregnancy occurs after treatment with ellaOne, as for all pregnancies, the possibility of an ectopic pregnancy should be considered. Ectopic pregnancy may continue, despite the occurrence of uterine bleeding.
After ellaOne intake menstrual periods can sometimes occur earlier or later than expected by a few days. In approximately 7% of the women, menstrual periods occurred more than 7 days earlier than expected. In 18.5% of the women a delay of more than 7 days occurred, and in 4% the delay was greater than 20 days.
This medicinal product contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Concomitant use of ellaOne with CYP3A4 inducers is not recommended due to interaction (e.g. rifampicin, phenytoin, phenobarbital, carbamazepine, efavirenz, fosphenytoine, nevirapine, oxcarbazepine, primidone, rifabutine, St John's wort/Hypericum perforatum, long term use of ritonavir).. Concomitant use of ulipristal acetate and emergency contraception containing levonorgestrel is not recommended (see section 4.5).
4.5 Interaction with other medicinal products and other forms of interaction
Potential for other medicinal products to affect ulipristal acetate:
Ulipristal acetate is metabolized by CYP3A4 in vitro.
- CYP3A4 inhibitors
In vivo results show that administration of ulipristal acetate with a potent and a moderate CYP3A4 inhibitor increased Cmax and AUC of ulipristal acetate with a maximum of 2- and 5.9-fold, respectively. The effects of CYP3A4 inhibitors are unlikely to have any clinical consequences.
The CYP3A4 inhibitor ritonavir can also have an inducing effect on CYP3A4 when ritonavir is used for a longer period. In such cases ritonavir might reduce plasma concentrations of ulipristal acetate. Concomitant use is therefore not recommended (see section 4.4). Enzyme induction wears off slowly and effects on the plasma concentrations of ulipristal acetate may occur even if a woman has stopped taking an enzyme inducer within the last 2-3 weeks.
- CYP3A4 inducers
In vivo results show that the administration of ulipristal acetate with a strong CYP3A4 inducer such as rifampicin markedly decreases Cmax and AUC of ulipristal acetate by 90% or more and decreases ulipristal acetate half-life by 2.2-fold corresponding to an approximately 10-fold decrease of ulipristal acetate exposure. Concomitant use of ellaOne with CYP3A4 inducers (e.g. rifampicin, phenytoin, phenobarbital, carbamazepine, efavirenz, fosphenytoine, nevirapine, oxcarbazepine, primidone, rifabutine, St John's wort/Hypericum perforatum) therefore reduces plasma concentrations of ulipristal acetate and may result in a decreased efficacy of ellaOne and is therefore not recommended (see section 4.4).
Medicinal products affecting gastric pH
Administration of ulipristal acetate (10 mg tablet) together with the proton pump inhibitor esomeprazole (20 mg daily for 6 days) resulted in approximately 65% lower mean Cmax, a delayed tmax (from a median of 0.75 hours to 1.0 hours) and 13% higher mean AUC. The clinical relevance of this interaction for single dose administration of ulipristal acetate as emergency contraception is not known.
Potential for ulipristal acetate to affect other medicinal products:
In vitro data indicate that ulipristal acetate and its active metabolite do not significantly inhibit CYP1A2, 2A6, 2C9, 2C19, 2D6, 2E1, and 3A4, at clinically relevant concentrations. After single dose administration induction of CYP1A2 and CYP3A4 by ulipristal acetate or its active metabolite is not likely. Thus, administration of ulipristal acetate is unlikely to alter the clearance of medicinal products that are metabolised by these enzymes.
P-gp substrates
In vitro data indicate that ulipristal acetate may be an inhibitor of P-gp at clinically relevant concentrations. Results in vivo with the P-gp substrate fexofenadine were inconclusive. The effects of the P-gp substrates are unlikely to have any clinical consequences.
Hormonal contraceptives
Because ulipristal acetate binds the progesterone receptor with high affinity, it may interfere with the action of progestogen-containing medicinal products:
- Contraceptive action of combined hormonal contraceptives and progestogen-only contraception may be reduced
- Concomitant use of ulipristal acetate and emergency contraception containing levonorgestrel is not recommended (see section 4.4).
4.6 Fertility, pregnancy and lactation
Pregnancy
ellaOne is contra-indicated during an existing or suspected pregnancy (see section 4.3).
Extremely limited data are available on the health of the foetus/new-born in case a pregnancy is exposed to ulipristal acetate. Although no teratogenic potential was observed, animal data are insufficient with regard to reproduction toxicity (see section 5.3).
HRA Pharma maintains a pregnancy registry to monitor outcomes of pregnancy in women exposed to ellaOne. Patients and health care providers are encouraged to report any exposure to ellaOne by contacting the Marketing Authorisation Holder (see section 7 ).
Breast-feeding
Ulipristal acetate is excreted in breast milk (see section 5.2). The effect on newborn/infants has not been studied. A risk to the breastfed child cannot be excluded. After intake of ellaOne breastfeeding is not recommended for one week. During this time it is recommended to express and discard the breast milk in order to stimulate lactation.
Fertility
A rapid return of fertility is likely following treatment with ellaOne for emergency contraception; therefore regular contraception should be continued or initiated as soon as possible following use of ellaOne to ensure ongoing prevention of pregnancy.Advice on how to proceed is presented in section 4.4.
4.7 Effects on ability to drive and use machines
No studies on the effect on the ability to drive and use machines have been performed.
ellane may have minor or moderate influence on the ability to drive or use machines: mild to moderate dizziness is common after ellaOne intake, somnolence and blurred vision are uncommon; disturbance in attention has been rarely reported.
4.8 Undesirable effects
The most commonly reported adverse reactions were headache, nausea, abdominal pain and dysmenorrhea.
Safety of ulipristal acetate has been evaluated in 4,718 women during the clinical development program.
The adverse reactions reported in the phase III program of 2,637 women are provided in the table below. The vast majority of adverse reactions were mild or moderate and resolved spontaneously.
Adverse reactions listed below are classified according to frequency and system organ class. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

MedDRA

Adverse reactions (frequency)

System Organ Class

Very common

≥1/10

Common

≥1/100 to <1/10

Uncommon

≥1/1,000 to <1/100

Rare

≥1/10,000 to <1/1,000

Infections and infestations

   

Vaginitis

Nasopharyngitis

Influenza

Urinary tract infection

Conjonctivitis infective

Hordeolum

Pelvic inflammatory disease

Metabolism and nutrition disorders

   

Appetite disorders

Dehydration

Psychiatric disorders

 

Mood disorders

Emotional disorder

Anxiety

Insomnia

Hyperactivity disorder

Libido changes

Disorientation

Nervous system disorders

 

Headache

Dizziness

Somnolence

Migraine

Tremor

Disturbance in attention

Dysgueusia

Poor quality of sleep

Parosmia

Syncope

Eye disorders

   

Visual disturbance

Abnormal sensation in eye

Ocular hyperaemia

Photophobia

Ear and labyrinth disorders

     

Vertigo

Vascular disorders

   

Hot flush

Haemorrhage

Respiratory, thoracic and mediastinal disorders

     

Upper respiratory tract congestion

Cough

Dry throat

Epistaxis

Gastrointestinal disorders

 

Nausea

Abdominal pain (NOS)

Abdominal pain upper

Abdominal discomfort

Vomiting

Abdominal pain lower

Diarrhoea

Dry mouth

Constipation

Dyspepsia

Flatulence

Gastro-oesophageal reflux disease

Toothache

Skin and subcutaneous tissue disorders

   

Acne

Skin lesion

Pruritus

Urticaria

Genital pruritus

Musculoskeletal and connective tissue disorders

 

Myalgia

Back pain

 

Pain in extremity

Arthralgia

Renal and urinary disorders

     

Urinary tract disorder

Chromaturia

Nephrolithiasis

Renal Pain

Bladder pain

Reproductive system and breast disorders

 

Dysmenorrhea

Pelvic pain

Breast tenderness

Menorrhagia

Vaginal discharge

Menstrual disorder

Metrorrhagia

Vaginal haemorrhage

Hot flush

Premenstrual syndrome

Genital pruritus

Dysfunctional uterine bleeding

Dyspareunia

Ruptured ovarian cyst

Vulvovaginal pain

Menstrual discomfort

Hypomenorrhea

General disorders and administration site conditions

 

Fatigue

Pain

Irritability

Chills

Malaise

Pyrexia

Chest discomfort

Inflammation

Thirst

The majority of women (74.6%) in the phase III studies had their next menstrual period at the expected time or within ± 7 days, while 6.8% experienced menses more than 7 days earlier than expected and 18.5% had a delay of more than 7 days beyond the anticipated onset of menses. The delay was greater than 20 days in 4 % of the women.
A minority (8.7%) of women reported intermenstrual bleeding lasting an average of 2.4 days. In a majority of cases (88.2%), this bleeding was reported as spotting. Among the women who received ellaOne in the phase III studies, only 0.4% reported heavy intermenstrual bleeding.
In the phase III studies, 82 women entered a study more than once and therefore received more than one dose of ellaOne (73 women enrolled twice and 9 enrolled three times). There were no safety differences in these subjects in terms of incidence and severity of adverse events, change in duration or volume of menses or incidence of intermenstrual bleeding.
4.9 Overdose
Experience with ulipristal acetate overdose is limited. Single doses up to 200 mg were administered to a limited number of subjects, and no severe or serious adverse reactions were reported.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Sex hormones and modulators of the genital system, emergency contraceptives. ATC code: G03AD02.
Ulipristal acetate is an orally-active synthetic selective progesterone receptor modulator which acts via high-affinity binding to the human progesterone receptor. The primary mechanism of action is inhibition or delay of ovulation. Pharmacodynamic data show that even when taken immediately before ovulation is scheduled to occur, ulipristal acetate is able to postpone follicular rupture in some women.
Ulipristal acetate also has high affinity for the glucocorticoid receptor and in vivo, in animals, antiglucocorticoid effects have been observed. However, in humans, no such effect has been observed even after repeat administration at the daily dose of 10 mg. It has minimal affinity to the androgen receptor and no affinity for the human estrogen or mineralocorticoid receptors.
Results from two independent randomized controlled trials (see Table) showed the efficacy of ulipristal acetate to be non-inferior to that of levonorgestrel in women who presented for emergency contraception between 0 and 72 hours after unprotected intercourse or contraceptive failure. When the data from the two trials were combined via meta-analysis, the risk of pregnancy with ulipristal acetate was significantly reduced compared to levonorgestrel (p=0.046).

Randomized controlled trial

Pregnancy rate (%) within 72h of unprotected intercourse or contraceptive failure1

Odds ratio [95% CI] of pregnancy risk, ulipristal acetate vs levonorgestrel1

Ulipristal acetate

Levonorgestrel

HRA2914-507

0.91

(7/773)

1.68

(13/773)

0.50 [0.18-1.24]

HRA2914-513

1.78

(15/844)

2.59

(22/852)

0.68 [0.35-1.31]

Meta-analysis

1.36

(22/1617)

2.15

( 35/1625)

0.58 [0.33-0.99]

1 – Glasier et al, Lancet 2010
Two trials provide efficacy data on ellaOne used up to 120 hours after unprotected intercourse. In an open-label clinical trial, which enrolled women who presented for emergency contraception and were treated with ulipristal acetate between 48 and 120 hours after unprotected intercourse, a pregnancy rate of 2.1% (26/1241) was observed. In addition, the second comparative trial described above also provides data on 100 women treated with ulipristal acetate from 72 to 120 hours after unprotected intercourse, in whom no pregnancies were observed.
5.2 Pharmacokinetic properties
Absorption
Following oral administration of a single 30 mg dose, ulipristal acetate is rapidly absorbed, with a peak plasma concentration of 176 ± 89 ng/ml occurring approximately 1 hour (0.5-2.0 h) after ingestion, and with an AUC0-∞ of 556 ± 260 ng.h/ml.
Administration of ulipristal acetate together with a high-fat breakfast resulted in approximately 45% lower mean Cmax, a delayed Tmax (from a median of 0.75 hours to 3 hours) and 25% higher mean AUC0-∞ compared with administration in the fasted state. Similar results were obtained for the active mono-demethylated metabolite.
Distribution
Ulipristal acetate is highly bound (>98%) to plasma proteins, including albumin, alpha-l-acid glycoprotein, and high density lipoprotein.
Ulipristal acetate is a lipophilic compound and is distributed in breast milk, with a mean daily excretion of 13.35 µg [0-24 hours], 2.16 µg [24-48 hours], 1.06 µg [48-72 hours], 0.58 µg [72-96 hours], and 0.31 µg [96-120 hours].
Biotransformation/elimination
Ulipristal acetate is extensively metabolized to mono-demethylated, di-demethylated and hydroxylated metabolites. The mono-demethylated metabolite is pharmacologically active. In vitro data indicate that this is predominantly mediated by CYP3A4, and to a small extent by CYP1A2 and CYP2A6. The terminal half-life of ulipristal acetate in plasma following a single 30 mg dose is estimated to 32.4 ± 6.3 hours, with a mean oral clearance (CL/F) of 76.8 ± 64.0 L/h.
Special populations
No pharmacokinetic studies with ulipristal acetate have been performed in females with impaired renal or hepatic function.
5.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, and genotoxicity. Most findings in general toxicity studies were related to its mechanism of action as a modulator of progesterone and glucocorticoid receptors, with antiprogesterone activity observed at exposures similar to therapeutic levels.
Reproduction toxicity data are insufficient due to lack of human and animal pharmacokinetic data. Due to its mechanism of action, ulipristal acetate has an embryolethal effect in rats, rabbits (at repeated doses above 1 mg/kg) and in monkeys. The safety for a human embryo is unknown. At doses which were low enough to maintain gestation in the animal species, no teratogenic potential was observed.
Carcinogenicity studies with ulipristal acetate have not been conducted.
6. Pharmaceutical particulars
6.1 List of excipients
Lactose monohydrate
Povidone K30
Croscarmellose sodium
Magnesium stearate
6.2 Incompatibilities
Not applicable
6.3 Shelf life
3 years
6.4 Special precautions for storage
Keep the blister in the outer carton in order to protect from light.
6.5 Nature and contents of container
PVC-PE-PVDC-Aluminium blister of 1 tablet.
The carton contains one blister of one tablet.
6.6 Special precautions for disposal and other handling
No special requirements
7. Marketing authorisation holder
Laboratoire HRA Pharma
15, rue Béranger
F-75003 Paris
France
醋酸乌利司他可以用于治疗子宫肌瘤
比利时Jacques Donnez及多国研究人研究发现除了可作为紧急避孕药外,醋酸乌利司他治疗子宫肌瘤效果显著。
据2012年2月2日出版的《新英格兰医学杂志》发表的2项临床试验报告,选择性孕酮调节剂醋酸乌利司他(ulipristal acetate) 短期治疗子宫肌瘤,控制出血、减小肌瘤体积以及改善疼痛效果优于安慰剂且非劣于亮丙瑞林。
在PEARLⅠ (醋酸乌利司他缓解子宫平滑肌瘤症状疗效评价)研究中, 242例重度月经过多及贫血的绝经前子宫肌瘤女性被随机分组,分别日服5 mg、10 mg乌利司他或安慰剂,疗程13 周。结果显示,5 mg和10 mg乌利司他组分别有91%和92%受试者月经过多症状得到控制,而安慰剂组仅为19%。血红蛋白和红细胞压积水平较安慰剂组提高明显,子宫肌瘤体积减少≥25%以及疼痛减轻的患者比例也显著高于安慰剂组。
PEARLⅡ研究是乌利司他与亮丙瑞林用于子宫肌瘤患者术前治疗的非劣性试验,共纳入307例患者。2组乌利司他日服剂量同PEARLⅠ研究,亮丙瑞林为1剂/月,疗程13 周。结果显示,治疗结束后,5 mg、10 mg乌利司他组和亮丙瑞林组患者月经过多控制率分别为90%、98%和89%,表明2种剂量乌利司他均非劣于亮丙瑞林。与亮丙瑞林组相比,乌利司他组月经过多控制得更为快速,出现闭经也相对较快。其他不良事件未见显著组间差异,乌利司他诱导的子宫内膜改变在6个月随访结束时消失。乌利司他和亮丙瑞林均未引起任何有临床意义的皮质激素、促甲状腺素、催乳素或葡萄糖水平变化。
如果研究进一步证实乌利司他等孕酮受体调节剂所诱发的子宫内膜改变确为良性,且在治疗结束时消失,醋酸乌利司他将是一种疗效最佳、安全顾虑最小的症状性子宫肌瘤间歇性治疗选择。
据统计,约四分之一妇女患有子宫肌瘤症状。醋酸亮丙瑞林作为一种促性腺激素释放激素(GnRH)激动剂,从1995年被批准后至今一直用于子宫肌瘤术前治疗。醋酸乌利司他能否成功挑战亮丙瑞林,成为子宫肌瘤术前药物治疗新选择,让后期试验来揭晓答案。
药物治疗主要用于没有症状的近绝经期50岁左右的小于3cm的肌瘤,或者是全身情况不能手术前治疗。药物只是抑制垂体、卵巢功能,降低雌激素水平,抑制其继续长大,效果不是很明显。部分人用药期间肌瘤会有相应的缩小,但停药后一段时间,肌瘤迅速长大,因此一般不作为主要的治疗方法。
主要的药物有:
(1) 促性腺激素释放激素类似物
常用药物:达菲林(曲普瑞林) 3.75mg/次或戈舍瑞林3.6mg/次
作 用:降低雌二醇水平以缓解症状,抑制肌瘤生长,萎缩,但停药后肌瘤又长大。
应用指征:缩小肌瘤以利于妊娠。术前治疗控制症状,纠正贫血。术前应用缩小肌瘤,降低手术难度,或使阴式手术成为可能。近绝经妇女,提前过渡到自然绝经,避免手术。
副作用:用药6个月以上可产生围绝经期综合征。骨质疏松等。
(2) 米非司酮类
常用药物;米非司酮12.5mg/d.o或者甲基睾丸素5mg/d.o
适应症;术前用药或是提前绝经。
副作用:米非司酮有拮抗糖皮质激素作用,不宜长期应用。睾丸素有男性化作用等,应用剂量<300mg/月。
复方醋酸棉酚片
棉酚是从棉籽中提取的双醛萘类化合物,对男女性有抗生育作用。一个月为一疗程 晚饭后服用 常规应少于6疗程,孕妇,哺乳期,老年人禁用。
作用:药物分子竞争性地与肌瘤组织中等的雌,孕激素受体相结合,迅速抑制雌,孕激素的生物作用,使肌瘤萎缩,症状缓解。 较长时间(>3个月)应用棉酚,对卵巢有一定的抑制作用,血中雌,孕激素水平下降。但作用轻微,具有可透性。对病变组织细胞DNA的合成有显著的抑制作用,且要大于孕酮和丹那唑。
副反应:低钾血症;食欲减退,恶心,呕吐?心悸?轻度肝功能改变;出现更年期症状:闭经,潮热,出汗等。
-----------------------------------------------
产地国家: 美国
原产地英文商品名:
Ellaone 30mg/Tablet
原产地英文药品名:
Ulipristal acetate
中文参考商品译名:
Ellaone 30毫克/片
中文参考药品译名:
醋酸乌利司他
生产厂家中文参考译名:
HRA Pharma Deutschland GmbH
生产厂家英文名:
HRA Pharma Deutschland GmbH
-----------------------------------------------
产地国家: 德国
原产地英文商品名:
Ellaone 30mg/Tablet
原产地英文药品名:
Ulipristal acetate
中文参考商品译名:
Ellaone 30毫克/片
中文参考药品译名:
醋酸乌利司他
生产厂家中文参考译名:
HRA Pharma Deutschland GmbH
生产厂家英文名:
HRA Pharma Deutschland GmbH

责任编辑:admin


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