您好,欢迎光临世界标品! 登录 注册(订药物标准品请用邮件联系我们)

中国医药研发对照标品提供商
Non-clinical Research-used
Medicine Sample Provider

当前本网站药物产品种数共 8351 处方药 7978 非处方药 267 保健品/医疗用具 106

世界标品医药目录搜索(中英文):
世界各国官方药品目录搜索(英文):
世界标品医药知识搜索(中英文):

联系方式
国际免费电话:
QQ客服1:1793093587
QQ客服2:1586083059
QQ客服3:2786706041
QQ客服6:2992753224
QQ客服7:2394834588

咨询邮箱:
scimed.shanghai@shijiebiaopin.com
info@shijiebiaopin.com
pharmacy.shijiebiaopin1@gmail.com
pharmacy.shijiebiaopin2@gmail.com

  药店国别: 美国药房
产地国家: 美国
所属类别: 维生素类及微量元素药物->铁过量
处方药:处方药
包装规格: 30片/瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
诺华公司
生产厂家英文名:
Novartis Pharma
该药品相关信息网址1:
https://www.jadenu.com/about-treatment/how-treatment-may-help/?site=43700019795450377&source=01030&irmasrc=jadwb25349&gclid=CKHUle7Cm94CFZqdxQIdTeYJbQ&gclsrc=ds&dclid=CPHGru7Cm94CFQvcWwodoVUOag
该药品相关信息网址2:
https://www.rxlist.com/jadenu-drug.htm
原产地英文商品名:
Jadenu 360MG/TAB 30TABS/bottle
原产地英文药品名:
DEFERASIROX
中文参考商品译名:
Jadenu片 360毫克/片 30片/瓶
中文参考药品译名:
地拉罗司斯
原产地国家批准上市年份:
2015/04/02
英文适应病症1:
Treatment of chronic iron overload caused by blood transfusion in patients 2 years of age and older
临床试验期:
完成
中文适应病症参考翻译1:
治疗2岁及以上患者输血引起的慢性铁超负荷
药品信息:

---------------------------------------------------------------
 详细处方信息以本药内容附件PDF文件(2018102219304923.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------
部分中文地拉罗司斯处方资料(仅供参考)

诺华新型口服铁螯合剂Jadenu获美国FDA批准上市 Jadenu是Exjade的一种新口服配方,是首个可直接吞服的每天1次口服铁螯合剂。Exjade则是一种分散片,必须在液体中混合并在饭前至少30min空腹服用。Jadenu则在有无便餐的情况下均可直接吞服,从而大大简化了慢性铁过载(CIO)的治疗管理。Jadenu的上市,对于需要定期服用铁螯合剂治疗以清除体内过量铁的广大患者而言,是一个大好消息

批准日期:2015年4月2日 公司:诺华 Novartis

JADENU(地拉罗司 deferasirox)片剂,用于口服使用

美国初步批准:2005年

警告:

死亡,死亡和胃肠道异物请参阅完整的处方信息以获得完整的盒装警告。

JADENU可能造成严重和致命:

肾毒性,包括失败

肝毒性,包括失败

胃肠道出血

JADENU治疗需要密切的患者监测,包括肾脏和肝脏功能的实验室测试。

剂量和管理,管理

警告和注意事项

过敏 ,严重皮肤反应 :

超敏反应:停止JADENU的严重反应,并进行医疗干预。 严重的皮肤反应,包括史蒂文斯 - 约翰逊综合征(SJS)。

作用机制

JADENU(deferasirox)是一种对铁有选择性的口服活性螯合剂(如Fe3+)。 它是以高比例以2:1的比例结合铁的三齿配体。 虽然地拉罗司对锌和铜具有非常低的亲和力,但是在施用地拉罗司之后,这些痕量金属的血清浓度存在可变的减少。 这些减少的临床意义是不确定的。

适应症和用法

JADENU是一种铁螯合剂,用于治疗2岁及以上患者输血引起的慢性铁超负荷。该指征在加速批准下基于肝铁浓度和血清铁蛋白水平的降低而得到批准。这种适应症的持续批准可能取决于在验证性试验中临床获益的验证和描述。 JADENU用于治疗10岁及以上患有非输血依赖性地中海贫血(NTDT)综合征和具有至少5mg Fe每克的肝脏铁(Fe)浓度(LIC)的患者的慢性铁超负荷干重(Fe/gdw)和血清铁蛋白大于300mcg/L。该指示在加速批准下基于肝铁浓度(小于5mg Fe/gdw)和血清铁蛋白水平的降低而得到批准。这种适应症的持续批准可能取决于在验证性试验中临床获益的验证和描述。

使用限制

尚未进行JADENU在骨髓增生异常综合征(MDS)和由于输血的慢性铁超负荷的患者中的受控临床试验。 JADENU与其他铁螯合疗法一起使用时的安全性和有效性尚未确定。

剂量和给药

转移铁超负荷:初始剂量14mg/kg(计算为最接近的整片),每天一次。

NTDT综合征:初始剂量7mg/kg(计算为最接近的整片),每天一次。

每月监测血清铁蛋白,并相应调整剂量。

每6个月监测LIC,并相应调整剂量。

服用空腹或低脂肪餐。

将中度(Child-Pugh B)肝损伤的剂量减少50%。避免在严重(Child-Pugh C)肝损伤的患者。

在肾损伤患者中减少剂量50%(ClCr 40-60mL/min)。 剂量形式和强度

片剂:90mg,180mg,360mg。

禁忌症

血清肌酐大于正常上限(ULN)或肌酐清除率(ClCr)的2倍以上小于40mL /min。

性能状态差的患者。

高危骨髓增生异常综合征(MDS)患者。

患有晚期恶性肿瘤的患者。

血小板计数小于50×109 / L的患者。

已知对地拉罗司或JADENU的任何组分的超敏反应。

警告和注意事项

骨髓抑制:中性粒细胞减少,粒细胞缺乏症,恶化贫血和血小板减少症,包括致命事件;在JADENU治疗期间监测血细胞计数。中毒治疗。

增加老年人的毒性:密切监测毒性。

不良反应

在输血性铁超负荷的患者中,最常发生(大于5%)的不良反应是腹泻,呕吐,恶心,腹痛,皮疹和血清肌酐升高。在地拉罗司治疗的NTDT综合征患者中,最常见的(大于5%)不良反应是腹泻,皮疹和恶心。

要报告可疑的不良反应,请联系诺华制药公司1-888-669-6682或FDA 1-800-FDA-1088或

www.fda.gov/medwatch。

药物相互作用

由于JADENU的作用机制,避免使用JADENU与含铝抗酸制剂。

地拉罗司增加CYP2C8底物瑞格列奈的暴露。考虑使用瑞格列奈的剂量降低和监测血糖水平。

避免使用JADENU与CYP1A2底物茶碱作为茶碱水平可以增加。

在特定人群中使用

怀孕:根据动物研究,可能导致胎儿伤害。

哺乳:停止药物或母乳喂养,考虑到药物对母亲的重要性。

-----------------------------------------------

产地国家: 美国

原产地英文商品名:

Jadenu 90MG/TAB 30TABS/bottle

原产地英文药品名: DEFERASIROX

中文参考商品译名:

Jadenu片 90毫克/片 30片/瓶

中文参考药品译名:

地拉罗司斯

生产厂家中文参考译名:

诺华公司

生产厂家英文名:

Novartis Pharma

STORAGE

25°C (77°F); excursions permitted to 15-30°C (59-86°F). Protect from moisture.

Norvar's new oral iron chelator Jadenu is approved by the US FDA Jadenu is a new oral formulation from Exjade and is the first oral iron chelating agent to be swallowed once a day. Exjade is a dispersible tablet that must be mixed in a liquid and taken on an empty stomach for at least 30 minutes before meals. Jadenu can be swallowed directly in the absence of a light meal, greatly simplifying the management of chronic iron overload (CIO) treatment. The marketing of Jadenu is a great news for the majority of patients who need to take iron chelator regularly to remove excess iron from the body

Approval date: April 2, 2015 Company: Novartis Novartis

JADENU (Daleras deferasirox) tablets for oral use

US Initial Approval: 2005

Warning:

Death, Death, and Gastrointestinal Foreign Body Please refer to the complete prescribing information for a complete boxed warning.

JADENU can be serious and fatal:

Nephrotoxicity, including failure

Hepatotoxicity, including failure

Gastrointestinal bleeding

JADENU treatment requires close patient monitoring, including laboratory testing of kidney and liver function.

Dose and management, management

Warnings and Precautions

Allergies, severe skin reactions :

Hypersensitive response: Stop the serious reaction of JADENU and perform medical intervention. Severe skin reactions include Stevens-Johnson Syndrome (SJS).

Action mechanism

JADENU (deferasirox) is an iron-selective oral active chelating agent (such as Fe3+). It is a tridentate ligand that binds iron in a ratio of 2:1 at a high ratio. Although deferasirox has a very low affinity for zinc and copper, there is a variable reduction in serum concentrations of these trace metals after administration of deferasirox. The clinical significance of these reductions is uncertain.

Indications and Usage

JADENU is an iron chelator used to treat chronic iron overload caused by blood transfusion in patients 2 years of age and older. This indication was approved under accelerated approval based on a reduction in liver iron concentration and serum ferritin levels. The continued approval of this indication may depend on the validation and description of the clinical benefit in the validation trial. JADENU is used to treat chronic iron overload dry weight (Fe/) in patients aged 10 years and older with non-transfusion dependent thalassemia (NTDT) syndrome and liver iron (Fe) concentration (LIC) with at least 5 mg Fe per gram. Gdw) and serum ferritin greater than 300 mcg/L. This indication was approved under accelerated approval based on a reduction in hepatic iron concentration (less than 5 mg Fe/gdw) and serum ferritin levels. The continued approval of this indication may depend on the validation and description of the clinical benefit in the validation trial.

Use restrictions

Controlled clinical trials of JADENU in patients with myelodysplastic syndrome (MDS) and chronic iron overload due to transfusion have not been performed. The safety and efficacy of JADENU in combination with other iron chelation therapies have not been established.

Dose and Administration

Transferred iron overload: initial dose 14 mg/kg (calculated as the nearest whole piece) once daily.

NTDT syndrome: initial dose 7 mg/kg (calculated as the closest whole tablet) once daily.

Monitoring serum ferritin monthly and adjusting the dose accordingly.

Monitor the LIC every 6 months and adjust the dose accordingly.

Take an empty stomach or low fat meal.

Reduce the dose of moderate (Child-Pugh B) liver damage by 50%. Avoid patients with severe (Child-Pugh C) liver damage.

Reduce the dose by 50% (ClCr 40-60 mL/min) in patients with renal impairment. Dosage form and intensity

Tablets: 90 mg, 180 mg, 360 mg.

Contraindications

Serum creatinine is greater than twice the upper limit of normal (ULN) or creatinine clearance (ClCr) and less than 40 mL / min.

Patients with poor performance status.

Ph. patients with high-risk myelodysplastic syndrome (MDS).

Patients with advanced malignancies.

Patients with platelet counts less than 50 x 109 / L.

A hypersensitivity reaction to any component of deferasirox or JADENU is known.

Warnings and Precautions

Myelosuppression: neutropenia, agranulocytosis, worsening of anemia and thrombocytopenia, including fatal events; monitoring of blood cell counts during JADENU treatment. Poison treatment.

Increase the toxicity of the elderly: closely monitor toxicity.

Adverse reactions

Among patients with transfusion-induced iron overload, the most common (greater than 5%) adverse events were diarrhea, vomiting, nausea, abdominal pain, rash, and elevated serum creatinine. Among the patients with NTDT syndrome treated with deferasirox, the most common (greater than 5%) adverse reactions were diarrhea, rash and nausea.

To report suspected adverse reactions, contact Novartis Pharmaceuticals at 1-888-669-6682 or FDA 1-800-FDA-1088 or

www.fda.gov/medwatch.

Drug interaction

Because of JADENU's mechanism of action, avoid using JADENU with aluminum-containing antacids.

Dalrosone increases exposure of CYP2C8 substrate repaglinide. Consider using repaglinide for dose reduction and monitoring blood glucose levels.

Avoid using JADENU with CYP1A2 substrate theophylline as the level of theophylline can be increased.

Use

in a specific population

Pregnant: According to animal studies, it may cause fetal harm.

Breastfeeding: Stop taking drugs or breastfeeding, taking into account the importance of the drug to the mother.

-----------------------------------------------

Country of origin: United States

origin English English product name:

Jadenu 90MG/TAB 30TABS/bottle

Original English drug name: DEFERASIROX

Chinese reference product translation name:

Jadenu tablets 90 mg / tablet 30 tablets / bottle

Chinese reference drug translation:

Dalros

Manufacturer Chinese reference translation:

Novartis

Manufacturer English name:

Novartis Pharma

STORAGE

25°C (77°F); excursions permitted to 15-30°C (59-86°F). Protect from moisture.

---------------------------------------------------------------
 详细处方信息以本药内容附件PDF文件(2018102219304923.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------

更新日期: 2018-12-26
附件:
2018112722393816.jpeg    

2018102219304923.pdf    

 
调控比例: 100%
订购表单下载
Copyrights © 2010,2011,2012 www.ShiJieBiaoPin.com, Inc., All rights Reserved www.ShiJieBiaoPin.com, Inc.
客服工作时间:太平洋时间18:00-24:00
国际免费电话:
友情提示:以上电话为免费电话,无需您承担任何费用,世界标品提供中文客服,请您放心拨打!
电子邮箱:info.shijiebiaopin.com@gmail.com, info@shijiebiaopin.com