产地国家：日本

处方药：是

所属类别： 2毫克/片 10片/盒

包装规格： 2毫克/片 10片/盒

计价单位：盒 ：

生产厂家英文名：Nippon Shinyaku

原产地英文商品名：Amnolake(アムノレイク錠)2mg/tab 10tabs/box

原产地英文药品名：Tamibarotene

中文参考商品译名：Amnolake(アムノレイク錠)2毫克/片 10片/盒

中文参考药品译名：他米巴罗汀

简介：

部份中文他米巴罗汀处方资料（仅供参考）

商品名：Amnolake

英文名：Tamibarotene

中文名：他米巴罗汀

生产商：日本新药株式会社アムノレイク锭2mg

药用类别名称：复发性和难治性急性粒细胞前白血病治疗剂

批准日期：2005年6月

商标名：Amnolake

一般名：タミバロテン（JAN）（英名）Tamibarotene（JAN）

化学名：4-[(5,6,7,8-Tetrahydro-5,5,8,8-tetramethyl-2-naphthyl)carbamoyl]benzoic acid

分子式：Ｃ22Ｈ25ＮＯ3

分子量：351.45

性状：它是一种白色的晶体或结晶性粉末。 n, 易溶于 n-二甲基甲醯胺, 微溶于甲醇或乙醇 (95), 微溶于乙醚, 几乎不溶于乙腈, 几乎不溶于水。熔点约232°c分佈係数:> 63900 [1-octanol/buffer (pH4.23, 25°c)]　854[1-octanol/buffer (ph7.07, 25°c)]批准条件商业使用后的一段时间后, 通过登记所有使用案例的例子进行上市后调查, 并调查疗效和安全性、维甲酸综合征、弥散性血管内凝血综合征、总胆固醇水准、甘油三酯值、肌酸激酶值, 重点研究淀粉酶值、皮肤症状、肝功能障碍、视力障碍、骨痛、高脂血症和药物之间的相互作用。

药用药理学：在apl[t (移位) 中导致特定染色体异常的pml-rara嵌合基因被认为参与了apl的发展, 通过抑制pml 或rar α的功能来抑制抑制分化和骨髓细胞凋亡。在这裡, apl细胞的pm-rara嵌合基因在其作用分离时的抑制机制被认为是诱导前骨髓圈分化的机制。

适应症：复发性或难治性急性粒细胞前白血病用法与用量缓解诱导治疗: 早晨 1天, 6g/2, 晚餐后口服, 给药, 直到获得骨髓缓解。 管理期限自代理人管理开始之日起不得超过八周。

包装：片剂，2mg: ptp10片

英文版说明书：

Amnolake Tablets 2mg(Tamibarotene)Brand name : Amnolake Tablets 2mg　Active ingredient: Tamibarotene　Dosage form: white tablet, diameter 7mm, thickness 3mm　Print on wrapping: (face) 402, (back) アムノレイク錠 2mgEffects of this medicineThis medicine has therapeutic action to differentiate myeloid cell.It is used to treat relapsed or refractory acute promyelocytic leukemia.Before using this medicine, be sure to tell your doctor and pharmacist•If you ever experienced any allergic reaction (itch, rash, etc.) to any medicines.Woman who has a possibility of being pregnant, or getting pregnant.If you are patient with hypervitaminosis A, hyperlipemia, disorders in liver/kidney, or reduced gastric acid secretion.If you are elderly patient, or 25 years or under.•If you are pregnant or breastfeeding.•If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)Dosing schedule (How to take this medicine)•Your dosing schedule prescribed by your doctor is <<to be written by a healthcare professional>>•General dosage regimen: Take 6mg/m2 in 2 divided doses a day after breakfast and dinner. This tablet contains 2mg of the active ingredient. Strictly follow the instructions of dosage regimen.•Swallow the medicine without breaking this tablet into small pieces or chewing.•If you missed a dose, skip the missed dose and continue your regular dosing schedule. DO NOT take a double dose to make up for the missed dose.•If you took too much of this medicine (more than ordered), check with your doctor/pharmacist.•Do not stop taking this medicine without the instructions of your doctor.Precautions while taking this medicine•Woman make sure to avoid pregnancy for at least 1 month before starting this medication, during taking this medicine and for at least 2 years after discontinuing it.•Man make sure to avoid pregnancy during taking this medicine, and for at least 6 month after discontinuing it.•Note that the grapefruit juice might strengthen the action of this medicine.•Note that St. John's wort-containing food might weaken the action of this medicine.•If you are taking vitamin A product (Chocola A etc.) or fibrate drug, tell your doctor/pharmacist before using this medicine.Possible adverse reactions to this medicineCommon side effects are reported as below. If any of them occurs, check with your doctor/pharmacist:rash, bone pain, fever, dry skin, etc.The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.•high fever of over 38℃, chest pain, breathlessness [retinoic acid syndrome]•cold-like symptoms, lassitude, vomiting [infection]•fever, dry cough, breathlessness [interstitial lung disease]•fever, chest pain, swallowing difficulty [mediastinitis]•muscle pain of the hands and feet, stiffness, numbness, lassitude, red/brown urine [rhabdomyolysis]The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.Storage conditions and other information•Keep out of the reach of baby and children. Store away from direct sunlight, high temperature and humidity.•Pay close attention to storage, not to lose this medicine.•Do not share this medicine with any other person, and make sure that any other person do not take it by mistake.•Discard the remainder. Do not store them. Ask the pharmacist how to discard.Nippon Shinyaku Co., Ltd.InternalRevised: 9/2006The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.