部份中文马法兰处方资料(仅供参考) 【作用特点】 本品为溶肉瘤素的左旋体,较消旋体溶内瘤素作用强。口服吸收良好,均匀分布体内各脏器,但不能透过血——脑脊液屏障。 【功能主治】 本品可用与多种肿瘤,在单一化疗及联合化疗中,为多发性骨髓瘤的首选药。对精原细胞瘤、乳腺癌、卵巢癌、慢性白血病、真性红细胞增多症,恶性淋巴瘤、儿童晚期神经母细胞瘤、甲状腺癌有效。动脉灌注治疗肢体恶性肿瘤如:恶性黑色素瘤、软组织肉瘤和骨肉瘤有较好疗效,偶用于治疗某些自身免疫性疾病以及防止器官移植时的排异反应。 【用法与用量】 因为美法仑具有骨髓抑制作用,故在治疗期间内,必需频繁监测血象(血细胞计数),必要时暂缓用药或调整剂量。或遵医嘱。 成年口服用药: 口服美法仑的吸收是易变的,为了确保达到可能的治疗水平。应谨慎增加剂量,直到出现出现骨髓抑制作用为止。 多发性骨髓瘤: 有多种治疗方案,应详细查阅文献,美法仑与强的松合用,可能比单用美法仑更有效,通常联合用药间歇进行。虽然延长连续用药的优越性仍未证实,但典型的剂量是每日每公斤体重0.15毫克分次服用共四天,六周后重复疗程。对治疗有反应者延长疗程超过一年不会改进疗效。 卵巢腺癌: 典型的治疗方案是每日每公斤体重0.2毫克共五天,每4~8周或当外周血象恢复时重复疗程;当出现骨髓毒性时应减低剂量。 晚期乳腺癌: 口服美法仑每日每公斤体重0.15毫克或每平方米体表面积6毫克,共5日,每六周重复疗程,也可使用美法仑静脉注射治疗。 真性红血球增多症:诱导缓解期,每日用6~10毫克共5~7天,之后可每日2~4毫克直至能满意地控制症状,维持剂量可每周一次用2~6毫克,其间必须对患者仔细谨慎地进行血液学控制,以血细胞计数结果为依据,适当调整剂量。 肾功能不全患者:依据目前建立的药动学数据,对中度至重度肾功能不全患者口服美法仑,并非绝对推荐降低剂量,但起始剂量需谨慎地降低。 【不良反应】 美法仑最常见的不良反应是骨髓抑制,可导致白细胞和血小板减少。高达30%的病人在口服常规剂量美法仑后,出现胃肠道不适,包括恶心和呕吐,使用常规剂量美法仑罕见胃炎发生,而接受高剂量静注美法仑有增加腹泻、呕吐和胃炎发生的可能。有报道称使用环磷酰胺前驱治疗可降低美法仑诱导的胃肠道损伤。偶有患者接受数月以上治疗,出现美法仑过敏反应,例如:荨麻疹、水肿、皮疹和过敏性休克,另有二例出现心脏停顿,但此副作用是否因美法仑引起仍未证实,斑丘疹和搔痒也偶有报道,曾有病例显示,在使用美法仑后,出现肺纤维化和出血性贫血,有脱发的报道,但不普遍。 【禁忌证】 对本品有过敏史及妊娠和哺乳期妇女禁用,近期内做过化疗、放疗而有白细胞减少者不宜用药。 【注意事项】 1. 肾功能不良着慎用。 2. 因本品可使血中尿素氮升高,故使用时应监测血象和血中尿素氮水平,当中性粒细胞低于2×109 /L时应停药。 【相互作用】 萘啶酸并用静脉滴注本品高剂量,会令儿童因出血性肠炎而导致死。骨髓移植者,由于术前用高剂量静脉注射本品来控制病情,术后再接受环磷酰胺防止受移植者的身体排斥新骨髓,可引起肾功能缺损。 【制剂规格】 片剂:2mg、5mg 粉针剂:50mg 【储藏】 片剂:2-8 oC一下保持干燥。针剂:避光贮存于30 oC一下。马法兰应用于多发性骨髓癌病的各种化疗方案参考,各方案的使用因病人的病情的不同需在医生的指导下使用,成人体表面积一般约1.5m2 且MP方案是马法兰方案中唯一可以口服的方案,其优点是便于在家治疗 。 包装 アルケラン錠2mg:25錠 瓶
完整处方资料附件:http://www.120ty.net/bencandy.php?fid=141&aid=5601&page=1 The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse effects (risks) as well as efficacies (benefits). It is important to minimize adverse effects and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment. Brand name : Alkeran Tablets 2mg Active ingredient: Melphalan Dosage form: white tablet, φ: 6.5 mm, thickness: 3.5 mm Print on wrapping: Effects of this medicine This medicine inhibits DNA synthesis of abnormal cells to suppress their growth. It is usually used to improve subjective symptoms such as lumbar pain and general malaise, anemia, thrombocytopenia and renal disorder. Before using this medicine, be sure to tell your doctor and pharmacist •If you ever experienced any allergic reaction (itch, rash etc.) to any medicine. If you are a patient with leucopenia, thrombocytopenia, infections, uremia or renal disorder. If you are receiving radiation therapy. •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 1 to 2 tablets (2-4 mg of the active ingredient) at a time, once daily, on consecutive days. You may also be instructed to take 3 to 5 tablets (6-10 mg of the active ingredient) at a time, once daily, for 4 to 10 consecutive days (total dosage 20-30 tablets [40-60 mg of the active ingredient]), then interrupt the medication (for 2-6 weeks in general) and take 1 tablet (2 mg of the active ingredient) daily, on consecutive days. In another dosing schedule, you may be instructed to take 3 to 6 tablets (6-12 mg of the active ingredient) at a time, once daily, for 4 to 10 consecutive days (total dosage 20-30 tablets [40-60 mg of the active ingredient]), then interrupt the medication (for 2-6 weeks in general) and repeat this schedule. You will undergo repeat blood tests while receiving the treatment and the dosage may be adjusted or treatment may be interrupted according to the results. Strictly follow the instructions of your doctor/pharmacist. •Take a dose as soon as possible. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. DO NOT take double doses to make up for the missed dose. •If you took too much of the medicine (more than ordered), check with your doctor/pharmacist. •Do not stop taking the medicine without the instructions of your doctor.
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