部份马利兰中文资料（仅供参考）
药品名称和成分
通用名：白消安片
商品名：马利兰
英文名：Busulfan Tablets，白血福恩，马利兰，Busulphan，MYLERAM
别名: 白消妥;白血福恩;二甲磺酸丁酯;马礼冷;马利兰;马利南;买勒兰;麦里浪;米埃罗生 ,白消安
外文名: Busulfan ,Myleran, BSF, BUS 主要成分：白消安。
化学名: 1,4-丁二醇二甲磺酸酯
结构式: 分子式 C6H14O6S2 分子量 246.29
生产厂家
Glaxo Smith Kline 英葛兰素
规 格
2mg
适应症
主要用于治疗慢性粒细胞白血病及真性红细胞增多症、骨髓纤维化等。
用量用法
口服：每日量成人２～８ｍｇ，儿童每千克体重０．０５ｍｇ。直到白细胞下降到１万～２万后停药或改为维持量（０．５～２ｍｇ，每日１次或每周２次）。 用间歇大剂量治疗慢性粒细胞白血病，疗效与上法基本相同，但可缩短诱导缓解的时间，且可能减少招致再生障碍性贫血的机会。
用法为：根据病人白细胞及血小板计数，分别选用１次给药８０～１００ｍｇ、５０ｍｇ、２０～３０ｍｇ的三种不同剂量（若１次服１００ｍｇ，一般分２次服用，在１～２日内服完）。２次服药的间歇时间为１～２周（根据血象而定），１次若服药８０～１００ｍｇ，需间隔２周以上。
任何疑问，请遵医嘱！
注意事项
1.可致胎儿畸形，因而在妊娠前３个月禁用。
2.一般很少引起消化道反应。如用量过大或给药时间过长可引起严重骨髓再生障碍。有的病人有闭经、胎儿发育障碍、色素沉着、脱发、皮疹、男性乳腺发育、睾丸萎缩等。个别病人长期服用时可有肺纤维变及肾上腺皮质功能低下。
3.慢性粒细胞白血病有急性变时应停用。
4.急性白血病和再生障碍性贫血或其他出血性疾患病人忌用。
5.肾上腺皮质功能不全病人慎用。
不良反应
骨髓抑制，胃肠道反应，色素沉着，伴有进行性呼吸困难与持续性干咳的广泛性肺部纤维化，荨麻疹，多形性红斑，结节性红斑，脱发，迟发性皮肤卟啉症，皮肤干燥与脆弱，口腔粘膜干燥和唇裂，男性乳房女性化，胆汁郁积性黄疸，心内膜纤维化，重症肌无力。
功能作用
本品口服吸收良好，迅速分布到各组织中去，t1/2约2～3小时。几乎所有药物经代谢后均以甲烷磺酸形式自尿中缓慢排出。24小时排出不足50％，反复用药可引起蓄积。但5例病人服用本品1mg／kg每6小时1次，连服4日，首剂后t1/2为3.4小时，末剂后t1/2为2.3小时。说明长期用药可促进自身代谢。
慢性粒细胞白血病资料
脾脏
慢性粒细胞白血病主要为血液、骨髓和脾内充满大量幼稚粒细胞。肿大的脾脏、正常结构为髓外造血细胞所取代，有粒细胞、幼红细胞和巨核细胞，甚至可发生梗死。轻度肿大的肝脏，虽有髓细胞浸润，但对肝细胞无明显损害。骨髓除见有各阶段粒细胞，并有一定程度纤维变性，随病程的进展，骨髓纤维变性不断加重，骨质硬化、髓腔狭窄，造血细胞显著减少。
治疗
1.放射治疗对病情进行性进展，白细胞数急剧增高，脾及淋巴结显著肿大的病例可进行脾区照射，5rad*开始，随后增至100～150rad，每日或隔日一次，当白细胞下降至20×109/L时停止照射，一般总剂量在1000～5000rad之间。
2.脾切除有下列情况者可考虑脾切除：
①巨脾，压迫症状显著；
②继发性脾功能亢进；
③药物控制不理想或发生顽固性血小板减少者；
④脾破裂、出血或栓塞者；
⑤能耐受手术治疗者。
3.白细胞清除术适用于白细胞过高者，是防止栓塞的应急办法，在短时间内可使过高的白细胞总数下降。
4.造血干细胞移植同种异基因骨髓移植，是目前唯一能根除白血病细胞株，达到临床治愈的方法。选择慢性期患者，经预处理后，再接受HLA相合同胞的骨髓移植，使临床部分病例长期无病存活。自体外周血干细胞移植和自体骨髓移植，一般在慢粒慢性期经治疗缓解后，用血细胞分离器自患者本身外周血中分离出白细胞或1次收集足够量的自身骨髓，深低温液氮保存，日后发生急变时经大量化疗和放疗预处理后，再将贮存的自身细胞或骨髓复温后回输给患者，使患者再回到慢粒慢性期。
慢粒为难治性疾病，生存期有限，治疗时先辨别标本所在，进行适宜论治，审其病机，正气不足为病之本，邪毒瘀结为病之标，在早、中期阶段，正气仍存，瘀毒尤甚之时，当祛其标实，祛：“毒”化瘀，以祛邪而达到扶正作用，让正气自然恢复，中、晚期，瘀毒热邪强盛，正气衰败，不宜强攻强泻，注意攻补兼施，对重症合并严重感染、出血、贫血者，应积极采取救治措施，给予足量抗生素、止血药物及输血等支持疗法。
方法用量
放射治疗
1.成人常用量
①慢性粒细胞白血病，每日总量按体表面积为4-6mg/平方米，直至白细胞计数下降至15×109/L以下停药。如服药3周，白细胞计数仍不见下降，可适当增加剂量。对缓解期短于3个月的患者，可给维持量每周2次，每次2mg以维持白细胞计数在10×109/L左右。
②真性红细胞增多症，每日4-6mg，分次口服，以后根据血象、病情及疗效调整剂量。
2．小儿常用量诱导剂量为每日按体重0.06-0.12mg/kg或按体表面积每日1.8-3.6mg/平方米。以后根据血象、病情及疗效调整剂量，以维持白细胞计数在20×109/L以上。
(1)服白消安时，需根据患者对药物的反应、骨髓抑制的程度、个体的差异而调节剂量。
(2)要告诫患者多摄入进液量，并使尿碱化，或给服别嘌醇，以防止高尿酸血症及尿酸性肾病的产生。
(3)发现血粒细胞或血小板数有迅速大幅度下降的征象时，应立即停止服药或减少用药剂量，以防止骨髓产生不可逆性抑制。
(4)近期内曾接受全疗程的放射治疗或足量的其他化疗药物者暂不宜选用本品。
(5)于开始治疗前及疗程中要每周1-2次定期密切随访血象与肝肾功能的动态变化，以便及时调整药物剂量。应定期检查肾功能(血尿素氮、内生肌酐清除率)、肝功能(血清胆红素、丙氨酸氨基转移酶)及测定血清尿酸量。
禁忌
肾上腺
(1)本品和其他烷化剂相同，有可能增加胎儿死亡及先天性畸形的危险，因此在妊娠初期3个月内不用此药。在妊娠3个月后如用此药，也需经过慎重考虑，因为所有抗肿瘤药物均能影响细胞动力学，在理论上均有可能引起胎儿基因突变及胎儿畸变。应用本品时应终止哺乳。
(2)下列情况应慎用：骨髓有抑制现象、痛风病史、感染、尿酸性肾结石病史、以往曾接受过细胞毒药物或放射治疗。肾上腺皮质功能低下.慢性粒细胞白血病有急变时应停药.急性白血病及再障病人忌用.肾上腺皮质功能低下者慎用。
生产厂家: Glaxo Smith Kline

Myleran Tablets 2mg
1. What Myleran is and what it is used for
Myleran tablets contain a medicine called busulfan. This belongs to a group of medicines called cytotoxics (also called chemotherapy). Myleran is used for certain blood problems and cancers of the blood. It works by reducing the number of new blood cells your body makes.
Myleran is used for:
•Chronic granulocytic leukaemia (also called chronic myeloid leukaemia) - a disease that increases the number of white blood cells. This can cause infections and bleeding
•Polycythaemia vera a disease which increases the number of red cells in your blood. This makes the blood thicken and causes blood clots. This leads to headaches, dizziness and shortness of breath
•Thrombocythaemia a disease which affects platelets (blood cells that help blood to clot). There may be an increase in platelets - which causes blood clots. Or the platelets do not work properly - which causes bleeding such as nose bleeds, bleeding gums and bruising easily
•Myelofibrosis a disease where bone marrow (where blood cells are made) is replaced by scar (fibrous) tissue. This causes red and white blood cells to be made wrongly. This can cause tiredness, bloated stomach, bleeding, and bruising
Ask your doctor if you would like more explanation about these diseases.
2. Before you take Myleran
Do not take Myleran if:
•You are allergic (hypersensitive) to busulfan or any of the other ingredients of Myleran tablets (See section 6: Further information)
•You have taken Myleran before and it did not work
Do not take if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Myleran.
Take special care with Myleran
Before you take Myleran, tell your doctor or pharmacist if:
•You have had radiotherapy, now or recently
•You have an inherited blood problem called thalassaemia
•You have ever had gout (painful and swollen joints caused by uric acid crystals). You may need treatment for your gout before you start taking Myleran.
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Myleran.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This includes herbal medicines.
In particular tell your doctor or pharmacist if you are taking any of the following:
•Other cytotoxic drugs (chemotherapy) - when used with Myleran there is a greater chance of side-effects, such as breathing problems
•Phenytoin (used to treat and prevent fits) - your doctor may need to change your phenytoin to a different medicine
•Vaccines which contain live organisms (such as oral polio, measles, mumps and rubella) - Myleran can make your body less able to fight infections
•Itraconazole (for fungal infections) or metronidazole (for bacterial infections) - they can cause serious side effects if used with Myleran
•Cyclophosphamide (used for certain types of blood disorders) - if used with Myleran, it is best that your first cyclophosphamide dose is given 24 hours or longer after the last Myleran dose. This will reduce the chance of any possible side effects
•An anaesthetic for an operation at the hospital or dentist. If so, tell your doctor or dentist that you are taking busulfan.
Fertility
Do not take Myleran if you are planning to have a baby. This applies to both men and women. Myleran can affect ovaries or sperm, which may cause fertility problems.
Reliable contraceptive precautions must be taken to avoid pregnancy whilst you or your partner are taking these tablets. Ask your doctor for advice.
Pregnancy and breast-feeding
Myleran is not recommended during pregnancy, particularly in the first three months, because it may cause permanent damage to a foetus. If you are pregnant, if you think you might be pregnant, or if you are planning to become pregnant, check with your doctor before you take Myleran. Your doctor will consider the risks and benefits to you and your baby of taking Myleran.
Breast-feeding is not recommended during treatment with Myleran. It is not known whether the ingredients of Myleran can pass into breast-milk. Talk to your doctor or midwife about this.
Important information about some of the ingredients of Myleran
Myleran tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before you take Myleran tablets.
3. How to take Myleran
Myleran should only be given to you by a specialist doctor who is experienced in treating blood problems.
Always take Myleran exactly as your doctor has told you. It is important to take your medicine at the right times. The label on your pack will tell you how many tablets to take and how often to take them. If the label doesn’t say or if you are not sure, ask your doctor, nurse or pharmacist.
•Swallow your tablets whole with a glass of water.
•Do not break, crush or chew the tablets.
The dose of Myleran depends on your blood problem or blood cancer (see section 1).
•Your doctor may also change your dose during your treatment, depending on your needs
•The dose can sometimes be changed if you are over-weight
•If you take a high-dose of Myleran, your doctor may also prescribe another medicine called a benzodiazepine. This will help to stop you having a fit.
•When you take Myleran your doctor will take regular blood tests. This is to check the number of cells in your blood. Your doctor may sometimes change your dose depending on the results of the blood samples.
Chronic granulocytic leukaemia (also called chronic myeloid leukaemia)
•The usual first dose is up to 4 mg, given as a single dose. Your doctor will then decide on the size of the next doses, based on your weight.
•The treatment is normally a course which lasts for 12 to 20 weeks. You may have more than one course of treatment.
•Some people have to take Myleran long term. If you have to take it long term, the usual dose is 0.5 mg to 2 mg each day. If your dose is less than 2 mg each day, your doctor might ask you to take tablets only on certain days. Follow your doctor’s instructions carefully.
•Chronic myeloid leukaemia is rare in children and there is no recommended dose of Myleran.
Polycythaemia vera
•The usual dose is 4 to 6 mg each day.
•The course is usually 4 to 6 weeks. This course can be repeated.
•Some people have to take Myleran long term. If you have to take it long term, the usual dose is 2 to 3 mg each day. Follow your doctor’s instructions carefully.
Myelofibrosis and essential thrombocythaemia
•The usual dose is 2 to 4 mg each day.
If you take more Myleran than you should
If you take more Myleran than you should, tell your doctor immediately or go to a hospital straight away. Take the medicine pack with you.
If you forget to take Myleran
Tell your doctor. Do not take a double dose to make up for a forgotten dose.
4. Possible side effcts
Like all medicines, Myleran can cause side effects, although not everybody gets them.
If you get any of the following, talk to your specialist doctor or go to hospital straight away:
•any signs of a high temperature or infection (sore throat, sore mouth or urinary problems). Treatment with Myleran can cause a lowering of the white blood cell count. White blood cells fight infection, and when there are too few white blood cells, infections can occur
•any unexpected bruising or bleeding, as this could mean that too few blood cells of a particular type are being produced
•if you suddenly feel unwell (even with a normal temperature).
Talk to your doctor if you have any of the following side effects which may also happen with this medicine:
Very common (affects more than 1 in 10 people)
•a drop in the number of blood cells and platelets
•feeling sick (nausea), being sick (vomiting), diarrhoea and mouth ulcers - with high doses of Myleran
•yellowing of the whites of the eyes or skin (jaundice) and liver damage - with high doses of Myleran
•in women, periods may stop, fertility may be affected and the menopause may start early - with high doses of Myleran
•in girls, the start of puberty may be delayed or prevented
•in boys and men, sperm production may be delayed, reduced or stopped and your testicles may reduce in size
•inflammation of the lung with no sign of infection - called pneumonia syndrome - with high doses of Myleran.
Common (affects less than 1 in 10 people)
•your heart may not be able to beat properly - especially if you have an inherited blood problem called thalassaemia
•inflammation of the lungs which causes breathlessness, cough and raised temperature – called pneumonitis
•hair loss (with high doses of Myleran)
•appearance of patches of dark skin
•signs of blood in your urine and pain when passing water (bladder inflammation) - with high doses of Myleran at the same time as taking a medicine called cyclophosphamide
•leukaemia.
Uncommon (affects less than 1 in 100 people)
•in women, periods may stop and fertility may be affected and menopause may start early - with usual doses of Myleran
Rare (affects less than 1 in 1,000 people)
•a severe drop in red blood cells which can cause tiredness, weakness, bruising and make you more likely to get infections – called aplastic anaemia
•fits or seizures - with high doses of Myleran
•cataracts or other eye problems - after bone marrow transplantation and with high doses of Myleran
•feeling or being sick (nausea or vomiting), diarrhoea and mouth ulcers - with usual doses of Myleran. This can be improved by splitting the dose through the day
•jaundice (yellowing of the whites of eyes or skin) and liver damage - with usual doses of Myleran
•hair loss (with normal doses of Myleran)
•dry mouth and lips or other skin changes including very dry skin, itching or rash
Very rare (affects less than 1 in 10,000 people)
•muscle weakness commonly leading to drooping eye lids and difficulty in speaking or using your arms and legs – called Myasthenia gravis
•enlargement of breasts in men
•weakness, feeling very tired, weight loss, feeling sick, being sick and dark skin patches – which resembles Addison’s disease (but with the adrenal glands working correctly)
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
The use of Myleran may increase the risk of developing a type of cancer called secondary acute leukaemia in the future.
Secondary acute leukaemia causes bone marrow (tissue in your bones that produces red and white blood cells) to produce large numbers of cells that do not work properly. Symptoms of this condition include tiredness, fever, infection and bruising.
The condition may also be detected by a blood test which will show if there are large numbers of cells in your blood that are not working properly and too few blood cells that are working properly.
Tell your doctor as soon as possible if you have any of these symptoms. You may need to stop taking Myleran, but only your doctor can tell you if that is necessary
5. How to store Myleran
•Keep out of the reach and sight of children.
•Do not use Myleran after the expiry date, which is stated on the bottle label and the carton after ‘Exp’. This is printed as month; year and refers to the last date of the month
•Do not store your Myleran tablets above 25°C.
•If your doctor tells you to stop taking the tablets, it is important to return any which are left over to your pharmacist, who will destroy them according to disposal of dangerous substance guidelines. Only keep the tablets if your doctor tells you to.
6. Further information
What Myleran contains
The active ingredient is busulfan. Each Myleran tablet contains 2 mg of busulfan.
The other ingredients are anhydrous lactose, pregelatinised starch, magnesium stearate, hypromellose, titanium dioxide (E171) and triacetin
What Myleran looks like and contents of the pack
Myleran tablets are white, film-coated tablets and are marked with ‘GX EF3’ on one side and ‘M’ on the other. Your Myleran tablets are in bottles of 100 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation holder:
Manufacturer:
EXCELLA GmbH
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产地国家： 德国
原产地英文商品名:
Myleran 2mg/tablets 25tablets/box
原产地英文药品名:
busulfan
中文参考商品译名:
马利兰 2毫克/片 25片/盒(本品10盒起订)
中文参考药品译名:
白消安
生产厂家中文参考译名:
葛兰素史克
生产厂家英文名:
GlaxoSmithKline
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产地国家： 德国
原产地英文商品名:
Myleran 2mg/tablets 100tablets/box
原产地英文药品名:
busulfan
中文参考商品译名:
马利兰 2毫克/片 100片/盒
中文参考药品译名:
白消安
生产厂家中文参考译名:
葛兰素史克
生产厂家英文名:
GlaxoSmithKline