奈拉滨注射剂Atriance 250MG/50ML(Nekarabine)

药店国别:

产地国家:意大利

处方药:

所属类别: 250毫克/50毫升 6瓶/盒

包装规格: 250毫克/50毫升 6瓶/盒

计价单位:盒

生产厂家中文参考译名:

生产厂家英文名:GlaxoSmithKline S.p.A.

原产地英文商品名:Atriance 250MG/50ML/VIAL 6VIALS/BOX

原产地英文药品名:Nelarabin

中文参考商品译名:Atriance 250毫克/50毫升 6瓶/盒

中文参考药品译名:奈拉滨

曾用名:

简介:部份中文奈拉滨处方资料(仅供参考)通用药名:奈拉滨注射液英文名称:Nekarabine商品名称:Arranon/ATRIANCE化学名称:9beta-D-Arabinofuranosyl-6-methoxy-9H-purin-2-amine分子式:C11H15N5O5分子量:297.27CAS.NO:121032-29-9剂 型:原料药、注射液注册分类:化药3+3规格:250mg/50ml

适 应 症:

用于至少接受过两种化学疗法之后病情复发或对药物无应答的T细胞急性成淋巴细胞性白血病和T细胞淋巴瘤患者。

用法用量:

成人推荐剂量1500 mg/m²,静脉输注2小时,21天为一疗程,在第1、3、5天给药,无需稀释。儿童推荐剂量为650mg/m²,静脉输注1小时,21天为一疗程,连续输注5天,无需稀释。

产品优势:

奈拉滨由葛兰素(GlaxoSmithKline)公司研发,2005年10月获得美国FDA的批准,成为治疗至少对两种化疗方案无反应或治疗后又复发的急性T-细胞淋巴母细胞性白血病(T-ALL)和T-细胞淋巴母细胞性淋巴瘤(T-LBL)的新药,2006年在美国正式上市。规模的临床试验表明,奈拉滨治疗T-细胞幼淋巴细胞白血病(T-PLL)和外周T-细胞淋巴瘤结果令人鼓舞。奈拉滨潜在的适应症还包括靶组织中有高水平核苷酸激酶的非T-cell 疾病。实际上,I和II期临床试验显示,奈拉滨单独或与其他药物联合使用治疗B-细胞慢性淋巴细胞白血病也有一定疗效。细胞内的ara-GTP水平可以预测病人是否对奈拉滨有反应。而奈拉滨和其他药物联合使用则可进一步扩展该产品的使用范围。此外,本品在给药方式上也有进一步扩展的余地,现在的给药方式是1-2小时静脉输液,每日1次,给药5天或采用隔日给药的方式。最后,由于该产品选择性地作用于T-细胞, 没有令人头疼的骨髓毒性,因此可开发在骨髓抑制方面的应用。

奈拉滨注射剂英文版说明书

Atriance 5 mg/ml solution for infusionWhat is it and how is it used?Atriance belongs to a group of medicines used to treat some types of cancer.Atriance is used to treat patients with:a type of leukaemia, called T-cell acute lymphoblastic leukaemia. Leukaemia causes an abnormal increase in the number of white blood cells in the body, and sometimes also the blood. The type of leukaemia relates to the type of white blood cell mainly involved. In this case, its cells called lymphoblasts.a type of lymphoma, called T-cell lymphoblastic lymphoma. This lymphoma is caused by a mass of lymphoblasts, a type of white blood cell.If you have any questions about your illness, talk to your doctor.What do you have to consider before using it?You (or your child, if he/she is being treated) must not receive Atrianceif you (or your child, if he/she is being treated) are allergic (hypersensitive) to nelarabine or any of the other ingredients of Atriance.Take special care with AtrianceSevere neurological side effects have been reported with the use of Atriance. Symptoms have included altered mental states (e.g. tiredness), effects on your nervous system (e.g. convulsions, feelings of numbness or tingling, weakness and paralysis). Your doctor will check for these symptoms regularly (see also “Possible side effects”).Your doctor also needs to know the following before you are given this medicine:if you (or your child, if he/she is being treated) have any kidney or liver problems. Your dose of Atriance may need to be adjustedif you (or your child, if he/she is being treated) have recently been, or plan to be vaccinated with a live vaccine (for example Polio, Varicella, Typhoid)Tell your doctor if any of these apply to you.Using other medicines Tell your doctor if you are taking any other medicines, or have recently taken any. This includes any herbal products or medicines you have bought without a prescriptionRemember to tell your doctor if you start to take any other medicines while you are on Atriance. Pregnancy and breast-feedingAtriance is not recommended for pregnant women. It may harm a baby if conceived before, during or soon after treatment. Consideration to appropriate birth control is recommended to be discussed with your doctor. Do not try and become pregnant/father a child until your doctor advises you it is safe to do so.Male patients, who may wish to father a child, should ask their doctor for family planning advice or treatment. If pregnancy occurs during treatment with Atriance, you must tell your doctor immediately.It is not known whether Atriance is passed on through breast milk. Breast-feeding must be discontinued while you are taking Atriance. Ask your doctor for advice before taking any medicine.See “Take special Care with Atriance”.Driving and using machinesAtriance can make people feel drowsy or sleepy, both during and for some days after treatment. If you feel tired or weak, do not drive, and do not use any tools or machines.Important information about some of the ingredients of AtrianceThis medicine contains at least 23 mg sodium per dose. To be taken into consideration by patients on a controlled sodium diet.How is it used?The dose of Atriance you are given will be based on:your/your child’s (if he/she is being treated) body surface area (which will be calculated by your doctor based on your height and weight).the results of blood tests carried out before treatmentAdults and adolescents (aged 16 years and older)A doctor or nurse will give you a suitable dose of Atriance as an infusion (a drip). It is usuallydripped into your arm over a period of about 2 hours.You will have an infusion (a drip) once a day on days 1, 3 and 5 of treatment. This pattern of treatment will normally be repeated every three weeks. This treatment may vary, depending on the results of your regular blood tests.Children and adolescents (aged 21 years and younger)A doctor or nurse will give you/your child (if he/she is being treated) a suitable dose of Atriance asan infusion (a drip). It is usually dripped into your arm over a period of about 1 hour.You/your child (if he/she is being treated) will have an infusion (a drip) once a day for 5 days. This pattern of treatment will normally be repeated every three weeks. This treatment may vary, depending on the results of regular blood tests.Stopping treatment with AtrianceYour doctor will decide when to stop the treatment.If you have any further questions on the use of this product, ask your doctor or pharmacist.What are possible side effects?Like all medicines, Atriance can cause side effects, although not everybody gets them.The majority of side effects reported with Atriance were seen in adults, children and adolescents. Some of the side effects were reported more often in adult patients. There is no known reason for this.If you have any concerns, discuss them with your doctor.Very Common side effectsThese may affect more than 1 in 10 people treated with Atriance.Signs of infection. Atriance may reduce the number of white blood cells and lower your resistance to infection (including pneumonia). This can even be life threatening. Signs of an infection include:feverserious deterioration of your general conditionlocal symptoms such as sore throat, sore mouth or urinary problems (for example, a burningsensation when urinating, which may be a urinary infection)Tell your doctor immediately if you get any of these. A blood test will be taken to check possible reduction of white blood cells.Other very common side effectsChanges in the sense of feeling in hands or feet, muscle weakness appearing as difficulty getting up from a chair, or difficulty walking ( peripheral neuropathy); reduced sensitivity to light touch, or pain; abnormal sensations such as burning and, prickling, a sensation of something crawling on the skin.Feeling generally weak and tired ( temporary anaemia). In some cases you may need a blood transfusion.Unusual bruising or bleeding, caused by a decrease in the number of clotting cells in the blood. This can lead to severe bleeding from relatively small injuries such as a small cut. Rarely, it can lead to even more severe bleeding ( haemorrhage). Talk to your doctor for advice on how to minimize the risk of bleeding.Feeling drowsy and sleepy; headache; dizziness.shortness of breath, difficult or laboured breathing; cough.Feeling of an upset stomach ( nausea); being sick/throwing up ( vomiting); diarrhoea; constipationMuscle pain.Swelling of parts of the body due to accumulation of abnormal amounts of fluid ( oedema).High body temperature ( fever); tiredness; feeling weak/loss of strength.Tell a doctor if any of these becomes troublesome.Common side effectsThese may affect up to 1 in 10 people treated with Atriance:Violent, uncontrollable muscular contractions often accompanied by unconsciousness that can be due to an epileptic attack ( seizures).Clumsiness and lack of coordination affecting balance, walking, limb or eye movements, or speech.Unintentional rhythmic shaking of one or more limbs ( tremors).Muscle weakness (possibly associated with peripheral neuropathy – see above), joint pain, back pain; pains in hands and feet including a sensation of pins and needles sensation and numbness.Lowered blood pressure.Weight loss and loss of appetite ( anorexia); stomach pains; sore mouth, mouth ulcers or inflammation.Problems with memory, feeling disoriented; blurred vision; altered or loss of sense of taste ( dysgeusia).Build up of fluid around the lungs leading to chest pain and difficulty in breathing ( pleural effusion); wheezingIncreased amounts of bilirubin in your blood, which may cause yellowing of the skin and may make you feel lethargic.Increases in blood levels of liver enzymes.Increases in blood creatinine levels (a sign of kidney problems, which might lead less frequent urination).The release of tumour cell contents ( tumour lysis syndrome), which may put extra stress on your body. Initial symptoms including nausea and vomiting, shortness of breath, an irregular heartbeat, clouding of urine, lethargy and/or joint discomfort. If this does occur, it is most likely to occur at the first dose. Your doctor will take appropriate precautions to minimise the risk of this.Low blood levels of some substances: — low calcium levels, which may cause muscle cramps, abdominal cramps or spasms — low magnesium levels, which may cause muscle weakness, confusion, “jerky” movements, high blood pressure, irregular heart rhythms and decreased reflexes with severely low blood magnesium levels. — low potassium levels may cause a feeling of weakness — low glucose levels, which may cause nausea, sweating, weakness, faintness, confusion or hallucinations.Tell a doctor if any of these becomes troublesome.If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.How should it be stored?Keep out of the reach and sight of children.Do not use Atriance after the expiry date which is stated on carton and vial.This medicinal product does not require any special storage conditions.Atriance is stable for up to 8 hours at up to 30°C once the vial is opened

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