美罗华冻干粉注射剂(MabThera Injection 1400mg/11.7ml)

产地国家：英国 处方药：是 所属类别： 1400毫克/毫升 11.7毫升/瓶 包装规格： 1400毫克/毫升 11.7毫升/瓶 计价单位：瓶 生产厂家英文名：Roche 原产地英文商品名：MabThera 1400mg/ml 11.7ml/Vial Subcutaneous Injection 原产地英文药品名：RITUXIMAB 中文参考商品译名：MabThera皮下注射剂型 1400毫克/毫升 11.7毫升/瓶 中文参考药品译名：利妥昔单抗

简介

2014年1月25日，罗氏(Roche)1月24日宣布，新剂型美罗华(MabThera/Rituxan，通用名：rituximab，利妥昔单抗)获得了欧洲药品管理局(EMA)人用医药产品委员会(CHMP)的积极意见。CHMP建议欧盟委员会(EC)批准皮下注射剂型美罗华(MabThera SC，1400mg)用于非霍奇金淋巴瘤(NHL)患者的治疗。罗氏预计，EC将在未来几个月内做出最终审查决定。目前，MabThera通过静脉滴注(intravenous，IV)给药，全程耗时2.5小时，皮下注射剂型MabThera则通过皮下注射(subcutaneous，SC)给药，耗时仅为5分钟，创伤更小，耗时更短，对患者及医护人员来说，均是一个显著改善。 CHMP的积极意见，主要基于一项2阶段、国际性III期SABRINA研究的数据，该项研究调查了MabThera SC相对于MabThera IV的药代动力学、药效和安全性，数据表明，MabThera SC具有与MabThera IV相一致的疗效和安全性，达到了非劣效性主要终点。MabThera SC是一种固定剂量的即用型(ready-to-use)液体配方，可大大简化护理程序。 关于美罗华(MabThera/Rituxan)：美罗华(MabThera/Rituxan)是一种治疗性单克隆抗体，靶向结合正常和恶性B细胞表面的CD20抗原，随后调动人体天然防御，攻击和杀死标记的B细胞。骨髓内的干细胞(B细胞祖细胞)缺乏CD20抗原，从而使健康的B细胞能够在治疗后再生，并在几个月内恢复至正常水平。

英文版说明书

MabThera (Rituximab)MabThera (Rituximab)belongs to a group of cancer drugs known as monoclonal antibodies|.Monoclonal antibodies recognise and lock onto specific proteins on the surface of cancer cells. This helps the body's immune system to recognise the cancer cells and destroy them. Monoclonal antibodies are sometimes called targeted therapies because they target cancer cells.How MabThera (Rituximab)worksMabThera (Rituximab) locks onto a protein called CD20, which is found on the surface of white blood cells called B-lymphocytes or B-cells. This triggers the body’s immune system to attack the cells and destroy them.As well as being found on the surface of normal B-cells, CD20 is also present on most of the abnormal B-cells which occur in many types of non‑Hodgkin lymphoma and on some of the abnormal B-cells found in CLL.MabThera (Rituximab) destroys both abnormal (malignant) and normal B-cells. However, the body can replace normal B-cells that are damaged so their numbers recover once treatment is over.When it is usedMabThera (Rituximab) is used to treat several types of non‑Hodgkin lymphoma. It may also be used to treat chronic lymphocytic leukaemia. It is often given in combination with chemotherapy| but may be given on its own.MabThera (Rituximab)may also be given to people with follicular lymphoma| who have no signs of cancer at the end of their treatment (remission). The aim is to keep the lymphoma away for as long as possible.This is called maintenance therapy and is given every three months, for up to two years.What it looks likeMabThera (Rituximab)forms a colourless fluid after being diluted.How it is givenMabThera (Rituximab)is given as a drip into a vein (intravenous infusion). It may be given on its own or with chemotherapy.Some people have an allergic reaction to rituximab. Reactions are most common with the first infusion so, to reduce the risk of a reaction, the first dose is given slowly over a number of hours. You will be given medicines before the treatment that help to prevent or reduce any reaction.If you have a reaction, the infusion can be stopped and started again when the symptoms are over. You may need to stay in hospital overnight for the first treatment so that you can be monitored. After that, MabThera (Rituximab)can usually be given in the outpatients department and over a shorter period of time.When used by itself, MabThera (Rituximab)is usually given weekly over a period of four weeks. The treatment may be repeated later if necessary.If MabThera (Rituximab)is used with chemotherapy, it is given with each course of treatment.Possible side effectsEach person’s reaction to cancer treatment is different. Some people have very few side effects, while others may experience more. The side effects described here won't affect everyone.We have outlined the most common side effects but haven't included those that are rare and therefore unlikely to affect you. If you notice any effects which aren't listed here, discuss them with your doctor or specialist nurse.The side effects of MabThera (Rituximab)are generally mild and some of these can be reduced with medicines.Side effects of MabThera (Rituximab)fall into two groups:Infusion-related side effects, which occur during the infusion or within a few hours of the drug being given. These are usually most noticeable with the first dose.Later side effects, which occur after a few days or weeks of treatment.Infusion-related side effectsThese are most common with first few infusions. Reactions are usually mild or moderate but sometimes they can be more severe.If you have a reaction it can usually be treated by slowing or stopping the drip until you feel better. You may also be given treatment such as an antihistamine or paracetamol. When you feel better the infusion can be continued. These reactions are less likely to happen after the second infusion.You’ll be monitored closely during your infusion but it's very important to tell your nurse or doctor if you feel unwell or have any of the following symptoms:flu-like symptoms, such as headache, feeling flushed, having a fever, chills, or dizzinessfeeling sickred, warm and itchy bumps on the skin (like nettle rash)a feeling of swelling in the lips, tongue or throatbreathlessness, wheezing, a cough or sudden difficulty in breathingpain in your back or tummychest tightness or chest pain.Sometimes an infusion-related reaction can happen a few hours after treatment. If you develop these symptoms or feel unwell after you get home, contact the hospital straight away for advice.Low blood pressure Some people have a fall in their blood pressure during the infusion. Your blood pressure will be checked regularly. If you normally take medicines to lower your blood pressure tell the doctor. You may be given instructions about when it's best to take these before MabThera (Rituximab) is given.Tumour pain Some people experience mild pain in the parts of the body where they have cancer during the infusion. Painkillers| can be given to relieve this.Other possible side effectsLowered resistance to infection (neutropenia) MabThera (Rituximab)can reduce the number of white blood cells produced by the bone marrow, making you more prone to infection|. Your blood cell numbers (blood count) will be monitored throughout your treatment.Contact your doctor or the hospital straight away if:your temperature goes above 38˚C (100.4˚F)you suddenly feel unwell, even with a normal temperature.Occasionally it may be necessary to delay your treatment if the number of blood cells is low.Bruising or bleeding MabThera (Rituximab)can reduce the production of platelets, which help the blood to clot. Tell your doctor if you have any unexplained bruising or bleeding, such as nosebleeds, bleeding gums, blood spots or rashes on the skin. They will advise you about this and any precautions you should take.Anaemia (low number of red blood cells) You may become anaemic while having treatment with rituximab. This may make you feel tired| and breathless|. Tell your doctor or nurse if you have these symptoms. You may need to have a transfusion of blood| if the number of red blood cells becomes too low.Feeling sick (nausea|) Your doctor can prescribe anti-sickness drugs to prevent or greatly reduce this if it occurs.Always let your doctor or nurse know about any side effects you have. There are usually ways in which they can be controlled or improved.Additional informationMabThera (Rituximab) may worsen heart problems for people who already have them. For this reason it is used with caution in anyone who has heart disease.Contraception It is not known what effect MabThera (Rituximab)may have on an unborn baby. It is recommended that women able to become pregnant, and men who are sexually active, use effective contraception while having MabThera (Rituximab)and for at least 12 months after the treatment has ended.It's also recommended that women don't breastfeed during the treatment or for at least 12 months afterwards.Vaccines You should avoid having live vaccines during treatment and for at least six months afterwards. Live vaccines include BCG, yellow fever, measles, mumps, rubella, liquid typhoid, poliomyelitis liquid and