什么是甲基硫堇氯化物Proveblue及其用途是什么？

Methylthioninium chloride Proveblue用于成人和所有年龄段的儿童，作为治疗由于使用某些药物或化学品引起的高铁血红蛋白血症症状的解毒剂。

血红蛋白血症是一种血液中血红蛋白（称为高铁血红蛋白）过多而无法有效输送氧气的病症。可能导致高铁血红蛋白血症的物质包括一些抗生素，局部麻醉剂，饮用水中的硝酸盐和杀虫剂。

Methylthioninium chloride Proveblue是一种“混合药物”。这意味着它类似于参考药物，含有相同的活性物质但浓度不同。甲基硫堇氯化物Proveblue的参考药物是Methylthioninium Chloride Injection USP 1％w / v。

Methylthioninium chloride Proveblue含有活性物质甲基硫堇氯化物。

如何使用Methylthioninium chloride Proveblue？

甲基硫堇氯化物Proveblue可作为注射用溶液（5mg / ml），在5分钟内缓慢注入静脉。它只能通过处方获得，必须由医疗保健专业人员提供。

成人和3个月以上儿童的常用剂量为每公斤体重1至2毫克。如果症状持续或恢复，或者血液中的高铁血红蛋白水平高于正常水平，则可在第一次给药后一小时给予重复剂量。

3个月或3个月以下儿童的剂量为0.3至0.5毫克/千克。它们也可在一小时后给予重复剂量。

Methylthioninium chloride Proveblue如何工作？

为了在血液中携带氧气，血红蛋白需要含有“铁”形式的铁原子（Fe2 +）。接触某些药物或化学物质会导致血红蛋白中的铁转变为高铁血红蛋白血症中的“铁”形式（Fe3 +），这种形式的氧运输能力较差。

甲基硫堇氯化物Proveblue中的活性物质，甲基硫堇氯化物（也称为亚甲基蓝），有助于加速异常血红蛋白转化为正常血红蛋白。它是通过一种名为'NADPH高铁血红蛋白血症还原酶'的酶接受带负电的电子粒子来实现的。然后电子被转移到异常血红蛋白中的铁原子，将它们转化为正常的亚铁形式。

研究显示甲基硫堇氯化物Proveblue有哪些好处？

由于甲硫堇氯化物已在欧盟使用了几十年来治疗高铁血红蛋白血症，该公司从已发表的文献中提供了其使用数据，该文献证实甲基硫堇氯化物可有效治疗因接触药物或化学物质引起的高铁血红蛋白血症。在成人和儿童。

甲基硫堇氯化物Proveblue有哪些风险？

甲基硫堇氯化物最常见的副作用是头晕，感觉异常（异常感觉如'针刺'），味觉障碍（味觉障碍），恶心（感觉不适），皮肤变色，色尿（尿液颜色异常），出汗和疼痛在注射部位或肢体部位。有关甲基硫堇氯化物报告的所有副作用的完整列表，请参阅包装说明书。

Methylthioninium chloride Proveblue不得用于对甲基硫堇氯化物过敏（过敏）的人，或任何其他噻嗪染料（甲基硫堇氯化物所属的组）。不得用于有下列情况的患者：

•葡萄糖-6-磷酸脱氢酶缺乏症（G6PD），

•氰化物中毒治疗期间由亚硝酸盐引起的高铁血红蛋白血症，

•氯酸盐中毒引起的高铁血红蛋白血症，

•酶NADPH还原酶缺乏。

为什么Methylthioninium chloride Proveblue获得批准？

委员会总结了使用活性物质甲基硫堇氯化物的长期经验，表明它可有效治疗高铁血红蛋白血症。CHMP决定该药物的益处大于其风险，并建议获得上市许可。

采取了哪些措施来确保安全有效地使用甲基硫堇氯化物Proveblue？

医疗专业人员和患者安全有效使用甲基硫堇氯化物Proveblue的建议和注意事项已包含在产品特性摘要和包装说明书中。

关于Methylthioninium chloride Proveblue的其他信息

欧盟委员会于2011年5月6日批准了欧盟有效的甲基硫堇氯化物Proveblue上市许可。

有关使用Methylthioninium chloride Proveblue进行治疗的更多信息，请阅读包装说明书（也是EPAR的一部分）或联系您的医生或药剂师。

Methylthioninium chloride Proveblue

methylthioninium chloride

Overview

This is a summary of the European public assessment report (EPAR) for Methylthioninium chloride Proveblue. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and itsconditions of use. It is not intended to provide practical advice on how to use Methylthioninium chloride Proveblue

For practical information about using Methylthioninium chloride Proveblue, patients should read the package leaflet or contact their doctor or pharmacist.

What is Methylthioninium chloride Proveblue and what is it used for?

Methylthioninium chloride Proveblue is used in adults and children of all ages as an antidote to treat symptoms of methaemoglobinaemia caused by the use of certain medicines or chemicals.

Methaemoglobinaemia is a condition where there is too much of an abnormal form of haemoglobin (called methaemoglobin) in the blood that is not able to transport oxygen effectively. Substances that may cause methaemoglobinaemia include some antibiotics, local anaesthetics, nitrates in drinking water and pesticides.

Methylthioninium chloride Proveblue is a ‘hybrid medicine’. This means that it is similar to a reference medicine, containing the same active substance but in a different concentration. The reference medicine for Methylthioninium chloride Proveblue is Methylthioninium Chloride Injection USP 1% w/v.

Methylthioninium chloride Proveblue contains the active substance methylthioninium chloride.

How is Methylthioninium chloride Proveblue used?

Methylthioninium chloride Proveblue is available as a solution for injection (5 mg/ml), which is injected slowly into a vein over a period of five minutes. It can only be obtained with a prescription and must be given by a healthcare professional.

The usual dose for adults and children aged above three months is 1 to 2 mg per kilogram (kg) body weight. A repeat dose may be given one hour after the first dose if symptoms persist or come back, or if the level of methaemoglobin in the blood stays higher than normal.

The dose in children aged three months or less is 0.3 to 0.5 mg/kg. They may also be given a repeat dose after one hour.

How does Methylthioninium chloride Proveblue work?

To carry oxygen in the blood, haemoglobin needs to contain an atom of iron in the ‘ferrous’ form (Fe2+). Exposure to certain medicines or chemicals can cause the iron in the haemoglobin to change to the ‘ferric’ form (Fe3+) seen in methaemoglobinaemia which is less able to transport oxygen.

The active substance in Methylthioninium chloride Proveblue, methylthioninium chloride (also called methylene blue), helps speed up the conversion of abnormal haemoglobin back into normal haemoglobin. It does this by accepting negatively charged electron particles through an enzyme called ‘NADPH methaemoglobinaemia reductase’. The electrons are then transferred to the iron atoms in the abnormal haemoglobin, converting them into the normal ferrous form.

What benefits of Methylthioninium chloride Proveblue have been shown in studies?

Because methylthioninium chloride has been used in the European Union for several decades to treat methaemoglobinaemia, the company presented data on its use from the published literature, which confirmed that methylthioninium chloride is effective in treating methaemoglobinaemia that has been caused by exposure to a medicine or chemical in adults and children.

What are the risks associated with Methylthioninium chloride Proveblue?

The most common side effects with methylthioninium chloride are dizziness, paraesthesia (unusual sensations like ‘pins and needles’), dysgeusia (taste disturbances), nausea (feeling sick), skin discoloration, chromaturia (abnormal colouration of the urine), sweating and pain at the site of injection or in a limb. For the full list of all side effects reported with methylthioninium chloride, see the package leaflet.

Methylthioninium chloride Proveblue must not be used in people who are hypersensitive (allergic) to methylthioninium chloride, or to any other thiazine dyes (the group to which methylthioninium chloride belongs). It must not be used in patients with the following conditions:

· glucose-6-phosphate dehydrogenase deficiency (G6PD),

· methaemoglobinaemia caused by nitrite during treatment of cyanide poisoning,

· methaemoglobinaemia caused by chlorate poisoning,

· deficiency in the enzyme NADPH reductase.

Why is Methylthioninium chloride Proveblue approved?

The Committee concluded the long experience with the active substance, methylthioninium chloride, shows that it is effective in treating methaemoglobinaemia. The CHMP decided that the medicine’s benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Methylthioninium chloride Proveblue?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Methylthioninium chloride Proveblue have been included in the summary of product characteristics and the package leaflet.

Other information about Methylthioninium chloride Proveblue

The European Commission granted a marketing authorisation valid throughout the European Union for Methylthioninium chloride Proveblue on 6 May 2011.

For more information about treatment with Methylthioninium chloride Proveblue, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.