部份中文醋酸格拉替雷处方资料（仅供参考）
英文名：Glatiramer Acetate Injection
商品名：COPAXONE
中文名：醋酸格拉替雷注射剂
生产商：梯瓦公司
药品简介
Copaxone(Glatiramer acetate)注射器-多发性硬化症长效注射剂是由以色列药厂TEVA研发制造，商品名Copaxone
作用机制
醋酸格拉默在复发型MS中发挥治疗作用的机制尚未完全阐明，但被认为涉及免疫过程的调节。对动物和MS患者的研究表明，醋酸格拉雷默作用于先天免疫细胞，包括单核细胞、树突状细胞和B细胞，进而调节B和T细胞的适应性功能，诱导抗炎和调节细胞因子分泌。治疗效果是否由上述细胞效应介导尚不清楚，因为MS的病理生理学仅部分了解。
适应症
Copaxone用于治疗复发型多发性硬化症（MS）（有关疗效已确定的人群的重要信息）。
在原发性或继发性进行性MS中未显示共轴突。
用法与用量
Copaxone治疗的开始应由神经科医生或有MS治疗经验的医生监督。
剂量
成人的推荐剂量为40mg醋酸格拉替拉默（一个预先填充的注射器），每周皮下注射三次，间隔至少48小时。
目前，尚不清楚患者应治疗多长时间。
关于长期治疗的决定应由治疗医生根据个人情况作出。
肾损害
尚未对肾功能损害患者的共轴突进行专门研究。
老年人
尚未对老年人的共轴突进行专门研究。
儿科人群
醋酸格拉默在儿童和青少年中的安全性和有效性尚未确定。关于18岁以下儿童和青少年使用Copaxone 40mg/ml TIW的信息不足，无法提出任何使用建议。因此，在该人群中不应使用40mg/ml的Copaxone TIW。
给药方法
Copaxone用于皮下注射。
患者应接受自我注射技术的指导，并在第一次自我注射和30分钟后接受医疗保健专业人员的监督。
每次注射都应选择不同的部位，这样可以减少注射部位出现任何刺激或疼痛的机会。自我注射的部位包括腹部、手臂、臀部和大腿。
如果患者希望使用注射装置进行注射，则可以使用CSYNC装置。CSYNC装置是一种自动注射器，用于Copaxone预填充注射器，尚未与其他预填充注射器一起测试。应按照设备制造商提供的信息中的建议使用CSYNC设备。
禁忌症
在下列情况下，禁止使用共轴：
•对列出的活性物质（醋酸格拉默）或任何赋形剂过敏
保质期
3年
储存的特殊预防措施
将预先填充的注射器放在外纸箱中，以防光线照射。
储存在冰箱中（2°C–8°C）。
不要冻结。
如果预充注射器不能储存在冰箱中，则可将其储存在15°C至25°C之间，一次最多可储存一个月。
一个月后，如果Copaxone预充注射器未使用，且仍处于原始包装中，则必须将其放回冰箱（2°C至8°C）中储存。
容器的性质和内容
预填充的注射用Copaxone 40 mg/ml溶液注射器由一个1 ml无色I型玻璃注射器筒、一根蓝色聚丙烯（可选聚苯乙烯）柱塞杆、一个橡胶柱塞塞和一个针头护罩组成。
每个预填充注射器单独包装在PVC泡罩包装中。
Copaxone 40mg/ml可分为3个、12个或36个预先填充的1ml注射溶液注射器的包装，或分为36个（3包12个）预先填充的1 ml注射溶液注射器。
请参阅随附的Copaxone完整处方信息：
https://www.medicines.org.uk/emc/product/7046/smpc
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COPAXONE*SC 28SIR 20MG/ML
MMUNOSTIMOLANTI
COPAXONE
C 28SIR 20MG/ML
TEVA PHARMA ITALIA Srl
Descrizione prodotto
COPAXONE*SC 28SIR 20MG/ML
Principio attivo
GLATIRAMER ACETATO
Forma farmaceutica
PREPARAZIONE INIETTABILE
ATC livello 3
IMMUNOSTIMOLANTI
Tipo prodotto
FARMACO ETICO
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COPAXONE(glatiramer acetate)Injection
Important Safety Information
COPAXONE® is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol.
Approximately 16% of patients exposed to COPAXONE® 20mg per mL compared to 4% of those on placebo, and approximately 2% of patients exposed to COPAXONE® 40 mg per mL compared to none on placebo experienced a constellation of symptoms that may occur immediately(within seconds to minutes, with the majority of symptoms observed within 1 hour) after injection and included at least 2 of the following: flushing, chest pain, palpitations, tachycardia, anxiety, dyspnea, throat constriction, and urticaria.
In general, these symptoms have their onset several months after the initiation of treatment, although they may occur earlier, and a given patient may experience 1 or several episodes of these symptoms.
Typically, the symptoms were transient and self-limited and did not require treatment; however, there have been reports of patients with similar symptoms who received emergency medical care.
Transient chest pain was noted in 13% of COPAXONE® 20 mg per mL patients compared to 6% of placebo patients, and approximately 2% of COPAXONE® 40 mg per mL patients compared to 1% on placebo. While some episodes of chest pain occurred in the context of the Immediate Post-Injection Reaction described above, many did not.
The temporal relationship of this chest pain to an injection was not always known.
The pain was usually transient, often unassociated with other symptoms, and appeared to have no clinical sequelae. Some patients experienced more than 1 such episode, and episodes usually began at least 1 month after the initiation of treatment.
At injection sites, localized lipoatrophy and, rarely, injection site skin necrosis may occur.
Lipoatrophy may occur at various times after treatment onset (sometimes after several months) and is thought to be permanent.
There is no known therapy for lipoatrophy.
Because COPAXONE® can modify immune response, it may interfere with immune functions. For example, treatment with COPAXONE® may interfere with recognition of foreign antigens in a way that would undermine the body's tumor surveillance and its defenses against infection.
There is no evidence that COPAXONE® does this, but there has not been a systematic eva luation of this risk.
In controlled studies of COPAXONE® 20 mg per mL, the most common adverse reactions with COPAXONE® vs placebo were injection site reactions (ISRs), such as erythema (43% vs 10%); vasodilatation (20% vs 5%); rash (19% vs 11%); dyspnea (14% vs 4%); and chest pain (13% vs 6%).
In a controlled study of COPAXONE® 40 mg per mL, the most common adverse reactions with COPAXONE® vs placebo were ISRs, such as erythema (22% vs 2%).
ISRs were one of the most common adverse reactions leadin