Glatiramer acetate(GA)是一种人工新合成的肽类制剂,由四种氨基酸组成.实验研究表明它对人类多发性硬化(MS)的动物模型,即实验性自身免疫性脑脊髓炎(EAE)有防治作用.GA对MS的临床前及临床Ⅰ期、Ⅱ期、Ⅲ期试验均表明也有治疗作用,虽还没有治愈MS的病例报道,但它能降低复发率及减轻病残,尤其对复发缓解型MS(RRMS)更有效.核磁共振(MRI)增强后显示病灶明显减少,这也支持上述观点.使用GA副作用小,病人可以耐受,有可能替代IFN-β.因此,GA可成为治疗MS的一线药.今后应扩大GA的试验范围(如用于治疗PPMS)及给药途径,进一步研究GA的临床应用。

Brand names: Copaxone®Copaxone® Patient Pack

Glatiramer Acetate Solution for injection

What is this medicine?

GLATIRAMER (gla TIR a mer) helps to decrease the number of multiple sclerosis relapses in people with relapsing-remitting forms of the disease. The medicine does not cure multiple sclerosis.
 
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
•immune system problems
•infection
•an unusual or allergic reaction to glatiramer, mannitol, other medicines, foods, dyes, or preservatives
•pregnant or trying to get pregnant
•breast-feeding

How should I use this medicine?

This medicine is for injection under the skin. You will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice.
 
It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.
 
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
 
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What may interact with this medicine?

Interactions are not expected.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:
•allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
•chest pain or tightness
•difficulty breathing
•fever, chills, or any other sign of infection
•rapid heartbeat or palpitations
•severe pain at the injection site
•swelling of the ankles

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
•anxiety
•dizziness
•drowsiness
•flushing
•joint aches
•nausea, vomiting
•pain, redness, itching, or irritation at the injection site
•tremor
•weakness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store in a refrigerator between 2 and 8 degrees C (36 and 46 degrees F). An unused prefilled syringe may be stored for up to 7 days between 15 and 30 degrees C (59 and 86 degrees F). Do not freeze. Protect from light. Throw away any unused diluted injection. Throw away any unused medicine after the expiration date.

药物名称

通用药物名称： 格拉默
生产厂家

Aventis
适应症

对于不能耐受β干扰素治疗的多发性硬化(MS)患者,给予醋酸格拉默(GA)替代治疗,可降低疾病复发率。
Copaxone注射含有的活性成分醋酸格拉默，被称为免疫调节剂。 醋酸格拉默包括天然氨基酸：L -谷氨酸，L -丙氨酸，L -酪氨酸和L -赖氨酸合成多肽。
用法用量

格拉默的推荐剂量为20毫克皮下注射（皮下）每日一次,注射不应由静脉给药.
如果您有任何疑问，请遵医嘱。
禁忌

妊娠。
对甘露醇或醋酸格拉默过敏。
不用于不到12岁的年龄组。
怀孕和哺乳

该药物的安全妊娠尚未确定,它不应该在怀孕期间使用。
目前还不清楚是否纳入母乳,应谨慎使用。
副作用

很常见（受影响的10人中超过1人）
注射部位反应，如红肿，疼痛，肿胀或注射部位发痒。
心跳（心悸）。
面红。
胸痛。
气促。
恶心，便秘，腹泻。
皮疹或出汗。
类似流感的症状，身体虚弱。
头晕。
肌肉僵硬。
关节痛或背部疼痛。
头痛。
抑郁或焦虑。
注意事项

如果下列任何发生,停止服药，尽快求医：
血尿
胸痛
胸闷或呼吸困难
心跳不规则或冲击
面部肿胀或浮肿
感染的迹象（症状可能包括发烧或发冷，严重腹泻，气短，长期头晕，头痛，脖子僵硬，体重减轻，或无精打采）
严重过敏反应的迹象（例如，腹部痉挛，呼吸困难，恶心，呕吐，或面部和喉咙肿胀）
储藏

储存在2℃和8℃（冰箱）
在原容器中储存，避光

英文药名: Copaxone (Glatiramer Prefilled Syringes)

中文药名: 格拉默预充式注射剂

生产厂家: Aventis