部分中文醋酸格拉默处方资料（仅供参考）

上市的通用名glatiramer用于多发性硬化症
印度Natco Pharma公司已在印度正式上市了Glatimer (glatiramer acetate，格拉默)用于治疗多发性硬化症的复发。公司也成为全球首个上市通用名格拉默的企业。
Glatiramer acetate(GA)是一种人工新合成的肽类制剂,由4种氨基酸组成.实验研究表明它对多发性硬化(multiple sclerosis,MS)及其动物模型即实验性自身免疫性脑脊髓炎(experimental autoimmune encephlomyelitis,EAE)均有防治作用.试验表明,GA可成为治疗MS尤其是复发-缓解型MS(relapsing-remitting MS,RRMS)的一线药.

Copaxone(醋酸格拉默Glatiramer acetate GA)注射液
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。

药物名称
通用药物名称：格拉默

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

GENERIC NAME: GLATIRAMER - INJECTION (glah-TEE-ruh-mer)

BRAND NAME(S): Copaxone

USES: This medication is used to treat a type of multiple sclerosis that occurs when symptoms appear in cycles of worsening and improvement (relapsing/remitting multiple sclerosis-MS). It is a protein that is thought to work by preventing your immune system from attacking the nerves in your brain and spinal cord. This effect can decrease the number of periods of disease worsening (relapses) and prevent or delay disability. This drug is known as an immunomodulator. It is not a cure for MS.

HOW TO USE: This medicine comes with a Patient Information Leaflet. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine.This drug is administered by injection under the skin. Learn all preparation and usage instructions in the product package. Your health care professional will teach you how to use this medication. If any of the information is unclear, consult your doctor or pharmacist. Your doctor will usually have you give your first injection in the office.Wash and dry your hands before injecting glatiramer. Before using, warm the drug if it has been refrigerated by keeping the syringe at room temperature for 20 minutes. Do not inject cold glatiramer because this can be painful. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Glatiramer is usually given at a dose of 20 milligrams once daily at the same time each day or as directed by your doctor.Before injecting each dose, clean the injection site with rubbing alcohol. It is important to change the injection site daily to prevent problem areas under the skin. Keep track of your injections and do not reuse the same injection site for at least 1 week. Inject the medication under the skin of the hip, thigh, abdomen, buttock, or back of the upper arm. Do not inject into a vein. After pulling out the needle, apply gentle pressure on the injection site. Do not rub the area. Discard any unused portion in the syringe after a single use. Do not save for later use.Dosage is based on your condition and response to therapy. Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time each day. Do not change your dose or stop using this medication without talking with your doctor.Learn how to discard needles and medical supplies safely. Consult your pharmacist.Inform your doctor if your condition worsens.

SIDE EFFECTS: Injection site reactions (e.g., pain, redness, soreness, and swelling) may occur. Nausea, chills, joint aches, neck pain, or headache may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.Immediately after injection, you may experience flushing, chest pain, fast heartbeat, anxiety, shortness of breath, or itching. This injection reaction usually starts to occur after you have used the drug for a few months but can occur after any injection. These symptoms disappear fairly quickly and usually do not require treatment. If these symptoms do not go away in a few minutes, seek immediate medical attention. Tell your doctor immediately about this reaction before your next injection. Ask your doctor if you should continue using this medication.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor immediately if any of these unlikely but serious side effects occur: dizziness/fainting, infection (e.g., fever, persistent sore throat), mental/mood changes (e.g., depression), severe pain at the injection site, shakiness (tremor), swelling of the legs/feet (water retention), vision problems.A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using glatiramer, tell your doctor or pharmacist if you are allergic to it; or to mannitol; or if you have any other allergies.Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease (e.g., chest pain, heart attack).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is not known if this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication, needles, or syringes with others.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Refrigerate the syringes in their carton between 36-46 degrees F (2-8 degrees C). Do not freeze. Do not use syringes that have been frozen. If refrigeration is not possible, the drug may be stored at room temperature at 59-86 degrees F (15-30 degrees C) for up to 1 week. Do not expose medication to strong light or high temperatures.Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
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原产地英文商品名:
GLATIMER (20/40)mg/ml/vial 30vials/box
原产地英文药品名:
GLATIRAMER ACETATE/MANNITOL USP
中文参考商品译名:
GLATIMER (20/40)毫克/毫升/瓶 30瓶/盒
中文参考药品译名:
醋酸格拉默/甘露醇 USP
生产厂家中文参考译名:
Natco Pharma
生产厂家英文名:
Natco Pharma