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  药店国别: 美国药房
产地国家: 美国
所属类别: 眼科药物->治疗眼痛药物
处方药:处方药
包装规格: 3毫升/瓶
计价单位:
  点击放大  
生产厂家中文参考译名:
爱尔康
生产厂家英文名:
ALCON PHARMS LTD
该药品相关信息网址1:
http://www.drugs.com/nevanac.html
该药品相关信息网址2:
http://www.rxlist.com/nevanac-drug.htm
原产地英文商品名:
NEVANAC 0.1% DROPS SUSP 3MLS/BTL
原产地英文药品名:
NEPAFENAC
中文参考商品译名:
NEVANAC 0.1%溶液滴剂 3毫升/瓶
中文参考药品译名:
奈帕芬胺
原产地国家批准上市年份:
2005/08/19
英文适应病症1:
Relieve pain
英文适应病症2:
Pain associated with cataract surgery
英文适应病症3:
Inflammation
临床试验期:
完成
中文适应病症参考翻译1:
止痛
中文适应病症参考翻译2:
白内障手术相关疼痛
中文适应病症参考翻译3:
炎症
药品信息:

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 详细处方信息以本药内容附件PDF文件(2011121417232932.pdf)的“原文Priscribing Information”为准
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部分中文Nevanac处方资料(仅供参考)

FDA批准奈帕芬胺(nepafenac,Nevanac)治疗白内障手术相关疼痛和炎症
    Alcon公司日前宣布,FDA批准0.1%奈帕芬胺眼科混悬液(nepafenac,Nevanac)的新药上市申请(NDA),本品用于治疗白内障手术相关的疼痛和炎症。本品所含的成分系一新颖的前体药物,可以快速渗入眼组织,是FDA批准的首个眼科用非激素类抗炎前体药物。Alcon公司在随后几周内将向市场推出本品。

  此次批准基于2项多中心安慰剂对照临床研究的结果,研究纳入了680例患者。本品一日3次,于白内障手术前1日开始给药,并持续至手术结束后14日。在基线,以及手术后第1、3、7和14日分别评估患者状况。

  结果显示,本品组患者在术后早期直至治疗结束的时间内,眼部疼痛和炎症状况显著低于安慰剂组患者。术后1日的评估显示,超过80%的本品组患者眼部疼痛消除,而安慰剂组该比例不足50%。治疗2周后,约95%的本品组患者疼痛消除,而安慰剂组该比例仅为45%。在术后第14日的评估结果显示,91%的本品组患者无显著的临床炎症症状,而安慰剂组该比例仅为47%。

  多项对照临床研究显示,接受白内障手术的患者最常见的眼部不良反应包括后囊混浊(capsular opacity)、视力减退、异物感、眼内压增加和胶粘感。上述不良反应在本品组和安慰剂组的发生率无显著差异,可能由白内障手术操作程序导致。

DIN (Drug Identification Number)
02308983  NEVANAC 0.1% OPHTHALMIC SUSPENSION (EYE DROPS)

How does Nevanac work? What will it do for me?
Nepafenac belongs to the class of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs). It works by reducing pain, swelling, and inflammation. Nepafenac eye drops are used to reduce eye pain and inflammation before and after cataract surgery.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are using this medication, speak to your doctor. Do not stop using this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to use this medication if their doctor has not prescribed it.

How should I use Nevanac?
The recommended dose of nepafenac eye drops is 1 drop in the affected eye 3 times daily, starting the day before cataract surgery, continued on the day of surgery, and for as long as your doctor asks you to keep using them. This may be for as long as 2 weeks after the surgery.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

To use eye drops properly:
1.Wash your hands before using the eye drops.
2.Shake the container well before use to ensure the medication is evenly mixed throughout the bottle.
3.Remove the cap and place it in a clean location. To avoid possible contamination, keep the tip of the container away from contact with any surface.
4.Tilt your head back and look towards the ceiling.
5.With your index finger, gently pull the lower eyelid down and away from the eye to form a pouch.
6.Apply one drop into the pouch but do not allow the tip of the container to touch the eye or areas around the eye.
7.Gently apply pressure to the inner corner of the eye (at the bridge of the nose) for about 30 seconds. (This is called nasolacrimal occlusion.) This prevents the medication from dripping down through the tear duct and entering the bloodstream, which could cause you to experience some side effects.
8.Repeat with the other eye, if prescribed by your physician.
9.Wash your hands again to remove any medication.

If you are using more than one topical eye medication (eye drops or ointment), wait at least 5 minutes before putting another medication in the eye.

Ask your doctor or pharmacist to show you the correct method of applying eye drops. It is very important to avoid touching the dropper tip to any surface, skin, or your eye. This contamination can result in a bacterial infection. Report any signs of an eye infection (e.g., redness, irritation, pain) to your doctor immediately.

It is important to use this medication exactly as prescribed by your doctor. If you miss a dose, instill it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not instill a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture and keep it out of the reach of children.

Safely discard any medication remaining in the dropper bottle after you have used the medication for the full length of time recommended by your doctor. Discard any remaining medication 28 days after opening the bottle.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does Nevanac come in?
Each mL of ophthalmic suspension contains nepafenac 1 mg (0.1%). Nonmedicinal ingredients: mannitol, carbomer 974P, sodium chloride, tyloxapol, edetate disodium, sodium hydroxide and/or hydrochloric acid (to adjust pH), purified water, and the preservative benzalkonium chloride 0.005%.

Who should NOT take Nevanac?
Do not use this medication if you:
•are allergic to nepafenac or any ingredients of this medication
•are allergic or sensitive to other NSAIDs (e.g., naproxen, acetylsalicylic acid, diclofenac)

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 详细处方信息以本药内容附件PDF文件(2011121417232932.pdf)的“原文Priscribing Information”为准
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更新日期: 2014-05-13
附件:




2011121417232932.PDF    

 
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