繁体中文
设为首页
加入收藏
当前位置:药品说明书与价格首页 >> 眼科 >> 新药动态 >> FDA批准新型体内植入物Retisert,用于治疗慢性非感染性葡萄膜炎

FDA批准新型体内植入物Retisert,用于治疗慢性非感染性葡萄膜炎

2018-10-19 15:21:05  作者:新特药房  来源:互联网  浏览次数:16  文字大小:【】【】【
简介:2005年4月16日,美国FDA批准Retisert(fluocinolone acetonide)玻璃体内植入物,用于治疗慢性非感染性葡萄膜炎影响后节。眼科医生通过平面平坦切口将植入物插入后段。适应症RETISERT:0.59mg是一种皮 ...

2005年4月16日,美国FDA批准Retisert(fluocinolone acetonide)玻璃体内植入物,用于治疗慢性非感染性葡萄膜炎影响后节。眼科医生通过平面平坦切口将植入物插入后段。
适应症
RETISERT:0.59mg是一种皮质类固醇,用于治疗慢性非感染性葡萄膜炎,影响眼后节。
包装规格
RETISERT IMPLANT D/S .59MG $27,126.80 FLUOCINOLONE ACETONIDE  VALEANT PHARMA  24208-0416-01 

 
Retisert(fluocinolone acetonide intravitreal implant) 0.59 mg
RETISERT 0.59 mg is a sterile implant designed to release fluocinolone acetonide locally to the posterior segment of the eye to deliver corticosteroid therapy for approximately 2.5 years where it's needed。
Indication
RETISERT(fluocinolone acetonide intravitreal implant) 0.59mg is a corticosteroid indicated for the treatment of chronic noninfectious uveitis affecting the posterior segment of the eye.
Important Safety Information
Surgical placement of RETISERT(fluocinolone acetonide intravitreal implant) 0.59 mg is contraindicated in active viral, bacterial, mycobacterial or fungal infections of the eye.
Based on clinical trials with RETISERT, during the 3-year post-implantation period, nearly all phakic eyes are expected to develop cataracts and require cataract surgery.
As with any surgical procedure, there is risk involved. Potential complications accompanying intraocular surgery to place RETISERT® into the vitreous cavity may include, but are not limited to, the following: cataract formation, choroidal detachment, endophthalmitis, hypotony, increased intraocular pressure, exacerbation of intraocular in ammation, retinal detachment, vitreous hemorrhage, vitreous loss, and wound dehiscence.
Following implantation of RETISERT®, nearly all patients will experience an immediate and temporary decrease in visual acuity in the implanted eye which lasts for approximately one to four weeks post-operatively.
Use of corticosteroids may result in elevated IOP and/or glaucoma. Based on clinical trials with RETISERT®, within 3 years post-implantation, approximately 77% of patients will require IOP lowering medications to control intraocular pressure and 37% of patients will require ltering procedures to control intraocular pressure.
Patients should be advised to have ophthalmologic follow-up examinations of both eyes at appropriate intervals following implantation of RETISERT®. Physicians should periodically monitor the integrity of the implant by visual inspection.
Ocular administration of corticosteroids has been associated with delayed wound healing and perforation of the globe where there is thinning of the sclera.
The most frequently reported ocular adverse events in clinical trials with RETISERT® occurring in 50-90% of patients included: cataract, increased intraocular pressure, procedural complications and eye pain. The most common non-ocular event reported was headache (33%).
http://www.bauschretinarx.com/retisert/ecp/about
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1ab0f849-2a0d-47ce-ad05-768094da8cc9

责任编辑:p53


相关文章
Retisert intravitreal implant 0.59mg(氟轻松玻璃体内植入物)
YUTIQ(fluocinolone acetonide 0.18mg for intravitreal injection)
ILUVIEN 0.19mg(fluocinolone acetonide intravitreal implant)
美国FDA批准新型植入剂YUTIQ,用于治疗慢性非感染性葡萄膜炎
YUTIQ(fluocinolone acetonide 0.18mg, for intravitreal injection)
Zilretta injectable suspension(曲安奈德缓释注射悬液)
骨关节炎的新型注射剂Zilretta获FDA批准上市
KENACORT-A INTRAMUSCULAR(康宁克通-A冻干粉注射剂)
ILUVIEN implant(氟轻松玻璃体内植入物)
Aphthaseal Tablet(曲安奈德口腔贴片)
 

最新文章

更多

· FDA批准新型体内植入物R...
· 美国FDA批准新型植入剂Y...
· FDA批准眼用悬浮液INVEL...
· 美国FDA批准新型眼用乳剂...
· 神经营养性角膜炎新药ce...
· FDA批准新型眼用溶液Ceq...
· Oxervate(cenegermin-bk...
· FDA于2018年8月批准的5种...
· FDA批准Inveltys混悬滴眼...
· 神经营养性角膜炎新药ce...

推荐文章

更多

· FDA批准新型体内植入物R...
· 美国FDA批准新型植入剂Y...
· FDA批准眼用悬浮液INVEL...
· 美国FDA批准新型眼用乳剂...
· 神经营养性角膜炎新药ce...
· FDA批准新型眼用溶液Ceq...
· Oxervate(cenegermin-bk...
· FDA于2018年8月批准的5种...
· FDA批准Inveltys混悬滴眼...
· 神经营养性角膜炎新药ce...

热点文章

更多

· FDA批准新型体内植入物R...
· 美国FDA批准新型植入剂Y...