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Kybella injection 10mg/ml(deoxycholic acid 脱氧胆酸无菌注射溶液)
药店国别  
产地国家 美国 
处 方 药: 是 
所属类别 10毫克/毫升/瓶 4瓶/盒 
包装规格 10毫克/毫升/瓶 4瓶/盒 
计价单位: 盒 
生产厂家中文参考译名:
Kythera Biopharmaceuticals,Inc.
生产厂家英文名:
Kythera Biopharmaceuticals,Inc.
该药品相关信息网址1:
http://www.drugs.com/kybella.html
该药品相关信息网址2:
https://www.facebook.com/KybellaPhotography
该药品相关信息网址3:
原产地英文商品名:
Kybella 10mg/mL/vials 4vials/bottle, cold chain product (storage at 2-8 degrees) extra charge for packaging
原产地英文药品名:
deoxycholic acid
中文参考商品译名:
Kybella注射液 10毫克/毫升/瓶 4瓶/盒 冷链产品(储存在2-8度),需要额外的包装费用
中文参考药品译名:
去氧胆酸
曾用名:
简介:

 

近日,细胞溶解药物deoxycholic acid, Acid(英文商标名:Kybella)获美国食品药品监督管理局(FDA)批准为全球首个局部溶脂药。
本品被批准用于治疗和改善成人中度至重度颏下脂肪的凸起或丰满(双下巴)。Kybella是皮下注射液,含10mg/mL脱氧胆酸,每小瓶有2mL。推荐给药剂量是每个点皮下注射0.2mL脱氧胆酸注射液,在计划注射治疗区域,每间隔1 cm,每次给药不超过50注射点或10 mL脱氧胆酸注射液。间隔不少于1个月最多可进行6次单次治疗。
批准日期:2015年4月29日  公司:Kythera
KYBELLA(脱氧胆酸 deoxycholic acid)注射,供注射用
美国初步批准:2015年
近期重大变化
警告和预防措施:2018年1月
作用机理
Kybella(脱氧胆酸)注射液是一种细胞溶解药物,当注射到组织中时,会物理破坏细胞膜,导致溶解。
适应症和使用
KYBELLA是一种细胞溶解药物,用于改善与颏下脂肪不饱和相关的中度到重度凸面或丰满的外观。
使用限制:Kybella的安全有效使用
对于治疗额下区以外的皮下脂肪,还没有建立,也不推荐。
剂量和给药
0.2ml注射,间隔1cm,直到计划治疗区的所有部位注射完毕。
单次治疗最多可注射50次或10毫升。
最多可间隔不少于1个月进行6次单次治疗。
注射前的给药和注射技术见一般注意事项。
剂型及强度
注射:10mg/ml无菌溶液,2ml小瓶提供。每个药瓶供单个患者使用。
不建议与其他化合物稀释或混合。
禁忌症
注射部位出现感染时禁止使用Kybella®。
警告和注意事项
下颌边缘神经(MMN)损伤:采用注射技术避免这种损伤。
使用kybella可能会出现吞咽困难。在已有吞咽困难的患者中使用可能会加重病情。
在Kybella®给药后,经常会出现额下血肿/瘀伤。在接受抗血小板或抗凝治疗或有凝血异常的患者中小心使用。
避免因组织损伤风险增加而注射到易受损伤的解剖结构附近。
注射部位脱发:停止后续治疗直到痊愈。
注射部位溃疡坏死:待完全消退后再给药。
不良反应
最常见的不良反应(>20%的受试者)包括注射部位水肿/肿胀、血肿、疼痛、麻木、红斑和硬结。
包装供应/储存和搬运
Kybella(脱氧胆酸)注射剂,10mg/ml是一种透明、无色、无菌的溶液,以2ml、单患者使用的小瓶供应于以下配药包中:
4小瓶,NDC 61168-101-04
储存在20°C至25°C(68°F至77°F)之间;允许在15°C至30°C(59°F至86°F)[见USP控制的室温]。
Kybella®在小瓶标签上有独特的全息图。如果您没有看到全息图,请不要使用该产品并拨打1-800-678-1605。
每个药瓶供一个病人使用。不要稀释。丢弃未使用的部分。
完整资料附件:https://www.allergan.com/assets/pdf/kybella_pi

Generic Name: deoxycholic acid
Date of Approval: April 29, 2015
Company: Kythera Biopharmaceuticals, Inc.
Treatment for: Submental Fullness

Kythera’s investigational submental contouring injectable ATX-101 may be a useful adjunct to plastic surgeons’ armamentarium for treating the dreaded double chin, according to a pooled analysis of two positive ATX-101 Phase III trials (REFINE-1 and REFINE-2) presented at the Annual Meeting of the American Society for Aesthetic Plastic Surgery (ASAPS) in San Francisco.
ATX-101 is a purified synthetic version of Deoxycholic acid that aids in the breakdown of dietary fat. When injected into subcutaneous fat, ATX-101 contours the area under the chin by destroying fat cells while leaving surrounding tissue largely unaffected. The fat is naturally excreted from the body.
According to the pooled analyses, 68.2% of study participants treated with ATX-101 (2 mg/cm2) demonstrated a simultaneous improvement of at least one grade from baseline on clinician and patient reported rating scales vs. 20.5% in the placebo arm.
After two treatments, 52.2% achieved at least a one grade change from baseline in the clinician submental fat ratings, and 71.5% after four treatments.
Approximately 80% of subjects treated with ATX-101 demonstrated at least a one-grade improvement in the clinician submental fat ratings regardless of age, gender, race, BMI, Fitzpatrick Skin Type, and baseline severity, the study showed.
Those treated with ATX-101 reported significant improvement in the visual and emotional impact of chin fat, including appearing thinner and more youthful, compared with those treated with placebo.
Close to 81% of ATX-101 treatment-emergent adverse events were mild, and 1.4% of ATX-101 subjects discontinued the studies due to adverse events. The most common adverse events included temporary injection site events of pain, swelling, bruising, and numbness. The incidence and severity of pain and swelling declined after the first treatment session.
Plastic Surgery Practice editorial advisor W. Grant Stevens, MD, a plastic surgeon in Marina del Rey, Calif, has been following ATX-101 as it moves through the pipeline. “I’m very excited about nonsurgical fat reduction,” he tells PSP. “This technology won’t replace liposuction, but it will expand the market.” Many individuals want to lose fat, but don’t want or can’t tolerate surgery and its associated downtime. If approved, ATX-101 will expand the audience of people who will opt to recountour their neck fat.” 

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