简介:
部份中文原纤维I型牛胶原蛋白凝胶处方资料(仅供参考)
英文名:Formulated bovine type I collagen
商品名:Excellagen gel 2.6%
中文名:原纤维I型牛胶原蛋白凝胶
生产商:Cardium Therapeutics
药品简介
2013年8月5日,美国食品药品监督管理局(FDA )批准Excellagen凝胶2.6%,用于治疗糖尿病足溃疡和其他皮肤伤口。使用说明表明在外科清创术后立即应用Excellagen,用于治疗糖尿病足溃疡和其他皮肤伤口。
Excellagen是一种基于注射器的专业用途药物配制的2.6%原纤维I型牛胶原蛋白匀浆,用作无细胞生物调节剂,可激活伤口愈合过程并显著加速肉芽组织的生长。Excellagen的FDA批准提供了非常广泛的标签,包括部分和全层伤口、压疮、静脉溃疡、糖尿病溃疡、慢性血管溃疡、隧道/破坏性伤口、手术伤口(供体部位/移植物、莫氏手术后、激光手术后、足病、伤口裂开)、创伤伤口(擦伤、撕裂、二度烧伤和皮肤撕裂)和引流伤口。
适应症:
伤口管理包括:部分和全层伤口、压疮、静脉溃疡、糖尿病溃疡、慢性血管溃疡、隧道/破坏性伤口、手术伤口(供体部位/移植物、莫氏手术后、激光手术后、足病、伤口裂开)、创伤伤口(擦伤、撕裂、二度烧伤和皮肤撕裂)和引流伤口。
成人和儿童:
参见文献。使用前进行清创或切除。直接在整个伤口表面和边缘涂上一薄层。可能被非粘性纱布和泡沫敷料堵塞;每周更换敷料和热敷。如果愈合不完全,可以重新涂抹凝胶;最多每周一次。
警告/注意事项:
在开始治疗之前,控制过度渗出、过度出血、急性肿胀和/或感染。如果出现感染、慢性炎症、过敏反应、过度发红、疼痛、肿胀,请停止或移除。不要冷冻或重复使用注射器。避免暴露在高温下。
药理学类别:
伤口护理装置。
不良反应:
局部反应(如感染、炎症、肿胀)。
供应方式:
套件—1个(4个预充式一次性[0.5L]注射器,带注射器

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U.S. Food and Drug Administration(FDA)to market and sell the Company’s new Excellagen™ professional-use, sterile, syringe-based advanced wound care product for the management of diabetic foot ulcers and other dermal wounds.
Directions for use indicate the application of Excellagen immediately following surgical debridement, which is routinely practiced in the treatment of diabetic foot ulcers and other dermal wounds.
Excellagen(Formulated bovine type I collagen)
Generic Name and Formulations:
Formulated bovine type I collagen (2.6%); topical gel.
Cold Chain Distribution: HKMED has extensive experience in storing, transporting and delivering cold-chain (2°C to 8°C) as well as ambient/controlled temperature products around the world. With temperature-controlled depots worldwide, the integrity of your products is always maintained.
Excellagen is a syringe-based, professional-use, pharmaceutically-formulated 2.6% fibrillar Type I bovine collagen homogenate that functions as an acellular biological modulator to activate the wound healing process and significantly accelerate the growth of granulation tissue. Excellagen's FDA clearance provides for very broad labeling including partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/graft, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns and skin tears) and draining wounds. Excellagen is intended for professional use following standard debridement procedures in the presence of blood cells and platelets, which are involved with the release of endogenous growth factors. Excellagen's unique fibrillar Type I bovine collagen homogenate formulation is topically applied through easy-to-control, pre-filled, sterile, single-use syringes and is designed for application at only one-week intervals.
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