——Excellagen(Formulated bovine type I collagen)-为新一代糖尿病足溃疡的治疗药 Cardium Therapeutics(CXM)开发的新产品Excellagen为胶原蛋白为基础的局部药膏,用於糖尿病患足部溃疡的手术伤口清创。 适用范围广:包括局部和全层伤口,压力性溃疡,静脉溃疡,糖尿病性溃疡,慢性血管性溃疡,隧道式/无规则伤口,外科伤口(供者手术位置/移植,伤口裂开)创伤(擦伤,撕裂伤,II度烧伤,皮肤撕裂)等。 Excellagen是专门用于标准清创术后,血细胞和血小板参与释放内源性生长因子 Excellagen独有的纤维性I型牛胶原匀浆的配方,通过简单操作,预先填充,无菌的,一次性使用的注射器局部使用。 在包括糖尿病足部溃疡在内的一系列伤口中使用Excellagen后触发肉芽组织快速生长,在压力性溃疡,静脉溃疡和mohs外科伤口病例中也获得较好疗效。甚至在某些常规治疗失败的案例中,Excellagen也能诱发肉芽组织快速生长。从皮肤学角度看,在诊断鳞状细胞和基底细胞癌术后患者中观察到前所未见的、惊人的伤口愈合反应,包括深至骨膜的外科伤口。 另外,因为使用简便,能够激活血小板,联合自身富血小板血浆疗法和胶原片产品,医生已经将Excellagen用于严重的近截肢状态的难愈性伤口。
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 new, FDA-cleared highly-refined fibrillar collagen-based topical gel (2.6%) designed to support favorable wound care management for the management of diabetic ulcers, partial and full thickness wounds, pressure ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears) and draining wounds. Excellagen's unique high molecular weight bovine Type I collagen formulation is topically applied through easy to control, pre-filled, single use syringes. Excellagen is intended for physician use during debridement procedures, and is engineered to support a favorable wound healing environment for non-healing lower extremity ulcers in diabetic patients. Excellagen's viscosity optimized biocompatible gel formulation requires application at only one or two week intervals. It is recommended that Excellagen be applied during debridement in the presence of blood cells and platelets, which are involved with the release of endogenous growth factors.Excellagen has been shown to activate human platelets, triggering the release of platelet-derived growth factor (PDGF). Cardium's market research indicates that physicians seek easy-to-use products to reduce preparation time and facilitate product application - and Excellagen's unique, ready-to-use syringe-based collagen gel requires no thawing, mixing, or suturing. Because of its specialized formulation, only a thin layer needs to be applied over the wound area, and one syringe containing 0.5 cc of Excellagen covers wounds up to 5cm2 in size using the supplied 24-gauge sterile, single-use flexible applicator tip. Cardium's Excellagen formulated fibrillar collagen topical gel also represents a new product platform that allows for the potential development of a portfolio of advanced wound care and therapeutic products. Cardium's Gene Activated Matrix (GAM) technology represents one extension of Cardium's FDA-cleared viscosity optimized, fibrillar collagen-based matrix for the localized topical delivery of agents that could include anti-infectives, antibiotics, peptides, proteins, small molecules, DNA, stem cells, differentiated cells and conditioned cell media. Formulated collagen gel accelerates healing rate immediately after application in patients with diabetic neuropathic foot ulcers. A recent publication from a Phase 2b clinical study in diabetic neuropathic ulcers reported that application of 2.6% formulated fibrillar collagen resulted in a statistically significant 173% relative improvement in the acceleration of healing (reduction in wound radius) during the first week following a one-time application compared to patients. EXCELLAGEN Rx Generic Name and Formulations: Formulated bovine type I collagen (2.6%); topical gel. Company: Cardium Therapeutics Indications for EXCELLAGEN: Management of wounds including: partial and full- thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/graft, post-Moh’s surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns and skin tears) and draining wounds.
Adults and Children: See literature. Perform debridement or excision prior to application. Apply a thin layer directly to the entire wound surface and edges. May be occluded with non-adherent, gauze and foam dressings; change dressings and reevaluate weekly. If healing is incomplete, gel may be reapplied; max once weekly.
Warnings/Precautions: Control excessive exudate, excessive bleeding, acute swelling, and/or infection before starting treatment. Discontinue or remove if infections, chronic inflammation, allergic reaction, excessive redness, pain, swelling occur. Do not freeze or reuse syringes. Avoid exposure to high temperature.
Pharmacological Class: Wound care device.
Adverse Reactions: Local reactions (eg, infections, inflammation, swelling).
How Supplied: Kit—1 (4 pre-filled, single-use [0.5mL] syringes w. applicators) |