复方肝素钠尿囊素凝胶（康瑞保）说明书

复方肝素钠尿囊素凝胶（康瑞保）说明书 复方肝素钠尿囊素凝胶说明书 [药品名称] 通用名称:复方肝素尿囊素凝胶 商品名称: 康瑞保? (Contractubex?) 英文名称:Compound Heparin Sodium and Allatoin Gel 汉语拼音:Fu Fang Gan Su Na Niao Nang Su Ning Jiao [成 份] 本品为复方制剂，其组分为:10.0克洋葱提取物，5000IU肝素钠，1.0克尿囊素，凝胶基质加至100.0克。 【形状】浅棕色不透明凝胶。 【适应症】 肥厚性瘢痕和瘢痕疙瘩，继发于手术、截肢、烧伤、痤疮及其它意外后产生的限制活动并影响美观的瘢痕:由于杜普伊特伦挛缩症(Dupuytren’s挛缩症)导致的挛缩:外伤导致的肌腱挛缩和瘢痕性狭窄。 【规格】10克/支，20克/支 【用法用量】 将本品涂在瘢痕部位，每天3-4次，并轻揉直到药物完全吸收。对于陈旧性瘢痕和质地硬的瘢痕，可以在涂药后用敷料封包过夜，使药物充分发挥作用。 根据瘢痕或挛缩的大小不同，疗程常需数周至数月不等。在治疗急性瘢痕时，应避免一些物理刺激，如过度寒冷、UV照射或剧烈地按摩。 【不良反应】 本品的耐受性较好，局部皮肤的刺激反应不常见。少数患者可以出现轻微痒感，一般不影响继续治疗。无系统不良反应。 【禁忌】对于烷基-4-羟基苯甲酸酯过敏者禁用本品。 【注意事项】请将药物储存在儿童不易接触的地方 【孕妇及哺乳期妇女用药】未进行该项实验且无可靠参考文献。 【儿童用药】未进行该项实验且无可靠参考文献。 【老年用药】未进行该项实验且无可靠参考文献。 【药物相互作用】未进行该项实验且无可靠参考文献。 【药物过量】目前为止未见有药物过量的报道。 【药理毒理】 本品具有抗纤维母细胞增生、抗炎症和软化瘢痕组织的作用。洋葱提取物通过抑制炎症介质的释放有抗炎作用，同时也有抗过敏的作用。洋葱提取物可以抑制多种来源的纤维母细胞，尤其是瘢痕来源的，除了抑制其有丝分裂，还能减少细胞外基质(如蛋白多糖)的合成。 肝素有抗炎症、抗过敏、抗增生及促进组织水合的作用，并能使胶原结构变疏松。 尿囊素能促进伤口愈合，具有促进上皮形成、增加组织水合能力的作用。本品的三种活性成分互相协同，能更好地抑制纤维母细胞增生，尤其是减少病理性的胶原过度增生。 根据目前的资料，未发现致突变、致畸和致癌的作用。 【药代动力学】未进行该项实验且无可靠参考文献。 【贮藏】置于25。C以下阴凉贮存。 【包装】10克/支/盒;20克/支/盒 【有效期】36个月 【执行】进口药品注册标准JX20030144 【批准文号】H2080635 Contractubex Gel for the treatment of scars COMPOSITION: Extr.Cepae 10.0g Heparin sodium 5000IU Allatoin 1.0g Gel base ad 100.0g PHARMACEUTICAL FORM: Gel CLINICAL PARTICULARS: Therapeutic indications Hypertrophic, keloidal, movement-restricting and cosmetically disfiguring scars after operations, amputations, burns, acne, accidents; contractures such as Dupuytren’s contracture, traumatic tendon contractures and cicatricial strictures. Dosage and method of administration Apply to the scar tissue several times daily and gently massage in until the gel has been completely absorbed. In the case of old, hard scars, allow the gel to take effect overnight under a dressing. Dependent on the size of the scar or contracture, treatment will be necessary for several weeks or months. When treating fresh scars, physical irritants such as extreme cold or UV light or too strong massaging should be avoided. Contra-indications Patients who are hypersensitive to alkyl-4-hydroxybenzoates should not use Contractubex. Special warnings and special precautions for use Not applicable. Interaction with other medicaments and other forms of interaction Not applicable. Pregnancy and lactation Not applicable. Effects on ability to drive and use machines Contractubex has no influence on the ability to drive or use machines. Undesirable effects In general, Contractubex is well tolerated, even on long-term use. Local skin irritations are to be expected only in rare cases. Overdose No case of overdose has been reported. PHARMACOLOGICAL PROPERTIES: Pharmacodynamic properties Contractubex has an antiproliferating, antiphlogistic, loosening and smoothening effect on scar tissue. Extr. Capae acts as an antiphlogistic by inhibiting the release of inflammation mediators and has an antiallergic effect. Extr. Capae inhibits the growth of fibroblasts of various origins and of keloidal fibroblasts in particular. In addition to a mitogenic inhibitory effect, the drug has been shown to diminish the formation of extracellular matrix constituents from fibroblasts(e.g. proteoglycans). Furthermore, Extr.Cepae has a bactericidal action. These properties stimulate primary wound healing and counteract unphy-siologic scar formation. Heparin is antiphlogistic, antiallergic, anti-proliferating and increase tissue hydration. It also has a loosening effect on collagen structure. For the treatment of scars, the anti-inflammatory effect of heparin and its effects on the constituents of the connective tissue matrix are more important than its known antithrombotic action. Allantion promotes wound healing; it has an epithelializing effect and increases the tissue’s water-binding capacity. In addition, its keratolytic and penetration-promoting properties improve the efficacy of the other active ingredients in Contractubex. Futhermore, allantoin has a soothing effect, which relieves the pruritus often associated with scar formation. The synergistic effect of this combination of active ingredients lies in the super-additive inhibition of fibroblast proliferation and especially of the pathologically increased collagen synthesis. Pharmacokinetic properties Not applicable. Preclinical safety data According to the present knowledge, there is no toxicological risk, especially with regard to mutagenic, teratogenic and carcinogenic effects. PHARMACEUTICAL PARTICULARS: Incompatibilities Not applicable. Shelf-life 3 years. Special precautions for storage Do not store above 25。C. Presentation Packages of 10 g, 20g.