Restylane
瑞蓝
Caution: Federal Law restricts this device to sale by or on the order of a physician or properly licend practitioner.
注意：联邦法限制该器械只出售给内科医师或有合法许可证的从业者使用。
Description
产品描述
Restylane is a gel of hyaluronic acid generated by Streptococcus species of bacteria, chemically crosslinked with BDDE, stabilized and suspended in physiologic buffer at pH = 7 and concentration of 20mg/ml.
瑞蓝提取自链球菌属的透明质酸凝胶，用化学交联的方法将其与BDDE交联产生的，产品能悬浮在pH=7，20mg/mL浓度的生理缓冲液中并且稳定。
Indication
适应症
Restylane is indicated for mid-to-deep dermal implantation for the correction of moderate to vere facial wrinkles and folds, such as nasolabial folds.
瑞蓝适用于面部中度至深度皱纹（例如法令纹）修复的中度真皮植入。
Contraindications
禁忌症
• Restylane is contraindicated for patients with vere allergies manifested by a history of拒绝学习 anaphylaxis, or history or prence of multiple vere allergies.
对于有严重过敏反应，过敏史，或者多种过敏的患者要禁用。
• Restylane contains trace amounts of gram positive bacterial proteins, and is contraindicated for patients with a history of allergies to such material.
雪罗隐
瑞蓝含有微量的革兰氏阳性菌蛋白，对此类物质（革兰氏阳性菌蛋白）过敏的患者禁用。
• Restylane is contraindicated for u in breast augmentation, and for implantation into bone, tendon, ligament, or muscle.
对于隆胸，骨、肌腱、韧带或肌肉的植入禁用。
• Restylane must not be implanted into blood vesls. Implantation of Restylane into dermal vesls may cau vascular occlusion, infarction, or embolic phenomena.
瑞蓝必须保证不能植入到血管内。瑞蓝植入到真皮血管内会造成脉管闭合、梗塞或栓塞现象。
Warnings
警告
新加坡动物园U of Restylane at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples, rashes, or hives) or infection is prent should be deferred until th
e inflammatory process has been controlled.
在炎症（皮疹，如囊肿、丘疹、发疹或荨麻疹）或感染部位使用瑞蓝要等到炎症或感染部位得到很好的控制后才能使用。
Hypernsitivity as an inflammatory reaction to Restylane has been obrved with swelling, redness, tenderness, induration and rarely acneform papules at the injection site. Refer to the adver events ction for details.
作为炎症反应的瑞蓝过敏症，在注射部位已经观察到了肿胀、发红、压痛、肿块及少量的痤疮样丘疹。详情见不良反应章节。
Injection site reaction to Restylane has been obrved consisting mainly of short-term inflammatory symptoms starting early after treatment and with less than 7 days duration. Refer to the clinical study ction for details.
观察到瑞蓝注射部位的反应主要是在治疗早期，为期不少于7天时会出现炎症现象。详情见临床研究章节。
Localized superficial necrosis may occur after injection in the glabellar area. It is thought竹石的作者是谁 to result from the injury, obstruction, or compromi of blood vesls.
在眉间区域注射瑞蓝可能会发生局部表层坏死。造成原因可能是由于血管的损伤、梗塞造成的
The safety or efficacy of Restylane for the treatment of lips has not been established in controlled clinical studies.
瑞蓝在对于嘴唇的应用治疗的安全有效性还未建立临床对照试验研究。
Precautions
注意事项
Restylane is packaged for single patient u. Do not resterilize. Do not u if package is opened or damaged.
瑞蓝是一次性包装使用。不能够再消毒。如果包装打开或已经损坏，请勿使用。
Bad on US clinical studies patients should be limited to 1.5cc per treatment site. The safety of injecting greater amounts has not been established.
根据美国临床研究，患者每个治疗部位的限度应控制在1.5cc。更大的注射安全剂量尚未建立。
The safety or effectiveness of Restylane for the treatment of anatomic regions other than nasonasolabial folds has not been established in controlled clinical studies.
瑞蓝对于除鼻唇沟（法令纹）之外的组织区域治疗的安全性或有效性尚未建立对照临床研究。
Long-term safety and effectiveness of Restylane beyond one year have not been investigated in陶器图片 clinical trials.黄昏时刻
五年级学生学情分析瑞蓝超过一年的长期的安全性或有效性还未建立临床试验研究。
As with all transcutaneous procedures, Restylane implantation carries a risk of infection. Standard precautions associated with injectable materials should be followed.
因为瑞蓝是进入皮肤的，存在着植入感染的风险。所以必须遵守植入材料相关的标准预防措施。
The safety of Restylane for u during pregnancy, in breastfeeding females or in patients under 18 years has not been established.
怀孕期、哺乳期及18岁以下者使用瑞蓝的安全性尚未建立
The safety of Restylane in patients with incread susceptibility to keloid formation and 黄豆烧肉hypertrophic scarring has not been studied. Restylane should not be u in patients with known susceptibility to keloid formation or hypertrophic scarring.
使用瑞蓝的患者瘢痕形成及增生性瘢痕敏感性增加的安全性尚未得到研究。已知患者对瘢痕形成及增生性瘢痕敏感的患者严禁使用瑞蓝。
Restylane should be ud with caution in patients on immunosuppressive therapy.
接受免疫抑制治疗的患者慎用瑞蓝
Patients who are using substances that reduce coagulation, such as aspirin and non-steroidal anti-inflammatory drugs may, as with any injection, experience incread bruising or bleeding at injection sites.
