英文药名: LUCENTIS solution for intravitreal injection（Ranibizumab[Genetical Recombination]） 中文药名: 重组兰尼单抗/雷珠单抗玻璃体内注射剂 生产厂家: 诺华制药 药品介绍 治疗类别名称 眼科VEGF注1）抑制剂（人源化抗VEGF单克隆抗体的Fab片段） 注1），VEGF：血管内皮生长因子（血管内皮生长因子） 2014年2月21日，眼科药物（Lucentis，通用名：兰尼单抗，雷珠单抗，ranibizumab）获日本批准，用于治疗糖尿病性黄斑水肿（DME）所致的视力损害。该药是日本批准用于DME治疗的首个抗VEGF疗法。同时，DME也是Lucentis在日本获批的第4个适应症。 目前，在日本，激光治疗是DME的标准疗法。激光治疗能稳定视力，但通常并不会提高视力。Lucentis是首个获批可显著改善亚洲DME患者视力的药物 Lucentis DME适应症的获批，是基于III期REVEAL试验的数据。REVEAL是首个专门评估Lucentis用于亚洲DME患者的疗效和安全性试验，涉及来自6个国家396例DME患者。 Lucentis是一种人源化的治疗性抗体片段，旨在阻断所有生物活性形式的血管内皮细胞生长因子A（VEGF-A），该因子的水平在湿性AMD和其他眼科疾病（如糖尿病性黄斑水肿（DME）、视网膜静脉阻塞（RVO））升高。Lucentis专门设计用于眼部，使系统性暴露（systemic exposure）最小化。 目前，Lucentis已获100多个国家批准，用于治疗湿性年龄相关性黄斑变性（wet-AMD）、糖尿病性黄斑水肿（DME）所致的视力损害、视网膜静脉阻塞（RVO）继发黄斑水肿（macular edema）所致的视力损害。此外，Lucentis已获40多个国家批准，用于病理性近视继发脉络膜新生血管(myopic CNV)引发的视力损害。 ルセンティス硝子体内注射液10mg/mL 包装规格[日本产品] Lucentis的玻璃体内注射： 10毫克/毫升1瓶（带针Toeki一头连着专用过滤器） 制造和销售 诺华制药有限公司 LUCENTIS solution for intravitreal injection（Ranibizumab(genetical recombination)） LUCENTIS solution for intravitreal injection 2.3mg/0.23mL[age-related macular degeneration associated with subfoveal choroidal neovascularization]（ルセンティス硝子体内注射液2.3mg/0.23mL［年龄相关性黄斑变性与凹下脉络膜新生血管］）  Brand name : LUCENTIS solution for intravitreal injection 2.3mg/0.23mL [age-related macular degeneration associated with subfoveal choroidal neovascularization] 　Active ingredient: Ranibizumab(genetical recombination) 　Dosage form: injection 　Print on wrapping: -------------------------------- LUCENTIS solution for intravitreal injection 2.3mg/0.23mL [choroidal neovascularisation in pathologic myopia]（ルセンティス硝子体内注射液2.3mg/0.23mL［病理性近视和脉络膜新生血管］） Brand name : LUCENTIS solution for intravitreal injection 2.3mg/0.23mL [choroidal neovascularisation in pathologic myopia] 　Active ingredient: Ranibizumab(genetical recombination) 　Dosage form: injection 　Print on wrapping: -------------------------------- LUCENTIS solution for intravitreal injection 2.3mg/0.23mL [diabetic macular edema]（ルセンティス硝子体内注射液2.3mg/0.23mL［糖尿病性黄斑水肿］） Brand name : LUCENTIS solution for intravitreal injection 2.3mg/0.23mL [diabetic macular edema] 　Active ingredient: Ranibizumab(genetical recombination) 　Dosage form: injection 　Print on wrapping: -------------------------------- LUCENTIS solution for intravitreal injection 2.3mg/0.23mL [macular edema following retinal vein occlusion]（ルセンティス硝子体内注射液2.3mg/0.23mL［视网膜静脉阻塞黄斑水肿］） Brand name : LUCENTIS solution for intravitreal injection 2.3mg/0.23mL [macular edema following retinal vein occlusion] 　Active ingredient: Ranibizumab(genetical recombination) 　Dosage form: injection 　Print on wrapping:  Effects of this medicine This medicine inhibits vascular endothelial growth factor (VEGF) which is involved in leakage of blood component from the retinal vessels and reduces the amount of leakage to improve macular edema. As a result, it improves failing vision. It is usually used to treat macular edema following retinal vein occlusion. Before using this medicine, be sure to tell your doctor and pharmacist •If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines. If you have: ocular/periocular infections or suspected of them, inflammation within the eye, a history of stroke or transient ischemic attack. •If you are pregnant or breastfeeding. •If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.) Dosing schedule (How to take this medicine) •Your dosing schedule prescribed by your doctor is <<to be written by a healthcare professional>> •In general, after initial dose, your symptoms and response to the treatment should be assessed monthly, and additional treatment may be given as needed. The treatment interval should be at least 1 month. This medicine is administerd by intraocular (intravitreal) injection. •Depending on your response to the treatment, this medicine may be administered over a long time. Precautions while taking this medicine •Since transient blurred vision may occur following the injection, avoid performing dangerous operations such as driving a car or operating machinery until resolution of the symptom. Possible adverse reactions to this medicine The most commonly reported adverse reactions include ocular inflammation, conjunctival bleeding and elevation of ocular pressure (eye pain, reduced visual acuity). If any of these symptoms occur, consult with your doctor or pharmacist. The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately. •reduced visual acuity, worsening of bloodshot eyes [retinal bleeding, iatrogenic traumatic cataract, eye disorder such as endophthalmitis] •decreased consciousness, one-sided paralysis, slurred speech [stroke] The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above. Storage conditions and other information Novartis Pharma K.K.Injection Revised: 3/2015 The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment. 完整处方资料附件：http://www.info.pmda.go.jp/go/pack/1319403A1036_1_02/1319403A1036_1_02?view=body