英文药名：LUCENTIS kit injection（Ranibizumab(genetical recombination)） 中文药名：重组雷珠单抗预充式注射器 生产厂家：诺华制药 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）的VEGF：血管内皮生长因子（血管内皮生长因子） ——为玻璃体内注射 适应证和用途 LUCENTIS适用于治疗以下患者： （1）新生血管(湿)年龄相关黄斑退行性变性(AMD) （2）视网膜血管闭塞(RVO)后黄斑水肿 （3）糖尿病黄斑水肿(DME) 剂量和给药方法 只为眼科玻璃体内注射。 新生血管(湿)年龄相关黄斑变性(AMD) 推荐LUCENTIS 0.5mg(0.05mL)玻璃体内注射1月1次(约28天)。 尽管不一样有效，患者可用三次每月剂量治疗接着用较低频数给药与有规则评估。在3次初始每月剂量后9个月，较低频数给药用4-5剂平均是期望维持视力而每月给药可能预期导致得到平均增加1-2字母。患者应定期评估。 尽管不一样有效，患者也可以4次每月剂量后每3个月用1次剂量治疗。与继续每月给药比较，在下9个月每3个月给药将导致平均约5-字母(1-行)视力丧失获益。患者应定期评估。 视网膜血管闭塞(RVO)后黄斑水肿(2.3) （1） 建议玻璃体内注射1个月1次(约28天)LUCENTIS 0.5mg(0.05mL)给药。在RVO临床研究中，患者每月接收LUCENTIS注射共6个月。尽管正是通过光学相干断层扫描[optical coherence tomography]和视力再-治疗标准，据经验患者然后在平均第6个月不治疗，而患者在第6个月不治疗在第7月丧失视力。患者应每个月被治疗。 糖尿病黄斑水肿(DME) （1）建议玻璃体内注射1个月1次(约28天)LUCENTIS 0.3mg(0.05mL)给药。 剂型和规格 （1）10mg/mL溶液(LUCENTIS 0.5mg) （2）6mg/mL溶液(LUCENTIS 0.3mg) 禁忌证 （1）眼或眼周围感染。 （2）超敏性。 警告和注意事项 （1）玻璃体内注射后可能发生眼内炎和视网膜脱离。注射后应监视患者。 （2）玻璃体内注射前和后均曾注意到眼内压增加(IOP)。 （3）使用VEGF抑制剂玻璃体后有动脉血栓栓塞事件潜在风险。 （4）在糖尿病黄斑水肿(DME)每个月用LUCENTIS治疗患者比对照组更频繁发生致命性事件。 不良反应 （1）最常见不良反应(LUCENTIS-治疗受试者比对照受试者报道更频繁)是结膜出血，眼痛，玻璃体飞蚊症，和IOP增加。 LUCENTIS kit for intravitreal injection（Ranibizumab(genetical recombination)） 玻璃体腔内注射只预充式注射器“Lucentis的®玻璃体内注射10毫克盒/mL 眼科VEGF抑制剂“Lucentis的®玻璃体内注射液2.3mg /0.23mL”[通用名称：兰尼单抗（基因重组）内注射10毫克盒/mL的“作为一种新剂型注射。 LUCENTIS kit for intravitreal injection 10mg/mL[age-related macular degeneration associated with subfoveal choroidal neovascularization]（ルセンティス硝子体内注射用キット10mg/mL［年龄相关性黄斑变性与凹下脉络膜新生血管］） Brand name : LUCENTIS kit for intravitreal injection 10mg/mL [age-related macular degeneration associated with subfoveal choroidal neovascularization] 　Active ingredient: Ranibizumab(genetical recombination) 　Dosage form: injection 　Print on wrapping: ------------------------------ LUCENTIS kit for intravitreal injection 10mg/mL[choroidal neovascularisation in pathologic myopia]（ルセンティス硝子体内注射用キット10mg/mL[病理性近视和脉络膜新生血管]） Brand name : LUCENTIS kit for intravitreal injection 10mg/mL[choroidal neovascularisation in pathologic myopia] 　Active ingredient: Ranibizumab(genetical recombination) 　Dosage form: injection 　Print on wrapping: ------------------------------ LUCENTIS kit for intravitreal injection 10mg/mL[diabetic macular edema]（ルセンティス硝子体内注射用キット10mg/mL[糖尿病性黄斑水肿]） Brand name : LUCENTIS kit for intravitreal injection 10mg/mL [diabetic macular edema] 　Active ingredient: Ranibizumab(genetical recombination) 　Dosage form: injection 　Print on wrapping: ------------------------------ LUCENTIS kit for intravitreal injection 10mg/mL[macular edema following retinal vein occlusion]（ルセンティス硝子体内注射用キット10mg/mL[视网膜静脉阻塞黄斑水肿]） Brand name : LUCENTIS kit for intravitreal injection 10mg/mL [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. http://www.info.pmda.go.jp/go/pack/1319403G1020_1_02/1319403G1020_1_02?view=body#21 ---------------------------------------- 产地国家：日本 原产地英文商品名: LUCENTIS（ルセンティス硝子体内注射用キット）10MG/ML/SYRINGE 1SYRINGES/KIT 原产地英文药品名: Ranibizumab（Genetical Recombination） 中文参考商品译名: LUCENTIS（ルセンティス硝子体内注射用キット）10毫克/毫升/注射器 1支注射器/套 中文参考药品译名: 兰尼单抗 重组雷珠单抗 生产厂家中文参考译名: 诺华制药 生产厂家英文名: Novartis