齐多拉米双夫定片说明书

For the use of a Registered Medical Practitioner or a Hospital or a Laboratory only

仅供注册医生、医院、实验室使用

Lamivudine, Zidovudine and Nevirapine Tablets IP

拉米夫定，齐多夫定和奈韦拉平片（印度药典级）

Duovir-N（商品名）

Warning警告

Duovir-N is not intended for use in patients who are just initiating therapy with nevirapine. Duovir-N should be administered only to patients who have received Zidovudine + Lamivudine (standard doses) + Nevirapine (200 mg OD) for 2 weeks and have demonstrated adequate tolerability to Nevirapine (see Indications, Dosage and Administration).

Duovir- N不适合那些刚开始使用奈韦拉平治疗的患者，Duovir- N只应施用于那些已经接受齐多夫定+ 拉米夫定（标准剂量）+ 奈韦拉平（200毫克，每天一次）达2周，并证明对奈韦拉平具有足够耐受性的患者（见适应症、剂量和服用）。

Zidovudine has been associated with haematologic toxicity including Neutropenia and severe anaemia. Particularly in patients with advanced disease (see Warnings and Precautions) .Prolonged use of Zidovudine has been associated with symptomatic myopathy.

齐多夫定与血液学毒性相关，包括中性粒细胞减少和严重贫血，特别是长期使用齐多夫定，一直伴随症状肌病的晚期患者（见警告和注意事项）。

Severe, life-threatening skin reactions, including fatal cases, have occurred in patients treated with Nevirapine. These have included cases of Stevens-Johnson syndrome. Toxic epidermal necrolysis, and hypersensitivity reactions characterised by rash, constitutional findings and organ dysfunction. Patients developing signs or symptoms of severe skin reactions or hypersensitivity reactions must discontinue Nevirapine as soon as possible (see Warnings and Precautions).

使用奈韦拉平治疗的患者，已经发生过严重、危及生命的皮肤反应，包括致命的病例，包括史蒂文斯- 约翰逊综合征(即：重症多形性红斑) 病例、中毒性表皮坏死、和过敏性反应，特征是皮疹、原发性症兆和器官功能障碍, 出现严重的皮肤反应、或过敏反应症状或体征的患者，必须尽快停止使用奈韦拉平（见警告和注意事项）。

Severe, life-threatening, and in some cases fatal hepatotoxicity, including fulminant and cholestatic hepatitis, hepatic necrosis and hepatic failure has been reported in patients treated with Nevirapine. In some cases, patients presented with non-specific prodromal signs or symptoms of hepatitis and progressed to hepatic failure. These events are often associated with rash. Women and patients with higher CD4 counts, are at increased risk of these hepatic events. Women with CD4 counts > 250 cells/mm3, including pregnant women receiving chronic treatment for HIV infection, are at considerably higher risk of these events. Patients with signs or symptoms of hepatitis must discontinue Nevirapine and seek medical evaluation immediately (see Warnings and Precautions).

已有报道，使用奈韦拉平治疗的患者，出现严重、危及生命，而且在某些情况下，呈现致命的肝毒性，包括：暴发性和胆汁淤积性肝炎、肝坏死和肝功能衰竭。在某些情况下，患者伴

有肝炎非特异性体征或症状, 并进展为肝功能衰竭，这些病症往往伴随皮疹，女性和CD4细胞计数较高的患者，肝病的风险在增加，CD4细胞计数> 250 cells（细胞）/mm3的女性，包括正在接受艾滋病毒感染（HIV）长期治疗的孕妇，这些病症有相当高的风险，出现肝炎症状或体征的患者，必须停止使用奈韦拉平，并立即寻求医疗评估（见警告和注意事项）。

It is essential that patients be monitored intensively during the first 18 weeks of therapy with Nevirapine to detect potentially life-threatening hepatotoxicity or skin reactions. The greatest risk of severe rash or hepatic events (often associated with rash) occurs in the first 6 weeks of therapy. However, the risk of any hepatic event, with or without rash, continues past this period and monitoring should continue at frequent intervals. In some cases, hepatic injury has progressed despite discontinuation of treatment. Nevirapine should not be restarted following severe hepatic, skin or hypersensitivity reactions. In addition, the 14-day lead-in period with Nevirapine 200 mg daily dosing must be strictly followed (see Warnings and Precautions).

至关重要的是，在使用奈韦拉平治疗的初始18周期间，加强对患者进行监测，以检测潜在的威胁生命的肝毒性或皮肤反应，最危险的、严重的皮疹或肝炎/肝衰竭(常伴随皮疹)发生在治疗的初始6周，然而，任何肝炎/肝衰竭的风险，伴有或不伴皮疹，在这段期间过去后，仍应以繁频的间隔，继续监测，在某些情况下，尽管治疗停药，肝脏损伤会有进展，伴随严重的肝、皮肤或过敏性反应，不应该重新启用奈韦拉平，此外，必须严格遵守使用奈韦拉平200毫克/日剂量的14天的导入期（见警告和注意事项）。

Lactic acidosis and severe hepatomegaly with steat o sis, including fatal cases, have been reported with the use of Nucleoside analogues alone or in combination, including Lamivudine, Zidovudine and other antiretrovirals (see ―Warnings and Precautions‖ section).

已有报道称, 由于单独或联合使用核苷类似物，包括：拉米夫定、齐多夫定和其他抗逆转录病毒药物（见“警告和注意事项”一节），出现乳酸性酸中毒和严重脂肪变性肝肿大，包括致命病例。

Composition 成分

Duovir-N

Each film-coated tablet contains Duovir-N每一薄膜包衣片含：

Lamivudine IP拉米夫定（印度药典）…………150mg毫克

Zidovudine IP齐多夫定（印度药典）………….300mg毫克

Nevirapine IP奈韦拉平（印度药典）…………..200mg毫克

Description说明

Duovir-N is a combination of 3 drugs commonly used in the management of Human Immunodeficiency Virus (HIV) infection. Both zidovudine and lamivudine belong to the nucleoside analogue class of antiretroviral drugs. Both drugs act by terminating the growth of the DNA chain and inhibiting the reverse transcriptase of HIV. Nevirapine is a non-nucleoside reverse transcriptase inhibitor. It acts by directly inhibiting reverse transcriptase.

Duovir-N是一个3种药物的组合，常用于人类免疫缺陷病毒（HIV即艾滋病毒）感染的处理，齐多夫定和拉米夫定都属于核苷类抗逆转录病毒药物，这两种药物的作用，终止脱氧核糖核酸（DNA）链生长，并抑制艾滋病毒（HIV）逆转录酶，奈韦拉平是一种非核苷逆转录酶抑制剂，它的作用，直接抑制逆转录酶活性。