以下资料仅供参考
药品使用说明书
拉米夫定，齐多夫定和奈韦拉平片（印度药典级）
每片包含的成分
Lamivudine IP拉米夫定………150mg毫克
Zidovudine IP齐多夫定………….300mg毫克
Nevirapine IP奈韦拉平…………..200mg毫克
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 character 齐多拉米双夫定片说明书_文库下载http://www.wenkuxiazai.com/doc/83a7bdbffd0a79563c1e726d.html ised 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 steatosis, 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
使用说明书
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
Each tablet of Duovir-N contains half of the commonly prescribed daily doses of zidovudine, lamivudine and nevirapine. All three drugs are to be administered twice daily, permitting a fixed-dose combination to be formulated. With the availability of this combination formulation, patients may be better able to adhere to triple drug regimens, thereby enhancing compliance. 每片Duovir- N含规定的齐多夫定、拉米夫定和奈韦拉平的每日服用剂量的一半，所有三种药物，每日服用两次，允许制定一个固定剂量组合，由于该组合制剂的有效性，患者能更好地坚持以三联药物疗法，从而提高了遵从性。
Indications 适应症
Duovir-N is indicated for the treatment of HIV infection, once patients have been stabilized on the maintenance regimen of nevirapine 200 mg bd, and have demonstrated adequate tolerability to nevirapine.
Duovir- N 用于治疗艾滋病毒感染，一旦患者按奈韦拉平200毫克，每日两次，已经稳定在维持状况，充分证明对奈韦拉平的耐受性。
Dosage and Administration剂量和用法
Adults: 1 tablet twice daily.
成人：一次一片，每日两次,。
Duovir-N should not be administered to patients who have just initiated therapy with nevirapine. This is because an initial lead-in dosing of 200 mg nevirapine once daily for 2 weeks is recommended. F 齐多拉米双夫定片说明书_文库下载http://www.wenkuxiazai.com/doc/83a7bdbffd0a79563c1e726d-3.html ollowing this lead-in dose, a dose escalation (maintenance dose) to 200 mg nevirapine bd may be carried out in the absence of any hypersensitivity reactions (e.g. rash, liver function test abnormalities; see Warnings and Precautions).
Duovir- N不应该用于那些刚开始使用奈韦拉平治疗的患者，这是因为推荐的奈韦拉平的初始导入剂量为200毫克，每日一次给药，持续2周时间，遵照该导入剂量，奈韦拉平剂量递增（维持剂量）到200毫克，每日二次，服用可能没有任何过敏反应（如：皮疹，肝功能检查异常; 见警告和注意事项）。
Monitoring of patients患者的监测
Intensive clinical and laboratory monitoring, including liver function test, is essential, especially at baseline, prior to dose escalation of nevirapine, and at two weeks post dose escalation. In some cases, hepatic injury has progressed despite discontinuation of treatment (see Warnings and Precautions).
强化临床和实验室监测，包括：肝功能检查，是必不可少的，特别是奈韦拉平剂量增加前的、剂量递增两个星期后的基准，在某些情况下，尽管停药，肝损伤会有进展（见警告和注意事项）。
Dosage Adjustment剂量调整
Because it is a fixed-dose combination, Duovir-N should not be prescribed for patients requiring dosage adjustment, such as those with low body weight (<50 kg).
因为它是一个固定剂量组合，对剂量需要调整的患者，例如那些体重较轻患者（<50公斤），不应该规定Duovir- N的剂量
齐多拉米双夫定片说明书_文库下载http://www.wenkuxiazai.com/doc/83a7bdbffd0a79563c1e726d-3.html
Because it is a fixed-dose combination, this formulation should not be prescribed for patients requiring dosage adjustment such as those with reduced renal function (creatinine clearance ≤ 50 ml/min) or those experiencing dose-limiting adverse events.
因为它是一个固定剂量组合，对剂量需要调整的患者，不应该规定此制剂的剂量，例如那些肾功能较低的患者（肌酐清除率≤50毫升/分）或那些受到剂量限制不良反应的患者。 :
Duovir-N should be discontinued if patients experience severe rash or a rash accompanied by constitutional findings (See Warnings and Precautions). Patients experiencing mild to moderate rash during the 14-day lead-in period of 200 mg/day should not have their nevirapine dose increased or start therapy with Duovir-N until the rash has resolved (see Warnings and Precautions).
如果患者遭受严重皮疹或伴随原发性症兆（见警告和注意事项），应停止继续服用Duovir -N，在14天200毫克/天的导入期，遭受轻度至中度皮疹的患者，不应增加奈韦拉平剂量，或直到皮疹已经解决，才可开始用Duovir- N的治疗（见警告和注意事项）。
If clinical hepatitis occurs, nevirapine should be permanently discontinued and not restarted after recovery.
如果发生临床肝炎，奈韦拉平应永久停用，而不要在恢复后重新启用。
Patients who interrupt nevirapine dosing for more than 7 days should r 齐多拉米双夫定片说明书_文库下载http://www.wenkuxiazai.com/doc/83a7bdbffd0a79563c1e726d-4.html estart the recommended dosing, using one 200mg Nevimune tablet daily for the first 14 days (lead-in) in combination with the other antiretrovirals, followed by 200 mg twice daily using Duovir-N in the absence of any signs of hypersensitivity.
中断奈韦拉平剂量，超过7天的病人，应重新启动推荐的剂量，初始14天（导入），每日服用一片200毫克的通用奈韦拉平（Nevimune）片剂，结合其他抗逆转录病毒药物200毫克，然后，在没有任何过敏症状的情况下，每日两次服用Duovir- N。
(第一页右半边完)
Pregnancy妊娠
Lamivudine, zidovudine and nevirapine are all classified under category C. There are no adequate and well-controlled studies in pregnant women. Duovir-N should be used during pregnancy only if the potential benefits outweigh the potential risk.
拉米夫定、齐多夫定和奈韦拉平，都归入C类，没有对妊娠妇女进行充分、严格的对照研究，只有当潜在的益处大于潜在的风险时，才可在怀孕期间使用Duovir- N。
Lactation哺乳期
It is recommended that HIV-infected mothers do not breastfeed their infants to avoid risking postnatal transmission of HIV infection. It is not known whether lamivudine is excreted in human milk. Nevirapine and zidovudine are present in breast milk.
建议受感染艾滋病毒感染的母亲，不要哺乳自己的婴儿，以避免产后艾滋病毒传播感染的风险。不知道人乳中是否分泌出拉米夫定，母乳中存在奈韦拉平与齐多夫定
齐多拉米双夫定片说明书_文库下载http://www.wenkuxiazai.com/doc/83a7bdbffd0a79563c1e726d-4.html
Paediatrics儿科
Duovir-N is not intended for use in paediatric patients.
Duovir- N是不供儿科患者使用。
Side Effects 副作用
Zidovudine and lamivudine 齐多夫定和拉米夫定
Observed during Clinical Practice: The following events have been identified during
post-approval use of lamivudine, zidovudine, and/or lamivudine / zidovudine. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to lamivudine, zidovudine, and/or
lamivudine/zidovudine.
在临床实践中观察到：在批准使用拉米夫定、齐多夫定，和/或拉米夫定/齐多夫定后期间，以下情况已被查明，因为它们来自一个未知规模人口的自愿报告，无法作出频率估计，这些情况已列入选择，由于报道综合了它们的严重性、频率、或与拉米夫定、齐多夫定，和/或拉米夫定/齐多夫定的潜在的因果关系。
Body as a Whole: Redistribution/accumulation of body fat (see Warnings and Precautions: Fat redistribution)
整体：体内脂肪重新分布/堆积（见警告和注意事项：脂肪的重新分布）
Cardiovascular: Cardiomyopathy.
心血管：心肌病
Endocrine and 齐多拉米双夫定片说明书_文库下载http://www.wenkuxiazai.com/doc/83a7bdbffd0a79563c1e726d-5.html Motabolic: Gynecomastia, hyperglycemia.
内分泌和代谢：男性乳房发育症，高血糖。
Gastrointestinal: Oral mucosal pigmentation, stomatitis.
胃肠道：口腔黏膜色素沉着，口腔炎。
General: Vasculitis, weakness
综合：脉管炎，四肢无力。
Haemic and Lymphatic: Aplastic anaemia, anaemia, lymphadenopathy, pure red cell aplasia, splenomegaly.
血液和淋巴管：再生障碍性贫血、贫血、淋巴结肿大、纯红细胞再生障碍性贫血、脾肿大。 Hepatic and Pancreatic: Lactic acidosis and hepatic steatosis, pancreatitis, post-treatment exacerbation of hepatitis B (see Warnings and Precautions).
肝和胰腺：乳酸性酸中毒和脂肪肝、胰腺炎、乙型肝炎治疗后发作（见警告和注意事项）。 Hypersensitivity: Sensitization reactions (including anaphylaxis), urticaria.
过敏症：致敏反应（包括过敏性反应）、荨麻疹。
Musculoskeletal: Muscle weakness, CPK elevation, rhabdomyolysis.
肌肉骨骼：肌肉无力、肌酸磷酸激酶(CPK)升高、横纹肌溶解症。
Nervous: Paraesthesia, peripheral neuropathy, seizures.
神经系统：感觉异常、周围神经病变、癫痫。
Respiratory: Abnormal breath sounds/wheezing.
呼吸系统：异常呼吸音 / 哮喘。
Skin: Alopecia, erythema multiforme, Stevens-Johnson syndrome.
皮肤：脱发、多形性红斑、史蒂文斯— 约翰逊综合征
齐多拉米双夫定片说明书_文库下载http://www.wenkuxiazai.com/doc/83a7bdbffd0a79563c1e726d-5.html
Nevirapine奈韦拉平
Clinical practice has shown that the most serious adverse reactions associated with nevirapine are clinical hepatitis/hepatic failure, Stevens-Johnson syndrome, toxic epidermal necrolysis, and hypersensitivity reactions. Clinical hepatitis/hepatic failure may be isolated or associated with signs of hypersensitivity which may include severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters, oral lesions, conjunctivitis, facial oedema, and/or hepatitis, eosinophilia, granulocytopenia, lymphadenopathy, and renal dysfunction.
临床实践表明，与奈韦拉平相关的最严重的不良反应，是临床肝炎/肝衰竭、史蒂文斯 — 约翰逊（Stevens – Johnson）综合征、中毒性表皮坏死和过敏反应，临床型肝炎/肝衰竭可能是孤立的，或伴随过敏症兆，其中可能包括严重皮疹或皮疹伴有发热、全身不适、乏力、肌肉或关节疼痛、水泡、口腔溃疡、结膜炎、面部水肿、和/或肝炎/嗜酸性细胞增多、粒细胞减少、淋巴结肿大和肾功能障碍。
Severe and life-threatening hepatotoxicity, and fatal fulminant hepatitis have been reported in patients treated with nevirapine. Hepatic adverse events have been reported to occur more frequently during the first 18 weeks of treatment, but such events may occur at any time during treatment.
据报道，使用奈韦拉平治疗的患者，出现严重、危及生命的肝毒性和致命的暴发性肝炎，有报道，肝不良反应更频繁地发生在治疗的初始18周，但治疗期间，这样的反应可能随时发生。
In controlled clinical trials, clinical hepatic events regardless of severity occurred in 4.0%(range
2.5% to 11.0%) of patients who received nevirapine and 1.2% of patients in c 齐多拉米双夫定片说明书_文库下载http://www.wenkuxiazai.com/doc/83a7bdbffd0a79563c1e726d-6.html ontrol groups. Transaminase elevations (ALT or AST ＞ 5 x ULN) were observed in 8.8% of patients receiving nevirapine and 6.2% of patients in control groups in clinical trials. In a retrospective analysis of controlled and uncontrolled clinical trials, patients with higher CD4 counts at initiation of nevirapine therapy, particularly women were at greater risk for acute symptomatic hepatic events, including death, especially in the first six weeks of therapy. Patients with chronic hepatitis B or C infection were at higher risk for later hepatic events.
对照临床试验中，接受奈韦拉平治疗的患者，发生临床肝炎病症，不论严重程度，在4.0％（范围在2.5％ — 11.0％），对照组患者为1.2％，临床试验中, 观察到接收奈韦拉平治疗的患者的8.8％、对照组患者的6.2％， 转氨酶升高（谷丙转氨酶[ALT]或谷草转氨酶[AST]>5 ×正常值上限[ULN]），控制和不控制临床试验的回顾性分析表明，CD4计数更高的患者，在开始奈韦拉平治疗时，特别是妇女患者的急性肝反应症状的风险更大，包括死亡，尤其是在治疗的初始6周时间，慢性乙型或丙型肝炎病毒感染的患者，后来的肝炎病症风险较高。
The most common clinical toxicity of navirapine is rash. Severe or life-threatening rash occurred in approximately 2% of nevirapine-treated patients, most frequently within the first 6 weeks of therapy. Rashes are usually mild to moderate, maculopapular erythomatous cutaneous eruptions, with or without pruritus, located on the trunk, face and extremities. Women tend to be at higher risk for development of navirapine associated rash.
奈韦拉平最常见的临床毒性是皮疹，大约2％受奈韦拉平治疗的患者，最常见是在治疗的初始6周内，发生严重、或危及生命的皮疹，皮疹通常是轻度至中度的全身性红斑狼疮斑丘疹
齐多拉米双夫定片说明书_文库下载http://www.wenkuxiazai.com/doc/83a7bdbffd0a79563c1e726d-6.html
侵犯皮肤的爆发，带有或不带瘙痒，分布于躯干，面部和四肢，妇女往往是发生与奈韦拉平相关的皮疹的高危人群。
With respect to laboratory abnormalities, liver function test abnormalities (SGOT, SGPT) were observed more frequently in patients receiving novirapine than in controls. Asymptomatic elevations in SGT occur frequently but are not a contraindication to continue nevirapine therapy in the absence of elevations of other liver function tests.
比较对照组，更频繁地观察到接受奈韦拉平治疗的患者的实验室检查异常、肝功能检查异常（谷草转氨酶[SGOT]，谷丙转氨酶[SGPT]），经常发生梅毒絮状沉淀试验（SGT：萨克—乔治试验）无症状升高，但不是继续奈韦拉平治疗的禁忌症 — 在其他肝功能检查数据没有升高的情况下。
Because clinical hepatitis has been reported in nevirapine-treated patients, intensive clinical and laboratory monitoring, including liver function tests, is essential at baseline and during the first 18 weeks of treatment, Monitoring should continue 齐多拉米双夫定片说明书_文库下载http://www.wenkuxiazai.com/doc/83a7bdbffd0a79563c1e726d-7.html at frequent intervals thereafter, depending on the patient’s clinical status.
由于已有报道，接受奈韦拉平治疗的患者发生临床肝炎，在基线时和初始18周治疗期间，加强临床和实验室监测，包括肝功能检查，是十分必要的，此后根据病人的临床状况，应以频繁的间隔，继续进行监测。
In addition to the adverse events indentified during clinical trials, the following events have been reported with the use of Nevirapine in clinical practice.
除了在临床试验中被证实的不良反应，已有报道使用奈韦拉平的下列临床反应：
Body as a Whole: fever, somnolence, drug withdrawal
全身：发热、嗜睡、药物戒断。
Gastrointestinal: vomiting
胃肠道反应：呕吐
Liver and Biliary: jaundice, fulminant and cholestatic hepatiltis, hepatic necrosis, hepatic failure 肝和胆：黄疸、暴发型和淤胆性肝炎、肝坏死、肝功能衰竭。
Haematology: anaemia, eosinophilia, neutropenia
血液学：贫血，嗜曙红细胞增多，嗜中性白血球减少症。
Musculoskeletal: arthralgia
肌肉骨骼：关节痛
Neurologic: paraesthesia
神经系统：感觉异常
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皮肤及附件：过敏反应、包括过敏性休克、血管神经性水肿、大疱爆发、溃疡性口腔炎和荨麻疹都有报道， 此外，与原发性病症相关的皮疹过敏综合征和过敏反应，如：发热、水泡、口腔溃疡、结膜炎、面部水肿、肌肉或关节疼痛、全身不适、疲劳或明显的肝功能异常，由于服用奈韦拉平，伴有一个或多个以下情况：肝炎、嗜酸性粒细胞增多、粒细胞减少、淋巴结肿大、和/或肾功能失调，都有报道。
Overdosage 过剂量
Lamivudine 拉米夫定
There is no known antidote for lamivudine. It is not known whether lamivudine can be removed by peritoneal dialysis or hemodialysis. If overdose occurs, the patient should be monitored, and standard supportive treatment applied as required.
没有已知的拉米夫定的解毒剂，不知是否可以通过腹膜透析或血液透析，来清除拉米夫定，如果发生过剂量时，应监测病人，根据需要，应用标准的支持治疗。
Zidovudine 齐多夫定
Acute overdoses of zidovudine have been reported in pediatric patients and adults. These involved exposures up to 50 grams. No specific symptoms or signs have been identified following acute overdosage with zidovudine apart from those listed as adverse events such as fatigue, headache, vomiting, and occasional reports of haema 齐多拉米双夫定片说明书_文库下载http://www.wenkuxiazai.com/doc/83a7bdbffd0a79563c1e726d-8.html tological disturbances. All patients recovered without permanent sequelae. Haemodialysis and peritoneal dialysis appear to have a negligible effect on the removal of zidovudine while elimination of its primary metabolite, GZDV, is enhanced.
据报道，发生过小儿患者和成人齐多夫定服用急性过量，这些涉及暴露量高达50克的。没有特定的症状或体征，识别服用齐多夫定急性过量，除了那些被列为的不良反应，如：疲劳、头痛、呕吐和偶尔报告的血液障碍，所有恢复的患者都没有永久的后遗症，血液透析和腹膜透析，似乎对清除齐多夫定的作用微不足道，然而增强了消除其主要代谢产物 — GZDV
【3’- 叠氮- 3’-5’- O-（β）-D-glucopyranuronosylthymidine】。
Nevirapine奈韦拉平
There is no known antidote for nevirapine overdosage.
没有已知的奈韦拉平过量的解毒剂。
Presentation赠品
Duovir-N……………………container of 30 tablets
Duovir- N... ...... ...... ...... ......30片容器装
(第一页左边完)
Contraindications禁忌症
Duovir-N is contraindicated in patients with clinically significant hypersensitivity to any of the components contained in the formulation.
临床上，对制剂中所含的任何成分明显过敏的患者，禁用Duovir- N
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Duovir-N is also contraindicated for patients who are just initiating therapy with nevirapine. These patients require a lead-in dose of nevirapine 200 mg o.d., whereas this formulation contains the maintenance dose of nevirapine 200 mg b.d. (see Indications).
刚开始服用奈韦拉平治疗的患者，也禁用Duovir- N，这些患者需要每天一次的奈韦拉平200毫克的导入剂量，而这一制剂包含的奈韦拉平的维持剂量，为200毫克，每天两次（见适应症）。
Warnings and Precautions警告和注意事项
Drug Interactions药物交互作用
Lamivudine is predominantly eliminated in the urine by active organic cationic secretion. The possibility of interactions with other drugs administered concurrently should be considered, particularly when their main route of elimination is active renal secretion via the organic cationic transport system(e.g. trimethoprim).
拉米夫定主要是通过活性有机阳离子的分泌，从尿液中排除，应考虑与其他同时服用药物的交互作用的可能性，尤其是当它们消除的主要途径，是通过有机阳离子传输系统（如：甲氧苄氨啶）的活跃肾脏分泌。
Trimethoprim 160 mg/sulphamethoxazole 800 mg once daily has been shown to increase lamivudine exposure (AUC). No change in dose of either drug is recommended. There is no information regarding the effect on lamivudine pharmacokinetics of higher doses of TMP/SMX such as those used to treat Pneumocystis carinii pneumonia. No data are available regarding interactions with other drugs that have renal clearance mechanisms similar to that of lamivudine. Lamivudine and zalcitabine may inhibit the intracellular phosphorylation of one another. Therefore, use of lamivudine in combination with zalcitabine is not recommended.
甲氧苄氨嘧啶160毫克/ 磺胺甲恶唑800毫克，每天一次，已被证明能增加拉米夫定暴露量（AUC：药时曲线下面积），不建议改变两种药物的剂量，没有关于拉米夫定药代动力学影响的资料 — 如高剂量的甲氧苄氨嘧啶/磺胺甲基异恶唑（TMP/ SMX），用于治疗卡氏肺孢菌肺炎， 无据可查类似拉米夫定与其他药物的相互作用的肾脏清除机理，拉米夫定和扎西他宾（zalcitabine抗艾滋病药)，可能会互相抑制细胞内磷酸化，因此，不推荐使用拉米夫定结合扎西他宾（zalcitabine抗艾滋病药)。
For patients experiencing pronounced anaemia or other severe zidovudine -associated events while receiving chronic administration of zidovudine and some of the following drugs - atovaquone, fluconazole, methadone, nelfinavir, probenecid, rifampin, ritonavir, valproic acid-zidovudine dose reduction may be considered. Since Duovir-N is a fixed dose combination, it cannot be used for this patient population.
对于患明显贫血或其他严重与齐多夫定相关反应的患者，同时接受长期服用齐多夫定和下列药物：阿托喹酮(atovaquone抗疟药)、氟康唑、美沙酮、奈非那韦、丙磺舒、利福平、利托那韦，、可以考虑减量的丙戊酸 — 齐多夫定，由于Duovir- N是一个固定剂量组合，它不能用于这个病患族群。。
Antiretroviral agents: Concomitant use of zidovudine with stavudine should be avoided since an antagonistic relationship has been demonstrated in vitro.
抗逆转录病毒药物：应避免齐多夫定与司他夫定（stavudine）相伴使用，因为已证明在体外的对立关系。
Some nucleoside analogues affecting DNA replication, such as ribavirin, antagonize the in vitro antiviral activity of zidovudine against HIV; concomitant use of such drugs should be avoided. 一些核苷(酸)类似物，影响脱氧核糖核酸（DNA）的复制，如：病毒唑，拮抗齐多夫定在体外对艾滋病毒的抗病毒活性，应避免此类药物的同时使用。
Doxorubicin: Concomitant use of zidovudine with doxorubicin should be avoided since an antagonistic relationship has been demonstrated in vitro.
阿霉素：应避免齐多夫定与阿霉素同时使用，因为已证明在体外的对立关系。
Phenytoin: Phenytoin plasma levels have been reported to be low in some patients receiving zidovudine，while in 1 case a high level was documented. However, in a pharmacokinetic interaction study in which 12 HIV-positive volunteers received a single 300-mg phenytoin dose alone and during steady-state zidovudine conditions (200 mg every 4 hours), no change in phenytoin kinetics was observed. Although not designed to optimally 齐多拉米双夫定片说明书_文库下载http://www.wenkuxiazai.com/doc/83a7bdbffd0a79563c1e726d-10.html assess the effect of phenytoin on zidovudine kinetics, a 30% decrease in oral zidovudine clearance was observed with phenytoin.
苯妥英钠：据报道，一些接受齐多夫定的患者，苯妥英钠的血浆水平低，1例高水平病例记录在案，然而，在一次药代动力学相互作用研究中，其中12名艾滋病毒抗体阳性的志愿者，单独接受单一的300毫克的苯妥英的剂量，在稳态阶段期间，齐多夫定的情况（每4小时200毫克），观察到苯妥英钠的动力学没有改变，虽然设计不是最适宜评估苯妥英钠对齐多夫定动力学的影响，但观察到口服齐多夫定的清除减少30％。
Overlapping Toxicities: Co-administration of ganciclovir, interferon-alpha, and other bone marrow suppressive or cytotoxic agents may increase the haematologic toxicity of zidovudine.
重叠毒性：更昔洛韦、α-干扰素、和其他骨髓抑制或细胞毒性药物的联合服用可能会增加齐多夫定的血液学毒性。
Navirapine is principally metabolized by the liver via the cytochrome P450 isoenzymes, 3A4 and 2B6. Nevireapine is known to be an inducer of these enzymes. Thus, if a patient has been stabilized on a dosage regimen for a drug metabolized by CYP3A, and begins treatment with nevirapine, dose adjustments may be necessary.
奈韦拉平主要通过细胞色素P450同功酶，3A4和2B6，由肝脏代谢，已知奈韦拉平是这些酶的诱导剂，因此，如果病人，一直稳定在由CYP3A药物代谢的给药方案，并开始用奈韦拉平治疗，剂量的调整可能是必要的。
Clinical comments about possible dosage modifications are given below:
可能修改的临床剂量意见，给出如下
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Established Drug Interactions with nevirapine 建立使用奈韦拉平的药物相互作用 Nevirapine and ketoconazole should not be administered concomitantly, because decreases in ketoconazole plasma concentrations may reduce the efficacy of the drug. 酮康唑：奈韦拉平，酮康唑不应该同时服用，因为酮康唑的血药浓度下降，可能会降低药物的疗效。
Clarithromycin: Clarithromycin exposure was significantly decreased by nevirapine; however, 14-OH metabolite concentrations were increased. Because clarithromycin active metabolite has reduced activity against Mycobacterium avium-intracetlulare complex, overall activity against this pathogen may be altered. Alternatives to clarithromycin, such as azithromycin, should be considered. 克拉克拉： 克拉霉素暴露量被奈韦拉平明显降低； 然而，14 - 羟基代谢物浓度增加，由于克拉霉素的活性代谢产物，减少对鸟 — 胞内分枝杆菌复合菌组活性，对抗这种病病原体的整体活性，可能会改变，应考虑克拉霉素的替代物，如：阿奇霉素。
established.
Concentrations of both drugs are decreased. Oral contraceptives and other hormonal methods of birth control should not 齐多拉米双夫定片说明书_文库下载http://www.wenkuxiazai.com/doc/83a7bdbffd0a79563c1e726d-11.html be used as the sole method of contraception in women taking nevirapine, since nevirapine may lower the plasma levels of these medications. An alternative of additional method of contraception is recommended. 炔雌醇和炔诺酮：这两种药物的浓度下降，服用奈韦拉平的妇女，不应该用口服避孕药及其他激素的节育方法作为避孕的唯一方法，因为奈韦拉平可能会降低这些药物的血浆水平，建议选择其他的避孕方法。
intersubject variability, however, some patients may experience large increases in rifabutin exposure and may be at higher risk for rifabutin toxicity. Therefore, caution should be used in concomitant administration. 利福布汀：利福布汀的浓度及其代谢产物，轻度增加，然而，由于个体之间的高度变异性，有些患者可能会受到利福布汀曝露量的大量增加，并可能冒较高的利福布汀毒性的风险。因此，应谨慎同时服用。
in nevirapine plasma concentrations may reduce the efficacy of the drug. Physicians needing to treat patients co-infected with tuberculosis and using a nevirapine-containing regimen may use rifabutin instead. 利福平：奈韦拉平，利福平不应该同时服用，因为奈韦拉平的血浆浓度下降，可能会降低药物的疗效，医生需要治疗因肺结核混合感染的患者，使用含有奈韦拉平治疗方案，可以可使用利福布丁代替
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concomitant administration, and patients should be monitored closely for nevirapine-associated adverse events. 氟康唑：由于奈韦拉平暴露量增加的风险，应谨慎同时服用，应严密监测患者的与奈韦拉平相关的不良事件监测反应。 not established, but an increase in the dosage of indinavir may be required. 茚地那韦：茚地那韦的浓度降低，没有建立这个组合的适当剂量，但增加茚地那韦剂量，可能是必需的。
recommended in combination with nevirapine
洛匹那韦/利托那韦：建议在与奈韦拉平组合中，洛匹那韦/利托那韦的剂量增加到133/533毫克，每天两次，结合食物。
The appropriate dose for nelfinavir in combination with nevirapine, with respect to safety and efficacy, has not been established.
奈非那韦：奈非那韦与奈韦拉平组合的适当剂量，关于安全性和有效性方面，尚未确定。 Appropriate doses for this combination are not established, but an increase in the dosage of saquinavir may be required. 沙奎那韦：这个组合的适当剂量，尚未确定，但可能需要增加沙奎那韦的剂量。 symptoms of opiate withdrawal. Methadone-mainta 齐多拉米双夫定片说明书_文库下载http://www.wenkuxiazai.com/doc/83a7bdbffd0a79563c1e726d-12.html ined patients beginning nevirapine therapy should be monitored for evidence of withdrawal and methadone dose should be adjusted accordingly. 美沙酮：美沙酮水平可能会下降，可能需要增加剂量，以防止鸦片戒断症状，应该监测开始奈韦拉平治疗的美沙酮替代维持患者的戒断证据，并且美沙酮剂量，应作相应调整。
Potential drug interactions are listed below:
下列是潜在的药物相互作用：
Examples of drugs in which plasma concentrations may be decreased by co-administration with nevirapine.
与奈韦拉平联合服用，药物血浆浓度可能降低的例子：
Antiarrhythmics: e.g. Amiodarone, disopyramide, lidocaine
抗心律不齐药：如:：胺碘酮、丙吡胺、利多卡因。
Anticonvulsants: e.g. Carbamazepine, clonazepam, ethosuximide
抗惊厥药物：如：卡马西平、氯硝西泮、乙琥胺。
Antifungals: e.g. Itraconazole.
抗真菌药：如：伊曲康唑。
Calcium channel blockers: Diltiazem, nifedipine, verapamil
钙通道阻滞剂：恬尔心、硝苯地平、异博定。
Cancer chemotherapy: Cyclophosphamide
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discontinued from nevirapine.
（接上）皮肤反应，包括未能按照14天导入期间的初始日剂量200mg和初期症状期发作后，延迟停止奈韦拉平治疗，如果病人患怀疑与奈韦拉平相关的皮疹，应检查肝功能，患与皮疹相关的谷丙转案酶（AST）或谷丙转氨酶（ALT）升高的病人，应永久停用奈韦拉平。 Therapy with nevirapine must be initiated with a 14-day lead-in period of 200mg/day, which has been shown to reduce the frequency of rash. If rash is observed during this lead-in period, dose escalation should not occur until the rash has resolved. (see Dosage and Administration). Patients should be monitored closely if isolated rash of any severity occurs.
使用奈韦拉平治疗，必须启动200毫克/天的14天的导入期，已证明可减少皮疹发生的频率，如果在此导入期，观察到皮疹，不应该递增剂量，直到皮疹已经解决 （见用法用量）。如果患者发生任何严重孤立的皮疹，应密切监测。
Women appear to be at higher risk than man of developing rash with nevirapine. The use of prednisone to prevent nevirapine associated rash is not recommended.
女性使用奈韦拉平，发展皮疹的风险在高于男性，不推荐使用强的松，以防止与奈韦拉平相关的皮疹。
Hepatic events肝病
Lactic acidosis/severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of antiretroviral nucleoside analogues alone or in combination. A majority of these cases have been in women. Obesity and prolonged nucleoside exposure may be risk factors. Caution should be exercised when administering zidovudine and lamivudine to any patient, and particularly to those with known risk factors for liver disease. Cases have also been reported in patients wi 齐多拉米双夫定片说明书_文库下载http://www.wenkuxiazai.com/doc/83a7bdbffd0a79563c1e726d-14.html th no known risk factors. Treatment should be discontinued in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked amino-transferase elevations). 据报道，已有由于单独或联合使用抗逆转录病毒核苷类似物，而脂肪变性的乳酸性酸中毒/严重肝肿大，包括致命病例发生，这些病例，多数在女性，过度肥胖和长期核苷暴露量可能是危险因素，任何病人服用齐多夫定和拉米夫定时，应谨慎行事，尤其是那些有肝脏疾病已知危险因素的，没有已知的危险因素的患者病例个案也有报道，任何病人出现的临床或实验室检查结果，暗示乳酸性酸中毒或肝毒性（其中可能包括肝肿大和脂肪变性，即使没有明显的氨基—转移酶升高），应停止治疗。
Severe, life-threatening and in some cases fatal hepatotoxicity, including fulminant and cholestatic hepatitis, hepatic necrosis and hepatic failure, have been reported in patients treated with nevirapine, The risk is greatest during the first 6 weeks of therapy, and continues through 18 weeks of treatment. However, hepatic events may occur at any time during treatment. In some cases, patients presented with non-specific prodromal signs or symptoms of fatigue, malaise, anorexia, nausea, jaundice, liver tenderness or hepatomegaly, with or without initially abnormal serum transaminase levels. Some of these events have progressed to hepatic failure with transaminase elevation, with or without hyperbilirubinaemia, prolonged partial thromboplastin time, or eosinophilia. Rash and fever accompanied some of these hepatic events. Patients with
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signs or symptoms of hepatitis must be advised to discontinue Duovir-N and immediately seek medical evaluation,which should include liver function tests.
已有报道，使用奈韦拉平治疗的患者，发生严重、危及生命、和一些致命的肝毒性病例，包括暴发性和胆汁淤积性肝炎、肝坏死和肝功能衰竭，最大的风险是，在初始6周的治疗，并持续到整个18周治疗时间，然而，肝病可能随时发生在治疗过程中，在某些情况下，患者出现非特异性的前驱迹象或症状、疲劳、不适、食欲减退、恶心、黄疸、肝区压痛或肝肿大、血清转氨酶水平有或没有最初异常，其中一些肝病已经进展到肝功能衰竭，伴随转氨酶升高，伴有或不伴高血胆红素症、部分凝血活酶时间时间延长、或嗜酸性粒细胞增多。皮疹和发热伴随这些肝病，有肝炎的症状或体征的患者，必须被劝告停用Duovir- N，并立即寻求医疗评估，其中应包括肝功能检查。
Women with high CD4 counts are at greatest risk of hepatic events. Increased SGOT or SGPT levels and/or co-infection with hepatitis B or C at the start of therapy are associated with a greater risk of hepatic adverse events
CD4细胞计数较高的女性，肝病的风险在增加，在开始治疗时，谷草转氨酶(SGOT)或谷丙转氨酶(SGPT)水平增加和/或B型或C肝炎重叠感染的，与肝脏不良反应的更大风险有关。
Intensive clinical and laboratory monitoring, including liver function tests is essential at baseline and during the first 18 weeks of treatment. Monitoring should continue at frequent intervals thereafter. Liver function tests should be performed immediately if a patient experiences signs or symptoms suggestive of hepatitis and/or hypersensitivity reaction, Liver function tests should also be obtained for all patients who develop a rash in the first 18 weeks of treatment. Physicians and patients should be vigilant for the appearance of signs 齐多拉米双夫定片说明书_文库下载http://www.wenkuxiazai.com/doc/83a7bdbffd0a79563c1e726d-15.html or symptoms of hepatitis，such as fatigue，malaise, anorexia, nausea, jaundice, bilirubinuria, acholic stools, liver tenderness or hepatomegaly. The diagnosis of hepatotoxicity should be considered in this setting, even if liver function tests are initially normal or alternative diagnoses are possible.
在基线时和初始18周治疗期间，加强临床和实验室监测，包括肝功能检查，是必不可少的，此后，应以频繁的间隔，继续进行监测，如果病人出现暗示肝炎和/或过敏反应的症状或体征，应立即进行肝功能检查，在初始18周治疗期间，出现皮疹的所有病人，也应得到肝功能检查，医生和患者都应警惕出现的肝炎症状或体征，如：疲劳、不适、食欲减退、恶心、黄疸，胆红素尿、灰白色大便、肝区压痛或肝肿大，在这样情况下，应考虑肝中毒的诊断，即使肝功能检查最初正常，或可能要替代诊断。
If clinical hepatitis occurs, Duovir-N should be permanently discontinued and not restarted after recovery. In some cases, hepatic injury progresses despite discontinuation of treatment.
如果发生临床肝炎，应永久停用Duovir- N，而不可在恢复后重新启用，在某些情况下，尽管停药，肝损伤会有进展。
Patients with HIV and hepatitis B virus coinfection.艾滋病毒与乙肝病毒同时感染的患者
Safety and efficacy of lamivudine have not been established for treatment of chronic hepatitis B in patients dually infected with HIV and HBV. In non-HIV-infected patients treated with lamivudine for chronic hepatitis B, emergence of lamivudine-resistant HBV has been detected and has been associated with diminished treatment response. Emergence of hepatitis B virus variants associated with resistance to lamivudine has also been reported in HIV-infected patients who have
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received lamivudine-containing antiretroviral regimens in the presence of concurrent infection with hepatitis B virus. Post-treatment exacerbations of hepatitis have also been reported (see Warnings).
尚未确定艾滋病毒与乙肝病毒的双重感染的慢性乙型肝炎患者的治疗用的拉米夫定的安全性和有效性，用拉米夫定治疗非感染艾滋病毒感染的慢性乙型肝炎患者，已被检测到出现乙肝病毒（HBV）对拉米夫定的耐药性，并伴随较差的疗效，也有报道，曾经接受含有拉米夫定的抗逆转录病毒疗法的艾滋病毒感染的患者，存在乙型肝炎病毒并发感染，出现耐药拉米夫定的乙型肝炎病毒变种型，肝炎治疗后，病情加重也有报道（见警告）。
Post-treatment Exacerbation of Hepatitis肝炎治疗后恶化
In clinical trials in non-HIV infected patients treated with lamivudine for chronic hepatic B, clinical and laboratory evidence of exacerbation of hepatitis have occurred after discontinuation of lamivudine. These exacerbations have been detected primary by serum ALT elevation in addition to re-emergence of HBV DNA. Although most events appear to have been self-limited, fatalities have been reported in some cases. Similar events have been reported from post-marketing experience after changes from lamivudine-containing HIV treatment regimens to non-lamivudine- containing regimens in patients infected with both HIV and HBV. The causal relationship to discontinuation of lamivudine treatment is unknown. Patients should be closely monitored with both clinical and laboratory followup for at least several months after stop 齐多拉米双夫定片说明书_文库下载http://www.wenkuxiazai.com/doc/83a7bdbffd0a79563c1e726d-16.html ping treatment. There is insufficient evidence to determine whether re-initiation of lamivudine alters the course of post-treatment exacerbations of hepatitis.
临床试验中，使用拉米夫定治疗非感染艾滋病毒的慢性乙型肝炎患者，在拉米夫定停药后，已发现肝炎恶化的临床和实验室证据，主要通过血清谷丙转氨酶（ALT）升高，加上乙肝病毒（HBV）脱氧核糖核酸（DNA），已检测这些病情的恶化，尽管大多数病情似已自愈（具自限性），某些病例仍有死亡率报道，从含有拉米夫定的艾滋病毒（HIV）治疗方案到不含拉米夫定的治疗方案的变化后，对艾滋病毒（HIV）和乙肝病毒（HBV）感染患者，据市场营销体验，仍有类似的（死亡）病情报道，尚未知道停止拉米夫定治疗的因果关系，停止治疗后，随后至少数个月，应对患者进行密切临床和实验室监测，肝炎的治疗后病情加重，没有足够的证据，以确定是否重新启用拉米夫定。
Bone marrow suppression骨髓抑制
Duovir-N should be used with caution in patients who have bone marrow compromise evidenced by granulocyte count< 1000 cells/mm3 or haemoglobin<9.5g/dL (see Side Effects). Frequent blood counts are strongly recommended in patients with advanced HIV disease who are treated with Duovir-N. For HIV-infected individuals and patients with asymptomatic or early HIV disease, periodic blood counts are recommended.
有粒细胞计数<1000 cells/mm3 （细胞/立方毫米）或血红蛋白<9.5g/dL（克/分升）的骨髓损害证据的患者，应慎用Duovir-N（见副作用），强烈建议，用Duovir- N治疗晚期艾滋病的患者，进行频繁的血球计数检查，对于艾滋病毒（HIV）感染者和无症状或早期艾滋病（HIV）的患者，建议定期血球计数检查。
Myopathy肌病
Myopathy and myositis, with pathological changes similar to that produced by HIV disease, have been associated with prolonged use of zidovudine and therefore may occur with therapy with
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Duovir-N.
有着类似艾滋病（HIV）产生病理变化的肌病和肌炎，与长期使用齐多夫定有关，因此用Duovir- N治疗，可能会发生。
Fat Redistribution脂肪重新分布
Redistribution/accumulation of body fat including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and ―cushingoid appearance‖ have been observed in patients receiving antiretroviral therapy. The mechanism and long- term consequences of these events are currently unknown. A causal relationship has not been established.
体内脂肪重新分布/堆积，包括腹部肥胖、颈背面的脂肪扩大（水牛背）、外围消瘦、面部消瘦、乳房增大，并已观察到接受抗逆转录病毒疗法的患者，出现“类库欣氏症表征外貌(cushingold: 垂体嗜碱细胞增殖)”，这些病症的机理和长期后果，目前还尚不清楚，还未确立其因果关系。
St. John’s wort 圣约翰草(芳香疗法用)
Concomitant use of St. John’s wort (hypericum perforatum) or St. John’s wort containing products and nevirapine is not recommended. Co-administration of Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs), including nevirapine, with St. John’s wort is expected to substantially decrease NNRTI concentrations and may result in sub-optimal levels of nevirapine and lead to loss of virologic response and possible resistance to nevirapine or to th 齐多拉米双夫定片说明书_文库下载http://www.wenkuxiazai.com/doc/83a7bdbffd0a79563c1e726d-17.html e class of NNRTIs.
不推荐使相伴用奈韦拉平与圣约翰草（hypericum perforatum:贯叶连翘）或含有圣约翰草的产品, 联合服用非核苷逆转录酶抑制剂（NNRTIs），包括奈韦拉平与圣约翰草，预计非核苷逆转录酶抑制剂（NNRTI）浓度，会大幅度降低，并可能产生奈韦拉平次优水平，及导致病毒学效果的损失，和对奈韦拉平或对非核苷逆转录酶抑制剂类（NNRTIs）的可能的抗药性。
Others其他
The duration of clinical benefit from antiretroviral therapy may be limited. Patients receiving nevirapine or any other antiretroviral therapy may continue to develop opportunistic infections and other complications of HIV infection, and therefore should remain under close clinical observation by physicians experienced in the treatment of patients with associated HIV diseases.
抗逆转录病毒疗法的临床受益的持续时间，可能有限，接受奈韦拉平或任何其他抗逆转录病毒疗法的患者，可能会继续发展成机会性感染和艾滋病毒感染等并发症，因此在治疗艾滋病毒相关疾病，有丰富经验的医生，应密切保持对患者的临床观察。
Renal Impairment 肾功能不全
Reduction of the dosage of zidovudine, lamivudine and nevirapine is required in patients with impaired renal function. Additional doses of nevirapine are required for patients on dialysis. Since Duovir-N is a fixed-dose combination, it should not be prescribed for this patient population.
肾功能受损患者，需要减少齐多夫定、拉米夫定和奈韦拉平的剂量，对透析患者，需要增加奈韦拉平的剂量，Duovir- N是固定剂量组合，它不应该作为处方开具给这一病患族群
Hepatic impairment肝功能受损
No dose adjustment for lamivudine is required for patients with impaired hepatic function. Safety and efficacy of lamivudine have not been established in the presence of decompensated liver disease.
肝功能受损的患者，无需调整拉米夫定的剂量，在失代偿性肝病方面，尚未建立拉米夫定的安全性和有效性。
Since Zidovudine is primarily eliminated by hepatic metabolism, a reduction in the daily dose may be necessary in these patients.
由于齐 齐多拉米双夫定片说明书_文库下载http://www.wenkuxiazai.com/doc/83a7bdbffd0a79563c1e726d-18.html 多夫定是主要由肝脏代谢排出，这些患者，有必要减少每日剂量。
Increased nevirapine levels and nevirapine accumulation may be observed in patients with serious liver disease. Nevirapine should not be administered to patients with severe hepatic impairment. 可以观察到严重肝脏疾病患者的奈韦拉平水平的增加和积累，严重肝损伤患者，不应该施用药奈韦拉平。
Since Duovir-N is a flxed-dose cornbination, it should not be prescribed for this patient population.
由于Duovir- N是固定剂量组合，它不应该作为处方开具给这一病患族群
