【科普】Modafinil与Ritalin 两种神秘的“聪明药”
今天正好有时间，我决定给大家翻译一下Armodafinil的说明书。因为国内还没有进口这种药，所以Armodafinil的说明书现在只有英文版。好多人都是没看说明书就开始吃，我想说，这样很不科学，用药前一定要看看说明书，特别是这种处方药。我给大家翻译一下，翻译完发到贴子里。在下英语水平有限，有些词可能翻译得不够准确，不喜勿喷。
①
For the use of a psychiatrist only.
本说明书仅供精神科医生使用。
Prescribing Information
处方信息
Armodafinil Tablets
阿莫达非尼片
Waklert
维克勒特（商品名）
Dosage form:
Tablet
剂型：
片剂
Composition:
Each Uncoated Tablet of Waklert 50 Contains:
Armodafinil IP 50mg
Each Uncoated Tablet of Waklert 150 Contains:
Armodafinil IP 150mg
Each Uncoated Tablet of Waklert 250 Contains:
Armodafinil IP 250mg
构成：
每片Waklert 50含有：
阿莫达非尼50mg
每片Waklert 150含有：
阿莫达非尼150mg
每片Waklert 250含有：
阿莫达非尼250mg
For the use of a psychiatrist only.
本说明书仅供精神科医生使用。
Prescribing Information
处方信息
Armodafinil Tablets
阿莫达非尼片
Waklert
维克勒特（商品名）
Dosage form:
Tablet
剂型：
片剂
Composition:
Each Uncoated Tablet of Waklert 50 Contains:
Armodafinil IP 50mg
Each Uncoated Tablet of Waklert 150 Contains:
Armodafinil IP 150mg
Each Uncoated Tablet of Waklert 250 Contains:
Armodafinil IP 250mg
构成：
每片Waklert 50含有：
阿莫达非尼50mg
每片Waklert 150含有：
阿莫达非尼150mg
每片Waklert 250含有：
阿莫达非尼250mg
②
Indications:
Waklert is indicated to improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS) , narcolepsy and shift work sleep disorder.
适应症：
1，抑郁症。
2，嗜睡症。
3，轮班工作睡眠紊乱。
注：我的翻译不是直译，我会尽可能用容易理解的词进行翻译，会省去一些普通人难以理解的医学专业术语。
Indications:
Waklert is indicated to improve wakefulness in patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS) , narcolepsy and shift work sleep disorder.
适应症：
1，抑郁症。
2，嗜睡症。
3，轮班工作睡眠紊乱。
注：我的翻译不是直译，我会尽可能用容易理解的词进行翻译，会省去一些普通人难以理解的医学专业术语。
③
In OSAHS, Waklert is indicated as an adjunct to standard treatment(s) for the underlying obstruction. If continuous positive airway pressure(CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating Waklert. If Waklert is used adjunctively with CPAP, the encouragement of and periodic assessment of CPAP compliance is necessary.
对于OSAHS，Armodafinil是对潜在梗阻标准治疗的辅助手段。
如果患者在进行CPAP治疗，请在CPAP治疗结束后再使用Armodafinil。
如果Armodafinil和CPAP同时使用，则要评估相关风险。
In OSAHS, Waklert is indicated as an adjunct to standard treatment(s) for the underlying obstruction. If continuous positive airway pressure(CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating Waklert. If Waklert is used adjunctively with CPAP, the encouragement of and periodic assessment of CPAP compliance is necessary.
对于OSAHS，Armodafinil是对潜在梗阻标准治疗的辅助手段。
如果患者在进行CPAP治疗，请在CPAP治疗结束后再使用Armodafinil。
如果Armodafinil和CPAP同时使用，则要评估相关风险。
④
In all cases, careful attention to the diagnosis and treatment of the underlying sleep disorder(s) is of utmost importance. Prescribers should be aware that some patients may have more than one sleep disorder contributing their excessive sleepiness.
在任何情况下，对嗜睡症的诊断和治疗都要特别谨慎。
医生应该意识到病人过度嗜睡可能不止由于一种原因。
In all cases, careful attention to the diagnosis and treatment of the underlying sleep disorder(s) is of utmost importance. Prescribers should be aware that some patients may have more than one sleep disorder contributing their excessive sleepiness.
在任何情况下，对嗜睡症的诊断和治疗都要特别谨慎。
医生应该意识到病人过度嗜睡可能不止由于一种原因。
⑤
The effectiveness of armodafinil tablets in long term use (greater than 12 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to prescribe armodafinil tablets for an extended time in patients should periodically reevaluate long term usefulness for the individual patient.
在安慰剂对照实验中，Armodafinil长期使用（超过12周）的有效性尚未得到认证。
长期服用Armodafinil的患者应定期进行有效性评估。
The effectiveness of armodafinil tablets in long term use (greater than 12 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to prescribe armodafinil tablets for an extended time in patients should periodically reevaluate long term usefulness for the individual patient.
在安慰剂对照实验中，Armodafinil长期使用（超过12周）的有效性尚未得到认证。
长期服用Armodafinil的患者应定期进行有效性评估。
⑥
Dosage and Administration
Obstructive sleep aonea/hypopnea syndrome (OSAHS) and narcolepsy: The recommended dose of Waklert for patients with OSAHS or narcolepsy is 150 mg or 250 mg given as a single dose in the morning. In patients with OSAHS, doses up to 250 mg/day, given as a single dose, have been well tolerated, but there is no consistent evidence that is dose confers additional benefit beyond that of the 150 mg/day dose.
用法用量
OSAHS和嗜睡症患者推荐剂量为每日150mg或250mg，早晨服用。
对于OSAHS患者，单次给药剂量250mg/day耐受性良好，但没有证据表明，剂量高于每日150mg/day会有更好的效果。
Dosage and Administration
Obstructive sleep aonea/hypopnea syndrome (OSAHS) and narcolepsy: The recommended dose of Waklert for patients with OSAHS or narcolepsy is 150 mg or 250 mg given as a single dose in the morning. In patients with OSAHS, doses up to 250 mg/day, given as a single dose, have been well tolerated, but there is no consistent evidence that is dose confers additional benefit beyond that of the 150 mg/day dose.
用法用量
OSAHS和嗜睡症患者推荐剂量为每日150mg或250mg，早晨服用。
对于OSAHS患者，单次给药剂量250mg/day耐受性良好，但没有证据表明，剂量高于每日150mg/day会有更好的效果。
⑦
Shift work sleep disorder (SWSD): The recommended dose of Waklert for patients with SWSD is 150mg given daily approximately 1 hour prior to the start of their work shift.
轮班工作睡眠障碍（SWSD）：建议SWSD患者在轮班工作开始前1小时服用150mgArmodafinil。
Shift work sleep disorder (SWSD): The recommended dose of Waklert for patients with SWSD is 150mg given daily approximately 1 hour prior to the start of their work shift.
轮班工作睡眠障碍（SWSD）：建议SWSD患者在轮班工作开始前1小时服用150mgArmodafinil。
⑨
Drugs that are largely eliminated via CYP2C19 metabolism, such as diazepam, propranolol, and phenytoin may have prolonged elimination upon coadministration with Waklert and may require dosage reduction and monitoring for toxicity.
通过CYP2C19代谢的药物，比如地西泮、普萘洛尔和苯妥英，与Armodafinil联合用药后可能会延长半衰期，因此可能需要减少剂量和监测毒性。
Drugs that are largely eliminated via CYP2C19 metabolism, such as diazepam, propranolol, and phenytoin may have prolonged elimination upon coadministration with Waklert and may require dosage reduction and monitoring for toxicity.
通过CYP2C19代谢的药物，比如地西泮、普萘洛尔和苯妥英，与Armodafinil联合用药后可能会延长半衰期，因此可能需要减少剂量和监测毒性。
⑩
Elderly: Safety and effectiveness of armodafinil tablets in individuals above 65 years of age have not been established. In elderly patients, elimination of armodafinil and its metabolites may be reduced as a consequence of aging. Therefore, consideration should be given to the use of lower doses in this population.
老年人：Armodafinil对65岁以上人群的安全性和有效性尚未确定。在老年患者中，Armodafinil及其代谢物的清除速度可能由于老化而减少。因此，应考虑在此类人群中使用较低剂量。
Elderly: Safety and effectiveness of armodafinil tablets in individuals above 65 years of age have not been established. In elderly patients, elimination of armodafinil and its metabolites may be reduced as a consequence of aging. Therefore, consideration should be given to the use of lower doses in this population.
老年人：Armodafinil对65岁以上人群的安全性和有效性尚未确定。在老年患者中，Armodafinil及其代谢物的清除速度可能由于老化而减少。因此，应考虑在此类人群中使用较低剂量。
Armodafinil说明书翻译11
Pediatric use: Safety and effectiveness of armodafinil use in individuals below 17 years of age have not been established. Serious rash has been seen in pediatric patients receiving modafinil.
儿童：17岁以下个体使用Armodafinil的安全性和有效性未得到确认。曾有使用Modafinil治疗的儿童出现过严重皮疹。
Pediatric use: Safety and effectiveness of armodafinil use in individuals below 17 years of age have not been established. Serious rash has been seen in pediatric patients receiving modafinil.
儿童：17岁以下个体使用Armodafinil的安全性和有效性未得到确认。曾有使用Modafinil治疗的儿童出现过严重皮疹。
Armodafinil说明书翻译12
Hepatic impairment: In patients with severe hepatic impairment, with of without cirrhosis, armodafinil tablets should be administered at a reduced dose.
肝功能损害：对于严重肝功能损害的患者，应降低Armodafinil的使用剂量。
Hepatic impairment: In patients with severe hepatic impairment, with of without cirrhosis, armodafinil tablets should be administered at a reduced dose.
肝功能损害：对于严重肝功能损害的患者，应降低Armodafinil的使用剂量。
Armodafinil说明书翻译13
Renal impairment: There is inadequate information to determine safety and efficacy of dosing in patients with severe renal impairment.
肾损害：没有足够的信息来确定Armodafinil对严重肾损害患者的安全性和有效性。
Renal impairment: There is inadequate information to determine safety and efficacy of dosing in patients with severe renal impairment.
肾损害：没有足够的信息来确定Armodafinil对严重肾损害患者的安全性和有效性。
Armodafinil说明书翻译14
Contra-indications:
In patients with known hypersensitivity to modafinil and armodafinil or its inactive ingredients.
禁忌症：
对Modafinil和Armodafinil或其非活性成分过敏的患者禁止使用。
Contra-indications:
In patients with known hypersensitivity to modafinil and armodafinil or its inactive ingredients.
禁忌症：
对Modafinil和Armodafinil或其非活性成分过敏的患者禁止使用。
Armodafinil说明书翻译15
Warnings and precautions:
Serious rash requiring hospitalization and discontinuation of treatment has been reported in adults and children in association with the use of modafinil, a racemic mixture of S and R modafinil (the latter is armodafinil).
警告和注意事项：
成人和儿童出现严重的皮疹时需要住院治疗并停止使用Armodafinil。
Warnings and precautions:
Serious rash requiring hospitalization and discontinuation of treatment has been reported in adults and children in association with the use of modafinil, a racemic mixture of S and R modafinil (the latter is armodafinil).
警告和注意事项：
成人和儿童出现严重的皮疹时需要住院治疗并停止使用Armodafinil。
Armodafinil说明书翻译16
Armodafinil has not been studied in pediatric patients in any setting and is not approved for use in pediatric patients for any indication.
Armodafinil没有在儿童中进行过研究，也没有批准可用于任何儿童患者的适用症。
Armodafinil has not been studied in pediatric patients in any setting and is not approved for use in pediatric patients for any indication.
Armodafinil没有在儿童中进行过研究，也没有批准可用于任何儿童患者的适用症。
Armodafinil说明书翻译17
In clinical trials of modafinil (the racemate), the incidence of rash resulting in discontinuation was approximately 0.8% (13 per 1,585) in pediatric patients (age <17 years); these rashes included 1 case of possible Stevens-Johnson Syndrome (SJS) and 1 case of apparent multiorgan hypersensitivity reaction. Several of the cases were associated with fever and other abnormalities (e.g., vomiting, leukopenia). The median time to rash that resulted in discontinuation was 13 days. No such cases were observed among 380 pediatric patients who received placebo. No serious skin rashes have been reported in adult clinical trials (0 per 4,264) of modafinil. Rare cases of serious of life-threatening rash, including SJS, Toxic Epidermal Necrolysis (TEN), and Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) have been reported in adults and children in worldwide post-marketing experience. The reporting rate of TEN and SJS associated with modafinil use, which is generally accepted to be an underestimate due to underreporting, exceeds the background incidence rate. Estimates of the background incidence rate for these serious skin reactions in the general population range between 1 to 2 case per million-person years.
在Modafinil（外消旋体）的临床试验中，皮疹发生率在儿童患者（年龄<17岁）中约为0.8%（13/1585）；这些皮疹包括1例可能是Stevens-Johnson综合征（SJS）和一例明显的多器官超敏反应。
其中一些病例与发热和其它异常（如呕吐、白细胞减少）有关。
皮疹的中位时间是13天。
380名接受安慰剂治疗的儿童患者中未发现此类病例。
Modafinil成人临床试验（0/4264）未发现严重皮疹。
世界各地的成人和儿童都报告了罕见的严重危及生命的皮疹，包括SJS、中毒性表皮坏死松解（TEN）和伴有嗜酸性粒细胞增多和全身症状（DRESS）的药疹。
与Modafinil使用相关的10例和SJS的报告率（由于报告不足而被普遍认为是低估）超过了背景发病率。
在一般人群中，这些严重皮肤反应的背景发病率估计在每百万人每年1至2例之间。
In clinical trials of modafinil (the racemate), the incidence of rash resulting in discontinuation was approximately 0.8% (13 per 1,585) in pediatric patients (age <17 years); these rashes included 1 case of possible Stevens-Johnson Syndrome (SJS) and 1 case of apparent multiorgan hypersensitivity reaction. Several of the cases were associated with fever and other abnormalities (e.g., vomiting, leukopenia). The median time to rash that resulted in discontinuation was 13 days. No such cases were observed among 380 pediatric patients who received placebo. No serious skin rashes have been reported in adult clinical trials (0 per 4,264) of modafinil. Rare cases of serious of life-threatening rash, including SJS, Toxic Epidermal Necrolysis (TEN), and Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) have been reported in adults and children in worldwide post-marketing experience. The reporting rate of TEN and SJS associated with modafinil use, which is generally accepted to be an underestimate due to underreporting, exceeds the background incidence rate. Estimates of the background incidence rate for these serious skin reactions in the general population range between 1 to 2 case per million-person years.
在Modafinil（外消旋体）的临床试验中，皮疹发生率在儿童患者（年龄<17岁）中约为0.8%（13/1585）；这些皮疹包括1例可能是Stevens-Johnson综合征（SJS）和一例明显的多器官超敏反应。
其中一些病例与发热和其它异常（如呕吐、白细胞减少）有关。
皮疹的中位时间是13天。
380名接受安慰剂治疗的儿童患者中未发现此类病例。
Modafinil成人临床试验（0/4264）未发现严重皮疹。
世界各地的成人和儿童都报告了罕见的严重危及生命的皮疹，包括SJS、中毒性表皮坏死松解（TEN）和伴有嗜酸性粒细胞增多和全身症状（DRESS）的药疹。
与Modafinil使用相关的10例和SJS的报告率（由于报告不足而被普遍认为是低估）超过了背景发病率。
在一般人群中，这些严重皮肤反应的背景发病率估计在每百万人每年1至2例之间。
Armodafinil说明书翻译18
No serious skin rashes have been reported in adult clinical trials of armodafinil. However, because armodafinil is the R isomer of racemic modafinil, a similar risk of serious rash with armodafinil cannot be ruled out.
Armodafinil成人临床试验中未发现严重的皮疹。
然而，由于Armodafinil是外消旋Modafinil的R异构体，不能排除Armodafinil的严重皮疹风险。
No serious skin rashes have been reported in adult clinical trials of armodafinil. However, because armodafinil is the R isomer of racemic modafinil, a similar risk of serious rash with armodafinil cannot be ruled out.
Armodafinil成人临床试验中未发现严重的皮疹。
然而，由于Armodafinil是外消旋Modafinil的R异构体，不能排除Armodafinil的严重皮疹风险。
Armodafinil说明书翻译19
There are no factors that are known to predict the risk of occurrence or the severity of rash associated with modafinil or armodafinil. Nearly all cases of serious rash associated with modafinil occurred within 1 to 5 weeks after treatment initiation. However, isolated cases have been reported after prolonged treatment (e.g., 3 months). Accordingly, duration of therapy cannot be relied upon as a means to predict the potential risk heralded by the first appearance of a rash.
没有已知方法可以预测与Modafinil或Armodafinil相关皮疹的发生风险和严重程度。
几乎所有与Modafinil相关的严重皮疹都发生在治疗开始后1至5周内。
然而，有在长期治疗（如3个月）后出现皮疹的病例。
因此，治疗时间不能作为皮疹不会出现的依据。
There are no factors that are known to predict the risk of occurrence or the severity of rash associated with modafinil or armodafinil. Nearly all cases of serious rash associated with modafinil occurred within 1 to 5 weeks after treatment initiation. However, isolated cases have been reported after prolonged treatment (e.g., 3 months). Accordingly, duration of therapy cannot be relied upon as a means to predict the potential risk heralded by the first appearance of a rash.
没有已知方法可以预测与Modafinil或Armodafinil相关皮疹的发生风险和严重程度。
几乎所有与Modafinil相关的严重皮疹都发生在治疗开始后1至5周内。
然而，有在长期治疗（如3个月）后出现皮疹的病例。
因此，治疗时间不能作为皮疹不会出现的依据。
Armodafinil说明书翻译21
One serious case of angioedema and one case of hypersensitivity (with rash, dysphagia, and bronchospasm), were observed among 1,595 patients treated with armodafinil. Patients should be advised to discontinue therapy and immediately report to their physician and signs or symptoms suggesting angioedema or anaphylaxis (e.g., swelling of face, eyes, lips, tongue or larynx; difficulty in swallowing or breathing; hoarseness).
在1595例使用Armodafinil治疗的患者中，观察到1例严重的血管性水肿和1例过敏（伴有皮疹、吞咽困难和支气管痉挛）。
出现该类问题应建议患者停止治疗，并立即向医生报告症状和体征（如面部、眼睛、嘴唇、舌头或喉部肿胀；吞咽或呼吸困难；声音嘶哑）。
One serious case of angioedema and one case of hypersensitivity (with rash, dysphagia, and bronchospasm), were observed among 1,595 patients treated with armodafinil. Patients should be advised to discontinue therapy and immediately report to their physician and signs or symptoms suggesting angioedema or anaphylaxis (e.g., swelling of face, eyes, lips, tongue or larynx; difficulty in swallowing or breathing; hoarseness).
在1595例使用Armodafinil治疗的患者中，观察到1例严重的血管性水肿和1例过敏（伴有皮疹、吞咽困难和支气管痉挛）。
出现该类问题应建议患者停止治疗，并立即向医生报告症状和体征（如面部、眼睛、嘴唇、舌头或喉部肿胀；吞咽或呼吸困难；声音嘶哑）。