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详细处方信息以本药内容附件PDF文件（20196915401728.pdf）的“原文Priscribing Information”为准
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部分中文PK-Merz处方资料（仅供参考）

【英文名称】PK-Merz

【适用证】

帕金森病综合症：

治疗帕金森病的症状，如严重，震颤，运动功能减退和运动不能

【用法用量】

在开始治疗前和开始治疗后1周和3周应记录ECG（50 mm / s），并手动确定Bazett频率校正的QT时间（QTc）。在任何后续剂量增加之前和之后2周也应记录这样的ECG。然后应该每年至少进行一次心电图检查。对于显示基线QTc值高于420毫秒，用PKMerz 100毫克薄膜包衣片治疗期间增加超过60毫秒，或用PK-Merz 100治疗时QTc超过480毫秒的患者，必须避免或停止治疗mg薄膜包衣片，以及显示可辨别的U波的患者。

通过遵循上述预防措施并考虑4.3节中列出的禁忌症，可以预防非常罕见但危及生命的副反应性室性心动过速。

帕金森综合征患者的治疗和药物相关的运动障碍通常应逐渐引入，剂量由治疗效果指导。

治疗应在头1至7天每天一次以1 PK-Merz 100 mg薄膜包衣片剂（相当于每天100 mg金刚烷胺）的剂量开始， 然后每周一次增加一片的日剂量，直至达到维持剂量。

通常的有效剂量是每天两次1至3个PK-Merz 100mg薄膜包衣片剂（相当于每天200-600mg金刚烷胺硫酸盐）。

在老年患者中，特别是那些有躁动，精神错乱或谵妄症状的患者，应以较低剂量开始治疗。

如果与其他抗帕金森病药物联合使用，应单独调整剂量。

在先前用金刚烷胺输注溶液治疗的患者中，可以选择更高的起始剂量。

如果在运动危象意义上帕金森病症状急剧恶化，应该进行金刚烷胺输注治疗。

【禁忌】

PK-Merz 100 mg薄膜包衣片不得用于以下患者：

- 对金刚烷胺化合物，黄橙漆（E 110）或任何药用辅料的超敏反应

- 严重失代偿性心力衰竭（NYHA IV级）

- 心肌病和心肌炎

- 2度或3度AV块

- 现有的心动过缓低于55次/分

- 已知的QT间期延长（Bazett QTc> 420 ms）或家庭记忆中可辨别的U波或先天性QT综合征

- 严重室性心律失常的病史，包括尖端扭转型室性心动过速

- 使用可延长QT间期的budipine或其他药物同时治疗（参见第4.5节）。

- 血液中钾或镁含量降低

【特殊警告和使用注意事项】

在开始治疗前和开始治疗后1周和3周应记录ECG（50 mm / s），并手动确定Bazett频率校正的QT时间（QTc）。在任何随后的剂量增加之前和之后2周也应该记录这样的ECG。然后应该每年至少进行一次心电图检查。对于显示基线QTc值高于420 ms的患者，在使用PKMerz 100 mg薄膜包衣片剂治疗期间QTc增加超过60 ms，或在PK-治疗期间QTc时间超过480 ms，必须避免或停止治疗Merz 100毫克薄膜包衣片，以及显示可辨别的U波的患者。

患有电解质不平衡风险的患者，例如对于利尿剂治疗，频繁呕吐和/或腹泻，在紧急情况下使用胰岛素或肾脏或厌食症状必须对实验室参数和适当的电解质替代进行充分监测，特别是钾和镁。

如果出现心悸，头晕或晕厥等症状，必须立即停止使用PK-Merz 100 mg薄膜包衣片进行治疗，并在24小时内检查患者QT延长时间。如果不存在QT延长，考虑到禁忌症和相互作用，可以重新开始用PK-Merz 100mg薄膜包衣片剂治疗。

对于心脏起搏器患者，无法准确确定QT时间，因此必须在与患者心脏病专家协商后，个别决定使用PK-Merz 100 mg薄膜包衣片。

补充管理金刚烷胺用于预防和治疗流感病毒感染是不可取的，应该避免过量服用的危险。

黄橙漆（E 110）可引发过敏反应。

乳糖：患有罕见遗传性半乳糖不耐症，Lapp乳糖酶缺乏症或葡萄糖 - 半乳糖吸收不良的患者不应服用该药。

【Therapeutic indications】

Parkinsonian syndromes:

treatment of symptoms of Parkinson’s disease such as rigor, tremor, hypokinesia and akinesia

【Dosage with single and daily doses】

An ECG (50 mm/s) should be recorded before and 1 and 3 weeks after commencing treatment and the Bazett frequency-corrected QT time (QTc) determined manually. Such an ECG should also be recorded before and 2 weeks after any subsequent dose increase. Further ECG check-ups should then take place at least once a year. Treatment must be avoided or discontinued in patients who show baseline QTc values above 420 ms, an increase of more than 60 ms during treatment with PKMerz 100 mg film-coated tablets, or a QTc in excess of 480 ms during treatment with PK-Merz 100 mg film-coated tablets, and in patients who show discernible U waves.

By following the above precautions and taking the contraindications listed in section 4.3 into account, the very rare, but life-threatening, side effect torsade de pointes ventricular tachycardia can be prevented.

Treatment of patients with parkinsonian syndromes and drug-related movement disturbances should normally be introduced gradually, with the dose guided by the therapeutic effect.

Treatment should be commenced at a dose of 1 PK-Merz 100 mg film-coated tablet (equivalent to 100 mg amantadine sulphate per day) once daily for the first 4 to 7 days, followed by a once-weekly increase in daily dose of one tablet until the maintenance dose is reached.

The usual effective dose is 1 to 3 PK-Merz 100 mg film-coated tablets twice daily (equivalent to 200- 600 mg amantadine sulphate per day).

In elderly patients, particularly those with states of agitation and confusion or delirious syndromes, treatment should be commenced at a lower dose.

If given in combination with other antiparkinsonian drugs, the dosage should be individually adjusted.

In patients previously treated with amantadine infusion solution, a higher starting dose can be chosen.

In the event of an acute worsening of parkinsonian symptoms in the sense of an akinetic crisis, amantadine infusion treatment should be administered.

【Contraindications】

PK-Merz 100 mg film-coated tablets must not be used in patients with:

- hypersensitivity to amantadine compounds, Yellow-orange lacquer (E 110) or to any of the excipients of the medicinal product

- severe decompensated heart failure (NYHA class IV)

- cardiomyopathies and myocarditis

- 2nd or 3rd degree AV block

- existing bradycardia under 55 beats/min

- known prolonged QT interval (Bazett QTc > 420 ms) or discernible U-waves or congenital QT syndrome in the family anamnesis

- history of serious ventricular arrhythmias including torsade de pointes

- simultaneous treatment with budipine or other drugs that prolong the QT interval (see section 4.5 ).

- reduced levels of potassium or magnesium in the blood

【Special warnings and precautions for use】

An ECG (50 mm/s) should be recorded before and 1 and 3 weeks after commencing treatment and the Bazett frequency-corrected QT time (QTc) determined manually. Such an ECG should also be recorded before and 2 weeks after any subsequent increase in dose. Further ECG check-ups should then take place at least once a year. Treatment must be avoided or discontinued in patients who show baseline QTc values above 420 ms, an increase in QTc of more than 60 ms during treatment with PKMerz 100 mg film coated tablets, or a QTc time in excess of 480 ms during treatment with PK-Merz 100 mg film-coated tablets, and in patients who show discernible U waves.

Patients at risk of electrolyte imbalances, owing e.g. to treatment with diuretics, frequent vomiting and/or diarrhoea, use of insulin in emergency situations or renal or anorectic conditions must undergo adequate monitoring of laboratory parameters and appropriate electrolyte replacement, particularly for potassium and magnesium.

In the event of symptoms such as palpitations, dizziness or syncope, treatment with PK-Merz 100 mg film-coated tablets must be immediately discontinued and the patient checked within 24 hours for QT prolongation. If no QT prolongation is present, treatment with PK-Merz 100 mg film-coated tablets can be recommenced, taking into account the contraindications and interactions.

In the case of patients with cardiac pacemakers, exact determination of QT times is not possible, therefore the decision on use of PK-Merz 100 mg film-coated tablets must be made on an individual basis in consultation with the patient’s cardiologist.

Supplementary administration of amantadine for the prevention and treatment of influenza virus A infection is inadvisable and should be avoided on account of the danger of overdose.

Yellow-orange lacquer (E 110) can trigger allergic reactions.

Lactose: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

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详细处方信息以本药内容附件PDF文件（20196915401728.pdf）的“原文Priscribing Information”为准
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