【Posology and method of administration】

Route of administration: Slow intravenous infusion over 1 hour.

A course of treatment with Zovirax I.V. usually lasts 5 days, but this may be adjusted according to the patient's condition and response to therapy. Treatment for herpes encephalitis usually lasts 10 days. Treatment for neonatal herpes infections usually lasts 14 days for mucocutaneous (skin-eye-mouth) infections and 21 days for disseminated or central nervous system disease.

The duration of prophylactic administration of Zovirax I.V. is determined by the duration of the period at risk.

Dosage in adults:

Patients with Herpes simplex (except herpes encephalitis) or Varicella zoster infections should be given Zovirax I.V. in doses of 5 mg/kg body weight every 8 hours provided renal function is not impaired (see Dosage in renal impairment).

Immunocompromised patients with Varicella zoster infections or patients with herpes encephalitis should be given Zovirax I.V. in doses of 10 mg/kg body weight every 8 hours provided renal function is not impaired (see Dosage in renal impairment).

In obese patients dosed with intravenous aciclovir based on their actual body weight, higher plasma concentrations may be obtained (see 5.2 Pharmacokinetic properties). Consideration should therefore be given to dosage reduction in obese patients and especially in those with renal impairment or the elderly.

Dosage in infants and children: The dose of Zovirax I.V. for infants and children aged between 3 months and 12 years is calculated on the basis of body surface area.

Infants and children 3 months of age or older with Herpes simplex (except herpes encephalitis) or Varicella zoster infections should be given Zovirax I.V. in doses of 250 mg per square metre of body surface area every 8 hours if renal function is not impaired.

In immunocompromised children with Varicella zoster infections or children with herpes encephalitis, Zovirax I.V. should be given in doses of 500 mg per square metre body surface area every 8 hours if renal function is not impaired.

The dosage of Zovirax I.V. in neonates and infants up to 3 months of age is calculated on the basis of body weight.

The recommended regimen for infants treated for known or suspected neonatal herpes is acyclovir 20 mg/kg body weight IV every 8 hours for 21 days for disseminated and CNS disease, or for 14 days for disease limited to the skin and mucous membranes.

Infants and children with impaired renal function require an appropriately modified dose, according to the degree of impairment (see Dosage in renal impairment).

Dosage in the elderly:

The possibility of renal impairment in the elderly must be considered and dosage should be adjusted accordingly (see Dosage in renal impairment below).

Adequate hydration should be maintained.

Dosage in renal impairment:

Caution is advised when administering Zovirax I.V. to patients with impaired renal function. Adequate hydration should be maintained.
 

【Contraindications】

Hypersensitivity to aciclovir or valaciclovir, or to any of the excipients listed in section 6.1.
 

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 详细处方信息以本药内容附件PDF文件（20194317191513.pdf）的“原文Priscribing Information”为准
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 详细处方信息以本药内容附件PDF文件（20194317191513.pdf）的“原文Priscribing Information”为准
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 部分中文AMIKIN PAED处方资料（仅供参考）

【英文名称】AMIKIN PAED

【适用证】

阿米卡星硫酸盐注射液适用于由革兰氏阴性菌敏感菌株引起的严重感染的短期治疗，包括假单胞菌属，大肠杆菌，吲哚阳性和吲哚阴性变形杆菌属，普罗威登斯菌种，克雷伯氏菌属。肠杆菌属 - 沙雷氏菌属物种和不动杆菌属（Mima-Herellea）物种。

临床研究表明，阿米卡星硫酸盐注射液可有效治疗细菌性败血症（包括新生儿败血症）;严重感染呼吸道，骨骼和关节，中枢神经系统（包括脑膜炎）和皮肤和软组织;腹腔感染（包括腹膜炎）;以及烧伤和术后感染（包括血管外手术）。临床研究表明阿米卡星对由于这些生物引起的严重复杂和复发性尿路感染也有效。包括阿米卡星硫酸盐注射液在内的氨基糖苷类药物并未在尿路感染的简单初始发作中表明，除非致病微生物对易受毒性较小的抗生素不敏感。

应进行细菌学研究以确定致病微生物及其对阿米卡星的敏感性。阿米卡星可被认为是疑似革兰氏阴性感染的初始治疗，可在获得药敏试验结果之前进行治疗。临床试验表明，阿米卡星对由革兰阴性生物的庆大霉素和/或妥布霉素抗性菌株引起的感染是有效的，特别是变形虫，普罗威登斯氏菌，粘质沙雷氏菌和铜绿假单胞菌。继续使用该药物治疗的决定应基于药敏试验的结果，感染的严重程度，患者的反应和 上面“警告”框中包含的重要附加注意事项。

阿米卡星也被证明对葡萄球菌感染有效，并且可以在某些条件下被认为是治疗已知或疑似葡萄球菌疾病的初始治疗，例如致病生物体可能是革兰氏阴性细菌的严重感染。或葡萄球菌，对其他抗生素过敏的患者中的葡萄球菌敏感菌株感染，以及混合葡萄球菌/革兰氏阴性感染。

在某些严重感染如新生儿败血症中，可能需要同时使用青霉素类药物进行治疗，因为可能会因革兰氏阳性菌如链球菌或肺炎球菌而感染。

为了减少耐药细菌的发展并保持阿米卡星和其他抗菌药物的有效性，阿米卡星应仅用于治疗或预防已被证实或强烈怀疑由易感细菌引起的感染。当获得培养和易感性信息时，应在选择或修改抗菌疗法时考虑这些信息。在缺乏此类数据的情况下，当地流行病学和易感性模式可能有助于经验性选择治疗。

【用法用量】

应获得患者的预处理体重以计算正确的剂量。 阿米卡星硫酸盐注射液可以肌内或静脉内给药。

应通过测量血清肌酐浓度或计算内源性肌酐清除率来估计肾功能状态。 为此目的，血尿素氮（BUN）的可靠性要低得多。 治疗期间应定期重新评估肾功能。

应尽可能测量血清中阿米卡星浓度，以确保足够但不过量。 期望在治疗期间间歇地测量峰值和谷值血清浓度。 应避免峰值浓度（注射后30至90分钟）高于35微克/ mL和低于10微克/毫升的谷浓度（恰好在下一次剂量之前）。

应根据指示调整剂量。

【禁忌】

对阿米卡星过敏的病史是其使用的禁忌症。 由于已知患者对该类药物的交叉敏感性，对氨基糖甙类药物过敏或严重毒性反应的病史可能禁止使用任何其他氨基糖苷类药物。

【Therapeutic indications】

Amikacin Sulfate Injection is indicated in the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria, including Pseudomonas species, Escherichia coli, species of indole-positive and indole-negative Proteus, Providencia species, Klebsiella-Enterobacter-Serratia species, and Acinetobacter (Mima-Herellea) species.

Clinical studies have shown Amikacin Sulfate Injection to be effective in bacterial septicemia (including neonatal sepsis); in serious infections of the respiratory tract, bones and joints, central nervous system (including meningitis) and skin and soft tissue; intra-abdominal infections (including peritonitis); and in burns and post-operative infections (including post-vascular surgery). Clinical studies have shown amikacin also to be effective in serious complicated and recurrent urinary tract infections due to these organisms. Aminoglycosides, including Amikacin Sulfate Injection are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are not susceptible to antibiotics having less potential toxicity.

Bacteriologic studies should be performed to identify causative organisms and their susceptibilities to amikacin. Amikacin may be considered as initial therapy in suspected Gram-negative infections and therapy may be instituted before obtaining the results of susceptibility testing. Clinical trials demonstrated that amikacin was effective in infections caused by gentamicin- and/or tobramycin-resistant strains of Gram-negative organisms, particularly Proteus rettgeri, Providencia stuartii, Serratia marcescens, and Pseudomonas aeruginosa. The decision to continue therapy with the drug should be based on results of the susceptibility tests, the severity of the infection, the response of the patient and the important additional considerations contained in the WARNINGS box above.

Amikacin has also been shown to be effective in staphylococcal infections and may be considered as initial therapy under certain conditions in the treatment of known or suspected staphylococcal disease such as, severe infections where the causative organism may be either a Gram-negative bacterium or a staphylococcus, infections due to susceptible strains of staphylococci in patients allergic to other antibiotics, and in mixed staphylococci/Gram-negative infections.

In certain severe infections such as neonatal sepsis, concomitant therapy with a penicillin-type drug may be indicated because of the possibility of infections due to Gram-positive organisms such as streptococci or pneumococci.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of amikacin and other antibacterial drugs, amikacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.