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[医药营销] Valcyte用于肾移植后巨细胞病毒感染患者

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发表于 2016-3-16 15:38:59 | 显示全部楼层 |阅读模式

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本帖最后由 皇后 于 2016-4-21 16:27 编辑

  部分中文更昔洛韦处方资料(仅供参考)

  【药品名】

  Valcyte

  【适应症】

  用于获得性免疫缺陷综合征(AIDS)患者巨细胞病毒(CMV)性视网膜炎。

  【药物剂型】

  片剂:450mg。溶液:50毫升/瓶;100毫升/瓶。

  【用法用量】

  口服,每次900mg,每日2次,一般于3周后改为每日1次维持。

  【禁忌症】

  1.禁用于对Valcyte过敏者。

  2.中性粒细胞<0.5×109/L、血小板<25×109/L、血红蛋白浓度<80g/L者禁用。

  3.血液透析患者禁用本品。

  4.本品用于儿童的安全性和疗效尚未确定,故儿童不推荐使用。

  【注意事项】

  1.肾功能不全患者应慎用本品,并适当调整剂量。孕妇慎用。原先存在骨髓抑制者、接受骨髓抑制药物或放疗,及有血细胞减少症史或血细胞减少反应者慎用。

  2.由于本品和更昔洛韦的生物利用度不同,因此不能一对一地替换用药。

  3.由于Valcyte的诱变作用可严重影响精子生成和生育能力,因此用药者在治疗期间及治疗后至少90天应采取避孕措施。

  4.过量服用可能导致肾毒性增加,血液透析和增加电解质可能有助于降低血浆药物浓度。

  5.15~30℃保存。

  【不良反应】

  1.胃肠道反应:腹泻、恶心、呕吐和腹痛。

  2.血液系统反应:中性粒细胞减少和贫血、血小板减少、骨髓抑制。

  3.中枢神经系统反应:发热、头痛、失眠、外周神经障碍、感觉异常、癫痫、精神病、幻觉。

  4.眼部反应:视网膜脱离。

  5.其他不良反应:肾功能减退、其他局部或全身反应。在动物试验中更昔洛韦有致癌性、致畸性,并导致无精子生成。

  附英文说明书

  Valcyte (Valganciclovir HCl)

  Valcyte (valganciclovir HCl) is an antiviral medicine that can treat the CMV (cytomegalovirus) infections of the eye. The CMV can be transmitted to a baby before even being born. The infection is usually harmless and rarely causes any diseases. For most healthy individuals that get this virus on birth, there are a few symptoms and no long term medical consequences. Once in the organism, the virus remains active, but generally latent throughout the patient’s life. There are two different forms of infection – primary and recurrent. The primary infection can cause more problems in pregnancy than the recurrent one. Anyway, if the immune system is weakened, the virus can easily turn active and cause various complications. Most infected adults and children don’t present any symptoms. Those who do, might present fever, gland inflammations, tiredness and fatigue. These symptoms usually show up 1 to 3 months after the infection is encountered.

  Valcyte (valganciclovir HCl) initially hit the market in 2001. It was immediately accepted by the FDA. The latest concentration formula is up since 2009 though. Although the CMV infection is not quite harmful, this medicine requires a medical prescription. As some of the CMV symptoms can easily be taken for a cold or a flu, the specialist doctor must first identify the exact cause of your condition. This medicine is only prescribed in the AIDS patients, with a low immune system. It might be too powerful for other people.

  Administration

  Valcyte (valganciclovir HCl) is available in two forms – tablets and oral suspension. The tablets are prescribed both for adults and children. They need to be swallowed whole, without being crushed or chewed. You can take them with a glass of water. Take both the tablets and the oral suspension with food. The food will help your organism assimilate the drug faster. The children who encounter problems while trying to swallow the tablets whole may get the oral suspension form of this medicine. The oral suspension is not quite advised in adults, since the dosage will be different at higher doses.

  The oral suspension form of Valcyte (valganciclovir HCl) comes with a special device used to measure the dose. Although it might look like a spoon, don’t use other similar tools, but only this medical recipient.

  Warnings

  Keep the distance when it comes to people suffering from contagious infections. Valcyte (valganciclovir HCl) lowers your immune system. Valcyte (valganciclovir HCl) will not prevent the HIV from being transmitted. Don’t share your personal hygiene objects and don’t have unprotected sexual intercourse.

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