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[含人参(Panax ginseng C. A. Meyer)药品内包装与药品说明书的对比分析]

[A comparative analysis of inner wrapping and package inserts for medicines containing Panax ginseng C. A. Meyer].

作者信息

Auricchio Mariangela Tirico, Batistic-Longatto Mônica Arcon, Nicoletti Maria Aparecida

机构信息

Serviço de Medicamentos, Instituto Adolfo Lutz, São Paulo, Brasil.

出版信息

Cad Saude Publica. 2007 Oct;23(10):2295-304. doi: 10.1590/s0102-311x2007001000005.

DOI:10.1590/s0102-311x2007001000005
PMID:17891291
Abstract

The information provided on package inserts and inner wrapping of eight products containing Panax ginseng from different manufacturers was compared internally and checked against data from the scientific literature. The inserts included extensive text, containing abundant information on indications for use, but no scientific evidence in humans. All the inserts lacked information on potential adverse effects and drug interaction. There was no standardization as to dose regimens, particularly in relation to the dried extract and ginsenoside concentration. The eight inserts thus showed no concern over standardization, indication for usage, or possible side effects and drug interactions.

摘要

对来自不同制造商的八种含人参产品的包装说明书和内包装所提供的信息进行了内部比较,并与科学文献中的数据进行了核对。说明书包含大量文本,有关于适应证的丰富信息,但缺乏人体科学证据。所有说明书都没有关于潜在不良反应和药物相互作用的信息。在给药方案方面没有标准化,特别是关于干提取物和人参皂苷浓度。因此,这八份说明书在标准化、用法适应证或可能的副作用及药物相互作用方面未显示出关注。

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