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Analysis of information for children in package inserts of medications commonly used in pediatrics of 15 hospitals / 中国药学杂志
Chinese Pharmaceutical Journal ; (24): 1446-1450, 2015.
Artigo em Chinês | WPRIM | ID: wpr-859603
ABSTRACT

OBJECTIVE:

To investigate and analyze the problems in information for children existing in package inserts of medications commonly used in pediatrics in 15 hospitals and try to establish a template and provide reference for standardizing package inserts of medications in China.

METHODS:

The method of text analysis and literature survey were used. Information for children in the package inserts were collected, analyzed and evaluated according to Guidance for Industry and Review Staff; Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling (Draft) issued by U.S. FDA and other references.

RESULTS:

In 660 package inserts of 338 medications, 8.0%, 56.9%, 16.4%, 11.7% and 45.8% contained the information on children's indications, dosages and administrations, adverse drug reactions, contraindications and precautions, respectively, while only 2.3% had information of pediatric clinical trials or children's pharmacokinetic data

CONCLUSION:

The current information for Children in package inserts are insufficient and lack of standards, so further management should be strengthened to improve the situation.

Texto completo: DisponíveL Índice: WPRIM (Pacífico Ocidental) Tipo de estudo: Guia de Prática Clínica Idioma: Chinês Revista: Chinese Pharmaceutical Journal Ano de publicação: 2015 Tipo de documento: Artigo

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Texto completo: DisponíveL Índice: WPRIM (Pacífico Ocidental) Tipo de estudo: Guia de Prática Clínica Idioma: Chinês Revista: Chinese Pharmaceutical Journal Ano de publicação: 2015 Tipo de documento: Artigo