Ethanol in herbal medicinal products for children : Data from pediatric studies and pharmacovigilance programs
| Autor: | Karen Kraft, Barbara Steinhoff, S. N. Okpanyi, Karin Nieber, Martin Adler, Heba Abdel-Aziz, Andreas Biller, Christian Nauert, Olaf Kelber |
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| Rok vydání: | 2015 |
| Předmět: |
medicine.medical_specialty
Kinderarzneimittel Alternative medicine 01 natural sciences law.invention 03 medical and health sciences Pharmacovigilance 0302 clinical medicine Age groups law Labeling Medicine Adverse Drug Reaction Reporting Systems Humans Nutzen-Risiko-Bewertung Dosing Drug reaction Phytotherapie Flüssige Darreichungsform Drug Labeling Traditional medicine Ethanol business.industry Plant Extracts Liquid dosing form General Medicine Pediatric medicinal product 0104 chemical sciences 010404 medicinal & biomolecular chemistry Ethanol content Themenschwerpunkt 030211 gastroenterology & hepatology Benefit–risk assessment Fach- und Gebrauchsinformation Pharmaceutical Vehicles business Phytotherapy Pediatric population |
| Zdroj: | Wiener Medizinische Wochenschrift (1946) |
| ISSN: | 1563-258X |
| Popis: | Summary Herbal medicinal products are indispensable in children, e. g., in functional gastrointestinal diseases and coughs and colds, especially when available in liquid dosing forms for which dosing can be adapted ideally to different age groups. Despite being generally accepted as safe, the ethanol content of many of these products, necessary for Galenic reasons, has raised questions regarding their safety. Therefore, safety data from more than 50,000 children in noninterventional pediatric studies with these products, as well as data from routine clinical use in several million children, were assessed. No evidence of the involvement of the ethanol content in any adverse drug reactions was found. This allows us to conclude that these herbal medicinal products are safe in the age groups for which they are authorized or registered and that the present labeling is adequate to allow for their safe use in the pediatric population. |
| Databáze: | OpenAIRE |
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