1. [International Comparison of Clinical Information Related to Contraception of Medicines].
- Author
-
Yonemura M, Fujishiro N, and Motonaga S
- Subjects
- Europe, Female, Humans, Japan, Male, Time Factors, United States, Contraception, Pharmaceutical Preparations
- Abstract
Most of the warnings about the contraceptive period when using medicines are described as"fixed period"in the package insert, and it is necessary for healthcare professionals to provide information on the specific contraceptive period when using medicines that require contraception. There are many situations where we have trouble. Furthermore, the presence or absence of a description that requires contraception and the contraceptive period differ even though the drugs are the same in Japan and overseas. For example, paclitaxel injection(albumin suspension type)in the package insert in Japan, an appropriate contraceptive period for a certain period have been given to female and male are required. In contrast, different warnings of contraception have been given to female and male another in Europe for 1 month and 6 months after administration, and in the United States for 6 months and for 3 months. The description of the contraceptive period in the package insert in Japan needs to be described after clearly stating the specific period, and it is necessary to describe detailed information including the contraceptive method in materials such as interview forms.
- Published
- 2021