Kvinder i den fødedygtige alder må derfor ikke anvende hormonale præventionsmidler (inklusive orale, injicerbare, transkutane og implantable former) som den eneste form for prævention, men skal anvende en supplerende eller en alternativ pålidelig form for prævention.
Therefore, women of childbearing potential must not use hormonal contraceptives (including oral, injectable, transdermal, and implantable forms) as the sole method of contraception but must use an additional or an alternative reliable method of contraception.