Undervisningsmateriale For at hjælpe ordinerende læger, farmaceuter samt patienter med at undgå føtal eksponering for isotretinoin skal indehaveren af markedsføringstilladelsen sørge for undervisningsmateriale for at underbygge advarslerne vedrørende isotretinoins teratogenicitet, for at give råd om prævention inden behandlingen påbegyndes, samt for at give retningslinier vedrørende behovet for at udføre graviditetsprøver.
Educational material In order to assist prescribers, pharmacists and patients in avoiding foetal exposure to isotretinoin the Marketing Authorisation Holder will provide educational material to reinforce the warnings about the teratogenicity of isotretinoin, to provide advice on contraception before therapy is started and to provide guidance on the need for pregnancy testing.