in the case of devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body and that are absorbed by or locally dispersed in the human body, warnings and precautions, where appropriate, related to the general profile of interaction of the device and its products of metabolism with other devices, medicinal products and other substances as well as contra-indications, undesirable side-effects and risks relating to overdose;
i gcás feistí atá comhdhéanta de shubstaintí nó de theaglamaithe substaintí a beartaíodh lena dtabhairt isteach i gcorp an duine agus a ionsúitear nó a scaiptear go logánta i gcorp an duine, rabhaidh agus réamhchúraimí, i gcás inarb iomchuí, i ndáil le próifíl ghinearálta idirghníomhaíocht na feiste agus a táirgí meitibileachta le feistí eile, le táirgí íocshláinte eile agus le substaintí eile chomh maith le fritásca, fo-iarsmaí neamh-inmhianaithe agus rioscaí a bhaineann le ródháileog;