Z ozirom na pomembnost ustreznega obvladovanja bolečin pri materah se CHMP strinja, v skladu s „ smernico o povzetku glavnih značilnosti zdravila “, da predlagano besedilo ostane v poglavju 4. 6 in se ne vključi kot kontraindikacija.
Because of the importance of an adequate pain management for the mother, the CHMP agrees, in accordance with the “ guideline on summary of product characteristics”, that the proposed text stays in section 4.6 and should not be included as a contra-indication.