Izobraževalni paket za zdravstvene delavce Izobraževalni paket za zdravstvene delavce naj vsebuje naslednje elemente: • Brošuro za zdravstvene delavce o zgodovino talidomida, povzetek podatkov o zdravilu Thalidomide Celgene in indikacijah, za katere je odobren, o odmerjanje, o najdaljše obdobje predpisovanja 4 tedne za ženske v rodni dobi 12 tednov za moške in ženske, ki ne morejo zanositi o opozorilo o teratogenosti in da je treba preprečiti izpostavljenost ploda, o obveznosti za zdravstvene delavce, ki nameravajo predpisovati ali izdajati zdravilo Thalidomide Celgene, kar vključuje: obveznost izčrpnega svetovanja in vodenja bolnika, bolniki morajo biti sposobni izpolnjevati zahteve za varno rabo talidomida, obveznost oskrbeti bolnike z zadevnim izobraževalnim gradivom, poročanje o vsaki nosečnosti, nevropatiji ali drugih neželenih učinkih podjetju Celgene in lokalnim zdravstvenim organom (če je primerno za državo članico) na obrazcu v „ Izobraževalnem paketu za zdravstvene delavce “.
Educational healthcare professional’ s kit The educational healthcare professional’ s kit shall contain the following elements: • Healthcare professional booklet o History of thalidomide, background on Thalidomide Celgene and its licensed indication o Posology o Maximum duration of prescription 4 weeks for women with childbearing potential 12 weeks for men and women without childbearing potential o Teratogenicity and the need to avoid foetal exposure o Obligations of healthcare professionals who intend to prescribe or dispense Thalidomide Celgene including The need to provide comprehensive advice and counselling to patients That patients should be capable of complying with the requirements for the safe use of thalidomide Need to provide patients with the appropriate patient educational material Report any pregnancy, neuropathy or other adverse events to Celgene and the local health authority (if applicable to a Member State) using the forms provided in the “ Educational Healthcare Professional’ s Kit” o Safety advice relevant to all patients Description and management of thromboembolic and cardiovascular events, and peripheral neuropathy Disposal of unwanted medicine Not to donate blood during treatment and for one week after treatment ends