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For the use of Denzapine® in a patient who does not meet the licensed indications or patient criteria as stated in the Summary of Product Characteristics (SmPC).
The Summary of Product Characteristics for DENZAPINE (clozapine) states that
‘DENZAPINE is indicated in treatment-resistant schizophrenic patients and in schizophrenia patients who have severe, untreatable neurological adverse reactions to other antipsychotic agents, including atypical antipsychotics.
Treatment resistance is defined as a lack of satisfactory clinical improvement despite the use of adequate doses of at least two different antipsychotic agents, including an atypical antipsychotic agent, prescribed for adequate duration.
DENZAPINE is also indicated in psychotic disorders occurring during the course of Parkinson's disease, in cases where standard treatment has failed.'
The Summary of Product Characteristics for DENZAPINE (clozapine) also describes those patients in whom Denzapine is not recommended or is contra-indicated (Please refer to SmPC for further guidance).
I, the undersigned, acknowledge and agree that Britannia Pharmaceuticals does not recommend the use of DENZAPINE in the circumstances applicable to the patient set out below, and that the decision to treat is my decision and clinical responsibility alone.
I hereby waive any rights I (or Hospital Name) may have against Britannia Pharmaceuticals, and release and discharge Britannia Pharmaceuticals from any claims (or Hospital Name) may have against Britannia Pharmaceuticals, arising in connection with the use of DENZAPINE in the circumstances applicable to the patient set out below.
Please state the reason(s) why the above-named patient does not meet the patient criteria (described in the SmPC for Denzapine®):