Clozapine use outside the terms for use as described in the Zaponex Product Information (e.g use in a
patient on contra-indicated co-medication or diagnosed with a non-registered indication) applies to the
patient above. In order to treat this patient with Zaponex® (clozapine), I, the undersigned, agree to the
following conditions for use and acknowledge that the monitoring criteria listed above apply:
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The patient is/will be treated off-licence with Zaponex. The use of Zaponex is/will be outside of
the marketing authorisation and is at the request and the responsibility of myself, the patient's
consultant. I will absolve Leyden Delta from any liability should, as a result of the Zaponex
treatment, the patient's medical condition deteriorates.
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It is my opinion, as the consultant, that the benefit of Zaponex treatment outweighs any possible
risks to the patient. It would, indeed, be considered detrimental to withhold Zaponex treatment.
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The patient has been informed of the risks involved in being treated with Zaponex and is in
agreement with me that Zaponex treatment outweighs any possible risks. Where the patient was
not competent to provide their informed consent, I confirm that I have taken all necessary steps
to reach the decision that Zaponex treatment is in the best interests of this patient. In reaching
this decision, I have taken into account the views of the patient's relatives/caregivers and, where
appropriate, have sought a second opinion from another consultant psychiatrist.
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