Consent to Assume Risks
I am requesting permission for myself to receive ANVIRZEL® during the time period determined by my physician and in doing so I assume full responsibility for any and all risks of this action related to my current medical condition.
I have been informed by my physician as follows: ANVIRZEL® is a new drug approved for sale by the Secretary of Health of Honduras, C.A. ANVIRZEL® has not received U.S.F.D.A. approval to treat, cure or prevent any specific illness.
Because clinical data collection is ongoing:
The use of ANVIRZEL® may be of unknown benefit; and the use of ANVIRZEL® may create unknown risks.
I understand that I am voluntarily requesting the use of ANVIRZEL® and that my physician may not be knowledgeable of all the risks, if any, in the use of ANVIRZEL®. I acknowledge that there may be limited scientific information available about ANVIRZEL®.
I understand that there may be unanticipated side effects or symptoms as a result of using ANIVIRZEL®, and that it is my responsibility to let the physician and other healthcare providers know if any unanticipated side effects or symptoms occur. If such side effects or symptoms occur, I understand that my physician may advise or direct administration of ANIVIRZEL® be stopped. I understand that no guarantee or assurance has been made to me as to the results that may be obtained from the use of ANVIRZEL® or any side effects that may occur.
I hereby assume full responsibility for any or all risks of this action, and hereby release the following entities or individuals from any liability other than that stated herein and for any consequences that may result by my action in voluntarily consenting to the use and the receipt of ANVIRZEL®:
Salud Integral, S.A. de C. V.; Droguería Salud Integral, S. de R. L.; Phoenix Biotechnology, Inc.; Chisos, Ltd.; Laboratorios Y Distribuciones Francelia, S.A de C. V., the referring physician and investigating physician.
However, nothing in this consent shall be construed to waive or appear to waive any of my legal rights, to release or appear to release the physician, the sponsor, or its agents from liability for negligence.
With full knowledge that there are unknown benefits and unknown risks, I consent to the use of ANVIRZEL® and assume full responsibility as a result of giving my consent.