of vials in relation to dosing has been developed and corrected. 2. Review has indicated that there is insufficient evidence for higher dosing in women with a history of previous fetus with ICH, at this time. 62 Dose 1. No IVIg has a TGA approved indication for NH. 1. Noted. 2. The recommendation to Refer to the current product information sheet for further 2. Referral to the product information under 'Dose' is misleading as no IVIg is indicated for the condition and available insert is included for additional Product Information will not contain further information for this condition. information (other than dose) that is not included in the publication of the Criteria for use or BloodSTAR (eg risks of adverse events). Post-transfusion purpura (PTP) 63 Qualifying criteria The use of criteria to judge response, i.e. platelet count of >30 or doubling of pre-treatment In PTP, the creation of and review criteria count within 72 hours is made without any evidence in this rare disorder. These criteria are outcome measures is for the the same as that proposed for ITP, for which we have indicated above are too stringent, recording of data only. The leading to the potential exclusion of patients who have experienced clinical benefit from qualifying criteria for Ig are the receiving further treatment . A level of platelet count or its doubling cannot be a substitute same for every dose that may for clinical judgment as to whether a clinical benefit has been achieved eg in the prevention be required (clinical diagnosis of bleeding. It is also not appropriate to simply transfer the criteria for ITP to PTP which are or suspicion of PTP with completely different disorders. platelet count <30x10 9/L and a risk of life threatening bleeding. Therefore, responder status is irrelevant in the qualifying criteria for PTP. However, a text box to support
of vials in relation to dosing has been developed and corrected. 2. Review has indicated that there is insufficient evidence for higher dosing in women with a history of previous fetus with ICH, at this time. 62 Dose 1. No IVIg has a TGA approved indication for NH. 2. The recommendation to Refer to the current product information sheet for further information under 'Dose' is misleading as no IVIg is indicated for the condition and available Product Information will not contain further information for this condition. 1. Noted. 2. Referral to the product insert is included for additional information (other than dose) that is not included in the publication of the Criteria for use or BloodSTAR (eg risks of adverse events). Post-transfusion purpura (PTP) 63 Qualifying criteria and review criteria The use of criteria to judge response, i.e. platelet count of >30 or doubling of pre-treatment count within 72 hours is made without any evidence in this rare disorder. These criteria are the same as that proposed for ITP, for which we have indicated above are too stringent, leading to the potential exclusion of patients who have experienced clinical benefit from receiving further treatment . A level of platelet count or its doubling cannot be a substitute for clinical judgment as to whether a clinical benefit has been achieved eg in the prevention of bleeding. It is also not appropriate to simply transfer the criteria for ITP to PTP which are completely different disorders. In PTP, the creation of outcome measures is for the recording of data only. The qualifying criteria for Ig are the same for every dose that may be required (clinical diagnosis or suspicion of PTP with platelet count <30x10 9/L and a risk of life threatening bleeding. Therefore, responder status is irrelevant in the qualifying criteria for PTP. However, a text box to support
feedback-to-the-proposed-changes-to-the-criteria-and-nba-responses2015-without-names.docx