the information provided overload. A statement response is in response to these rate and volume acceptable. ‘Infusion include a consideration of need to be adapted the relevance for the RMP, according to clinical and any specific conditions, most notably in information needed to the elderly or in the address this issue in the paediatric population.’ has RMP. For any safety been included in the revised considerations so raised, PI documents” and the the sponsor should important potential risk: provide information that is and ‘Hypervolaemia relevant and necessary to haemodilution in high risk address the issue in the patients’ has now been RMP. included as a safety concern. [information redacted]If Albunate is supplied in Australia, assurance is provided that safety surveillance will be performed in accordance with CSL Behring's on-going routine pharmacovigilance practices”. Notwithstanding the The sponsor states: This is “The evaluation of the clinical definition of important acceptable. aspects of the safety identified risk and specification: for important potential risk ‘Potential off-label use’ of the (Good Pharmacovigilance states that the practices (GVP) I) is potential for off-label use constitutes an ‘what is a class-effect for all HA important risk will depend products and it cannot be upon several factors, excluded that HA products including the impact on the are used outside the individual, the seriousness approved indications. of the risk and the impact on Consequently it is public health’. Currently, suggested that the sponsor there is no available data consider including and/or evidence showing use’ as an important that off-label use of HAS potential risk. It is noted causes serious individual that routine risk or public health pharmacovigilance and concerns. Therefore, routine risk minimisation use’ has not been listed activities are already in the ASA Summary table of proposed for this ongoing Safety Concerns as an safety concern and only important potential risk. the ASA need be revised Spontaneous and other accordingly. reports of off-label use will be reviewed in accordance with CSL Behring's ongoing routine pharmacovigilance practices.”
the information provided in response to these include a consideration of the relevance for the RMP, and any specific information needed to address this issue in the RMP. For any safety considerations so raised, the sponsor should provide information that is relevant and necessary to address the issue in the RMP. overload. A statement ‘Infusion rate and volume need to be adapted according to clinical conditions, most notably in the elderly or in the paediatric population.’ has been included in the revised PI documents” and the important potential risk: ‘Hypervolaemia and haemodilution in high risk patients’ has now been included as a safety concern. [information redacted]If Albunate is supplied in Australia, assurance is provided that safety surveillance will be performed in accordance with CSL Behring's on-going routine pharmacovigilance practices”. response is acceptable. Notwithstanding the evaluation of the clinical aspects of the safety specification: ‘Potential for off-label use’ of the states that the potential for off-label use is a class-effect for all HA products and it cannot be excluded that HA products are used outside the approved indications. Consequently it is suggested that the sponsor consider including use’ as an important potential risk. It is noted that routine pharmacovigilance and routine risk minimisation activities are already proposed for this ongoing safety concern and only the ASA need be revised accordingly. The sponsor states: “The definition of important identified risk and important potential risk (Good Pharmacovigilance practices (GVP) I) is ‘what constitutes an important risk will depend upon several factors, including the impact on the individual, the seriousness of the risk and the impact on public health’. Currently, there is no available data and/or evidence showing that off-label use of HAS causes serious individual risk or public health concerns. Therefore, use’ has not been listed in the ASA Summary table of Safety Concerns as an important potential risk. Spontaneous and other reports of off-label use will be reviewed in accordance with CSL Behring's ongoing routine pharmacovigilance practices.” This is acceptable.
auspar-albumin-human-170502.docx