Since the majority of countries that will license quadrivalent influenza vaccine (QIV) are expected to use the name FluQuadri, Sanofi Pasteur proposes to continue to use the name FluQuadri for QIV in Australia, unless there is a more compelling scientific or medical rationale to change. The proposed wording in the The sponsor has The evaluator indication might lead to proposed a revised notes the revised incorrect administration of the indication in indication for final vaccine. The risks are response as follows: consideration by presented below; the Delegate. FluQuadri is indicated There is potential risk of for use in adults and administration of the whole 0.5 children 3 years and ml in children aged 6 months older. to 35 months at one time, FluQuadri Junior is There is potential risk of indicated for use in incorrect preparation, children aged 6 months measurement and storage of to 35 months inclusive. the half dose, Additionally the There is potential risk that the sponsor has provided vaccine might be used in the following sequential patients. comments: It is recommended that the clear instructions … risks mentioned above are regarding the addressed in the RMP. preparation, administration, and storage of the vaccine (which is only supplied in a single-dose syringe presentation) are provided in the proposed PI. Accordingly, it is not considered necessary to include further measures to address the above risks in the RMP. It is recommended that the The sponsor proposes to This Delegate may wish to replace keep the wording more recommendation is Handbook” general in nature as the for “Immunisation with Immunisation overall intention for this consideration by “Australian Handbook” in the proposed labelling is that it will be the Delegate. and administration” applicable in both “Dose Section.
Since the majority of countries that will license quadrivalent influenza vaccine (QIV) are expected to use the name FluQuadri, Sanofi Pasteur proposes to continue to use the name FluQuadri for QIV in Australia, unless there is a more compelling scientific or medical rationale to change. The proposed wording in the indication might lead to incorrect administration of the vaccine. The risks are presented below; There is potential risk of administration of the whole 0.5 ml in children aged 6 months to 35 months at one time, There is potential risk of incorrect preparation, measurement and storage of the half dose, There is potential risk that the vaccine might be used in sequential patients. It is recommended that the risks mentioned above are addressed in the RMP. The sponsor has proposed a revised indication in response as follows: FluQuadri is indicated for use in adults and children 3 years and older. FluQuadri Junior is indicated for use in children aged 6 months to 35 months inclusive. Additionally the sponsor has provided the following comments: … clear instructions regarding the preparation, administration, and storage of the vaccine (which is only supplied in a single-dose syringe presentation) are provided in the proposed PI. Accordingly, it is not considered necessary to include further measures to address the above risks in the RMP. The evaluator notes the revised indication for final consideration by the Delegate. It is recommended that the Delegate may wish to replace “Immunisation Handbook” with “Australian Immunisation Handbook” in the proposed “Dose and administration” Section. The sponsor proposes to keep the wording more general in nature as the overall intention for this labelling is that it will be applicable in both This recommendation is for consideration by the Delegate.
auspar-influenza-virus-haemagglutinin-150206.docx