consideration by the Delegate. In the The statement Guillain-Barré syndrome has This is ‘Precautions’ ‘If section, the PI occurred within 6 weeks of previous influenza considered should contain a acceptable in vaccination, the decision to give Afluria Quad statement with vaccine should be based on careful consideration the context of regard to giving the of the potential benefits and risks.’ has been this application vaccine to patients added in the updated PI. for RMP who had purposes syndrome in pending the last 6 weeks. consideration by the Delegate. In the This statement is currently listed in the Dosage This is ‘Interactions’ section the PI considered and Administration section of the PI which the should contain a sponsor believes to be the most appropriate acceptable in statement that if placement of this statement as it relates to the context of Fluvax vaccine administration of the vaccine not an interaction. this application were to be for RMP administered purposes concurrently with pending other vaccines, consideration separate syringes by the and a separate arm Delegate. should be used. In the The statement Quad is contraindicated This is ‘Afluria in children < 18 because the safety and considered ‘Contraindications’ section, the PI efficacy in this age group has not been acceptable in should contain the context of established’ has been added in the updated PI. younger this application ‘patients than 18 years of for RMP age’ as a purposes contraindication. pending consideration by the Delegate. In the and The statement Quad vaccine should be This is ‘Dosage ‘Afluria Administration’ administered by a health care practitioner in an considered section, the PI appropriate setting with an appropriate acceptable in should include a observation period.’ has been added the context of statement that in the updated PI. this application administration for RMP should occur by a purposes health care pending practitioner in an consideration appropriate setting by the with an Delegate. appropriate observation period.
consideration by the Delegate. In the ‘Precautions’ section, the PI should contain a statement with regard to giving the vaccine to patients who had syndrome in the last 6 weeks. The statement ‘If Guillain-Barré syndrome has occurred within 6 weeks of previous influenza vaccination, the decision to give Afluria Quad vaccine should be based on careful consideration of the potential benefits and risks.’ has been added in the updated PI. This is considered acceptable in the context of this application for RMP purposes pending consideration by the Delegate. In the ‘Interactions’ section the PI should contain a statement that if Fluvax vaccine were to be administered concurrently with other vaccines, separate syringes and a separate arm should be used. This statement is currently listed in the Dosage and Administration section of the PI which the sponsor believes to be the most appropriate placement of this statement as it relates to administration of the vaccine not an interaction. This is considered acceptable in the context of this application for RMP purposes pending consideration by the Delegate. In the ‘Contraindications’ section, the PI should contain ‘patients younger than 18 years of age’ as a contraindication. The statement ‘Afluria Quad is contraindicated in children < 18 because the safety and efficacy in this age group has not been established’ has been added in the updated PI. This is considered acceptable in the context of this application for RMP purposes pending consideration by the Delegate. In the ‘Dosage and Administration’ section, the PI should include a statement that administration should occur by a health care practitioner in an appropriate setting with an appropriate observation period. The statement ‘Afluria Quad vaccine should be administered by a health care practitioner in an appropriate setting with an appropriate observation period.’ has been added in the updated PI. This is considered acceptable in the context of this application for RMP purposes pending consideration by the Delegate.
auspar-inactivated-quadrivalent-influenza-vaccine-split-virion-170720.docx