activities, it is recommended to the Delegate that the draft PI document be revised as follows: The Delegate may wish to As previously outlined in This replace the response to recommendation is “Immunisation Handbook” with Recommendation 4 referred to the “Australian Immunisation Handbook” in above it is proposed to Delegate for final the proposed Dose and keep the wording more consideration. administration Section general in nature based ACSOV supported on the intent that this the RMP labelling will be evaluator’s applicable in both recommendation. Australia as well as New Zealand. The Delegate may wish to add The sponsor agrees and The proposed PI should not be has added an change is noted “Immunisation performed during a febrile or appropriate statement and referred to the illness” under within Delegate for final contraindication in the consideration. “Contraindications” Australian PI in the light of an section. already approved Australian PI of another influenza vaccine. The Delegate may wish to add The sponsor agrees and The proposed PI a statement in the draft PI has language change is noted regarding advice on consistent with that and referred to the “general overdose management. included in the PIs for Delegate for final other licensed influenza consideration. vaccines. The Delegate may wish to The sponsor believes the The strengthen the wording in the age indication for recommendation is Australian PI regarding the use FluQuadri is clearly referred to the of this vaccine in children stated in the proposed Delegate for trial below the age of 6 months PI. Therefore, no consideration. (that is, FluQuadri/FluQuadri changes are proposed to Junior are not recommended in be made to this wording. children below the age of 6 months). The Delegate may wish to add The sponsor The proposed PI the following statement to the acknowledges the change is noted proposed PI for FluQuadri/ request to add the above and referred to the FluQuadri Junior about the advice, which would be Delegate for final potential risk of interaction consistent with the consideration. with other medicines: current Vaxigrip Australian PI; however, vaccine can impair “Influenza alternative language is the metabolism of warfarin, proposed that is theophylline, phenytoin, consistent with the phenobarbitone and company’s updated core carbamazepine by the hepatic
activities, it is recommended to the Delegate that the draft PI document be revised as follows: The Delegate may wish to replace “Immunisation Handbook” with “Australian Immunisation Handbook” in the proposed Dose and administration Section As previously outlined in the response to Recommendation 4 above it is proposed to keep the wording more general in nature based on the intent that this labelling will be applicable in both Australia as well as New Zealand. This recommendation is referred to the Delegate for final consideration. ACSOV supported the RMP evaluator’s recommendation. The Delegate may wish to add “Immunisation should not be performed during a febrile or illness” under contraindication in the Australian PI in the light of an already approved Australian PI of another influenza vaccine. The sponsor agrees and has added an appropriate statement within “Contraindications” section. The proposed PI change is noted and referred to the Delegate for final consideration. The Delegate may wish to add a statement in the draft PI regarding “general advice on overdose management. The sponsor agrees and has language consistent with that included in the PIs for other licensed influenza vaccines. The proposed PI change is noted and referred to the Delegate for final consideration. The Delegate may wish to strengthen the wording in the Australian PI regarding the use of this vaccine in children below the age of 6 months (that is, FluQuadri/FluQuadri Junior are not recommended in children below the age of 6 months). The sponsor believes the age indication for FluQuadri is clearly stated in the proposed PI. Therefore, no changes are proposed to be made to this wording. The recommendation is referred to the Delegate for consideration. The Delegate may wish to add the following statement to the proposed PI for FluQuadri/ FluQuadri Junior about the potential risk of interaction with other medicines: “Influenza vaccine can impair the metabolism of warfarin, theophylline, phenytoin, phenobarbitone and carbamazepine by the hepatic The sponsor acknowledges the request to add the above advice, which would be consistent with the current Vaxigrip Australian PI; however, alternative language is proposed that is consistent with the company’s updated core The proposed PI change is noted and referred to the Delegate for final consideration. trial
auspar-influenza-virus-haemagglutinin-150206.docx