P450 system. Results from labelling document studies have been variable in (CCDS), which will soon degree of interaction and time be reflected in a new after vaccination for the version of the Vaxigrip interaction to take effect. The Australian PI. The interaction may be proposed language is as idiosyncratic. Patients taking follows: warfarin, theophylline, inhibition of “Although phenytoin, phenobarbitone or hepatic clearance of carbamazepine should be phenytoin, theophylline advised of the possibility of an and warfarin has been interaction and told to look out reported after influenza for signs of elevated levels of vaccination, subsequent medication. studies have not shown The immunological response any evidence of may be diminished if the patient undesirable effects is undergoing related to this immunosuppressant phenomenon.” treatment”. The Delegate may wish to add The sponsor agrees and The proposed PI the following statement in the has added proposed change is noted proposed Australian PI the wording to the and referred to the “Effects Section of on on Laboratory Tests” Delegate for final “Effects Laboratory Tests”; section. consideration. influenza “Following vaccination, false positive results in serology tests using the Enzyme-linked Immunosorbent Assay (ELISA) method to detect antibodies against HIV1, hepatitis C virus and especially Human virus Type I (HTLV1) have been observed. The Western Blot technique disproves the results. The transient false positive reactions could be due to the IgM response due to the vaccine”. In regard to the proposed See below See below routine risk minimisation activities, it is recommended to the Delegate that the draft CMI document be revised as follows: That the draft CMI is based on The proposed The the other approved influenza FluQuadri/FluQuadri changes to the CMI vaccine marketed by the same Junior CMI have been are noted and sponsor. referred to the updated to align with
P450 system. Results from studies have been variable in degree of interaction and time after vaccination for the interaction to take effect. The interaction may be idiosyncratic. Patients taking warfarin, theophylline, phenytoin, phenobarbitone or carbamazepine should be advised of the possibility of an interaction and told to look out for signs of elevated levels of medication. The immunological response may be diminished if the patient is undergoing immunosuppressant treatment”. labelling document (CCDS), which will soon be reflected in a new version of the Vaxigrip Australian PI. The proposed language is as follows: “Although inhibition of hepatic clearance of phenytoin, theophylline and warfarin has been reported after influenza vaccination, subsequent studies have not shown any evidence of undesirable effects related to this phenomenon.” The Delegate may wish to add the following statement in the proposed Australian PI the Section of “Effects on Laboratory Tests”; “Following influenza vaccination, false positive results in serology tests using the Enzyme-linked Immunosorbent Assay (ELISA) method to detect antibodies against HIV1, hepatitis C virus and especially Human virus Type I (HTLV1) have been observed. The Western Blot technique disproves the results. The transient false positive reactions could be due to the IgM response due to the vaccine”. The sponsor agrees and has added proposed wording to the “Effects on Laboratory Tests” section. The proposed PI change is noted and referred to the Delegate for final consideration. In regard to the proposed routine risk minimisation activities, it is recommended to the Delegate that the draft CMI document be revised as follows: See below See below That the draft CMI is based on the other approved influenza vaccine marketed by the same sponsor. The FluQuadri/FluQuadri Junior CMI have been updated to align with The proposed changes to the CMI are noted and referred to the
auspar-influenza-virus-haemagglutinin-150206.docx