| ▲ Theratetect Pre-Filled Syringe (Photo=provided by Ilyang Pharmaceutical) |
[메디컬투데이=남연희 기자] Ilyang Pharmaceutical’s flu vaccine identified ‘Terectect Prefilled Syringe Inj.’ adverse event expression rate of 17.57%. Bronchitis, hypotension, urticaria, somnolence, and hypersensitivity to stimuli are added to the adverse events.
The Ministry of Food and Drug Safety announced on the 11th that it would prepare a change (draft) for approval based on the results of the re-inspection of Ilyang Pharmaceutical’s ‘Theratect Prefilled Syringe (split flu vaccine)’ on 25 May. .
Precautions to Use In the ‘Adverse Events’ section, the results of domestic post-marketing investigations following a re-examination will be newly added.
As a result of a post-marketing survey conducted on 734 children and adolescents aged 3 to 19 years for 4 years to be re-examined in Korea, the incidence rate of adverse events was 17.57% (129/734 patients, total) what regardless of causal relationship (206 cases).
Among them, there were 0 serious adverse drug reactions for which a causal relationship could not be ruled out, and unexpected adverse drug reactions accounted for 0.82% (6/734 patients, 6 cases). Bronchitis, hypotension, urticaria, somnolence, and irritability were uncommonly reported.
As a result of clue information analysis and evaluation based on adverse event report data after domestic marketing, confirmed adverse events are also included in the approval change plan, but this does not mean that the causal relationship between the component and the adverse event experienced. .
This item is used to prevent influenza diseases caused by influenza A viruses and influenza B viruses contained in this vaccine in children, young people and adults aged 3 years or older. Production performance in 2021 recorded 32 billion won.
Reporter Nam Yeon-hee of Medical Today (ralph0407@mdtoday.co.kr)
[저작권자ⓒ 메디컬투데이. 무단전재-재배포 금지]
