Cefuroxime 1.5 Powder for Injection
*Company:
Flynn Pharma LtdStatus:
No Recent UpdateLegal Category:
Product subject to medical prescription which may be renewed (B)Active Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 14 August 2024
File name
2024-08-14_ie-spc-1-5g-cl.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Minor changes to sections 4.4 and 4.8 are made to reorder safety information. Section 5.1 has been updated to relocate MIC information outside of the product information, with a link to the ema website provided in replacement.
Updated on 23 May 2024
File name
ie-spc-1-5g-cl.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Sections 4.4 and 4.8 have been updated with information following reports of neurotoxicity being identified in association with cephalosporin treatment.
Updated on 23 May 2024
File name
2024-05-22_ie-pl-cl.pdf
Reasons for updating
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Updated with information following reports of neurotoxicity being identified in association with cephalosporin treatment.
Updated on 23 May 2024
File name
2024-05-22_ie-spc-1-5g-cl.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Sections 4.4 and 4.8 have been updated with information following reports of neurotoxicity being identified in association with cephalosporin treatment.
Updated on 14 April 2023
File name
PlTI Cefuroxime IE (Verona) 19.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Free text change information supplied by the pharmaceutical company
Update in line with PRAC
Updated on 14 April 2023
File name
SmPC 1500mg clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Update in line with PRAC
Updated on 24 June 2022
File name
SmPC 1500mg 2022 06 23.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
MAH address change
Updated on 24 June 2022
File name
PIL mockup 2022 06 23.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Free text change information supplied by the pharmaceutical company
MAH address change
Updated on 19 January 2021
File name
Cefuroxime 750mg and 1.5g PIL 2018.pdf
Reasons for updating
- New PIL for new product
Updated on 06 August 2018
File name
131-spc-injection1point5g-clean.pdf
Reasons for updating
- Change to section 3 - Pharmaceutical form
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
align with Zinacef including EUCAST updates; update of reconstitution instructions including description of solution; update of sodium warning in line with updates to Excipients Guideline
Updated on 28 February 2018
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may be renewed (B)
Updated on 28 February 2018
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 7 - Marketing authorisation holder
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 28 February 2018
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 7 - Marketing authorisation holder
Free text change information supplied by the pharmaceutical company
Updated on 26 February 2016
Reasons for updating
- Improved electronic presentation
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 26 February 2016
Reasons for updating
- Improved electronic presentation
Free text change information supplied by the pharmaceutical company
Updated on 13 July 2012
Reasons for updating
- New SPC for medicines.ie
Legal category:Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 13 July 2012
Reasons for updating
- New SPC for medicines.ie