SmPC - Flucloxacillin 125mg/5ml Sugar-free Powder for Oral Solution: Change history
View Summary of Product Characteristics (SmPC - Flucloxacillin 125mg/5ml Sugar-free Powder for Oral Solution)
Last updated on this site: 20 Jul 2023
Variation Description: To update section 4.5 of the SmPC in line with the PRAC recommendation (EPITT no 19849): Drug interaction with flucloxacillin leading to subtherapeutic voriconazole levels. To update sections 2 and 4.4 of the SmPC and to update the PIL to add excipient information for sodium benzoate, sodium and sorbitol. The labelling has also been updated.
SmPC sections updated – 2, 4.4, 4.5 and 10.
PIL sections updated – 2, 3, 4 and 6.
Last updated on this site: 20 Jul 2023
Variation Description: To update section 4.5 of the SmPC in line with the PRAC recommendation (EPITT no 19849): Drug interaction with flucloxacillin leading to subtherapeutic voriconazole levels. To update sections 2 and 4.4 of the SmPC and to update the PIL to add excipient information for sodium benzoate, sodium and sorbitol. The labelling has also been updated.
SmPC sections updated – 2, 4.4, 4.5 and 10.
PIL sections updated – 2, 3, 4 and 6.
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Changes: (Updated: 20 Jul 2023)
Variation Description: To update section 4.5 of the SmPC in line with the PRAC recommendation (EPITT no 19849): Drug interaction with flucloxacillin leading to subtherapeutic voriconazole levels. To update sections 2 and 4.4 of the SmPC and to update the PIL to add excipient information for sodium benzoate, sodium and sorbitol. The labelling has also been updated.
SmPC sections updated – 2, 4.4, 4.5 and 10.
PIL sections updated – 2, 3, 4 and 6.
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Changes: (Updated: 01 Jun 2023)
Variation Description: To update section 6.2 of the SmPC to change Sulph to Sulf - SmPC section 6.2 Incompatibilities from "with colistin polymyxin B sulphate." to "with colistin polymyxin B sulfate." and editorial error correction in SmPC section 6.2 from "As for penicillins. Incompatibilities with colistin polymyxin B." to "As for penicillins, incompatibilities with colistin polymyxin B..". for the 125mg/5ml strength to correct and bring in line with the 250mg/5ml strength.
SmPC section(s) updated: 6.2, 10.
No changes to artwork- only deletion of OLS Almus artwork.
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Changes: (Updated: 21 Sep 2022)
Initial upload