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Publication #8315
Reference
Drug alert 53/2024
Name
Drug Alert Class 4 Drug Alert 53 2024 – Class 4 medicines defect information – caution in use – Ennogen Healthcare Ltd – Zoledronic Acid Ennogen 4mg/5ml Concentrate for Solution for Infusion
Categories
Scottish Government
Drug Alerts
Organization
Scottish Government Health and Social Care Department
Keywords
NHS
Scotland
Drugs
Safety
Risks
Pharmaceutical Industry
Drug Shortages
Description
Ennogen Healthcare Limited has identified that action had not been taken to ensure the Patient Reminder Card (PRC) was distributed alongside the packs of product as part of the approved Additional Risk Minimisation Measures (RMM).
The purpose of the PRC is to alert patients to the risk of osteonecrosis of the jaw (ONJ) and remind them of the precautions to take before and during treatment with zoledronic acid. This Class 4 Caution in Use notification applies to all batches for PL40739/0233 listed above which were distributed before 17-May-2024.
Ennogen Healthcare Limited has confirmed that all product distributed since 17-May-2024 has been, and shall continue to be, supplied with the PRC.
Contact Name
Irene Fazakerley
Contact Email
Contact Address
Contact Phone
Created
2024-11-07 09:38:00
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