Dexamethasone 4 mg/ml injection (Organon Laboratories Limited): reformulation with changes in name, concentration, storage conditions, and presentation - GOV.UK
Dexamethasone 4 mg/ml injection (Organon Laboratories Limited): reformulation with changes in name, concentration, storage conditions, and presentation - GOV.UK"
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Dexamethasone 4 mg/ml injection is indicated for general and local glucocorticoid injection therapy (eg, joint inflammation) and for any acute condition in which intravenous glucocorticoids
may be life-saving (eg, severe asthma, severe allergic reactions, and cerebral oedema).
Dexamethasone 4 mg/ml injection has been reformulated to harmonise the formulations available within the EU market and to improve the manufacturing process. Aspen Pharma Trading Limited has
taken over the licence from Organon Laboratories Ltd. All orders placed from October 2014 onwards will be supplied with the new formulation called Dexamethasone 3.8 mg/ml solution for
injection (PL 39699/0060; Aspen Pharma Trading Limited). The old formulation, Dexamethasone 4 mg/ml injection (PL 00065/0106R; Organon Laboratories Limited), will no longer be available.
Patient information leaflet and technical information leaflet (85Kb)
Letter sent to healthcare professionals in September 2014 (123Kb)
Article citation: Drug Safety Update volume 8 issue 3, October 2014: A2
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