Revised SPC: EpiPen Adrenaline (Epinephrine) Auto-Injectors -

Revised SPC: EpiPen Adrenaline (Epinephrine) Auto-Injectors
Information type: Drug prescribing
Source: electronic Medicines compendium
Specialities: Allergy and immunology | Emergency medicine and urgent care | Infection and infectious diseases
Summary
Various changes have been made to the SPC. This includes addition of the following statement: “rare cases of serious skin and soft tissue infections, including necrotizing fasciitis and myonecrosis caused by Clostridia (gas gangrene) are known from post-marketing experience”.
UKMi comment
Section 4.4 of the SPC has also been updated, and now states that in case of injection performed by a caregiver, immobilization of the patient’s leg should be ensured during injection to minimize the risk of injection site laceration. The needle should never be reinserted after use.

Section 6.6 has been changed and now states to hold firmly in place for 3 seconds (previously 10 seconds). Instructions to massage the injection area have been removed.
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