Investigational Product Dose Modifications Management Sample Clauses

Investigational Product Dose Modifications Management of Injection Site Reactions Acute symptoms of injection site reactions typically resolve within 48 hours of injection, but more persistent reactions are not unexpected. Grade 2 reactions may include a painful, raised, fluid-filled blister that mimics a sterile abscess. Injection site reactions do not typically warrant antibiotic intervention as they have been found to be sterile. A culture of the fluid can be obtained—using sterile technique—if infection is strongly suspected (i.e., associated with fever persisting more than 24 hours after injection). Ice and acetaminophen should be administered prophylactically according to §7.3.1. Symptomatic treatment with ice, acetaminophen and narcotics is acceptable. Due to their potentially suppressive effects, the use of NSAIDs within 24 hours of dosing with IP should be avoided, if clinically feasible.
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