openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
warnings and cautions
5 WARNINGS AND PRECAUTIONS Spread of Localized Injection ( 5.1 ) Ocular Damage ( 5.2 ) 5.1 Spread of Localized Injection Hyaluronidase should not be injected into or around an infected or acutely inflamed area because of the danger of spreading a localized infection. Hyaluronidase should not be used to reduce the swelling of bites or stings. 5.2 Ocular Damage Hyaluronidase should not be applied directly to the cornea.
6 ADVERSE REACTIONS The most frequently reported adverse experiences have been local injection site reactions. Hyaluronidase has been reported to enhance the adverse events associated with co-administered drug products. Edema has been reported most frequently in association with hypodermoclysis. Allergic reactions (urticaria, angioedema) have been reported in less than 0.1% of patients receiving hyaluronidase. Anaphylactic-like reactions following retrobulbar block or intravenous injections have occurred, rarely. The most frequently reported adverse reactions have been local injections site reactions. Allergic reactions (urticarial, angioedema) anaphylactic-like reactions have been reported, rarely. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Akorn, Inc. at 1-800-932-5676, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .