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warnings and cautions
5. Warnings and Precautions Spread of Localized Infection ( 5.1 ) Ocular Damage ( 5.2 ) 5.1. Spread of Localized Infection 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. It is not for topical use.
6. Adverse Reactions The following adverse reactions have been identified during post-approval use of hyaluronidase products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The most frequently reported adverse reactions have been mild local injection site reactions such as erythema and pain. Hyaluronidase has been reported to enhance the adverse reactions associated with co-administered drug products. Edema has been reported most frequently in association with subcutaneous fluid administration. Allergic reactions (urticaria or 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. Allergic and anaphylactic-like reactions have been reported, rarely. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Halozyme,ºInc. at 1-877-877-1679 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .