1 INDICATIONS & USAGE 1.1 Subcutaneous Fluid Administration HYLENEX recombinant is indicated as an adjuvant in subcutaneous fluid administration for achieving hydration.

1.2 Dispersion and Absorption of Injected Drugs HYLENEX recombinant is indicated as an adjuvant to increase the dispersion and absorption of other injected drugs.

1.3 Subcutaneous Urography HYLENEX recombinant is indicated as an adjunct in subcutaneous urography for improving resorption of radiopaque agents.

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.