1 INDICATIONS AND USAGE Amphadase ® is an endoglycosidase indicated as an adjuvant: • in subcutaneous fluid administration for achieving hydration ( 1.1 ) • to increase absorption and dispersion of other injected drugs ( 1.2 ) • in subcutaneous urography for improving resorption of radiopaque agents ( 1.3 ) 1.1 Subcutaneous Fluid Administration Amphadase ® is indicated as an adjuvant in subcutaneous fluid administration for achieving hydration.

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

1.3 Subcutaneous Urography Amphadase ® 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 local injection site reactions.

Hyaluronidase has been reported to enhance the adverse reactions 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.

Allergic and anaphylactic-like reactions have been reported, rarely ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Amphastar Pharmaceuticals, Inc.

at 1-800-423-4136 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.