Hydase Injection

Name: Hydase Injection

Patient Counseling Information

Important Precautions Regarding Hydase™

Instruct patient that Hydase™ is being used to increase the dispersion and absorption of fluids or other injected drugs, as appropriate to the intended use.

What Patients Should Know About Adverse Reactions

The most frequently reported adverse reactions have been mild local injection site reactions such as redness, swelling, itching, or pain.

Anaphylactic-like reactions, and allergic reactions, such as hives, have been reported rarely in patients receiving hyaluronidases.

Patients Should Inform Their Doctors If Taking Other Medications

You may not receive furosemide, the benzodiazepines, phenytoin, dopamine and/or alpha agonists with Hydase™. These medications have been found to be incompatible with hyaluronidase.

If you are taking salicylates (e.g., aspirin), steroids (e.g., cortisone or estrogens) or antihistamines your doctor may need to prescribe larger amounts of hyaluronidase for equivalent dispersing effect.

AKORN
Manufactured by: Akorn, Inc.
Lake Forest, IL 60045
HD00N           Rev. 10/15

Principal Display Panel Text for Container Label:

NDC 17478-560-01

Hydase™

(hyaluronidase

injection) Bovine,

150 USP Units/mL

1 mL

Single-Use Vial

Rx only

Not recommended

for IV use.

Principal Display Panel Text for Carton Label:

NDC 17478-560-01

Hydase™

(hyaluronidase

injection) Bovine,

150 USP Units/mL

1 mL

Single-Use Vial

Rx only

Akorn Logo

HYDASE 
hyaluronidase injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:17478-560
Route of Administration SUBCUTANEOUS, RETROBULBAR, INTRAMUSCULAR, INTRAOCULAR, INFILTRATION, INTERSTITIAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Hyaluronidase (Hyaluronidase) Hyaluronidase 150 [USP'U]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Calcium Chloride  
Edetate Disodium  
Sodium Chloride  
Sodium Phosphate, Monobasic  
Sodium Hydroxide  
Water  
Packaging
# Item Code Package Description
1 NDC:17478-560-01 1 VIAL, SINGLE-USE in 1 CARTON
1 1 mL in 1 VIAL, SINGLE-USE
2 NDC:17478-560-06 6 VIAL, SINGLE-USE in 1 CARTON
2 1 mL in 1 VIAL, SINGLE-USE
3 NDC:17478-560-10 10 VIAL, SINGLE-USE in 1 CARTON
3 1 mL in 1 VIAL, SINGLE-USE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021716 11/05/2015
Labeler - Akorn, Inc. (062649876)
Establishment
Name Address ID/FEI Operations
Akorn, Inc 063434679 PACK(17478-560), LABEL(17478-560)
Establishment
Name Address ID/FEI Operations
Akorn, Inc. 155135783 MANUFACTURE(17478-560), ANALYSIS(17478-560), STERILIZE(17478-560)
Revised: 11/2015   Akorn, Inc.
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