rmed to assess whether hyaluronidase impaired fertility; however, it has been reported that testicular degeneration may occur from the production of organ-specific antibodies against this enzyme following repeated injections.
•16 HOW SUPPLIED/STORAGE AND HANDLING
VITRASE (hyaluronidase injection) Ovine is supplied sterile as 200 USP Units/mL of ovine hyaluronidase non-preserved, 1.2 mL in a single-use 2 mL glass vial with a rubber stopper and aluminum seal.
•NDC 67425-002-10
STORAGE
•Protect from light.
•Store unopened vial in refrigerator at 2-8°C (35-46°F).
•Do not freeze.
•17 PATIENT COUNSELING INFORMATION
17.1 Important Precautions Regarding VITRASE
Instruct patient that VITRASE is being used to increase the dispersion and absorption of fluids or other injected drugs, as appropriate to the intended use.
17.2 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.
17.3 Patients Should Inform Their Doctors If Taking Other Medications
You may not receive furosemide, the benzodiazepines, phenytoin, dopamine and/or alpha agonists with VITRASE. 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.
©ISTA Pharmaceuticals®, Inc.
Distributed by: ISTA Pharmaceuticals, Inc., Irvine, CA 92618
Manufactured by: Alliance Medical Products, Inc., CA 92618
® and ™ marks owned by ISTA Pharmaceuticals, Inc.
•PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
NDC 67425-002-10
Vitrase (hyaluronidase injection)
Ovine Rx ONLY
200 USP Units/mL
Contains 1.2 mL
Sterile
6 single-Use Vials (Nonpreserved)
Not recommended for IV use.
Usual Dosage: See accompanying prescribing information.
Protect from light.
DO NOT FREEZE.
Store unopened vial in refrigerator at 2-8°C (35-46°F).
After admixture with drug, store at 15-25°C (59-77°F) and use within 6 hours.
Each vial contains 200 USP units (U) per milliliter ovine hyaluronidase with 0.93 mg/mL lactose NF, 0.36 mg/mL potassium phosphate dibasic USP, 0.23 mg/mL potassium phosphate monobasic NF, and 9.0 mg/mL sodium chloride USP. Contains no preservative.
•INGREDIENTS AND APPEARANCE
VITRASE hyaluronidase, ovine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67425-002
Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYALURONIDASE, OVINE (UNII: 64R4OHP8T0) (HYALURONIDASE, OVINE - UNII:64R4OHP8T0) HYALURONIDASE, OVINE 200 [USP'U] in 1 mL
Inactive Ingredients
Ingredient Name Strength
LACTOSE (UNII: J2B2A4N98G) 0.93 mg in 1 mL
POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) 0.36 mg in 1 mL
POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51) 0.23 mg in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) 9.0 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date |
