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Amphadase

FDA Approved Hyaluronidase Injection

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Amphadase Injection for Ophthalmology

Amphadase (hyaluronidase injection, USP) is indicated to increase the absorption and dispersion of other injected drugs and contraindicated where hypersensitivities to hyaluronidase or any other ingredient in the formulation exist.

Amphadase is FDA approved bovine hyaluronidase supplied in a single dose vial (150 USP units/mL)  with a 2-year shelf life.

Hyaluronidase Facts*

  • Hyaluronidase potentially enhances the effectiveness of local anesthesia at the time of co-administration.
  • Hyaluronidase has been established as an effective adjuvant in a variety of surgical disciplines, to include ophthalmology.
  • For more than 60 years, hyaluronidase has demonstrated its efficacy in combination with peribulbar, retrobulbar, or sub-Tenon’s anesthesia.

*Buhren BA, Schrumpf H, Hoff NP, Bölke E, Hilton S, Gerber PA. Hyaluronidase: from clinical applications to molecular and cellular mechanisms. Eur J Med Res. 2016 Feb 13;21:5.

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Amphadase Description

Amphadase is a preparation of purified bovine testicular hyaluronidase, a protein enzyme. The exact chemical structure of this enzyme is unknown. However, the amino acid sequence for the primary structure of the enzyme has been deduced from the sequence of purified peptides.

Amphadase (hyaluronidase injection) is supplied as a sterile, clear, colorless, ready for use solution. Each vial contains 150 USP units of hyaluronidase per mL with 8.5 mg sodium chloride, 1 mg edetate disodium, 0.4 mg calcium chloride, monobasic sodium phosphate buffer, and not more than 0.1 mg thimerosal (mercury derivative).

Amphadase has an approximate pH of 6.8 and an osmolality of 295 to 355 mOsm.

WA-003 Rev 01/2018

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