Hyaluronidase,drug info
1 ML hyaluronidase, human recombinant 150 UNT/ML Injection [Hylenex]
What it is used for
1. Indications and Usage HYLENEX recombinant is an endoglycosidase indicated as an adjuvant in subcutaneous fluid administration for achieving hydration to increase the dispersion and absorption of other injected drugs in subcutaneous urography for improving resorption of radiopaque agents 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.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective November 11, 2024. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
Hyaluronidase is an endoglycosidase used to increase the dispersion and absorption of co-administered drugs when administered subcutaneously. It is a glycosylated single-chain protein produced by genetically engineered Chinese Hamster Ovary (CHO) cells containing a DNA plasmid encoding for a soluble fragment of human hyaluronidase (PH20). Hyaluronidase has an approximate molecular weight of 61 kDa. HYLENEX recombinant (hyaluronidase) injection is supplied as a sterile, clear and colorless, nonpreserved, ready-for-use 1 mL solution in a single-dose vial for infiltration use, for interstitial use, for intramuscular use, for intraocular use, for peribulbar use, for retrobulbar use, for soft tissue use, or for subcutaneous use. Each mL contains 150 USP units of hyaluronidase with albumin human (1 mg), dibasic sodium phosphate (1.4 mg), methionine (1.5 mg), polysorbate 80 (0.2 mg), and sodium chloride (8.5 mg). Hydrochloric acid and sodium hydroxide may be added during manufacture to adjust the pH. HYLENEX has an approximate pH of 7.0.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective November 11, 2024. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
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