SUMMARY
HYLENEX recombinant is a purified preparation of the enzyme recombinant human hyaluronidase. HYLENEX recombinant is produced by genetically engineered Chinese Hamster Ovary (CHO) cells containing a DNA plasmid encoding for a soluble fragment of human hyaluronidase (PH20). The purified hyaluronidase glycoprotein contains 447 amino acids with an approximate molecular weight of 61,000 Daltons.
Subcutaneous Fluid Administration
HYLENEX recombinant is indicated as an adjuvant in subcutaneous fluid administration for achieving hydration.
Dispersion and Absorption of Injected Drugs
HYLENEX recombinant is indicated as an adjuvant to increase the dispersion and absorption of other injected drugs.
Subcutaneous Urography
HYLENEX recombinant is indicated as an adjunct in subcutaneous urography for improving resorption of radiopaque agents.
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NEWS HIGHLIGHTS
Published Studies Related to Hylenex Recombinant (Hyaluronidase)
Adjuvant hyaluronidase to epidural steroid improves the quality of analgesia in
failed back surgery syndrome: a prospective randomized clinical trial. [2014]
STUDY DESIGN: Prospective randomized trial... CONCLUSION: We conclude that adding hyaluronidase to the epidural injectate was
Comparative pharmacokinetics and insulin action for three rapid-acting insulin
analogs injected subcutaneously with and without hyaluronidase. [2013]
CONCLUSIONS: Coinjection of rHuPH20 with rapid-acting analogs accelerated insulin
Clinical trial for safety evaluation of hyaluronidase as diffusion enhancing
adjuvant for infiltration analgesia of skin with lidocaine. [2012]
as a lidocaine adjuvant... CONCLUSION: The addition of hyaluronidase to lidocaine in intracutaneous
Topical betamethasone and hyaluronidase in the treatment of phimosis in boys: a
double-blind, randomized, placebo-controlled trial. [2011]
secondary goal, we compared the outcomes after 30 and 60 days of treatment... CONCLUSIONS: Betamethasone Valerate 0.1%, 0.2% and 0.2% in combination with
The role of adding hyaluronidase to fluoroscopically guided caudal steroid and
hypertonic saline injection in patients with failed back surgery syndrome: a
prospective, double-blinded, randomized study. [2010]
caudal steroid and hypertonic saline in patients with FBSS... CONCLUSION: The addition of hyaluronidase to fluoroscopically guided caudal
Clinical Trials Related to Hylenex Recombinant (Hyaluronidase)
Pharmacokinetic and Safety Study of HYLENEX Recombinant-Augmented Subcutaneous Ceftriaxone Administration [Completed]
The objectives of this study are:
- to establish the safety of subcutaneous administration of ceftriaxone at different
concentrations, with and without HYLENEX recombinant, and to determine the maximum
tolerated concentration;
- and to establish the pharmacokinetic comparability of subcutaneous administration of
ceftriaxone with HYLENEX recombinant to subcutaneous administration without HYLENEX
recombinant and to IV administration.
CONSISTENT 1: Metabolic and Safety Outcomes of Hylenex Recombinant (Hyaluronidase Human Injection) Preadministered at CSII Infusion Site in Participants With Type 1 Diabetes Mellitus (T1DM) [Active, not recruiting]
Study of Subcutaneous Rehydration With Recombinant Human Hyaluronidase for Infants and Children [Completed]
The aim of the study is to evaluate the safety, effectiveness and ease of use of
subcutaneous (SC) rehydration using HYLENEX-augmented SC infusion of fluids and electrolytes
for the rehydration of pediatric patients with mild to moderate dehydration.
INFUSE Morphine Study [Completed]
Double-blind study comparing the pharmacokinetics, safety and tolerability of morphine
administered subcutaneously (SC) with and without human recombinant hyaluronidase (HYLENEX)
and intravenously conducted in patients in a hospice care setting or through a palliative
care medicine setting. In this within-patient controlled study, each eligible study patient
receives a single injection by each of the three methods of morphine administration,
sequentially on three consecutive days, according to the order specified by a randomization
schedule.
Each of the three injections consists of 5 mg of morphine (1. 0 mL of 5 mg/mL solution). The
HYLENEX injection will be 1 mL of 150 units. Although the IV administration will not be
blinded, the two SC injections will be double-blinded, using the same volume of normal
saline (0. 9% sodium chloride) placebo (1. 0 mL) as HYLENEX.
Descriptive Study of Cardiac Output During Rehydration With Recombinant Human Hyaluronidase in Pediatrics [Active, not recruiting]
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