Clinical Information
Gen. Code and Des.
58597 hyaluronidase,ovine INJECTION VIAL 200/ML
GCN and Des.
24064 hyaluronidase,ovine INJECTION VIAL 200/ML
Strength
200UNITS
Dose Form
VIAL (ML)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
44000000 ENZYMES
Active Ingredients
8994 hyaluronidase, ovine
Inactive Ingredients
18822 rubber, unspecified
2432 lactose 64044515
hyaluronidase, ovine injection, solution Bausch & Lomb Incorporated 1 INDICATIONS AND USAGE 1.1 Subcutaneous Fluid Administration VITRASE� (hyaluronidase injection) is indicated as an adjuvant in subcutaneous fluid administration for achieving hydration. 1.2 Dispersion and Absorption of Injected Drugs VITRASE is indicated as an adjuvant to increase dispersion and absorption of other injected drugs. 1.3 Subcutaneous Urography VITRASE is indicated as an adjuvant in subcutaneous urography for improving resorption of radiopaque agents. 2 DOSAGE AND ADMINISTRATION Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. VITRASE (hyaluronidase injection) should be administered as discussed below, since its effects relative to absorption and dispersion of other drugs are not produced when it is administered intravenously. 2.1 Subcutaneous Fluid Administration (Hypodermoclysis) Insert needle with aseptic precautions. With tip free and movable between skin and muscle, begin clysis; fluid should start in readily without pain or lump. Then inject VITRASE (hyaluronidase injection) into rubber tubing close to needle. An alternate method is to inject VITRASE under skin prior to clysis. 200 Units will facilitate absorption of 1,000 mL or more of solution. As with all parenteral fluid therapy, observe effect closely, with same precautions for restoring fluid and electrolyte balance as in intravenous injections. The dose, the rate of injection, and the type of solution (saline, glucose, Ringer's etc.) must be adjusted carefully to the individual patient. When solutions devoid of inorganic electrolytes are given by hypodermoclysis, hypovolemia may occur. This may be prevented by using solutions containing adequate amounts of inorganic electrolytes and/or controlling the volume and speed of administration. VITRASE may be added to small volumes of solution (up to 200 mL), such as small clysis for infants or solutions of drugs for subcutaneous injection. For infants and children less than 3 years old, the volume of a single clysis should be limited to 200 mL; and in premature infants or during the neonatal period, the daily dosage should not exceed 25 mL/kg of body weight; the rate of administration should not be greater than 2 mL per minute. For older patients, the rate and volume of administration should not exceed those employed for intravenous infusion. 2.2 Absorption and Dispersion of Injected Drugs Absorption and dispersion of other injected drugs may be enhanced by adding 50 � 300 Units, most typically 150 Units of VITRASE hyaluronidase to the injection solution. 2.3 Subcutaneous Urography The subcutaneous route of administration of urographic contrast media is indicated when intravenous administration cannot be successfully accomplished, particularly in infants and small children. With the patient prone, 75 Units of VITRASE (hyaluronidase injection) is injected subcutaneously over each scapula, followed by injection of the contrast medium at the same sites. 3 DOSAGE FORMS AND STRENGTHS Ovine hyaluronidase 200 USP Units/mL single use vials DESCRIPTION VITRASE is a preparation of purified ovine testicular hyaluronidase, a protein enzyme. The exact chemical structure of this enzyme is unknown. VITRASE (hyaluronidase injection) is supplied as a sterile, non-preserved, colorless solution with a pH of 6.4 to 7.2. Each mL contains 200 USP units of ovine hyaluronidase with 0.93 mg lactose, 0.36 mg potassium phosphate dibasic, 0.23 mg potassium phosphate monobasic, and 9.0 mg sodium chloride. 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Hyaluronidase is a spreading or diffusing substance, which modifies the permeability of connective tissue through the hydrolysis of hyaluronic acid, a polysaccharide found in the intercellular ground substance of connective tissue, and of certain specialized tissues, such as the umbilical cord and vitreous humor. Hyaluronic acid is also present in the capsules of type A and C hemolytic streptococci. Hyaluronidase hydrolyzes hyaluronic acid by splitting the glucosaminidic bond between C1 of the glucosamine moiety and C4 of glucuronic acid. This temporarily decreases the viscosity of the cellular cement and promotes diffusion of injected fluids or of localized transudates or exudates, thus facilitating their absorption. Hyaluronidase cleaves glycosidic bonds of hyaluronic acid and, to a variable degree, some other acid mucopolysaccharides of the connective tissue. The activity is measured in vitro by monitoring the decrease in the amount of an insoluble serum albumen-hyaluronic acid complex as the enzyme cleaves the hyaluronic acid component.
