.) 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
•4 CONTRAINDICATIONS
VITRASE is contraindicated in patients with known hypersensitivity to hyaluronidase or any other ingredient in the formulation. A preliminary skin test for hypersensitivity to VITRASE can be performed. The skin test is made by intradermal injection of approximately 0.02 mL (4 Units) of a 200 Units/mL solution [see Dosage and Administration (2)]. A positive reaction consists of a wheal with pseudopods appearing within 5 minutes and persisting for 20 to 30 minutes and accompanied by localized itching. Transient vasodilation at the site of the test, i.e., erythema, is not a positive reaction.
Discontinue VITRASE if sensitization occurs.
•5 WARNINGS AND PRECAUTIONS
5.1 Spread of Localized Infection
Hyaluronidase should not be injected into or around infected or acutely inflamed area because of the danger of spreading to a localized infection. Hyaluronidase should not be used to reduce the swelling of bites or stings.
5.2 Ocular Damage
VITRASE should not be applied directly to the cornea.
5.3 Enzyme Inactivation with Intravenous Administration
VITRASE should not be used for intravenous injections because the enzyme is rapidly inactivated.
•6 ADVERSE REACTIONS
The following adverse reactions have been identified during post-approval use of hyaluronidase products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The most frequently reported adverse reactions have been local injection site reactions.
Hyaluronidase has been reported to enhance the adverse reactions associated with co-administered drug products. Edema has been reported most frequently in association with hypodermoclysis.
Allergic reactions (urticaria, angioedema) have been repor |
